Letter to the editor of “Behavioral Sleep Medicine”: Towards Standardization in the Reporting of Measures & Outcomes in Insomnia Randomized Controlled Trials

Standard guidelines for randomized clinical trials (RCTs) of treatments for insomnia have focused on making recommendations for the choice of measures to characterize insomnia and/or the reporting of intervention rules or outcomes (Reed & Sacco, Citation2016). Recommended outcome measures for insomnia RCTs include sleep diaries to assess self-reported sleep continuity, global self-report questionnaires to assess insomnia symptoms, and actigraphy to assess objective measures of sleep continuity. While these guidelines have helped to standardize the choice of measures in research studies, considerable variation between studies remains in how outcomes are reported. For instance, the reporting of sample demographic information is sometimes lacking in key variables, such as race, ethnicity, health status (e.g., number and severity of medical comorbidities), education, socioeconomic status, relationship status, and variables related to living circumstances. In addition, the reporting of study assessment methodology (e.g., calculation of key variables) and the findings from these measures (e.g., specific choice of variables and statistics reported) can be highly variable between studies.

As a starting point, it is important to re-affirm the need for adherence to general clinical trial reporting standards. Guidelines from the International Committee of Medical Journal Editors (ICMJE) (Rosenberg et al., Citation2013), the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) (Chan, Tetzlaff, Altman, et al., Citation2013; Chan, Tetzlaff, Gotzsche, et al., Citation2013), and Consolidated Standards of Reporting Trials (CONSORT) (Boutron et al., Citation2017) have codified recommendations for assessment and reporting in RCTs. Pre-registration in clinical trial registries is a critical element of these guidelines (e.g., clinicaltrials.gov). In the context of these sets of guidelines, investigators conducting insomnia RCTs should remain vigilant of current reporting standards, pre-register studies in clinical trial registries (Rosenberg et al., Citation2013), (International Committee of, Citation2021) and include trial registration information (trial number and URL of pre-registration) and relevant guideline checklists (e.g., the CONSORT Checklist) in the appendix/supplementary materials of resulting publications.

The aim of this paper is to discuss the need for reporting standards for important and clinically relevant insomnia outcomes while reiterating recommended assessments for insomnia RCTs. While this issue has been taken up by others in the past specifically (Buysse et al., Citation2006), there has been little movement in these arenas. As such, there is a need to pick-up this discussion and codify these suggestions both here (briefly) and as a consensus statement in a white paper, to follow. Please know that while our goal is to advocate for standardization across the field, we also advocate for such freedom in the use of methods; however, movement from a standard approach should be clearly rationalized and explained in the methods and/or the results and should be provided in contrast with the results from the nonstandard approach. By improving comparability across studies, such standards would facilitate appropriate synthesis of findings and enhance rigor and reproducibility in insomnia RCTs.