Journal of Clinical Oncology, Vol 21, Issue 18
(September), 2003: 3502-3511
© 2003 American Society for Clinical Oncology
Beyond the Development of Health-Related Quality-of-Life (HRQOL) Measures: A Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials—Does HRQOL Evaluation in Prostate Cancer Research Inform Clinical Decision Making?
Fabio Efficace,
Andrew Bottomley,
David Osoba,
Carolyn Gotay,
Henning Flechtner,
Sven D’haese,
Alfredo Zurlo
From the European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Unit and Genitourinary Unit, EORTC Data Center, Brussels; QOL consulting, West Vancouver, BC, Canada; Cancer Research Center of Hawaii, University of Hawaii, Honolulu, HI; and Clinic for Psychiatry and Psychotherapy of Children and Adolescents, University of Cologne, Cologne, Germany.
Address reprint requests to Fabio Efficace, MSc, Ave E Mounier 83, 1200 Brussels, Belgium; e-mail: fef{at}eortc.be.
Purpose: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer.
Materials and Methods: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making.
Results: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions.
Conclusion: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.
F.E. is supported by the Camilla Samuel Fellowship in memory of Lady Grierson.
The contents of this article are solely the views of the authors and do not necessarily represent the official views of the respective organizations.
Presented at the Thirty-Ninth Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31–June 3, 2003.
This article has been cited by other articles:
|
|
|
|
 
F. Efficace, A. Novik, M. Vignetti, F. Mandelli, and C. S. Cleeland
Health-related quality of life and symptom assessment in clinical research of patients with hematologic malignancies: where are we now and where do we go from here?
Haematologica,
December 1, 2007;
92(12):
1596 - 1598.
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. Joly, J. Vardy, M. Pintilie, and I. F. Tannock
Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer
Ann. Onc.,
December 1, 2007;
18(12):
1935 - 1942.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. P. Rock, J. A. Scott, D. L. Kennedy, R. Sridhara, R. Pazdur, and L. B. Burke
Challenges to Use of Health-Related Quality of Life for Food and Drug Administration Approval of Anticancer Products
J Natl Cancer Inst Monographs,
October 1, 2007;
2007(37):
27 - 30.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. M. Blazeby, K. Avery, M. Sprangers, H. Pikhart, P. Fayers, and J. Donovan
Health-Related Quality of Life Measurement in Randomized Clinical Trials in Surgical Oncology
J. Clin. Oncol.,
July 1, 2006;
24(19):
3178 - 3186.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Bottomley, R. Gaafa, C. Manegold, S. Burgers, C. Coens, C. Legrand, M. Vincent, G. Giaccone, and J. Van Meerbeeck
Short-Term Treatment-Related Symptoms and Quality of Life: Results From an International Randomized Phase III Study of Cisplatin With or Without Raltitrexed in Patients With Malignant Pleural Mesothelioma: An EORTC Lung-Cancer Group and National Cancer Institute, Canada, Intergroup Study
J. Clin. Oncol.,
March 20, 2006;
24(9):
1435 - 1442.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. A. Rummans, M. M. Clark, J. A. Sloan, M. H. Frost, J. M. Bostwick, P. J. Atherton, M. E. Johnson, G. Gamble, J. Richardson, P. Brown, et al.
Impacting Quality of Life for Patients With Advanced Cancer With a Structured Multidisciplinary Intervention: A Randomized Controlled Trial
J. Clin. Oncol.,
February 1, 2006;
24(4):
635 - 642.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. P. van Meerbeeck, R. Gaafar, C. Manegold, R. J. Van Klaveren, E. A. Van Marck, M. Vincent, C. Legrand, A. Bottomley, C. Debruyne, and G. Giaccone
Randomized Phase III Study of Cisplatin With or Without Raltitrexed in Patients With Malignant Pleural Mesothelioma: An Intergroup Study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada
J. Clin. Oncol.,
October 1, 2005;
23(28):
6881 - 6889.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Apolone and A. Buda
Topotecan versus paclitaxel in second-line therapy: a lost opportunity for quality-of-life evaluation?
Ann. Onc.,
September 1, 2004;
15(9):
1443 - 1444.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Bottomley, L. Biganzoli, T. Cufer, R. E. Coleman, C. Coens, F. Efficace, H. A. Calvert, T. Gamucci, C. Twelves, P. Fargeot, et al.
Randomized, Controlled Trial Investigating Short-Term Health-Related Quality of Life With Doxorubicin and Paclitaxel Versus Doxorubicin and Cyclophosphamide As First-Line Chemotherapy in Patients With Metastatic Breast Cancer: European Organization for Research and Treatment of Cancer Breast Cancer Group, Investigational Drug Branch for Breast Cancer and the New Drug Development Group Study
J. Clin. Oncol.,
July 1, 2004;
22(13):
2576 - 2586.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
