The authors also found limitations to these studies even thought he incorporation of QOL is increasing in the Cancer treatment clinical trials. The inconsistencies lies in the quality statical methods, description of statistical power and/or sample size calculation for the QOL outcomes, documentation of missing data, and reporting of the clinical significance of the QOL findings.
The authors provide the following recommendations based on their updated review findings:
1) QOL should be included as a secondary endpoint in adjuvant therapy trials only when the treatment expectation is equivalence or noninferiority, for example, when treatment decisions will be based on differences in patient outcomes between study arms or when the trial focuses on a vulnerable population (eg, elderly women) or is testing substantially different modalities (eg, endocrine vs chemotherapy) or a new treatment for which descriptive information is needed;
2) QOL assessments should be included in metastatic breast cancer treatment trials only when a minimal survival difference is expected or the treatments have substantial differences in toxicity or descriptive information about a new treatment is needed;
3) QOL-specific sample size calculations should be performed and QOL should be measured only in the subset of the study population that was defined by these calculations;
4) when QOL is not the primary trial endpoint, the results should ideally appear in a companion article published at the same time as the medical outcomes article, so that a complete appraisal of the risks and benefits of the intervention can be evaluated ().
Full Text of the article at the JNCI, The Journal Of The National Cancer Institute