Diversifying the evidence base used to make global guideline decisions

Commentary by Nora Engel

To ensure that tuberculosis interventions, drugs, vaccines and diagnostics are responsible as well as responsive to the settings of use and affected communities, it is essential to not only evaluate to what extent the intervention was successful in achieving its intended outcomes (as is commonly assessed in drug or vaccine trials and diagnostic laboratory studies). It is equally important to study how an intervention or technology aligns with the context, what the undesired outcomes are, and what the impact has been in terms of reduction or increase of inequality and injustice in health and well-being (1).

The World Health Organization (WHO) uses the GRADE evidence to decision framework to support panel members of guideline development groups (GDGs) to assess available evidence in systematic, structured and transparent ways and decide on recommendations for new interventions. Using the GRADE framework, GDGs members assess evidence along several criteria (benefits and harms of the options, values and balance of effects, cost effectiveness, equity, acceptability, feasibility). Among these, qualitative research with its focus on understanding meaning and lived experiences is uniquely suited to provide evidence on implications for equity and implementation considerations, and the preferences and values, feasibility and acceptability considerations of diverse stakeholders (including people receiving and providing care, affected communities, as well as managers, community workers, laboratory personnel, programme officers) (2).

Since 2012, WHO GDGs have included qualitative evidence in the form of both qualitative evidence syntheses and original qualitative studies alongside clinical trial data and cost-effectiveness studies. For the Optimize guidelines on health workers role for maternal and newborn health, WHO formally commissioned and included qualitative evidence in the form of a thematic analysis of an email discussion list, in-depth case studies of country programs and four systematic reviews of qualitative evidence  (3, 4). Since then, similar qualitative evidence have been used for a number of guidelines development groups by WHO (i.e. on health workers’ role in providing safe abortions; use of ARVs for treating and preventing HIV infection; antenatal care guidelines; health promotion interventions for maternal and newborn health, user perspectives on TB diagnostics, etc.).

While the grade framework has originally been developed to make decisions on new treatment regimens, it is also used to make decisions on diagnostics and other public health interventions. From my own research experience on diagnostics, many steps and actors are required before diagnostics have an impact on patient important outcomes (e.g. somebody needs to seek care, order a test, provide a specimen, conduct test, convey result, act on result, monitor quality, maintain device, supply reagents, etc.) (5, 6). This difference has two important implications: 1. Decision-making on new policies and guidelines for diagnostics should include voices from affected communities, different cadres of healthcare workers (including nurses, community health workers for contract tracing; laboratory staff, clinicians) and program officers, implementers and suppliers who are all part and parcel of making diagnostics work. Qualitative research can provide important insights for GDGs, for instance, on how decisions to order and utilize tests are made; on communication between providers and patients about diagnostics; on how different actors handle uncertainty regarding results and the work done by clinicians, laboratory staff and patients to make sense of results. 2. Defining how people value the health effects of diagnostics is more indirect than for drugs; being diagnosed faster is not considered a health outcome in GRADE. Yet, if people feel anxious, emotional, angry, tense or guilty because of diagnostic delays or relieved once they have a diagnosis these can be called health effects and is important information for GDGs to consider under the value criteria.

By complementing clinical, epidemiological and economic data with evidence representing the voices of people receiving and providing interventions, their questions and issues are included into the bones of a GDG outcome, and there is accountability and an onus created for implementers to deal with them.

Missing from this approach of recommending individual interventions is an assessment of how different diagnostics, treatment regimens and interventions hang together. How do changes in diagnostics interact with clinical work and decision-making on the ground? How does decentralizing testing interact with the capacity to treat or the other way around? What do we define as an intervention? Where are the boundaries, is specimen transport and results communication part of a diagnostic? Is monitoring and counseling part of a treatment regimen?

Qualitative research is an important tool to diversify the evidence we use to make decisions on TB interventions. It can offer reflection and provide attention to different viewpoints, needs, and practices of various stakeholders and the responsibility that is assigned to others through specific interventions or technologies and how they hang together.

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