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

Full 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 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.

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Author information

Author/s: Blazeby, Jane M (JM); Avery, Kerry (K); Sprangers, Mirjam (M); Pikhart, Hynek (H); Fayers, Peter (P); Donovan, Jenny (J);

Affiliation: Department of Social Medicine and Clinical Sciences at South Bristol, University of Bristol, Bristol, United Kingdom. j.m.blazeby(-atsign-)bristol.ac.uk

Journal and publication information

Publication Type: Journal Article; Review

Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol), published in United States. (Language: eng)

Reference: 2006-Jul; vol 24 (issue 19) : pp 3178-86

Dates: Created 2006/06/30; Completed 2006/07/19; Revised 2007/11/15;

PMID: 16809741, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Humans
Neoplasms - surgery
Quality of Life
Randomized Controlled Trials as Topic

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