Evaluation of NCD service integrated into a general OPD and HIV service in Matsapha, , 2017

Authors Ansbro, Eimhin; Meyer, Inga; Okello, Velephi; Verdecchia, Maria; Keus, Kees; Piening, Turid; Sadique, Zia; Roberts, Bayard; Perel, Pablo; Jobanputra, Kiran

Download date 02/10/2021 17:01:29

Link to Item http://hdl.handle.net/10144/619308

Kingdom of Eswatini

MSF INTERNAL REPORT

Evaluation of NCD service integrated into a general OPD and HIV service in Matsapha, Eswatini, 2017

Author: Éimhín Ansbro1

Contributors: Inga Meyer2, Velephi Okello3, Maria Verdecchia2, Kees Keus2, Turid Piening4, Zia Sadique1, Bayard Roberts1, Pablo Perel1, Kiran Jobanputra5

1London School of Hygiene and Tropical Medicine, London, UK; 2Médecins Sans Frontières (MSF), , Eswatini; 3Ministry of Health, Eswatini; 4MSF, Amsterdam, The Netherlands; 5MSF, London, UK

This report is available in several versions, linked below:

• Executive Summary (1 page) • Report – Short Version (5 pages) • Report – Extended Version (42 pages)

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LIST OF ACRONYMS

AHF AIDS Healthcare Foundation

ART Antiretroviral Therapy

BP Blood Pressure

DRTB Drug-resistant Tuberculosis

DSTB Drug-sensitive Tuberculosis

FBG Fasting Blood Glucose

HIV Human Immunodeficiency Virus

LSHTM London School of Hygiene and Tropical Medicine

MOH Ministry of Health

MSF Médecins sans Frontières

NCDs Noncommunicable diseases

OPD Out-patient department

PPPY Per person per year

SOPs Standard Operating Procedures

TB Tuberculosis

WHO World Health Organization

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TABLE OF CONTENTS

EXECUTIVE SUMMARY ...... 4 REPORT – SHORT VERSION ...... 5 REPORT – EXTENDED VERSION ...... 11 Background ...... 11 Evaluation aim and objectives ...... 15 Methodology ...... 16 Study design ...... 16 Study Setting ...... 16 Data sources and collection ...... 17 Data analysis ...... 19 Ethical considerations ...... 23 Study implementation ...... 23 Key Results ...... 24 Model of integrated NCD care ...... 24 Effectiveness of NCD care delivery ...... 32 Predictors of NCD treatment outcomes ...... 37 Costing results ...... 38 Discussion and Lessons Learned ...... 42 Limitations ...... 50 Recommendations for application in MSF settings ...... 51 Recommendations for broader changes to policy and practice ...... 52 Future Research ...... 53 Acknowledgements ...... 53 References ...... 54 Annexes ...... 59 12.1 Matsapha Comprehensive Clinic Site Plan ...... 59 12.2 Logistic regression to determine risk factors for uncontrolled fasting blood sugar among diabetic patients enrolled in Matsapha NCD programme ...... 60 12.3 Patient flow, staffing and NCD/HIV screening In Matsapha NCD Programme ...... 61 12.4 Input quantities and unit prices for MSF Eswatini MOH NCD programme cost analysis ...... 62 12.5 Drugs prescribed by NCD diagnosis ...... 72 12.6 SOP for MSF Eswatini MOH Matsapha NCD Programme ...... 73

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EXECUTIVE SUMMARY

Background: Swaziland faces a growing noncommunicable disease (NCD) burden alongside HIV and TB epidemics. MSF provided primary care services, HIV and TB programmes at Matsapha MOH comprehensive clinic from 2011 to 2018. With MOH collaboration, MSF integrated NCD care into general outpatient (OPD), HIV and TB services in April 2016. A retrospective analysis of routine clinical and programmatic data was undertaken to examine programme processes, effectiveness and costs in order to strengthen the service, facilitate handover and inform MSF and MOH policy and scale-up. The specific objectives were to: 1) describe the care model; 2) examine its effectiveness; 3) examine predictors of NCD treatment outcomes, including HIV status; and 4) determine incremental total and unit service costs.

Methods: We undertook a retrospective evaluation of routine data from Matsapha Comprehensive Care Clinic, located outside Manzini, Eswatini’s largest city. This comprised: care model description; routine cohort data analysis to investigate effectiveness of care and predictors of reaching clinical targets; and incremental costing analysis. Enrolment criteria included: a diagnosis of established cardiovascular disease (CVD), hypertension, diabetes mellitus (DM) types 1 or 2, chronic respiratory disease; and committing to regular attendance. Routine clinical data of adults aged 18 or over, enrolled from July 2016 to July 2017, were analysed using descriptive statistics and logistic regression modelling. A costing analysis from the providers’ perspective utilised routine accounting, service and consumption data.

Results: Model of care description: We implemented: staff training; locally adapted protocols; chronic care files; a revised appointment system and patient flow; and a new database. Doctors reviewed patients at first visit, and saw complex or unstable patients monthly, resulting in significant workload. Nurses reviewed stable patients three-monthly; patients requiring treatment initiation/adjustment, ad hoc blood testing or external referral were referred back to doctors. Thus, task sharing to nurses did not occur as intended. Specific health literacy, adherence support groups or lay counsellor involvement were lacking. Integrating NCD care resulted in longer consultation times. Repeated medication stock outs occurred despite MSF’s efforts to support the MOH supply chain. Routine cohort data analysis: Of 895 enrolled patients, mean age was 55 years (IQR 5.3 to 10.6); 66% were women, of whom 54.6% were obese. Mean follow-up was 8 months; 16.3% defaulted during the study period. The most common diagnoses at enrolment were: hypertension (85.7%) and DM type 2 (37.4%), asthma (3.8%) and DM type 1 (1.2%). 3 patients had known CVD; none had known chronic obstructive pulmonary disease. At last visit, 60.4% (n=608) of hypertensive patients and 63.3% (n=289) of diabetics were at target. Obesity and HIV positivity were weakly associated with an increased risk of uncontrolled hypertension. Descriptive costing analysis: Total 2016 incremental financial costs were: INT$437,228. The principle costs drivers were human resources (61% of total) and drugs (18%; insulin accounting for a quarter). Per patient per year (PPPY) incremental costs (INT$ 448.52) were similar to those reported for chronic HIV programmes.

Conclusions and Lessons Learned: NCD care can be integrated into a HIV department and OPD setting in an MSF- supported primary care centre by utilising pre-existing structures, and can achieve acceptable intermediate clinical outcomes and retention rates at a cost that is similar to HIV programmes. The current model of NCD care is complex and time consuming, resulting in significant doctor workload. Streamlined, algorithm-driven protocols and work with the local government to extend prescribing rights for NCD medications to nurses may facilitate task sharing and decentralisation of care. Drug supply chain strengthening is required and advocacy around drug prices could reduce programme costs. Inclusion of specific treatment support and adherence counselling, learning lessons from HIV and TB care, is also essential to integrating NCD care into pre-existing services.

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REPORT – SHORT VERSION

Background: The growing burden of noncommunicable diseases (NCDs) among the patients that present to Médecins sans Frontières (MSF) clinics has prompted the organisation to set up and evaluate pilot projects in diverse settings to learn how MSF can best deliver this type of care. Eswatini is challenged by an increasing burden of NCDs on a background of a dual epidemic of human immunodeficiency virus (HIV) and tuberculosis (TB). Life expectancy for these communicable diseases is improving and people living with HIV/ TB are at increased risk of developing NCDs. This, coupled with the effects of urbanisation and commercialisation, mean that NCDs are expected to grow as a cause of death and disability in Eswatini and in the region.

MSF has been supporting the provision of adult and maternal and child health primary care services at Matsapha Ministry of Health (MOH) comprehensive clinic since 2011, including HIV and drug-sensitive and drug-resistant TB programmes. In response to increasing patient need, the project moved from providing ad hoc NCD consultations to introducing a more systematic approach in April 2016, leveraging their experience in delivering primary level HIV care. One of the key aims was to integrate NCD care into the existing general outpatients (GOPD), HIV and TB services to provide care for these comorbidities at a single consultation.

Objectives: To document the lessons learned from this experience and to inform handover of most clinical services in Matsapha clinic to AHF (Aids Healthcare Foundation, an American HIV-focussed NGO) a rapid evaluation was undertaken in July and August 2017. This examined the processes, the effectiveness and the costs of integrating HIV and NCD care in the clinic. The specific objectives were to: 1) Describe the model of care, including integration of NCD and HIV/TB services; 2) Examine the effectiveness of the NCD care delivered; 3) Examine predictors of NCD treatment outcomes, including HIV status; and 4) Determine the incremental costs the NCD service entailed in addition to the GOPD and HIV services.

Methods:

Design: This was a retrospective analysis of routine cohort data from Matsapha Comprehensive Care Clinic. The evaluation comprised: a description of the model of integrated NCD care; an analysis of routine cohort data to investigate both effectiveness of care delivered and predictors of reaching treatment target; and an incremental costing analysis of adding NCD care to pre-existing services.

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Setting: The clinic is located in Matsapha, the industrial hub of the Kingdom of Eswatini, located just outside of Manzini, Eswatini’s largest city.

Data sources: Routine service data included: project reports, protocols, guidelines, standard operating procedures, supervisory reports, routine cohort data of adults aged 18 years or older enrolled between July 2016 and July 2017, cost data extracted from accounting records, supply orders, pharmacy consumption data, project reports and informal staff interviews and communiqués.

Data collection and analysis: Data for the evaluation were collated and analysed in July and August 2017. Cohort data were analysed using descriptive statistics and logistic regression modelling. A facility-based costing analysis was performed from the providers’ perspective using a combination of step-down (allocating a proportion of clinic-, project- and coordination level overheads to the programme) and ingredients-based (including capital and running costs) approaches and was subjected to sensitivity analyses.

Ethics: This evaluation met the MSF Ethics Review Board criteria for exemption from formal ethics review. Approval was sought from the Eswatini National Health Research Review Board and was granted by the Ethics Review Committee of the London School of Hygiene and Tropical Medicine (LSHTM).

Results: Model of care description: In setting up this service, staff training on management of NCDs was undertaken, NCD clinical guidelines and clinic files were introduced, and a revised patient flow and an appointment system were implemented. A specially designed database was introduced to monitor the quality of care delivered and to explore the feasibility and effectiveness of the decentralised and integrated approach to NCD care.

The NCD service was integrated into the existing patient flow and staffing arrangements without any additional staff or major equipment being required. Clinical standard operating procedures (SOPs) were produced, adapting MSF NCD guidelines to match the local availability of drugs and investigations. Programmatic SOPs (including admission, triage, internal and external referral criteria and patient flow) and treatment support tools were introduced. Bidirectional screening was implemented whereby NCD screening was integrated into general outpatient department (GOPD), HIV and TB service guidelines and NCD patients were encouraged to attend HIV testing and counselling.

Patients were seen monthly until stable and three-monthly thereafter. Nurses provided the majority of NCD consultations in all three departments, including joint NCD/TB or NCD/HIV consultations. The duration of NCD appointments was estimated to be twice that of non- NCD appointments. Doctors saw all patients for their detailed, 30 minute enrolment visit, all patients flagged by the triage nurse for doctor review and all patients meeting criteria for

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doctor referral by nurses (estimated to be 40% of all nurse-delivered NCD consultations). Criteria for nurses to refer for doctor review included: unstable patients, those not meeting clinical targets, and those requiring treatment initiation/adjustment, ad hoc blood testing or external referral. This resulted in a significant increase in workload for the doctors. The high referral rate from nurses to doctors was thought to be, in part, due the inherent complexity of NCD management; the relative inexperience of staff in managing NCDs and multimorbidity; and Eswatini legislation, which precluded nurses from initiating or adjusting NCD medications.

Patients were admitted to the NCD service if they had a target NCD or risk factor: established cardiovascular disease (CVD) [myocardial infarction, angina, ischaemic stroke, transient ischaemic attack or peripheral vascular disease], hypertension, diabetes mellitus (DM) Type I or II, asthma or chronic obstructive pulmonary disease (COPD) and if they demonstrated commitment to attending the service by adhering to appointments over a three-month period.

Routine cohort data analysis: 895 patients were enrolled in the NCD patient cohort during the reporting period, of whom two thirds (66.6%) were women and whose mean age was 55 years (IQR: 48-64). The mean and median duration of follow-up were 8 and 9.2 months respectively (IQR: 5.3 to 10.6); 16.3% per year were lost to follow up. CVD risk factors recorded at enrolment included the following: 2.9% of patients were current smokers, 6.9% were current consumers of alcohol and over 70% of patients were overweight or obese [Body mass index (BMI) >25 kg/m2]. The most common NCD diagnoses at enrolment were: Hypertension (85.7%), DM Type 2 (37.4 %), Asthma (3.8%) and DM Type 1 (1.2%). Only 3 patients were diagnosed with CVD and no patients were diagnosed with COPD. Among the cohort, 17.2 % (n=154) self-reported they were HIV positive at enrolment; of these, 97 attended Matsapha for their HIV care. Data on TB status were available for only 11% of the cohort.

Indicators of clinical quality were examined. Among hypertensive patients, 98.2% (n=608) had their BP checked at their last visit and, of these, 60.4% were at target (< 140/90 mmHg). Among diabetic patients, 96.7% (n=289) had a fasting blood glucose (FBG) recorded at their last visit and, of these, 63.3% were at target (FBG 4.4-8.3 mmol/L) at last visit. Factors associated with having uncontrolled clinical parameters were explored. Being obese (BMI >30 kg/m2) increased the risk of having uncontrolled hypertension in hypertensive patients after adjusting for other risk factors (OR: 1.9, CI: 1.1-3.2). Being HIV positive was weakly associated with having an increased risk of uncontrolled BP (OR=1.6, CI: 1.0-2.6). No statistically significant risk factors for having uncontrolled blood sugar levels in diabetics were identified in this cohort.

Descriptive costing analysis: The total annual incremental financial cost for NCD care delivery during the base year 2016 was $437,228 International Dollars (INTD). The annual

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economic cost was $461,002 INTD. The financial cost per patient per year was $488.52 and the cost per visit was $109.06 INTD. The majority of financial costs were incurred at facility level (58.81%), while MSF administration costs at field-level and coordination-level costs accounted for 33.49% and 7.71% respectively. The main cost drivers were: personnel, drugs and capital investment, which represented 61%, 18% and 16% of total financial costs respectively. MSF personnel costs at field level alone accounted for 32% of total costs. The most expensive drugs were: rapid acting insulin (20.0%); the antihypertensive drugs: hydrochlorothiazide (16.4%) and enalapril (14.0%); metformin (7.4%); and beclomethasone (6.7%). Sensitivity analyses performed around drug- and personnel-related costs showed that PPPY cost was most sensitive to a reduction in appointment duration, which resulted in a 4% drop. The incremental costs of integrating NCD care into GOPD and HIV departments within the same clinic were similar, due to the overlapping nature of the services and the shared assumptions regarding internal referral rates and duration of consultations.

Discussion and Lessons Learned: NCD care was found to be relatively complex and time consuming. While most consultations were performed by nurses, the envisioned level of task sharing, similar to decentralised, nurse-led anti-retroviral therapy (ART) delivery, was not fully realised. Much of the complex workload fell to doctors who saw all new patients; all patients not meeting treatment targets (up to 40%); and all those requiring either external referral, specific education (e.g. regarding inhalers or insulin) or enhanced treatment support. Clinicians identified a need for increased treatment support and behaviour change counselling. Existing HIV/TB counsellors were unavailable and untrained to deliver this additional care and thus it was mainly undertaken by doctors.

Repeated medication stock outs occurred despite MSF’s efforts to support the MOH supply chain. MSF management estimated that they they provided 70% of all NCD drug supplies for Matsapha, including the entire supply of certain medications (e.g. insulin and atorvastatin), which were unavailable locally. While not formally evaluated here, stock outs are likely to have had implications for patient adherence and related treatment effectiveness, patient cost (as they returned to clinic more frequently for refills) and for staff workload.

Very high rates of obesity were encountered in this middle-aged cohort, particularly amongst women. Diagnoses at admission reflected local NCD prevalences, with most presenting with hypertension and approximately one third with Diabetes Type II. Despite the high population prevalence of TB (which is a risk factor for COPD) and high prevalence of CVD risk factors, very few patients were diagnosed with either COPD or CVD. This may have been due to underdiagnosis (due to lack of clinical knowledge or appropriate equipment), misidentification (e.g. identifying patients with chronic chest symptoms as having TB) or underrecording. While traditionally patients with CVD and COPD are cared for at secondary/tertiary levels in Eswatini, it is notable that no new cases were identified and referred to a higher level of care during the study period. This area requires increased focus in terms of training, diagnostics and algorithms. In addition, fewer than 1% of the

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Matsapha HIV cohort were enrolled in the NCD programme, less than would be expected based on regional NCD risk factor prevalence in HIV cohorts. This also may reflect underdiagnosis or the relatively young age of the Matsapha HIV cohort. Enhanced screening may identify a significant additional NCD burden amongst this group.

The quality of care outcomes, in terms of clinical target attainment and retention in care, are as good or better than those demonstrated by the limited data available from SSA-based NCD programmes. Obesity was the only risk factor identified as increasing the odds of having an uncontrolled blood pressure amongst hypertensive patients. Age was also weakly associated with uncontrolled BP.

Tasks included in routine clinical review, e.g. BP measurement, were consistently performed but tasks involved in annual review requiring time, specific training, supplies or equipment, e.g. diabetic foot check, were poorly performed. This may indicate that workload, clinical competencies and supply chain issues need to be reviewed.

The incremental cost per patient per year of the NCD service (INT$490.98) was comparable to costs for delivering ART in the region. The annual per visit cost (INT$109.61) was less than the average per visit cost of delivering ART at different health system levels in Eswatini, as estimated in one study. The principle costs drivers were human resources (with 31.5% of these incurred at field level) and drugs. The latter accounted for 18% of total costs, with insulin contributing 25% of the total drug budget. This experience reinforces the calls for greater affordability and availability of insulin in SSA. Supplies accounted for a negligible proportion of the budget when compared to known supply costs for diabetes programmes in SSA, likely reflecting the fact that only 8.8% of the cohort was prescribed insulin. Cost efficiencies may be possible if different salary or supervision structures were introduced and if drug cost prices were reduced.

This evaluation highlights the fact that NCD care can be successfully introduced into existing MSF-supported MOH programmes but requires the implementation of specific tools, locally adapted protocols and human resources as well as capacity building of local staff. The findings underline the need to work closely with the MOH and local partners to strengthen health systems, particularly the supply chain, to ensure sustainability of chronic disease care. They highlight the importance of introducing locally adapted clinical and programmatic SOPs and patient education materials and emphasise the need for structured supervision and training of clinical staff, with specific focus on treatment adherence support and behaviour change counselling.

A key finding is the need to acknowledge the complexity and time-consuming nature of NCD consultations and the resultant workload implications. This experience suggests that if task sharing to nurses similar to that of decentralised ART programmes is to occur in practice, NCD care must be simplified, streamlined and largely algorithm-driven. MSF and other actors involved in NCD care need to explore local competencies and the national policy and

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regulatory environment, and provide intense training of nurses on a simplified guideline. Ensuring consistent supply of medications, potentially through provision of buffer stocks, and budgeting for the more expensive drugs is also of key importance. However, it is notable that the drug cost per patient per year obtained in this analysis was far lower than that for an ART programme. Medicines access, particularly for insulin, is a clear area for MSF advocacy to be brought to bear and will be essential for MSF if and when planning for eventual handover of NCD programmes to other actors. The evaluation also illustrated the value of data capture and of quality data systems, monitoring and evaluation.

Conclusion:

This programme has demonstrated that NCD care can be integrated into a HIV department and general adult outpatient setting in an MSF-supported MOH primary care centre by utilising pre-existing structures, and can achieve acceptable intermediate clinical outcomes and retention rates at a cost that is similar to ART programme costs. Lessons learned from this experience will facilitate strengthening of this programme and planning and budgeting for future integration of NCD care into pre-existing, MSF-supported MOH programmes.

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REPORT – EXTENDED VERSION

BACKGROUND

Médecins sans Frontières, a humanitarian medical organisation, has typically engaged in short-term medical relief efforts in response to emergency or conflict situations. However, the growing burden of noncommunicable diseases (NCDs) among the patients that present to their clinics has prompted the organisation to set up and evaluate pilot projects in several diverse settings to learn lessons on how MSF can best deliver this type of care.

NCDs represent a burgeoning global epidemic. Currently, they account for 38 million deaths worldwide each year, equivalent to almost 70% of total deaths1. The term NCD refers to a broad group of chronic diseases, which result from a combination of genetic, environmental, behavioural and physiological exposures2. Four major NCD groups are responsible for the majority of global NCD deaths: cardiovascular diseases (CVD), cancer, chronic respiratory diseases and diabetes1. Low- and middle-income countries are disproportionately affected, carrying the burden of more than three quarters (31 million) of global NCD deaths1. The driving forces of these diseases, which include rapid unplanned urbanization, globalization of unhealthy lifestyles and population ageing, partially explain this unbalanced distribution3.

Eswatini is challenged by an increasing burden of NCDs on the background of a dual epidemic of human immunodeficiency virus (HIV) and tuberculosis (TB). It has the world’s highest prevalence and incidence of HIV infection amongst adults, with a measured HIV prevalence of 31% among those aged 18–49 years4. It also has one of the world’s highest incidences of TB at 398/100,000 per year. Among TB patients, an estimated 10-15% have a drug-resistant strain, and approximately 80% are co-infected with HIV5,6. The NCD disease burden is likely to be higher than is reflected by the existing limited data. NCDs are estimated to account for 28% of deaths in Eswatini7, with HIV/TB contributing the majority of the rest. Due to the successful scale up of anti-retroviral therapy, this pattern is now likely to be reversing itself – NCDs are expected to be the major contributors to mortality by 20208.

The NCD burden is likely aggravated by the typical nutrition transition from traditional diets to highly refined food, which Eswatini has undergone9,10. The 2014 WHO STEPS report characterised the NCD risk factors amongst the Eswatini population. The typical diet is high in refined carbohydrates and fat; low in fruits and vegetables; and high in salt9. Tobacco use

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is relatively low9, while 8.3% of participants reported engaging in heavy episodic drinking9. There is a high prevalence of overweight and obesity, especially among females (59.9%). The survey also found significant levels of undiagnosed, untreated or uncontrolled hypertension and previously unidentified hyperglycaemia. In addition, 4.4% reported a history of known CVD 9.

HIV / TB and NCD synergy

The increasing NCD burden in Eswatini is likely to be influenced by 1) the numbers of people living with HIV, 2) the numbers taking lifelong ART, (85% of those eligible11) and 3) the resultant ageing of people living with HIV (PLWHIV). Recent data suggest that HIV infection itself is a risk factor for cardiovascular disease, possibly mediated through immunomodulation and chronic inflammatory processes12. Indeed, a recent meta-analysis has shown that people living with HIV are twice as likely to develop CVD as those without and the global burden of HIV associated CVD has tripled over the last two decades with Eswatini, Lesotho and Burundi’s populations proportionally most affected13. While long- term combination ART usually decreases CVD risk overall, treatment with certain ART drugs, including abacavir and protease inhibitors (e.g. lopinavir/ritonavir) have been variously associated with an increase in cardiovascular disease12,14. ART may also increase diabetes risk through lipotoxicity and reduced insulin sensitivity15.

It is hoped that the move to the novel antiretroviral, dolutegravir, which will be introduced as first line treatment in Eswatini in October 2018, will reduce these side effects16,17. HIV and NCD comorbidity is also complicated by possible drug interactions between drugs used for both such as the additive renal side effects of tenofovir and ACE inhibitors and interactions between NNRTIs and Calcium Channel blockers.

With increased coverage of ART the HIV epidemic in Eswatini is evolving to resemble those of resource-rich settings, with an ageing population of PLWHIV. The overall cancer burden amongst this group has increased as ART has prolonged life18. ART has reduced the incidence of certain HIV-associated cancers (Kaposi sarcoma and non-Hodgkin’s lymphoma) but has not reduced the incidence of cervical cancer, of which HIV positive women are at increased risk versus HIV negative women19.

The communicable and noncommunicable disease overlap is also prominent. In TB-endemic countries such as Eswatini, pulmonary TB is strongly associated with chronic lung disease in adults, including bronchiectasis and chronic obstructive pulmonary disease, and has a synergistic relationship with diabetes 20,21.

Leveraging HIV management pathways in NCD care

As the treatment options for HIV have expanded and improved, management approaches have transitioned from acute, emergency care to chronic care. The health care system in

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Eswatini addressing HIV is well developed due to the high incidence and the joint effort of the MOH and international actors to control the epidemic. The chronic care management pathways developed for HIV can potentially be leveraged to integrate newly developing NCD services22,23. Figure 1 from FHI360, below, highlights the similarities in the care pathways for HIV and NCDs, in terms of prevention, detection, care and long-term management and points out where the two can be integrated. In addition, experts have suggested that advocacy to promote treatment for hypertension could mirror the “90-90-90 by 2020” advocacy approach taken by the HIV/AIDS community i.e. that, by a specified deadline, 90% of affected people with will know their status, of those 90% will be in treatment, and of those, 90% will reach treatment goals24,25. Current levels of hypertension diagnosis, treatment and control in LMICs fall far short of this25.

Figure 1. Potential for integration of HIV and Noncommunicable Disease care pathways

From: Integration of HIV and noncommunicable disease care: https://www.fhi360.org/sites/default/files/media/documents/NCD_Factsheet_v3_WEB.pdf

Implementing NCD care

The economic burden due to lost economic output of those affected by NCD morbidity and premature mortality is predicted to increase and to outstrip public health spending over the next decade26. Cost-effective and high-impact interventions to prevent and control NCDs are available26,27. An integrated approach at primary care level, in the setting of universal health care, has been mooted to ensure that these interventions are delivered in an efficient and effective manner and have the desired impact28. However there is a lack of

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evidence on how best to implement primary level NCD care in sub-Saharan African settings, particularly NCD care integrated into pre-existing primary care and HIV services 29,30,31.

The role of MSF

Médecins sans Frontières (MSF) focuses on providing short-term, acute interventions in medical emergencies and humanitarian crises. While MSF has provided chronic HIV and TB care for decades, it has not, until recently, focused on care for chronic non-infectious diseases. While MSF has been treating NCDs in a setting specific manner for several years, the organisation has been increasingly challenged by the growing NCD burden globally amongst its patient populations. These include those in sub-Saharan African urban and rural, conflict and HIV care settings and more recently in conflict settings in the Middle East. Thus, MSF has recently taken a more formal approach to NCDs by initiating pilot projects, (including this one), to gain understanding of NCD needs and priorities, and develop appropriate models of care32–34. MSF also drafted a comprehensive, evidence-based NCD guideline, including programmatic guidance, which is currently undergoing field-testing in various MSF settings35.

MSF NCD service in Matsapha Comprehensive Clinic

MSF has supported a Ministry of Health (MOH) comprehensive primary care clinic in Matsapha, Eswatini, since March 2011. The Matsapha Comprehensive Clinic has three departments: General Adult Outpatients (GOPD), HIV and TB. Antenatal and postnatal care, paediatric outpatients, vaccinations and sexual and gender based violence care all take place in the GOPD. See Annex 12.1 for a clinic map.

MSF provides human resources, training and supervision, drug and laboratory reagent buffer stocks, and logistics services. While the main focus has been on HIV and TB treatment, MSF has provided treatment for key NCDs since the clinic opened, namely: hypertension, cardiovascular diseases (CVD), diabetes mellitus (DM) types I and II, asthma and chronic obstructive pulmonary disease (COPD).

Initially, all NCD consultations were treated as single, acute encounters. However, in view of the prevalence, particularly of hypertension and diabetes, a more systematic approach with routine patient follow-up was introduced in June 2015. In July 2016, a formal registration system was introduced. NCD care was gradually integrated with HIV and Tuberculosis (TB) care, such that patients with either HIV or TB and a comorbid NCD received one-stop care for both conditions in the same consultation36 . NCD care was also integrated into usual GOPD activity, rather than being concentrated in a specific time slot.

Doctors reviewed all patients at their enrolment visit and at each subsequent monthly visit until they were stable (i.e. meeting clinical target). Nurses provided follow-up clinical review on a three-monthly basis to stable patients and could arrange medication refills but not

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initiate or adjust medications. Both nurses and doctors provided lifestyle and behaviour change advice; lay counsellor cadres had not been incorporated into NCD care delivery. The programme model is described in more detail below.

MSF supported the MOH to run the clinic until April 2017, when AIDS Healthcare Foundation (AHF) took over the supporting role in the general adult OPD, HIV and drug- sensitive TB (DSTB) services. AHF, an international NGO providing HIV care in Eswatini since 2007, is specialized in HIV/TB treatment and is interested in going beyond the vertical HIV approach, exploring the treatment of HIV within a comprehensive care medical context. MSF has committed to evaluating the NCD element of its programme and to developing a full set of standard-operating procedures (SOPs) as part of the handover process to AHF.

EVALUATION AIM AND OBJECTIVES

An evaluation of the NCD model of care in Matsapha comprehensive clinic, lessons learned, and outcomes was conceived of to add value for MSF, AHF and the Eswatini Ministry of Health, who are managing a growing epidemic of NCDs within health services already stretched by the HIV epidemic response. For MSF, the Matsapha model is an example of a ‘light’ approach to NCD care horizontally integrated into a general OPD and integrated within a parallel, vertical HIV service. As such, it offered a valuable opportunity to identify the challenges and best practice lessons around providing care for these conditions, that could complement existing literature and that could potentially be scaled up and transferred to other settings37.

The aim of this evaluation was to examine the processes, the effectiveness and the costs of integrating HIV and NCD care in Matsapha comprehensive clinic.

The specific objectives were to:

1. Describe the model of care, including integration of NCD and HIV/TB services. 2. Examine the effectiveness of the NCD care delivered. 3. Examine predictors of NCD treatment outcomes, including HIV status. 4. Determine the incremental costs that the NCD service entails in addition to the GOPD and HIV services: a. Determine the total annual financial and economic cost and the average cost per patient and cost per visit of providing NCD care in Matsapha clinic. b. Compare the incremental costs of integrating NCD care into the general OPD department and to the HIV department activity. c. Determine the major cost drivers and perform a structural sensitivity analysis.

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METHODOLOGY

STUDY DESIGN

This retrospective cohort study using routine service data took place in July and August 2017. It comprised a description of the model of integrated NCD care; an analysis of routine cohort data to investigate both effectiveness of care and predictors of reaching treatment targets; and an incremental costing analysis of adding NCD care to pre-existing services.

STUDY SETTING

Eswatini is a small (17,36 km2), predominantly rural, landlocked country with 1.2 million inhabitants, and is surrounded by and . It is a lower middle- income country, but its income distribution is highly skewed, with an estimated 20% of the population controlling 80% of the nation’s wealth while 63% of the population lives in poverty38. The town of Matsapha, the “industrial hub” of the Kingdom of Eswatini, is located just outside of Manzini, Eswatini’s largest city. It has the largest concentration of institutional settlements in the country and significant numbers of migrant workers.

Matsapha Comprehensive Care Clinic offers comprehensive outpatient care including HIV services, drug sensitive (DS) and drug resistant (DR) TB treatment, general adult outpatient care, paediatric outpatients, childhood vaccination, sexual violence services and ante- and postnatal care. In 2016, approximately 7000 consultations took place per month.

In April 2017, MSF handed most of its clinic-based activities to AIDS Healthcare Foundation (AHF), including the outpatient department (OPD), DSTB and HIV services, where most NCD patients are seen. The laboratory and DRTB (drug-resistant TB) services received on-going support from MSF until April 2018. The MSF NCD advisor continued to act as technical referent for NCD patients treated within the AHF-directed services until August 2017.

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DATA SOURCES AND COLLECTION

TABLE 1. DATA SOURCES Objective Data Sources 1. Describe model of care Routine service data (Project reports, protocols, guidelines, standard operating procedures, supervisory reports) 2. Examine effectiveness of NCD care delivered Routine cohort data

3. Examine predictors of NCD treatment outcomes, Routine cohort data including HIV status 4. Determine incremental NCD service costs Cost data (Accounting records, supply orders, pharmacy consumption data, project reports, informal staff interviews)

Description of model of care

Routine project documentation and quality assurance outputs were used to describe the MSF model of NCD care in Matsapha clinic. The description focussed on: integration of NCD and HIV/TB services; development and adaptation of materials from the HIV/TB services to meet the needs of the NCD service; modification of the patient circuit to include NCDs (including who, what, where and when of care delivery); and implementation of NCD- related training, tools, resources and supervision.

Effectiveness of NCD care delivered and predictors of NCD treatment outcomes

For this evaluation, effectiveness was determined by examining clinical and process indicators.

Routine cohort data included those from all adult patients, aged 18 years and older, with confirmed, pre-defined NCDs (hypertension, cardiovascular disease, diabetes types I and II, asthma and chronic obstructive pulmonary disease) registered in the MSF NCD service at Matsapha clinic between July 21st 2016 and June 30th 2017, and attending the clinic for at least three months.

Trained data clerks obtained clinical data from routine patient files and entered this data into a custom-made NCD database and the Eswatini AIDS Programme Monitoring Register. Data on HIV-related clinical outcomes were obtained from files of those NCD patients who also attended Matsapha Clinic for their HIV care. The dataset was cleaned using data contained in patient hand-held NCD files.

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Incremental NCD service costs

The total cost of NCD clinical care was informed by an activity-based cost collection and expenditure analysis. Prior to cost data collection, discussions were held with medical supervisory staff to determine the nature, location and mode of delivery of the NCD services within Matsapha clinic and a data collection tool was devised to record the relevant financial costs incurred at coordination, field and facility level. Costs were classified into capital and recurrent costs and were collected at each level by MSF medical and research staff. The costs of internal or external referrals were excluded.

NCD care was delivered in an overlapping manner between the GOPD and HIV department. The MSF expatriate doctor and one national staff doctor per day (salaried by MSF) were based in the GOPD each clinic day. They reviewed all NCD patients for their first visit and on a monthly basis until they were considered stable. Triage nurses (who triaged GOPD patients but not those already enrolled in HIV or TB services) referred patients who were unwell or were not meeting clinical targets directly to doctors. Nurses from both GOPD and HIV departments reviewed stable patients on a three-monthly basis and provided medication refills but could not initiate or adjust NCD medications. They referred an estimated 40% of their NCD patient load back to the doctors for treatment adjustment. A flow diagram of NCD activity was created to guide the allocation of clinic overheads and NCD-related activity to each department (Appendix 12.3).

Capital costs included: building costs, biomedical equipment, vehicle costs and a start-up training course undertaken by two staff members. The costs of sending two staff on a one- off international training course were determined using transport, accommodation, per diem, service provider costs and the opportunity cost of lost clinical contact time. Recurrent costs included: personnel; building maintenance and operation; rent of the MSF warehouse (attributed to the coordination budget); vehicle maintenance and operation; supplies (drugs, clinic and laboratory equipment and consumables, and stationary); supply delivery; and recurrent training. Costs of one hour weekly recurrent training were calculated using salary costs of clinical and supervisory staff and were attributed to the facility budget.

Data were collected from the drug management and supply chain using financial information (e.g. monthly expenditure budgets, MSF salary scales, equipment and furnishing inventories and both MSF and MOH drug price lists), activity data (e.g. operational reports, facility level drug consumption data) and discussion with management and clinical staff.

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DATA ANALYSIS

Table 2. Clinical and process indicators used to determine effectiveness of care for each NCD or HIV*

CONDITION OUTCOME INDICATOR PROCESS INDICATOR Hypertension  Number / % hypertensive patients with last  Number/% hypertensive patients with FBG recorded BP < 140/90 mmHg measured within checked within reporting period reporting period*  Number / % hypertensive patients with creatinine checked within the reporting period Diabetes Mellitus Number / % of included DM patients with last  Number / % DM patients with an FBG (DM) recorded BP < 140/90 mmHg, measured within recorded at their last visit reporting period*  Number / % DM patients with a BP  Number / % DM patients that have a last recorded recorded at their last visit FBG > 4.2 and ≤ 8.3 mmol/L measured within the  Number / % DM patients that have had reporting period* urinary protein testing performed within reporting period  Number / % DM patients that have had foot exam performed at least once within reporting period Asthma  Number/% patients with asthma / COPD who are  Number/ % asthmatic patients that receive free from self-reported exacerbations/ admissions control review at least once since within reporting period* registration  Number/ % asthmatic patients with inhaler technique checked at least once within reporting period* Obesity  Number / % overweight or obese patients on registration with reduction in BMI from baseline CVD  Number / % patients with previous CV event on statin and aspirin HIV  Number / % patients with last recorded CD4 < baseline after registration  Number / % patients with HIV with last recorded VL < 1000 after registration All  Retention in care (target >80%)

The reporting period was June 2016 to July 2017 and data from patients aged 18 years or older enrolled in the NCD cohort at any time during that period were included. Patients had to have adhered to 3 monthly appointments before being formally enrolled in the NCD cohort and having their NCD data recorded in the database. The diagnostic or baseline blood results were not captured in the database.

Predictors for reaching treatment outcome targets

Predictors for reaching target treatment outcomes were explored in the cohort as a whole and then stratified by HIV status. The predictors were as follows: age group, gender, smoking status, alcohol status (drinks alcohol or not), BMI, HIV status.

Routine cohort data analysis

Analysis of routine cohort data was conducted using STATA 12.1 (StataCorp, College Station, TX, USA). Descriptive statistics were used to describe the patient cohort, explore clinical outcomes and analyse trends in outcome measures from baseline. Univariate analysis described patient and time characteristics of the cohort population. Patient

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variables included: age; gender; months of NCD follow up; smoking status and alcohol status (drinks alcohol or not); baseline BMI; baseline blood pressure, heart rate and FBG on entry to NCD cohort; current number of NCD medications taken; multimorbidity status (diagnosed with two or more chronic conditions); and HIV status. Among NCD patients also attending Matsapha for HIV care, person variables included: time since first HIV diagnosis, time since ART treatment initiation, baseline CD4 count and first VL. Time variables included: time of enrolment (by quarter) and median time in the cohort.

Summary tables were generated and analysis included proportions and means, presented with 95% confidence intervals (95%CI). Differences in proportions were measured using Pearson χ2 test or Fischer exact tests while differences in means were measured using a Wilcoxon signed-rank test as the distributions were not normal, and were presented with p- values.

Predictors for not meeting treatment targets were analysed using logistic regression modelling. Separate models were developed for BP control in hypertensive patients (< 140/90 mmHg at last visit) and blood sugar control in Type II diabetic patients (FBG 4.4 – 8.3 mmol/L at last visit). These were adjusted for age, gender and HIV status (Table 3).

Determinants for not meeting treatment outcome targets included: age group, gender, smoking status, alcohol status, BMI category and HIV Status. See Table 3 below.

Table 3. Predicted risk factors for not reaching target treatment outcomes.

PATIENT TREATMENT PREDICTED RISK FACTORS GROUP TARGET Hypertensive BP < 140/90 Age group, gender, smoking status, alcohol status, BMI category on Patients entry, HIV status

Type II DM FBG 4.4 – 8.3 mg/L Age group, gender, smoking status, alcohol status, BMI category on patients entry, HIV status

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Costing data analysis

This retrospective costing study was undertaken from the health provider perspective and uses both ingredients-based and step-down costing approaches. Ingredients-based costing requires the identification and specification of each resource component, or input, used for delivering an individual service in order to calculate a total unit cost, e.g. how many minutes each staff cadre spends with the patient during the consultation.

The step-down costing method is used to allocate clinic overhead costs or resources in a step-wise fashion to all the overhead departments and then to final cost centres39, in this case, clinical consultation for NCD patients. Both financial costs and economic costs were estimated. Financial costs refer to those costs resulting from actual expenditure on goods and services while economic costs include the value of all resources used, including donated goods and volunteers’ time.

Ten percent was added to building costs to account for furnishing. Five percent was added to equipment and vehicle costs to account for importation costs. It was assumed that all building costs were incurred locally so no importation cost was added. Capital costs were annualised using straight-line depreciation and a lifespan of 10 years for building and 5 or 7 years for vehicles and equipment, respectively 40. Economic capital costs were annualised and discounted at the standard rate for healthcare (3%) 41,42. The costs of the one-off training trip were treated as a capital expenditure and annualised using a lifespan of three years (the average duration of an MSF project).

Proportion of salaries of all facility clinical staff allocated to NCDs were calculated based on consultation volume, proportion of new versus review appointments, proportion of nurse consultations referred to doctors and estimated duration of nurse versus doctor and new versus review NCD consultation. These estimates were based on routine activity data and supervisor estimates. Clinic staff involved with NCD patients included: cough officer, registrar, doctors, nurses, laboratory technician and supervisor, pharmacy supervisor, pharmacist and pharmacy technician, cleaner and security staff. Staff involved in HIV/TB counselling, adherence support, IEC and defaulter tracing were excluded, as they had no input in management of NCD patients. While the MOH pays a small proportion of facility staff salaries, we assumed that all were paid entirely by MSF at MSF rates, since MOH salary data were unavailable. The total expenditure on both national and international staff salaries, expenses and accommodation were calculated at field and coordination level and allocated as described below. The expatriate medical supervisor provided approximately half of all doctor NCD consultations as well as overall NCD programme supervision; this input was analysed separately by dividing into facility-level direct consultation time and field-level supervisory time.

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Drugs were analysed as a separate input as they were anticipated to account for a high proportion of total cost. MOH supplied the medications through their central supply chain, which incurred frequent stock-outs. Thus, we estimated that MSF provided 70% of medication supplies, either via importation from Europe or via local purchase if they were not included in the MSF medicines list. Annual consumption figures and total annual cost per drug were calculated. Ten per cent was added to account for wastage and five per cent was added to MSF drug prices to cover importation costs.

The proportion of coordination and field-level personnel, capital and recurrent costs devoted to NCDs was estimated at 3% and 5% respectively. The NCD supervisor dedicated 50% of activity to NCDs via direct clinical contact and supervision. Clinical overheads and activity shared between all clinic services were allocated at 6.3 % to NCDs, based on the proportion of total clinic consultations attributed to NCDs. The laboratory, pharmacy and data encoder staff time dedicated to NCDs was estimated at 17%, 2% and 20% respectively, based on supervisors’ estimates. Laboratory consumables’ total annual consumption data were provided and costs were apportioned at 6.3% as per clinic activity.

Costs were incurred in both South African Rand and in Euro in different years (range: 2011 – 2017). They were inflated or deflated to the base year 2016 cost and then converted to International dollars using the general purchasing power parity (PPP) index43. The PPP index is recommended for comparing costs across countries as it adjusts for differences in relative prices between economies44.

The total cost of NCD clinical care was calculated by adding the allocated capital and recurrent costs incurred at facility, field and capital level. Unit costs were expressed as cost per patient enrolled and per visit in the NCD programme during the study period.

Initially, it was planned to allocate NCD activity/costs to GOPD, HIV and TB departments. However, of the 895 enrolled NCD patients, 97 (11%) were also enrolled in the HIV department and 6 (0.6%) in the TB department. It was decided to estimate distribution of total costs to the HIV and GOPD department using the proportion of patients enrolled in each, since much of the activity was overlapping, and the actual distribution of clinical NCD activity taking place in each department was not documented.

Total financial and economic costs were calculated with and without capital and personnel inputs. The major cost drivers were identified. Structural sensitivity analyses were performed around drug and personnel costs since these were the principle cost drivers. The assumption regarding drug wastage was varied by 10% in both directions. Drug costs were recalculated using 100% MSF and 100% MOH prices. However, it was assumed the MOH paid the MSF price if no local price was available and vice versa. Duration of doctor and nurse consultations was varied to minimum (fifteen and five, respectively) and maximum (forty and fifteen, respectively) to account for different estimations of staff time provided.

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ETHICAL CONSIDERATIONS

This study protocol met the MSF Review Board criteria for exemption from full ethics review, as it involved retrospective analysis of routinely collected data, and the Medical Director of MSF-OCA assumed ethics oversight. The protocol was submitted to the Eswatini National Health Research Review Board and was approved by the London School of Hygiene and Tropical Medicine Ethics Review Committee (Reference 14419).

Written, informed consent was not sought since this retrospective cohort study used only anonymised data. Information sheets displayed on clinic walls informed patients of the study and of their right to withdraw their data from the analysis.

STUDY IMPLEMENTATION

This was a collaborative partnership between MSF, the Ministry of Health of Eswatini, AHF and the London School of Hygiene and Tropical Medicine (LSHTM). The protocol was developed by MSF with inputs from the other partners. MSF UK provided funding for LSHTM involvement.

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KEY RESULTS

MODEL OF INTEGRATED NCD CARE

While in high-income countries NCD care and prevention has been the focus of the medical community for decades, it is a newer development in middle and lower income countries to shift attention and resources to NCD care. While there are several conceptual models of integrating NCD care into existing health systems31 and of low budget preventive and control strategies26, very few reports on practical experience exist.

Setting up an NCD service Matsapha Comprehensive Clinic

As described earlier, MSF has been providing medical care in Matsapha Comprehensive Clinic since March 2011. The clinic has three departments: General Adult Outpatients (GOPD), HIV and TB. When the clinic first opened, most clinical encounters were acute and episodic and NCD care was provided in an ad-hoc manner. However, the prevalence and the chronic nature of NCDs, and the limited access to alternative reliable and adequate NCD care, prompted a more focused and systematic approach from 2016.

In Eswatini, NCD services are provided by doctors and are concentrated at hospital and health centre level. NCD drug supply is intermittent and the choice of NCD drugs is limited; some essential medications, such as insulin, are often unavailable through the public system. Screening and treatment of patients is suboptimal9. In setting up a formal NCD programme in Matsapha, MSF chose to leverage their experience of delivering HIV care. The evolution of the HIV care model involved decentralisation to primary care level and task sharing of treatment initiation and modification to registered nurses, and of counselling and treatment support to lay workers, thereby facilitating improved access to and quality of HIV care. MSF felt that task sharing to nurses could be replicated for NCDs but had not involved the existing HIV/TB counselling and support team in the initial Matsapha NCD model. The need for NCD-related adherence and psychosocial support became increasingly apparent to the team but the existing lay counsellors didn’t have the training or time to provide it.

A particular emphasis was placed on offering a comprehensive medical service to the most vulnerable group of people: those with high blood pressure or diabetes and comorbid HIV and/or TB. The goal was to implement an integrated NCD service providing combined ART and NCD consultations and follow up.

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In August 2016 a formal, integrated NCD care program was implemented. The target population was the population of Matsapha and environs but the programme was open to any adult seeking long-term NCD care. In planning the service, staff training on management of NCDs was undertaken; and clinical standard operating procedures (SOPs), paper-based NCD clinic files and a revised patient flow were implemented. The protocols for the HIV and TB service were altered to include blood glucose screening for all patients at treatment initiation and then annually and for blood pressure screening with CVD recalculation to be performed by the nurse at each clinic contact.

One responsible medical doctor and one nurse were identified to be the NCD reference points. They attended a weeklong, MSF-delivered training course on NCD services in Amman, Jordan. A weekly medical training session for staff was already in place, and trainings were regularly held on the MSF NCD guidelines, the programmatic SOPs (Annex 12.6), patient flow, available drugs and their side effects.

A patient register with clinic-held NCD cards was set up to record relevant data (see section on patient circuit below). In addition, a specially designed database was introduced to monitor the quality of care delivered and to explore the feasibility and effectiveness of the decentralised and integrated approach to NCD care.

MSF clinical NCD guidelines

The clinical NCD guidelines for the Matsapha project were based on the MSF NCD guidelines, which were developed using MSF experience and informed by NICE, SIGN, BTS, GOLD, ECS, ADA, NIH, WHO PEN guidelines and the UNHCR-supported NCD training package1. They provide programmatic and evidence-based clinical guidance for NCD management, addressing: diagnosis; clinical examination; patient education regarding the pathology, lifestyle modification and self-management of their illness; targets for disease control; medical management in including the assessment and management of global cardiovascular risk; management of acute and chronic complications; and onward referral.

1 NICE: The National Institute of Clinical Excellence (England and Wales); SIGN: Scottish Intercollegiate Guidelines Network; BTS: British Thoracic Society; GOLD: Global Initiative for Chronic Obstructive Lung Disease; ECS: European Society of Cardiology; ADA: American Diabetes Association; NIH: National Institute of Health (USA); WHO PEN: World Health Organisation Package of Essential Noncommunicable Disease Interventions; UNHCR: United Nations Commissioner for Refugees.

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These were adapted to reflect Eswatini national treatment guidelines and local availability of diagnostics and drugs and are summarised as clinical SOPs (Annex 12.6). Local adaptations included using hydrochlorothiazide as first-line antihypertensive (except for patients with diabetes or renal impairment); trial of medication to diagnose asthma as no spirometry was available; use of symptom score rather than peak expiratory flow rate (PEFR) to monitor asthma symptoms due to lack of PEFR meters; and removal of long acting beta-agonists and ipratropium bromide from the treatment protocol due to their unavailability.

Enrolment in the NCD Service

Patients of any age were eligible to enrol if they have a newly diagnosed or known (including those previously treated elsewhere or defaulting from Matsapha) target NCD: hypertension, diabetes mellitus (Type 1 and Type 2), cardiovascular disease (CVD), [which includes ischaemic heart disease, stroke, transient ischaemic attack and peripheral vascular disease], asthma or chronic obstructive lung disease. However, the patient must have also demonstrated commitment to continuing treatment at Matsapha Clinic by returning to set appointments during the first 2-3 months after diagnosis. This criterion was introduced to exclude patients who attended Matsapha on an ad-hoc basis simply to access NCD drugs when the supply at their usual treatment centre was interrupted. Patients with other NCDs, such as epilepsy and cancer care, were not included in the service and were referred to MOH services.

The patient received a hand-held patient passport at their first visit. On formal enrolment to the service, they were issued a unique NCD number and a clinic-held chronic care file, containing personal details, contact details, biometric data, HIV status, medical history and medication, vital signs (recorded at each visit), laboratory results and notes on the course of treatment. Chronic care files were initially colour-coded by diagnosis: pink for hypertension and/or diabetes and blue for asthma and COPD patients; those fitting both categories were given blue files.

Patient circuit

A cough officer screened all patients entering the Matsapha clinic to identify TB suspects, who were then referred for nurse evaluation. NCD patients requiring blood tests, including fasting diabetics, attended the laboratory before being registered. Patients with known TB attended a separate area of the laboratory for infection control reasons. Adult patients, including patients enrolled in the NCD service (but not the HIV or TB services) were then registered in the standard OPD register. The registrar retrieved the patient’s NCD file.

After registration, patients proceeded to triage where a triage nurse assistant measured blood pressure, heart rate, temperature and weight at each visit and then directed patients

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to the appropriate service using a colour-coded card system. Triage criteria allowed the triage nurse to refer directly to the doctors using a red card and NCD criteria were added to these (blood pressure or blood glucose above target). The triage nurse did not categorise the cases by level of urgency.

Known patients attending the HIV and DSTB services (including those with NCDs) were registered in the standard MOH register by the registrar, given their HIV or DSTB file (and NCD file if appropriate) and then directed to the relevant department. DRTB patients bypassed this system and attended the DRTB service directly. The majority of consultations in all three departments were nurse-led and two doctors covered all three areas.

Clinical consultation

Doctors reviewed all newly diagnosed or enrolled patients, those not meeting clinical targets (i.e. “unstable”) and complex cases referred by nurses. At first consultation, doctors recorded a complete medical history, medication and family medical history and performed a clinical examination. HIV status was routinely asked but TB status was not. Lifestyle CVD risk factors including smoking status and alcohol use were recorded; BMI and the 10 year cardiovascular risk score were calculated; acute complications were identified and treated and long-term medications were prescribed.

The patient was reviewed a month after the first visit and then monthly until stable. Nurses reviewed stable patients at three-monthly intervals but patients returned monthly for medication refills in the interim. Stability was defined as meeting clinical targets for hypertension (< 140/90 mmHg) or diabetes (BSL < 8.3 mmol/L) with no/stable complications or having good control for asthma.

Follow-up visits involved review of patients’ symptoms and disease control, vital signs and laboratory results. Unlike in HIV care, follow up frequency and content was the same irrespective of particular NCD diagnosis or patient’s age group. If they were not meeting clinical targets, patients could be referred back to the doctor for adjustment and/or initiation of new medications, to arrange additional laboratory tests or to be referred to external health providers as required. Nurses provided wound care and injections as needed.

Box 1. Referral criteria from the nurse back to the doctor:

. Uncontrolled hypertension >140/90 mmHg . Blood sugar < 2.8 mmol/l or >8.3 mmol/l . Acute exacerbation of asthma/COPD or poorly controlled asthma/COPD . New diagnosis/worsening of angina or other cardiac symptoms e.g. dyspnoea . New diagnosis/worsening of diabetic foot/wound . New diagnosis/worsening of kidney disease: Creatinine Clearance <50 ml/min or reduction by >15 ml/min

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The laboratory provided glucose, total cholesterol, bilirubin, electrolytes, creatinine and thyroid stimulating hormone testing using a MOH-issued biochemistry analyser and locally sourced reagents. On patient arrival, the laboratory carried out routine blood tests requested by the nurse or doctor at the patient’s previous visit. All patients with hypertension, diabetes, and established or at high risk of CVD received a urine dipstick test, creatinine and blood glucose at first visit and then annually. An annual cholesterol profile was added from April 2017. Diabetics had fasting blood glucose checked with a glucometer at each visit. Liver function tests were performed before initiation of a statin and then annually. Nurses could request routine and annual tests and doctors could request additional ad hoc tests. An HbA1c point-of-care machine was initially introduced but the team encountered difficulties with maintenance of the machine and supply of reagents.

The doctor recorded prescriptions on the patient hand-held and clinic-held records. Nurses could renew a prescription if the medications and doses were unchanged. Pharmacists located at the onsite pharmacy dispensed between one and three months’ supply of medication, depending on available stocks, and checked patients’ understanding of their treatment. Known TB patients attended a special pharmacy window separate to the other patients. Medications used were those considered standard of care in Eswatini and equally were on the MSF Green List. However, even though Eswatini has a comprehensive list of standard medication in their national guidelines, the medication is not reliably available. MSF supplemented the drug supply through importation and provided 100% of difficult-to- access drugs, such as insulin and atorvastatin.

Doctors could refer to external services, including those services particularly relevant to NCD patients (ophthalmology, nephrology and cardiology). Dialysis was available for end stage kidney disease and the single practicing cardiologist in the public sector provided advice on medical management; invasive cardiology interventions were unavailable. Investigations, such as ultrasound, x-ray or endoscopy, were available at the national hospitals in Manzini or Mbabane. The patient had to pay a small fee for consultation and treatment at an external MOH service. The patient could also choose to pay to attend a private clinic or doctor.

Patient support, education and counselling (PSEC)

The doctors and nurses provided education at each consultation about the disease, management and possible complications as summarised in the clinical SOPs. A focus was placed on lifestyle changes and the patient’s role in management of the disease; recommendations on diet and exercise were adapted to local habits. Nurses or nurse aids delivered group health education in the general waiting room before consultations started, covering various topics, including NCDs, but not according to a defined programme and not targeting particular patient groups. No appointment reminders, defaulter tracing,

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adherence support or treatment literacy support for NCDs were provided by the PSEC or nursing team, largely due to lack of training and capacity. Nurses used clinical parameters as a guide to patient adherence and referred those patients outside of the normal range to a doctor. Doctors therefore managed all patients who required psychosocial or treatment support and education on insulin and inhaler use and could spend up to 40 minutes per consultation. By contrast, nurse-led NCD consultations where estimated to last approximately 15 minutes, while non-NCD consultations with nurses or doctors lasted 5 to 10 minutes. Bi-directional NCD and HIV screening Widespread screening for NCDs was introduced at the clinic. Blood pressure was checked for all adult patients (irrespective of age or cardiovascular risk), by the triage nurse in GOPD, by the nurse in the HIV department and by the nurse in the TB department on initiation of ART/ TB therapy and then annually. Of note, patients stable on ART usually entered a “fast- track” involving three-monthly medication pick-ups from the pharmacy, six monthly HIV counsellor review and six-monthly nurse review. However, if enrolled as an NCD patient, stable ART patients were switched to three-monthly nurse review and seen more often (by doctors) if unstable. Blood pressure monitoring was added to the nurse review. Random blood glucose screening was introduced for all patients initiating ART, DS- or DRTB treatment and on annual review. Hypertension and/or diabetes were then diagnosed in accordance with the NCD guidelines. All women in antenatal care were screened for diabetes using random blood glucose testing and patients with a high-risk profile or clinical suspicion of diabetes also had glucose testing performed.

Data and Monitoring and Evaluation After the initial consultation, the data encoder created a new electronic patient record and filed the paper NCD card. At each clinic visit, the clinician updated the paper-based file and new data were subsequently entered into the database. Initially, normal laboratory results were brought by a nurse to the data encoder to add to the patient record whereas a laboratory technician passed abnormal results to the doctors to be actioned. They were then filed to the paper file, bypassing the data encoder.

Integration with OPD and HIV/TB services and workload The NCD system was integrated into the existing clinic structure and existing staffing arrangements within all three departments. Certain cadres of staff had additional duties to fulfil. The registrar obtained the patient’s NCD file before each consultation and afterwards passed it to the data clerk. The data clerks updated the NCD database after each patient visit and collected paper-based results from the laboratory, encoded and then filed them for each visit. The triage nurse aids followed additional triage rules introduced for NCD patients and the nurses and doctors in all departments were asked to screen all attending patients, register new patients and provide clinical follow up for registered patients. Workload for doctors and nurses increased as the estimated time for consultations increased from the

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five to ten minutes usually required for a non-NCD consultation to fifteen minutes for nurses’ and thirty to forty minutes for doctors’ NCD consultations. The workload of the laboratory and pharmacy staff also increased with the formal introduction of the service as the volume of tests performed increased and the consumption (and processing) of NCD- related drugs increased.

No additional staff was recruited specifically for the NCD service and this limited the services that could be provided. The team identified the need for health education and mental health and psychosocial support specific to NCDs but HIV psychosocial counsellors were already at capacity in terms of workload and could not deliver this care. Most relevant medical equipment was already in place, including weighing scales and blood pressure cuffs in all departments, glucometers in the laboratory and in the TB department. Height measuring tapes were bought and installed in consultation rooms. Additional material, such as wide blood pressure cuffs for obese patients and monofilaments to detect peripheral neuropathy in diabetic patients were requested but were unavailable in the country.

Adaptation of the service and challenges faced

A number of challenges were encountered in implementing the formal NCD service and adaptations were made to address them. These involved clinical and cultural challenges; supply chain and data capture issues and, most prominently, challenges around workload and the need for additional staff and services. As the programme evolved, programmatic SOPs were developed to clarify triage, inclusion and exclusion, screening, laboratory monitoring and referral criteria. The patient circuit was also documented. To improve treatment consistency, the clinical SOPs were adapted into wall charts, and treatment support wall charts were developed.

Several clinical and diagnostic challenges arose. Spirometry was unavailable to diagnose COPD or clarify uncertain diagnoses of asthma. Clinical staff used symptom scoring rather than peak expiratory flow rate to determine asthma control. Peak flow metres were available but not used, reportedly due to lack of staff training. Microfilaments were unavailable for diagnosis of peripheral neuropathy in diabetic patients. Diagnosis of cardiovascular disease equally was largely clinical. An ECG machine was available in the TB department but was rarely used by the clinicians; ECG stress testing was unavailable; echocardiography was difficult to access and of doubtful quality. According to the NCD supervisor, the population and health workers had limited knowledge of heart attack or stroke. In addition, a shortage of urine cups for much of the project life prevented routine performance of urine dipsticks to identify renal impairment.

Despite MSF buffering, repeated shortages of medication occurred as a knock-on effect of stock outs occurring in other MOH clinics, which prompted their patients to attend

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Matsapha for NCD drug refills. This led to inconvenience for Matsapha-enrolled NCD patients, potential treatment interruptions and additional workload for clinicians. It was intended that stable patients would receive a three-month medication supply but, in times of medication shortage, a two-week supply was dispensed and patients were asked to return for further refills. According to clinical staff, many patients failed to return due to the added inconvenience and cost. Clinicians also spent time adapting dosages to the medications available.

Drawing on the experience of HIV care in planning the NCD service, it was intended that much of the workload would be task shared with nurses. However, Eswatini law precludes nurses from initiating or adapting most medical treatments for chronic diseases. In the course of task sharing in the HIV program, nurses had to undergo special training to enable them to initiate patients on ART and national regulations were changed to facilitate it.

As a consequence, patients requiring modification or initiation of treatment, i.e. with clinical parameters out of the norm, had to be referred by nurses to a doctor. Health education required for NCD patients was provided by nurses and doctors during the clinical consultation and was found to be time consuming and complex. Clinicians reported difficulty in implementing diet and lifestyle advice in this patient cohort. They found that most patients were poor, had a diet rich in refined carbohydrates and were not familiar with the idea of exercise to promote health. Indeed, being overweight was culturally desirable.

Nurses identified poor adherence through poorly controlled clinical parameters, rather than via a specific focus on adherence support or late attendance, and referred these patients to the doctors also. Doctors also provided the specific education required for patients initiating insulin treatment or inhaler use. Unlike in the HIV or TB services, additional health education or adherence support structures, such as patient support groups or psychosocial counselling, were not in place for NCD patients. This was perceived as a gap by staff.

Thus, instead of sharing work to the nurses as intended, the system increased the workload for the two doctors who were covering all three departments. Indeed, nurses reported that some NCD patients referred directly from triage or by nurses were unwilling to wait to see the doctor and, consequently, they referred fewer uncontrolled patients.

Data capture issues included quality and consistency of documentation in the NCD file and capture of blood test results. The NCD file was reportedly filled less consistently for ART and TB patients than for GOPD patients. If patients attended the clinic without their patient-held booklet containing their NCD number, they were not issued their NCD file at registration and the file was not updated during the clinical consultation. In order to ensure data capture of the NCD-related blood tests, the patient’s NCD number was added to the blood results. An issue arose because “red flag” laboratory results were returned to the requesting nurse or doctor for action and were then filed, bypassing the data clerk. A

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protocol was introduced to ensure these results reached the data clerk, who also performed quality checks to confirm all laboratory results were captured.

EFFECTIVENESS OF NCD CARE DELIVERY

Description of patient cohort

895 patients were registered in the NCD patient cohort between July 2016 and June 2017. The overall mean age was 55 years (IQR: 48-64) and two thirds (66.6%) of the cohort was female (Table 4). The mean and median duration of follow-up was 8 and 9.2 months respectively (IQR: 5.3 to 10.6). Cumulatively, 146 patients (16.3%) were lost to follow up during the one-year study period, defined as patients that had no contact for 90 days since last planned or attended appointment.

In terms of risk factors for cardiovascular diseases, 2.9% of patients were current smokers and 6.9% currently drank alcohol. A greater proportion of men than women both smoked (6.4% vs. 1.2%) and drank alcohol (17.1% vs. 1.9%). Over 70% of patients were overweight or obese with a Body Mass Index (BMI) of 25 or more. Of note, 46.5% of total patients and 54.6% of women were obese (BMI>=30).

The most common NCD diagnosis at enrolment was hypertension (85.7%, n=767), followed by diabetes type II (37.4%, n=335), asthma (3.8%, n=34) and diabetes type I (1.2%, n=11). Only 3 patients had known CVD and none had known COPD at enrolment; no patients were newly diagnosed with either of these conditions during the study period. Over a quarter (27.6%, n=247) presented with both hypertension and diabetes, while none presented with hypertension, diabetes and asthma. The majority of patients with hypertension (86%) and diabetes type II (85.7%) were over 45 years of age. Patients with diabetes type I or asthma (mean ages 35.8 and 37.1 years respectively) were younger than patients with diabetes type II or hypertension (mean ages 55.5 and 57.2 years respectively).

At registration, the median number of NCD drugs prescribed was 2 (IQR: 2-3) and over 90% of patients were prescribed 1-4 drugs. 23.2% of hypertensive patients received 3 drugs or more. 18 patients overall (2.0%) received atorvastatin and 6 received both atorvastatin and aspirin (all were hypertensive patients). Among the 346 diabetic patients, 76.3% and were prescribed only oral hypoglycaemic agents (OHG) only; 15.9% were prescribed both OHGs and insulin and 6.9% were prescribed only insulin drugs. Among asthma patients 69.7% were prescribed only Salbutamol and 30.3% were also prescribed Beclomethasone.

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Table 4. Baseline characteristics of 895 patients registered in the NCD service

Whole Cohort (N=895) Female (N=596, 66.6%) Male (N=299, 33.4%) Comparison in means Male v Female N (%) Mean Median (IQR) N (%) Mean Median (IQR) N (%) Mean Median (IQR) p-value † Wilcoxon signed-rank test p-value₸ Age 55.5 55 (48-64) 56.5 56 (49-64) 53.7 54 (46-63) 0.07 0.01 <25 13 (1.5) 6 (1.0) 7 (2.3) 25-44 147 (16.4) 89 (14.9) 58 (19.4) 45-64 531 (59.3) 355 (59.6) 176 (58.9) 65 + 204 (22.8) 146 (24.5) 58 (19.4) Smoking 26 (2.9) 7 (1.2) 19 (6.4) <0.01 Alcohol 62 (6.9) 11 (1.9) 51 (17.1) <0.01 BMI (93 missing, 10.4%) 30.1 29.4 (25.4-33.9) 31.4 31.1 (26.9-35.5) 27.6 27.3 (24.2-30.8) <0.01 <0.01 Underweight (<18.5) 15 (1.9) 7 (1.3) 8 (3.0) Normal (18.5-24.9) 166 (20.7) 86 (16.1) 80 (29.7) Overweight (25.0-29.9) 248 (30.9) 149 (28.0) 99 (36.8) Obese (>=30) 373 (46.5) 291 (54.6) 82 (30.5) Type of NCD on enrolment Hypertension 767(85.7) 533 (89.4) 234 (78.3) <0.01 Diabetes Type I 11 (1.2) 6 (1.0) 5 (1.7) 0.52¥ Diabetes Type II 335 (37.4) 198 (33.2) 137 (45.8) <0.01 Cardiovascular 3 (0.3) 2 (0.3) 1 (0.3) 1.0 Asthma 34 (3.8) 22 (3.7) 12 (4.0) 0.81 Hypertension & Diabetes 247 (27.6) 158 (26.5) 89 (29.8) 0.30 # of chronic conditions 0.45 (HTN, DM, Asthma and CVD) 1 640 (71.5) 431 (72.3) 209 (69.9) 2 255 (28.5) 165 (27.7) 90 (30.1) † chi square test was used unless specified ¥ Fisher exact test ₸ Wilcoxon signed-rank test-to-test difference in means for non-normally distributed data

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The majority (71.5%) of NCD patients were HIV negative, while 17.2% were HIV positive and 11.3% had an unknown HIV status. HIV positive patients were younger than HIV negative patients (25.4% and 16.9% respectively were less than 45 years, p-value <0.01) and more HIV negative patients (69.5%) were female compared to HIV positive patients (56.5%) (p- value = 0.01). (Table 4 and Table 5). HIV negative patients had a slightly longer duration of follow-up in NCD care compared to HIV positive patients (8.4 vs. 6.9 months). There were no significant differences between the HIV negative and the HIV positive cohort in terms of BMI (Table 5).

HIV positive patients were less likely to present with hypertension (77.3%) than HIV negative patients (87.0%) but more likely to present with diabetes type II than HIV negative patients (48.1% and 35.5% respectively), although, notably, none was prescribed a protease inhibitor.

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Table 5: Modifiable CVD Risk factor prevalence by HIV status

Whole Cohort (N=895) HIV negative (N=640, 71.5%) HIV positive (N=154, 17.2%) HIV Unknown (N=101, 11.3%) Comparison in means HIV + vs. HIV - N (%) Mean Median N (%) Mean Median N Mean Median N (%) Mean Median p-value Wilcoxon (IQR) (IQR) (%) (IQR) (IQR) signed-rank test p-value₸ Age 55.5 55 56.3 56 50.7 50 58.5 58 <0.01 <0.01 (48-64) (49-64) (44-59) (50-66) <25 13 (1.5) 11 (1.72) 1 (0.65) 1 (1.0) 25-44 147 (16.4) 97 (15.2) 38 (24.7) 12 (11.9) 45-64 531 (59.3) 373 (58.3) 100 (64.9) 58 (57.4) 65 + 204 (22.8) 159 (24.8) 15 (9.7) 30 (29.7)

Smoking 26 (2.9) 17 (2.7) 4 (2.6) 5 (5.0) 0.41¥ Alcohol 62 (6.9) 37 (5.8) 13 (8.4) 12 (11.9) 0.06 BMI (93 missing, 10.4%) 29.4 29.5 28.7 29.7 30.1 30.2 29.3 31.0 0.88 0.22 (25.4-33.9) (25.6-33.9) (25.2-32.8) (26.3-35.9)

Underweight (<18.5) 15 (1.9) 11 (1.9) 3 (2.2) 1 (1.3) Normal (18.5-24.9) 166 (20.7) 125 (21.2) 26 (19.4) 15 (19.0) Overweight (25.0-29.9) 248 (30.9) 176 (29.9) 48 (35.8) 24 (30.4) Obese (>=30) 373 (46.5) 277 (47.0) 57 (42.5) 39 (49.4) NCD on enrolment Hypertension 767 (85.7) 557 (87.0) 119 (77.3) 91 (90.1) <0.01 Diabetes Type I 11 (1.2) 7 (1.1) 3 (2.0) 1 (1.0) 0.63¥ Diabetes Type II 335 (37.4) 227 (35.5) 74 (48.1) 34 (33.7) 0.01 Cardiovascular 3 (0.3) 3 (0.5) 0 0 1.00¥ Asthma 34 (3.8) 28 (4.4) 4 (2.6) 2 (2.0) 0.48¥ Hypertension & Diabetes 247 (27.6) 174 (27.2) 46 (29.9) 27 (26.7) 0.78 # of chronic conditions 0.86 (HTN, DM, Asthma , CVD) 1 640 (71.5) 458 (71.6) 108 (70.1) 74 (73.3) 2 255 (28.5) 182 (28.4) 46 (29.9) 27 (26.7)

† chi square test was used unless specified; ¥ Fisher exact test; ₸ Wilcoxon signed-rank test to test difference in means for non-normally distributed data. 35

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Of the 154 HIV positive patients only 97 received HIV care at Matsapha HIV clinic and therefore had HIV related clinical information available for analysis. Their median time since HIV diagnosis was 4.1 years (IQR: 2.4-7.0) and 95 of them were on antiretroviral therapy (ART) before registering in the NCD cohort with a median time on ART of 3 years (IQR: 1.1- 4.8) (data not shown). Data on TB diagnosis was only available for this sub-group of NCD service patients, of whom 65 had a documented TB status, equating to 11% of the total NCD cohort.

At enrolment, just over 50% of patients among the whole cohort had their blood pressure (BP) under control, which dropped to 46.7% among known hypertensive patients. 52.7% of patients presenting with diabetes at enrolment had their fasting blood sugar (FBS) at target (Table 6).

Quality of Care outcomes

Quality of care indicators were calculated among patients enrolled in the service for more than 3 months and with at least one follow-up visit.

Among hypertensive patients, 98.2% (n=608) had their BP checked at their last visit and, of these, 60.4% were at target. FBS and creatinine were checked at least once since enrolment in 62.7% and 70.3% of hypertensive patients respectively.

Among diabetic patients (both Types I and II), 96.7% (n=289) had a FBS recorded at their last visit and, of these, 63.3% were at target. Among the 296 diabetic patients that had FBS checked at least once at follow up 63.2% were at target. The vast majority (96%) of diabetic patients had their BP recorded at their last visit and 13.7% and 6.0% of diabetic patients, respectively, had a urinary protein test and a foot exam performed at least once within the reporting period (either at enrolment or at a subsequent visit). Both were intended to be performed at baseline and annually thereafter.

Among the 27 asthmatic patients, 88.9% received a control review and 85.2% had inhaler technique checked at least once after registration; 96.3% of the patients were free from an exacerbation of asthma requiring hospital attendance since their last review.

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Table 6: Quality of Care Indicators#

Whole HIV HIV HIV Cohort negative positive Unknown (N=619) (N=468) (N=82) (N=69) Hypertension (N=619) N (%) N (%) N (%) N (%) p-value†

Patients with a BP recorded at their last visit 608 (98.2) 460 (98.3) 80 (97.6) 68 (98.6) 0.88

Patients with FBS checked at least once* 388 (62.7) 300 (64.1) 49 (59.8) 39 (56.5) 0.40

Patients with creatinine checked at least once* 435 (70.3) 333 (71.2) 60 (73.2) 42 (60.9) 0.2

Patients with a BP at target at last visit (N=608) 367 (60.4) 283 (61.5) 44 (55.0) 40 (58.8) 0.53

Patients with last recorded BP at target^ (1 patient has no BP recorded 374 (60.5) 288 (61.7) 45 (54.9) 41 (59.4) 0.50 at FU) (N=618) Diabetes (N=299)

Patients with a FBS recorded at their last visit 289 (96.7) 205 (96.7) 59 (96.7) 25 (96.2) 0.99

Patients with a BP recorded at their last visit 287 (96.0) 207 (87.6) 54 (88.5) 26 (100.0) <0.01

Patients that have had urinary protein testing performed at least once* 41 (13.7) 26 (12.3) 10 (16.4) 5 (19.2) 0.49

Patients that have had foot exam performed at least once* 18 (6.0) 13 (6.1) 4 (6.6) 1 (3.8) 1.00¥

Patients that have FBS at target at last visit. N=289 184 (63.3) 132 (64.4) 35 (59.3) 17 (68.0) 0.69

Patients that have a last recorded FBS at target^ (never recorded at FU 187 (63.2) 134 (64.1) 36 (59.0) 17 (65.4) 0.75 for 3 patients) N=296

Asthma (N=27)

Patients that receive control review at least once after registration 24 (88.9) 22 (88.0) 1 (100.0) 1 (100.0) 0.87

Patients that have inhaler technique checked at least once after 23 (85.2) 22 (88.0 0 1 (100.0) 0.05 registration Patients who are free from exacerbation of asthma requiring hospital 26 (96.3) 24 (96.0) 1 (100.0) 1 (100.0) 0.96 attendance since their last review after registration # This table refers to patients who were in care for >3 months and had attended at least one follow up visit. * At least once refers to at registration visit or at a follow up visit ^ Last recorded reading at target refers to last visit after registration visit † Chi square test (unless otherwise specified) ¥ Fischer exact test

PREDICTORS OF NCD TREATMENT OUTCOMES

Risk factors for uncontrolled BP or uncontrolled FBS among hypertensive and diabetic patients respectively were investigated. Among hypertensive patients, being obese (BMI>=30) increased the odds of having an uncontrolled BP after adjusting for all the other risk factors (OR: 1.9, CI: 1.1-3.2). There was weak evidence that a HIV positive status (OR=1.6, CI: 1.0-2.6; p= 0.07) and increasing age (1.0 (1.0-1.); p=0.09) were associated with increased odds of having uncontrolled BP after adjusting for all the other risk factors (Table 7). Among Type 2 diabetic patients no risk factors were identified for having an uncontrolled FBS. (Annex 12.2).

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Table 7: Logistic regression to determine risk factors for uncontrolled BP among hypertensive patients (N=618) *

Crude association (N=618) Adjusted model (N=573) Characteristics OR (95% CI) P-value OR (95% CI) P-value Gender Female Reference - Male 1.3 (0.9-1.8) 0.15 1.3 (0.9-2.0) 0.2 Age (linear: 1 year increase) 1.0 (1.0-1.0) 0.18 1.0 (1.0-1.0) 0.09 Smoking 0.4 (0.1-1.8) 0.22 0.3 (0.1-1.7) 0.19 1.1 (0.6-2.2) 0.73 1.4 (0.7-3.1) Alcohol 0.35 most recent BMI (N=573) * Normal - - - - Underweight 1.0 (0.2-5.9) 0.99 1.2 (0.2-6.9) 0.86 Overweight 1.1 (0.7-2.0) 0.65 1.3 (0.7-2.2) 0.44 Obese 1.6 (1.0-2.6) 0.07 1.9 (1.1-3.2) 0.02 HIV status - - - - Negative Reference Positive 1.3 (0.8-2.1) 0.25 1.6 (1.0-2.6) 0.07 Unknown 1.1 (0.7-1.8) 0.72 1.2 (0.7-2.2) 0.5

* Includes hypertensive patients in care for >3 months with at least one follow-up visit and with BP measurements at their last recorded visit.

COSTING RESULTS

Table 10 shows the total annual financial and economic costs by cost category. The total annual financial cost was estimated as $439,429 and the total annual economic cost at $463,203 International Dollars (INT$) for the base year 2016. The most notable feature of this breakdown is the proportion of total financial costs attributable to personnel (61%). Drug supplies (18.46%) and capital outlay (15.49%) were the next most costly inputs, the latter largely driven by buildings costs. Underlying data show that total capital economic costs exceeded financial costs because the cost of donated land was included in the former.

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Table 10. Total cost per cost category for NCD care delivered in Matsapha Clinic for base year 2016

Cost Category Financial Costs Economic Costs Total US$ 2016 % of total Total US$ 2016 % of total costs costs CAPITAL Buildings and Storage 64,885 14.77% 76,098 16.43% Equipment 4,145 0.94% 7,326 1.58% Vehicles 854 0.19% 14,995 3.24% Start Up Training 1,808 0.41% 2,649 0.57% Total Capital Costs 68,081 15.49% 101,069 21.82% RECURRENT Total Personnel 267,172 60.80% 267,172 57.68% Supplies 7,689 1.75% 7,689 1.66% Vehicle Operation and Maintenance/ Transportation 6,169 1.40% 6,169 1.33% Building Operation and Maintenance 8,530 1.94% 11,064 2.39% Recurrent Training 6 0.00% 12 0.00% Consultancies 677 0.15% 1,473 0.32% Total Recurrent Costs 290,243 66.05% 281,029 60.67% DRUGS 81,105 18.46% 81,105 17.51%

TOTAL ANNUAL COST 439,429 100.00% 463,203 100.00%

Table 11 presents the costs incurred at different system levels (coordination, field and facility) in delivering the integrated NCD service in Matsapha clinic. The most notable feature is that personnel costs at field level exceeded those at facility level. This may have been driven by expatriate salaries and expenses. As expected, facility-level costs account for the majority of financial (59%), with personnel, drug and capital costs driving this. By contrast, running costs were negligible.

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Table 11. Costs incurred at different system levels for NCD services in Matsapha Clinic for base year 2016

Cost Level Financial Costs Economic Costs

Total % of total Total % of total (INT$ 2016) annual (INT$ 2016) annual financial costs economic costs Coordination Level Capital 1,281 0.29% 2,616 0.56% Recurrent costs (without personnel) 5,461 1.24% 5,461 1.16% Personnel 27,048 6.14% 27,048 5.74% Total 33,790 7.67% 35,124 7.46% Field Level Capital 1,560 0.35% 3,904 0.83% Recurrent costs (without personnel) 6,419 1.46% 9,583 2.04% Personnel 138,778 31.51% 138,778 29.48% Total 146,758 33.32% 152,265 32.34% Facility Level Capital 72,399 16.44% 89,977 19.11% Recurrent costs (without personnel) 5,082 1.15% 10,996 2.34% Personnel 101,346 23.01% 101,346 21.53% Drugs 81,105 18.41% 81,105 17.23% Total 259,932 59.01% 283,424 60.20%

TOTAL ANNUAL COST 440,480 100.00% 470,813 100.00%

Table 12 breaks down the total drug cost, presenting consumption and cost figures for the ten most expensive drugs used in the programme. Notably, rapid acting insulin (actraphane) is the most costly drug, accounting for 19.4% of the total budget, followed by the antihypertensive medications, hydrochlorothiazide and enalapril. The asthma inhalers beclomethasone (6.5%) and salbutamol (3.9%) and spacer devices (5.0%) accounted for a combined 15% of programme drug costs despite low consumption figures.

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Table 12. Annual consumption, annual financial cost and proportion of total drug cost for each of ten most expensive drugs used in Matsapha NCD service in 2016/2017.

Drugs Consumption Financial Costs (INT$) Annual Total Proportion of total consumption with (INT$ 2016) annual drug costs 10% wastage (%)

1. Insulin - actraphane 1,777 15,761 19.4% 2. Hydrochlorthiazide 25mg 170,500 12,962 16.0% 3. Enalapril 5mg 300,137 11,057 13.6% 4. Metformin 500mg 299,750 5,857 7.2% 5. Beclomethasone inhaler 100mcg 206 5,272 6.5% 6. Insulin - isophane 471 4,255 5.2% 7. Spacer with mouthpiece 67 4,094 5.0% 8. Atorvastatin 10mg 38,777 3,709 4.6% 9. Amlodipine 5mg 149,235 3,361 4.1% 10. Salbutamol inhaler 1,183 3,200 3.9% Subtotal 69,526 85.7% Other drugs 11,579 14.3% TOTAL ANNUAL DRUG COST 81,105 100.0%

Table 13 presents the unit costs with and without capital and drug costs. The financial per patient per year (PPPY) cost was $490.98 and the cost per visit was $109.61 INTD. Removing capital costs reduced the financial PPPY to $412. The drug cost PPPY was $90.62.

Table 13. Cost per patient per year and cost per visit: base case and without capital and drug costs

Unit Costs Per Year Without Without capital costs drug costs Output N INT$ INT$ INT$ INT$ INT$ INT$ indicator (financial) (economic) (financial) (economic) (financial) (economic) Registered NCD 895 490.98 517.55 412.45 404.62 400.36 426.93 patients NCD visits 4,009 109.61 115.54 92.08 90.33 89.38 95.31 per annum

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Table 14 shows the results of sensitivity analyses performed around drug prices and clinical personnel time. The PPPY cost was most sensitive to a reduction in appointment duration (4% drop).

Table 14. Sensitivity analyses for MSF Matsapha NCD programme costing analysis

Total and Base Drugs Drugs Drug Drug Nurse Nurse Min Max Reduce Unit Case 100% 100% waste waste to to appt appt d Expat financial MOH MSF 0% 20% doctor doctor time* time* MD costs in price price referral referral role^ INT$ 2016 20% 40% Total cost 423,55 439,429 444,209 439,429 432,056 445,535 436,929 441,928 421,869 444,323 9

Annual per patient cost 490.98 496.32 490.98 482.74 497.80 488.19 493.77 471.36 496.45 473.25 (PPPY) % change in PPY vs base 0 1.09 0.00 -1.68 1.39 -0.57 0.57 -4.00 1.11 -3.61 case Cost per 109.61 110.80 109.61 107.77 111.13 108.99 110.23 105.23 110.83 105.65 visit *Min appointment time is 5 minutes for nurse appointment, 10 minutes for doctor appointment; max appointment time is 15 minutes for nurse appointment, 40 minutes for doctor appointment. ^Reduced Expat MD role means that doctor appointments were provided by national staff doctors and that Expatriate doctor NCD supervision time was reduced to 5%

DISCUSSION AND LESSONS LEARNED

MSF has successfully implemented a programme integrating primary care level NCD care into pre-existing general OPD and HIV services in the MOH Matsapha Comprehensive Clinic in Eswatini. MSF provided structured NCD care to almost 900 patients over a one-year period and introduced NCD screening by modifying the pre-existing patient flow and staffing structures and adapting the service over time.

Service Delivery

As has been recommended, the MSF NCD guidelines35,45 were modified for the local setting taking into account national MOH NCD protocols. Drugs and dosing were adapted to local availability and diet and lifestyle advice was modified to suit local custom. Programmatic SOPs and clinical support tools were introduced, in order to improve the consistency of care delivered and to support hand-over to other agencies and replication in other settings.

It was intended that the majority of NCD care would be nurse-led as is the case in the decentralised MSF HIV care model and in certain MSF NCD programmes46. However, due to legal constraints on nurse prescribing, the complexity of NCD care, and the emerging patient needs that were not factored into the original programme design (such as treatment adherence, education and behaviour change support), much of this complex workload fell to

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the doctors. Patient support education and counselling (PSEC) have not traditionally been incorporated into general OPD settings but is integral to HIV and TB programmes, where it is usually delivered by lay counsellors rather than clinicians. The need for a specific NCD group or individual counselling and treatment support was identified once the programme was underway and existing clinic counsellors were neither available nor trained to deliver NCD- related PSEC.

The complex and time-consuming nature of NCD consultations was highlighted by the increased consultation times for NCDs compared to usual OPD consultations. Doctors’ increased workload led to long patient waiting times and increased programme costs (see below). Increased waiting times may have contributed to inconsistent referral to doctors, with patients thus receiving suboptimal treatment for a prolonged period. Reliable options for external referral of patients in need of specialist review, investigations or interventions were lacking, as has been found in other MSF settings.

Stock outs occurred on several occasions despite MSF’s regular supplementation of the MOH drug supply due to stock outs occurring elsewhere in the MOH system. This increased the burden of clinical attendance on patients and increased workload on clinical and pharmacy staff. While not specifically evaluated here, inconsistency of supply may have affected medication adherence and resultant patient clinical outcomes47.

Cohort Description

As would be expected in a chronic disease programme, most patients were middle-aged or older. Levels of overweight and obesity were significant, with over half of women (54.6%) and about one third of men (30.5%) enrolled being obese. The most common diagnoses at enrolment were hypertension (85.7%) and diabetes type 2 (37.4%). These are the most prevalent NCDs or NCD risk factors in Eswatini and neighbouring countries9,48. Relatively few patients presented with asthma and diabetes type 1 and, as expected, they were younger than the average with a mean age of 37.1 and 35.8 years respectively. The mean age for diabetes type 1 is older than would be expected in high-income country settings (HIC) and reflects the very limited published research available on type I diabetes in SSA as well as MSF experience49,50. The few patients diagnosed with CVD (n=3) may reflect under-diagnosis since CVD risk factors are increasing amongst the Eswatini population and the WHO STEPS report found a 4.4% prevalence of established CVD9,51. Under-diagnosis may be due to a lack of knowledge and training amongst the staff and, indeed, the locally adapted SOP did not contain a section on CVD (Annex 12.6). However, 18 of the cohort were prescribed a statin, which is indicated in the MSF NCD guidelines for secondary prevention in established CVD or for those at high risk, thus some additional cases of CVD may have been diagnosed but not recorded35,52.

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Patients were enrolled on a rolling basis from programme start-up in June 2016 to the end of the study period, July 2017, which is reflected by the mean duration of follow up of 8 months. The loss to follow up rate of 16.3% per annum is reasonable among a group of pre- selected patients who had already demonstrated commitment to attending the programme before enrolment and is far lower than that noted in a primary level NCD programme in Cameroon53. No formal defaulter tracing system was in place during this first year of the programme.

The HIV positive patients amongst the cohort were younger than the HIV negative patients, which may reflect earlier manifestation of NCDs due to the pro-inflammatory effects of HIV infection, the increased diabetes risk associated with some ART drugs, or may reflect their increased contact with medical services compared to the HIV-negative population. HIV positive patients were more likely to present with diabetes type II than HIV negative patients (48.1% and 35.5% respectively) although none was taking a protease inhibitor, which is associated with increased diabetes risk54. The 97 NCD programme patients with Matsapha ART records represent less than 1% of total Matsapha ART patients, in a cohort running since 2011. Given the NCD prevalence identified in other SSA HIV cohorts, the low numbers of NCD patients identified from amongst the HIV cohort may indicate that screening could be improved48. The mean duration of ART implies that NCD diagnoses were not picked up on screening at ART initiation but may have been based on symptoms or at annual review.

It is notable that no patients were diagnosed with COPD despite the TB prevalence, although smoking rates are relatively low in this cohort. Symptom-based diagnosis was used since spirometry was unavailable in this setting55,35. Patients with COPD, and indeed with CVD-associated dyspnoea and chest pain, may have been lost among the sputum negative TB patients, particularly as staff and the patient flow were more sensitized to identifying TB cases. It is also possible that patients with post-TB obstructive lung diseases were treated for TB more than once due to persistence of cough or that COPD patents were misclassified as asthmatics, as has been found in other settings56.

More than one quarter of the cohort (28.5%) presented with at least two target NCDs, fitting the definition for multimorbidity57. Since other NCDs, such as arthritis and epilepsy, were not recorded, many more patients may have fit this definition, including those with a dual diagnosis of HIV and at least one NCD (N = 154, 17.2 %). Multimorbidity is associated with increased healthcare utilization and greater management complexity for clinicians, often resulting in polypharmacy57. Patients suffer a greater burden in terms of disease understanding, self-management and navigation of complex treatment regimens57,58. Here, 6.5% of patients met one of several definitions for polypharmacy (5 or more regular medications), although only programme-prescribed NCD drugs were recorded and not those prescribed to treat HIV, TB or other conditions.

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Effectiveness of care

Among the patients for whom quality of care indicators were calculated, disease control rates were similar or better than hospital-based programmes in similar settings, although less strict MSF-specific control targets were used in Matsapha59,60. Approximately two thirds of hypertensive and diabetic patients met clinical targets (60.5% and 63.2% respectively) with both groups’ clinical parameters improving since enrolment (46.7% and 52.7% respectively). This improvement may reflect contact with the programme but would require further research, ideally with a comparator group, to elucidate. Asthma patients were also well controlled, with 96.3% reportedly free from exacerbation requiring hospital attendance during the study period. As noted above, these control rates were achieved in a select patient group who had already demonstrated commitment to regular service attendance. In addition, diagnostic thresholds and treatment targets (and indicators) are derived and modified from high-income country study populations.

Tasks associated with regular review appointments were well performed e.g. BP monitoring in both diabetic and hypertensive patients and FBS checks in diabetic patients. However, parameters that were checked at enrolment and then on an annual basis were less well performed: few diabetic patients had urinary protein testing (13.7%) and foot exams recorded (6.0%). This may have been influenced by supply chain issues (poor supply of urine cups and unavailable monofilaments) but also may reflect a training need (other elements of the foot exam were not performed) or a recording error (exams performed but not recorded). Asthma reviews were well performed with most patients having a review of their control and an inhaler check performed at least once since registration (88.9% and 85.2% respectively), both of which should take place at each clinical review.

Predictors of treatment outcomes

Risk factors for failing to meet clinical targets amongst diabetic and hypertensive patients, including HIV status, were investigated in order to better target the intervention for those patients. Obesity (BMI>30 kg/m2) was the only risk factor that increased the odds of having an uncontrolled BP in hypertensive patients (p=0.02) after adjusting for age, gender, smoking status, alcohol use and HIV status. Alcohol use and smoking did not appear to increase the risk of uncontrolled BP in this group but numbers reportedly engaging in these behaviours were small. As would be expected, increasing age was found to be weakly associated with having an uncontrolled BP. While we would also expect that high BMI, for example, would be a risk factor for not meeting treatment targets amongst diabetic patients, this analysis did not identify risk factors for uncontrolled FBS amongst those investigated.

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Comparison with other studies

Leveraging established HIV chronic care structures has been recommended and attempted for chronic disease programmes in SSA 22,23,61. While existing staffing, patient flow, data collection and physical structures were utilised here, key elements that defined decentralised HIV care (nurse-led with individual lay person delivered counselling and patient support groups) were not harnessed in delivery of NCD care within the HIV department and were unavailable within the GOPD department. Also, HIV care has evolved away from requiring patients to attend for several counselling sessions before ART initiation towards successful early initiation of treatment 62. It may be worth reflecting on such lessons learned from HIV care in future design of NCD programmes.

Our findings regarding the workload implications of integrating NCD care with HIV and other services reflect those of other studies of integrated care 63. Economies of scale - more services delivered by the same staff - were realised here, and further economies of scope - reduction of costs or improved efficiencies through joint production of services - may be possible e.g. integration of adherence counselling for ART and for NCDs.

This is one of the first studies to characterise a cohort of NCD patients in Eswatini and obesity rates reflect regional changes, while the relatively low rates of alcohol (6.9%) and tobacco use (2.9%) reflect the WHO STEPS figures for Eswatini 9,51. Clinical challenges around NCD management such as CVD risk scoring and appropriate statin prescribing and misclassification of COPD patients as asthmatic have been described in other MSF or SSA settings 56,64. The experience reported by programme staff reflects findings from other MSF programmes, which highlight the importance of psychosocial and educational support for NCD patients and families and of culturally appropriate, cost-sensitive dietary advice in supporting NCD treatment adherence 46.

Costs of integrated NCD care

To our knowledge, this is one of the first studies to provide a detailed description of the resources used to provide integrated NCD care within a primary care general outpatient and HIV department in Sub-Saharan Africa. Our findings show that major drivers of total cost were personnel costs and drug costs and that addressing these areas could result in greater cost efficiency.

The total annual financial and economic costs for delivering integrated NCD care in Matsapha clinic for 2016/2017 were $439,429 and $463,203 INTD, respectively. Capital costs accounted for 15% of total financial costs, driven almost entirely by building costs, which reflects MSF’s investment in building and expanding the clinic. Personnel costs accounted for 58% of total financial cost, with the majority incurred at field level (31.5% of total costs). Facility-level personnel costs (24% of total costs) were largely driven by the expatriate MD’s salary and the laboratory technician’s time, where one full-time equivalent

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was dedicated to NCDs. The cost of direct clinical contact time for nurses and doctors may have been underestimated by using per-minute consultation time, rather than estimated proportion of workload, as this did not account for non-contact time spent on NCDs. We estimated costs using MSF salary levels, since the majority of staff were paid by MSF, and MOH salary data were unavailable. Different salary payment structures, with fewer expatriate salaries, may reduce programme cost but it should be noted that the national doctor staff salaries exceeded those of the expatriate doctor.

Overall, drug costs contributed 18% to the total cost, with the top ten most expensive drugs contributing approximately 85% of this. Rapid acting insulin alone accounted for almost 20% of the drug budget while the antihypertensive medications hydrochlorothiazide and enalapril contributed a combined 30%, driven by high consumption figures. Asthma inhalers and spacer devices also contributed significantly to drug costs, despite low numbers of asthma patients, due to their very high unit prices (Annex 12.5). Atorvastatin, with its recent off-patent status facilitating its addition to the MSF Essential Medicines List, accounted for 4.6% of the drug budget, although it was prescribed to only 18% of the cohort. Other supplies accounted for only 1.75% of annual financial cost.

The cost per patient per year (PPPY) was $490.98 and the cost per visit was $109.61 INTD. These unit costs dropped by 15% when capital costs were removed (to $415 and $89 INTD respectively), reflecting the costs that would be incurred by introducing NCD care into a pre- existing health structure. The PPPY drug cost was a fraction of the cost of ART provision at $90.63 INTD, although this was not broken down by disease. For example, PPPY drug cost for a patient with asthma may be significantly greater than that for a patient with hypertension controlled on a single, cheap, generic antihypertensive agent. The incremental unit costs of adding NCD care to a general OPD or HIV department are similar in this case since many of the cost components overlapped (capital outlay, running costs, supply and drug costs) and staff activity was estimated in the same manner for both departments (using consultation length and proportion of nurse versus doctor appointments).

Structural sensitivity analyses performed around drugs and personnel costs did not significantly alter the total or unit prices compared to the base case but were most sensitive to a change in appointment duration. The same price for two of the most expensive drugs was used in both drug cost scenarios since no local price was available for insulin and no MSF price was available for enalapril 10 mg or 20mg.

There are few comparable studies identifying unit costs of delivering NCD care in SSA. One Ugandan study, exploring the costs of chronic disease provision at different health system levels, calculated a unit cost of less than $5 (USD 2012) per NCD hospital visit. Care must be taken, however, in comparing these studies as inputs in terms of staff salaries, staff numbers, laboratory testing, medication supply etc. were very different 56.

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The annual per patient costs for the Matsapha NCD service are comparable to costs of HIV treatment services in the region. Reflecting the steep drop in drug prices over time, the PPPY cost of ART delivery in SSA fell from around $1,000 USD to $208 USD in 2013 (an average in four low-income SSA countries); while, in neighbouring South Africa the PPPY remains $682 due to higher personnel costs65. PEPFAR recently reported an average PPPY cost of $642 for ART treatment support programmes in low-income and lower middle- income countries, representing the full cost incurred at facility level and above. Drug costs accounted for an average of 42% of costs across their programmes66. One study estimated a mean per visit cost of $133.01 (INT$ 2013), for HIV chronic care across ten facilities (8 public and 2 NGO affiliated) in Eswatini, which was 21% greater than our estimates42. The higher per visit costs of chronic ART delivery in Eswatini versus other SAA countries likely reflects the higher public sector HR costs in the country42,67.

Drug costs are usually the biggest cost driver in chronic HIV care42,67,68. However, ART was not included in costs for this study since we calculated the incremental cost of adding NCD services to pre-existing services. HR was the main cost contributor in our study while supplies were less prominent, in contrast to studies of diabetes programmes in SSA where diabetes-related supplies (glucometers, glucose reagent strips and lancets) account for the majority of costs69,70. This may be because the MSF European purchase prices were used for these items and because only 38% of the cohort was diabetic. However, despite only a minority (8.8%) of the cohort being prescribed insulin (Annex 12.5), it contributed one quarter of the total drug budget. Much has been written about the unavailability or unaffordability of insulin and other NCD drugs in Sub-Saharan Africa70,50 and sustainability of insulin supply will be important in budget planning and eventual handover for this and other MSF NCD programmes. However, recent progress has been made as manufacturers have reduced insulin prices for least developed countries71.

MSF utilises various models of care integrated to a variable degree with local services. The costs described reflect the fact that MSF often builds or renovates health structures; imports, stores and transports drugs and other supplies; and provide coordination, logistical and medical supervisory support, usually at central and local level via a team of national and expatriate staff. Increased cost efficiencies may be possible at lower salary levels, with increased task sharing with nurses, and with a reduction in drug prices.

Lessons learned for this programme

This programme has demonstrated that NCD care can be integrated into a HIV department and general adult outpatient setting in an MSF-supported MOH primary care centre, building on pre-existing structures, and can achieve acceptable intermediate clinical outcomes and retention rates at a cost that is similar to ART programme costs. The key lessons learned were that the rationalised, streamlined, locally-adapted NCD management algorithms would likely facilitate task sharing from doctors to nurses and other health

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worker cadres; and that cost savings can be made through better collaboration with the MOH in terms of human resources and supply chain strengthening and through advocacy to reduce drug prices. We have also documented in detail the specific challenges encountered or adaptations made regarding clinical and programmatic content, patient flow and workforce planning, programme costs and supplies, and data capture.

SOPs adapted to the local limitations in drug supply and diagnostics and clinical decision- making support tools were introduced, which facilitated standardisation of care. Reinforcing task sharing of certain clinical task to nurses and PSEC tasks to counsellors would likely increase programme efficiency and reduce costs as well as potentially improving patient outcomes. This may require further adaptation of the MSF guideline with implementation and evaluation of more streamlined SOPs; further training of each health worker cadre; and advocacy with the Eswatini authorities to empower nurses to initiate and modify NCD medications in a similar manner to ART. Medication and laboratory supply chains and consumption planning may need to be further reinforced as repeated stock outs may have impacted patient and provider convenience, cost and clinical outcomes.

NCD screening of the HIV cohort may need to be emphasised and identification of COPD and CVD patients improved upon. Targeted spirometry and ECG testing within the scope of a diagnostic algorithm that acknowledges the symptom overlap may assist in identifying COPD and CVD patients from amongst those presenting with chronic chest symptoms. While locally adapted patient education materials were produced, staff identified a clear need for improved, individualised patient education and for group education. To provide this, it may require reinforcing nurse PSEC training (particularly on practical aspects such as insulin initiation and inhaler use); employing and training additional counsellors on NCD behaviour change and adherence counselling; and up skilling existing HIV/ TB counsellors to integrate NCD topics into their sessions.

Education content may need to be further refined to emphasise the importance of a culturally appropriate healthy diet, weight control and exercise in managing and preventing NCDs. However, while there is clear evidence regarding the costs and risks of physical inactivity to the individual and to health systems, there is limited evidence on successful interventions for physical activity promotion in LICs72. Still less is known about the ideal interventions at programmatic level. Obese patients (constituting almost half of the cohort) may be a group to particularly target in the future. In addition, exploring reasons for defaulting may assist retention and adherence.

Important lessons were learned in setting up and managing an NCD database. An NCD specific patient ID number allowed better tracking of patient data, e.g. blood test results, and systems were introduced to ensure data did not bypass the data encoder. It may be useful to record certain additional information for quality control and clinical monitoring, such as TB status (current or history of TB treatment) and CVD risk score.

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Recording the first screening and diagnostic BP/ BSL readings would facilitate more accurate examination of the effect of programme exposure. For this analysis, the first reading recorded is the enrolment reading but patients may in fact have been attending the programme or another clinic and taking treatment for several months and thus have achieved disease control before formal enrolment in the NCD monitoring cohort. In addition, to better ascertain clinical and cost effectiveness, it would be useful to record numbers screened, numbers screening positive, numbers returning for diagnostic second test (if relevant) and numbers finally enrolled. Documentation of the number of shared HIV/NCD and TB/ NCD appointments and numbers of referrals from nurses to doctors would assist programme and workforce planning.

LIMITATIONS

Patients lost to follow up post NCD diagnosis, ad hoc attenders and those initially enrolled in the cohort but failing to return are not included in the quality of care analyses. Not all NCD clinical or dispensing activity is attributable to or captured by the integrated NCD programme since “visiting” NCD patients could attend for ad-hoc consultations and medications. Patient adherence was not assessed (other than via assessment of clinical control) in this evaluation. In addition, we did not assess variance in key outcomes over time or include indicators looking at visit frequency.

Data provided in Euro for building costs was likely initially incurred in local currency, especially the salary costs. These were converted to Euro using an unknown conversion rate rather than PPP. The drug cost per patient is likely overestimated as consumption data included “visiting” NCD patients not enrolled in the NCD programme. Cost per visit is also likely overestimated as consultations that include NCD care for patients other than those registered in the cohort is not captured. This analysis did not examine patient-level data in terms of service use. Each patient was treated the same regardless of date of entry to cohort, duration of follow-up or whether an active or defaulting patient. Human resource costs were based on estimates of staff time spent on clinical consultation, pharmacy and laboratory activity rather than on formal staff time observation, which may have reduced the accuracy of these costs.

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RECOMMENDATIONS FOR APPLICATION IN MSF SETTINGS

This evaluation highlights the fact that NCD care can be successfully introduced into existing MSF programmes, including those supporting an MOH facility, and that an NCD programme requires the implementation of specific tools, guidelines and human resources as well as capacity building of local staff. The findings underline the need to work closely with the MOH and local partners to strengthen health systems, particularly the supply chain, and to ensure sustainability of chronic disease care. They highlight the importance of introducing locally adapted clinical and programmatic SOPs and patient education materials and emphasise the need for structured supervision and training of clinical staff, with specific focus on treatment adherence support and behaviour change counselling. Leveraging MSF’s experience with patient support groups and HIV community adherence groups would be valuable in designing future NCD programmes. Ensuring appropriate equipment is in place, in use and maintained (e.g. Hba1c machine, ECG machine, spirometry) and that adequate and reliable external referral pathways specific to NCDs have been identified are also important.

A key finding is the need to acknowledge the complexity and time-consuming nature of NCD consultations and the workload implications of this. This may be due to the fact that this programme was new to both patients and staff. However, the experience suggests that if task sharing to nurses akin to ART programmes is to occur in practice, MSF needs to distil its evidence based NCD guidelines down to a locally-adapted, simplified, algorithm driven protocol, which involves fewer treatment permutations, minimises testing and finely targets doctors’ involvement. In addition, MSF needs to explore local competencies and the national policy and regulatory environment, as well as providing intense training of nurses on such a simplified local protocol.

Ensuring consistent supply of medications, potentially through provision of buffer stocks, and budgeting for the more expensive drugs will be important. However, it is notable that the drug cost per patient per year obtained in this analysis was far lower than that for an ART programme. Medicines access, particularly for insulin, is a clear area for MSF advocacy to be brought to bear and will be essential for MSF if and when planning for eventual handover of NCD programmes to other actors.

The evaluation also illustrated the value of data capture and of quality data systems, monitoring and evaluation. The additional recording of numbers screened, numbers diagnosed and numbers receiving treatment may facilitate assessment of effectiveness. Adding certain clinical information to the database e.g. CVD risk score, history of TB or malnutrition may also assist in clinical management of NCDs in similar settings.

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RECOMMENDATIONS FOR BROADER CHANGES TO POLICY AND PRACTICE

We demonstrate that an NCD programme can be successfully decentralised and integrated at primary care level and recommend building on this model. Following the ART model, we recommend a nurse-led approach with a strong patient treatment support component, delivered by trained counsellors and in the setting of patient support and adherence groups. As discussed earlier, this would necessitate streamlining and simplification of MSF NCD guidelines to facilitate locally adapted algorithm-based treatment with fewer possible medication combinations. Fixed-dose combination pills may have a role in streamlining the potentially complex task of e.g. hypertension treatment. Negotiating appropriate local and national policy and regulatory change and capacity building of several health worker cadres will facilitate such an approach.

Beyond programme implementation, we recommend advocacy with drug manufacturers and strengthening of supply chains to improve availability, accessibility and affordability of NCD medications, especially insulin. Our findings also highlight the key role that prevention policy and interventions must play in managing the growing NCD burden in humanitarian settings. A multisectoral approach is needed, especially targeting obesity and inactivity amongst women, as well as the effects of urbanisation, commercialisation of the food and agricultural sector and harnessing the education sector.

Panel: Policy Recommendations

 Decentralised NCD care and treatment to be integrated at primary level with the following adaptations: . Nurse-led approach with a strong patient treatment support component . Includes trained counsellors and adherence groups  Streamlining of MSF NCD guidelines to produce locally adapted algorithm-based treatment protocols with fewer treatment steps  Inclusion of fixed dose combination drugs in drug lists and clinical algorithms  National policy and regulatory change and capacity building of health worker cadres to facilitate NCD integration.  A multisectoral approach toward prevention and treatment of NCDs  Supply chain strengthening to ensure a sustainable NCD drug supply

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FUTURE RESEARCH

To further clarify the effect that enrolment in an MSF NCD programme has on control of intermediate clinical outcomes, a cohort of NCD patients would ideally be compared with a control cohort. Generating evidence on the feasibility, clinical- and cost-effectiveness of a locally adapted, streamlined NCD protocol, as described above, may enable further simplification of the MSF NCD guideline. Future studies of NCD programme cohorts in SSA could explore the effect of medication adherence, other comorbidities, time since diagnosis, use of insulin, urban vs. rural living, exercise levels and diet composition to further investigate factors influencing diabetes and hypertension control.

More work is needed to characterise the epidemiology of NCD risk factors and to define clinically relevant disease thresholds and treatment targets for a sub-Saharan African population such as this50. Identifying successful lifestyle and behaviour change interventions, such as programming to improve exercise levels, dietary composition and weight loss is also an important area for future research.

The interplay between HIV and/or TB and NCD conditions and risk factors should be further elucidated, ideally identifying prevalence of NCD risk factors among the entire HIV and TB cohort in Matsapha and more broadly. This would assist with service planning for established HIV/TB programmes in Eswatini and in neighbouring countries, which are turning their attention to co-morbid NCDs.

ACKNOWLEDGEMENTS

Funding was provided by MSF OCA and MSF UK for this evaluation. It was performed by the MSF OCA Eswatini field, coordination and research team with the support of the OCA NCD advisor, in collaboration with LSHTM.

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41. Drummond, M.F.; Sculpher, M.J.; Torrance, G.W.; O’Brien, B.J.; Stoddart GL. Methods for the economic evaluation of health care programme. Third edition - Research Database, The University of York. Oxford Univ Press. 200AD. https://pure.york.ac.uk/portal/en/publications/methods-for-the-economic- evaluation-of-health-care-programme-third-edition(e43f24cd-099a-4d56-97e6- 6524afaa37d1)/export.html. Accessed October 19, 2017.

42. Obure CD, Sweeney S, Darsamo V, et al. The Costs of Delivering Integrated HIV and Sexual Reproductive Health Services in Limited Resource Settings. Postma M, ed. PLoS One. 2015;10(5):e0124476. doi:10.1371/journal.pone.0124476.

43. OECD. Purchasing power parities (PPP) (indicator). 2017. doi:10.1787/1290ee5a-en.

44. Kanavos P, Mossialos E. International Comparisons of Health Care Expenditures: What We Know and What We Do not Know. J Health Serv Res Policy. 1999;4(2):122-126. doi:10.1177/135581969900400211.

45. Jobanputra K, Boulle P, Roberts B, Perel P. Three Steps to Improve Management of Noncommunicable

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Diseases in Humanitarian Crises. PLOS Med. 2016;13(11):e1002180. doi:10.1371/journal.pmed.1002180.

46. Murphy A, Biringanine M, Roberts B, Stringer B, Perel P, Jobanputra K. Diabetes care in a complex humanitarian emergency setting: a qualitative evaluation. BMC Health Serv Res. 2017;17(1):431. doi:10.1186/s12913-017-2362-5.

47. Straka RJ, Keohane DJ, Liu LZ. Potential Clinical and Economic Impact of Switching Branded Medications to Generics. Am J Ther. 2017;24(3):e278-e289. doi:10.1097/MJT.0000000000000282.

48. Divala OH, Amberbir A, Ismail Z, et al. The burden of hypertension, diabetes mellitus, and cardiovascular risk factors among adult Malawians in HIV care: consequences for integrated services. BMC Public Health. 2016;16(1):1243. doi:10.1186/s12889-016-3916-x.

49. MSF. Management of Diabetes and Associated Costs in a Complex Humanitarian Setting in the Democratic Republic of Congo: A 3-Year Retrospective Cohort Study.; 2017.

50. Atun R, Davies JI, Gale EAM, et al. Diabetes in sub-Saharan Africa: from clinical care to health policy. lancet Diabetes Endocrinol. 2017;5(8):622-667. doi:10.1016/S2213-8587(17)30181-X.

51. Mensah GA. Descriptive Epidemiology of Cardiovascular Risk Factors and Diabetes in Sub-Saharan Africa. Prog Cardiovasc Dis. 2013;56(3):240-250. doi:10.1016/J.PCAD.2013.10.014.

52. WHO | WHO/ISH cardiovascular risk prediction charts. WHO. 2011. http://www.who.int/cardiovascular_diseases/guidelines/Chart_predictions/en/. Accessed November 27, 2017.

53. Labhardt ND, Balo J-. R, Ndam M, Grimm J-. J, Manga E. Task sharing to non-physician clinicians for integrated management of hypertension and diabetes in rural Cameroon: a programme assessment at two years. BMC Heal Serv Res. 2010;10. doi:10.1186/1472-6963-10-339.

54. De Wit S, Sabin CA, Weber R, et al. Incidence and risk factors for new-onset diabetes in HIV-infected patients: the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. Diabetes Care. 2008;31(6):1224-1229. doi:10.2337/dc07-2013.

55. GOLD - the Global initiative for chronic Obstructive Lung Disease. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Accessed December 8, 2015.

56. Settumba SN, Sweeney S, Seeley J, et al. The health system burden of chronic disease care: an estimation of provider costs of selected chronic diseases in Uganda. Trop Med Int Health. 2015;20(6):781-790. doi:10.1111/tmi.12487.

57. Wallace E, Salisbury C, Guthrie B, Lewis C, Fahey T, Smith SM. Managing patients with multimorbidity in primary care. BMJ. 2015;350:h176. doi:10.1136/BMJ.H176.

58. Cooper JA, Cadogan CA, Patterson SM, et al. Interventions to improve the appropriate use of polypharmacy in older people: a Cochrane systematic review. BMJ Open. 2015;5(12):e009235. doi:10.1136/bmjopen-2015-009235.

59. Assayed AA, Muula AS, Nyirenda MJ. The quality of care of diabetic patients in rural Malawi: A case of Mangochi district. Malawi Med J. 2014;26(4):109-114.

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http://www.ncbi.nlm.nih.gov/pubmed/26167259. Accessed December 8, 2017.

60. Cohen DB, Allain TJ, Glover S, et al. A survey of the management, control, and complications of diabetes mellitus in patients attending a diabetes clinic in Blantyre, Malawi, an area of high HIV prevalence. Am J Trop Med Hyg. 2010;83(3):575-581. doi:10.4269/ajtmh.2010.10-0104.

61. Rabkin M, Nishtar S. Scaling up chronic care systems: leveraging HIV programs to support noncommunicable disease services. J Acquir Immune Defic Syndr. 2011;57. doi:10.1097/QAI.0b013e31821db92a.

62. World Health Organization, World Health Organization. Department of HIV/AIDS. Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV.

63. Sweeney S, Obure CD, Terris-Prestholt F, et al. The impact of HIV/SRH service integration on workload: analysis from the Integra Initiative in two African settings. Hum Resour Health. 2014;12:42. doi:10.1186/1478-4491-12-42.

64. Collins DRJ, Jobanputra K, Frost T, et al. Cardiovascular disease risk and prevention amongst Syrian refugees: mixed methods study of Médecins Sans Frontières programme in Jordan. Confl Health. 2017;11(1):14. doi:10.1186/s13031-017-0115-z.

65. Tagar E, Sundaram M, Condliffe K, et al. Multi-country analysis of treatment costs for HIV/AIDS (MATCH): facility-level ART unit cost analysis in Ethiopia, Malawi, Rwanda, South Africa and Zambia. PLoS One. 2014;9(11):e108304. doi:10.1371/journal.pone.0108304.

66. 2013 Report on Costs of Treatment in the President’s Emergency Plan for AIDS Relief (PEPFAR) Background. https://www.pepfar.gov/documents/organization/212059.pdf. Accessed December 21, 2017.

67. Bratt JH, Torpey K, Kabaso M, Gondwe Y. Costs of HIV/AIDS outpatient services delivered through Zambian public health facilities. Trop Med Int Heal. 2011;16(1):110-118. doi:10.1111/j.1365- 3156.2010.02640.x.

68. Rosen S, Long L, Sanne I. The outcomes and outpatient costs of different models of antiretroviral treatment delivery in South Africa. Trop Med Int Heal. 2008;13(8):1005-1015. doi:10.1111/j.1365- 3156.2008.02114.x.

69. Besançon S, Fall I-S, Doré M, et al. Diabetes in an emergency context: the Malian case study. Confl Health. 2015;9(1):15. doi:10.1186/s13031-015-0042-9.

70. Beran D, Ewen M, Laing R. Constraints and challenges in access to insulin: a global perspective. Lancet Diabetes Endocrinol. 2016;4(3):275-285. doi:10.1016/S2213-8587(15)00521-5.

71. Access to Insulin Commitment. https://www.novonordisk.com/sustainable-business/performance-on- tbl/access-to-care/our-access-to-insulin-commitment.html. Accessed July 25, 2018.

72. Sallis JF, Bull F, Guthold R, et al. Progress in physical activity over the Olympic quadrennium. Lancet. 2016;388(10051):1325-1336. doi:10.1016/S0140-6736(16)30581-5.

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ANNEXES

12.1 MATSAPHA COMPREHENSIVE CLINIC SITE PLAN

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12.2 LOGISTIC REGRESSION TO DETERMINE RISK FACTORS FOR UNCONTROLLED FASTING BLOOD SUGAR AMONG DIABETIC PATIENTS ENROLLED IN MATSAPHA NCD PROGRAMME

Characteristics Crude association (N=289) Adjusted model (N=272) OR (95% CI) P-value OR (95% CI) P-value Gender Female Reference Reference Male 0.8 (0.5-1.3) 0.41 0.9 (0.5-1.5) 0.63 Age (linear: 1 year increase) 1.0 (1.0-1.0) 0.64 1 (1.0-1.0) 0.99 Smoking 0.3 (0.0-2.4) 0.25 0.4 (0.0-3.7) 0.42 0.3 (0.1-1.4) 0.13 Alcohol 0.4 (0.1-2.1) 0.29 most recent BMI (N=272)* Normal Reference - Reference - Underweight - -

Overweight 0.7 (0.3-1.7) 0.44 0.7 (0.3-1.6) 0.41 Obese 0.8 (0.4-1.7) 0.54 0.7 (0.3-1.6) 0.45 HIV status Negative Reference 0.71 Reference Positive 1.2 (0.7-2.2) 0.72 1.2 (0.6-2.2) 0.66 Unknown 0.9 (0.4-2.1) 0.8 (0.3-2.3) 0.74 ^ refers to diabetic patients in care for >3 months with at least one follow up visit and with an FBS measurement at their last visit. * BMI is very likely missing at random so a complete cases model was used.

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12.3 PATIENT FLOW, STAFFING AND NCD/HIV SCREENING IN MATSAPHA NCD PROGRAMME

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12.4 INPUT QUANTITIES AND UNIT PRICES FOR MSF ESWATINI MOH NCD PROGRAMME COST ANALYSIS

Key Data or Assumptions Input Data Other FTE Comments/ Source

PRICE CONVERSIONS AND INFLATION PPP to USD for Euro area 2016 0.71 https://data.oecd.org/conversion/purchasing-power-parities-ppp.htm citation: OECD (2017), Purchasing power parities (PPP) (indicator). doi: PPP to USD for South African Rand 2016 5.853 10.1787/1290ee5a-en (Accessed on 05 October 2017) Health care annual inflation rate 1.03 http://ycharts.com/indicators/us_health_care_inflation_rate Health care annual deflation rate 0.97 Drummond ; Creese and Parker Project life (years) 3 Discount rate @3% for project life 2.829 ALLOCATION FACTORS Activity or supplies wholly devoted to NCDs e.g. drugs and NCD training (%) 1 MSF Capital Office Activity allocation to NCDs (%) 0.03 Estimate MedCo MSF Project Office Activity allocation to NCDs (%) 0.05 Estimate MedCo TOTAL CLINIC ACTIVITY Proportion total activity to NCDs (Total NCD consultations (new+follow up)/Total annual consultations whole clinic) 0.063 GENERAL OPD Total number of General OPD consultations 25270 Monthly Medical Report Total Number of NCD consultations within GOPD 3996 Monthly Medical Report Proportion of GOPD activity devoted to NCDs (for overheads and shared non-clinical staff) 0.16 Proportion of doctor NCD consultations within GOPD 0.2 Proportion of nurse NCD consultations within GOPD 0.8 Duration of doctor NCD consultation within GOPD (minutes) 30 Range of estimated duration of doctor NCD consultation (minutes) 10,40 Duration of nurse NCD consultations within GOPD (minutes) 15 Range of estimated duration of nurse NCD consultation in either dept (minutes) 5,15 Duration of non-NCD consultation for doctors in GOPD and in HIV (minutes) 10 Duration of non-NCD consultation for nurses in GOPD and in HIV (minutes) 5 HIV DEPT Total number of HIV department consultations 28424 Total Number of HIV/NCD consultations (assume 97 patients x nurse review every 3 months = Note, all consultations initially performed by the nurse except with an 400/ year) 400 additional first visit consultation by the doctor Proportion of HIV/ NCD consultations referred to doctors 0.3 range 30-40%

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Key Data or Assumptions Input Data Other FTE Comments/ Source

Duration of doctor HIV/ NCD joint consultation (minutes) 30 Duration of nurse HIV/ NCD joint consultation (minutes) 15 OTHER CLINIC ACTIVITY Based on additional FTE added to account for increased activity related to Lab activity allocation to NCDs 0.167 NCDs Pharmacy activity allocation to NCDs 0.02 Based on supervisor estimate CAPITAL Building costs were inflated to 2016 then annualised; provided in Euro but BULDINGS AND STORAGE likely incurred in local currency and converted using ? Exchange rate Building life expectancy 10 years Creese and Parker Inflation Annualisation factor taken from table in: Guidelines for Cost Effectiveness Discount rate 3% Analysis of Syphilis Screening Strategies ? Reference - PLOS paper Allocation is based on proportion of total clinic consulations dedicated to NCD allocation 0.063 NCDs Year of Euro Purchase Architect service 16906 2011 MSF built clinic in 2012 on town council land (donated) Consultancy costs and architect fees were assumed to have been paid in Consultancy service 30000 2011 2011 at the start of the building project Walkways various 14001.48 2011 Conference +office block 798598.97 2016 Parkhomes Clinic 2469494 2011 Guard House etc 1465511 2011 Drainage +Pavements 86028.5 2011 Play place 29965 2013 Waiting area 76562.42 2013 HTC, DOTS, Suspects 1081946.03 2014 Paving Cabro + Washing area 131605.02 2014 Log store/ Pharmacy 342047.9 2013 Assumed that incinerator building cost based on other building costs and Incinerator building 1250000 2013 that year of build was 2011 Year of SAR Purchase 2016 price range for land is 160-236 Swazil Lilangeni per square metre; 2016 price per m2 for land purchase in Matsapha 198 2011 median was used

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Key Data or Assumptions Input Data Other FTE Comments/ Source

2,376,000 Estimated cost of land purchase (12,000*198=2,376,000 SAR) SAR 2011 Other Based on map supplied by field logistic team; General OPD space is all of OPD space that is involved in delivering NCD care including reception, waiting area, clinical consultation rooms, treatment rooms, counselling Clinic land square metres estimate 12,000 rooms (office block, parkhomes clinic, guard house, play place, waiting area, HTC, Furnishing cost added to relevant building costs 10% Log store/ pharmacy) Cost price was used for economic cost rather than current value as this was not available MSF office space in Matsapha monthly rent (Rand) 0 MSF build premises and did not pay rent Proportion of MSF office workload devoted to NCD care (estimate) 0.05 MSF Coordination office space monthly rent (Rand) MSF capital warehouse space monthly rent (Matsu) Estimated proportion of capital warehouse space devoted to NCD care; 0.01 EQUIPMENT (Included all equipment purchased for the NCD service even if not currently Year of in use; equipment > 100 US dollars and lasting more than one year; Euro Purchase included; Furnishing/IT equipment etc is accounted for in additional 10% Generator 13825 2011 added to building costs for furnishing; MSF price list used and assumption Biomedical Equipment 74790.41 2011 that equipment was purchased in 2011 VEHICLES Logistics inventory monitoring sheets; discussion with Expat MD Year of 2016 purchase price was used to estimate annualised economic cost of PROJECT LEVEL Euro Purchase each vehicle Toyota 4x4 23333 2012 Toyotas imported by MSF; imprts are tax free Toyota 4x4 26766 2015 Toyota 4x4 26766 2015 Toyota 4x4 29000 2016 Assumed based on local purchase price currently i.e. 219,900 for used Avanza 250000 2016 2016; 204,00 for new 2015 and 274, 990 SAR for new 2017 Year of CAPITAL LEVEL Euro Purchase Toyota 4x4 0 2012 Toyota 4x4 0 2012 Avanza 250000 2016 https://www.autotrader.co.za/new-cars/toyota/avanza/2017 Avanza 250000 2016 Avanza 250000 2016

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Key Data or Assumptions Input Data Other FTE Comments/ Source

Other Allocation factor to NCD care for project-level vehicles 5% Allocation factor to NCD care for capital-level vehicles 3% Estimated shipping cost added to MSF imports 5% START UP TRAINING approximate conversion from 2017 course fee for London-based Primary Estimated course fee 1000 Care International London-based course Training accommodation costs 500 Amsterdam training unit Transfer costs 100 Local knowledge Assumed the lifespan of this training was 3 years, the approximate project life 3 Allocation to NCD 1. 0 One Expat doctor and one national staff nurse attended week-long NCD training course in Jordan in April 2016; assumed economic cost for one working week (total annual salary/52) Converted SAR for nurse salary economic cost to Euro using April 2016 Salary conversion for nurses salary 0.059520344 historical exchange rate RECURRENT PERSONNEL (2016 ANNUAL salaries) Assumed all staff paid by MSF at MSF salary levels; 4 staff were acutally PROJECT LEVEL paid by the MOH and MOH salary scales were unavailable Used average salary when multiple workers of same cadre paid at different Expatriate personnel Euro FTE points on salary scale Expat salary includes expenses, insurance, pension, NOT per diem Assume that monthly salary of all expatriates is a nominal figure of 3200 Euro 38,400 source: Human Resources Coordination team Expat MD 38,400 1 National personnel SAR FTE If expenses are not listed separately, they have been included in the salary cost Salary Expenses Assume salaries in 2016 SA Rand; converted to USD 2016 using PPP 5.853 Administration/ Logistics (non-clinical personnel) 11611325.00 980623.00 n/a Cough Officer 105569.00 0.00 1 source: MedCo; average of Cough Officer’s salary inclusive of all expenses Registrar 68648.00 24156.40 3 All patients Triage nurse aid 169207.86 27864.39 3 Estimate based on other salary figures. All patients ; except HIV Source: Medical Coordinator (MedCo); average all nurses' salaries including Labtech 208177.00 25757.00 6 seniority, overtime, pension, health insurance Pharmacist / dispenser 270274.00 0.00 1 Source: MedCo; (inclusive seniority, pension, health insurance). Pharmacy technician 169207.86 27864.39 1 Pharmacy assistant 111021.00 0.00 5

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Key Data or Assumptions Input Data Other FTE Comments/ Source

Data encoder 172740.00 26313.00 3 Cleaner 46868.00 17691.40 3 Nurse in GOPD; sees all GOPD patients 181233.03 29377.62 n/a See staff time calculations Local MD annual salary; sees new, unstable NCD patients and those referred from triage/HIV/GOPD nurses 416687.72 34862.41 n/a See staff time calculations source: MedCo; NCD supervisor (expat MD) per diem (+12 *monthly 4000 Expat annual converted salary (Rand) 52320 48000 Rand) Allocations Allocations NCD allocation depends on their role in NCD care Labtech allocation to NCDs is one WTE 0.17 Source: MedCo email Pharmacist / dispenser activity allocation to NCDs 0.02 Source: MedCo email Data encoder 0.2 Source: MedCo email;NCD supervisor Rest of staff (other than nurses and MD) allocation to NCDs 0.063 Source: MedCo email NCD supervisor time - 50% is spent on NCDs 0.5 Source: MedCo email;NCD supervisor COORDINATION LEVEL total annual expenditure coordination level NATIONAL staff 2016 SAR Health costs 330,207 Source: MedCo email Pension 97,900 Source: MedCo email Provident Fund 25,672 Source: MedCo email Workmans Compensation 54,721 Source: MedCo email Salaries 2,468,180 Source: MedCo email total annual expenditure for coordination level EXPAT staff SAR FTE Monthly salary plus expenses 52,320 5 Source: MedCo email Annual rent of four houses 384,000 Source: MedCo email 4 x annual utility costs 72,000 Source: MedCo email DRUGS Assumptions MoH supplies drugs but has frequent stock outs and makes an order to MSF to make up for the shortfall; MSF Medical Coordinator Some drugs supplied 100% by MSF:(e.g. insulin, atorvastatin) so the MSF price in Euro was used MSF Medical Coordinator Some drugs supplied 100% by MOH: (e.g. propranolol) so the MOH price in South African Rand was used MSF Medical Coordinator Otherwise, it was assumed that 50% of each drug was supplied by MOH and 50% by MSF MSF Medical Coordinator An additional 10% was added to consumption data to account for wastage Assumption (Creese and Parker) MSF imports drugs from Europe; additional 5% added to represent shipping cost Assumption (Creese and Parker)

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Key Data or Assumptions Input Data Other FTE Comments/ Source

Consumption data includes only drugs dispensed to patients Assumption Drug cost was calculated on a monthly basis; MSF Medical Coordinator MSF 2017 prices were deflated to 2016 prices; Only MOH prices for 2017 were available (deflated to 2016 prices for July - Dec 2016); See separate table for drug unit prices and consumption CONSUMABLES Unit Cost + Consumption 5% shipping + 10% Item (SAR) wastage Source: Laboratory manager and research coordinator emails 2. CONSUMABLES - CLINIC Cotton wool 1.48176 128 Sharps containers 4.0446 240 Alcohol hand gel 3.465 36 Medication bags 0.30408 57,272 3.CONSUMABLES - LAB Surfanios 0.945 26 95% ethanol/ Alcohol 8.9985 13 urine specimen containers 0.087087 330 Small Gloves 0.026733 13,200 Medium Gloves 0.026733 6,600 Large Gloves 0.026733 2,640 Cotton wool 1.48176 40 BD vacutainer - red 0.2345175 19,800 Microtainer, K2EDTA - lavender 0.2345175 660 Butterfly Vacutainer needle 23G 0.29678775 660 (blds.syst.) NEEDLE, sterile, 21G (Vacutainer) 0.0617925 11,880 Auto Safety Lancets 0.1903125 13,200 Lancets 0.006615 13,200 Toner catridge CANON FX10 TB Printer 18.1335 11 Urine dipsstick, Combur test strip 0.07413 53 Glucose elite 0.483 66 4. STATIONARY plastic covers for patient files 0.042 1,723 Paper for printing patient files 0.0105 15,928 Pens 0.189 1,584

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Key Data or Assumptions Input Data Other FTE Comments/ Source

5. OTHER - LIFE LONGER THAN ONE YEAR Measuring tapes 15.75 4 Job Aides (laminated clinic posters) 10.5 9 3.CONSUMABLES - LAB in rand 0 0 Reagent Glucose (1/month) 11.55 13 Reagent Creatinine (2/month) 6.825 26 Reagent ALT (2/month) 11.55 26 Reagent Cholesterol (1/month) 1.7842965 13 Reagent Triglycerides (1/month) 1.9071465 13 Reagent HDL (1/month) 59.22 13 Reagent LDL (1/month) 76.44 13 Deproteinizer 75.726 13 Cleaner 0 13 Cleaner cassette 59.85 13 Micro cuvettes 3.255 13 Sample cups with white hole 0 13 Cuvette waste container 0 13 Assumptions Assumed all supplies are imported; 5% import cost added to account for shipping costs Assumption (Creese and Parker) Assumed all with prices in Green List are imported from Amsterdam; assumed all without prices in Green List are locally purchased in SAR and that pirces provided by field are in Rand Assumed price of measuring tape based on prices of biomed equipment in Green List and personal experience; Assumed patient files= 10 x A4 paper + plastic cover; prices from Green List.; Number of patient files according to NCD supervisor: 1,448 NCD supervisor Allocations Clinic consumables - 0.06 allocation applied as per total clinic activity allocation 0.06 Lab consumables - appliedallocation to NCDs as per lab activity allocation 0.17 VEHICLE OPERATION AND MAINTENANCE AND/OR TRANSPORTATION Annual per vehicle cost Avanza (SAR) Petrol/Diesel 31137 Email research coordinator Oil 1024 Email research coordinator Maintenance 4140 Email research coordinator

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Key Data or Assumptions Input Data Other FTE Comments/ Source

Insurance 18226 Email research coordinator Registration 110 Email research coordinator Spare parts 3992 Email research coordinator Project units 1 Email research coordinator Capital units 3 Email research coordinator Annual per vehicle cost Land Cruiser (SAR) Petrol/Diesel 59496.00 Email research coordinator Oil 6144.00 Email research coordinator Maintenance 13632.00 Email research coordinator Insurance 23820.00 Email research coordinator Registration 185.00 Email research coordinator Spare parts 6878.00 Email research coordinator Project units 4.00 Email research coordinator Capital units 0.00 Email research coordinator Assumptions Assumed prices provided by the team are in SAR Assumed annual costs for the operation/maintenace of ONE of each type of vehicle (not total fleet) Assumed 4 landcruisers and 1 Avanza at project level and the same at capital level Source: MSF inventory and discussion with NCD supervisor Distance from capital city to project is 5 km so round trip is 10 km 10 Email research coordinator; MedCo Distance from project office to clinic is 1.5 km so round trip is 3km 3 Email research coordinator; MedCo H) BUILDING OPERATION AND MAINTENANCE assumed that the project office had the same utility costs as the clinic i.e. Allocations counted them once only Apportioned clinic operation costs 0.063 Apportioned project operational costs 0.05 Apportioned capital office operational costs 0.03 Single warehouse used for both capital and project: "Matsu"; 0.01 Rent SAR Annual rent for capital office 277,200 Source: MedCo email Annual rent for project office 277,200 Source: MedCo email Annual rent for Matsu warehouse 324,872 Source: MedCo email Monthly utilities project/clinic SAR Telephone/fax 0.00 Source: MedCo email

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Key Data or Assumptions Input Data Other FTE Comments/ Source

Water 82986.00 Source: MedCo email Electricity 0.00 Source: MedCo email Maint/repair, Cleaner/ non clinical waste 0.00 Source: MedCo email Clinical waste disposal 0.00 Source: MedCo email Monthly utilities coordination office Telephone/fax 82923.00 Source: MedCo email Water 18267.00 Source: MedCo email Electricity 15400.00 Source: MedCo email Maint/repair, Cleaner/ non clinical waste 46868.00 Source: MedCo email Clinical waste disposal None Source: MedCo email I) RECURRENT TRAINING Recurrent on-job training costed out separately for opportunity cost of one hour of clinical time per week of 2 doctors' and 17 nurses' time; 46 working weeks per year L) CONSULTANCIES Euro NCD Advisor headquarters visit (14 days, salary, per diem, MSF accommodation) 400.00 Source: MedCo email; NCD Advisor Life of effect 3 years STAFF TIME total vacation days/year 32.00 Email MSF Research coordinator 7.8.17 total clinic active days/year 299.00 Email MSF Research coordinator 7.8.17 total worked days/ year per health worker 267.00 Email MSF Research coordinator 7.8.17 total working hours/day 9.00 Email MSF Research coordinator 7.8.17 total worked hours/year 2403.00 total worked minutes/year 144180.00 working minutes in costing period 144180.00 Annual Relevant Salaries SAR allowances Nurse 181233.03 29377.62 Email MSF Research coordinator 7.8.17 Local MD 416687.72 34862.41 Email MSF Research coordinator 7.8.17 Expat MD salary + allowances (Rand) 0.00 80820 Email MSF Research coordinator 7.8.17 Euro Expat MD annual salary (Euro) 38400.00 Workflow Total New appointments in study period: 895.00 Monthly Medical Report Total follow up appointments in the study period (GOPD) 3114.00 Monthly Medical Report Proportion of MD appointments done by Expat MD 0.50 Email NCD supervisor;MedCo Assumed a proportion - 30% - referred to doctors and a second 30 minute consultation is 0.30 Email NCD supervisor: 40% not at target but of these 25% didn’t go back to

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Key Data or Assumptions Input Data Other FTE Comments/ Source done. MD (not referred/didn’t attend) Number enrolled patients attending Matsapha for HIV care 97.00 Database; Monthly Medical Report Assumed no. follow up appointments per patient for HIV dept NCD pts. 3.00 Email NCD supervisor During study period i.e. 3 x 3 monthly appt.s - first appointment is "new" with MD, then f/u apppt every 3 months Assumed total no. f/u appts for NCD in HIV dept by nurse 291.00 Email NCD supervisor Assumed no. of HIV NCD patient referred by nurse to MD 87.30 Email NCD supervisor Assumed no. new appts for HIV Dept NCD patients by all MD 97.00 Email NCD supervisor MD appointments for HIV Dept NCD patients each by local MD/ Expat MD 92.15 Assumed total no. f/u appts for NCD in GOPD by nurse 2823.00 Assumed no. of GOPD NCD patient referred by nurse to MD 846.90 Assumed no. new appts for GOPD Dept NCD patients by MD 798.00 MD appointments for GOPD NCD patients each by local/ Expat MD 822.45 Estimates of duration of consultations Minutes - general OPD nurse (non NCD): 5-10 Email NCD supervisor - general OPD nurse (NCD): 5 minutes (refill, no complications) to 15 minutes (refill with ordinary problems/counseling) 5-15 Email NCD supervisor - general OPD doctor (non NCD): 10-20 minutes 10-20 Email NCD supervisor - general OPD doctor (NCD): 10-30 minutes 10-30 Email NCD supervisor - pediatric OPD nurse: 10 to 15 minutes 10-15 Email NCD supervisor - HIV refill nurse: 5-15 minutes 5-15 Email NCD supervisor - DSTB refill nurse: 10-15 minutes 10-15 Email NCD supervisor - ante natal care nurse: 15-20 minutes 15-20 Email NCD supervisor PROJECT OUTPUTS Patients registered in programme 895 Patients retained by end of evaluation period 749 Number of NCD consultations 3996

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12.5 DRUGS PRESCRIBED BY NCD DIAGNOSIS Whole Cohort (N=895) HIV negative (N=640) HIV positive (N=154) HIV Unknown (N=101) N (%) N (%) N (%) N (%)

# taking atorvastatin (whole 18 (2.0) 12 (1.9) 1 (0.7) 5 (5.0) cohort) of which 6 are also taking aspirin

# of hypertensive drugs among hypertensive patients * 1 261 (34.3) 188 (33.9) 45 (38.5) 28 (30.8) 2 324 (42.5) 231 (41.7) 55 (47.0) 38 (41.8) 3+ 177 (23.2) 135 (24.4) 17 (14.5) 25 (27.5) # taking atorvastatin 18 (2.4) 12 (2.2) 1 (0.8) 5 (5.5) Drugs among diabetic patients Only OHG** (metformin and/or 264 (76.3) 181 (77.4) 58 (75.3) 25 (71.4) glibenclamide) Only insulin (protophane and/or 24 (6.9) 16 (6.8) 6 (7.8) 2 (5.7) actrapid)

Both OHG and Insulin 55 (15.9) 36 (15.4) 12 (15.6) 7 (20.0) Atorvastatin 10 (2.9) 7 (3.0) 1 (1.3) 2 (5.7) Drugs among Asthma patients Only Salbutamol 23 (69.7) 18 (66.7) 3 (75.0) 2 (100.0) Salbutamol and beclomethasone 10 (30.3) 9 (33.3) 1 (25.0) 0 * 5 hypertensive patients were not prescribed drugs ** OHG=Oral hypoglycaemic drug

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12.6 SOP FOR MSF ESWATINI MOH MATSAPHA NCD PROGRAMME

SOP NCD program

Matsapha Comprehensive Care Clinic

Version I July 2017

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Table of Contents

1. Introduction 2. Programmatic SOPs a. Identification of NCD patients b. Entry to the service for NCD patients c. Registration d. Process of each visit i. Triage ii. Clinical consultation iii. Health Education iv. Laboratory v. Pharmacy vi. Arrangement of follow up e. Monitoring and evaluation 3. Clinical SOPs a. Asthma/COPD b. Hypertension c. Diabetes mellitus 4. Appendix a. Chronic care Card b. CVD Management c. Patient education on Hypertention d. Patient education on Diabetes mellitus Typ II e. Diet advice: low salt diet f. Diet advice: low fat diet g. Diet advice: fruit and vegetables

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1. Introduction

Swaziland has a high burden of NCDs and a very high TB and HIV prevalence. Around 16 % of patients with Hypertension and Diabetes are HIV positive. In 2014 NCDs accounted for 25% of deaths in Swaziland, with HIV / TB accounting for the majority of the rest. Due to the successful scale up of ART, this pattern is now likely to be reversing itself – NCDs are expected to represent the main cause of mortality by 2020.

There is a high prevalence of modifiable risk factors of non-communicable diseases. Tobacco use is relatively low overall but high among the men. The diet is high in carbohydrates and fat, 92% of the population consume less than the recommended amount of fruits and vegetables. Salt consumption is high, a 5th of the population daily consumes processed food high in salt. The composition of diet factors and physical inactivity leads to a generally high prevalence of overweight and central obesity especially among females. Subsequently the prevalence of both diagnosed and undiagnosed hypertension and diabetes mellitus was found to be high. (WHO Steps report 2014)

Besides presenting a serious threat to public health, NCDs are a significant burden to the health care budget, lead to impoverishment and physical handicap. Fortunately, cost-effective and high-impact interventions to prevent and control NCDs are available. In order to ensure that these interventions are delivered in an efficient and effective manner and have the desired impact an integrated approach is necessary.

As the treatment options for HIV have expanded and improved, management approaches have transitioned from acute, emergency care to chronic care. The health care systems in Swaziland addressing HIV are well developed due to the extent of the incidence and the joint effort of the MOH and international actors to control the epidemic. The chronic care management for HIV is a platform that can be leveraged to integrate NCD services that are otherwise lacking. The similarities in prevention, detection, care and long-term management of HIV and NCDs, as shown in the chart, highlight such opportunities.

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Integration of HIV and noncommunicable disease care: https://www.fhi360.org/sites/default/files/media/documents/NCD_Factsheet_v3_WEB.pdf

Matsapha Comprehensive Care Clinic has treated common NCDs since its opening in March 2011. From July 2015, a chronic care model was introduced whereby patients were followed-up and checked if they were well-maintained on treatment. In August 2016 a formal, integrated NCD care program was implemented into the service. Staff training on management of NCDs was undertaken, and clinic files and a monitoring database were implemented which has provided (for the first time) some visibility on this cohort and the quality of care delivered.

The following SOPs show the structure and clinical features of the implemented NCD program. Emphasize has been put on basic service that are easy implementable and cost effective. Over time with growing resources the program can and should be extended to cover care for other NCDs and put more effort into prevention and patient education.

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2. Programmatic SOPs

a. Identification of NCD patients

Inclusion criteria: patients with one of the following conditions: Hypertension, Diabetes mellitus (Typ 1 and Typ 2), CVD, Asthma, Chronic obstructive lung disease either:

- Newly diagnosed by a clinician at Matsapha CCC (see diagnostic criteria in the clinical section) - Diagnosed at another facility (and receiving ongoing treatment) but seeking for their care to be transferred to Matsapha CCC

Exclusion criteria: all other NCDs, patients under continuous care at other health facilities who do not wish for their care to be transferred to Matsapha CCC

b. Entry of services for NCD patients

Patients may enter the clinic services through general OPD, the TB department (suspect or confirmed cases), the DR TB department and the HIV department.

In every department adult patients should be screened for Hypertension and Diabetes.

In OPD: vital signs are taken at triage

In TB and ART departments: vital signs are taken during consultation with the nurse

All patients starting ART or TB treatment will be screened for Hypertension and Diabetes (random blood sugar measurement) at initiation and further on annually. If impaired glucose close follow up.

All patients entering the clinic will undergo cough screening, aimed at identification of TB cases. However those patients will be evaluated for TB symptoms. If TB is excluded but chronic cough or asthma symptoms present they should be referred to the doctor for evaluation of possible COPD or Asthma.

c. Registration

All patients should be registered as chronic care NCD patients, if:

- The NCD diagnosis fulfills the inclusion criteria mentioned in section 1 - The patient expressed his/her commitment to continue treatment at Matsapha Clinic and the commitment has been evaluated by returning to the set appointments during the first 2- 3 months.

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At registration the patient receives his/her unique NCD number and a clinic held chronic care file. The general patient information on Name, age, contact details, gender, biometrical data (weight, height) and comorbidities will be filled in on the registration date.

The prescribed medication will be filled in with the start date and starting dose. If the patient has been on medication prior to entering our medical services the date he/she started the NCD medication should be determined.

After consultation the patient will hand over the chronic care file to the registration desk at the clinic. It will be passed on to the data encoder who will create a new electronic patient record and subsequently file the NCD card in the cabinet.

d. Process of each visit i. Triage regulations

Hypertension  >140/90mmHg at triage  AND again at least 30 mins after (on the same day) when rested  Ideally take at least 3 BP readings each time it is checked and ignore the first one. Take the best of the second two readings. This should be with an appropriately sized cuff so that it can overlap at least 1/3 of the Velcro when fastened

Severity of HTN Systolic BP Diastolic BP Triage action:

Normal BP <140 mmHg <90 mmHg No action needed

Mild >140 mmHg >90 mmHg -> refer to nurse

Moderate >160 mmHg >100 mmHg -> refer to nurse

Severe >180 mmHg >110 mmHg -> all patients refer to MD

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Diabetes - Check if patients had breakfast (random vs. fasting blood sugar) - Send to lab for BS test - Triage according to BS level

Blood sugar levels

New patients Triage action

Fasting glucose <7  Refer to nurse Random glucose < 11.1mmol/L HbA1c <6.5%

Fasting glucose >= 7mmol/L  refer to nurse Random glucose >= 11.1mmol/L

HbA1c >= 6.5%

Registered NCD patients  refer to MD Fasting glusoce >= 8.3 mmol/l HbA1c >= 8%  refer to MD Glucose < 2,8 mmol/l > 18 mmol/l

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Urgency criteria

>180mmHg systolic, >110 mmHg diastolic Blood Call doctor + Symptoms like vomiting, respiratory pressure distress, severe chest pain, vomiting, or take patient to the severe headache doctor personally

Or < 90mHg syst. + Sweating, respiratory distress, vomiting, reduced consciousness

<40 bpm or >130 bpm Call doctor

Pulse or take patient to the doctor personally And/or signs of shock (sweating, increased respiratory rate, vomiting, coma)

Children >10 years and Adults: >25

Respiratory Children <6 years: >50 Call doctor Rate Children 6-10 years: >30 or take patient to the doctor personally

And/or feeble respiratory effort, exhaustion/confusion/coma, Cyanosis

Call doctor or take patient to the doctor Blood sugar Severe hypoglycaemia: < 2.8mmol/l personally Severe hyperglycaemia: > 18 mmol/l If hypoglycaemia: make the patient eat, if unconscious, requires rapid treatment (glucagon injection, 10% glucose iv infusion)

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ii. Clinical Consultation:

Registered NCD patients enter the clinic via the cough screening if not already on TB treatment.

If the screening result is negative, they proceed to either the OPD or the ART services.

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The clinical consultations for NCDs in general OPD, HIV and DSTB services are nurse led if BP and FBS are in the normal range.

Each visit has to be documented on the chronic care file, 2nd page.

During the consultation the nurse has to:

- record the vital signs, weight and FBS if necessary - calculate and record BMI - check knowledge of medical treatment and adherence - check knowledge on lifestyle recommendation (diet, physical activity) and give/enforce advice - ask about disease specific symptoms/problems: - asthma control and rate of exacerbation for asthmatic/COPD patients - symptoms of hypoglycemia, visual check and foot exam for diabetic patients - re-calculate the cardiovascular risk score on each visit and ask about cardiac symptoms for hypertensive and/or diabetic patients - check if baseline laboratory tests have been performed - check if medication prescribed is accurate and sufficient, prescribe for 3 months - give next appointment in 3 months

If a referral to the doctor is necessary (see referral criteria) the doctor in addition will:

- adjust the medical treatment if necessary and document all changes in medication with the date and reason on the 1st page of the chronic care file - possibly order further laboratory investigations - if necessary refer to another health care facility for further management or treatment - usually the doctor will prescribe the medication for 1 months to check if with change of medication or enforced adherence the disease control has improved - in specifically instable patients the interval can be reduced due to the doctors consideration

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iii. Laboratory testing

Routine blood tests are done according to NCD:

- For diabetic patients FBS on each visit, done on arrival before consultation (Hba1c not implemented yet due to technical difficulties) - FBS annually for hypertensive patients - Creatinine and Urine dipstick annually for all hypertensive and/or diabetic patients - Liver enzymes for all patients when initiated on a Statin - Lipid profile for high risk patients and all patients with risk profile on 2nd line ART (PI)

If urgent blood tests are necessary the nurse or doctor can request those during the consultation and the patient will wait at the laboratory and return with the results later. The result will be immediately recorded in the patient file and then placed in the NCD laboratory result inbox at the data encoder’s desk to be digitalized.

Routine blood tests will be done at registration after the consultation. If the result is:

a. Within the normal range will be passed to the NCD laboratory result inbox at the data encoders desk, they will be digitalized and placed in the NCD file. At the next patient visit the result will be available in the file, the nurse/doctor will document the results on the chronic care file and react accordingly if necessary. b. Without the normal range it will be passed to the clinician for further action (possibly the patient will be called back early). After reacting to the result it will be placed in the NCD laboratory result inbox at the data encoders desk to be digitalized.

iv. Pharmacy

The nurse/doctor writes the prescription in the patient held booklet. A prescription includes the name of the medication, dosage and duration of treatment.

At patient will proceed with the booklet to the pharmacy where the medication will be dispensed and information on how to take it will be provided again.

Specific considerations:

If the patient does not have a fridge but needs to inject insulin the maximum amount of insulin provided will be for 1 month. The patient will be advised to store the insulin in a safe and cool place (e.g. using the double pot technique)

v. Patient education and support

Main education done by the nurse and doctor during consultations

Group health education in waiting room sometimes addresses NCDs.

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vi. Referrals

1. Referrals within Matsapha CCC

Referral criteria to the doctor:

- Acute complications: o Uncontrolled Hypertension >140/90 mmHg o Blood sugar < 2,8 mmol/l or >8,3 mmol/l o Acute exacerbation of asthma/COPD are poorly controlled Asthma/COPD o New diagnosis/worsening of angina or other cardiac symptoms e.g. dyspnea o New diagnosis/worsening of diabetic foot/wound o New diagnosis/worsening of kidney disease: Creatinine Clearance <50 ml/min or reduction by >15 ml/min

2. Referrals to other health care facilities

Referral for investigations

- Ultrasound scan/ echocardiographie: Mbabane hospital, RFM, Mankayane, NTBH for Tb patients

- X-Ray: Mbabane hospital, RFM, Mankayane, NTBH for Tb patients

- CT-Scan: Mbabane hospital

- Endoskopy: RFM

- Ophthalmologist: St. Theresa Eye Clinic

- Cardiologist: Mbabane hospital

- Neurologist: Mbabane Government

- Gynecology: RFM, Mankayane, Mbabane

- General surgery: RFM, Mankayane, Mbabane hospital

- Orthopedic surgeon: Thursdays at Matsapha Health Care, Mbabane hospital

Referral for acute complications / emergencies

- Acute cases can be referred to RFM or Mbabane hospital. Besides basic medical care there is the possibility of surgical interventions, blood transfusions, dialysis, oxygen therapy

Referral for chronic complications:

- Deteriorating vision: St. Theresa Eye clinic

- Chronic ulcers: RMF, Mbanbane hospital for surgery/amputation

- Chronic renal failure: RFM and Mbabane for dialysis if end stage renal failure

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VII. Arrangement of follow up

All chronic care patient files are kept at the clinic.

On registering the patient the file will be handed to him or the consulting nurse/doctor. After consultation the file goes back to the data room where the data collected during the last visit will be digitally recorded before the file is put back in the cabinet.

All laboratory results will be taken to the data clerk who will enter the results in the digital patient file.

e. Monitoring and Evaluation

A quarterly analysis will be done:

- Patient numbers and retaining of patients in the service (number of patients that came in the last quarter and returned in the following quarter) - Quality of clinical consultation based on - Asthma patients: how many had the inhaler technique checked during consultation (registration and follow up) - Diabetic patients: foot exam performed during consultation - Clinical control of disease: - Among asthma patients that came at least once in the quarter how many (%) had an acute exacerbation reported and have been diagnosed before January 2017. - Among diabetic patients (both types) diagnosed before October 2016 how many have fasting blood sugar <= 8.3 - Among HTN patients diagnosed before October 2016 how many have a controlled (both) Systolic (<=140) and diastolic (<=90) blood pressure.

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3. Clinical SOPS

a. Asthma/COPD

MSF Field Guide 2016 ASTHMA: DIAGNOSIS Adults and children CONSIDER THE DIAGNOSIS of ASTHMA IN: Children and younger adults OR older adults with a long history of similar features who present with: BREATHLESSNESS OR WHEEZE/CHEST TIGHTNESS OR COUGH Ask the following questions (‘yes’ answers make asthma more likely) :  Are symptoms worse at night and early morning? Unlike most other chest conditions asthma symptoms often change over the day (often worse in the early hours of the morning and on waking, and better in the evening).  Do symptoms come with/after exercise?  Do symptoms come with allergen exposure or cold air?  Do symptoms come on after taking aspirin/beta-blockers? NOTE: Children who are usually well and ONLY wheeze when they have a viral illness should NOT be diagnosed with asthma. They have viral wheeze. Inhaled short acting beta-agonists (salbutamol) may help. Do NOT use inhaled OR oral steroids, either regularly or when wheezing (research shows no benefit and slows growth). EXAMINATION:  When well: examination should be normal.  When unwell: there should be widespread expiratory wheeze throughout the chest. In more severe illness, there will be an increased respiratory rate and tachycardia.  In very severe (life threatening) asthma the chest may be silent and there may be haemodynamic changes (tachycardia, hyper or hypotension). See the section on acute severe asthma.  If infection has caused asthma, you may hear crepitations in one part of the chest with widespread wheeze across the rest of the chest.  Fine crepitations low in the chest which reduce higher up are more likely to be heart failure. EXCLUDE OTHER DISEASES: Think about the following symptoms, which may suggest another disease:  Dizziness/light headedness/peripheral tingling (hyperventilation?)  Repeatedly normal chest exam when patient is symptomatic (including normal peak flow (PEFR) if able to test this) (hyperventilation?)  Chronic cough in the absence of wheeze/breathlessness (COPD?)  Significant smoking history (an average of 20 cigarettes/day for 10 years)? (COPD? Lung cancer?)  Voice disturbance (is this laryngeal: foreign body, croup, epiglottitis? Is it gastroesophageal reflux?)  Symptoms only with viral upper respiratory tract infection URTIs (viral induced wheeze?)  Cardiac disease or ankle swelling or waking at night (heart failure?) (night time waking does also occur in asthma)  Weight loss (TB, lung cancer?)  Haemoptysis (TB, infections, lung cancer, pulmonary embolus, bronchiectasis?)  Occupational risks for other lung diseases (asbestosis, pulmonary fibrosis?)  Aspergillus (may be seen on chest Xray, with elevated eosinophil count) CONFIRM WITH INVESTIGATIONS IF AVAILABLE: REMEMBER! A good history is more important than any test: focus on the features above (Xrays and blood tests only helpful if another condition suspected) No tests available: ‘trial of treatment’ Trial of oral steroids: Give 30mg daily of oral prednisolone for 14 days (give 20mg if 2-5 years) then review to see if CHEST symptoms have improved (less wheeze, less breathlessness, less chest tightness). Remember patients on steroids feel better all over (fewer aches and pains, better mood): ask therefore about improvements in CHEST symptoms.

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ASTHMA: chronic stable disease MANAGEMENT MSF Field Guide 2016 Adults and children This is for maintenance NOT managing acute exacerbations of asthma! STEP APPROACH TO DRUG THERAPY: When to step up/step down: use the RCP 3 questions: In the last month:  Have you had asthma symptoms during the day (cough/wheeze/chest tightness/breathlessness)?  Have you had difficulty sleeping because of your asthma symptoms/cough?  Has your asthma interfered with your usual activities (housework, work, school)? ‘No’ to all 3 questions below suggests good control. Continue current drugs OR consider reducing inhaled steroids, if used. If ‘yes’ to any of these questions, take a good history – if using salbutamol (reliever) inhaler more than 3x a week OR waking at night more than once a week, then step up treatment. If currently unwell and breathless do NOT step up: treat as acute exacerbation (oral steroids +/- antibiotics). Step 5 Always check compliance and inhaler technique before increasing drugs. Step 4 Children and adults: Step 3 Check inhaler use + refer to specialist. ADD SECOND PREVENTER technique. Step 2 (If these drugs are not Review diagnosis: is this In ADULTS only consider: Step 1 ADD PREVENTER: available go to step 4): asthma? DAILY ORAL STEROIDS START RELIEVER inhaled steroids Over 5 years: Long acting THERAPY: at ‘normal’ doses. beta-agonist eg.Salmeterol INCREASE to ‘HIGH OR Short acting BECLOMETASONE Child 2-5y: leukotriene DOSE’ INHALED Leukotriene receptor bronchodilators (‘Brown’) receptor antagonist STEROIDS antagonist if not yet SALBUTAMOL (‘Blue’). montelukast REFER CHILDREN started Alternative: CONTINUE reliever (Add montelukast ) CONTINUE OTHER IPRATROPIUM therapy CONTINUE OTHER INHALERS CONTINUE OTHER ASTHMA ASTHMA DRUGS DRUGS DRUG DOSES AND NOTES ALWAYS use a spacer with an inhaler: make one from a bottle if none available. Spacers improve delivery of drug to lungs. In pregnancy, use inhaled drugs in the same way as you would in non-pregnant people: Step 1 drugs: relievers SALBUTAMOL DOSE: Inhaled: 200mcg as needed (as required as good as regular use). Use ORAL Short acting only if no inhalers: many side effects. ORAL DOSES (3-4x/day): Age 2-6y 1-2mg, 6- bronchodilators 12 years 2mg, 12-adult 2-4mg. (relievers) IPRATROPIUM Usually less effective than salbutamol: use only if salbutamol not available Step 2 drugs: preventers BECLOMETASONE NORMAL DOSES: ADULTS: 200-400mcg twice daily, CHILD: 100-200mcg twice Inhaled steroids at FLUTICASONE daily normal doses All inhaled steroids equally effective: use the cheapest that is easily available. Step 3 drugs: second line preventers Long acting beta- SALMETEROL 50-100mcg twice daily NEVER USE WITHOUT inhaled steroids! agonists Do NOT use in children less than 6 years old (no evidence of benefit). Step 4 drugs Inhaled steroids at BECLOMETASONE HIGH DOSE: ADULTS: 1000mcg twice daily, CHILD over 5y: 400mcg twice daily. high doses FLUTICASONE In children inhaled steroids at high doses can affect growth: seek specialist help Other preventers Not on WHO Essential Medicines list but may be available in MSF. Widely used in all ages if long acting Leukotriene receptor beta-agonists not available. antagonist In adults, higher dose inhaled steroids may give better control. MONTELUKAST DOSE (once daily): Child 2-5y: 4mg. Child 6-15y: 5mg. Over 15years-adult: 10mg. Start at 25mg daily. Aim to reduce to 5-10mg daily within 1-2 months Long term use thins bones and ORAL PREDNISOLONE causes weight gain which can worsen asthma. If used for more than 3 weeks reduce dose slowly, do NOT stop suddenly: risk of death! Not on WHO EML. Sometimes used at stage 5 outside MSF. Toxicity is a real risk (vomiting, agitation, (ORAL THEOPYLLINE dilated pupils, tachycardia, arrhythmias, hyperglycaemia, haematemesis, convulsions, severe or AMINOPHYLLINE) hypokalaemia). Monitoring strongly recommended Disease monitoring: Review whenever admitted. If stable review every 6 months. Lifestyle Stop smoking! This includes the parents of children with asthma. Avoid smoky environments. Assess control See ‘Step approach to drug therapy’ (above). Ask how often each inhaler is used. Check inhaler technique at EVERY visit! See the field guide for using Medication inhalers. Make sure patients understand the difference between reliever therapy and preventer therapy

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and what to do if their asthma gets worse. A cough is a sign the asthma is poorly controlled: step up asthma drugs. Do NOT use antihistamines or mucolytics/cough suppressants.

CHILDREN MSF Field Guide 2016 ASTHMA: Acute exacerbations: MANAGEMENT 15 years and under NOTE: Children who are usually well and ONLY wheeze when they have a viral illness should NOT be diagnosed with asthma. They have viral wheeze. Inhaled short acting beta-agonists (salbutamol) may help. Do NOT use inhaled OR oral steroids, either regularly or when wheezing (research shows no benefit and slows growth). ASSESS SEVERITY Always assess: Ability to speak or feed/Pulse/Blood pressure/Respiratory rate Agitation/use of accessory muscles to breathe If possible, assess: Oxygen saturations (less than 92% is abnormal at any age) Do not delay treatment to get a chest x-ray

SEVERE EXACERBATION LIFE THREATENING EXACERBATION WARNING: Some children with severe asthma do not look distressed and some clinical signs may be normal Too breathless to talk or feed OR talks in short phrases Feeble respiratory effort Often agitated, using accessory muscles Exhaustion/confusion/coma Less than 6 y 6 – 10 years 10-15 years Cyanosed old Pulse Over 130 Over 120 Over 110 Bradycardia or hypotension Respiratory rate Over 50 Over 30 Over 25 Silent chest MANAGEMENT OF ACUTE EXACERBATION ►►►► Get help NOW! ◄◄◄◄ 1. High flow OXYGEN via face mask (if available). 2. Short acting beta-agonist: SALBUTAMOL (ventolin) EITHER: Inhaler and spacer (preferred option): Give 10 puffs SALBUTAMOL over 10-15 minutes. Always use a spacer. Shake inhaler before every puff. OR: Nebuliser: SALBUTAMOL 2.5-5mg if under 10 years, 10mg if over 10 years. Repeat inhalers/nebulisers as often as needed until improves (respiratory rate decreases, BP normal, can talk in whole sentences without needing to take a breath). Pulse often stays high: side effect of salbutamol. 3. Oral PREDNISOLONE: 2-5 years:20mg 6 -15 years: 30-40mg Intravenous hydrocortisone is an alternative (If 2-5 years: 25mg iv, if 6-10 years: 50mg iv, if 10-15 years: 100mg iv ) Do NOT use intramuscular steroids (less effective). 4. Intravenous drugs: only if life threatening asthma and not responding to nebulisers (limited benefit). Intravenous SALBUTAMOL (15mcg/kg by slow iv infusion over 10mins) (safest option in children) Aminophylline only if life threatening AND no improvement with nebulisers. Loading dose: 5mg/kg over more than 20 minutes. NEVER GIVE LOADING DOSE if on oral theophylline. Then infuse 0.5- 1mg/kg/hour. Stop as soon as improving. Magnesium sulphate: Up to 40mg/kg/day (maximum 2g) by slow iv infusion. Limited evidence. Severe disease only. Often available because same drug as used to treat pre-eclampsia. 5. Antibiotics: not indicated unless clear evidence of infection (fever, productive cough). ONCE STABLE discharge SALBUTAMOL 4-6 puffs via spacer or 10mg via nebuliser 2-4 hourly or more for 24 hours then review. PREDNISOLONE orally for 3 2-5 years: 20mg daily 6-15 years: 30-40mg daily days then stop START INHALED STEROIDS: Beclomethasone via spacer: 2 puffs of 50mcg twice daily ANTIBIOTICS: Only if clear evidence of infection (fever, productive cough, consolidation on xray) Before discharge ensure parents and patient:  Know how to use inhalers and how to take prednisolone  Know signs of early deterioration and when to return.  Follow up in clinic 3-7 days later.

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ADULTS MSF Field Guide 2016 ASTHMA: Acute exacerbations: MANAGEMENT 16 years and older ASSESS SEVERITY Always assess: Ability to speak/Pulse/Blood pressure/Respiratory rate If possible, assess: Peak flow/Oxygen saturations Do not delay treatment to get a chest x-ray

MODERATE EXACERBATION SEVERE EXACERBATION LIFE THREATENING EXACERBATION Speaks whole sentences in 1 breath Talks in short phrases: can’t complete Can’t talk/feeble respiratory effort Pulse less than 110 sentences in 1 breath Cyanosed Respiratory rate less than 25 Respiratory rate more than 25/minute Bradycardia Increasing symptoms but not meeting criteria Pulse more than 110/minute Hypotension for severe/life threatening asthma Peak flow 33-50% predicted Exhaustion/confusion/coma Peak flow 50-75% expected Peak flow less than 33% predicted Usually only inhaled salbutamol and oral Oxygen saturations less than 92% steroids needed (2 & 3 below) ►► Get help NOW! ◄◄

MANAGEMENT OF ACUTE EXACERBATION 1. High flow OXYGEN via face mask 2. Short acting beta-agonist: SALBUTAMOL (ventolin) EITHER: Inhaler and spacer (preferred option): Give 10 puffs SALBUTAMOL over 10-15 minutes. Before every single puff shake the inhaler well. Always use a spacer. OR: Nebuliser: SALBUTAMOL 10mg nebulised via oxygen (if available). Add IPRATROPIUM in severe/life threatening asthma. Do not use ipratropium alone unless salbutamol not available. Repeat inhalers/nebulisers as often as needed until improves (respiratory rate decreases, BP normal, can talk in whole sentences without needing to take a breath). Pulse often remains high: side effect of salbutamol. 3. Oral steroids: PREDNISOLONE 40-50mg by mouth. Intravenous hydrocortisone is an alternative (hydrocortisone 100mg iv. Repeat 6 hourly until able to take oral steroids). Do NOT use intramuscular steroids (less effective). 4. Intravenous drugs: only if life threatening asthma not responding to nebulisers (limited benefit). MAGNESIUM SULFATE (1.2-2g intravenously over 20mins) (preferred option) AMINOPHYLLINE: Only if life threatening AND no improvement with nebulisers AND magnesium sulfate not available. Loading dose: 5mg/kg over more than 20 minutes. NEVER GIVE LOADING DOSE if on oral theophylline. Then infuse 0.5mg/kg/hour (you must weigh the patient). Stop as soon as improving. Risk of arrhythmias. SALBUTAMOL 250mcg by slow intravenous injection diluted to at least 50mcg/ml. 5. Antibiotics: not indicated unless clear evidence of infection (fever, productive cough). ONCE STABLE Moderate asthma: manage at home Severe/life threatening asthma: admit SALBUTAMOL Via spacer: 2-4 puffs 4-6 hourly for 24 hours then SALBUTAMOL 4-6 puffs via spacer or 10mg via nebuliser 2-4 hourly or more reduce to twice daily. for 24 hours then review. PREDNISOLONE: 30-40mg orally for 3 days then stop (no need to reduce slowly with short courses) START INHALED STEROIDS: Beclomethasone via spacer: 2 puffs of 100mcg twice daily ANTIBIOTICS: Only if clear evidence of infection (fever, productive cough, consolidation on xray) FOLLOW UP: 1 week later FOLLOW UP: 3-7 days later Before discharge ensure patient:  Knows how to use their inhalers and how to take prednisolone  Knows signs of early deterioration and when to return for follow up. Based on BTS/SIGN Asthma Guidelines 2014, BNF 2014, WHO Essential Medicines List (2015), MSF Greenlist 2016. See Copyright and Disclaimer on page 1.

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b. Hypertension

New Case is defined as THREE high blood pressure readings;

 >140/90 at triage  AND ideally again after review one week later, alternatively at least 30 mins later (on the same day) when rested  AND after review 1 week later  Ideally take at least 3 BP readings each time it is checked and ignore the first one. Take the best of the second two readings. This should be with an appropriately sized cuff so that it can overlap at least 1/3 of the Velcro when fastened

Severity of HTN Systolic BP Diastolic BP

Mild >140 >90

Moderate >160 >100

Severe >180 >110

History to gather from the patient:

 Do they have any other medical conditions?  Have they ever had a heart attack or a stroke?  What is their HIV status?  Do they have a family history of high blood pressure, diabetes, heart attacks or stroke (particularly if the family member developed it <60years)?  Do they smoke?  Do they drink alcohol?  Information about their lifestyle/stress at home etc

Tests to perform on newly diagnosed Hypertensives;

 Weight, height and BMI  FBS – within the last year (if normal or repeat if > 6.0)  Urea and Creatinine if not done in the last 1 year

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 Urine dip to check for protein and blood For Mild Hypertension explain the diagnosis to the patient. Discuss:

 What blood pressure is and what HIGH blood pressure is  What are the risks of having high blood pressure – increased risks of heart attacks, strokes, kidney disease, eye disease and poor sight  Explain that high blood pressure has no symptoms so must be checked at the clinic or on a home monitoring machine  Discuss the lifestyle factors that contribute to high blood pressure

Lifestyle factors to discuss and advice to give:

Dietary Behaviour

Low/NO added Salt Exercise

Low Fat Stop smoking

Lots of green veg and fruit Weight loss

No alcohol/reduce Stress/lifestyle change if possible

 Stop smoking if smoker – this is the single biggest risk factor for having heart disease and strokes  Stop/reduce alcohol as this raises BP  Lose weight if you are overweight  Regular physical activity – 30 minutes of activity that makes the patient sweat/breathless 5 x a week  Reduce salt intake to less than one teaspoon each day  Reduce caffeine containing drinks (energy drinks, coke, pepsi, tea, coffee)  Eat a healthy diet; o At least five portions of a variety of fruit and vegetables per day. o Only 1/3 of meals should be starch-based foods (such as cereals, pap, wholegrain bread, potatoes, rice, pasta), plus fruit and vegetables.

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o Not much fatty food such as fatty meats, cheeses, full-cream milk, fried food, butter, etc. Use low-fat spreads. o Include 2-3 portions of fish per week if possible. At least one of which should be 'oily' such as herring, mackerel, sardines, kippers, pilchards, salmon. Canned is fine (not stored in salt) o Eat lean meat or eat poultry such as chicken. Make sure to cut off as much fat as possible before cooking. o If frying food, choose a vegetable oil such as sunflower, rapeseed or olive.

Once diagnosed with Mild hypertension

 Give them 3 – 6 MONTHS to improve then for another review at the clinic  After 6 months if BP is <140/90 then continue with diet and lifestyle management

 If BP >140/90 discuss with them if they are ready to start treatment (emphasise that this is lifelong). If they fall into the moderate category before the 3-6 months is up then start treatment earlier.  If ready to start treatment and NOT diabetic (or other contraindication) start HCTZ 12.5 mg od

Side effects of HCTZ to warn patients of:

 Passing more urine than usual  Mild GI disturbance  Postural hypotension  Low potassium or sodium (feeling very weak or dizzy)  Gout

Contraindications to HCTZ

 Gout – increases risk of gout  Low potassium ( or if taking other drugs that lower potassium eg MDR drugs, spironolactone, lasix)  Diabetes – increases sugar levels  High cholesterol or risk of high cholesterol  Avoid if pregnant/risk of pregnancy

Review after 1 month

 If well, no side effects/problems with medication and BP <140/90 then give 3 month prescriptions and follow up date  If BP >140/90 - refer to the Doctor

Target Blood Pressure

 BP target is 140/90

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Follow up Nurse Visits for Hypertension

On each visit check:

 BP  Heart rate  Weight  BMI  Check the patient has had the following tests in the last year. If not arrange for these; o Fasting blood sugar o Creatinine o Urine dip to check for protein o Cholesterol  Make sure that they know the correct advice about diet, exercise, smoking and alcohol  Ensure that they know how to take their medicines and what they are for Make sure that all of these things are documented on the patient’s NCD card and green book.

Reasons to refer to the Doctor:

 BP is >140/90 x 2 (repeated on the same visit)  Creatinine is >120  Urine dip reveals protein or blood (even trace of protein)  Cholesterol result is more than 5.0  Any other clinical need or query

How often to review patients  New diagnosis or stepping up or down treatment as BP unstable – monthly  Stable patients - 3- 6 monthly  Severe Hypertension – depending on severity and whether end organ damage present – weekly - fortnightly

Common Side effects of other Anti-hypertensives

ACE Inhibitors (e.g. Enalapril, Captopril)  Cough is the main side effect – this is dose dependant so if occurs at higher doses can try decreasing the dose  Cough can happen at any time after starting and can take months to stop after stopping the drug  Contraindicated in aortic and renal stenosis

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 Can cause renal impairment – which is why regular monitoring after starting and dose changes is advised if possible  Avoid in women of child bearing age as teratogenic

Calcium Channel blockers (e.g. amlodipine, nifedipine – slow release)

 Ankle swelling is the main side effect  If they are also using Simvastatin to lower cholesterol the max dose of Simvastatin is 20mg as there is an increased risk of myopathy (not with atorvastatin or other statins)  Potential for higher doses needed if on Efavirenz based ART regime  If taking PI may lead to increased concentration so slower titration and more monitoring.

Beta-Blockers

 Lethargy  Impotence  NEVER USE IF HISTORY OF ASTHMA  Never use in 2nd and 3rd degree AV block  Safe in COPD  Can increase glucose levels and antagonise the action of oral anti-diabetics

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HYPERTENSION: DIAGNOSIS  Hypertension is not a disease; it is a risk factor for cardiovascular disease. Reducing high blood pressure reduces the chance of cardiovascular death and disability.  Remember that most people with high blood pressure will have no symptoms.  This section does NOT apply to pregnant women: in pregnancy BP 140/90 or more can be a sign of pre-eclampsia which can be fatal. Diagnosis of hypertension

Clinic blood pressure reading If first BP reading is raised (140/90 or more), repeat straight away. If still raised, repeat BP after the patient has sat quietly for 30 minutes.

Less than 140/90 140-159/90-99 160-179/100-109 180/110 or more Normotensive Stage 1 hypertension Stage 2 hypertension Severe stage 2

Tell patient to return in 1 week for another reading

Do not start treatment until you have three raised readings 1 week apart

Diabetes OR Cardiovascular disease (angina, myocardial infarction, transient ischaemic attack, cerebrovascular accident, peripheral arterial disease) OR 10 year cardiovascular risk 20% or more (Use WHO charts for local population http://tinyurl.com/WHO-CVD-risk)

NO = low risk stage 1 YES = high risk stage 1

NORMOTENSIVE BORDERLINE HYPERTENSION DIAGNOSE HYPERTENSION SEVERE HYPERTENSION: Re-check BP in 5 Low risk: monitor annually Investigate (see below) DIAGNOSE HYPERTENSION years, sooner if Investigate (see below). Offer drug treatment AND Treat TODAY! See ‘severe clinically indicated. Treatment is with lifestyle lifestyle changes (see over for hypertension’ chart. change NOT drugs (see over). management) NOTE: if either the systolic or diastolic are elevated, treat them according to the higher number – for example in the flow chart above, someone with a blood pressure of 165/115 would fall into the severe hypertension group (180/110 or more). Investigations 10% will have a cause. Look for the following:  History to gather from the patient:  What is their HIV status?  Do they have any other medical conditions? History of heart attack or a stroke, vision problems?  Do they have a family history of high blood pressure, diabetes, heart attacks or stroke (particularly if the family member developed it <60years)?  Do they smoke? Do they drink alcohol?  Information about their lifestyle (regular exercise, diet habits, stress at home etc.)  Weight, height and BMI  Screen for diabetes: do fasting glucose or HbA1c (random glucose acceptable but not as good).

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 Creatinine and urine test for protein (to look for renal disease) HYPERTENSION: MANAGEMENT (Does NOT apply to pregnant women.) LIFESTYLE ADVICE FOR ALL Reduce salt intake: salt is a major cause of hypertension. Less than 1 teaspoon ADDED salt (6g)/day. Diet Advise weight loss if obese. Advise low fat, sugar and salt diet for all to reduce cardiovascular risk. 2.5hours/week of activity that causes shortness of breath/light sweat. Encourage walking. Exercise lowers blood Exercise pressure and reduces cardiovascular risk. Smoking Advise smoking cessation: smoking increases cardiovascular risk. ASSESS CARDIOVASCULAR RISK (at diagnosis and then annually) Offer statin (Simvastatin 40mg / Atorvastatin 20mg) if: (Check baseline LFTs. Avoid statin if >3x normal limit)  Cardiovascular disease (angina/myocardial infarction/transient ischaemic attack/cerebrovascular accident/peripheral arterial disease) or  10 year cardiovascular risk 20% or more  Do NOT give aspirin (no evidence of significant benefit) UNLESS known cardiovascular disease (secondary prevention) DRUG THERAPY BP 160/100 or more AFTER 3 months lifestyle change (start immediately if can’t/won’t change) START DRUG OR THERAPY IF: BP 140/90 or more AND cardiovascular disease OR 10 year cardiovascular risk 20% or more. BP above 140/90, but check first: are they taking their drugs regularly? Following diet/lifestyle? STEP UP IF: Check BP monthly when stepping up therapy – once stable check every 6 months. If BP above 140/90 on 3 drugs: If BP above 140/90 on 2 drugs:

If BP above 140/90 on 1 drug: ADD ADD Start with a single drug ADD rd 4th drug of different class. 2nd drug of different class. 3 drug of different class. from the 4 classes Do not stop other drugs. below. Do not stop 1st drug. Do not stop other drugs. Drug therapy (based on WHO Essential Medicines List 2015) Add in the order shown. Sub-Saharan Africans without diabetes should start with CCB (then ACE). ACE inhibitors are always preferred first line in DIABETES, because they offer kidney protection. 6/10 people need 3 different drugs: increase to tolerated dose of 1st drug before adding in a 2nd drug. May get fewer side effects with several drugs below maximum dose than with a single drug at maximum dose. 1.DIURETICS 2.ACE INHIBITORS 3.CALCIUM CHANNEL 4.BETA-BLOCKERS Hydrochlorothiazide: Start at Enalapril start at 5mg. Increase to BLOCKERS Bisoprolol: Start at 2.5mg daily. usual dose (12.5-25mg daily) maximum of 40mg daily. Amlodipine: Usual dose Increase every 2-4 weeks to Do NOT use loop diuretics Angiotensin receptor blockers (eg. 10mg daily (5mg if 10mg daily. (furosemide) as less effective. losartan, candesartan) cause less cough frail/old) Atenolol 50mg once daily but are more expensive and no better. Use only if ACE inhibitor essential and cough (100mg rarely better) >4wks. Common side effects Common side effects Common side effects Common side effects Urinary frequency, electrolyte Cough: may start at any time, can take Ankle swelling Lethargy, impotence imbalance, gout, worse glycaemic months to stop. If using amlodipine with NEVER use if history of asthma, control. Avoid if risk of pregnancy. Renal impairment. Check renal simvastatin (not other statins), 2nd and 3rd degree AV block function 2 weeks after starting, and at maximum dose of simvastatin Safe in COPD. every dose increase. 20mg (risk of myopathy) If Diabetic patient or chronic kidney disease (including HIVAN) 1.ACE INHIBITORS 2.CALCIUM CHANNEL BLOCKERS 3.DIURETICS 4.BETA-BLOCKERS Enalapril start at 5mg. Increase Hydrochlorothiazide: to maximum of 40mg daily.

Disease monitoring: every 6 months if BP well controlled (under 140/90) Diet and lifestyle As above. Blood pressure Measure every 3 months if stable. Monthly if not controlled. Ask if dizziness on standing or falls (suggests Target: 140/90 postural hypotension: may need to reduce BP drugs). Medication Check compliance. How often do they forget their tablets? Ask about side effects. Review cardiovascular If not on statin, every year assess cardiovascular risk. If on statin, no need to test cholesterol.

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risk Every year, check kidney function and screen for diabetes. c. Diabetes mellitus Type I

Type 1 diabetes is a chronic illness characterized by the body’s inability to produce insulin due to the autoimmune destruction of the beta cells in the pancreas. Onset most often occurs in childhood, but the disease can also develop in adults in their late 30s and early 40s. [1]

See Clinical Findings in Diabetes Mellitus, a Critical Images slideshow, to help identify various cutaneous, ophthalmologic, vascular, and neurologic manifestations of DM.

The classic symptoms of type 1 diabetes are as follows:

 Polyuria  Polydipsia  Polyphagia  Unexplained weight loss  Other symptoms may include fatigue, nausea, and blurred vision.

The onset of symptomatic disease may be sudden. It is not unusual for patients with type 1 diabetes to present with diabetic ketoacidosis (DKA). (see section below)

Diagnosis

Diagnostic criteria by the American Diabetes Association (ADA) include the following [2] :

A fasting plasma glucose (FPG) level ≥126 mg/dL (7.0 mmol/L), or

A 2-hour plasma glucose level ≥200 mg/dL (11.1 mmol/L) during a 75-g oral glucose tolerance test (OGTT), or

A random plasma glucose ≥200 mg/dL (11.1 mmol/L) in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis

Management

1. Insulin therapy

Patients with type 1 diabetes require lifelong insulin therapy. Most require 2 or more injections of insulin daily, with doses adjusted on the basis of self-monitoring of blood glucose levels. Insulin replacement is accomplished by giving a basal insulin and a preprandial (premeal) insulin. The basal insulin is either long-acting (glargine or detemir) or intermediate-acting (NPH). The preprandial insulin is either rapid-acting (lispro, aspart, insulin inhaled, or glulisine) or short-acting (regular).

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2. Diet and activity

All patients on insulin should have a comprehensive diet plan, created with the help of a professional dietitian, that includes the following:

A daily caloric intake prescription

Recommendations for amounts of dietary carbohydrate, fat, and protein

Instructions on how to divide calories between meals and snacks

Exercise is also an important aspect of diabetes management. Patients should be encouraged to exercise regularly.

KETOACIDOSIS

PRACTICE ESSENTIALS

Diabetic ketoacidosis (DKA) is an acute, major, life-threatening complication of diabetes that mainly occurs in patients with type 1 diabetes, but it is not uncommon in some patients with type 2 diabetes. This condition is a complex disordered metabolic state characterized by hyperglycemia, ketoacidosis, and ketonuria.

SIGNS AND SYMPTOMS

The most common early symptoms of DKA are the insidious increase in polydipsia and polyuria. The following are other signs and symptoms of DKA:

 Malaise, generalized weakness, and fatigability  Nausea and vomiting; may be associated with diffuse abdominal pain, decreased appetite, and anorexia  Rapid weight loss in patients newly diagnosed with type 1 diabetes  History of failure to comply with insulin therapy or missed insulin injections due to vomiting or psychological reasons or history of mechanical failure of insulin infusion pump  Decreased perspiration  Altered consciousness (eg, mild disorientation, confusion); frank coma is uncommon but may occur when the condition is neglected or with severe dehydration/acidosis

Signs and symptoms of DKA associated with possible intercurrent infection are as follows:

 Fever  Coughing  Chills  Chest pain

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 Dyspnea  Arthralgia

Diagnosis

On examination, general findings of DKA may include the following:

 Ill appearance  Dry skin  Labored respiration  Dry mucous membranes  Decreased skin turgor  Decreased reflexes  Characteristic acetone (ketotic) breath odor  Tachycardia  Hypotension  Tachypnea  Hypothermia

In addition, evaluate patients for signs of possible intercurrent illnesses such as MI, UTI, pneumonia, and perinephric abscess. Search for signs of infection is mandatory in all cases.

TESTING

Initial and repeat laboratory studies for patients with DKA include the following:

 Serum glucose levels  Serum electrolyte levels  Urine dipstick  Ketone levels  CBC count  BUN and creatinine levels

MANAGEMENT

GOALS

Treatment of ketoacidosis should aim for the following:

 Fluid resuscitation  Reversal of the acidosis and ketosis  Reduction in the plasma glucose concentration to normal  Replenishment of electrolyte and volume losses  Identification the underlying cause

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Diabetes mellitus Type II

Diagnosing Diabetes

. Fasting glucose >= 7mmol/L (Best test)

. Random glucose > =11.1mmol/L (Least accurate test)

. Glycosylated Hb- HbA1c >= 6.5% (limitations)

Each of these tests needs to be done on 2 separate occasions OR only once if symptoms present

. If fasting glucose <6.0 = normal

. If fasting glucose between 6.0 and 6.9 this is impaired fasting glucose and has a high risk of progression to diabetes so needs intensive counselling about lifestyle and diet to prevent this. Repeat annually.

Diabetes Symptoms

 Polydipsia – excessive thirst  Polyuria – excessive passing of urine  Blurry vision  Fatigue  Headache  Weight loss/weight gain  Recurrent thrush, recurrent infections, poorly healing wounds

History to gather from the patient

 What is their diet like?  Do they have any other medical conditions?  Have they ever had a heart attack or a stroke?  What is their HIV status?  Do they have a family history of high blood pressure, diabetes, heart attacks or stroke (particularly if the family member developed it <60years)?  Do they smoke?  Do they drink alcohol?  Information about their lifestyle/stress at home etc 

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Investigations to perform on newly diagnosed diabetics (If all cannot be done at initial diagnosis, focus on blood tests and do foot exam and eyes on next few visits).

Tests to perform at Diagnosis Blood glucose Blood pressure Weight and Height Urine Dipstick to look for protein (including trace), ketones, glucose and signs of infection (leuc/nit) Urea and Creatinine HbA1c – result next visit Calculation of Cardiovascular Risk Score

Table 1: test to perform after confirmation of diagnosis of diabetes

Once Diagnosis is confirmed;

 Focus on educating patient about diabetes, what it is; For example – “Insulin is a hormone. It works as a chemical messenger that helps your body use the glucose (sugar) in your blood to give you energy. Sugar is the fuel for the body. You can think of insulin as the key that unlocks the door to the body’s cells. Once the door is unlocked glucose can enter the cells where it is used as fuel.  Type 2 Diabetes develops when the insulin-producing cells in the body are unable to produce enough insulin or when the insulin that it produces does not work properly (known as insulin resistance)”.  Highlight the symptoms of diabetes (as above) and what the complications of the disease are (see diagram below)  Ensure that the patient knows that this is a lifelong condition and that it can be well controlled but only if advice is followed +/- medication is taken long term (lifelong)

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Complications of diabetes

Eyes (retinopathy) Brain and cerebral circulation (cerebrovascular disease)

Kidney (nephropathy) Heart and coronary circulation (coronary heart disease)

Peripheral nervous system (neuropathy)

Lower limbs (peripheral Diabetic foot (ulceration and vascular disease) amputation)

Emphasise that there are three main ways to manage diabetes

1. Changing your diet & lifestyle 2. Keeping active and losing weight 3. Medications

Key messages for Diet change

1. Eat regular meals – do not save up and eat one or two large meals 2. Keep an eye on portion sizes – try to reduce these, use a smaller plate, don’t go back for seconds etc. 3. Teach about carbohydrate counting and what glycaemic index means i.e. High GI = quick release of sugar and Low GI = slow release of sugar. Try to eat more low GI and less high GI. Give some examples.

Low GI  Medium GI High GI  Pasta Rice Millet (pap) Lentils Banana White Bread Beans Mango Ice Cream Soya Potatoes Pineapple Nuts Yams Raisins Apples Sweet Potatoes French Fries/Chips

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4. Reduce fat 5. Eat 5 portions of fruit and vegetables a day 6. Reduce salt 7. Eat more fish – canned oily fish such as mackerel, sardines or salmon is fine. If possible eat 2 x week 8. Eat more beans, lentils and pulses 9. Reduce sugary things to just an occasional treat 10. Stay hydrated – drink 8-10 glasses of fluid per day, preferably water

Discuss the benefits of getting and staying active

 help you lose weight or maintain a healthy weight  increase the amount of glucose used by the muscles for energy, so it may sometimes lower blood glucose (sugar) levels  help the body to use insulin more efficiently – regular activity can help reduce the amount of insulin or other medications that you have to take  improve your diabetes management (particularly Type 2 diabetes)  strengthen your bones  reduce stress levels and symptoms of depression and anxiety  improve your sleep  Start slow and build up  Target 30mins 5 x week of exercise that makes the patient breathless and sweaty

Medical Treatment

Target of treatment

 HbA1C of 6.5-7.5%  Fasting glucose of between 4.2 - 8.3  Target blood pressure of diabetics = 130/80

Target blood sugar control

If this is broken down further – younger people should be aiming for tighter control and older people can be a little more relaxed.

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How often to monitor patients

Monthly - if medication is being adjusted or if blood sugar persistently >10

THREE Monthly – if fasting sugar is < 8.3 and no/stable complications

Annually – check diabetic complications (see below) and record on NCD card

What to check at each follow up visit

 Blood pressure – target 130/80  Heart rate  Weight  Fasting blood sugar  Ensure they are aware of dietary and lifestyle advice

What to check annually

 HbA1c (possibly more often if medications changing)  Creatinine  Urine dipstick to look for protein  Check eyes - visual acuity using Snellen chart (see below for details)  Check feet and re-enforce foot care advice (see below for details)  Calculate Cardiovascular Risk score

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Aspirin & Diabetes

If a diabetic patient has established macrovascular disease i.e. they have had a heart attack, angina, a stroke, transient ischemic attack or peripheral vascular disease then the patient should be started on 75mg Aspirin od (150mg od if 75mg not available).

Diabetic patients who DO NOT have the above problems DO NOT need aspirin. This is because the risk of gastric ulcers and bleeding/complications are larger than it’s benefits.

Statins (Atorvastatin) & Diabetes

Diabetic patients that should be started on Atorvastatin 20mg;  Preferably anyone with 10yr CVD risk >20%, calculated using the WHO charts OR  Any diabetic patient with a total cholesterol >5.0  Any diabetic patient with microvascular complications (nephropathy, retinopathy, neuropathy)  Those who have previously had a heart attack /stroke /angina/TIA / peripheral vascular disease (these patients should preferably be on 80mg but due to availability of drugs and pill burden, 20mg may be O.K.)  If the patient is more than 40 years old

ACE Inhibitors (Enalapril) & Diabetes

Enalapril is the first drug of choice for treating hypertension in diabetic patients. It should also be given to any patient who has anything from a trace of protein in their urine (on 2 occasions in the absence of a urine infection). Protein in the urine is suggestive of diabetic nephropathy and an ACEI can help to slow progression/improve the disease.

Aim to have patients taking a minimum of Enalapril 20mg od to have a positive effect on kidney. This should be started slowly and then creatinine monitored 2 weeks after starting the medicine. If there is a rise in creatinine of 30% then stop the ACEI.

ENCOURAGE ALL PATIENTS WITH A DIAGNOSIS OF DIABETES TO START TREATMENT

 If the fasting sugar is not too raised and the patient is not keen to start medication then it may be reasonable to allow them some time to try lifestyle and dietary changes for 3 – 6 months before discussing. Do explain though that they need to be very committed to make a real difference to their sugars First line for all patients (see cautions/contra indications below)

 Metformin 500mg od  This should be taken with food but can be taken on an empty stomach although side effects will be more likely  Side effects to warn patients about; o Nausea o Diarrhoea o Abdominal pain

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 After first diagnosis and introduction of treatment, patients should be reviewed after 2 weeks (possibly more frequently if sugar is very high). Dose then slowly increased by 500mg/day to a max of 2.5 -3g a day.  Side effects are dose dependent so try to slowly decrease the dose if they are experiencing side effects at higher doses to see if it will help  Most people will tolerate twice daily metformin well. If side effects are a problem then can be split to TDS but remember that adherence is likely to be very difficult with a TDS regime  Contraindications to Metformin o Liver failure – ALT or AST 3 x normal limit o Renal failure – patients with eGfR of <30 DO NOT USE Metformin. o If eGfR is <45 – 30 max dose is 1g/day o You can also use creatinine to guide you if you cannot calculate eGfr – Creatinine 130-174 still OK to use at max 1g/day. If creatinine >175 DO NOT USE o History of lactic acidosis or at risk of dehydration  Benefits of Metformin o Encourages weight loss o Cardiac protection – prevents against MI and heart failure o Safe and cheap

Second Line Drugs

Glibenclamide/Gliclazide (sulfonylureas)

If patient on highest dose of Metformin or cannot tolerate metformin due to side effects then a sulfonylurea should be started.

For Glibenclamide;

 Start at 5mg od  Review monthly and increase by 5mg/day until max (15mg/day)

Most common side effects

 Weight gain  Hypoglycaemia (see below) Third Line Drug = Insulin

If a patient is on maximum oral therapy;

 Metformin 2.5-3g/day  AND Glibenclamide 15mg/day  AND aware of lifestyle advice and has tried as much as possible

Then the next step is insulin.

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Explain to the patient that their body is no longer making enough of this hormone and that the tablets cannot push the body to make any more so we have to give it to the patient via a tiny injection that they start with once a day.

If the patient is willing then the easiest way to start is with a single daily injection of intermediate acting insulin (NPH / Protaphane).

 Continue the maximum dose of Metformin  Stop the sulfonylurea (glibenclamide)  Starting dose is 0.3 units/kg Protaphane at bedtime  It starts acting after 1-2 hours and its effect lasts 16-24 hours

Monitoring for patients on insulin at each visit

If sugars need to be improved then increase insulin as suggested above. Maximum dose of Protaphane is 0.6 units/kg/day If symptoms of hypoglycaemia are present then  If possible give patients a glucometer to monitor their own sugars for a period of time. 1- 2 weeks then review with the results o 3 pre-meal and 1 bedtime sugar and whenever they feel the hypo symptoms  Switch the insulin to twice a day regime. Split the delivery so that 2/3 is in the morning and 1/3 is in the evening o For example a 50kg woman may be taking 30 units in the evening (50 x 0.6). If she is having hypos she could be changed to 20 units am & 10 units pm ((2/3 x 30) & (1/3 x 30)) If sugars are still not controlled on maximal protophane (0.6mg/kg) & Metformin then change insulin to mixed insulin (Actraphane).

Actraphane is a mixture of two different types of insulin;

 Short acting (70%)  Intermediate acting (30%)

The idea is that the same intermediate acting insulin is used as previously but it also has additional short acting insulin to control the spike in sugar levels that occurs after eating meals.

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If changing from Protaphane then the same number of units can be used with Actraphane (i.e. 2/3 units in am and 1/3 units in pm) then monitor to see if this improves.

If starting Actraphane (for example type 1 diabetics will always have to start on this) then start with 0.5units/kg/day in two divided doses. Again 2/3 in AM 15 minutes before morning meal and 1/3 in PM 15mins before evening meal.

The main difference is that this regime has a significantly higher chance of causing serious hypoglycaemia. This can be very dangerous and even fatal. This regime should only be started if the patient can ensure regular morning and evening meals.

Ideally all patients starting this insulin should be loaned a glucometer for the initial period to monitor their sugars. They should be advised to take (and write down) a sugar level pre- meal (pre breakfast, lunch and dinner) 3 x a day and also pre-bedtime. They must be educated on what a normal sugar reading is and what to do if it is very low or very high.

This may also help the clinician to decide if they are poorly or well controlled at times. They can choose 2 -3 days a week to monitor the 4 sugar readings a day for a few weeks. They can then bring these records to the clinician to assess whether the medication needs adjusting.

The “Dawn Phenomenon”

The morning pre-breakfast glucose reflects the action of the evening insulin dose (either NPH or Biphasic insulin) overnight – adjust the evening dose based on this reading. Persistent high morning sugars may reflect the “dawn phenomenon”, a rebound hyperglycaemia in response to an overnight hypoglycaemia. If suspected, ask the patient to record several readings at 2 am. A snack at bedtime will reduce overnight hypoglycaemia.

3rd Line insulin regime

If the above regime with BD Actraphane also fails to establish good sugar control then the patient (if agreeing) can try to add boluses of short acting insulin at meal times.

This should only be done under very close supervision by an experienced clinician and with a very motivated patient who has good knowledge of their condition.

If it is to be initiated then the current total dose of Actraphane can be halved and this dose is then switched to Protaphane and the dose split between morning and evening injections.

For example if the patient was previously taking 40 units of Actraphane AM and 20 units PM then this is halved = 30 units of Protaphane (40+20 = 60/2 = 30). This then gets split between AM and PM dose = 15units AM & 15 units PM.

In addition to this – fast/short acting insulin is used 15mins before each meal – here we have Actrapid or Novorapid. The remaining 30 units (as total Actraphane was 60units) is

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split evenly between the meals. So pre-breakfast = 10units, pre-lunch = 10units and pre- dinner = 10units.

The patient continues to monitor his 3 pre-meal sugars and pre-bedtime sugars so that insulin doses can be adjusted. All patients on this regime need access to a glucometer and strips and be very aware of hypo’s.

In most of these cases, a specialist should be consulted before initiating.

How and where to inject insulin

Explain to the patient how to administer the insulin.

Injection technique: a. Wash hands. b. Check your vial of insulin has been open less than 28 days and mix it by rolling the vial of insulin between your palms. c. Remove the cap from the needle and place the needle into the vial. d. Draw up the appropriate dose and check there is no air in there. e. Find an appropriate site to inject the insulin, see image opposite and pinch a bit of skin between your thumb and forefinger. f. Place needle into pinched skin at a 90 degree angle and inject insulin. Leave needle in place for 10 seconds before removal.

g. Remove and dispose of the needle into the sharps bin

Note: Change injection sites regularly to avoid unsightly lipodystrophy and reduced absorption

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Areas that insulin can be injected

Insulin is injected just underneath the skin into the fatty layer so generally anywhere that has a fatty collection can be injected

Education for patients taking insulin

1. Hypoglycaemia Patients must be aware of the risk of low sugars. The symptoms of hypoglycaemia should be explained and they should be told that action must be taken as soon as these symptoms are felt.

Symptoms occur at a blood sugar level of about 2.5-3.0. These include;

 Blurry Vision  Dizziness  Anxiety  Hunger  Weakness/fatigue  Palpitations  Headache  Shakiness  Sweating  Irritability

Treatment for hypoglycaemia

 If the patient is conscious o 100ml of sugary drink OR 5 sweets OR 5 tablespoons of sugar OR if in stock in pharmacy give 1 x hypostop o THEN follow this up with some normal food/meal e.g. sandwich otherwise the low sugar will reoccur

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 If the patient is unconscious o 50% dextrose 25ml IV, repeat after 15min It is important not to drive if any of these symptoms are felt or if the sugar level is below 5 (if they have a glucometer). The most common reasons for this happening are a late or missed meal, extra or unplanned exercise, too much insulin or tablets, not drinking enough, hot weather or alcohol.

2. Sick Day rules When patients are sick their sugar levels will increase, even if they are not eating or drinking. It is important that they know the following rules;

a. Never stop taking their insulin b. Check blood sugar levels every 3 hours if they have a glucometer c. Drink 2-3 litres of non sugary drinks between meals d. Try to eat even if you don’t feel like it – bread, crackers, plain biscuits, milky drinks. Avoid spicy foods. e. Seek medical help if blood sugar is persistently >16 or if they cannot keep drinking or very thirsty and persistent vomiting or breathing is deep and rapid f. Exercise – eat a snack before exercising to avoid hypoglycaemia g. If the patient drinks alcohol then drink small amounts with food only. Double the pre-bed snack and eat a larger breakfast

Managing Diabetic Complications

For most complications, the treatment is tighter diabetic and blood pressure control. There are a few cases where referral can treat/prevent these complications

Eyes – Retinopathy/Cataracts/Poor vision – refer to government eye clinic and try to improve diabetic and blood pressure control. Cataracts can be removed her and retinopathy can receive laser eye treatment but the earlier the treatment the better the outcome so better to refer early.

Nephropathy – evidenced by any protein in the urine (including trace). Must be on ACEI – if using Enalapril aim for minimum dose 20mg od, preferably 40mg od if creatinine tolerates it. Also aim to improve diabetic and blood pressure control.

Neuropathy - can be painful or painless. If it is painful try Amitriptyline 12.5mg at night slowly increased to a maximum of 75mg at night every day. Also aim to improve diabetic control.

Diabetic Foot Complications & Examination

Diabetics are more at risk of foot problems because;  Poor control of blood sugar damages blood vessels and nerves  This causes loss of normal feeling, leading to a risk of injury  Because the blood supply is poor, injuries do not heal well

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You can use the following method to examine Diabetic feet. Patients should have this done annually. It only takes a few minutes when you have done it a few times.

 Ask  Look  Touch  Test  Questions to ask:

 Do you have pain in your calves on walking? (this indicates poor circulation)  Do your feet feel numb or painful (usually described as burning pain)?

Look at

 Both feet together  Colour (blue/purple – lack of blood supply, red - inflamed, normal)  Presence of ulcers or calluses  Correct cutting of toe nails – should cut their toe nails straight with clippers  Presence of fungal infection  Presence of hair on lower leg (lack of hair indicates poor blood supply)

Touch

 Feel the temperature of the feet  Pulses – posterior tibial (inner ankle) and dorsalis pedis (top of foot)

. Capillary refill time – (press firmly on the big toe for 30 seconds and then when you release, count the time it takes for the colour of the toe to return to normal) . Less than 2 seconds = normal . More than 5 seconds = definitely not normal

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Test foot sensation For this you can use a monofilament (or bristle from a suitable broom). If this cannot be found then the tip of a pen or other small blunt object is O.K. If you are using a monofilament you should touch it to the skin until it bends (see picture below).

Ask patient to close eyes and indicate when he feels the touch. Begin at the tip of the big toe. If there is no feeling there, move progressively up to the ankles, the anterior shin, over the knee – until the patient is able to feel it.

Test 6 points over the sole of the foot:  under the big toe  under the little toe  under the heads of the 1st metatarsal  under the head of the 3rd metatarsal  under the head of the 5th metatarsal  under the heel

These are the areas that should be tested on the soles of the feet and this is how a monofilament looks when used correctly

Is the foot at risk? . Low risk: normal pulses and feeling of touch, no signs of damage . Moderate risk: weak or absent pulses, reduced feeling of touch . High risk: cool foot, no pulses, little or no feeling. Ulcers or injuries may be present . For the purpose of recording – anything more than low risk is recorded on the NCD card as high risk

Advice to give patients about foot care

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 Ask patient to check their feet every night: o Look for injuries, colour change, infection o Feel for coldness, ulcers  Never walk barefoot.  Wear shoes that enclose the feet  Ensure that feet fit comfortably into the shoes, without any compression of the feet, especially the toes  Do not wear sandals, especially those with thongs  Check inside shoes before putting them on, to ensure there are no stones inside

Assessing vision using a Snellen Chart

To check if the patient’s vision is O.K. ask them to stand 6 meters away (or 3 meters using a mirror) from the Snellen chart which looks like this;

If they normally wear glasses, make sure that they are wearing their glasses otherwise it is an unfair test. Ask the patient to cover one eye and read the smallest line of letters that they can. If it is easier to explain you can ask the patient to start at the top and read all the way down to where they find it difficult. Record the line that they are able to read for each eye.

For example if the patient can only read to the line “M Y T A” and not the line below (or only a few letters of the line below) then this is 18.

The visual assessment is recorded as a fraction. The top number is how many meters away the patient is from the chart (always 6 in our case). The bottom number is the line that they can read until.

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For example if a patient is standing 6 meters away from the chart and can read until the line “T Y H M I W A” clearly then this would be recorded as 6/6. This is what is sometimes referred to as 20/20 vision (in USA) and indicates normal or very good vision. If they can read the line below this then their eyesight is very good for far away objects.

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MSF Field Guide 2016 TYPE 2 DIABETES: Case finding, diagnosis, monitoring Diabetes increases cardiovascular risk and causes damage to eyes, kidneys, nerves and blood vessels. Aim of treatment is to reduce symptoms and stop this damage. Lifestyle changes are very important! CASE FINDING Most people with diabetes will have no symptoms, so you need to consider it in those with risk factors for diabetes:  Obese. Body mass index 30 or more or waist circumference: measure half way between bottom of ribs and top of pelvis. Men: 94cm or more (90cm or more if south Asian/Chinese/Japanese). Women (all) 80cm or more.  Hypertension or cardiovascular disease  Frequent infections, particularly skin infections (diabetes supresses immune system) (and consider HIV testing)  On drugs that cause high blood glucose: oral steroids, antiretrovirals, antipsychotics (courses over 1 month).  History of gestational diabetes (screen every 2 years, sooner if develop symptoms)  Family history of diabetes (parent, brother sister) (screen every 2 years, sooner if develop symptoms). If people have symptoms, the commonest symptoms are polyuria, polydipsia, unexplained weight loss. Type 1 diabetes: type 1 diabetes occurs in children and young people. Symptoms develop over days / weeks. Symptoms include polyuria, polydipsia, weight loss, tiredness, blurred vision. May present with very high blood sugar and diabetic ketoacidosis: reduced consciousness/coma: THIS IS LIFE THREATENING. See diabetic emergencies page. DIAGNOSIS (WHO criteria) If symptoms (=polyuria, polydipsia, unexplained weight loss) only a single test is needed (but always try to do 2 tests). If no symptoms you MUST do two tests on two separate occasions. Oral glucose tolerance test for pregnancy only. Fasting glucose (Best test) Random glucose Glycosylated haemoglobin (HbA1c) Eat/drink nothing but water for 10 (Least accurate) Do 2 tests at least 2 weeks apart. Do not use if significant anaemia or hours before test haemoglobinopathies (inaccurate). May miss type 1 diabetes. 126mg/d l or more 200mg/dl or more 48mmol/mol or more 7mmol/l or more 11.1mmol/l or more 6.5% or more NEWLY DIAGNOSED TYPE 2 DIABETES There is a lot to tell a person newly diagnosed with diabetes. It will take several visits. Always allow plenty of time. At the start of each visit, check what they already know and what questions they have. Once diagnosis confirmed:  Find out what people know about diabetes, including what frightens them about being diabetic. They may be worried about injections or frightened they may end up having an amputation.  Discuss lifestyle changes (see below). This is the most important part of diabetes care. What changes is the patient willing and able to make? Remember: small changes do make a difference.  Over the next few weeks see the patient regularly to check they understand about diabetes/lifestyle changes. Check BP at each visit. If over 140/90 on most readings start treatment. Use an ACE inhibitor if possible.  Soon after diagnosis assess CVD risk using WHO chart and start statin if risk is >20%. (If no chart start statin if >40yrs old).  Start metformin because it protects cardiovascular system as well as reducing blood sugar.

FREQUENCY OF MONITORING IN TYPE 2 DIABETES At diagnosis Every 1-3 months Once a year See ‘Newly diagnosed type 2  Review lifestyle: what changes can be made?  Review cardiovascular risk diabetes’ - above  Check BP  Look for and treat complications (eyes,  Check blood sugar kidney, feet, nerves). DIABETIC EMERGENCIES Severe hypoglycaemia: If blood sugar less than 50 mg/dl or 2.8mmol/l, make the patient eat. If unconscious, requires rapid treatment (glucagon injection, 10% glucose iv infusion). See separate field guide. Make sure patient knows how to recognise and prevent future hypoglycaemic episodes. Severe hyperglycaemia: If blood sugar more than 325mg/dl or 18 mmol/l test for ketones (rare in type 2 diabetes). If ketones present start rehydration (0.9% sodium chloride iv) and soluble insulin 0.1 units/kg/hour. Watch potassium. If no ketones, management similar but slower rehydration and lower infusion rate for insulin.

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ASPECTS OF DIABETES MANAGEMENT: 1. Lifestyle Lifestyle is the most important part of diabetes care! But changing lifestyle is difficult: help your patient work out what they can do and what is too difficult. Small changes do make a difference. The main lifestyle changes are: Smoking Help people to stop smoking because it increases the risk of cardiovascular disease. Healthy diet for all: low sugar, low fat and low salt. If overweight aim to lose 5-10% of body weight. Diet and weight Being overweight increases the risk of cardiovascular disease and makes blood sugar control harder. Exercise Reduces cardiovascular disease and helps weight loss. Encourage walking for 30 minutes a day. 2. Cardiovascular risk management Blood pressure control maybe more important than blood sugar control. BP Aim for BP 140/90 or less, but this is difficult to achieve. Try not to change drugs because of a single BP reading. Follow the hypertension field guide. Use ACE inhibitor first (offers kidney protection). Assess CVD risk: If >20% : SIMVASTATIN 40mg/ ATORVASTATIN 20mg daily. Cholesterol Do NOT offer aspirin (unless secondary prevention for known CVD) 3. Blood sugar control Venous glucose Capillary glucose Glycosylated haemoglobin (HbA1c) (BEST

Aim for blood sugar mg/dl mmol/l mg/dl mmol/l TEST) less than: Fasting 75 - 150 4-8 115 6.5 64mmol/mol or 8% After meal 180 10 160 9 If blood sugar is above these levels (try not to change based on a single reading) OR if complications develop:  Review lifestyle: what changes can still be made? Step 5  Check compliance: are they taking their tablets regularly? Step 4 INCREASE INSULIN Or  Step 3 ADD INSULIN Avoid causing hypoglycaemia. CHANGE INSULIN REGIME ADD SULPHONYLUREA Seek expert advice. Step 2 (see table below) Eg.Gliclazide/ glibenclamide Continue lifestyle/ & Review Lifestyle Increase Continue metformin & healthy metformin. Stop sulphonylurea Step 1 METFORMIN to max LIFESTYLE CHANGES start lifestyle METFORMIN Drug Dose Start at 500mg once daily. Increase to 2000-3000mg/day if tolerated in divided doses with each meal. Main side effects: Metformin nausea/diarrhoea. Low risk of hypoglycaemia. Avoid in renal failure (creatinine more than 150mmol/l/eGFR less than 30). Use with caution in renal impairment (creatinine 130-150, 30-45eGFR) Start at 5mg with breakfast. Increase as needed to maximum of 15mg/day. Main side effects: hypoglycaemia (especially in elderly or low Glibenclamide weight patients), weight gain. Start only if you are experienced and have fully explained use of insulin and risks of hypoglycaemia to patient. Use intermediate acting insulin (Protaphane). Single daily dose as effective as other regimens with less weight gain. Usual starting dose 0,3 units/kg at night but seek advice for each patient. Sometimes split to twice daily if needing high doses or experiencing morning hypoglycaemia. Main risks: hypoglycaemia and complications from incorrect use.

Insulin

4. Look for and treat complications Ask about symptoms of hypoglycaemia (sweating, sudden tiredness, feel weak, dizzy, pale, confused, unconscious). Make sure Hypoglycaemia patient and family know what to do. Nephropathy: rising creatinine and proteinuria (routine Creatinin + Urine dipstick 1/year). Treat with ACE inhibitor, monitoring renal Renal function function carefully as ACE inhibitors can also cause renal failure. Check for cataracts and retinopathy. In retinopathy tighter sugar control may slow progression. Cataracts: surgery only if impairing Eyes ability to do everyday activities. Ask about neuropathic (burning) pain Look for ulcers/deformity. Check leg pulses. Feet If ulcers, absent foot/weak leg pulses, no sensation. Treat ulcers and improve diabetes control! Autonomic Ask about: bloating/nausea/vomiting after meals, sudden diarrhoea in night, erectile dysfunction, no warning signs when getting neuropathy hypoglycaemic (very serious in drivers). If found, improve blood sugar and BP control, encourage lifestyle change.

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4. Appendix

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Infomaterial for Patients on High Blood Pressure

Blood pressure is the pressure needed to circulate blood through the body. When too much of this force is pressing against the artery walls, it is called high blood pressure.

The only way to tell if you have high blood pressure is to have it measured with a blood pressure cuff. You can look and feel terrific and still have high blood pressure.

No one knows for sure why some people have high blood pressure. But one out of four adults in Swaziland has it. What is high blood pressure?

High blood pressure is when your blood pressure is usually higher than it should be. It is also called hypertension.

It’s like a car tire with too much air in it. If the tire pressure is not lowered, there is risk for tire damage. If your high blood pressure is not lowered, there is risk for damage to your eyes, brain, heart, blood vessels, and kidneys. How to Control High Blood Pressure

Most high blood pressure cannot be cured, but it can be controlled with lifestyle changes and medications. Controlling blood pressure can help prevent a heart attack, stroke, or kidney failure. Daily treatment usually must be continued for life in order to get your blood pressure down and keep it down. High blood pressure can cause a stroke

A stroke happens when a blood vessel leaks or is blocked by a clot. Then part of the brain does not get enough oxygen. This can cause brain damage, which may be permanent and life changing. Many effects from a stroke can be successfully treated. Lowering blood pressure can help prevent strokes. Pills Are Just Part of the Treatment

If your doctor has prescribed medication, you must take it daily to lower your blood pressure. Make efforts to lose weight (those extra few pounds may raise your blood pressure). Cut back on salt, and your pressure may fall or help the medication work more effectively. Exercise in moderation may also help you control your blood pressure.

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Here are 10 lifestyle changes you can make to lower your blood pressure and keep it down.

1. Lose extra pounds and watch your waistline Blood pressure often increases as weight increases. Being overweight also can cause disrupted breathing while you sleep (sleep apnea), which further raises your blood pressure. Weight loss is one of the most effective lifestyle changes for controlling blood pressure. Losing just 10 pounds (4.5 kilograms) can help reduce your blood pressure. Besides shedding pounds, you generally should also keep an eye on your waistline. Carrying too much weight around your waist can put you at greater risk of high blood pressure. In general: Men are at risk if their waist measurement is greater than 40 inches (102 centimeters). Women are at risk if their waist measurement is greater than 35 inches (89 centimeters). These numbers vary among ethnic groups. Ask your doctor about a healthy waist measurement for you. 2. Exercise regularly Regular physical activity — at least 30 minutes most days of the week — can lower your blood pressure by 4 to 9 millimeters of mercury (mm Hg). It's important to be consistent because if you stop exercising, your blood pressure can rise again. If you have slightly high blood pressure (prehypertension), exercise can help you avoid developing full-blown hypertension. If you already have hypertension, regular physical activity can bring your blood pressure down to safer levels. The best types of exercise for lowering blood pressure include walking, jogging, cycling, swimming or dancing. Strength training also can help reduce blood pressure. Talk to your doctor about developing an exercise program. 3. Eat a healthy diet Eating a diet that is rich in whole grains, fruits, vegetables and low-fat dairy products and skimps on saturated fat and cholesterol can lower your blood pressure by up to 14 mm Hg. This eating plan is known as the Dietary Approaches to Stop Hypertension (DASH) diet. It isn't easy to change your eating habits, but with these tips, you can adopt a healthy diet: - Keep a food diary. Writing down what you eat, even for just a week, can shed surprising light on your true eating habits. Monitor what you eat, how much, when and why. - Consider boosting potassium. Potassium can lessen the effects of sodium on blood pressure. The best source of potassium is food, such as fruits and vegetables, rather than supplements. Talk to your doctor about the potassium level that's best for you. - Be a smart shopper. Read food labels when you shop and stick to your healthy-eating plan when you're dining out, too.

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4. Reduce sodium in your diet Even a small reduction in the sodium in your diet can reduce blood pressure by 2 to 8 mm Hg. The effect of sodium intake on blood pressure varies among groups of people. In general, limit sodium to less than 2,300 milligrams (mg) a day or less. To decrease sodium in your diet, consider these tips: - Read food labels. If possible, choose low-sodium alternatives of the foods and beverages you normally buy. - Eat fewer processed foods. Only a small amount of sodium occurs naturally in foods. Most sodium is added during processing. - Don't add salt. Just 1 level teaspoon of salt has 2,300 mg of sodium. Use herbs or spices to add flavor to your food. - Ease into it. If you don't feel you can drastically reduce the sodium in your diet suddenly, cut back gradually. Your palate will adjust over time. 5. Limit the amount of alcohol you drink Alcohol can be both good and bad for your health. In small amounts, it can potentially lower your blood pressure by 2 to 4 mm Hg. But that protective effect is lost if you drink too much alcohol — generally more than one drink a day for women and for men older than age 65, or more than two a day for men age 65 and younger. One drink equals 12 ounces of beer, five ounces of wine or 1.5 ounces of 80-proof liquor. Drinking more than moderate amounts of alcohol can actually raise blood pressure by several points. It can also reduce the effectiveness of blood pressure medications. 6. Quit smoking Each cigarette you smoke increases your blood pressure for many minutes after you finish. Quitting smoking helps your blood pressure return to normal. People who quit smoking, regardless of age, have substantial increases in life expectancy. 7. Cut back on caffeine The role caffeine plays in blood pressure is still debated. Caffeine can raise blood pressure by as much as 10 mm Hg in people who rarely consume it, but there is little to no strong effect on blood pressure in habitual coffee drinkers. 8. Reduce your stress Chronic stress is an important contributor to high blood pressure. Occasional stress also can contribute to high blood pressure if you react to stress by eating unhealthy food, drinking alcohol or smoking. Take some time to think about what causes you to feel stressed, such as work, family, finances or illness. Once you know what's causing your stress, consider how you can eliminate or reduce stress. If you can't eliminate all of your stressors, you can at least cope with them in a healthier way. Try to: - Change your expectations. Give yourself time to get things done. Learn to say no and to live within manageable limits. Try to learn to accept things you can't change. - Think about problems under your control and make a plan to solve them. You could talk to your boss about difficulties at work or to family members about problems at home. - Know your stress triggers. Avoid whatever triggers you can. For example, spend less time with people who bother you or avoid driving in rush-hour traffic. - Make time to relax and to do activities you enjoy. Take 15 to 20 minutes a day to sit quietly and breathe deeply. Try to intentionally enjoy what you do rather than hurrying through your "relaxing activities" at a stressful pace. - Practice gratitude. Expressing gratitude to others can help reduce stressful thoughts. 9. Monitor your blood pressure at home and/or see your doctor regularly Home monitoring can help you keep tabs on your blood pressure, make certain your lifestyle changes are working, and alert you and your doctor to potential health complications. Blood pressure monitors are

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available widely and without a prescription. Talk to your doctor about home monitoring before you get started. Regular visits with your doctor are also key to controlling your blood pressure. If your blood pressure is under control, you might need to visit your doctor only every six to 12 months, depending on other conditions you might have. If your blood pressure isn't well-controlled, your doctor will likely want to see you more frequently. 10. Get support Supportive family and friends can help improve your health. They may encourage you to take care of yourself, drive you to the doctor's office or embark on an exercise program with you to keep your blood pressure low. If you find you need support beyond your family and friends, consider joining a support group. This may put you in touch with people who can give you an emotional or morale boost and who can offer practical tips to cope with your condition. Treatments and drugs Changing your lifestyle can go a long way toward controlling high blood pressure. Your doctor may recommend you eat a healthy diet with less salt, exercise regularly, quit smoking and maintain a healthy weight. But sometimes lifestyle changes aren't enough. In addition to diet and exercise, your doctor may recommend medication to lower your blood pressure. Medications to treat high blood pressure Thiazide diuretics: Diuretics, sometimes called water pills, are medications that act on your kidneys to help your body eliminate sodium and water, reducing blood volume. Thiazide diuretics are often the first, but not the only, choice in high blood pressure medications. Thiazide diuretics include hydrochlorothiazide (HCTz) and others. Beta blockers: These medications reduce the workload on your heart and open your blood vessels, causing your heart to beat slower and with less force. Beta blockers include bisoprolol, carvedilol, atenolol and others. When prescribed alone, beta blockers don't work as well, especially in black and older people, but may be effective when combined with other blood pressure medications. Angiotensin-converting enzyme (ACE) inhibitors: These medications — such as enalapril, captopril and others — help relax blood vessels by blocking the formation of a natural chemical that narrows blood vessels. People with chronic kidney disease and Diabetes may benefit from having an ACE inhibitor as one of their medications. Calcium channel blockers: These medications — including amlodipine, nifedipine and others — help relax the muscles of your blood vessels. Some slow your heart rate. Calcium channel blockers may work better for black and older people than do ACE inhibitors alone.

Aldosterone antagonists:

For example spironolactone (Aldactone). These drugs block the effect of a natural chemical that can lead to salt and fluid retention, which can contribute to high blood pressure.

To reduce the number of daily medication doses you need, your doctor may prescribe a combination of low- dose medications rather than larger doses of one single drug. In fact, two or more blood pressure drugs often are more effective than one. Sometimes finding the most effective medication or combination of drugs is a matter of trial and error.

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Type 2 Diabetes

What Is Type 2 Diabetes?

Insulin is a hormone. It works as a chemical messenger that helps your body use the glucose (sugar) in your blood to give you energy. You can think of it as the key that unlocks the door to the body’s cells. Once the door is unlocked glucose can enter the cells where it is used as fuel.

Type 2 Diabetes develops when the insulin-producing cells in the body are unable to produce enough insulin or when the insulin that it produces does not work properly (known as insulin resistance).

Common Symptoms of Diabetes

 Going to the toilet a lot, especially at night.  Being really thirsty.  Feeling more tired than usual.  Losing weight without trying to.  Genital itching or thrush.  Cuts and wounds take longer to heal.  Blurred vision.

These symptoms occur because some or all of the glucose stays in the blood, and isn’t being used as fuel for energy. The body tries to reduce blood glucose levels by flushing the excess glucose out of the body in the urine.

Why Do We Treat Diabetes?

Type 2 diabetes can be easy to miss as it develops slowly, especially in the early stages when it can be harder to spot the symptoms. But untreated diabetes affects many major organs, including your heart, blood vessels, nerves, eyes and kidneys. Being diagnosed early and controlling your blood sugar levels can help prevent these complications.

How Do We Treat Diabetes?

The good news is that Diabetes is a very manageable condition and if you look after yourself and follow advice and treatment from your doctor then you can help avoid the complications of Diabetes. There are three main things that help manage diabetes;

4. Changing your diet & lifestyle 5. Keeping active and losing weight 6. Medications

10 Ways to Eat Well With Diabetes

Whether you're living with diabetes or not, the whole family will benefit from eating well. And, the good news is that it's easy to get started. Try out these top tips for healthy eating.

1. Eat regular meals

Space your meals evenly throughout the day, and make sure everyone has breakfast. Avoid having just one or two large meals.

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2. Keep an eye on portion sizes

Be mindful of your overall portion sizes of your food. If you are trying to lose weight, you may need to adjust them.

 Try using smaller plates.  For main meals, dish out your vegetables first and let this fill up your plate.  Separate the different foods on the plate rather than piling them on each other.  Resist the temptation for a second helping; have a glass of water first.

3. Carbs count

Include carbohydrates in the food you eat each day. Healthier sources include wholegrain (brown) starchy foods, fruits and vegetables, pulses and some dairy foods. As all carbohydrates effects blood glucose levels, be conscious of the amounts you eat.

Lower GI (glycaemic index) foods release sugar more slowly. Try to eat lower GI foods and avoid higher GI foods. If you want to eat higher GI foods, just try eating smaller portions of these. Here are some examples

Low GI  Medium GI High GI  Pasta Rice Millet (pap) Lentils Banana White Bread Beans Mango Ice Cream Soya Potatoes Pineapple Nuts Yams Raisins Apples Sweet Potatoes French Fries/Chips

4. Cut the fat

Everyone needs some fat as part of a healthy diet. But, cut back on saturated fats, which are found in foods that are made of animal products like butter and cheese, red and processed meats, palm oil, coconut oil, ghee, and cakes and pastries.

5. Get your five a day

Aim for at least five portions of fruit and veg a day, so that you and your family get the range of vitamins, minerals and fibre you need to eat well. They may also help protect against stroke, heart disease, high blood pressure and some cancers. Choose seasonal produce to cut costs.

6. Cut back on salt

Too much salt is associated with high blood pressure, which increases the risk of diabetes complications. Adults should have no more than 1 teaspoon (6g) of salt per day, while children have even lower targets. Most of the salt we eat comes from processed foods so cut back on these and try to cook from scratch, flavouring your food with herbs and spices instead. It is always a good idea to read labels and choose lower salt options whenever possible.

7. Dish up the fish

All types of fish are good sources of protein, and oily fish is particularly good, as it's rich in omega-3 (polyunsaturated fat), which protects against heart disease. Fresh, frozen or canned are all good – choose canned fish in spring water, and look out for added salt.

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Avoid fried fish, or, if you do have it, remove the batter. Aim to eat two portions of oily fish, such as mackerel, sardines or salmon, every week.

8. Eat more beans

Beans, lentils and pulses are low in fat, high in fibre, cheap to buy and packed with nutrients. They don’t have a big impact on blood glucose and may help to control blood fats such as cholesterol. Try kidney beans, chickpeas, green lentils, and even baked beans, hot in soups and casseroles or cold in salads.

9. What about sugar?

Even with diabetes, you can include some sugar in foods and baking. The trick is not to overdo it, by keeping sugary foods and drinks for an occasional treat, and finding alternatives where you can. Try using artificial sweeteners when sweetening food and drinks at home.

10. Hydrate

We all need to stay hydrated by drinking 8–10 glasses of fluid per day. Water is best, but milk, tea and coffee (without sugar), herbal teas and some foods, particularly fruit and veg, all contribute to this total.

You don’t have to cut out alcohol and sugary drinks altogether – just keep an eye on what you’re drinking and how much.

Getting Active And Staying Active

Being active will:  help you lose weight or maintain a healthy weight  increase the amount of glucose used by the muscles for energy, so it may sometimes lower blood glucose (sugar) levels  help the body to use insulin more efficiently – regular activity can help reduce the amount of insulin or other medications that you have to take  improve your diabetes management (particularly Type 2 diabetes)  strengthen your bones  reduce stress levels and symptoms of depression and anxiety  improve your sleep

How much activity do we need to do?

As well as activity in your daily routine such as getting to work, gardening or doing the housework, if you’re able, try to do some exercise. You can start with something gentle, like walking, and gradually work your way up to 30 minutes a day of moderate intensity exercise, five times a week.

Whatever your age, the less time you are sedentary the better, except for time spent sleeping.

What is moderate physical activity?

Moderate-intensity activity will raise your heart rate, make you breathe faster and feel warmer. One way to tell if you're working at a moderate intensity is if you can still talk, but you can't sing the words to a song. You should be slightly out of breath.

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What is vigorous intensity physical activity?

Vigorous-intensity activity means you're breathing hard and fast, and your heart rate has gone up quite a bit. If you're working at this level, you won't be able to say more than a few words without pausing for a breath.

Getting Active: Top Tips

1. Enjoy it – if you enjoy it you are more likely to keep it up 2. Start slow - Doing just a little bit more than you did before will still make a difference. So build up gradually, and give your body time to adapt 3. Make small changes 4. Set yourself goals - You’re more likely to stick to your more active life if you set goals 5. Variety is important – vary your routine so you don’t get bored 6. Make it social – try walking, gardening or exercising with friends 7. Don’t give up – you won’t see results immediately but stick with it and you will

Medications

Your doctor will decide with you if you need to start taking medicines to control your diabetes.

Diabetes medication lowers blood sugar levels, and there are a number of different types which work in different ways. Diabetes medication cannot cure diabetes, and most people will have to take it for the rest of their lives. It is very important to keep taking your medication every day and attend clinics for your scheduled check-ups. You can always come sooner if you have any problems before your check-up date.

You may find that, despite keeping to a healthy diet, physical activity and taking your diabetes medication regularly, your diabetes control is not as good as it was. This is because Type 2 diabetes is a progressive condition and, over time, you may need more help to manage your blood sugar levels.

There are three main types of medications that we use to control blood sugars;

1. Metformin 2. Glibenclamide (Daonil) 3. Insulin (Actraphane or Protophane)

Metformin

This is often the first medicine that is used for people with diabetes. It has been used for a long time and even with lots of new drugs, it is still the best one that we have.

As well as controlling blood sugars it has two additional benefits. It helps protect the heart from heart disease and heart attacks and it helps you to lose weight.

Metformin works in two ways:

 It helps to stop the liver producing new glucose  It helps to overcome insulin resistance by making insulin carry glucose into muscle cells more effectively

You should take your metformin with a meal or a snack as often as directed by your doctor. This will help to avoid side effects.

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Common side effects include feeling sick, diarrhoea and abdominal (tummy) pain. These symptoms usually pass after the first few days of treatment. If you experience side effects and they persist, it is important to tell your doctor.

Glibenclamide (Daonil)

This is often used as the second medicine to treat diabetes. This tablet works by increasing the amount of insulin that your body produces. This helps to reduce the amount of sugar in your blood.

Common side effects include; feeling or being sick, constipation, diarrhoea, low blood sugar and weight gain.

Low blood sugar

It is important to know the signs of low blood sugar. These are;

If you notice these symptoms you should eat something containing sugar such as a sweet biscuit or a sugary drink (not diet) and follow this up with a snack such as a sandwich. Tell your doctor if you notice these symptoms.

Insulin

If you are taking the highest doses of both of these medications and your sugars are still high then your doctor may discuss insulin with you.

Insulin is taken by injecting it with a very small, fine needle into the fatty layer underneath your skin. This normally starts as once a day but it may be as many times as three times a day, depending on your sugars. You may be asked to monitor your sugar level with a small machine at home. If you need to do this then your doctor will discuss this with you in detail.

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Eat less salt to lower blood pressure

Eating too much salt is the biggest cause of high blood pressure - the more salt you eat, the higher your blood pressure will be. Salt makes your body retain water. If you eat too much, the extra water stored in your body raises your blood pressure. This can be a particular problem if you have high blood pressure. Also, eating too much salt may mean that blood pressure medicines, such as diuretics, don't work as well.

Therefore cutting the amount of salt you eat is one of the quickest ways to lower your blood pressure (especially if you have high blood pressure). However this is easier said than done as most of the salt we consume is already in food we eat.

How much salt is too much?

An adult should eat no more than 6g of salt a day, but most of us eat much more than this - the latest data shows we’re consuming around 8g a day. Although current intake is down from 8.5g in 2011 and 8.8g in 2005/2006 it’s still too high.

Most of the salt we eat every day is ‘hidden’ which means it’s already in processed foods like bread, biscuits and breakfast cereals, and prepared ready meals or takeaways. This ‘hidden’ salt accounts for around 75% of the salt we eat, only 25% comes from the salt we add while cooking or at the table.

What salt levels mean

To avoid hidden salt and cut down your salt intake, it is best to eat foods that are low in salt and stop using salt when cooking or at the table.

By reading food labels, you can see if a food is low, medium or high in salt (do not confuse with sodium, see below):

Low - 0.3g salt or less per 100g of food - Eat plenty of these.

Medium - 0.3-1.5g salt per 100g of food - Eat small amounts occasionally.

High - 1.5g salt or more per 100g of food - Try to avoid these.

What sodium levels mean

By law companies have to list the salt content of a food on the packaging however for some imported foods the label may still list how much sodium it contains. Salt is sodium chloride and the sodium is the part that raises blood pressure.

1g of sodium is the same as 2.5g of salt:

Low - 0.1g sodium or less per 100g of food - Eat plenty of these.

Medium - 0.1-0.6g sodium per 100g of food - Eat small amounts occasionally.

High - 0.6 sodium or more per 100g of food - Try to avoid these.

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If the label does not say how much salt or sodium the food contains, look at the ingredients list. The closer to the top of the list salt appears, the more salt it is likely to contain.

Tips to eat less salt and help your blood pressure - Don’t add salt when cooking. This includes salty foods like soy sauce, stock cubes and gravy granules. - Get extra flavour with herbs and spices, and from seasonings like chilli, ginger, lemon or lime juice. - Jarred cooking sauces and table sauces like ketchup, mustard and pickles can contain a lot of salt. Check the label and choose low-salt options. - Bread and breakfast cereals can contain a lot of salt. Check the labels to compare brands. - Fast food like burgers, fries, chips etc. contain much food, limit your intake. Prefer cooking yourself! - Smoked and processed meats and fish contain a lot of salt. Limit your intake of these. - If you are eating out, ask if your meal can be made with less salt. This may not be possible, but it is always worth asking.

At first, food without salt may taste bland, but don’t give up. After a few weeks your taste buds will adjust and you will start to enjoy food with less salt. 6g of salt a day is the maximum you should eat, and the less you eat the better.

Sodium in medication and supplements

Effervescent and soluble tablets, for example vitamin C supplements and soluble painkillers such as aspirin and Alka Seltzer, contain sodium carbonate or bicarbonate which makes them fizz.

However the sodium in these supplements is just as harmful and these tablets can contain the equivalent of 1g of salt so try to avoid these and use non-effervescent alternatives.

Limit your intake of saturated fat Your body needs a certain amount of cholesterol to work properly, but not too much. If there is too much cholesterol in your blood it can build up on the sides of your arteries, narrowing them and increasing your risk of a heart attack or stroke. The type of fat that you eat is important as some types of fats are more likely to raise your cholesterol levels while other types of fat will help to lower it.

Saturated fat and cholesterol Your body uses saturated fat to make cholesterol therefore eating too much saturated fat will raise your cholesterol. Too much cholesterol can raise your risk of heart disease and stroke, so if you have high blood pressure it is very important to keep your cholesterol levels low. Saturated fat is usually found in animal products for example red meats, pork, butter, ghee and cheese. It’s also found in many baked goods such as pastries, cakes and biscuits and in the plant-based oils coconut oil and palm oil. When shopping, try to avoid foods high in saturated fat – those that have a red traffic light.

Unsaturated fats A diet that is rich in unsaturated fats can help lower the levels of unwanted cholesterol even further. Polyunsaturated and mono-unsaturated fats are found in olive oil, rapeseed oil and sunflower oil. These fats don’t raise your cholesterol levels but can still make you gain weight if you eat too much of them. TIP: When cooking use rapeseed oil or sunflower oil in place of olive oil as it shouldn’t be heated to very high temperatures.

Eat your way to lower cholesterol - One of the best ways to keep your cholesterol levels in check is to enjoy a balanced diet. This means eating plenty of fruit and vegetables, with starchy wholegrain foods and low levels of saturated fat.

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- Try to eat fish at least 2-3 times a week. White fish is low in fat and high in vitamins and minerals. Oily fish is rich in Omega-3 essential fatty acids which may help reduce blood pressure, reduce the tendency of blood to clot, regulate the rhythm of your heart beat and reduce triglyceride levels. - Always choose lean meats, poultry (without the skin), and lower-fat dairy foods instead of the fatty meats and full-fat dairy products. When cooking, remove any visible fat from meat and skim off the fat from sauces, gravy and casseroles. - Avoid saturated fats found in butter, ghee, lard, full-fat dairy foods and animal products. Replace them with products high in monounsaturated fat such as rapeseed and olive oil, or high in polyunsaturated fats such as sunflower and corn oil. - Oats, beans, nuts and soya are also good choices.

Simple cooking methods to keep foods low in fat Some of the unwanted fat that we eat comes from the cooking oils we use when frying. Because of this, it is best to use other methods of cooking that don’t need cooking oil: - Instead of frying foods, steam, boil, poach, grill, bake, microwave, barbecue or stir-fry them. - Use only a small amount of oil when cooking and choose brands high in polyunsaturated or monounsaturated fat. Alternatively, try cooking in wine, water or tomato juice. - Measure oil using a teaspoon or tablespoon rather than just pouring it into the saucepan or use an oil spray. Trim meat of all visible fat and remove skin from poultry before cooking.

Eat more fruit and vegetables to lower blood pressure

Eating more fruit and vegetables has been proven to help lower blood pressure.

Fruit and vegetables are full of vitamins, minerals and fibre to keep your body in good condition.

They also contain potassium, which helps to balance out the negative effects of salt. This has a direct effect on your blood pressure, helping to lower it.

Eat at least 5 portions a day

To help lower blood pressure, adults should eat at least 5 different portions of fruit and vegetables per day. A portion is 80 grams, or roughly the size of your fist. The following amounts represent a portion: A dessert bowl of salad Three heaped tablespoons of vegetables Three heaped tablespoons of pulses (chickpeas, lentils, beans) One medium-sized fruit (apple, orange, pear or banana) Two smaller fruits (plums, apricots, satsumas) One slice of a large fruit (melon, pineapple or mango) Two to three tablespoons of berries or grapes A glass (150ml) of fruit or vegetable juice One tablespoon of dried fruit

What counts as a portion: All fruit and veg counts whether it’s fresh, frozen or canned. However if it is canned try to check it is in natural juices or water and doesn’t have added sugar or salt.

Pulses, unsweetened fruit juice and smoothies, and vegetable juice all count towards your five a day total. However they only count as one portion no matter how much you eat or drink. A 30-40g portion of dried fruit also counts but as it is so high in sugar it is recommended you only eat dried fruit at mealtimes to minimise tooth decay.

Potatoes, yams, cassava and plantain are starchy foods and so do not count towards your 5-a-day, however sweet potatoes and other root veg such as turnips, parsnips and swedes do count.

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Tips to increase your fruit and vegetable intake - Add a handful of berries or stewed fruit to your cereal or have mashed banana or avocado and sliced tomato on your toast in the morning. - If you’re having eggs for breakfast add a side of grilled tomatoes, mushrooms or wilted spinach. - At lunch and dinner make sure you include a side salad or at least of two portions of veg. - Add salad to sandwiches and wraps. - Add grated or chopped vegetables and pulses to pasta sauces, soups and stews. - Snack on fruit and vegetables during the day.

Get the most from your fruit and vegetables - Don’t buy fruit and vegetable dishes that come with sauces. They often contain a lot of fat, salt & sugar. - Vary the types of fruit and vegetables you eat. Each has different health benefits and it will keep your meals interesting. - Don’t add sugar to fruit or salt to vegetables when you cook or serve them. - Try to eat fresh fruit and vegetables as soon as possible. They will lose their nutrients over time, so if you want to store your ingredients for a while, it is best to freeze them or buy frozen packets. - Avoid leaving vegetables open to the air, light or heat if they have been cut. Always cover and chill them, but don't soak them because the vitamins and minerals can dissolve away. - Vegetables keep more of their vitamins and minerals if you lightly steam or bake them, instead of boiling or frying them. - If you boil vegetables, use as little water as possible to help keep the vitamins and minerals in them.

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