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

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.

[1]  J. Sloan Asking the obvious questions regarding patient burden. , 2002, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[2]  A. Bottomley,et al.  Quality of life in patients undergoing systemic therapy for advanced breast cancer. , 2002, The Lancet. Oncology.

[3]  P. Fayers,et al.  Health-related quality of life measurement in randomized clinical trials in surgical oncology. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[4]  D. Moher,et al.  The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration , 2001, Annals of Internal Medicine.

[5]  G. Guyatt,et al.  Interpreting treatment effects in randomised trials , 1998, BMJ.

[6]  N. Aaronson,et al.  Methodological quality of patient-reported outcome research was low in complementary and alternative medicine in oncology. , 2006, Journal of clinical epidemiology.

[7]  Patrick Marquis,et al.  A comprehensive strategy for the interpretation of quality-of-life data based on existing methods. , 2004, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[8]  A. Bottomley,et al.  Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomised controlled trials. , 2004, European journal of cancer.

[9]  D. Moher,et al.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials , 2001, The Lancet.

[10]  D. Osoba,et al.  Interpreting the significance of changes in health-related quality-of-life scores. , 1998, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[11]  D. Osoba,et al.  Letters to the editor: Assessing quality of life in clinical trials , 1993 .

[12]  A. Bottomley,et al.  Health-related quality of life in non-small-cell lung cancer: methodologic issues in randomized controlled trials. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[13]  D. Osoba,et al.  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? , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[14]  R. Einarsson,et al.  Monitoring palliative chemotherapy in advanced gastrointestinal cancer using serial tissue polypeptide specific antigen (TPS) measurements. , 1996, Acta oncologica.

[15]  Gordon H Guyatt,et al.  Methods to explain the clinical significance of health status measures. , 2002, Mayo Clinic proceedings.

[16]  David Moher,et al.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials , 2001, Annals of Internal Medicine.

[17]  Andrew Bottomley,et al.  Health related quality of life in prostate carcinoma patients , 2003, Cancer.

[18]  W. Lee,et al.  Early quality of life assessment in men treated with permanent source interstitial brachytherapy for clinically localized prostate cancer. , 1999, The Journal of urology.

[19]  M. King The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30 , 1996, Quality of Life Research.

[20]  D. Osoba,et al.  Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group. , 2005, European journal of cancer.

[21]  P. Lachenbruch Statistical Power Analysis for the Behavioral Sciences (2nd ed.) , 1989 .

[22]  P. Ganz,et al.  Health-related quality-of-life measurement in randomized clinical trials in breast cancer--taking stock. , 2003, Journal of the National Cancer Institute.

[23]  G. Guyatt,et al.  How can quality of life researchers make their work more useful to health workers and their patients? , 2007, Quality of Life Research.