PASSReviewer 1· 80% conf
Methods are detailed, the trial is registered, negative results and limitations are reported transparently, and funding/competing interests are disclosed; the reporting guideline is not explicitly named.
Evidence
direct quote[Methods, Study design]
“ClinicalTrials.gov registration: NCT04224987 (http://clinicaltrials.gov/ct2/show/NCT04224987)”paraphrase[Results, Primary endpoints]
“In the nasopharynx, macrolide resistance was not statistically significant between treatment groups.”direct quote[Methods, Reporting summary]
“Further information on research design is available in the linked to this article.”PASSReviewer 2· 75% conf
The trial is registered, methods are complete, negative results are transparently reported, limitations are thoroughly discussed, and funding is disclosed. The CONSORT checklist is not explicitly named but a Reporting Summary is mentioned.
Evidence
direct quote[Abstract and Methods, Study design]
“ClinicalTrials.gov registration: NCT04224987”direct quote[Discussion, paragraph 6]
“This study has multiple limitations inherent to simple, large, randomized controlled trials.”direct quote[Acknowledgements]
“This work was funded by the Bill and Melinda Gates Foundation (INV-002454: T.M.L.), the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (R01AI175250: T.M.L. and K.S.O’B.) and an unrestricted grant from Research to Prevent Blindness.”PASSReviewer 3· 93% conf
Methods are detailed, trial is registered, reporting guidelines are followed, all outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.
Evidence
paraphrase[Methods, entire section]
“Paraphrase: The Methods section provides comprehensive details on study design, randomization, blinding, intervention, sample collection, DNA sequencing, bioinformatics, and statistical analysis.”direct quote[Abstract and Methods]
“ClinicalTrials.gov registration: NCT04224987”paraphrase[Discussion, paragraphs 3-8]
“Paraphrase: The Discussion addresses limitations such as lack of phenotypic analysis, cross-sectional sampling, pooling, generalizability, and potential for spillover.”