Health-related quality of life measurement in randomised clinical trials in surgical oncology

J. M. Blazeby, K. Avery, M. A. G. Sprangers, H. Pikhart, Peter Fayers, J. Donovan

Research output: Contribution to journalArticle

90 Citations (Scopus)

Abstract

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 HBQL 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 HBQL. 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 HBQL 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 HROL 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.

Original languageEnglish
Pages (from-to)3178-3186
Number of pages9
JournalJournal of Clinical Oncology
Volume24
Issue number19
DOIs
Publication statusPublished - Jul 2006

Keywords

  • ADVANCED PROSTATE-CANCER
  • LOW RECTAL CANCERS
  • COLONIC J-POUCH
  • BREAST-CANCER
  • TOTAL GASTRECTOMY
  • RADICAL PROSTATECTOMY
  • ESOPHAGEAL-CARCINOMA
  • PANCREATIC-CANCER
  • GASTRIC-CARCINOMA
  • MG MONOTHERAPY

Cite this

Health-related quality of life measurement in randomised clinical trials in surgical oncology. / Blazeby, J. M.; Avery, K.; Sprangers, M. A. G.; Pikhart, H.; Fayers, Peter; Donovan, J.

In: Journal of Clinical Oncology, Vol. 24, No. 19, 07.2006, p. 3178-3186.

Research output: Contribution to journalArticle

Blazeby, J. M. ; Avery, K. ; Sprangers, M. A. G. ; Pikhart, H. ; Fayers, Peter ; Donovan, J. / Health-related quality of life measurement in randomised clinical trials in surgical oncology. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 19. pp. 3178-3186.
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abstract = "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 HBQL 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 HBQL. 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 HBQL 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 HROL 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.",
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N2 - 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 HBQL 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 HBQL. 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 HBQL 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 HROL 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.

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KW - PANCREATIC-CANCER

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