DEBATE-statistical analysis plans for observational studies.

ABSTRACT:

Background

All clinical research benefits from transparency and validity. Transparency and validity of studies may increase by prospective registration of protocols and by publication of statistical analysis plans (SAPs) before data have been accessed to discern data-driven analyses from pre-planned analyses.

Main message

Like clinical trials, recommendations for SAPs for observational studies increase the transparency and validity of findings. We appraised the applicability of recently developed guidelines for the content of SAPs for clinical trials to SAPs for observational studies. Of the 32 items recommended for a SAP for a clinical trial, 30 items (94%) were identically applicable to a SAP for our observational study. Power estimations and adjustments for multiplicity a

SUBMITTER: Hiemstra B 

PROVIDER: S-EPMC6902479 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature