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Sepsis Sepsis: Recognition, Assessment and Early Management

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Sepsis Sepsis: Recognition, Assessment and Early Management National Institute for Health and Care Excellence Final version Sepsis Sepsis: recognition, assessment and early management NICE guideline 51 Appendices I-O July 2016 . Developed by the National Guideline Centre hosted by the Royal College of Physicians Sepsis Contents Disclaimer Healthcare professionals are expected to take NICE clinical guidelines fully into account when exercising their clinical judgement. However, the guidance does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of each patient, in consultation with the patient and, where appropriate, their guardian or carer. Copyright National Institute for Health and Care Excellence, 2016 ISBN 978-1-4731-1998-7 National Institute for Health and Care Excellence, 2016 Sepsis Contents Contents Appendices .................................................................................................................................. 5 Appendix I: Economic evidence tables .......................................................................................... 5 Appendix J: GRADE tables ............................................................................................................ 12 Appendix K: Forest plots ............................................................................................................... 45 Appendix L: Excluded clinical studies ......................................................................................... 109 Appendix M:Excluded health economic studies ......................................................................... 147 Appendix N: Research recommendations ................................................................................... 149 Appendix O: NICE technical team ................................................................................................ 155 References: Appendix I-O .......................................................................................................... 156 National Institute for Health and Care Excellence, 2016 4 Economic tables evidence Sepsis National Institute for Health and Care Excellence, 2016 Care Excellence, and Health for Institute National Appendices Appendix I: Economic evidence tables I.1 Scoring systems None. I.2 Signs and symptoms None. I.3 Blood tests 5 None. I.4 Lactate None. I.5 Serum creatinine None. I.6 Disseminated intravascular coagulation None. Economic tables evidence Sepsis National Institute for Health and Care Excellence, 2016 Care Excellence, and Health for Institute National I.7 Antimicrobial treatment None. I.8 IV fluid administration None. I.9 Escalation of care None. I.10 Inotropic agents and vasopressors None. 6 I.11 Supplemental oxygen None. I.12 Use of bicarbonate None. I.13 Early goal-directed therapy (EGDT) Study Mouncey 2015827 Study details Population & interventions Costs Health outcomes Cost effectiveness Economic analysis: CUA Population: Total costs (mean per QALYs (mean per patient): ICER (Intervention 2 versus Intervention 1): (health outcome: QALYs) Patients with early signs of patient): Intervention 1: 0.054 Intervention 2 dominated (more expensive Economic tables evidence Sepsis National Institute for Health and Care Excellence, 2016 Care Excellence, and Health for Institute National septic shock and less benefit) Intervention 1: £11,424 Intervention 2: 0.054 Probability Intervention 2 cost-effective Study design: Within trial Intervention 2: £12,414 Incremental (2−1): -0.001 analysis (RCT) Patient characteristics: Incremental (2−1): £989 (95% CI: -0.006 to 0.005); (£20K/30K threshold): 12%/12% (read from graph) N = 1251 (95% CI: -726 to 2,705; p=0.85) Approach to analysis: Mean age: invtn 1 = 64.3 p=NR) Analysis of individual level (15.5), intvn 2 = 66.4 (14.6) Analysis of uncertainty: (a) data for mortality and EQ- Male: invtn 1 = 58.6%, intvn Currency & cost year: Some form of PSA undertaken to generate 5D. Unit costs were cost effectiveness plane and cost 2 = 57% 2012 UK pounds applied to resource use. effectiveness acceptability curve. 500 estimates obtained. Intervention 1: Cost components Perspective: UK NHS Usual care incorporated: Sensitivity analyses undertaken include: The usual care group - Equipment and Time horizon/Follow-up continued to receive consumables – 2 monitors - Manufacturer list price used for monitoring machines instead of discounted price used in 90 days QoL follow up monitoring, investigation capable of oxygen Treatment effect and treatment as saturation monitoring base case duration: Resuscitation determined by the clinician. assumed to be needed per - Staff monitoring time varied from 10 minutes per hour in the base case to 5 and 15 7 protocol was followed for hospital. Costs of 6 hours minutes. Intervention 2: consumables including the catheter capable of - Location of protocol implementation; if Early Goal Directed Therapy monitoring, pressure protocol is implemented in the ED, staffneed Discounting: Costs: NR; (EGDT). Outcomes: NR transducers. to be trained but in critical care they do not. Following a resuscitation Sensitivity analysis assumed that the protocol protocol involving central - Blood products and dobutamine was implemented either exclusively in the ED venous catheter insertion or critical care. with central venous oxygen - Staff time to deliver the - Re-admission data in the base case was saturation monitoring protocol; time for vascular gathered both from the health services capability and intensive catheter insertion and time questionnaire sent out and the Intensive Care therapy of other for monitoring patients National Audit & Research Centre Case Mix interventions (assumed 10 minutes of nurse time per hr of the Programme Database. In a sensitivity analysis resus protocol). Staff time only the database was used to avoid any for training, assumed to be potential double counting. 20 minutes per ED staff - Baseline covariates were adjusted for member every 5 years (5 components of the Mortality in Emergency years assumed to be the life Department Sepsis (MEDS) score Economic tables evidence Sepsis National Institute for Health and Care Excellence, 2016 Care Excellence, and Health for Institute National of the protocol) - Costs and QALYs were assumed to be - Hospital stay/ICU stay gamma distributed, compared to normally - Re-admissions distributed in the base case. EGDT remained cost-ineffective in all sensitivity analyses. Data sources Health outcomes: Mortality data taken from the RCT (proMISe trial) alongside the economic evaluation. Quality-of-life weights: EQ-5D scores were elicited at 90 days, assuming an EQ-5D score of zero at randomisation, and a linear interpolation between randomisation and 90 days. Zero QALYs were assumed for people who died before 90 days. Cost sources: Costs of monitor and central venous catheter with monitoring capability was derived from the manufacturer. These costs are over 50% discount on list prices. It was assumed each site would require 2 monitors which would have a lifespan on average of 5 years. Monitor costs per patient were calculated by dividing the total costs of the monitors (£4000) by the expected number of eligible patients over 5 years. Annual number of eligible patients calculated by taking average number of potentially eligible patients per site per year from the trial screening log data (23 patients per site per year). Some consumables sourced from hospital finance departments. Training costs per patient per hour derived from total training costs per site divided by eligible patients over 5 years. Blood products from NHS blood and transplant price list 2012. Drugs from BNF 2012. Staff costs and outpatient and community health service costs from PSSRU 2012. Hospital stay costs from NHS 8 reference costs 2012. Comments Source of funding: NR Limitations: Adverse events not taken account of in cost effectiveness analysis (either their treatment costs or impact on QoL). Methodology behind probabilistic analysis unclear. Short time horizon. Overall applicability(d): Directly applicable Overall quality: potentially serious limitations Abbreviations: 95% CI: 95% confidence interval; CUA: cost–utility analysis; da: deterministic analysis; EQ-5D: Euroqol 5 dimensions (scale: 0.0 [death] to 1.0 [full health], negative values mean worse than death); ICER: incremental cost-effectiveness ratio; NR: not reported; pa: probabilistic analysis; PSSRU: Personal Social Services Research Unit; QALYs: quality-adjusted life years (a) The paper states incremental costs and QALYs were estimated using ‘a seemingly unrelated regression model’, and they used ‘the estimates of the means, variances and the covariance from the regression model to generate 500 estimates of incremental costs and QALYs from the joint distribution of these endpoints’. By generating a cost effectiveness plane and cost effectiveness acceptability curve this implies some kind of probabilistic analysis was done but the methodology quoted isn’t clear. I.14 Monitoring None. Economic tables evidence Sepsis National Institute for Health and Care Excellence, 2016 Care Excellence, and Health for Institute National I.15 Patient education, information and support None. I.16 Training and education Study Suarez 20111076 Study details Population & interventions Costs Health outcomes Cost-effectiveness Economic analysis: CEA/CUA Population: Total costs (mean per QALYs (mean per patient): ICER (Intervention 2 versus Intervention (health outcome: Life Years Patients with severe sepsis patient): Intervention 1: 3.75 1):
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