SPIRIT-based template modestly improves trial protocol reporting completeness

Researchers randomly allocated 70 manuscripts reporting randomised trial protocols, each requiring minor or major revision after initial peer review at BMJ Open, to standard review or use of a SPIRIT 2025-based manuscript template. The template provided structured subheadings and reporting guidance. The primary outcome was a score based on 11 commonly under-reported SPIRIT items, assessed in revised manuscripts and adjusted for baseline. Outcome assessors were masked; authors were not told about the study.

Completeness scores improved by 0.61 points more with the template than with standard review (95% confidence interval 0.20 to 1.01) on a rescaled 0-10 measure. Mean scores rose from 5.42 to 6.70 in the template group and from 5.77 to 6.32 in the control group. The largest gains involved reporting of recruitment, data collection methods and access to data. Median time to submit a first revision was similar: 27.10 versus 29.86 days.

Among 14 template-group survey respondents, 8 of 13 said it was time-consuming and 5 of 13 called it burdensome; most respondents who answered relevant questions found it easy to use and helpful. The study supports a modest improvement in protocol reporting in this journal setting, but its small sample and limited survey response constrain generalisability. Harms were not systematically collected.