SISAQOL Project

The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium has been convened by the EORTC with the aim to develop recommendations for standardising the analysis and interpretation of patient reported outcomes and quality of life data in cancer randomised trials. The SISAQOL consortium is comprised of key Quality of Life researchers, statisticians, and stakeholders worldwide, so that standards can be set that are technically correct, comprehensive, and balanced. 

 

THE COMPLEXITY OF QUALITY OF LIFE DATA

Clinical research and clinical care move towards a more patient-centred approach in which health-related quality of life (HRQOL) and other patient-reported outcomes (PRO) play a central role. However, diverse ways of analysing 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 analysed.

 

THE PROPOSED SOLUTION

The goal of the SISAQOL initiative is to set an international recommendation on how to analyse 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. 

 

RERERENCE:

Bottomley, A., Pe, M.L., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Dueck, A., Devlin, N., Flechtner, H., Gotay, C., Greimel, E., Griebsch, I., Groenvold, M., Hamel, J.F., King, M., Kluetz, P.G., Koller, M., Malone, D.C., Martinelli, F., Mitchell, S., Moinpour, C.M., Musoro, J., O’Connor, D., Oliver, K., Piault-Louis, E., Piccart, M., Pimentel, F., Quinten, C., Reijneveld, J., Schürmann, C., Smith, A.W., Soltys, K., Taphoorn, M., Velikova, G., & Coens, C.  (2016). Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards. The Lancet Oncology, 17, e510-e514. doi: 10.1016/S1470-2045(16)30510-1

The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium has been convened by the EORTC with the aim to develop recommendations for standardising the analysis and interpretation of patient reported outcomes and quality of life data in cancer randomised trials. The SISAQOL consortium is comprised of key Quality of Life researchers, statisticians, and stakeholders worldwide, so that standards can be set that are technically correct, comprehensive, and balanced.

 

Read more about the Consortium in their published piece in the Lancet Oncology (Personal View): https://www.ncbi.nlm.nih.gov/pubmed/27769798

For more information, please visit: www.eortc.org/sisaqol

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