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.
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: M E Hamaker; K J Schulkes; D Ten Bokkel Huinink; B C van Munster; L H van Huis; F van den Bos Journal: Qual Life Res Date: 2016-07-05 Impact factor: 4.147
Authors: Patrick L Ergina; Jonathan A Cook; Jane M Blazeby; Isabelle Boutron; Pierre-Alain Clavien; Barnaby C Reeves; Christoph M Seiler; Douglas G Altman; Jeffrey K Aronson; Jeffrey S Barkun; W Bruce Campbell; Jonathan A Cook; Liane S Feldman; David R Flum; Paul Glasziou; Guy J Maddern; John C Marshall; Peter McCulloch; Jon Nicholl; Steven M Strasberg; Jonathan L Meakins; Deborah Ashby; Nick Black; John Bunker; Martin Burton; Marion Campbell; Kalipso Chalkidou; Iain Chalmers; Marc de Leval; Jon Deeks; Adrian Grant; Muir Gray; Roger Greenhalgh; Milos Jenicek; Sean Kehoe; Richard Lilford; Peter Littlejohns; Yoon Loke; Rajan Madhock; Kim McPherson; Peter Rothwell; Bill Summerskill; David Taggart; Parris Tekkis; Matthew Thompson; Tom Treasure; Ulrich Trohler; Jan Vandenbroucke Journal: Lancet Date: 2009-09-26 Impact factor: 79.321
Authors: Elsbeth F Taminiau-Bloem; Florence J van Zuuren; Margot A Koeneman; Bruce D Rapkin; Mechteld R M Visser; Caro C E Koning; Mirjam A G Sprangers Journal: Health Qual Life Outcomes Date: 2010-07-16 Impact factor: 3.186