A consensus checklist to help clinicians interpret clinical trial results analysed by Bayesian methods

Area of Science:

• Biostatistics
• Clinical Trials
• Medical Research

Background:

• Bayesian statistical methods are increasingly used in analyzing clinical trial data.
• Existing interpretation guidelines are not suitable for clinicians lacking statistical expertise.
• There is a need for a tool to aid in understanding Bayesian analysis in phase III randomized clinical trials (RCTs).

Purpose of the Study:

• To establish and validate a checklist for interpreting phase III RCTs analyzed with Bayesian methods.
• To support clinicians, even those without statistical knowledge, in understanding Bayesian trial results.
• To identify crucial items for assessing the validity of Bayesian analyzed trial data.

Main Methods:

• A checklist was developed by biostatisticians, incorporating existing items and literature review findings.
• The checklist items were validated through three rounds of review by anesthesiology residents.
• The validation process focused on items crucial for interpreting Bayesian analyzed RCT results.

Main Results:

• A consensus checklist was formed after three rounds of validation.
• Eleven items were identified as important for understanding the validity of results.
• Three essential items were highlighted: prior specification, source of informative priors, and effect size with credible interval.

Conclusions:

• The developed checklist aids clinicians in interpreting Bayesian analyzed phase III RCTs.
• The checklist ensures the presence and validity of key statistical elements for non-statisticians.
• Results from trials lacking the three essential items (prior, source, effect size) should be interpreted with caution due to unestablished validity.