Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials

Abstract
Background: There is currently a lack of consensus on how health-related quality of life and other patient-reported
outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare
results across RCTs, synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines,
and health policy. [AQ: 1]The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of
Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations
to standardize analyses of patient-reported outcome data in cancer RCTs.
Methods and Results: Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data
from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated
a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms,
including ‘‘missing data,’’ ‘‘health-related quality of life,’’ and ‘‘patient-reported outcome.’’ Based on the meeting proceedings,
the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives,
identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to
evaluate and deal with missing data.
Conclusion: The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad
Consortium membership which includes regulators, patients, clinicians, and academics