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Health-Related Quality of Life Measurement in Randomized Clinical Trials in Surgical Oncology

Jane M. Blazeby, Kerry Avery, Mirjam Sprangers, Hynek Pikhart, Peter Fayers, Jenny Donovan

From the Department of Social Medicine and Clinical Sciences at South Bristol, University of Bristol, Bristol; Department of Epidemiology and Public Health, University College London, London; Department of Public Health, University of Aberdeen Medical School, Aberdeen, Scotland, United Kingdom; Department of Medical Psychology, Academic Hospital Amsterdam, University of Amsterdam, the Netherlands; and the Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Technology and Science, Trondheim, Norway

Address reprint requests to Jane M. Blazeby, MD, Level 7, Surgery, Clinical Sciences at South Bristol, Bristol Royal Infirmary, Bristol BS2 8HW, United Kingdom; e-mail: j.m.blazeby{at}bristol.ac.uk

PURPOSE: There is debate about the value of measuring health-related quality of life (HRQL) in clinical trials in oncology because of evidence suggesting that HRQL does not influence clinical decisions. Analysis of HRQL in surgical trials, however, may inform decision making because it provides detailed assessment of the immediate detrimental short-term impact of surgery on HRQL that needs to be considered against the long-term survival benefits and functional outcomes of surgery. This study evaluated whether HRQL in randomized trials in surgical oncology contributes to clinical decision making.

METHODS: A systematic review identified randomized trials in surgical oncology with HRQL. Trials were evaluated independently by two reviewers and the value of HRQL in clinical decision making was categorized in three ways: whether trial investigators reported that HRQL influenced final treatment recommendations, whether trial investigators reported that HRQL would be useful for informed consent, and whether HRQL was assessed robustly according to predefined criteria.

RESULTS: Thirty-three randomized trials with valid HRQL questionnaires were identified; 22 (67%) concluded that HRQL outcomes influenced treatment decisions or provided valuable data for informed consent, and seven of these trials had robust HRQL design. Another five trials had robust HRQL design but investigators reported that HRQL outcomes were not clinically important enough to influence treatment recommendations.

CONCLUSION: In surgical trials in oncology, HRQL informed clinical decision making. It is recommended that HRQL be included in relevant surgical trials, and that information be used to inform clinicians and patients about the impact of surgery on short- and long-term HRQL.

Authors' disclosures of potential con- flicts of interest and author contributions are found at the end of this article.

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