As patient-reported outcomes (PROs) play a growing role in assessing cancer treatments, a group of experts and stakeholders was formed to determine how to analyze PRO data in randomized, controlled trials (RCTs) of cancer therapies. This group, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium, recently presented their findings in a report in the journal Lancet Oncology.

The SISAQOL Consortium involved participants from varied backgrounds, including members of patient organizations, academics, industry representatives, regulators, statisticians, and others. The Consortium’s goal was the development of recommendations for incorporating PROs into RCTs in cancer.

The 4 main priority areas identified by the Consortium were, as stated in the report, “developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods to address specific PRO research objectives, standardising statistical terminology related to missing data, and determining appropriate ways of managing missing data.”

Consortium members used discussions and literature reviews to develop recommendations for inclusion of PROs in cancer RCTs. At a meeting with 31 participants in attendance, a total of 32 recommendations were ratified, out of 43 possible recommendations that had been proposed for consideration.

Some recommendations that were ratified centered on clearly defining research objectives for PRO analyses. Others included specific guidance regarding statistical tests for evaluating PROs. Many of the ratified recommendations were aimed at the handling and reporting of missing data. Some of these included recommendations involving the reasons for missing data, the reporting of numerators and denominators used to calculate any rates, and statistical methods used in the context of missing data.

“We believe this set of recommendations will support clinical researchers, trialists, and statisticians to improve the conceptualisation and design of PRO studies, the quality of statistical analysis, and the clinical interpretation of PROs in cancer clinical trials,” the authors stated in their report.


Coens C, Pe M, Dueck AC, et al; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium. Lancet Oncol. 2020;21(2):e83-e96.