What is it about?
This study aimed to evaluate reports of Japanese cancer RCTs that utilized PRO/QOL using the same criteria as the previous SISAQOL study to determine potential differences in the statistical analysis methods used between Japan and other countries and whether any specific issues are unique to Japanese trials.
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Why is it important?
Although the reporting rates of clinical hypotheses and MIDs in the previous reports tended to be similar to those in our study, the reporting rates for HRQOL/PRO compliance and the handling of missing values tended to be higher in previous reports. Overall, the statistical methods used for HRQOL/PRO evaluation in the Japanese cancer RCT were similar to those used in the previous SISAQOL study, indicating that the reporting methods of Japanese studies are not inferior to those of Western countries.
Perspectives
The standardization of statistical and reporting methods is expected to progress domestically and internationally, following the guidelines presented by SISAQOL and regulatory agencies.
Naomi Kiyota
Kobe University Hospital
Read the Original
This page is a summary of: Statistical Analysis Methods and Reporting of Patient-Reported Outcomes in Randomized Controlled Trials for Cancer Conducted in Japan: A Systematic Review, Cureus, May 2024, Springer Science + Business Media,
DOI: 10.7759/cureus.60804.
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