Reporting of Sociodemographic Variables in Randomized Clinical Trials, 2014-2020

Orkin, Aaron; Nicoll, Gina; Persaud, Navindra; Pinto, Andrew D.

doi:10.1001/jamanetworkopen.2021.10700

Cited by 39 publications

(26 citation statements)

References 6 publications

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“…Our finding that sex and the “Plus” characteristic of age and disability were commonly reported (e.g., in baseline tables and covariate adjustment) is consistent with other studies 33 , 34 and may point to these data being more readily available (e.g. within health administrative data).…”

Section: Discussionsupporting

confidence: 90%

Health equity considerations in pragmatic trials in Alzheimer's and dementia disease: Results from a methodological review

Nicholls

Al‐Jaishi

Niznick

et al. 2023

Alz & Dem Diag Ass & Dis Mo

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Introduction To improve dementia care delivery for persons across all backgrounds, it is imperative that health equity is integrated into pragmatic trials. Methods We reviewed 62 pragmatic trials of people with dementia published 2014 to 2019. We assessed health equity in the objectives; design, conduct, analysis; and reporting using PROGRESS‐Plus which stands for Place of residence, Race/ethnicity, Occupation, Gender/sex, Religion, Education, Socioeconomic status, Social capital, and other factors such as age and disability. Results Two (3.2%) trials incorporated equity considerations into their objectives; nine (14.5%) engaged with communities; 4 (6.5%) described steps to increase enrollment from equity‐relevant groups. Almost all trials (59, 95.2%) assessed baseline balance for at least one PROGRESS‐Plus characteristic, but only 10 (16.1%) presented subgroup analyses across such characteristics. Differential recruitment, attrition, implementation, adherence, and applicability across PROGRESS‐Plus were seldom discussed. Discussion Ongoing and future pragmatic trials should more rigorously integrate equity considerations in their design, conduct, and reporting. Highlights Few pragmatic trials are explicitly designed to inform equity‐relevant objectives. Few pragmatic trials take steps to increase enrollment from equity‐relevant groups. Disaggregated results across equity‐relevant groups are seldom reported. Adherence to existing tools (e.g., IMPACT Best Practices, CONSORT‐Equity) is key.

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Section: Discussionsupporting

confidence: 90%

Health equity considerations in pragmatic trials in Alzheimer's and dementia disease: Results from a methodological review

Nicholls

Al‐Jaishi

Niznick

et al. 2023

Alz & Dem Diag Ass & Dis Mo

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“…Trial teams need to set targets for recruitment and retention of different ethnic groups and monitor progress against those targets, which means trial teams need to collect data on participants’ ethnicity. At present, most trials do not collect and report ethnicity data [ 11 ]. Even for COVID-19 where the importance of ethnicity is not in doubt, a recent review found only 34 of 209 preprints reported ethnicity data [ 12 ].…”

Section: Improving Recruitment and Retention Of Ethnic Minority Parti...mentioning

confidence: 99%

Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice

Dawson

Banister

Biggs

et al. 2022

Trials

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Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effective. This does not always happen. The UK National Institute for Health and Care Research (NIHR) INCLUDE project identified many groups in the UK that are under-served by trials, including ethnic minorities.This guidance document presents four key recommendations for designing and running trials that include the ethnic groups needed by the trial. These are (1) ensure eligibility criteria and recruitment pathway do not limit participation in ways you do not intend, (2) ensure your trial materials are developed with inclusion in mind, (3) ensure staff are culturally competent and (4) build trusting partnerships with community organisations that work with ethnic minority groups. Each recommendation comes with best practice advice, public contributor testimonials, examples of the inclusion problem tackled by the recommendation, or strategies to mitigate the problem, as well as a collection of resources to support implementation of the recommendations.We encourage trial teams to follow the recommendations and, where possible, evaluate the strategies they use to implement them. Finally, while our primary audience is those designing, running and reporting trials, we hope funders, grant reviewers and approvals agencies may also find our guidance useful.

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“…This could be attributed to the seniority of the midwives at the referral hospital. Moreover, this was in an urban setting and the effectiveness of the intervention was probably linked with income and educational level of birth companions [ 42 ]. It was probably easier for them to comprehend and execute given instructions from the midwives.…”

Section: Discussionmentioning

confidence: 99%

Effect of Midwife-Provided Orientation of Birth Companions on Maternal Anxiety and Coping during Labor: A Stepped Wedge Cluster Randomized Control Trial in Eastern Uganda

Wanyenze

Nalwadda

Byamugisha

et al. 2023

IJERPH

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The study aimed to assess the effect of midwife-provided orientation of birth companions on maternal anxiety and coping during labor. A stepped wedge cluster randomized trial design was conducted among 475 participants (control n = 240), intervention n = 235) from four clusters. Midwives in the intervention period provided an orientation session for the birth companions on supportive labor techniques. Coping was assessed throughout labor and anxiety scores were measured after birth. Independent t-test and Chi-Square tests were used to assess the differences by study period. Anxiety scores were reduced among women in the intervention period (p = 0.001). The proportion of women able to cope during early active labor was higher during the intervention period (p = 0.031). Women in the intervention period had 80% higher odds of coping (p = 0.032) compared to those in the control period. Notable differences in anxiety and coping with labor were observed among first-time mothers, younger women, and when siblings provided support. Midwife-provided orientation of birth companions on labor support lowers maternal anxiety and improves coping during labor. Findings could inform the planning and development of policies for the implementation of the presence of birth companions in similar low-resource settings.

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Reporting of Sociodemographic Variables in Randomized Clinical Trials, 2014-2020

Abstract: This cross-sectional study assesses the frequency and thoroughness of reporting of sociodemographic variables in randomized clinical trials published in 5 high-impact health journals from January 2014 to July 2020.

Cited by 39 publications

References 6 publications

Health equity considerations in pragmatic trials in Alzheimer's and dementia disease: Results from a methodological review

Health equity considerations in pragmatic trials in Alzheimer's and dementia disease: Results from a methodological review

Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice

Effect of Midwife-Provided Orientation of Birth Companions on Maternal Anxiety and Coping during Labor: A Stepped Wedge Cluster Randomized Control Trial in Eastern Uganda

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