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.
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
Tax calculation will be finalised during checkout.
Consolidated standards of reporting trials
- EORTC QLQ-C30:
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30
Functional Assessment of Cancer Therapy-General
Health-related quality of life
Randomised controlled trial
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.
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.
de Haes, J. C., van Knippenberg, F. C., & Neijt, J. P. (1990). Measuring psychological and physical distress in cancer patients: Structure and application of the Rotterdam symptom checklist. British Journal of Cancer, 62, 1034–1038.
Spitzer, W., Dobson, A., & Hall, J. (1981). Measuring the quality of life of cancer patients: A concise QL-index for use by physicians. Journal of Chronic Diseases, 34, 585–597.
Brundage, M., Bass, B., Davidson, J., Queenan, J., Bezjak, A., Ringash, J., et al. (2011). Patterns of reporting health-related quality of life outcomes in randomized clinical trials: Implications for clinicians and quality of life researchers. Quality of Life Research, 20, 653–664.
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.
Efficace, F., Osoba, D., Gotay, C., Sprangers, M., Coens, C., & Bottomley, A. (2007). Has the quality of health-related quality of life reporting in cancer clinical trials improved over time? Towards bridging the gap with clinical decision making. Annals of Oncology, 18, 775–781.
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.
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.
Blazeby, J. M., Avery, K., Sprangers, M., Pikhart, H., Fayers, P., & Donovan, J. (2006). Health-related quality of life measurement in randomized clinical trials in surgical oncology. Journal of Clinical Oncology, 24, 3178–3186.
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.
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.
Efficace, F., Bottomley, A., Vanvoorden, V., & Blazeby, J. M. (2004). Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomised controlled trials. European Journal of Cancer, 40, 187–197.
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.
Fitzsimmons, D., Gilbert, J., Howse, F., Young, T., Arrarras, J. I., Brédart, A., et al. (2009). A systematic review of the use and validation of health-related quality of life instruments in older cancer patients. European Journal of Cancer, 45, 19–32.
Gujral, S., Avery, K. N., & Blazeby, J. M. (2008). Quality of life after surgery for colorectal cancer: Clinical implications of results from randomised trials. Supportive Care in Cancer, 16, 127–132.
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.
Calvert, M., Blazeby, J., Altman, D. G., Revicki, D. A., Moher, D., Brundage, M. D., et al. (2013). Reporting of patient-reported outcomes in randomized trials: The CONSORT PRO extension. Journal of the American Medical Association, 309(8), 814–822.
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.
The authors are grateful to Katarina Halling, Anders Ingelgård, Anna Niklasson, Sindre Rolstad (AstraZeneca AB, Mölndal, Sweden), Chris Miller (AstraZeneca, Wilmington, USA) and Clare McGrath (AstraZeneca Pharmaceuticals Ltd., Macclesfield, UK) for their thoughtful comments and suggestions on an earlier draft of this paper. Adam B. Smith was supported through a Knowledge Transfer Partnership Grant (KTP007957) funded jointly by the UK Technology Strategy Board and AstraZeneca Ltd.
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.
About this article
Cite this article
Smith, A.B., Cocks, K., Parry, D. et al. 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). Qual Life Res 23, 971–976 (2014). https://doi.org/10.1007/s11136-013-0534-2
- Health-related quality of life
- Patient-reported outcomes
- Randomised controlled trials