Engaging knowledge users in development of the CONSORT-Equity 2017 reporting guideline: a qualitative study using in-depth interviews.

BACKGROUND: Randomized controlled trials ("randomized trials") can provide evidence to assess the equity impact of an intervention. Decision makers need to know about equity impacts of healthcare interventions so that people get healthcare that is best for them. To better understand the equity impacts of healthcare interventions, a range of people who were potentially the ultimate users of research results were involved in a six-phase project to extend the CONsolidated Standards Of Reporting Trials Statement for health equity ("CONSORT-Equity 2017"). We identified these "knowledge users" as: patients and healthcare researchers, decision makers and providers. This paper reports on one project phase: specifically, a qualitative study designed to integrate the expertise of knowledge users. The experiences and perspectives of knowledge users provided many insights about the reporting of health equity issues in randomized trials. This paper describes key informant interviews with knowledge users that contribute to a better understanding of the effects of an intervention on health equity. Additionally, the paper shows how these insights were used to develop CONSORT-Equity 2017. METHODS: A qualitative study that used the framework analysis method was conducted in collaboration with an international study executive and advisory board team. In-depth semi-structured interviews were conducted with a purposive sample of key informants who: consider the research ethics of, fund, conduct, participate in, publish, or use research evidence generated in randomized trials. Transcripts were coded and analyzed using the seven-stage framework analysis method, and data reported to reflect knowledge user suggestions to develop CONSORT-Equity 2017. RESULTS: Thirteen key informants, of which three were patients, chose to participate in interviews. Seven themes emerged: "Differentiate the type of trial", "Prompts for health equity", "Ethics matter", "Describe unique research strategies", "Clarity of reporting", "Implications of equity for sampling and analysis", "Think beyond the immediate trial". The interviews provided direction for the extension of 16 CONSORT-Equity 2017 items. CONCLUSIONS: Key informant interviews were used to identify new concepts that were not generated in our other studies and to develop CONSORT-Equity 2017. We encourage the use of key informant interviews in guideline development to obtain and include the real-life expertise of knowledge users

Engaging knowledge users in development of the CONSORT-Equity 2017 reporting guideline: a qualitative study using in-depth interviews

BACKGROUND: Randomized controlled trials ("randomized trials") can provide evidence to assess the equity impact of an intervention. Decision makers need to know about equity impacts of healthcare interventions so that people get healthcare that is best for them. To better understand the equity impacts of healthcare interventions, a range of people who were potentially the ultimate users of research results were involved in a six-phase project to extend the CONsolidated Standards Of Reporting Trials Statement for health equity ("CONSORT-Equity 2017"). We identified these "knowledge users" as: patients and healthcare researchers, decision makers and providers. This paper reports on one project phase: specifically, a qualitative study designed to integrate the expertise of knowledge users. The experiences and perspectives of knowledge users provided many insights about the reporting of health equity issues in randomized trials. This paper describes key informant interviews with knowledge users that contribute to a better understanding of the effects of an intervention on health equity. Additionally, the paper shows how these insights were used to develop CONSORT-Equity 2017. METHODS: A qualitative study that used the framework analysis method was conducted in collaboration with an international study executive and advisory board team. In-depth semi-structured interviews were conducted with a purposive sample of key informants who: consider the research ethics of, fund, conduct, participate in, publish, or use research evidence generated in randomized trials. Transcripts were coded and analyzed using the seven-stage framework analysis method, and data reported to reflect knowledge user suggestions to develop CONSORT-Equity 2017. RESULTS: Thirteen key informants, of which three were patients, chose to participate in interviews. Seven themes emerged: "Differentiate the type of trial", "Prompts for health equity", "Ethics matter", "Describe unique research strategies", "Clarity of reporting", "Implications of equity for sampling and analysis", "Think beyond the immediate trial". The interviews provided direction for the extension of 16 CONSORT-Equity 2017 items. CONCLUSIONS: Key informant interviews were used to identify new concepts that were not generated in our other studies and to develop CONSORT-Equity 2017. We encourage the use of key informant interviews in guideline development to obtain and include the real-life expertise of knowledge users

Reporting of health equity considerations in cluster and individually randomized trials

CITATION: Petkovic, J., et al. 2020. Reporting of health equity considerations in cluster and individually randomized trials. Trials, 21:308, doi:10.1186/s13063-020-4223-5.The original publication is available at https://trialsjournal.biomedcentral.comBackground: 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.https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-4223-5Publisher's versio

Sex/gender reporting and analysis in Campbell and Cochrane systematic reviews: a cross-sectional methods study

Abstract Background The importance of sex and gender considerations in research is being increasingly recognized. Evidence indicates that sex and gender can influence intervention effectiveness. We assessed the extent to which sex/gender is reported and analyzed in Campbell and Cochrane systematic reviews. Methods We screened all the systematic reviews in the Campbell Library (n = 137) and a sample of systematic reviews from 2016 to 2017 in the Cochrane Library (n = 674). We documented the frequency of sex/gender terms used in each section of the reviews. Results We excluded 5 Cochrane reviews because they were withdrawn or published and updated within the same time period as well as 4 Campbell reviews and 114 Cochrane reviews which only included studies focused on a single sex. Our analysis includes 133 Campbell reviews and 555 Cochrane reviews. We assessed reporting of sex/gender considerations for each section of the systematic review (Abstract, Background, Methods, Results, Discussion). In the methods section, 83% of Cochrane reviews (95% CI 80–86%) and 51% of Campbell reviews (95% CI 42–59%) reported on sex/gender. In the results section, less than 30% of reviews reported on sex/gender. Of these, 37% (95% CI 29–45%) of Campbell and 75% (95% CI 68–82%) of Cochrane reviews provided a descriptive report of sex/gender and 63% (95% CI 55–71%) of Campbell reviews and 25% (95% CI 18–32%) of Cochrane reviews reported analytic approaches for exploring sex/gender, such as subgroup analyses, exploring heterogeneity, or presenting disaggregated data by sex/gender. Conclusion Our study indicates that sex/gender reporting in Campbell and Cochrane reviews is inadequate

The effectiveness of evidence summaries on health policymakers and health system managers use of evidence from systematic reviews: a systematic review

Abstract Background Systematic reviews are important for decision makers. They offer many potential benefits but are often written in technical language, are too long, and do not contain contextual details which make them hard to use for decision-making. There are many organizations that develop and disseminate derivative products, such as evidence summaries, from systematic reviews for different populations or subsets of decision makers. This systematic review aimed to (1) assess the effectiveness of evidence summaries on policymakers’ use of the evidence and (2) identify the most effective summary components for increasing policymakers’ use of the evidence. We present an overview of the available evidence on systematic review derivative products. Methods We included studies of policymakers at all levels as well as health system managers. We included studies examining any type of “evidence summary,” “policy brief,” or other products derived from systematic reviews that presented evidence in a summarized form. The primary outcomes were the (1) use of systematic review summaries in decision-making (e.g., self-reported use of the evidence in policymaking and decision-making) and (2) policymakers’ understanding, knowledge, and/or beliefs (e.g., changes in knowledge scores about the topic included in the summary). We also assessed perceived relevance, credibility, usefulness, understandability, and desirability (e.g., format) of the summaries. Results Our database search combined with our gray literature search yielded 10,113 references after removal of duplicates. From these, 54 were reviewed in full text, and we included six studies (reported in seven papers) as well as protocols from two ongoing studies. Two studies assessed the use of evidence summaries in decision-making and found little to no difference in effect. There was also little to no difference in effect for knowledge, understanding or beliefs (four studies), and perceived usefulness or usability (three studies). Summary of findings tables and graded entry summaries were perceived as slightly easier to understand compared to complete systematic reviews. Two studies assessed formatting changes and found that for summary of findings tables, certain elements, such as reporting study event rates and absolute differences, were preferred as well as avoiding the use of footnotes. Conclusions Evidence summaries are likely easier to understand than complete systematic reviews. However, their ability to increase the use of systematic review evidence in policymaking is unclear. Trial registration The protocol was published in the journal Systematic Reviews (2015;4:122

Considerations and guidance in designing equity-relevant clinical trials

Abstract Health research has documented disparities in health and health outcomes within and between populations. When these disparities are unfair and avoidable they may be referred to as health inequities. Few trials attend to factors related to health inequities, and there is limited understanding about how to build consideration of health inequities into trials. Due consideration of health inequities is important to inform the design, conduct and reporting of trials so that research can build evidence to more effectively address health inequities and importantly, ensure that inequities are not aggravated. In this paper, we discuss approaches to integrating health equity-considerations in randomized trials by using the PROGRESS Plus framework (Place of residence, Race/ethnicity/culture/language, Occupation, Gender, Religion, Education, Socio-economic status, Social capital and “Plus” that includes other context specific factors) and cover: (i) formulation of research questions, (ii) two specific scenarios relevant to trials about health equity and (iii) describe how the PROGRESS Plus characteristics may influence trial design, conduct and analyses. This guidance is intended to support trialists designing equity-relevant trials and lead to better design, conduct, analyses and reporting, by addressing two main issues: how to avoid aggravating inequity among research participants and how to produce information that is useful to decision-makers who are concerned with health inequities

Engaging knowledge users in development of the CONSORT-Equity 2017 reporting guideline: a qualitative study using in-depth interviews

Abstract Background Randomized controlled trials (“randomized trials”) can provide evidence to assess the equity impact of an intervention. Decision makers need to know about equity impacts of healthcare interventions so that people get healthcare that is best for them. To better understand the equity impacts of healthcare interventions, a range of people who were potentially the ultimate users of research results were involved in a six-phase project to extend the CONsolidated Standards Of Reporting Trials Statement for health equity (“CONSORT-Equity 2017”). We identified these “knowledge users” as: patients and healthcare researchers, decision makers and providers. This paper reports on one project phase: specifically, a qualitative study designed to integrate the expertise of knowledge users. The experiences and perspectives of knowledge users provided many insights about the reporting of health equity issues in randomized trials. This paper describes key informant interviews with knowledge users that contribute to a better understanding of the effects of an intervention on health equity. Additionally, the paper shows how these insights were used to develop CONSORT-Equity 2017. Methods A qualitative study that used the framework analysis method was conducted in collaboration with an international study executive and advisory board team. In-depth semi-structured interviews were conducted with a purposive sample of key informants who: consider the research ethics of, fund, conduct, participate in, publish, or use research evidence generated in randomized trials. Transcripts were coded and analyzed using the seven-stage framework analysis method, and data reported to reflect knowledge user suggestions to develop CONSORT-Equity 2017. Results Thirteen key informants, of which three were patients, chose to participate in interviews. Seven themes emerged: “Differentiate the type of trial”, “Prompts for health equity”, “Ethics matter”, “Describe unique research strategies”, “Clarity of reporting”, “Implications of equity for sampling and analysis”, “Think beyond the immediate trial”. The interviews provided direction for the extension of 16 CONSORT-Equity 2017 items. Conclusions Key informant interviews were used to identify new concepts that were not generated in our other studies and to develop CONSORT-Equity 2017. We encourage the use of key informant interviews in guideline development to obtain and include the real-life expertise of knowledge users

Additional file 2: of The effectiveness of evidence summaries on health policymakers and health system managers use of evidence from systematic reviews: a systematic review

Grey Literature Searches. (DOCX 15 kb

Engaging knowledge users in development of the CONSORT-equity 2017 reporting guideline: A qualitative study using indepth interviews

© The Author(s) 2018. Background: Randomized controlled trials (“randomized trials”) can provide evidence to assess the equity impact of an intervention. Decision makers need to know about equity impacts of healthcare interventions so that people get healthcare that is best for them. To better understand the equity impacts of healthcare interventions, a range of people who were potentially the ultimate users of research results were involved in a six-phase project to extend the CONsolidated Standards Of Reporting Trials Statement for health equity (“CONSORT-Equity 2017”). We identified these “knowledge users” as: Patients and healthcare researchers, decision makers and providers. This paper reports on one project phase: Specifically, a qualitative study designed to integrate the expertise of knowledge users. The experiences and perspectives of knowledge users provided many insights about the reporting of health equity issues in randomized trials. This paper describes key informant interviews with knowledge users that contribute to a better understanding of the effects of an intervention on health equity. Additionally, the paper shows how these insights were used to develop CONSORT-Equity 2017. Methods: A qualitative study that used the framework analysis method was conducted in collaboration with an international study executive and advisory board team. In-depth semi-structured interviews were conducted with a purposive sample of key informants who: Consider the research ethics of, fund, conduct, participate in, publish, or use research evidence generated in randomized trials. Transcripts were coded and analyzed using the seven-stage framework analysis method, and data reported to reflect knowledge user suggestions to develop CONSORT-Equity 2017. Results: Thirteen key informants, of which three were patients, chose to participate in interviews. Seven themes emerged: “Differentiate the type of trial”, “Prompts for health equity”, “Ethics matter”, “Describe unique research strategies”, “Clarity of reporting”, “Implications of equity for sampling and analysis”, “Think beyond the immediate trial”. The interviews provided direction for the extension of 16 CONSORT-Equity 2017 items. Conclusions: Key informant interviews were used to identify new concepts that were not generated in our other studies and to develop CONSORT-Equity 2017. We encourage the use of key informant interviews in guideline development to obtain and include the real-life expertise of knowledge users

Reporting of health equity considerations in cluster and individually randomized trials

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 health-equity 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 pilot-tested 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