JAMA : the journal of the American Medical Association
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Review Practice Guideline
Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension.
Complete information in a trial protocol regarding study outcomes is crucial for obtaining regulatory approvals, ensuring standardized trial conduct, reducing research waste, and providing transparency of methods to facilitate trial replication, critical appraisal, accurate reporting and interpretation of trial results, and knowledge synthesis. However, recommendations on what outcome-specific information should be included are diverse and inconsistent. To improve reporting practices promoting transparent and reproducible outcome selection, assessment, and analysis, a need for specific and harmonized guidance as to what outcome-specific information should be addressed in clinical trial protocols exists. ⋯ This SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement provides 9 outcome-specific items that should be addressed in all trial protocols and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.
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Randomized Controlled Trial Multicenter Study Comparative Study
Effect of a Community Health Worker-Delivered Personal Sound Amplification Device on Self-Perceived Communication Function in Older Adults With Hearing Loss: A Randomized Clinical Trial.
Age-related hearing loss that impairs daily communication is associated with adverse health outcomes, but use of hearing aids by older adults is low and disparities exist. ⋯ Among older adults with hearing loss, a community health worker-delivered personal sound amplification device intervention, compared with a wait-list control, significantly improved self-perceived communication function at 3 months. Findings are limited by the absence of a sham control, and further research is needed to understand effectiveness compared with other types of care delivery models and amplification devices.