Quality, interpretation and presentation of European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 data in randomised controlled trials

被引:134
作者
Cocks, Kim [1 ]
King, Madeleine T. [2 ,3 ]
Velikova, Galina [4 ]
Fayers, Peter M. [5 ,6 ]
Brown, Julia M. [1 ]
机构
[1] Univ Leeds, Clin Trials Res Unit, Leeds LS2 9JT, W Yorkshire, England
[2] Univ Sydney, Psychooncol Cooperat Res Grp, Qual Life Off, Sydney, NSW 2006, Australia
[3] Univ Technol Sydney, CHERE, Sydney, NSW 2007, Australia
[4] Univ Leeds, St James Hosp, Can Res UK Clin Ctr, Leeds LS2 9JT, W Yorkshire, England
[5] Univ Aberdeen, Sch Med, Dept Publ Hlth, Aberdeen AB9 1FX, Scotland
[6] NTNU, Fac Med, Dept Canc Res & Mol Med, Trondheim, Norway
关键词
quality of life; interpretation; QLQ-C30; reporting;
D O I
10.1016/j.ejca.2008.05.008
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Aim: To review reporting standard, presentation and interpretation for quality of life (QOL) outcomes in randomised controlled trials (RCTs) using the European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC QLQ-C30). Methods: Cancer RCTs reporting EORTC QLQ-C30 data were identified and reviewed against a reporting quality checklist. Interpretation/presentation methods for QOL data were also recorded. Results: Eighty-two papers were reviewed. Seventy percent met criteria for high quality reporting; 94% reported mean scores; 84% presented results in tables/graphs; 80% reported p-values or statistical significance. Clinical significance was addressed in 38%. Where clinical significance was not addressed, reliance was usually on statistical significance to interpret the results. Discussion: EORTC QLQ-C30 results are generally reported well, although it was common to rely on statistical significance alone for interpreting results. Whilst interpretation in terms of clinical significance has improved in recent years, there is still a lack of robust clinical interpretation of QOL results even in papers reported to a high standard. (C) 2008 Elsevier Ltd. All rights reserved.
引用
收藏
页码:1793 / 1798
页数:6
相关论文
共 24 条
[1]   The revised CONSORT statement for reporting randomized trials: Explanation and elaboration [J].
Altman, DG ;
Schulz, KF ;
Moher, D ;
Egger, M ;
Davidoff, F ;
Elbourne, D ;
Gotzsche, PC ;
Lang, T .
ANNALS OF INTERNAL MEDICINE, 2001, 134 (08) :663-694
[2]   Health-related quality of life measurement in randomized clinical trials in surgical oncology [J].
Blazeby, Jane M. ;
Avery, Kerry ;
Sprangers, Mirjam ;
Pikhart, Hynek ;
Fayers, Peter ;
Donovan, Jenny .
JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (19) :3178-3186
[3]   Health-related quality of life in non-small-cell lung cancer: Methodologic issues in randomized controlled trials [J].
Bottomley, A ;
Efficace, F ;
Thomas, R ;
Vanvoorden, V ;
Ahmedzai, SH .
JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (15) :2982-2992
[4]   Quality of life in patients undergoing systemic therapy for advanced breast cancer [J].
Bottomley, A ;
Therasse, P .
LANCET ONCOLOGY, 2002, 3 (10) :620-628
[5]  
Cohen J., 1988, POWERSTATISTICALSCIE, DOI 10.4324/9780203771587
[6]   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? [J].
Efficace, F ;
Bottomley, A ;
Osoba, D ;
Gotay, C ;
Flechtner, H ;
D'haese, S ;
Zurlo, A .
JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (18) :3502-3511
[7]   Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomised controlled trials [J].
Efficace, F ;
Bottomley, A ;
Vanvoorden, V ;
Blazeby, JM .
EUROPEAN JOURNAL OF CANCER, 2004, 40 (02) :187-197
[8]   Health related quality of life in prostate carcinoma patients - A systematic review of randomized controlled trials [J].
Efficace, F ;
Bottomley, A ;
van Andel, G .
CANCER, 2003, 97 (02) :377-388
[9]   Methodological quality of patient-reported outcome research was low in complementary and alternative medicine in oncology [J].
Efficace, Fabio ;
Horneber, Markus ;
Lejeune, Stephane ;
Van Dam, Frits ;
Leering, Suzanne ;
Rottmann, Michael ;
Aaronson, Neil K. .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2006, 59 (12) :1257-1265
[10]   Monitoring palliative chemotherapy in advanced gastrointestinal cancer using serial tissue polypeptide specific antigen (TPS) measurements [J].
Glimelius, B ;
Hoffman, K ;
Einarsson, R ;
PAhlman, L ;
Graf, W .
ACTA ONCOLOGICA, 1996, 35 (02) :141-148