Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials

Abstract

BackgroundHealth equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT).Methods/designA six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying “equity-relevant trials,” (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension.DiscussionThis work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies.

Reporting of health equity considerations in cluster and individually randomized trials

“…This methods study was conducted as part of a larger project to develop a reporting guideline for health-equity relevant trials for which a protocol was published [31].…”

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework

“…We convened a collaborative research team and advisory board including interdisciplinary and international knowledge users in a deliberative, consensus building process as part of a larger study described elsewhere. 12 We searched for and did not find any frameworks to define an equity-relevant randomised trial. 12 We then conducted a series of meetings that included representatives of potential knowledge user groups, including: bioethicists, clinicians, funders, journal editors, patient representatives, members of the public, policymakers, systematic review authors and trialists.…”

“… 12 We searched for and did not find any frameworks to define an equity-relevant randomised trial. 12 We then conducted a series of meetings that included representatives of potential knowledge user groups, including: bioethicists, clinicians, funders, journal editors, patient representatives, members of the public, policymakers, systematic review authors and trialists. We engaged in a process to define features of randomised trials that provide evidence about health equity, which we define as ‘health equity-relevant’ randomised trials.…”

“… 11 To address the poor reporting and analysis of equity impacts in randomised trials, we are assessing the need for additional reporting guidelines for randomised trials that provide evidence about potential impact on health equity. 12 An extension of the internationally recognised Consolidated Standards for Reporting Trials (CONSORT) statement, an evidence-based guideline to encourage completeness and transparency of reporting in randomised trials 13 is under way. The purpose of this paper is to describe the development and validation of a conceptual framework to identify when a randomised trial provides evidence about health equity.…”

Salud para Todos: Conceptualización y perspectivas

“…Los procesos deliberativos pueden ser convocados por los diferentes actores institucionales: universidades, entidades de I+D o de servicios científicos tecnológicos, entidades de desarrollo tecnológico, instituciones o agencias del Estado, proveedores, clientes, organizaciones superiores, organizaciones no gubernamentales y organizaciones sin fines de lucro, entidades intermedias del conocimiento, servicios científicos-tecnológicos, instituciones o agencias del Estado, proveedores, clientes, organizaciones superiores, consultoras, polo científico-productivo y grupos integradores. (5,41) Para obtener impacto sobre el proceso de salud-enfermedad-atención-cuidadosen cada una de las dimensiones local/global basándose en la mejor evidencia disponible, deben preverse la siguiente secuencia de estrategias. (52) • monitoreo del estado de salud para identificar los problemas de salud en los niveles locales, • diagnóstico de los problemas identificados y de los riesgos potenciales en niveles regionales o globales, • información, educación y empoderamiento de personas y comunidadessobre asuntos de salud, • movilización del partenazgo comunitario para identificar y controlar riesgos y resolver los problemas potenciales,.…”