PASSReviewer 1· 90% conf
The study demonstrates strong reporting transparency, including trial registration, adherence to reporting guidelines, discussion of limitations, and clear funding/COI statements. It also transparently reports changes from the protocol and post-hoc analyses.
Evidence
paraphrase[Methods, throughout]
“The methods section provides extensive detail on study design, setting, procedures, eligibility criteria, measures, intervention content, and statistical analysis, sufficient for replication.”direct quote[Abstract, Trial registration]
“Trial registration UMIN Clinical Trials Registry UMIN000051388.”direct quote[Methods, paragraph 1]
“In this paper we report the results in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 extension for cluster randomised controlled trials.”direct quote[Strengths and limitations of this trial, paragraph 1]
“However, some limitations should be acknowledged. Baseline data on total alcohol consumption and readiness to change drinking behaviour were not collected. Although this was to avoid the potential effect of intensive screening, it became difficult to balance between group differences in these outcomes at baseline due to random error.”direct quote[Funding]
“Funding: The EASY (Education on Alcohol after Screening to Yield moderated drinking) study was conducted with a grant from the Japan Agency for Medical Research and Development (AMED) (23he0122018j0003), awarded to the consortium comprising CureApp, the Kurihama Medical and Addiction Centre, and Okayama City Hospital.”direct quote[Changes from the protocol and the statistical analysis plan, paragraph 2]
“Of note, among the outcomes analysed, only total alcohol consumption was prespecified in the protocol, statistical analysis plan version 1.0, and trial registry. Analyses of readiness to change drinking behaviour, as well as diet and smoking behaviour, were inadvertently omitted from both the protocol and the trial registration and are therefore considered post hoc analyses.”PASSReviewer 2· 90% conf
Reporting is transparent with trial registration, CONSORT adherence, and limitations discussed.
Evidence
direct quote[Abstract]
“Trial registration UMIN Clinical Trials Registry UMIN000051388.”direct quote[Methods]
“In this paper we report the results in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 extension for cluster randomised controlled trials.”direct quote[Discussion, Strengths and limitations]
“However, some limitations should be acknowledged. Baseline data on total alcohol consumption and readiness to change drinking behaviour were not collected.”