The call for universal health coverage requires the urgent implementation and scale-up of interventions that are known to be effective, in resource-poor settings. Achieving this objective requires high-quality implementation research (IR) that evaluates the complex phenomenon of the influence of context on the ability to effectively deliver evidence-based practice. Nevertheless, IR for global health is failing to apply a robust, theoretically driven approach, leading to ethical concerns associated with research that is not methodologically sound.
Inappropriate methods are often used in IR to address and report on context. This may result in a lack in understanding of how to effectively adapt the intervention to the new setting and a lack of clarity in conceptualising whether there is sufficient evidence to generalise findings from previous IR to a new setting, or if a randomised controlled trial (RCT) is needed. Some of the ethical issues arising from this shortcoming include poor-quality research that may needlessly expose vulnerable participants to research that has not been adapted to suit local needs and priorities, and the inappropriate use of RCTs that denies participants in the control arm access to treatment that is effective within the local context.
To address these concerns, we propose a complementary approach to clinical equipoise for IR, known as contextual equipoise. We discuss challenges in the evaluation of context and also with assessing the certainty of evidence to justify an RCT. Finally, we describe methods that can be applied to improve the evaluation and reporting of context and to help understand if contextual equipoise can be justified or if significant adaptations are required. We hope our analysis offers helpful insight to better understand and ensure that the ethical principle of beneficence is upheld in the real-world contexts of IR in low-resource settings.
- public health
- health policy
- randomised control trial
- other study design
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Handling editor Seye Abimbola
Twitter @nadineseward, @MartinKGHI, @sridhartweet
TC and MJP contributed equally.
Contributors NadineS drafted the paper; NadineS and CH conceptualised the idea for the paper; CH, TC and NickS reviewed several drafts of the manuscript; SV reviewed the manuscript and offered expertise on the ethical aspects of equipoise; JM reviewed the manuscript and offered expertise for the evaluation of context; MP offered critical inputs and reviewed later drafts of the manuscript NickS provided technical expertise to the role of implementation science in contextual equipoise; all authors contributed to the evolution of the concept of contextual equipoise detailed in this paper.
Funding NadineS, CH, MJP and NickS are funded by the National Institute of Health Research (NIHR) Global Health Research Unit on Health System Strengthening in sub-Saharan Africa, King’s College London (GHRU 16/136/54) using UK aid from the UK Government to support global health research. NickSs’ research is further supported by the NIHR Applied Research Collaboration South London at King’s College Hospital NHS Foundation Trust, and by the ASPIRES research programme in LMICs (Antibiotic use across Surgical Pathways—Investigating, Redesigning and Evaluating Systems), funded by the Economic and Social Research Council. NickS is a member of King’s Improvement Science, which offers cofunding to the NIHR ARC South London and comprises a specialist team of improvement scientists and senior researchers based at King’s College London. Its work is funded by King’s Health Partners (Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, King’s College London and South London and Maudsley NHS Foundation Trust), Guy’s and St Thomas’ Charity and the Maudsley Charity. CH additionally receives funding support from AMARI as part of the DELTAS Africa Initiative (DEL-15-01). The views expressed here are not necessarily those of the NIHR or the Department of Health and Social Care, the NHS, the ESRC, AMARI or the DELTAS Africa Initiative.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement There are no data in this work
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