APPENDIX 18: METHODOLOGY CHECKLIST: ECONOMIC

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1 APPENDIX 18: METHODOLOGY CHECKLIST: ECONOMIC EVALUATIONS This checklist is designed to determine whether an economic evaluation provides evidence that is useful to inform the decision-making of the Guideline Development Group (GDG). It is not intended to judge the quality of the study per se or the quality of reporting. Study identification CLARK2008 Guideline topic: Psychosis with coexisting substance misuse (PSM) Checklist completed by: Matthew Dyer (MD) Review question no: 3 Section 1: Applicability (relevance to specific guideline review question(s) and the NICE reference case) This checklist should be used first to filter out irrelevant studies. 1.1 Is the study population appropriate for the 1.2 Are the interventions appropriate for the / /Unclear / 1.3 Is the healthcare system in which the study was conducted sufficiently similar to the current UK NHS context? 1.4 Are costs measured from the NHS and personal social s (PSS) perspective? US Health Societal (includes legal and community s costs) 1.5 Are all direct health effects on individuals Subjective quality of life (QoL) year 1.6 Are both costs and health effects discounted at an annual rate of 3.5%? 3% and 5% Psychosis with substance misuse: full guideline DRAFT (July 2010) 1

2 1.7 Is the value of health effects expressed in terms of qualityadjusted life years (QALYs)? 1.8 Are changes in health-related quality of life (HRQoL) reported directly from patients and/or carers? 1.9 Is the valuation of changes in HRQoL (utilities) obtained from a representative sample of the general public? 1.10 Overall judgement: applicable QoL Year Subjective QoL scores taken from patients Section 2: Study limitations (the level of methodological quality) This checklist should be used once it has been decided that the study is sufficiently applicable to the context of the clinical guideline Does the model structure adequately reflect the nature of the health condition under evaluation? Is the time horizon sufficiently long to reflect all important differences in costs and outcomes? Are all important and relevant health outcomes Are the estimates of baseline health outcomes from Are the estimates of relative treatment effects from // Unclear/ 3 years RCT Are all important and relevant costs Legal and community costs Are the estimates of resource use from the best Are the unit costs of resources from the best Is an appropriate incremental analysis presented or can it be calculated from the data? RCT US National sources Psychosis with substance misuse: full guideline DRAFT (July 2010) 2

3 2.10 Are all important parameters whose values are uncertain subjected to appropriate sensitivity analysis? 2.11 Is there no potential conflict of interest? One-way sensitivity analyses 2.12 Overall assessment: Minor limitations Ratios of cumulative quality of life years to total costs rather than ICERs were computed by authors Psychosis with substance misuse: full guideline DRAFT (July 2010) 3

4 Study identification CRAIG2008 Guideline topic: PSM Review question no: 3 Checklist completed by: MD Section 1: Applicability (relevance to specific guideline review question(s) and the NICE reference case) This checklist should be used first to filter out irrelevant studies. 1.1 Is the study population appropriate for the 1.2 Are the interventions appropriate for the 1.3 Is the healthcare system in which the study was conducted sufficiently similar to the current UK NHS context? 1.4 Are costs measured from the NHS and personal social s (PSS) perspective? 1.5 Are all direct health effects on individuals Are both costs and health effects discounted at an 1.6 annual rate of 3.5%? 1.7 Is the value of health effects expressed in terms of qualityadjusted life years (QALYs)? 1.8 Are changes in health-related quality of life (HRQoL) reported directly from patients and/or carers? 1.9 Is the valuation of changes in HRQoL (utilities) obtained from a representative sample of the general public? 1.10 Overall judgement: applicable / /Unclear / Includes criminal justice costs Psychiatric symptoms, drug and alcohol consumption, quality of life, social functioning 18-month study period Array of effectiveness measures Psychosis with substance misuse: full guideline DRAFT (July 2010) 4

5 Section 2: Study limitations (the level of methodological quality) This checklist should be used once it has been decided that the study is sufficiently applicable to the context of the clinical guideline Does the model structure adequately reflect the nature of the health condition under evaluation? Is the time horizon sufficiently long to reflect all important differences in costs and outcomes? // Unclear/ 18 month time horizon Are all important and relevant health outcomes Are the estimates of baseline health outcomes from Single UK study Are the estimates of relative treatment effects from Are all important and relevant costs Direct costs only Are the estimates of resource use from the best Single UK cluster RCT Are the unit costs of resources from the best Is an appropriate incremental analysis presented or can it be calculated from the data? 2.10 Are all important parameters whose values are uncertain subjected to appropriate sensitivity analysis? 2.11 Is there no potential conflict of interest? 2.12 Overall assessment: Minor limitations National sources Costconsequenc es analysis formal synthesis of costs and effectiveness data (simple cost analysis) Multiple effectiveness measures (psychiatric symptoms, drug and alcohol consumption, quality of life, social functioning) Psychosis with substance misuse: full guideline DRAFT (July 2010) 5

6 Study identification FRENCH1999 Guideline topic: PSM Review question no: 5 Checklist completed by: MD Section 1: Applicability (relevance to specific guideline review question(s) and the NICE reference case) This checklist should be used first to filter out irrelevant studies. 1.1 Is the study population appropriate for the 1.2 Are the interventions appropriate for the 1.3 Is the healthcare system in which the study was conducted sufficiently similar to the current UK NHS context? 1.4 Are costs measured from the NHS and personal social s (PSS) perspective? 1.5 Are all direct health effects on individuals Are both costs and health effects discounted at an 1.6 annual rate of 3.5%? 1.7 Is the value of health effects expressed in terms of qualityadjusted life years (QALYs)? 1.8 Are changes in health-related quality of life (HRQoL) reported directly from patients and/or carers? 1.9 Is the valuation of changes in HRQoL (utilities) obtained from a representative sample of the general public? 1.10 Overall judgement: applicable / /Unclear / US Health US Health provider Substance use, HIV-risk behaviour, psychological symptoms 12-month study period Array of effectiveness measures Psychosis with substance misuse: full guideline DRAFT (July 2010) 6

7 Section 2: Study limitations (the level of methodological quality) This checklist should be used once it has been decided that the study is sufficiently applicable to the context of the clinical guideline Does the model structure adequately reflect the nature of the health condition under evaluation? Is the time horizon sufficiently long to reflect all important differences in costs and outcomes? Are all important and relevant health outcomes Are the estimates of baseline health outcomes from // Unclear/ 12 month time horizon cohort study Are the estimates of relative treatment effects from Are all important and relevant costs Direct costs only Are the estimates of resource use from the best Are the unit costs of resources from the best Is an appropriate incremental analysis presented or can it be calculated from the data? 2.10 Are all important parameters whose values are uncertain subjected to appropriate sensitivity analysis? 2.11 Is there no potential conflict of interest? 2.12 Overall assessment: Potentially serious limitations cohort Several sources Costconsequenc es analysis formal synthesis of costs and effectiveness data Multiple effectiveness measures (substance use, criminal activity, HIV-risk behavior, psychological status, employment status) Psychosis with substance misuse: full guideline DRAFT (July 2010) 7

8 Study identification HADDOCK2003 Guideline topic: PSM Review question no: 4 Checklist completed by: MD Section 1: Applicability (relevance to specific guideline review question(s) and the NICE reference case) This checklist should be used first to filter out irrelevant studies. 1.1 Is the study population appropriate for the 1.2 Are the interventions appropriate for the / /Unclear / 1.3 Is the healthcare system in which the study was conducted sufficiently similar to the current UK NHS context? 1.4 Are costs measured from the NHS and personal social s (PSS) perspective? Societal patient costs (travel, outof-pocket payments, productivity losses) 1.5 Are all direct health effects on individuals Global Assessment of Functioning (GAF) scale Are both costs and health effects discounted at an 1.6 annual rate of 3.5%? 1.7 Is the value of health effects expressed in terms of qualityadjusted life years (QALYs)? 1.8 Are changes in health-related quality of life (HRQoL) reported directly from patients and/or carers? 1.9 Is the valuation of changes in HRQoL (utilities) obtained from a representative sample of the general public? Costs discounted at 6% rate Psychosis with substance misuse: full guideline DRAFT (July 2010) 8

9 1.10 Overall judgement: applicable Section 2: Study limitations (the level of methodological quality) This checklist should be used once it has been decided that the study is sufficiently applicable to the context of the clinical guideline Does the model structure adequately reflect the nature of the health condition under evaluation? Is the time horizon sufficiently long to reflect all important differences in costs and outcomes? Are all important and relevant health outcomes Are the estimates of baseline health outcomes from Are the estimates of relative treatment effects from // Unclear/ 18 months Single UK RCT Are all important and relevant costs Patient costs, productivity losses Are the estimates of resource use from the best Are the unit costs of resources from the best Is an appropriate incremental analysis presented or can it be calculated from the data? 2.10 Are all important parameters whose values are uncertain subjected to appropriate sensitivity analysis? 2.11 Is there no potential conflict of interest? 2.12 Overall assessment: Minor limitations Single UK RCT UK National estimates ICER calculated by authors but not reported One-way sensitivity analyses and CEAC presented Psychosis with substance misuse: full guideline DRAFT (July 2010) 9

10 Authors did not present ICER but did present probability of intervention being less costly than routine care Study identification JERRELL1997 Guideline topic: PSM Review question no: 4 Checklist completed by: MD Section 1: Applicability (relevance to specific guideline review question(s) and the NICE reference case) This checklist should be used first to filter out irrelevant studies. 1.1 Is the study population appropriate for the 1.2 Are the interventions appropriate for the 1.3 Is the healthcare system in which the study was conducted sufficiently similar to the current UK NHS context? 1.4 Are costs measured from the NHS and personal social s (PSS) perspective? 1.5 Are all direct health effects on individuals Are both costs and health effects discounted at an 1.6 annual rate of 3.5%? 1.7 Is the value of health effects expressed in terms of qualityadjusted life years (QALYs)? 1.8 Are changes in health-related quality of life (HRQoL) reported directly from patients and/or carers? / /Unclear / US health US health Psychological functioning, psychiatric and substance abuse symptoms Psychosis with substance misuse: full guideline DRAFT (July 2010) 10

11 1.9 Is the valuation of changes in HRQoL (utilities) obtained from a representative sample of the general public? 1.10 Overall judgement: applicable Section 2: Study limitations (the level of methodological quality) This checklist should be used once it has been decided that the study is sufficiently applicable to the context of the clinical guideline Does the model structure adequately reflect the nature of the health condition under evaluation? Is the time horizon sufficiently long to reflect all important differences in costs and outcomes? Are all important and relevant health outcomes Are the estimates of baseline health outcomes from Are the estimates of relative treatment effects from Are all important and relevant costs Are the estimates of resource use from the best Are the unit costs of resources from the best Is an appropriate incremental analysis presented or can it be calculated from the data? 2.10 Are all important parameters whose values are uncertain subjected to appropriate sensitivity analysis? 2.11 Is there no potential conflict of interest? // Unclear/ 18 months study study US local estimates Costminimisati on analysis 2.12 Overall assessment: Potentially serious limitations As no differences were detected in clinical outcomes study became cost-minimisation Psychosis with substance misuse: full guideline DRAFT (July 2010) 11

12 analysis Insufficient description of resource use and cost estimates Study identification MORSE2006 Guideline topic: PSM Review question no: 3 Checklist completed by: MD Section 1: Applicability (relevance to specific guideline review question(s) and the NICE reference case) This checklist should be used first to filter out irrelevant studies. 1.1 Is the study population appropriate for the 1.2 Are the interventions appropriate for the 1.3 Is the healthcare system in which the study was conducted sufficiently similar to the current UK NHS context? 1.4 Are costs measured from the NHS and personal social s (PSS) perspective? 1.5 Are all direct health effects on individuals Are both costs and health effects discounted at an 1.6 annual rate of 3.5%? 1.7 Is the value of health effects expressed in terms of qualityadjusted life years (QALYs)? 1.8 Are changes in health-related quality of life (HRQoL) reported directly from patients and/or carers? 1.9 Is the valuation of changes in HRQoL (utilities) obtained from a representative sample of the general / /Unclear / US Health Societal (Social security and transfer payments) Client satisfaction, psychiatric symptoms, substance use Psychosis with substance misuse: full guideline DRAFT (July 2010) 12

13 public? 1.10 Overall judgement: applicable Section 2: Study limitations (the level of methodological quality) This checklist should be used once it has been decided that the study is sufficiently applicable to the context of the clinical guideline Does the model structure adequately reflect the nature of the health condition under evaluation? Is the time horizon sufficiently long to reflect all important differences in costs and outcomes? Are all important and relevant health outcomes Are the estimates of baseline health outcomes from Are the estimates of relative treatment effects from // Unclear/ 24 months RCT Are all important and relevant costs Legal and community costs Are the estimates of resource use from the best Are the unit costs of resources from the best Is an appropriate incremental analysis presented or 2.9 can it be calculated from the data? 2.10 Are all important parameters whose values are uncertain subjected to appropriate sensitivity analysis? 2.11 Is there no potential conflict of interest? 2.12 Overall assessment: Minor limitations RCT US National sources Psychosis with substance misuse: full guideline DRAFT (July 2010) 13

14 Simple cost-analyses no attempt to combine mean total cost differences with differences in outcome measures Psychosis with substance misuse: full guideline DRAFT (July 2010) 14