Principal investigator(s)
Andrew Bottomley
EORTC
Brussels, Belgium
, Corneel Coens
EORTC
Brussels, Belgium
Project coordinator(s)
Madeline Pe
EORTC
Brussels, Belgium
, Lien Dorme
EORTC
Brussels, Belgium

Project summary

The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium has been convened by the EORTC with the aim to develop recommendations for standardizing the analysis and interpretation of patient reported outcomes and quality of life data in cancer randomized trials. The SISAQOL consortium is comprised of leading HRQOL researchers and statisticians, key individuals from various international oncologic and medical societies, advisory and regulatory bodies, academic societies, pharmaceutical industry, cancer institutes and crucially patient advocacy organizations, so that standards can be set that are technically correct, comprehensive, and balanced.
With patient-centered care garnering a more central role in oncology, patient-reported health-related quality of life (HRQL) is also increasingly being identified as an important source of data to help describe clinical benefit in cancer randomized controlled trials (RCTs). However, diverse ways of analyzing PRO and HRQOL endpoints make it difficult to compare results across various cancer clinical trials. Subsequent inconsistencies in the results cause inefficient resource use, fragmented reporting, and interpretational barriers. This could undermine the credibility of the Quality of Life field since it can lead to differences in interpretation of the findings depending on how the data is analyzed. The goal of the SISAQOL initiative is to set an international recommendations on how to analyze PRO and HRQOL in clinical trials. In order to be successful, these recommendations need to be supported by a broad consensus, balancing different needs and requirements. The ideal outcome would be a short guideline for practitioners and researchers to guide them in their analysis of HRQOL data, supplemented with a more detailed manual and with open access templates for statistical analysis plans and software macros. It is hoped that these guidelines and tools would facilitate the analysis of PRO and HRQOL data and would result in more reliable findings, improved interpretability and faster dissemination of data that stem from a higher quality use of statistical methods.

Achievements

After the start of SISAQOL in 2016, and a consensus meeting in January 2017 to set the priorities and actions for the year, three multidisciplinary working groups were set-up: the research objectives, statistical methods and the missing data working groups. These three working groups will join forces to work on three SISAQOL priorities: (1) generating a taxonomy of research objectives; (2) matching research objectives with appropriate statistical methods; and (3) developing recommendations for the appropriate handling of missing data.

Achievements per working group:
Research Objectives: The consortium developed an initial draft of a framework of research objectives and is currently working on standardizing definitions of common research objectives.

Statistical methods: The consortium identified crucial statistical terms where no consensus definitions are available. Work towards standardizing these terms is currently on-going. Furthermore, a first step towards selecting appropriate statistical methods was done by identifying essential statistical properties.

Missing data: Work on macros for missing data and the development of guidelines regarding what to do with missing data is currently on-going.

Future plans

Building on the current work of the Research Objectives and the Statistical Methods Working Groups, the next step is to come up with a selection of appropriate statistical methods for the analysis of HRQOL/PRO data and match these with the research objectives.

For patients

The SISAQOL project can make a real difference in the lives of cancer patients. A patient’s health-related quality of life during treatment and in the long-term is important. Cancer patients and their families are not only concerned about a cure, but also about the symptoms (e.g. pain, fatigue) and other physical and emotional consequences that come along with the disease and treatment, impacting the daily life of the patient. It is therefore essential that these health aspects are taken into account when evaluating any new therapies. Questionnaires to measure health-related quality of life are increasingly being used throughout cancer research. Patients devote their time to completing these questionnaires, but often it is unclear how the responses are analyzed and reported. The SISAQOL project will help clinicians and patients make better sense of the numbers and make research findings more understandable for them. The establishment of the SISAQOL Consortium encourages patients, researchers, clinicians, and other stakeholders to all work together with the aim of improving patient-centered cancer care. [text from Oliver K. & Peuters C. 2017. Working together to foster better patient-centered care. Brain Tumour Magazine pp. 14-15]

Publications

  • Bottomley A, Pe M, Sloan J, et al. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards. Lancet Oncol. 2016;17(11):e510-e514. doi:10.1016/S1470-2045(16)30510-1.