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

Author:

Bottomley Andrew1,Pe Madeline1,Sloan Jeff2,Basch Ethan3,Bonnetain Franck4,Calvert Melanie5,Campbell Alicyn6,Cleeland Charles7,Cocks Kim8,Collette Laurence1,Dueck Amylou C9,Devlin Nancy10,Flechtner Hans-Henning11ORCID,Gotay Carolyn12,Greimel Eva13,Griebsch Ingolf14,Groenvold Mogens15,Hamel Jean-Francois16,King Madeleine17,Kluetz Paul G18,Koller Michael19,Malone Daniel C20,Martinelli Francesca1,Mitchell Sandra A21,Moinpour Carol M22,Musoro Jammbe Z1,O’Connor Daniel23,Oliver Kathy24,Piault-Louis Elisabeth6,Piccart Martine25,Pimentel Francisco L2627,Quinten Chantal28,Reijneveld Jaap C29,Schürmann Christoph30,Smith Ashley Wilder21,Soltys Katherine M31,Sridhara Rajeshwari18,Taphoorn Martin J B32,Velikova Galina33,Coens Corneel1

Affiliation:

1. Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium

2. Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA

3. Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA

4. Methodology and Quality of Life Unit in Cancer, INSERM U1098, University Hospital of Besançon, Besançon, France

5. Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK

6. Genentech, San Francisco, CA, USA

7. Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

8. Adelphi Values, Bollington, UK

9. Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA

10. Office of Health Economics, London, UK

11. Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany

12. School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada

13. Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria

14. Boehringer Ingelheim, Frankfurt, Germany

15. Department of Public Health, University of Copenhagen and Bispebjerg Hospital, Copenhagen, Denmark

16. Methodology and Biostatistics Department, University Hospital of Angers UNAM, Angers, France

17. School of Psychology and Sydney Medical School, University of Sydney, Sydney, NSW, Australia

18. US Food and Drug Administration, Silver Spring, MD, USA

19. Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany

20. College of Pharmacy, University of Arizona, Tucson, AZ, USA

21. Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA

22. Fred Hutchinson Cancer Research Center, Seattle, WA, USA

23. Medicines and Healthcare Products Regulatory Agency, London, UK

24. International Brain Tumour Alliance, Surrey, UK

25. Internal Medicine/Oncology, Institut Jules Bordet, Brussels, Belgium

26. Blueclinical Phase I, Porto, Portugal

27. Centro de Estudos e Investigação em Saúde da Universidade de Coimbra, Coimbra, Portugal

28. European Centre for Disease Prevention and Control, Surveillance and Response Support Unit, Epidemiological Methods Section, Stockholm, Sweden

29. VU University Medical Center, Department of Neurology & Brain Tumor Center, Amsterdam, The Netherlands

30. Institute for Quality and Efficiency in Health Care, Cologne, Germany

31. Health Canada, Ottawa, ON, Canada

32. Leiden University Medical Center/Haaglanden Medical Center, Leiden/The Hague, The Netherlands

33. Leeds Institute of Cancer and Pathology, University of Leeds, St James’s Hospital, Leeds, UK

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 randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. 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.

Funder

Fonds Cancer Belgium

Boehringer Ingelheim

Publisher

SAGE Publications

Subject

Pharmacology,General Medicine

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3