Protocol for LLM-Generated CONSORT Report for Increased Reporting: A Parallel-Arm Randomized Controlled Trial (Protocol)

Background Randomized controlled trials (RCTs) often have incomplete methods reporting despite widespread adoption of the CONSORT guideline. The editorial process is supposed to detect these shortcomings and request clarifications from authors, which is time-consuming. We developed an LLM-based CONSORT Rohe Nordberg Report that highlights which CONSORT items appear fully or partially reported and checks page references claimed by authors, and then creates follow up questions for authors to more easily correct missing information. Methods This parallel-arm, superiority RCT will randomize eligible RCT submissions (after desk screening) 1:1 into intervention (editorial team and authors receive the Rohe Nordberg Report) or control (standard editorial review only). The primary outcome is whether manuscripts improve their reporting of CONSORT items in the Methods and Results sections between the original submission and first revision. This will be assessed by blinded human reviewers who evaluate the textual changes for improvements between the original and revised manuscripts for each relevant CONSORT item. Secondary outcomes include time to editorial decisions, rejection and non-resubmission rates, if authors can correctly identify where CONSORT items are reported, and extent of revisions. Human evaluators will be blinded to whether the manuscript was in the intervention or control group. Discussion By providing authors and the editorial team with specific follow up questions for each underreported CONSORT item, we hypothesize that basic underreporting will be more efficiently detected and corrected. Using blinded human reviewers as the primary outcome assessors ensures a rigorous, unbiased evaluation. If successful, this approach may help align manuscripts more closely with CONSORT standards, ultimately benefiting evidence synthesis.