Recent Systematic Review Highlights the Need for Greater Transparency in Behavioral Medicine Clinical Trials

Heather L. McGinty, PhD, Evidence-Based Behavioral Medicine Special Interest Group (EBBM SIG) Co-Chair; Eimear C. Morrissey;  Heather S. Jim, PhD, EBBM SIG Co-Chair

The EBBM SIG is dedicated to the creation of an evidence base in behavioral medicine, improving research methodology in the field, and translating evidence-based knowledge into evidence-based behavioral medicine practice. One vehicle for achieving these goals is the summary of existing literature into systematic reviews and meta-analyses, allowing for researchers and clinicians alike to efficiency consume the evidence available on a particular topic. The EBBM SIG is dedicated to training researchers in these skills as well as disseminating these highly impactful reviews as they become available. In this issue of Outlook, we highlight a recent review from our very own EBBM SIG members.

Morrissey, Durand, Nieuwlaat et al. recently published their work in Psychology & Health (2017), providing a closer look at behavioral interventions for medication adherence in a specific group of patients - those receiving care for hypertension. This review and meta-analysis offered a hypertension specific update to the Cochrane Review on medication adherence by Nieuwlaat et al. (2014). They identified 26 interventions and documented significant but modest post-intervention improvements in blood pressure outcomes among hypertensive patients.

Given the significant result of the available interventions and the variety of intervention techniques employed across studies, Morrissey et al. (2017) took the further step of trying to identify the key characteristics that may be driving the improvements in patient outcomes. The authors used the Theoretical Domains Framework  (TDF; Cane, O'Connor, & Michie, 2012) to explore which theoretical factors and behavior change processes the interventions may have been targeting. With this information, they could examine how the addition of intervention techniques impacted the size of the intervention effects on blood pressure.

According to study authors, coding interventions by theoretical domain using the TDF was the greatest challenge of the review process. The lack of intervention detail in some of the papers occluded the accuracy and confidence in coding what, if any, theoretical factors were being targeted. Several other reviews have also identified this problem.

This absence of clear, documented behavioral science theory in the development of behavioral medicine interventions is a fundamental problem that prevents progress in research. Using theory refines intervention design and promotes more accurate description and analysis of intervention effects, including identifying the ‘key ingredients’ most responsible for improved patient outcomes. The Office of Behavioral and Social Sciences Research collaborated with the National Institutes of Health and Food and Drug Administration to help social and behavioral scientists performing clinical trials research increase the transparency in reporting clinical research protocols. The newly available Clinical Trial E-Protocol Tool and Template was developed for drug and device trials, but provides useful protocol reporting standards for social and behavioral trials as well. Much work is needed, however, to overcome limited space in publications for elaborating on the techniques of social or behavioral interventions. Future research should aim to comprehensively report methodology through detailed method sections or pre-trial methods papers to fully describe the interventions, supplementary intervention descriptions that accompany published results, or by making intervention manuals widely available.

References

Morrissey, E. C., Durand, H., Nieuwlaat, R., Navarro, T., Haynes, R. B., Walsh, J. C., & Molloy, G. J. (2017). Effectiveness and content analysis of interventions to enhance medication adherence and blood pressure control in hypertension: A systematic review and meta-analysis. Psychology & Health, 1-38.

Cane, J., O'Connor, D., & Michie, S. (2012). Validation of the theoretical domains framework for use in behaviour change and implementation research. Implementation Science, 7(1), 37-53. doi: 10.1186/1748-5908-7-37

Nieuwlaat, R., Wilczynski, N., Navarro, T., Hobson, N., Jeffery, R., Keepanasseril, A., . . . Haynes, R. B. (2014). Interventions for enhancing medication adherence. Cochrane Database Syst Rev, 11, CD000011. doi: 10.1002/14651858.CD000011.pub4