INTRODUCTION: The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the public's 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 (RecMap). METHODS AND ANALYSIS: This is a protocol for a multi-method study. Through an online survey, we will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCTs) in three populations to test alternative formats of presenting health recommendations: adults, parents, and youth, with at least 240 participants in each population. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. 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 (standard language version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the recommendation formats. Each population's results will be analyzed separately. However, we are planning a meta-analysis of the results across populations. At the end of each survey, participants will be invited to participate in an optional one-on-one, virtual semi-structured interview to explore their user experience. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach. ETHICS AND DISSEMINATION: Through Clinical Trials Ontario, 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). Findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media. TRIAL REGISTRATION: Clinicaltrials.gov NCT05358990 . Registered on May 3, 2022.

Alberta Research Centre for Health Evidence Department of Pediatrics Faculty of Medicine and Dentistry University of Alberta Edmonton Alberta Canada

Biostatistics Unit Father Sean O'Sullivan Research Centre St Joseph's Healthcare Hamilton Ontario Canada

Canadian Arthritis Patient Alliance Toronto Ontario Canada

Centre for Addiction and Mental Health Toronto Ontario Canada

Centre for Development of Best Practices in Health Yaoundé Central Hospital Yaoundé Cameroon

Centre for Immunization Readiness Public Health Agency of Canada Ottawa Canada

Child Health Evaluative Sciences The Hospital for Sick Children Research Institute Toronto Ontario Canada

Cochrane Child Health Department of Pediatrics University of Alberta Edmonton Alberta Canada

Cochrane South Africa South African Medical Research Council Cape Town South Africa

Czech National Centre for Evidence Based Healthcare and Knowledge Translation Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University 625 00 Brno Czech Republic

Department of Anesthesia McMaster University Hamilton Ontario Canada

Department of Biomedical Sciences Humanitas University Milan Italy

Department of Family Medicine Western University London Ontario Canada

Department of Internal Medicine American University of Beirut Beirut Lebanon

Department of Pediatrics McMaster University Hamilton Ontario Canada

Department of Psychiatry University of Toronto Toronto Ontario Canada

Departments of Science and International Studies St Elizabeth University of Public Health and Social Science Bratislava Slovak Republic

Division of Clinical Pharmacology Department of Medicine and Division of Epidemiology and Biostatistics Department of Global Health Faculty of Medicine and Health Sciences Stellenbosch University Stellenbosch South Africa

Division of Epidemiology and Biostatistics Department of Global Health Stellenbosch University Cape Town South Africa

Division of Neonatology The Hospital for Sick Children Toronto Ontario Canada

Faculty of Nursing University of Alberta Edmonton Alberta Canada

Five02 Labs Inc Toronto Ontario Canada

Institute of Health Policy Management and Evaluation University of Toronto Toronto Ontario Canada

Michael G DeGroote Cochrane Canada and McMaster GRADE Centres Department of Health Research Methods Evidence and Impact McMaster University 1280 Main St W Hamilton Ontario L8S 4K1 Canada

National Institute for Health Technology Assessment Federal University of Rio Grande do Sul Porto Alegre Brazil

Postgraduate Institute of Medical Education and Research Chandigarh India

Schulich School of Medicine and Dentistry Western University London Ontario Canada

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Plain Language vs Standard Format for Youth Understanding of COVID-19 Recommendations: A Randomized Clinical Trial

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ClinicalTrials.gov
NCT05358990