Reporting of health equity considerations in cluster and individually randomized trials

Abstract

Background: The randomized controlled trial (RCT) is considered the gold standard study design to inform decisions about the effectiveness of interventions. However, a common limitation is inadequate reporting of the applicability of the intervention and trial results for people who are "socially disadvantaged" and this can affect policy-makers' decisions. We previously developed a framework for identifying health-equity-relevant trials, along with a reporting guideline for transparent reporting. In this study, we provide a descriptive assessment of healthequity considerations in 200 randomly sampled equity-relevant trials. Methods: We developed a search strategy to identify health-equity-relevant trials published between 2013 and 2015. We randomly sorted the 4316 records identified by the search and screened studies until 100 individually randomized (RCTs) and 100 cluster randomized controlled trials (CRTs) were identified. We developed and pilottested a data extraction form based on our initial work, to inform the development of our reporting guideline for equity-relevant randomized trials. Results: In total, 39 trials (20%) were conducted in a low-and middle-income country and 157 trials (79%) in a high-income country focused on socially disadvantaged populations (78% CRTs, 79% RCTs). Seventy-four trials (37%) reported a subgroup analysis across a population characteristic associated with disadvantage (25% CRT, 49% RCTs), with 19% of included studies reporting subgroup analyses across sex, 9% across race/ethnicity/culture, and 4% across socioeconomic status. No subgroup analyses were reported for place of residence, occupation, religion, education, or social capital. One hundred and forty-one trials (71%) discussed the applicability of their results to one or more socially disadvantaged populations (68% of CRT, 73% of RCT). Discussion: In this set of trials, selected for their relevance to health equity, data that were disaggregated for socially disadvantaged populations were rarely reported. We found that even when the data are available, opportunities to analyze health-equity considerations are frequently missed. The recently published equity extension of the Consolidated Reporting Standards for Randomized Trials (CONSORT-Equity) may help improve delineation of hypotheses related to socially disadvantaged populations, and transparency and completeness of reporting of health-equity considerations in RCTs. This study can serve as a baseline assessment of the reporting of equity considerations.

The influence of telehealth-based cancer rehabilitation interventions on disability: a systematic review

“…The high number of White participants, as well as the large number of studies that did not report ethnicity ( n = 30, 44%), may limit the ability to generalize findings to other race and ethnicity groups. Similar to findings in this review, this has been a persistent challenge in the larger world of clinical trials [ 95 ], including in rehabilitation medicine [ 96 ]. This lack of inclusion for historically or socially marginalized groups may undermine personalized medicine efforts and contribute to the persistence of health inequities [ 97 ].…”

Reporting of social deprivation in musculoskeletal trials: An analysis of 402 randomised controlled trials

“…This is the first comprehensive assessment of the reporting of social deprivation measures in musculoskeletal trials. Social deprivation indices and measures of social deprivation are also poorly reported in non‐musculoskeletal trials (Callander & McDermott, 2017; Malmivaara, 2019; Petkovic et al, 2020). Measures that are most frequently reported in musculoskeletal trials are similar to those reported in non‐musculoskeletal trials, namely education level, employment status and salary.…”

Enrollment, retention, and strategies for including disadvantaged populations in randomized controlled trials: a systematic review protocol

“…RCTs will be included in the initial title and abstract screening if the RCT authors identify their participants as a disadvantaged group concordant with one or more of the following PROGRESS-Plus criteria: place of residence, race/ethnicity/culture/language, occupation, gender/sex, religion, education, socioeconomic status, and social capital [14,15,[19][20][21][22][23]. Due to the terminologic complexity regarding disadvantaged status, author framing of disadvantage using terms such as "vulnerable," "hard-to-reach," or "underserved" will merit inclusion.…”

“…In the context of this study, we operationalize one commonly used term, the construct of "disadvantage," in relation to RCTs. We define disadvantage as social, cultural, or financial disparities that imply environmental, historical-structural, or social restriction to opportunities for health [14,15,[19][20][21][22][23]. We recognize that disadvantage may involve one or more specific attributes, contexts, or group types.…”

“…We will utilize the PROGRESS-Plus framework to guide our review. PROGRESS-Plus is a health equity framework intended to ensure that social determinants of health are considered when conducting research; the acronym stands for place of residence, race/ethnicity/ culture/language, occupation, gender/sex, religion, education, socioeconomic status, and social capital [23].…”