Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies
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Abstract
Introduction
The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public, including adults, parents, and youth, to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the public’s (youth, parents, and adult populations) understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (herein referred to as the RecMap).
Methods and Analysis
This is a protocol for a multi-method study. We will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCT) in three populations to test alternative formats of presenting health recommendations: adults (21 years of age or older), parents (18 years or above and are a parent or legal guardian of a child under 18 years old), and youth (15 to 24 years old), with at least 240 participants in each population. The research will consist of a randomized online survey and an optional one-on-one interview. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. In each population group, the intervention arm will receive a plain language recommendation (PLR) format while the control arm will receive the corresponding original recommendation format as originally published by the guideline organizations (herein referred to as Standard Language Version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the two recommendation formats. Each population’s results will be analyzed separately. However, we are planning a meta-analysis of the results across populations, and will also explore potential interaction and subgroup effects within each population. At the end of each survey, participants will be invited to participate in a one-on-one, virtual semi-structured interview to explore their user experience and their learning preferences and future research. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach. Iterative member checking, triangulation, interpretation, and saturation of themes will be sought to enhance reliability.
Ethics and Dissemination
Through Clinical Trials Ontario (CTO), the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta has approved the parent portion of the trial (Project ID:00114894). All potential participants will be required to provide informed consent. The findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media.
Strengths and limitations of this study
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We are following a multi-method approach: randomized controlled trials and qualitative interviews. The qualitative results will supplement and help explain our quantitative findings.
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This protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), which enhances transparency and completeness. The trials use previously validated outcomes from similar trials. This will strengthen the credibility of our results.
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Our study is testing an optimized plain language recommendation format, which makes our intervention relevant to our stakeholder groups, and is recruiting internationally, which ensures the inclusion of a diverse population. Recruitment will take place online using social media, and data will be collected using an online survey. This allows for self-selection and limits accessibility to those who have no or limited digital access, which in turn limits generalizability.
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While the recommendations are offered in multiple languages through the RecMap, the study is only testing English plain language recommendation summaries.
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SciScore for 10.1101/2022.05.09.22274842: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
Software and Algorithms Sentences Resources We will recruit English-speaking (mother tongue or fluent) participants globally through our experienced RecMap investigator team (https://covid19.recmap.org/about), the Cochrane Consumer Network and various Cochrane networks, guideline co-authors who interact with youth (including the international Young Persons’ Advisory Groups), parents, and adult citizens. Cochrane Consumersuggested: (ChiCTR - Chinese Clinical Trial Registry, RRID:SCR_006037)Allocation Concealment: The allocation sequence is concealed using SurveyMonkey® software based on a commercial, but unknown algorithm without a … SciScore for 10.1101/2022.05.09.22274842: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
Software and Algorithms Sentences Resources We will recruit English-speaking (mother tongue or fluent) participants globally through our experienced RecMap investigator team (https://covid19.recmap.org/about), the Cochrane Consumer Network and various Cochrane networks, guideline co-authors who interact with youth (including the international Young Persons’ Advisory Groups), parents, and adult citizens. Cochrane Consumersuggested: (ChiCTR - Chinese Clinical Trial Registry, RRID:SCR_006037)Allocation Concealment: The allocation sequence is concealed using SurveyMonkey® software based on a commercial, but unknown algorithm without a pre-identified sequence. SurveyMonkey®suggested: NoneCochrane Consumer Network, adult stakeholders, and parent stakeholders. Cochrane Consumer Networksuggested: (ChiCTR - Chinese Clinical Trial Registry, RRID:SCR_006037)All interviews will be analyzed using thematic analysis, where transcripts or written notes will be coded using NVivo software (QSR, 2018) for data management. NVivosuggested: (NVivo, RRID:SCR_014802)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT05358990 Not yet recruiting Knowledge Mobilization Activities to Support Decision-Making… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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