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Table 2 WHO-INTEGRATE framework and suggested methods for evidence synthesis and assessment of quality of evidence (adapted from Rehfuess and colleagues) [6]

From: When complexity matters: a step-by-step guide to incorporating a complexity perspective in guideline development for public health and health system interventions

Criterion and definition Sub-criteria Evidence synthesis methods Approaches to assessing quality of evidence
Balance of health benefits and harms
The balance of health benefits and harms reflects the magnitude and types of health impact of an intervention on individuals or populations, taking into account how those affected value different health outcomes.
• Efficacy or effectiveness on health of individuals
• Effectiveness or impact on health of a population
• Patients’/beneficiaries’ values in relation to health outcomes
• Safety-risk-profile of the intervention
• Broader positive or negative health-related impacts
• Systematic reviews of efficacy/effectiveness for anticipated effects [32]
• Qualitative evidence syntheses [33, 34] and mixed-method reviews [35] or cross-sectional studies [36] for patients’/beneficiaries’ values in relation to health outcomes
• Scoping reviews for unanticipated effects [37]
• GRADE [38]
• GRADE CERQual (where applicable) [39]
Human rights and sociocultural acceptability
This criterion encompasses two distinct constructs: The first refers to an intervention’s compliance with universal human rights standards and other considerations laid out in international human rights law beyond the right to health (as the right to health provides the basis of other criteria and sub-criteria in this framework). The second, sociocultural acceptability, is highly time- and context-specific and reflects the extent to which those implementing or benefiting from an intervention as well as other relevant stakeholder groups consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention.
• Accordance with universal human rights standards
• Socio-cultural acceptability of intervention by patients/ beneficiaries and those implementing the intervention
• Socio-cultural acceptability of intervention by the public and other relevant stakeholder groups
• Impact on autonomy of concerned stakeholders
• Intrusiveness of intervention
• Ethics syntheses [40, 41] for accordance with universal human rights standards
• Qualitative evidence syntheses [33, 34, 42] and mixed-method reviews [35] for socio-cultural acceptability and impact on autonomy of concerned stakeholders and intrusiveness of interventions
• GRADE CERQual (where applicable) [39]
• Q-SEA for ethics analyses [43]
Health equity, equality and non-discrimination
Health equity and equality reflect a concerted and sustained effort to improve health for individuals across all populations, and to reduce avoidable systematic differences in how health and its determinants are distributed. Equality is linked to the legal principle of non-discrimination, which is designed to ensure that individuals or population groups do not experience discrimination on the basis of their sex, age, ethnicity, culture or language, sexual orientation or gender identity, disability status, education, socioeconomic status, place of residence or any other characteristics.
• Impact on health equality and/or health equity
• Distribution of benefits and harms of the intervention
• Affordability of the intervention
• Accessibility of the intervention
• Severity and/or rarity of the condition
• Lack of a suitable alternative
• Quantitative systematic reviews [44] using PROGRESS or PROGRESS PLUS [45, 46], where possible using pre-specified sub-group analyses
• Quantitative systematic reviews targeting disadvantaged groups
• Equity weights and social welfare functions in economic analyses (see Financial and economic considerations).
• Qualitative evidence syntheses [33, 34, 42] and mixed-method reviews [35]
• Ethics syntheses [40, 41]
• No standardised approach
• GRADE for subgroup analyses (where applicable) [38]
• Relevant considerations, such as including health equity as an outcome, in Welch et al. [47]
Societal implications
Societal implications recognise that health interventions do not take place in isolation and may enhance or inhibit broader social, environmental or economic goals in the short or long term. It also reflects the fact that many regulatory, environmental or other population-level health interventions are directly aimed at system-level rather than individual-level changes.
• Social impact
• Environmental impact
• Systematic reviews of effectiveness [44]
• Qualitative evidence syntheses [33, 42]
• Mixed-method reviews [35]
• Health technology assessments [48]
• No standardised approach
• GRADE (where applicable) [38]
Financial and economic considerations
Financial and economic considerations acknowledge that available financial (budgetary) resources are constrained and take into account the economic impact of an intervention on the health system, government or society as a whole.
• Financial impact
• Impact on economy
• Comparison of costs to benefits
• Comprehensive or representative cost or budget impact data at the appropriate level (global, regional, national, sub-national)
• Economic burden of disease studies undertaken at the appropriate level (global, regional, national, sub-national).
• Economic analyses undertaken at the appropriate level [49] or economic analysis reviews [50]
• No standardised approach
• Relevant considerations in Drummond et al. [49] and Brunetti et al. [51]
Feasibility and health system
Feasibility and health system considerations recognise that the most appropriate and feasible interventions may vary significantly across different contexts, both across countries and across jurisdictions within countries. Legislation and governance, the structure of the health system and existing programmes as well as human resources and infrastructure should be taken into account.
• Legislation
• Leadership and governance
• Interaction with and impact on health system
• Need for, usage of and impact on health workforce and human resources
• Need for, usage of and impact on infrastructure
• Qualitative evidence syntheses [33, 42]
• Mixed-method reviews [35]
• No standardised approach
• GRADE CERQual (where applicable) [39]
Quality of evidence
Quality of evidence reflects the confidence that the available evidence is adequate to support a recommendation. Quality of evidence is a meta-criterion that can be applied across all criteria in the WHO-INTEGRATE framework (see approaches to assessing quality of evidence).
  1. Notes: CERQual Confidence in the Evidence from Reviews of Qualitative research, GRADE Grading of Recommendations Assessment, Development, and Evaluation, PROGRESS PLUS Place of Residence, Race, Occupation, Gender/sex, Religion, Socioeconomic Status, Q-SEA Quality Standards for Ethics Analyses, WHO-INTEGRATE World Health Organization INTEGRATe Evidence