Assessing reporting completeness and characteristics in decentralized randomized controlled trials: a scoping review protocol.

Abstract

<h4>Background</h4>With the development of remote technology, decentralized clinical trials have rapidly increased in recent years. Despite the comprehensive reporting guidance provided by the CONSORT 2025 guideline, decentralized randomized controlled trials still face specific reporting challenges. Therefore, we aim to evaluate the reporting characteristics and completeness of decentralized randomized controlled trials, using a specially designed checklist that has been extended according to the CONSORT 2025 original items.<h4>Methods</h4>We will search six databases (Embase, Ovid MEDLINE®, PubMed, CNKI, VIP, Wanfang) for decentralized randomized controlled trials published in Chinese or English during 2023. A pre-designed form will be used to extract general characteristics. Reporting completeness will be assessed using a custom 26-item "CONSORT-DRCT" checklist. This checklist includes 17 items focused on design, implementation, quality control, and key technologies related to decentralized elements, while 9 items pertain specifically to intervention details (5 for pharmacological interventions and 4 for non-pharmacological interventions). To ensure consistency, a standard operating procedure for scoring reporting completeness will be developed. Each item will be evaluated independently by two reviewers, and inter-rater agreement will be calculated to assess consistency between reviewers. Data will undergo descriptive analysis, with subgroup analyses performed where applicable to explore factors influencing reporting completeness.<h4>Discussion</h4>This protocol outlines a methodological framework for conducting the review, which aims to identify the current reporting characteristics and completeness of decentralized randomized controlled trials. The results may offer valuable insights into the development of a CONSORT extension guideline for decentralized randomized controlled trials.<h4>Systematic review registration</h4>This study has been registered with the Open Science Framework ( https://osf.io/c9pdx/ ).