| Balance of health benefits and harms. | Efficacy or effectiveness on health of individuals/populations: RCTs, pragmatic trials, quasi-experimental studies, comparative observational studies; longer term observational studies, modelling (eg, transmission modelling for infectious diseases). Patients’/beneficiaries’ values in relation to health outcomes: qualitative studies (eg, semistructured interviews, focus groups), cross-sectional studies. Safety risk profile of intervention: RCTs, quasi-experimental studies, comparative observational studies for anticipated harms; registry studies, longer term observational studies, case series, case reports for unanticipated effects. Broader positive or negative health-related impacts: RCTs, quasi-experimental studies, observational studies, qualitative studies.
| Systematic reviews of efficacy/effectiveness83 for anticipated effects. Qualitative evidence syntheses84 85 and mixed-method reviews86 or cross-sectional studies66 for patients’/beneficiaries’ values in relation to health outcomes. Scoping reviews87 88 for unanticipated effects.
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| Human rights and sociocultural acceptability. | Accordance with universal human rights standards: mapping of relevant aspects, pro et contra analysis,93 ethical analysis (eg, casuistry, coherence analysis, wide reflective equilibrium),94 power analyses, human rights impact assessment.95 Sociocultural acceptability of intervention, impact on autonomy of concerned stakeholders, intrusiveness of intervention: mapping of relevant aspects, pro et contra analysis,93 discourse analysis, qualitative studies (ideally longitudinal to examine changes over time), discrete choice experiments, cross-sectional studies,66 longitudinal quantitative studies (to examine changes over time), mixed-method studies.
| Ethics syntheses96 97 for accordance with universal human rights standards. Qualitative evidence syntheses84 85 98 and mixed-method reviews86 for sociocultural acceptability and impact on autonomy of concerned stakeholders and intrusiveness of interventions.
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| Societal implications. | Social impacts: RCTs, quasi-experimental studies, comparative observational studies, longitudinal implementation studies, qualitative studies, case studies, power analyses. Environmental impacts: RCTs, quasi-experimental studies, comparative observational studies, longitudinal implementation studies, qualitative studies, case studies, environmental impact assessments, modelling studies. Combined social, environmental and economic impacts: health impact assessments, modelling studies (eg, decision-analytical modelling).
| Systematic reviews of effectiveness.83 Qualitative evidence syntheses.11 84 85 Mixed-method reviews.86 Health technology assessments.68
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| Health equity, equality and non-discrimination. | Impact on health equality and/or health equity, distribution of benefits and harms of intervention: human rights impact assessment,95 disaggregated RCTs, quasi-experimental or comparative observational studies, RCTs and quasi-experimental or comparative observational studies conducted in disadvantaged groups,100 power analyses, GIS-based studies, qualitative studies, ethical analysis. Affordability of intervention: cross-sectional or longitudinal observational studies, discrete choice experiments, qualitative studies, catastrophic health expenditure studies. Accessibility of intervention: health system barrier studies, cross-sectional or longitudinal observational studies, discrete choice experiments, qualitative studies, ethical analysis, GIS-based studies. Severity and/or rarity of the condition: health state valuations, cross-sectional studies for severity of condition; observational studies for frequency (incidence, prevalence) of condition. Lack of a suitable alternative: situation analysis of intervention options; quantitative or qualitative studies of adverse effects of existing options.
| Quantitative systematic reviews83 using PROGRESS101 or PROGRESS PLUS,102 where possible using prespecified subgroup analyses. Quantitative systematic reviews targeting disadvantaged groups. Equity weights and social welfare functions in economic analyses (see Financial and economic considerations). Qualitative evidence syntheses11 84 85 and mixed-method reviews.86 Ethics syntheses.96 97
| | No standardised approach. GRADE70 71 for subgroup analyses (where applicable). Relevant considerations, such as including health equity as an outcome, in Welch et al.103
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| Financial and economic considerations. | Financial impact: prices and price justifications for unit costs per beneficiary/population according to relevant perspectives, budget impact analysis.104 Impact on economy: economic burden of disease studies,105 quasi-experimental studies, comparative observational studies, longitudinal implementation studies, qualitative studies, case studies, modelling studies. Ratio of costs and benefits: economic analyses as a comparative analysis of alternative courses of action in terms of their costs and consequences (eg, cost-minimisation analysis, cost-effectiveness analysis, cost-utility analysis, cost-benefit analysis).
| Comprehensive or representative cost or budget impact data at the appropriate level (global, regional, national, subnational). Economic burden of disease studies undertaken at the appropriate level (global, regional, national, subnational). Economic analyses undertaken at the appropriate level106 107 or economic analysis reviews.108–111
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| Feasibility and health system considerations. | Legislation, leadership and governance, interaction with and impact on health system, need for, usage of and impact on health workforce, human resources and infrastructure: health systems research,113 including mapping of relevant aspects, situation analysis, cross-sectional studies, qualitative studies, case studies.
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