IMPORTANCE: To ensure that youths can make informed decisions about their health, it is important that health recommendations be presented for understanding by youths. OBJECTIVE: To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of youths provided with a digital plain language recommendation (PLR) format vs the original standard language version (SLV) of a health recommendation. DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, allocation-concealed, blinded, superiority randomized clinical trial included individuals from any country who were 15 to 24 years of age, had internet access, and could read and understand English. The trial was conducted from May 27 to July 6, 2022, and included a qualitative component. INTERVENTIONS: An online platform was used to randomize youths in a 1:1 ratio to an optimized digital PLR or SLV format of 1 of 2 health recommendations related to the COVID-19 vaccine; youth-friendly PLRs were developed in collaboration with youth partners and advisors. MAIN OUTCOMES AND MEASURES: The primary outcome was understanding, measured as the proportion of correct responses to 7 comprehension questions. Secondary outcomes were accessibility, usability, satisfaction, preference, and intended behavior. After completion of the survey, participants indicated their interest in completing a 1-on-1 semistructured interview to reflect on their preferred digital format (PLR or SLV) and their outcome assessment survey response. RESULTS: Of the 268 participants included in the final analysis, 137 were in the PLR group (48.4% female) and 131 were in the SLV group (53.4% female). Most participants (233 [86.9%]) were from North and South America. No significant difference was found in understanding scores between the PLR and SLV groups (mean difference, 5.2%; 95% CI, -1.2% to 11.6%; P = .11). Participants found the PLR to be more accessible and usable (mean difference, 0.34; 95% CI, 0.05-0.63) and satisfying (mean difference, 0.39; 95% CI, 0.06-0.73) and had a stronger preference toward the PLR (mean difference, 4.8; 95% CI, 4.5-5.1 [4.0 indicated a neutral response]) compared with the SLV. No significant difference was found in intended behavior (mean difference, 0.22 (95% CI, -0.20 to 0.74). Interviewees (n = 14) agreed that the PLR was easier to understand and generated constructive feedback to further improve the digital PLR. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, compared with the SLV, the PLR did not produce statistically significant findings in terms of understanding scores. Youths ranked it higher in terms of accessibility, usability, and satisfaction, suggesting that the PLR may be preferred for communicating health recommendations to youths. The interviews provided suggestions for further improving PLR formats. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05358990.

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 Ontario 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 Brno Czech Republic

Department of Anesthesia McMaster University Hamilton Ontario Canada

Department of Biomedical Sciences Humanitas University Milan Italy

Department of Family Medicine Schulich School of Medicine and Dentistry Western University London Ontario Canada

Department of Health Research Methods Evidence and Impact McMaster University Hamilton Ontario Canada

Department of Medicine McMaster University Hamilton Ontario Canada

Department of Pediatrics McMaster University Hamilton Ontario Canada

Department of Psychiatry University of Toronto Toronto Ontario Canada

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

Division of Epidemiology and Biostatistics Department of Global Health Faculty of Medicine and Health Sciences Stellenbosch University Stellenbosch 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

Grading of Recommendations Assessment Development and Evaluation Centre McMaster University Hamilton Ontario Canada

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

Michael G DeGroote School of Medicine McMaster University Hamilton Ontario Canada

Postgraduate Institute of Medical Education and Research Chandigarh India

Schulich School of Medicine and Dentistry Western University London Ontario Canada

World Health Organization Collaborating Centre for Infectious Diseases Research Methods and Recommendations McMaster University Hamilton Ontario Canada

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ClinicalTrials.gov
NCT05358990