Swipe om te navigeren naar een ander artikel
The preliminary results of this study were previously presented as poster at 14th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR, Madrid, November 2011).
Disclaimer: The views expressed herein are those of the authors and do not reflect the official policy or position of AstraZeneca Pharmaceuticals Ltd (UK) or York Health Economics Consortium.
The inclusion of patient-reported outcome (PRO) instruments to record patient health-related quality of life (HRQOL) data has virtually become the norm in oncology randomised controlled trials (RCTs). Despite this fact, recent concerns have focused on the quality of reporting of HRQOL. The primary aim of this study was to evaluate the quality of reporting of HRQOL data from two common instruments in oncology RCTs.
A meta-review was undertaken of systematic reviews reporting HRQOL data collected using PRO instruments in oncology randomised controlled trials (RCTs). English language articles published between 2000 and 2012 were included and evaluated against a methodology checklist.
Four hundred and thirty-five potential articles were identified. Six systematic reviews were included in the analysis. A total of 70,403 patients had completed PROs. The European Organization for Research and Treatment of Cancer QLQ-C30 and Functional Assessment of Cancer Therapy-General questionnaire accounted for 55 % of RCTs. Eighty per cent of RCTs had used psychometrically validated instruments; 70 % reported culturally valid instruments and almost all reported the assessment timing (96 %). Thirty per cent of RCTS reported clinical significance and missing data. In terms of methodological design, only 25 % of RCTs could be categorised as probably robust.
The majority of oncology RCTs has shortcomings in terms of reporting HRQOL data when assessed against regulatory and methodology guidelines. These limitations will need to be addressed if HRQOL data are to be used to successfully support clinical decision-making, treatment options and labelling claims in oncology.
Log in om toegang te krijgen
Met onderstaand(e) abonnement(en) heeft u direct toegang:
Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute,85, 365–376. PubMedCrossRef
Cella, D. F., Tulsky, D. S., Gray, G., Sarafian, B., Linn, E., Bonomi, A., et al. (1993). The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. Journal of Clinical Oncology,11, 570–579. PubMed
Cocks, K., King, M. T., Velikova, G., Fayers, P. M., & Brown, J. M. (2008). Quality, interpretation and presentation of European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 data in randomised controlled trials. European Journal of Cancer,44, 1793–1798. PubMedCrossRef
Calvert, M., Blazeby, J., Revicki, D., Moher, D., & Brundage, M. (2011). Reporting quality of life in clinical trials: A CONSORT extension. The Lancet,2011(378), 1684–1685. CrossRef
Efficace, F., Bottomley, A., Osoba, D., Gotay, C., Flechtner, H., D’haese, S., et al. (2003). Beyond the development of health-related quality of life (HRQOL) measures: A checklist for the evaluation of HRQOL evaluation in cancer clinical trials. Journal of Clinical Oncology,21, 3502–3511. PubMedCrossRef
Claassens, L., van Meerbeeck, J., Coens, C., Quiten, C., Ghislain, I., Sloan, E. K., et al. (2011). Health-related quality of life in non-small-cell lung cancer: An update of a systematic review on methodologic issues in randomized controlled trials. Journal of Clinical Oncology,29, 2104–2120. PubMedCentralPubMedCrossRef
Efficace, F., Bottomley, A., & van Andel, G. (2004). Health related quality of life in prostate carcinoma patients: A systematic review of randomized controlled trials. Cancer,97, 377–388. CrossRef
Efficace, F., Kemmler, G., Vignetti, F., Madelli, F., Molica, S., & Holzner, B. (2008). Health-related quality of life assessment and reported outcomes in leukaemia randomised controlled trials: A systematic review to evaluate the added value in supporting clinical decision making. European Journal of Cancer,44, 1497–1506. PubMedCrossRef
Kvam, A. K., Fayers, P., Hjermstad, M., Gulbrandsen, N., & Wisloff, F. (2009). Health-related quality of life assessment in randomised controlled trials in multiple myeloma: A critical review of methodology and impact on treatment recommendations. European Journal of Haematology,83, 279–289. PubMedCrossRef
Reeve, R. B., Wyrwich, K. W., Wu, A. W., et al. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research. doi: 10.1007/s11136-012-0344-y.
- Reporting of health-related quality of life (HRQOL) data in oncology trials: a comparison of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (FACT-G)
Adam B. Smith
- Springer International Publishing