The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

PROJECT REPORT 2009 - 2010

MSc Public Health

Stream: General Stream

Title: The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff

Candidate Number: 491709 Word Count: 9,217

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff

Candidate 491709 MSc Summer Project 2009/10

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

ABBREVIATIONS

BME Black and Minority Ethnic Groups

CI Confidence Interval

DES Directly Enhanced Service

DH Department of Health

FT Foundation Trust

GP General Practice

LES Locally Enhanced Service

MH Mental Health

NHS National Health Service

PCT Primary Care Trust

PR Probability Ratio

SC Social Care

SHA Strategic Health Authority

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

CONTENTS

Executive Summary ...... 6

1. Introduction ...... 7

1.1 Background ...... 7

1.1.1 The 2009 Swine Flu Pandemic – Global and National Picture ...... 7

1.1.2 A Brief Overview of the UK Healthcare System ...... 8

1.1.3 The Need for Vaccinating Frontline Healthcare Staff ...... 9

1.1.4 Swine Flu Vaccination Campaign – Policy Overview ...... 10

1.1.5 Wider Context of the Swine Flu Vaccination Campaign ...... 13

1.1.6 Policy on Vaccination for Frontline Staff ...... 14

1.1.7 Influenza Vaccinations – Why Use This for Comparison to the Swine Flu Vaccination ...... 16

1.2 Aims and Objectives ...... 19

1.3 Importance of this Work ...... 20

2. Materials and Methods ...... 21

2.1 Swine Flu Uptake Data Analysis ...... 21

2.1.1 Data Access ...... 21

2.1.2 Data Analysis ...... 21

2.2 Literature Review ...... 22

2.2.1 Search Strategy ...... 22

2.2.2 Inclusion Criteria ...... 22

3. Results ...... 23

3.1 Swine Flu Data Analysis ...... 23

3.1.1 Uptake by SHAs Across England ...... 23

3.1.2 Trust Uptakes by Performance Bands ...... 24

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

3.1.3 Lowest and Highest Achieving Trusts ...... 25

3.1.4 Performance in London by Specific Trust Types – Primary Care Trusts ...... 29

3.1.5 Performance in London by Specific Trust Types – Acute Trusts and an Ambulance Trust ...... 31

3.1.6 Performance in London by Specific Trust Types – Mental Health Trusts ...... 32

3.1.7 Performance in London by Specific Trust Types – Foundation Trusts ...... 33

3.2 Literature Review ...... 34

3.2.1 Staff Vaccination Uptakes Over the Last Decade ...... 34

3.2.2 Is There Any Potential for Improvement? ...... 34

3.2.3 Barriers to Uptake of Staff Vaccinations ...... 35

3.2.4 Facilitators to Uptake of Staff Vaccinations ...... 35

4. Discussion ...... 39

5. Policy Recommendations ...... 41

5.1 Local Level ...... 41

5.2 National Level ...... 42

6. Future Work ...... 44

7. Acknowledgements ...... 45

8. References ...... 46

9. Appendices ...... 48

APPENDIX A - CARE Form ...... 48

APPENDIX B – Ethics Approval ...... 60

APPENDIX C – Extension Authorisation Documentation ...... 61

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

EXECUTIVE SUMMARY

Background The Swine Flu Pandemic was a major global health treat in 2009 and proved to be a real test of world-wide health systems. In the UK, devising an effective vaccination campaign for frontline healthcare staff was a particular challenge that proved difficult to overcome. This work looked at the uptake of the Swine Flu vaccination campaign in England and probed further into the issues relating to uptake of staff vaccination campaigns overall in order to make policy recommendations for similar campaigns that may be needed in the future.

Methods Review of England Swine Flu Vaccination Uptake data for frontline staff in England by Strategic Health Authority, Primary Care Trust, and specific trust types within London (a Swine Flu „Hot-Spot‟). Subsequent literature review of the nine published journal articles relating to vaccination campaigns for frontline staff in England to identify barriers and facilitators to uptake that fit the search criteria.

Results Although frontline staff vaccination uptake during the recent Swine Flu pandemic was better than the seasonal flu vaccination uptake, it remains low. The average uptake by SHA in England was 40% (range 7-92%) for the Swine Flu vaccination in comparison to 20% influenza vaccination uptake.

Conclusions The findings of this work suggests that there is more that can be done at a local and national level to ensure planning of future staff vaccinations campaigns are more effectively, particularly in the emergency setting. Awareness of the barriers and facilitators to staff vaccination and incorporation into future campaigns seems to be key to this. Further qualitative work is also needed in order to study the more in depth issues surrounding staff vaccinations and why there is such poor uptake.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

1. INTRODUCTION

1.1 Background

1.1.1 The 2009 Swine Flu Pandemic – The Global and National Picture

In April 2009, the first case of a novel influenza virus called „Swine Flu‟ or more formally the H1N1 subtype of the Influenza A virus, composed of swine, avian and human viral elements was detected in Mexico. This caused heightened rapidly cascading global concern about pandemic threat, further exacerbated by subsequent cases emerging from other countries shortly thereafter. Interestingly, the Swine Flu virus seemed to have a worse prognosis in healthy young adults and pregnant women, which was unlike the seasonal Influenza virus. The seasonal flu tends to fare worse in very young children and the elderly, but the novel H1N1 virus bore more of a resemblance in its morbidity and mortality patterns to the 1918 Spanish Flu.

Within two months there were 30,000 confirmed cases affecting more than 74 countries worldwide. 4,323 of these were UK based cases, and particular UK hot-spots were West Midlands (1,516 cases) and London (985 cases)1. Figure 1 demonstrates the extent to which Swine Flu cases were geographically dispersed within two months from onset.

Figure 1: Laboratory confirmed Swine Flu caseload by country worldwide. April to June 2009. Source: World Health Organisation

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

Although Swine Flu cases seemed to be associated with a lower morbidity and morbidity than may have been expected of a global emergency of this scale, it now met the WHO Phase 6 pandemic alert criteria (human-to-human spread of the virus in at least two countries in one WHO region, and community level outbreaks in at least one other country in a different WHO region), the World Health Organisation therefore declared the first global pandemic for 41 years in June 2009. In the UK, the next levels of emergency measures were implemented to deal with this, including the actioning of jointly developed multi-sector multi-agency plans that had only previously been trialled through role play and scenario discussion. Intense work to develop a vaccine using the circulating viral strain commenced urgently and by October 2009 a Swine Flu vaccine (Pandemrix, GlaxoSmithKline) had been authorised for use. It is reported that the UK purchased 60 million doses of this vaccine2. UK health systems began the massive roll out of this vaccine to priority groups, and this was continued for nine months until the WHO officially declared the pandemic to be over on 10 July 2010. Before the vaccine roll-out is discussed in further detail, a brief overview of the UK health system is provided to enable a fuller understanding of the background to this work.

1.1.2 A Brief Overview of the UK Healthcare System Healthcare in the UK is predominantly provided by the National Health Service (NHS) which is a public service funded from general taxation and is provided free of charge to all UK residents at the point of use. The main exceptions are fees for prescriptions, and also dental or eye care. There is also the provision of private healthcare, but this is thought to be used by less than 8% of the population3.

Figure 2 summarises the structure of the NHS in early 2009. From this, it can be seen that the Department of Health funds, direct and supports the NHS. The role of commissioning primary and secondary care and ensuring that it is meeting the local needs rests with the Primary Care Trusts, and that this role of the PCTs is overseen by Strategic Health Authorities. The multiple components of Primary and Secondary Care are depicted in Figure 2. The feedback mechanism provided by the contribution of patients and public into ensuring the appropriate and satisfactory care provision is shown.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

Figure 2: Structure of the UK National Health Service in Early 2009. Source: National Health Service Website4.

For the example of a vaccination programme, the Department of Heath decides upon necessary measures nationally following assessment of the available evidence and allocates individual SHA/PCT funding according to needs. They also set over-arching goals and targets to be achieved such as the entitled groups, coverage needed, timescales etc. At PCT level, this information is used by groups (usually already existing committees, but otherwise these will be set up) such as Child Health Committees or Immunisation Boards. This is a multi-agency group that come together to review related issues, including the planning and oversight of these programmes. Individual members will then be tasked with the implementation of related actions and data collection. This activity will be useful to assess the campaign and also to provide data back to SHAs or the DH for national comparison.

This overview of the NHS structure provides an understanding of the mechanisms in place to deliver existing and new health interventions of numerous types, including routine services and also those necessitated in emergency situations such as the Swine Flu vaccination campaign.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

1.1.3 The Need for Vaccinating Frontline Healthcare Workers There are approximately 1.5 million people working as frontline staff in the National Health Service (NHS) in England5 and their daily services prove to be increasingly important as the UK population ages and expands. Between these staff, healthcare is provided for the 50 million people making up the population in England6, as well as the many visitors to the country; and in their care are some of the most frail, vulnerable and medically complex people in the country.

The need to protect the health of frontline workers is therefore very clear, both for their own benefit given their higher exposure through work to infectious illness; and also to safeguard their families and patients, many of whom are already at higher risk just by being unwell. But the most effective ways to achieve this are not always as clear. Even when the best available evidence has been studied and recommendations made for frontline health staff to take up particular health interventions (such as a Staff Wellness Programme to promote heath and well being, Stop Smoking Campaigns for one-to-one support for staff to quit smoking, or even vaccinations to protect against particular strains of illness such as the seasonal Influenza virus), it does not always follow that there will be good take up of these.

The sub-optimal performance of these programmes poses interesting questions for those designing and implementing health programmes. What is stopping many frontline staff, who are delivering healthcare themselves and therefore generally more knowledgeable about health risk and services available, from taking up health programmes and advice? What are the barriers to their engagement? What would facilitate them to engage with these services and take them up?

Although these questions have received some attention in the literature, the focus until recently has been relatively limited. But yet their answers could potentially hold a very valuable insight, not only for possible improvements for future staff health programmes, but it could also have wider implications for the general population and provide understanding of additional factors that may facilitate their improved engagement with health services. This may be as simple as staff needing to be convinced of the value of an intervention before being able to convince others, or may prove more complex being deeply socially and culturally ingrained.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

1.1.4 Swine Flu Vaccination Campaign - Policy Overview As mentioned already, in October 2009 the UK‟s Department of Health instigated plans to roll-out the vaccine, starting with the priority groups identified. Each PCT in the country was instructed to develop plans to vaccinate the following priority groups:

 Individuals aged six months and up to 65 years in the current seasonal flu vaccine clinical at risk groups

 Pregnant women, subject to licensing condition on trimesters

 Household contacts of immune-compromised individuals

 People aged 65 years and over in the current seasonal flu vaccine clinical at risk groups

And also:

 Frontline health and social care workers (including private sector providers)

This amounted to an initial target population of approximately 14 million people overall. For the first four priority groups (totalling 9.5 million people), arrangements were made by the Department of Health for vaccination to take place through their local GP Practices. A national contract and payment scheme was agreed and vaccination commenced following the local delivery of the vaccines.

In addition to supporting this programme, PCTs were given the responsibility of designing and implementing their own programmes for frontline health and social care staff (totalling the remaining 4.5 million people in the target population). This was further extended in November 2009 to include higher risk prison staff as well. Each PCT used their own means to select the best method in which to run this campaign and was given relatively little directive on the design and implementation of their respective campaigns. Some of the techniques used by PCTs, which have been published online for public access, include the following:

 Inclusion of the vaccination of frontline staff onto the agreed General Practice campaign at additional cost (e.g. LES to supplement the DES)

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

 provision of the campaign thorough local non-General Practice teams such as o PCT Infection Control staff nurses o Immunisation teams

o Occupational Health teams o Any other teams qualified to deliver vaccinations

 tendering the project to an external provider (voluntary sector, private sector, or other)

As can be seen, there was considerable variety in individual programmes. In addition, there was a free choice of who within the PCT should lead the programme (Public Health teams, Primary Care Commissioning teams, Performance Management teams, etc), and the nature of the campaign (clinic locations, methods of engagement with local staff, resources put into the programme, extent of liaison with other teams, onset of the vaccination campaign, etc). No specific target uptake figures were set nationally, only an expectation that as many eligible staff as possible get vaccinated in order to optimally protect themselves and their patients from the Swine Flu virus. Given the associated time pressures, general anxiety about the pandemic, and need to continue to provide all routine services in addition to this, as well as commence planning for a possible second wave of Swine Flu activity, a considerable challenge was being faced that required rapid, but effective decision making by those in charge of planning healthcare.

The Department of Health and key partners monitored Swine Flu and vaccination activity closely through daily electronic reporting mechanisms, emergency meetings, conferences, and multiple electronic, verbal and media communications with staff and public. During the subsequent months, the Swine Flu activity began to diminish and fears about a second wave began to fade. In February 2010, the Department of Health published the preliminary data on uptake of the Swine Flu vaccine by PCT and SHA for higher risk groups and also frontline staff and similar report s began to be published worldwide. For although the Swine Flu Pandemic may not have been the disaster that at times it was feared to become, it certainly proved to be an excellent opportunity for those in healthcare to test their ability to cope under the intense pressures of a threatened emergency, still perform to their very best, and learn valuable lessons for the future.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

1.1.5 Wider Context of the Swine Flu Vaccination Campaign With any intervention it is important to note the wider environment in which the activity is being planned and carried out as this may additionally influence its successes or failures. For the UK Swine Flu vaccination campaign (October 2009 to March 2010), there were several such issues that must be acknowledged. These include the large-scale NHS changes taking place, the UK economic crisis, as well as other national and global crises.

At PCT level, a major split of their two main functions, commissioning and providing, was taking place. The predominant provider function and all related staff were being moved out of the PCTs and into the community, and the commissioning element remained within the PCT organisations. In the commissioning function of the PCT there is a primary care (community) and secondary care (acute services and hospitals) component. Already a split of this had begun, with the responsibility of commissioning of acute services being increasingly given to hospital trusts. This was further developing in 2009, and with the provider arm also being removed from the PCTs, this was a time of considerable health service change for NHS staff and local population groups. In addition to this, issues affecting staff involved with the planning of the swine flu vaccination programme included plans to create more joined up working between the PCTs and their local authority counter-parts with possible relocation of staff being discussed, changes to inspection methods for PCTs and respective organisations being introduced, the completion of the first year of the MMR catch- up programme coming to an end, the two year HPV vaccination catch-up programme commencing, and multiple other issues. Despite these circumstances, all staff were required to continue with their normal daily work, as well as providing care for the surplus caseload caused by the Swine Flu.

The wider economic picture also added to the challenges being faced. In January 2009, it was officially acknowledged that the UK was in the midst of an economic recession, and in the months that followed it became apparent that this was the worst economic crisis faced by the UK in the post-war era. This had major implications on the health and wellbeing of staff and the general public. And in addition to this, the impending national election bring the possibility of a new government and early cuts to major sectors such as the NHS brought additional considerations as the 2009/2010 began to close.

On the backdrop of this sits the joy and hopefulness associated with the preparations for UK hosting the Olympics in 2012 giving promise of a boost to the UK (and particularly East London) population, the election of the first African American US President, the G20 summit

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project) meeting and the UNFCC climate change conference; counter-forced by the anxieties and problems of middle-Eastern and other political unrest, heightened concerns about terrorist activities and actions underway to combat this in the country and abroad, concerns about the fragile environmental situation, and a complex myriad of interweaving factors and individual stories.

1.1.6 Policy on Vaccinations for Frontline Staff Department of Health guidance (Green Book) states that “healthcare workers have a duty of care towards their patients which includes taking reasonable precautions to protect themselves from communicable diseases” in order to “protect individuals and their families, patients and service users, and other healthcare and laboratory staff, and also to allow the efficient running of services without disruption” 7. In addition to stressing the importance of safe work practices, guidance is given by staff group on specific vaccinations and this is summarised in Figure 3. This excludes information for staff handling specific infectious specimens as it does not fully relate to this project.

STAFF INVOLVED WITH DIRECT PATIENT CARE - For staff who have regular clinical contact with patients and are directly involved with patient care (including doctors, nurses, paramedics, ambulance drivers, occupational therapists, physiotherapists, radiographers, and trainees) the following vaccinations are recommended:

 Staff should be up to date with tetanus, diphtheria, polio, MMR  BCG is recommended for staff in close contact with infectious patients  Hepatitis B is recommended for all those in direct contact with patients body fluids  Influenza is recommended for all healthcare workers in this category  Varicella is needed for those susceptible to the infection (e.g. those who have not had chickenpox previously)

NON-CLINICAL STAFF IN HEALTHCARE SETTINGS - For non-ancillary staff who may have social contact with patients but are not directly involved with patient care (including receptionists, wards clerks, porters and cleaners) the following vaccinations are recommended:

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

Staff should be up to date with tetanus, diphtheria, polio, MMR  BCG is recommended for staff in close contact with infectious patients  Hepatitis B is recommended for all those in direct contact with patients body fluids  Varicella is needed for those susceptible to the infection (e.g. those who have not had chickenpox previously)  Influenza and BCG are not routinely recommended for these healthcare workers

LABORATORY AND PATHOLOGY STAFF - For laboratory and other staff who regularly handle pathogens or potentially infected specimens (including mortuary staff, technical staff, cleaners, porters, secretaries and receptionists in laboratories, and those in academic or commercial research laboratories handling clinical specimens or pathogens) the following vaccinations are recommended:

 Staff should be up to date with tetanus, diphtheria, polio, MMR

 A booster of polio-containing vaccine every decade for those handling faecal specimens.  A booster of diphtheria-containing vaccine is recommended for staff exposed to diphtheria in laboratories and clinical infectious units if needed  in close contact with infectious patients  BCG for those at higher risk (including technical staff and autopsy attendants)  Hepatitis B is recommended for all those in direct contact with patients body fluids

Figure 3: Department of Health Guidance on Vaccinations for main staff groups. Source: Department of Health Green Book

Although the exact wording of local NHS vaccination policies varies from one NHS organisation to another8,9,10, they are usually based generally on the Department of Health guidance and expect good uptake of staff vaccinations. Although some are elective and staff members can opt out (such as the Influenza vaccine), other immunisations are considered mandatory. Staff who refuse these „mandatory‟ vaccines and are unable to show evidence of immunity could be excluded from particular areas of clinical practice in order to safeguard themselves and to protect their patients. Confirmation of immunisation status and provision of additional doses required in most NHS organisations is the responsibility of the respective occupational health department of that organisation, often as part of initial checks at the outset of employment.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

1.1.7 Influenza Vaccinations – Why use this for comparison to the Swine Flu Vaccination? Unfortunately there is no similar emergency vaccination campaign that can be used effectively as a model for comparison to the Swine Flu vaccination programme for healthcare workers that was implemented in 2009/2010. Although flu pandemics are infrequently recurrent in nature, approximately every half-decade, the three that were experienced in the 20th century prior to the Swine Flu Pandemic do not provide model examples for this purpose. The first was the Spanish Flu in 1918, followed by the 1957 Asian Flu, and then the Hong Kong Flu in 1968. In all of these, no comparable vaccination programme for healthcare workers was instigated. Additionally, during this time the NHS had been created (1948) and was radically changing so comparison to the system in 1968, 42 years ago, would not take into account the new structures and technological advances of modern day healthcare.

Instead, the vaccination programme used annually to protect healthcare workers from the seasonal strains of influenza in circulation has been chosen as the next best alternative. The influenza vaccination has been available since the 1960‟s, and as already outlined, it is a vaccination recommended for all healthcare workers who have regular clinical contact with patients and are directly involved with patient care (including doctors, nurses, paramedics, ambulance drivers, occupational therapists, physiotherapists, radiographers, and trainees) .

The influenza vaccine is a means of preventing influenza illness, which otherwise accounts for 3000 to 4000 deaths annually, and is thought to transfer 70-80% protection against influenza. The Influenza vaccine has been shown11 to reduce incidence, mortality and hospital admissions wit bronchopneumonia in the older age groups; reduce influenza-like respiratory illness by up to 90% in the 1-15 year age range; and reduce influenza-associated otitis media by up to 30% in children.

In the UK, the vaccination is administered on an annual basis between September and November and is modified each year to include cover of the main circulating strains of virus. Everyone over the age of 65 years in England is entitled to free vaccination against influenza through the NHS. All those aged between 6 months and 65 years who are deemed to be at higher risk (including those suffering from chronic respiratory, heart, renal or neurological disease, or immunosuppression or diabetes) are also entitled to the vaccine. Both of these groups are predominantly offered vaccination through their local General Practices.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

Healthcare workers directly involved in patient care are the third main group recommended to have the vaccine and it is the responsibility of the employing organisations (e.g. healthcare trusts) to provide vaccination for them.

Although the influenza vaccine has generally been well taken up by the over 65 year old age group over the last 10 years (Figure 4) with uptake being consistently over 70%, which is very close to the WHO target of 75%, this is not the case for the other two eligible groups.

The second clinical group, those over 6 months and under 65 years who are at higher risk, have proved more of a challenge to vaccinate and uptake figures have remained at considerably lower levels of between 40-51%.

Figure 4: Influenza vaccine uptake since 2000 in both clinical groups (over 65 years, and those at higher risk aged between 6 months and 65 years). Source: Health Protection Agency12.

But, probably most worrying has been the uptake amongst frontline workers in England. This has been the poorest of all three eligible groups, continuing to remain at average uptake levels of less than 20%. Data published on the Health Protection Agency website covers 2007-2009 and the levels by England SHA are shown in Figure 5.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

Figure 5: Influenza vaccine uptake by SHA in England between 2007 and 2009. Source: Health Protection Agency13.

This poses numerous and interesting questions: - How does the uptake of the emergency Swine Flu vaccination campaign in 2009/10amongst healthcare staff in England compare to their poor uptake of the seasonal influenza vaccine? Why was this the case? - What is known about the factors influencing healthcare staff decision to take up or not take up a vaccine that is recommended to them? How can this knowledge be used to improve future vaccination campaign planning and what further work is needed?

The following sections aim to answer these questions. The next section will look at the available data on healthcare worker uptake of the swine flu vaccine to see if it shows similar patterns to the seasonal influenza vaccine. Then a review of available literature will be done to summarise current knowledge of healthcare worker attitudes to vaccination in England. A discussion of this material will then follow, concluding with a set of recommendations for future campaigns and research in this area.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

1.2. Aims and Objectives

The aim of this work is contribute to the improvement of NHS vaccination campaigns for frontline health care workers through the study of the recent emergency Swine Flu vaccination campaign in England and literature review on barriers and facilitators for healthcare staff vaccination. .

The objectives of this work are:

 To determine the overall uptake of the Swine Flu vaccination campaign for frontline healthcare staff in England and compare this to the performance of the Seasonal Influenza vaccine campaign uptake which has already been discussed

 To review the data by SHA and PCT and identify any areas of strengths in the programme or potential improvements

 To review the data for London, which was a swine-flu hotspot, to look for local variation between trusts

 To review the literature on vaccination campaigns for frontline healthcare staff to identify known barriers and facilitators to their engagement.

 To briefly look at some of the high achieving Primary Care Trusts and assess whether the programme design accounted for the factors identified in the literature

 To suggest potential improvements and make policy recommendations based on the findings of this project

1.3. Importance of this work

The major pressures on the NHS budget and the massive UK £168 billion deficit dictate that future health programmes require robust design and implementation, in ways that best serve

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project) their intended purposes. They need to effectively engage fully with target population groups and minimise the wastage of valuable resources through the use of less effective methods. Fundamental to this will be the understanding of the barriers to engagement with health programmes and services, and the factors facilitating engagement. Incorporation of this understanding into the planning stages of a health programme could potentially make the difference between wasted resources and an effective and successful health intervention that benefits staff and the local population. This is particularly true of emergency situations when time to research best ways of engaging with people is limited, and a reliance is placed on prior knowledge of how best to do this.

Engagement with frontline healthcare staff is particularly important for the functioning of healthcare systems, not only due to their higher risk of exposure to illness and risk of exposing potentially vulnerable groups. They are critical to the provision of healthcare, and in an emergency setting provide the supporting framework on which the wider population can be protected against illness.

One such emergency was faced globally that threatened to seriously affect the health of many populations worldwide in 2009 – the Swine Flu Pandemic. Although it eventually proved to be a relatively mild illness, it also proved to be an invaluable trial run for the emergency mechanisms that are in place should a much more serious form occur in the future. The lessons learnt from this Swine Flu pandemic could potentially save numerous lives should the „real thing‟ occur and this work aims to capture some of these lessons.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

2. MATERIALS AND METHODS

The uptake of the 2009/10 Swine Flu Vaccination amongst frontline staff in England by Strategic Health Authority and Healthcare Trust was collected by the Department of Health throughout the campaign and the preliminary findings were published as data tables (a small table of performance by SHA, followed by a longer table of performance by each trust in England) on their website. They are currently in an archived position but still accessible through a search on their website. The first part of this project involves the analysis of that dataset to identify uptake patterns, trends and areas for improvement.

2.1 Swine Flu Vaccination Uptake Data Analysis

2.1.1 Data Access The dataset on the 2009/10 Swine Flu Vaccination Campaign for frontline workers in England (by SHA and Trust) was gathered through an electronic search of the Department of Health and Health Protection Agency websites in August 2010. Additional datasets on the Influenza vaccination campaigns for 2007/2008 and 2008/2009 were also obtained at this time. Reference lists containing all NHS trusts by type were also obtained from the NHS and NHS London Websites during August 2010.

2.1.2 Data Analysis Manual counting methods applied to the swine flu dataset and reference lists enabled a Microsoft Excel spreadsheet to be created which displayed the uptake of each SHA, and also NHS Trust by Performance Band (uptake by each 10% between 0% and 100%) and trust type (Acute, Primary Care, Ambulance, Mental Health, Care, Foundation). Counts were thrice repeated to ensure maximal accuracy. Using Microsoft Excel formulae means and quartiles were calculated, and graphs were created for display. Similar methods were applied to the Influenza datasets to provide a baseline for comparison and the graphs for this have already been presented. The results were analysed for trends and identification of areas for improvement.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

2.2 Literature Review

Vaccination campaigns rely on both the design of a good process and also a willingness from staff to take up the vaccine. From the policy documentation and summary so far it was clear that programme structure for frontline healthcare staff vaccination campaigns was varied in nature, partially due to national directives and freedoms given to NHS organisations to ensure adequate provision. It is likely that this impacted on the subsequent uptakes and respective variability. However, it is also likely t o have been affected by the individual perceptions of staff members about vaccination campaigns and their willingness to take up a vaccine. To enable understanding of this, a literature review was conducted to establish what is already understood about the barriers and facilitators to staff vaccination. This is presented in subsequent sections.

2.2.1 Search Strategy A literature search of the electronic databases PubMed, MEDLINE, EMBASE, Cochrane Library, Global Health, CINAHL Plus, NHS National Library and Trip Database was performed for relevant articles dated January 2000 to August 2010. Limits were published literature only (no grey literature or unpublished work was included), English language, studies on humans (not animals). The key words (in singular and plural format, only singular version listed below) were grouped into four concepts. Searches for each concept was conducted and the four searches combined. They were as follows:

 Concept 1: vaccination, immunisation, campaign, programme

 Concept 2: frontline, health, healthcare, staff, worker, personnel

 Concept 3: uptake, performance, coverage, take up, engagement, acceptance, declining

 Concept 4: perception, attitude, opinion, factor, influence, reason, barrier, activator, facilitator

2.2.2 Inclusion Criteria All study types and healthcare worker groups were included. Studies in locations other than England were selected out. Although initial intentions had been to focus on studies looking at Swine Flu vaccination campaigns in England, no studies were yielded relating to Swine Flu in this search, so instead the search was widened to include all staff vaccines.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

3. RESULTS

3.1 Swine Flu Data Analysis

The uptake of the 2009/10 Swine Flu Vaccination amongst frontline staff in England by Strategic Health Authority and Primary Care Trust was collected by the Department of Health throughout the campaign and the preliminary findings were published as data tables (a small table of performance by SHA, followed by a longer table of performance by each trust in England) on their website. They are currently in an archived position but still accessible through a search on their website.

It is important to bear in mind that this data is subject to various factors that make it difficult to strongly ascertain differences and clearly draw conclusions. These include potential variability in reporting (for example staff classification, completeness, errors associated with manual counts and typing, etc), various geographical and workload differences between individual SHAs and PCTs, unidimensional nature, and other factors. It is however interesting despite these to review the uptake data as it demonstrates some interesting patterns.

3.1.1 Uptake by SHAs Across England

The uptake by SHA (shown in Figure 6) reveals a relatively even performance throughout the country with an average uptake of 40%; a more promising performance than the respective Influenza vaccine healthcare staff uptake data. This would seem to support the suggestion in the literature14 that vaccination campaigns on the whole will be able to achieve an uptake of 40% if designed and implemented well, but due to various ill-understood factors the achievement of higher than this is unlikely and difficult.

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Average uptake amongst these trust = 41.02%

The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

Average uptake amongst these trusts = 40%

Figure 6: Preliminary Cumulative Data to 28 February 2010 on percentage uptake of Swine Flu Vaccine by frontline healthcare staff in each SHA in England. Source: Healthcare Worker Data Collection Via the ImmForm Website, Department of Health.

3.1.2 Trust Uptakes by Performance Bands

A more detailed look at this data reveals a more varied picture. Figure 7 shows the number of trusts in England achieving uptake rates in each 10% uptake band.From this, it appears that the overall achievement across trusts in England actually follows more of a normal distribution.

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Figure 7: Preliminary Cumulative Data to 28 February 2010 on percentage uptake of Swine Flu Vaccine by frontline healthcare staff in each PCT in England. Source: Healthcare Worker Data Collection Via the ImmForm Website, Department of Health.

3.1.3 Lowest and Highest Achieving Trusts

A look at the lowest and highest uptake areas gives interesting insight into further issues.

The trusts achieving uptakes in the lowest two bands were :

 0 to 9.9%: Oxfordshire Learning Disability NHS Trust (6.7%)

 10.0 to 19.9%: Birmingham and Solihull Mental Health NHS Foundation Trust (11.5%), North West Ambulance Service NHS Trust (13.7%), Surrey and Borders Partnership NHS Foundation Trust (14.4%), Sheffield Care Trust (14.9%), Kent and Medway NHS and Social Care Partnership Trust (15.7%), Lancashire Care NHS Foundation Trust (18.1%), South Birmingham PCT (18.6%), East Lancashire Hospitals NHS Trust (19.1%), and Calderstones Partnership NHS Foundation Trust (19.6%).

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The trusts achieving uptakes in the highest three bands were :

 70.0 to 79.9%: Papworth Hospital NHS Foundation Trust (78.7%), Barking and Dagenham PCT (74.6%), South Central Service Ambulance Trust (73.8%), and Blackpool PCT (70.1%).

 80.0 to 89.9%: Birmingham Children‟s Hospital NHS Foundation Trust (88.1%) and Lincolnshire PCT (80.4%).

 Over 90.0%: County Durham PCT (92%)

The first point is that this data for Swine Flu vaccine uptakes amongt healthcare staff in England SHAs and trusts actually includes uptakes for a number of different trusts in one table including acute trusts, mental health trusts, ambulance trusts, Care Trusts and Primary Care Trusts. But each trust is likely to consist of different staff numbers, staff compositions and organisational structures. Therefore the percentages presented as one table falsely disguise the individual challenges faced by one trust compared to another. For example, in an acute trust all members of staff entitled to the vaccination are more likely to be based on the same site than other trusts based more in the community such as Primary Care Trusts. Similarly, staff in the community may have more flexibility in their workload to access the vaccination than those in acute trusts whose workload may be more unpredictable.

Having taken into consideration this, it is still worrying to note that of the ten lowest uptake trusts, mental health trusts make up 70% (Sheffield Care Trust is classified as a Mental Health Trust and a Care Trust15). Figure 8 shows the composition of this group.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

Figure 8: Trusts types to achieve the lowest staff swine flu vaccination uptake based on preliminary Cumulative Data to 28 February 2010 on percentage uptake of Swine Flu Vaccine by frontline healthcare staff in each PCT in England. Source: Healthcare Worker Data Collection Via the ImmForm Website, Department of Health.

In order to explore this further, the performance of all 58 mental health trusts has been analysed and the uptake data is presented in Figure 9. Of note isthat 48 of the 58 mental health trusts (83%) achieved uptakes below the national average of 40%, with an average uptake amongst mental health trusts of 29.6%. Additionally, and possibly more worrying is that 12% of all mental health trusts in England achieved within the lowest 3% of uptakes in the country, and this may be an indication of particular problems faced engaging care staff with staff health programmes (for example, due to accessibility). This may highlight particular issues faced by these particular organisations that need to be addressed in order to make future campaigns a success. Further study into this would also be valuable.

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----- average uptake amongst all England trusts ____ average uptake amongst mental health trusts

Figure 9: Swine Flu Vaccine uptake by frontline staff in Mental Health Trusts in England based on preliminary Cumulative Data to 28 February 2010. Source: Healthcare Worker Data Collection Via the ImmForm Website, Department of Health.

The next section will now study the performance of five different trust types (Primary Care, Acute, Ambulance, Mental Health, and Foundation Trusts) within a swine flu hotspot in England – London.

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London is a geographically small but intensely varied Capital city which holds the largest cohort of healthcare workers (159, 458) out of all the England SHAs. Its considerable international links and large population density made it an important area in terms of disease containment. Thus achievement of a good staff uptake of the swine flu vaccination campaign in London was partulcalry important and has been chosen for further study.

In London there are 31 Primary Care Trusts, 21 Acute Trusts, 3 Mental Health Trusts, an Ambulance Trust, and 15 Foundation Trusts16. All except the last group are overseen by NHS London. Monitor, an independent body, regulates the activity of Foundation Trusts.

3.1.4 Performance in London by Specific Trust Types – Primary Care Trusts

The analysis of performance of primary care trusts in the London SHA region highlights another interesting point (Figure 10). Although London SHA which was one of the „Swine Flu hot spots‟, and thus the centre of considerable media attention and Swine Flu focus, the majority of uptake by PCT remains below 50%. Four PCTs surpassing their London PCT counterparts by reaching performances of approximately 60% to75%, and particularly noteable seems the performance of Barking and Dagenham PCT of 74.6%.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

Figure 10: Preliminary Cumulative Data to 28 February 2010 on percentage uptake of Swine Flu Vaccine by frontline healthcare staff in each London PCT. Source: Healthcare Worker Data Collection Via the ImmForm Website, Department of Health.

This is particularly notable in this region given its challenging diverse and mobile East London population, and models applied here to achieve such good uptake could potentially be of use when designing other vaccination campaigns for staff and population groups given the enegagement challenges. However, an important point about the dataset is highlighted through this – the variability of the denominator population. That is, the number of healthcare workers in that trust eligible to the vaccination. This group in Barking and Dagenham PCT is 342 (of which 255 were vaccinated), for other London PCTs such as Waltham Forest PCT it is as low as 7, and for others the cohort exceeds 1000, such as Camden PCTwhere it is 1404 or Sutton and Merton PCT where it is 1656.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

3.1.5 Performance in London by Specific Trust Types – Acute Trusts and An Ambulance Trust

Average uptake amongst these trusts = 41.02%

Figure 11: Preliminary Cumulative Data to 28 February 2010 on percentage uptake of Swine Flu Vaccine by frontline healthcare staff in each London Acute (blue) and Ambulance (orange) Trust. No data is available for three Acute Trusts (Hilingdon Hospital NHS Trust, Lewisham Hospital NHS Trust, and Whittington Hospital NHS Trust). Source: Healthcare Worker Data Collection Via the ImmForm Website, Department of Health.

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This data shows seemingly higher performance slightly than the other trust types, with the Ambulance Trust achieving lower than most of the Acute Trusts. This is difficult to interpret given the very low numbers and therefore little scope for comparison.

3.1.6 Performance in London by Specific Trust Types – Mental Health Trusts

Average uptake amongst these trusts = 32%

Figure 12: Preliminary Cumulative Data to 28 February 2010 on percentage uptake of Swine Flu Vaccine by frontline healthcare staff in each London Mental Health Trust. Source: Healthcare Worker Data Collection Via the ImmForm Website, Department of Health.

Again, there are few numbers but this seems to be in keeping with previous findings of mental health trusts achieving lower uptakes than the other trust types.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

3.1.7 Performance in London by Specific Trust Types – Foundtion Trusts

Average uptake amongst these trusts = 40.6%

Figure 13: Preliminary Cumulative Data to 28 February 2010 on percentage uptake of Swine Flu Vaccine by frontline healthcare staff in each London Foundation Trust (FT). No data is available for Royal Marsden NHS Foundation Trust. Source: Healthcare Worker Data Collection Via the ImmForm Website, Department of Health.

Performance by Foundation Trusts seems to be mixed, with seemingly higher numbers achieving over the 40% average, but counterbalanced by lower performances in six.

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3.2 Literature Review

A total of 236 studies were identified through the searches of the electronic databases, but the majority of these were based in countries outside of England. Once manual selection of the articles relating only to England and regions within England was conducted, only nine articles remained that met the inclusion criteria. Details of these studies and a brief summary of their features, findings and gaps are given on figure XX. The studies are predominantly cross-sectional studies focusing on the Influenza vaccination campaign for staff. One commentary article and one randomised controlled trial as the exceptions. It was hoped that some qualitative studies on staff attitudes would be available or that individual trust experiences in England would have been published, but neither could be found.

3.2.1 Staff vaccination uptakes over the last decade

Uptake of staff vaccination campaigns in England have remained persistently low over the last 10 years. Individual uptake levels in the literature varied from 8% to 30%. Although uptake varies from one NHS site to another, it does not seem to be linked to particular geography or NHS trust type, and does not seem to rise about this 30% level. There is insufficient evidence however to comment on this properly due to the lack of published data on this area.

3.2.2 Is there any potential for improvement?

There is general pessimism in the literature about the potential for improving vaccination campaign uptakes above current low levels. Although Smedley et al suggests that there is scope for further improvement through improved awareness and access, she also states that these strategies are „unlikely to increase annual uptake rates above 40% approximately and are likely to be costly‟. Their recommendation is therefore that until more evidence is available, resources may be better use to prepare for epidemics or pandemics rather than trying to increase annual uptakes without much success. Similarly, a randomised controlled trial conducted by Dey et al failed to significantly increase uptakes despite intensive promotional campaign and felt that this health belief model is unlikely to yield much benefit. Instead, she suggests the evaluation of strategies addressing both individual and organisational influences.

So, in summary the literature reveals the persistent problem of low staff uptake of vaccination programmes. Additioanlly two key issues are highlighted – the need to ensure that individual staff vaccination campaigns are the best use of resources, and if they are

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project) deemed to be so, considerable efforts need to be invested to ensure they achieve optimal uptakes. This is likey to require a combined approach (individual and organisation level) and requires considerable further study in order to minimise resource wastage through non- efficient means.

3.2.3 Barriers to uptake of staff vaccinations

The strongest reasons for declining Influenza vaccination include concern about side effects, lack of time, doubts about efficacy, lack of awareness about the availability of the vaccine or lack of access. Additionally features of the staff group under study seems to make a difference. For example, uptake was found to decrease with youth (PR 2.2 in older vs youngest groups, 95% CI 1.8–2.8). Additionally findings of linkage to smoking status was reported. It was found that non-smokers tend to be more likely to opt out vaccination. However, it is possible that these are subject to confounding from other factors and given the few studies available it is hard to accept without further evidence that these links are certain. The literature also suggests that clinical professionals are less likely to be vaccinated than non-professional healthcare staff. Additionally, that reasons for non-vaccination seems to vary between different staff groups. For example, doctors were found to be more likely to attribute non-vaccination to lack of time or access (PR 2.2) whereas nurses were more likely to be concerned about possible side-effects (PR 1.2, 95% CI 1-1.4). But again, it is possible that this is due to training, work practices, or communication amongst peers in any staff group type. Additionally, Harrison and Abbott suggests that the contradictory messages and lack of clear direction from the Chief Medical Officer and Government played a contributory role in the lack of success of the vaccination campaign in the earliest part of this century.

3.2.4 Facilitators to uptake of staff vaccination

The factors identified in the literature as being the most likely to encourage uptake of the Influenza vaccine is protected time / easier access, and more information about efficacy, side effects, workload and staff absences. It was generally felt that financial rewards would not significantly promote uptake. It was reported in one study that workers would be more likely to accept vaccination in the event of epidemic activity, or a change in the balance of personal benefit and risk to favour vaccination. Shroufi et al found that 70% of the care home staff studied would rely on advice from their general practitioner about vaccination rather than information from the government, practice nurses or managers. Qureshi et al found that visual material displayed in workplaces strongly encouraged vaccination uptake as did clear and consistent messages to staff about the benefit to them and their patients, as well as easy access to information about side effects. Other articles suggest that clear policies and

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project) involvement of occupational health tends to assist increasing vaccine uptake. Given the limited number of studies in this literature review it is difficult to conclude with any certainty what would be required in future campaigns but interesting suggestions have been gleamed that would warrant further study.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

Paper Study Type Participants Methods Findings Influenza vaccine Authors: Shroufi A et al. Institutions: 62 care homes in Postal questionnaire 90% response rate in initial survey to care home uptake amongst Journal: Public Health Nottinghamshire surveys. Initial total sample matrons. 77% response rate by staff sample. Low staff in care homes Year: 2009 Staff groups: Care home staff survey to care home vaccine uptake (17-20%) amongst care home staff. in Nottinghamshire Sample type: random cluster matrons about staff Uptake higher in care homes with a policy Sample size: 219 (staff sample) in vaccination levels. recommending the vaccination for staff (42% second survey Subsequent survey to staff uptakes vs 22%, p=0.01) sample exploring attitudes and beliefs.

Influenza Authors: Smedley J et al. Institutions: 6 acute hospitals Cross-sectional survey using 54% response rate. 19% uptake of 2002/3 influenza immunisation: Journal: Occup Environ Med recruited across England, Scotland postal questionnaire. vaccine. Main reason for accepting was belief of attitudes and beliefs Year: 2007 and N. Ireland Questions relate to uptake self-protection (66%). Main reasons for declining of UK healthcare Staff groups: All nurses, doctors, and attitudes / beliefs. were concerns about safety (31%), concerns about workers professions allied to medicine, lab efficacy (29%), and lack of time (22%). Scope for technicians and porters increasing uptake through improved access (36%), Sample type: whole sample more risk / benefit information (34%) and impact on Sample size: 11,670 staff absences (24%).

Healthcare workers Authors: Siriwardena AN Institutions: More info needed More info needed and influenza Journal: J Clin Nurs Staff groups: vaccination. Year: 2007 Sample type: Commentary on Sample size: Canning HS, Phillips More info needed J & Allsup S (2005).

Health care workers Authors: Canning HS, Institutions: 2 hospitals in Liverpool Cross-sectional study (self- Uptake 7.6%. Main reasons for not being vaccinated beliefs about Phillips J, Allsup S Staff groups: Nurses and healthcare completed surveys) include no felt need (29%), lack of awareness (18%), influenza vaccine Journal: J Clin Nurs. assistants and concerns about side effects (11%). Main and reasons for Year: 2005 Sample type: whole sample perceived benefits include reduced sick leave (44%), non-vaccination Sample size: 144 and personal protection (28%).

Factors influencing Authors: Qureshi AM et al Institutions: One Acute Trust Structured, self- 53% response rate. 28% vaccine uptake. uptake of influenza Journal: Occup Med (Lond) Staff groups: All healthcare workers administered postal Occupational Health posters strongly influenced the vaccination Year: 2004 Sample type: Random sample questionnaire 6 months decision to accept the vaccine (p<0.0001). Females amongst hospital- Sample size: 1040 after the 2000-2001 9.11 times more likely to have the vaccine than based health care influenza vaccination males (95% CI = 1.26 – 65.72). Those perceiving risk workers campaign of contracting influenza 7.70 times more likely to

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

have the vaccine (95% CI = 1.44 – 41.05).

Healthcare workers Authors: Stephenson I, Institutions: One Leicester hospital Questionnaire-based cross- Increased uptake was associated with previous and their attitudes Roper JP, Nicholson KG Staff groups: healthcare workers and sectional study influenza vaccination (OR = 1000, 95% CI = 20 – to influenza Journal: Commun Dis Public occupational health nurses 3,333), age over 45 years (OR 4.45, 95% CI = 1.66 – vaccination Health Sample type: Whole sample 11.9) and belief that influenza is a serious illness Year: 2002 Sample size: 615 (OR = 3.8, 95% CI = 1.3 – 10.6).

Survey of NHS Staff Authors: Akinosi B et al Institutions: Cross-sectional study More info needed attitudes to Journal: Commun Dis Public Staff groups: influenza Health Sample type: immunisation Year: 2002 Sample size: More info needed

Vaccination against Authors: Harrison J, Abbott Institutions: 8 NHS Trusts (who Cross-sectional study of Vaccination uptake low (9-30%). Distribution is influenza: UK health P volunteered their information for the NHS Trust campaign uptake broadly similar to distribution of staff in the trusts, care workers not Journal: Occup Med (Lond) study) with under-representation of nursing staff (37.1% on-message Year: 2002 Staff groups: All healthcare workers vs 44.6%) and over-representation of ancillary staff Sample type: Whole sample (26% vs 13.4%). (No significance testing evident. Sample size: 8 Unclear definitions, e.g. ‘over-representation of ancillary staff)

Promoting uptake Authors: Dey P et al Institutions: Bury and Rochdale Nested randomised Low uptake. In PHCT group: 21.9% in intervention of influenza Journal: J Public Health Med Health Authority controlled trial: group, 21% in the control group (no significant vaccination among Year: 2001 Staff groups: Primary health care difference, p=0.91). In the NH group: 10.2% in the health care workers: teams (PHCT) and nursing home (NH) Intervention: Awareness intervention group and 5.6% in the control group a randomized staff raising campaign through (no significant difference, p=0.34). Hence intensive controlled trial Sample size: 457 PHCT and 768 NH Public Health nurse promotional campaign failed to increase uptake. staff in intervention group, 395 PHCT Control: Same staff groups and 1364 NH staff in the control but no PH nurse visit group Sampling: Worksite stratification into PHCT and NH and random allocation into control or intervention groups.

Figure 14: Summary and references of the 9 published journal articles identified through the literature review.

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project)

4. DISCUSSION

The Swine Flu pandemic in England in 2009 provided an invaluable opportunity to not only test emergency plans and preparedness, but also to test existing theories about approaches to use to engage staff in vaccination campaigns. The results show that in comparison to the Influenza vaccine uptake by frontline healthcare staff, the Swine Flu vaccination campaigns overall proved more successful and achieved more than double the latest available uptake of the former (40% vs 15%). However, this still reflects a poor vaccination uptake overall and considerably less than the WHO expectations of 75% for the seasonal Influenza vaccination campaign.

Although the dataset as presented contains mixed data for several NHS Trust types and with then variety in staff groups and numbers, nevertheless analysis of the staff uptake data in England revealed a number of issues that need to be addressed. The low uptake of the vaccine amongst Mental Health Trust staff is a key finding that needs to be mentioned. Given that 12% of England Mental Health Trusts achieved within the lowest 3% of uptakes, and that 82% of this group achieved less than the national average, this could signify numerous problems for future vaccination campaigns in the event of a more serious pandemic than that just experienced. Issues could include lack of staff access to information or to the vaccine due to the nature of their work, lack of national or trust emphasis on this, or individual factors such as lack of perceived need, specific concerns about side effects or lack of time. Although this may not signify a problem as it may be generic factors that mean mental health trust staff genuinely do not want vaccination more than their non-mental health trust counterparts it is important to explore this issue to ensure it is not due to a lack of information, opportunity or support.

Analysis of the dataset also reveals some examples of very high uptake achievement. Given that this is rare, both in the literature and in practice (both for the Swine Flu and Influenza vaccination campaigns), it is important to analyse these performances further to determine their routes to high achievement. Informal discussion with two leads from high achieving trusts revealed insightful information. In one case, factors attributed to their success (despite a large denominator) were the leadership of an experienced clinician, good joint working (especially with occupational health, infection control and public health teams), good strategic overview, early planning and vaccination, provision of drop-in sessions (8am to 8pm) at different work sites, team targets for immunisation, and good communication with staff, the public and managers. The other attributed their high achievement was actually a

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The Swine Flu Vaccination Campaign in England: Uptake and Perceptions amongst Frontline Healthcare Staff (MSc Summer Project) reflection of low number of staff entitled to vaccination (denominator) and that their proximity to these staff members enabled easier encouragement and knowledgeable support from senior staff members which helped overcome individual issues and facilitated vaccination uptake. Although this highlights the already-mentioned problems of comparing multiple trust types together without taking into account the denominators and also organisational set up (thus access to eligible staff), it also highlights the importance of peer support and ability to have questions answered by trustworthy sources and sensible information. Although these are only informal comments and could potentially be biased or missing other equally successful factors, they nevertheless provide key lessons and options for consideration for future programmes. Successes such as these should be explored and shared where appropriate.

Literature review of the attitudes of staff to vaccination campaigns, and relative barriers and facilitators also revealed some interesting findings. The increased uptake during the Swine Flu vaccination programme compared to the Influenza vaccination programme seems to be in keeping with the general literature findings. However, the very high uptakes achieved do not seem consistent with the pessimistic view in the literature that uptakes over 40% are unlikely, and instead provide hope that this is possible. It may be that the additional media hype and anxieties surrounding the Swine Flu were the reasons for this, and although this would not be the case for routine vaccination programmes it would apply to future emergency campaigns and so should be explored further. Qualitative study of staff perceptions may help to clarify this and provide further insight

Major barriers to vaccination identified through the literature includes a lack of time, lack of information and lack of access. It was commented that a lack of Chief Medical Officer / Department of Health direction and conflicting messages also contributed to this. from Factors that would encourage uptake include provision of more and clearer information to justify the need for vaccination, evidence base, side effects, and improved accessibility. Protected time was identified as a factor that may help. Additionally clear communication, involvement of Occupational Health and General Practice, and a clearer central input rather than open leeway for trusts to design their own programmes were also suggested as helpful. In the next section policy recommendations based on all these findings are given followed by suggestions for future work.

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5. POLICY RECOMMENDATIONS

- 5.1. Local Level -

 Emergency Planning should include a detailed outline of a vaccination campaign for frontline staff. Additionally, trial runs to test plans should include the ability to devise a successful vaccination campaign.

 Ensure good working links between Occupational Health, Immunisation, Infection Control, and Public Health teams so that in the event of an emergency these links are already established. Consideration should be given to the use of general practice to vaccinate staff as well as patients and assessment of the local appropriateness of this as an alternative.

 Conduct focus groups with staff members regularly to review existing and proposed vaccination campaigns so that their concerns and questions are addressed, and that best possible means of engaging with them are pursued.

 Immunisation leads should be updated on the evidence relating to vaccination campaigns for frontline staff, barriers and facilitators so that campaigns can be tailored to take these into account. This could be through a yearly training session, workshop or just information sheet.

 Clear and accessible information should be provided to staff groups, ideally tailored to their individual groups based on what is known about their concerns. This information should focus on justifying why vaccination is needed (what the benefits are to staff, family and patients) and a summary of the evidence available for vaccination should be provided (including efficacy and side effect profile).

 If protected time can be arranged, this may help increase uptake. Alternatively, drop- in sessions could be arranged so that staff members can attend at their convenience

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rather than keeping to a set time.

- 5.2. National Level -

 A need to assess whether particular vaccination campaigns are indeed the best use of resources rather than alternative measures (such as disease control on occurrence) and if so this justification needs to be clearly relayed to trusts and from there to individual staff members. It would seem that this is a key component to convincing in the current climate and something that is currently lacking .

 Ensure clear direction – rather than allowing individual trusts full flexibility to choose their programme design, national supervision and closer oversight of this process is needed. National oversight should be improved so that even in an emergency setting, directives include targets, examples of successful designs or key points to include in campaign planning, brief summary of evidence for the vaccine and monitoring of performance with feedback by trust and region.

 Input should be given by the overseeing body into the campaign designs to ensure some national uniformity of standard (not necessarily design as each trust has a different set-up, but of the robustness and quality of the plan) before roll-out. For emergency vaccination campaigns this could be input into the plans or emergency meetings with leads just prior to roll out.

 Examples of best practice should be shared nationally so that other trusts can compare ideas and select methods of working. For each type of trust, networks of immunisation leads could be set up to share best practice, or partnering to occur so that trusts struggling to get uptake could be supported by better performing trusts. This is particularly true for mental health trusts where performance has been particularly poor.

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 Ensure consistent communication (ideally from all partner organisations including non-healthcare).

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6. FUTURE WORK

Considerable further work is needed in the area of staff vaccination programmes in order to improve performance and prevent resource wastage using sub-optimal methods. Future research needs to include more thorough study of the complex genetic, organisational and socio-cultural factors that are currently only touched upon in the literature for England. It is likely that qualitative studies of staff perceptions will yield useful information as they will enable thorough probing of these areas. This would be particularly interesting in different trust types, and especially within Mental Health trusts.

Given the time requirements of this type of work, it may be interesting in the meanwhile to conduct reviews of the wider global literature on these issues to enable study using greater volume of research. However, care would be needed to ensure feasible comparison due to the varied nature of worldwide healthcare systems.

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7. ACKNOWLEDGEMENTS

I would like to extend my warm gratitude to Berndadette Khoshaba for her academic advice. Her kind willingness to work flexibly to a schedule convenient to myself was invaluable given the additional pressures faced during that time. Similar thanks go to Hannah Babad.

Thanks are also given to my training Education Supervisor, Programme Director and dear family who have provided invaluable support throughout the year.

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8. REFERENCES

1 BBC News: Swine Flu Cases Soar in England. http://news.bbc.co.uk/1/hi/health/8121292.stm (accessed 5 July 2010)

2 BBC News: Uk Swine Flu Vaccine approved. http://news.bbc.co.uk/1/hi/8274374.stm (accessed 5 July 2010)

3 Wikipedia: Healthcare in England. http://en.wikipedia.org/wiki/Healthcare_in_England (accessed 7 July 2010)

4 NHS Choices: About the NHS – NHS Structure. http://www.nhs.uk/NHSEngland/thenhs/about/Pages/nhsstructure.aspx (accessed 12 July 2010)

5 UK National Statistics: NHS Hospital & Community Health Service (HCHS) and General Practice workforce as at 30 September each specified year. http://www.statistics.gov.uk/hub/health-social-care/health-care-system/health-care- personnel-finance-and-performance (accessed 1 August 2010)

6 Wikipedia: England. en.wikipedia.org/wiki/England (accessed 1 August 2010)

7 Department of Health: Infection Control Guidance http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digital asset/dh_117994.pdf (accessed 21 July 2010)

8 Yeovil Hospital: Infection Control Policy http://www.yeovilhospital.nhs.uk/LinkClick.aspx?fileticket=IFRSUiN6mYQ%3D&tabid=600& mid=1350 (accessed 21 July 2010)

9 West Midlands Mental Health Trust: Infection Control Policy http://www.wlmht.nhs.uk/docs/policies/V8%20- %20Immunisation%20Policy%20for%20Staff.pdf (accessed 21 July 2010)

10 Sutton and Merton NHS Trust: Infection Control Policy http://www.suttonandmerton.nhs.uk/ec/files/docuploads/CHAPTER%2017.pdf (accessed 21 July 2010)

11 Patient UK: Influenza Vaccination http://www.patient.co.uk/doctor/Influenza- Vaccination.htm (accessed 10 August 2010)

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12 Health Protection Agency: Influenza vaccine uptake monitoring on behalf of the government. http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1195733756886#r3 (accessed 10 August 2010)

13 Health Protection Agency: Healthcare Worker Uptake Data. http://www.dh.gov.uk/en/Publichealth/Immunisation/Keyvaccineinformation/DH_104070#_3 (accessed 12 July 2010)

14 J Smedley, J Poole, E Waclawski et al. Influenza immunisation: Attitudes and beliefs of UK Healthcare Workers. Occup Environ Med. 2007 64: 223-227

15 NHS Website: Mental Health Trusts in England. http://www.nhs.uk/ServiceDirectories/Pages/MentalHealthTrustListing.aspx (accessed 10 August 2010)

16 NHS London: NHS in London. http://www.london.nhs.uk/your-nhs-in-london/nhs-in-london (accessed 10 August 2010)

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APPENDIX A

COMBINED ACADEMIC RISK ASSESSMENT AND ETHICS

APPROVAL (CARE) FORM

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London School of Hygiene & Tropical Medicine (University of London)

Combined Academic, Risk assessment and Ethics (CARE) approval form for MSc Project Reports *This form must be completed electronically. For detailed guidance, please refer to the Project Handbook for your course.

SECTION 1 – STUDENT AND COURSE INFORMATION MSc DETAILS AND DEADLINES (deadlines to be communicated by Course Director) Academic Year 2009-10 MSc course (and stream, where applicable) Public Health (General Stream) Deadline for Supervisor approval 18/03/10 Deadline for Course Director approval 23/03/10 Deadline for submission to Ethics Committee Friday 26 March 2010 Target for approved form to be passed to TSO Friday 30 April 2010 STUDENT, SUPERVISOR AND TUTOR DETAILS (to be completed by student) Full name of student Student email address Year of study (part-time students only) First Year Second Year Supervisor name

Supervisor email address Supervisor status (at time of this Confirmed Provisional Still to be identified version of the form being completed) Name of personal tutor (where Supervisor is still to be identified)

SECTION 2 – APPROVAL AND SUBMISSION STATUS *Students please note: It is a requirement of your LSHTM degree that you obtain all required approvals before beginning your project work. To comply with legal requirements, your Supervisor and Course Director must specifically give Risk Assessment approval. Ethical approval must also be obtained if required (answers in Section 5 will help determine if so).

STUDENT DECLARATION (to be completed for all projects) I agree to conduct my project on the basis set out in this form, and to consult staff (initially, my Supervisor) if making any subsequent changes – especially any that would affect the information given with respect to ethics approval. I agree to comply with the relevant safety requirements, and will submit a separate request for LSHTM travel insurance where relevant. *Where seeking ethical approval for a study involving human subjects, please also attach copies of any information sheets, consent forms, and other relevant documents. Date of declaration 15/02/10

*Further note: when submitting your final project report at the end of the summer, you should also include a copy of your approved CARE form (which will be seen by the project markers); but to preserve anonymity, the page above – with your name – should be omitted.

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STAFF APPROVAL *Staff please note: Sections 3 and 4 of the form should be completed by the student before you are asked to sign. If you tick ‘no’ to any of the ‘Yes/No’ questions below, or disagree with any of the statements given, or have any other concerns, then you should not give approval – instead, please contact the student immediately to inform them of your concerns and discuss changes which they may need to make before you may be willing to give approval. *Supervisors and Course Directors should also be aware that in the exceptional case of a request to undertake a project in a country or region to which the Foreign & Commonwealth Office advise against travel, the student would need to fill out a separate form which will then need further School-level approval by the Safety Manager and Secretary & Registrar.

SUPERVISOR’S APPROVAL (required for all projects – this approval should be given first) I agree that Section 3 of this form is a reasonable summary of the Yes No proposed project. I agree that responses in Section 4 of this form address the main Yes No risks connected with a project of this nature. Name of Supervisor (if not yet identified, personal tutor or Course Director should approve) Date of approval June 2010

COURSE DIRECTOR’S APPROVAL (required for all projects – should follow Supervisor approval) I agree that the academic content of the proposed project, set out at Yes No Section 3 of this form, is suitable for this MSc. I agree that responses in Section 4 of this form address the main Yes No risks connected with a project of this nature. Name of Course Director (or nominee) Date of approval June 2010

DEPARTMENTAL SAFETY SUPERVISOR’S APPROVAL (only required if project involves working with pathogenic organisms, human blood or radiochemicals – should follow Supervisor approval) I agree that the proposed project, as set out in this form and Yes No particularly Section 4, may proceed. Name of Departmental Safety Supervisor (or nominee) Date of approval

ETHICAL APPROVAL (required for all projects involving human subjects or human data, except for public domain data that cannot enable the identification of living people – NB that Supervisor approval must have been received before the application is submitted to the Ethics Committee) Date application received Ethics Committee application number assigned On behalf of the Ethics Committee, I approve the project Yes No proposal set out on this form. Name of Ethics Committee scrutineer Date of approval

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SECTION 3 – APPLICATION FOR ACADEMIC APPROVAL *All students should complete all sub-sections (3.1, 3.2 and 3.3); if particular questions are not applicable to you then please write ‘N/A’.

3.1 PROJECT OUTLINE (should not normally exceed 750 words total) Proposed project title: (should not normally exceed 20 words) The Swine Flu Vaccination Programme for Frontline Health Staff in England – A Study of Uptake and Perceptions Proposed project type: *See course-specific section of Project Handbook for details of project types permitted for each MSc. Be aware that restrictions may apply for individual courses. Health Policy Review Proposed project length: *For almost all students, this will be ‘Standard’. Long and extended projects are only available for certain ITD courses; they have a different schedule and allow a slightly greater word count. Standard Long Extended Background: (about 200 words) *Indicate why this topic is of interest or relevance. *If the project involves work with a specific organisation please give details. *Please give any other details specifically relevant for consideration by the Ethics Committee, e.g. related to purpose. The Swine Flu Pandemic was a major health problem globally in 2009. Particular challenges faced in UK related to predicting the scale of the problem and containing the extent of its development. Part of this was ensuring timely vaccination of the population once the swine flu vaccine became available.

The vaccination campaign targeted higher-risk population groups and also frontline staff groups. Although considerable efforts have been invested into studying the barriers to engagement of some higher risk groups (such as ethnic minorities, those in areas of higher deprivation, etc) with health services, relatively less focus has been given to the frontline health workers. Broadly, this is a group of individuals better aware of health risk and services available, and may therefore be expected to have a higher uptake than the general population, particularly in an emergency setting such as this.

This project looks at the uptake of the Swine Flu Vaccination Programme amongst frontline health staff in England to determine whether or not the uptake was as good as would be expected and to explore further the reasons behind this.

Hypothesis: (about 30 words, where applicable) Not Applicable

Overall aim of project: (about 30 words) To study the uptake and perceptions of the Swine Flu Vaccination Programme amongst frontline workers in England and to identify recommendations for future vaccination campaigns.

Specific objectives of project: (about 70 words)  Objective 1: To review the characteristics of the population and existing routine vaccination campaigns for frontline health staff  Objective 2: To review the extent of the 2009 Swine Flu Pandemic in England and the planned vaccination campaigns (against the national policy issued)  Objective 3: To review the uptake of the Swine Flu Vaccination amongst frontline staff in England through local and national comparison.

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 Objective 4: To study the reasons for uptake or not of the vaccine amongst this group  Objective 5: To review the literature about engagement with frontline staff, previous problems faced in similar health programmes for frontline staff and how these were overcome  Objective 6: To provide suggestions on possible improvements for future campaign design

Proposed methods: (about 200 words) *Please summarise methods, and include any relevant details for consideration by the Ethics Committee such as numbers of participants and procedures to be performed. Proposed method of achieving each objective:

 Objective 1: This will be achieved through a brief review of Public Health reports

 Objective 2: This will be achieved through a brief review of the Department of Health guidance documents for the vaccination programme1,2,3

 Objective 3: These will be achieved through a descriptive data analysis of pre-collected national datasets looking at Swine Flu vaccination coverage data from primary and secondary care (not patient identifiable) sources.

 Objective 4: This will be achieved through a cross-sectional study of frontline staff looking at uptake, reasons of this, views on the campaign and suggestions for improvement (changed to literature review due to personal circumstances and time limitations)

 Objective 5: This will be achieved through a background review of published reports / grey literature about problems faced when engaging frontline staff with health campaigns (particularly routine vaccination campaigns) and how these were overcome

 Objective 6: This will be done through a summary of the project findings through methods already explained, identification of success and shortcomings, and suggestions for improvement.

References: (max 150 words) *List any key references which will shape the project, including for methods to be used. It should not normally be necessary to quote more than 5 references.

[1] Dalton, I. (2009) A (H1N1) Swine Flu Influenza: Phase 2 of the Vaccination Programme, http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/ digitalasset/dh_108855.pdf, Date accessed 14/02/10.

[2] Nicholson, D. (2009) Priority Groups for the Swine Flu Vaccination, http://www.dh.gov.uk/en/Publichealth/Flu/Swineflu/InformationandGuidance/Vaccinationprogramme/ DH_105455, Date accessed 10/02/10.

[3] Salisbury, D. (2009) The H1N1 Swine Flu Vaccination Programme 2009-2010, http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/ DH_106300, Date accessed 12/02/10.

Prior work: (only where relevant; max 100 words) *Indicate any previous work you have done related to this project topic, including student work, professional work, or publications.

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3.2 FEASIBILITY (about 100 words total – but can write more or write less if appropriate) What could cause this project to fail, i.e. prevent you from achieving your objectives? *Please indicate any aspects of your proposed approach which could potentially experience difficulties, e.g. delays with permissions, data collection or storage problems, lack of sufficient comparable information, etc. You may also wish to mention any wider matters which could affect your project, e.g. civil unrest, natural disasters, transport availability.  Problems with my finding time to obtain and review the datasets  Data availability (e.g. removal of data from the public domain)  Data quality (e.g. differences in recording between different sites, not comprehensive data)  Lack of published data on similar problems encountered in previous programmes / poor comparability

What alternative plans do you have in case you encounter any of the potential problems you have identified?  I have already checked the availability of the various papers and reports, and know that they do exist. Given that this is a Health Policy report, the literature review section will only be brief and can be shortened should the need arise. Therefore for both the data and the literature for this project, further alternative plans are not needed.  Alternative projects have been identified if I need to completely change this project (e.g. look at the uptake amongst risk groups of the swine flu vaccination programme, or evaluation of another Public Health programme).

3.3 INTELLECTUAL PROPERTY, COPYRIGHT AND OTHER PERMISSIONS *Please also see Section 5.2 regarding any specific data rights limitations arising from local ethical or research governance requirements If you expect to use existing data, how will you obtain it and what permissions will be required? The data is in the public domain and has already been obtained Having considered whether intellectual property rights (IPR) or copyright issues may affect your project, will any specific agreements be required? *Please tick all boxes that apply, and attach copies of any forms/agreements (even if in draft). No specific IPR, Copyright or permissions issues should apply to this project (student retains Copyright and related IPR by default, in line with LSHTM registration declaration) IPR to be retained by LSHTM (specific LSHTM form to be completed) Copyright to be transferred to LSHTM (specific LSHTM form to be completed) IPR, Copyright or other agreements/permissions required with external parties/organisations Please give any further relevant details about IPR, copyright or other permissions.

SECTION 4 – APPLICATION FOR RISK ASSESSMENT APPROVAL *All students should answer all questions in sub-section 4.1; this will make clear which of the following sub-sections you need to complete. Ensuring safety during project work is the responsibility of each individual student, and not of LSHTM or LSHTM staff. *Please see the Project Handbook for further guidance.

4.1 TYPE OF RISK (to be completed by all students) Where will the project be carried out? (please tick all that apply) *Note that work away from LSHTM or outside the UK means any form of work for your project,

6 of 12 not just primary data collection. Some courses may have specific restrictions on this. All work will take place either at LSHTM, in libraries in the UK, or at my personal residence in the UK. [If so, you do not need to complete either section 4.2 or section 4.3] Some work will take place in the UK that is away from LSHTM sites in London, is non-Library-based, and is not at my personal residence. [If so, section 4.2 on ‘Work away from LSHTM’ must be completed] Some work will take place at my personal residence outside the UK [If so, section 4.3 on ‘Work outside the UK’ must be completed] Some work will take place outside the UK that is not at my personal residence [If so, both sections 4.2 and 4.3 on ‘Work away from LSHTM’ and ‘Work outside the UK’ must be completed] Will the project involve working with or handling any of the following materials? Pathogenic organisms Yes No Human blood Yes No Radiochemicals Yes No [If ‘Yes’ to any of the above, Sections 4.4 and 4.5 must be completed] Are any other potentially hazardous activities likely to be carried out during the project? Yes No [If ‘Yes’, Section 4.5 must be completed] Do any special requirements (e.g. disability-related issues) or other concerns need to be taken into account for either you as a student, study participants or colleagues? Yes No [If ‘Yes’, Section 4.6 must be completed]

4.2 WORK AWAY FROM LSHTM (to be completed if any work will be done away from LSHTM, other than at your home or at libraries elsewhere in the UK) Will the project be based in an established hospital, college, research Yes No institute, NGO headquarters, field station or other institutional site? If ‘Yes’, please give the name and location of the site(s); describe approximately what proportions of your project will be spent there; and state name and role of person who has confirmed willingness to support you at each site (indicating extent of correspondence, especially what they have confirmed in writing).

Will you have an ‘external supervisor’, co-supervisor or other main Yes No advisor, or be working with any specific organisation(s), during your work away from LSHTM? If ‘Yes’, please indicate the name, role, contact details, and level of support that any such external advisors are expected to provide, and give details about any organisations you will be working with.

Will the project involve personal visits, interviews or interactions with Yes No people in their homes, workplaces, community settings or similar? If ‘Yes’, please give details, including approximately what proportion of your project this will involve.

Will the project involve lone/isolated work or significant travel? If Yes No ‘Yes’, please give details, including approximately what proportion of your project this will involve, and state how you can be contacted while working or travelling.

What arrangements are proposed for contact with your main supervisor while you are

7 of 12 away from LSHTM? Indicate expected ease and frequency of contact, and communication methods to be used.

Please tick to confirm: I have read the LSHTM Code of Practice on off-site work.

4.3 WORK OUTSIDE THE UK (to be completed if any work will be done outside the UK) What form of project work will be undertaken outside the UK? (please tick all that apply) Work at my family home or personal residence only Work at an established hospital, college, research institute, NGO headquarters, field station or other institutional site Work away from my personal residence or an established site *Note that for either the second or third options, you should also have completed Section 4.2. Name the country/countries and region(s) in which work will be undertaken: Country or countries: Region(s) : Do the Foreign & Commonwealth Office’s (FCO) Travel Advice Notices Yes No (www.fco.gov.uk/en/travelling-and-living-overseas/travel-advice-by-country/) advise against travel to the regions(s), country or countries involved? *Note that if ‘Yes’, the School will not normally permit such travel for project work. In exceptional circumstances only, requests may be considered by the Safety Committee and require approval by the Safety Manager and Secretary & Registrar. Please tick to confirm: I understand that LSHTM travel insurance is required for any international travel as part of my project. *Travel insurance can be applied for using a separate form.

4.4 WORK WITH HAZARDOUS SUBSTANCES (to be completed if the project involves any work with pathogenic organisms, human blood or radiochemicals – NB that this will require approval by the Departmental Safety Supervisor) Name the organism or organisms to be used:

Identify all potential routes of infection:

Name the radiochemical or radiochemicals to be used:

List laboratories where work with pathogens or radioisotopes will be carried out:

List disinfectants to be used, and describe arrangements for disposal of used material:

Will or might Health Surveillance be required for you or any staff Yes No working with you? If ‘Yes’, please give details.

4.5 PRECAUTIONS AGAINST HAZARDS (to be completed if any potentially hazardous activities are likely to be carried out during the project. Refer to Project Handbook and School safety documentation for further information. Departmental Safety Supervisor’s approval should be obtained where felt appropriate by project Supervisor.) Indicate any procedures, activities or aspects of the proposed project which may entail hazards (including work with hazardous substances as per Section 4.4, or anything else relevant). Please set distinct hazards out separately, in a numbered list.

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None Indicate the precautions you will take to prevent or mitigate such potential hazards. Please number these to refer to the specific hazards identified in the preceding question. Not applicable

4.6 SPECIAL REQUIREMENTS (to be completed if the project involves any special requirements, e.g. disability-related issues, or other concerns that need to be taken into account for either you as a student, study participants or colleagues) What special requirements or concerns need to be taken into account? None Do these need to be considered in planning arrangements? Yes No If ‘Yes’, please give details.

Do these impact on supervision arrangements? Yes No If ‘Yes’, please give details.

Does the project location need to be considered in relation to these? Yes No If ‘Yes’, please give details.

Do arrangements for access to specialist medical treatment need to be Yes No considered? If ‘Yes’, please give details.

SECTION 5 – APPLICATION FOR ETHICS APPROVAL *All students should answer all questions in sub-sections 5.1 and 5.2. Answers to 5.1 will make clear whether approval by the LSHTM Ethics Committee is necessary, and which later sub-sections you may need to complete. Section 5.2 covers any external approvals required.

5.1 SCOPE OF STUDY (to be completed by all students) *Before completing this part of the form, please read the Ethics Approval Policy & Procedure plus guidance notes at http://intra.lshtm.ac.uk/reference/ethicsstuds.html . This describes what to do next if formal LSHTM ethics approval is required. NB that supervisor approval must be obtained before an application is submitted to the Ethics Committee. Which of the following applies to your project? (please tick one option only) *Note – the term ‘human data’ includes any documentary data, datasets or biological samples.

Project does not involve any human subjects or any human data. [If so, formal LSHTM ethics approval is not required and you do not need to complete Sections 5.3 or 5.4] Project involves human data, but all this human data is fully in the public domain. [If so, formal LSHTM ethics approval is not required and you do not need to complete Sections 5.3 or 5.4] *Public domain human data must be: available to any member of the public without special permission; to which access is not restricted in any way; and which does not enable the identification of living people, either directly or by linking to other data. Project involves some non-public-domain human data, all of which was previously collected in another study or studies. [If so, formal LSHTM ethics approval is required and Section 5.3 must be completed] Project involves some additional collection of data, further to an ongoing or previously completed study or studies. [If so, formal LSHTM ethics approval is required

9 of 12 and Section 5.4 must be completed] Project is a completely new study which will involve human subjects or human data. [If so, formal LSHTM ethics approval is required and Section 5.4 must be completed]

5.2 LOCAL ETHICAL APPROVAL OR RESEARCH GOVERNANCE APPROVAL (to be completed by all students) * As well as approval from the LSHTM Ethics Committee, projects may require specific approval from other involved or responsible bodies. For example, in the UK you may need specific authorisation to work in an NHS facility, or to work with vulnerable groups such as patients or children. Outside the UK a wide range of requirements may apply e.g. from local or national Ethics Committees, government departments etc. Students must investigate all potential local approval required for your project work. Failure to check or gain any necessary external approval may invalidate LSHTM approval. Is local approval required for the work being done (whether this Yes No approval is still to be obtained, or has already been granted)? Not needed *This should include any forms of ethical approval, research governance for revised approval or other specific permissions that may apply. project If ‘Yes’, give details of local approval to be obtained (this must be in place before commencing fieldwork) or which has already been granted. *Please name all bodies whose approval is required, or indicate where work is expected to take place using permissions already granted for a ‘parent’ project. Where approval has already been granted, quote approval reference numbers and if possible give web links to documents. If ‘No’, explain why formal local approval is not required, and describe any less formal permissions, invitations or support you are being given for this work. *If you will be working away from LSHTM with human subjects or human data, but cannot identify a local Ethics Committee or believe that no formal approval is required, then please give details and explain what you have done to check this. In such cases, if you do not have formal approval you should always demonstrate appropriate local support, such as correspondence with local government officials or an involved Non-Governmental Organisation.

For data to be used or collected in the project, will any specific data Yes No rights permissions be required or usage limitations apply?

5.3 PROJECTS USING ONLY PREVIOUSLY-COLLECTED HUMAN DATA (to be completed if project involves non-public-domain human data, datasets or biological samples previously collected in another study or studies; if collecting any new data, complete Section 5.4 instead) *Further guidance is given at http://intra.lshtm.ac.uk/reference/ethicsstuds.html Summary of purpose and methods of the original study or studies: (max 100 words)

Give details of all approvals under which the original study or studies took place: *Please quote names of Ethics Committees and approval reference numbers (required if previous approval was from LSHTM); if possible give web link to original study application.

Proposed study: Ensure that the project outline given in Section 3.1 states the purpose, methods and procedures of the new work to be done in your project, and describes how this builds on the previous study or studies (for which participants will already have been recruited, data or samples collected, and procedures performed). Do not reproduce here. Will your analyses be for purposes not covered by the original Yes No application detailed above? If ‘Yes’, indicate how you will obtain (i) permission to use the data from the principal investigator responsible for each original study; and (ii) retrospective consent, where appropriate, from the

10 of 12 participants in each original study.

Does the project involve analysis of documentary information and/or Yes No data already collected from or about human subjects? If ‘Yes’, specify analyses briefly.

Does the project involve laboratory analysis of human biological Yes No samples already collected, or new or additional analysis of stored samples? If ‘Yes’, specify the laboratory analyses or tests to be performed.

Specify how confidentiality will be maintained. When small numbers are involved, indicate how possible identification of individuals will be avoided.

5.4 PROJECTS COLLECTING ANY NEW HUMAN DATA (to be completed if project involves collection of human data, datasets or human biological samples – either as a completely new study, or collecting additional data further to an ongoing or previously completed study) *Further guidance is given at http://intra.lshtm.ac.uk/reference/ethicsstuds.html Proposed study: Ensure that the project outline given in Section 3.1 contains sufficient detail (inc. purpose, methods, procedures for both new data collection and any work building on previous studies), so as to allow the Ethics Committee to make an informed decision without reference to other documents. Do not reproduce here. Is your project a randomised trial? Yes No Will any human biological samples be collected? If ‘Yes’, specify details. Yes No

Will any human biological material be stored at LSHTM for more than Yes No 24 hours? If ‘Yes’, specify which samples and how they will be stored. *Further guidance is given at http://intra.lshtm.ac.uk/safety/Safety%20manual-3-HTA.pdf

Specify the number - with scientific justification for sample size – age, gender, source and method of recruiting subjects for the study.

State the location and likely duration of new or additional human data collection, and the extent to which this will be carried out by you alone, or in collaboration with others, or by others.

State the potential distress, discomfort or hazards, and their likelihood, to which research subjects may be exposed (these may include physical, biological and/or psychological hazards). What precautions are being taken to control and modify these hazards?

Specify how confidentiality will be maintained. When small numbers are involved, indicate how possible identification of individuals will be avoided.

State the manner in which consent will be obtained from subjects and supply copies of the information sheet and consent form.  Written consent is normally required. Where not possible, explain why and confirm that a record of those giving verbal consent will be kept.

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 Where appropriate, please state if and how the information and consent form will be translated into local language(s). Part of questionnaire (sample attached) As well as collecting new data, will your project also make use of any Yes No human data or biological samples collected in a previous study or studies? If ‘Yes’, summarise the purpose and methods of the original study or studies – for which participants will already have been recruited, data or samples collected, and procedures performed. (max 100 words) Summary data from NHS London on Uptake by PCT (published on the internet for public access) and Tower Hamlets data on uptake (collated as a table included in published Board reports, not person identifiable)

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APPENDIX B

ETHICS APPROVAL FOR

INITIAL PROJECT IDEA

From: To: " >XXXX Date: Fri, 23 Jul 2010 15:36:50 +0100

------Paula Elliott Administrator LSHTM Ethics Committee

London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT

Tel: 020 7927 2221

>>> Ursula Gompels 23/07/2010 15:30 >>> Hi Paula, This application is approved. I have a edit for the questionaire to add the word 'potential' as follows :was a potential major health problem.

Regards, Ursula.

------Dr UA Gompels Reader in Molecular Virology Department of Infectious & Tropical Diseases London School of Hygiene & Tropical Medicine University of London Keppel St., London WC1E 7HT, UK Telephone: +44 (0)20 7927 2315 Fax (Dept): +44 (0)20 7637 4314 Email: [email protected]

APPENDIX C

CONFIRMATION OF MSc SUMMER PROJECT

EXTENSION

------Forwarded message ------From: To: "Lisa Grisolia" Date: Fri, 17 Sep 2010 12:55:57 +0100 Subject: Fwd: Project extension for XXXXXXXX MSc PH TG3 Dear Lisa,

XXXX's new hand-in date will be Thursday 30 September. XXXX is aware that we cannot extend beyond this if we want to be able to try to have the marking turned around in time for the Exam Board.

Hannah

------Forwarded message ------From: To: Date: Fri, 17 Sep 2010 12:53:08 +0100 Subject: Re: Fwd: Re: MSc PH Project Request Dear XXXX,

I will inform TSO that you have an extension until 30 September.

Hannah

>>> 16/09/10 12:05 >>> Dear Hannah

Many thanks for your emails. In light of the information you have kindly given me and also my grades XXXXXXXXX... I think it would be best for me to hand in what I have done by the end of September which should at least be a good first draft. I will work towards this and hopefully it should be enough for me to pass the MSc overall.

Thanks for your help Best wishes XXXX

>>> Hannah Babad 13/09/10 7:31 PM >>> Dear XXXX,

Further to my earlier email of today, I realise that I need to clarify that graduation is possible at a later stage during the year but most students want to try to get through the October exam board so that they can have completed the MSc.

In retrospect an Interruption of Study might have been advisable after the exams before you started your project, so that you could have come back next year to do the project. However, we must move forward with the situation as is.

If you can see yourself managing to hand in your project at the end of September, then you can be considered in October, just in time - we would make an effort to try to ensure that your project is marked. Anything later than that and it becomes difficult for me to guarantee that it will get marked in time.

If that is impossible, then your results will have to go through and be processed later in the next academic year.

Please feel free to contact me or speak to your tutor, if you want to discuss your situation rather than email. I am not in tomorrow but should be around,, even if not in the office, for much of the rest of the week.

Hannah

>>> Hannah Babad 13/09/10 12:32 >>> Dear XXXX,

If you are not able to hand in your project by the end of September, it will probably miss the marking round and you will not be able to have your grades considered at the Exam Board and so cannot graduate in October.

I can extend an additional week until September 30 and then I would advise that you hand in your project. The aim of the extension is not to enable you to do the best possible piece of work, as we would all appreciate that this is difficult under the circumstances, but the aim is to enable you not to be substantially disadvantaged by your circumstances.

I hope this helps.

Hannah

>>> 11/09/10 22:58 >>> Dear Hannah

My apologies for having to write to you again about my project. Since you kindly granted me a three week extension for my MSc project I have made some headway but am struggling quite a lot to find the time to further it properly. The problem is that the three week extension overlapped with XXXX.... I am really concerned that I really will struggle to meet the deadline of 22nd Sep. I know that you said in your email that we could reassess the situation nearer the 22nd Sep deadline, and I am therefore writing to inform you of my situation and please ask for the deadline to be extended to third week of October please. I am hoping that XXXXX. . , so hopefully that will give me a clear three weeks to complete the work.

My sincere apologies for all these issues and thank you for your support. With best wishes XXXX

>>> Hannah Babad 16/07/10 09:22 >>> Dear Lisa,

I have authorised an extension of 3 weeks for XX. The new project hand-in date will be Wednesday 22 September at noon by which time the project must be submitted to TSO, electronic and hard copies.

Many thanks, Hannah

—------Dr. Hannah Babad Lecturer and Faculty Taught Course Director Faculty of Public Health and Policy London School of Hygiene and Tropical Medicine 15-17 Tavistock Place London WC1H 9SH Tel: +44 (0) 20 7927 2328 —------