Measuring health-related quality of life in drug clinical trials: is it given due importance?
- 126 Downloads
Aim of the review Efficacy estimations of drug clinical trials have been based on clinical measurements and survival rates. However, advances in psychometric techniques have allowed to incorporate a new dimension based on quality of life. Questionnaires aimed at measuring patients’ health status outlook, now enable us to quantify the loss of quality of life caused by disease and the improvement that can be achieved by pharmacological treatments. The Aim of this study is to make a quantitative evaluation of the use of health related quality of life (HRQL) measures in drug clinical trials. Methods A systematic review was performed, in duplicate, of the five journals with highest contribution to the ACP Journal Club, i.e. New England Journal of Medicine, JAMA, The Lancet, Annals of Internal Medicine and the British Medical Journal. HRQL measures were evaluated in published articles referring to drug clinical trials. Results We identified 193 articles that reported the results of clinical trials, of which 28 included QOL measures as secondary end points and two as primary end points: in total, these comprised 16% of the articles analysed. Discussion Without considering the relevance of HRQL measures as a tool in the allocation of resources, it should be included as a health outcome dimension in drug clinical trials. The absence of this evaluation in studies about chronic diseases that affects patients’ daily life activities would not be justified. Conclusions HRQL measures are not used on a regular basis in drug clinical trials that are reported in the relevant literature. Systematic incorporation of QOL measures into clinical trials would make it possible to measure the benefit obtained from drug treatments taking into account the patients’ perceptions. Moreover, it would encourage the development of prospective cost-effectiveness studies with patient recorded data in the context of clinical trials. Our findings have a direct impact on practice. Being conscious of the low use of HRQL in clinical trials, it could contribute to increase the demand for these measures by health care professionals. The manuscript is also a useful tool to identify where basic concepts about HRQL measures can be found.
KeywordsHealth related quality of life Quality of life Clinical trial Pharmacoeconomics
The authors thank Dr. Carlos Aguilar and Dr. Valentín del Villar (Hospital of Soria) for their valuable help in drafting this manuscript.
- 7.Patrick DL. What constitutes quality of life? Concepts and dimens Clin Nutr 1988;7:53–63.Google Scholar
- 11.EuroQol group. EuroQol––A new facility for the measurement of health related quality of life. Health Policy 1990;16:199–208.Google Scholar
- 12.Hunt SM, McEwen J, McKenna SP. Measure health status. London: Croom Helm; 1986.Google Scholar
- 18.Mahoney FI, Barthel DW. Functional evaluation: the Barthel index. Md Med J 1965;14:61–5.Google Scholar
- 20.Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR, The Clinical Significance Consensus Meeting Group. Mayo Clin Proc 2002;77:371–83.Google Scholar
- 21.Gold MR, Patrick DL, Torrance GW, et al. Identifying and valuing outcomes. In: Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.Google Scholar
- 22.National Institute for Clinical Excellence. Guide to the methods of technology appraisal. London: NICE; 2004.Google Scholar
- 25.Sackett DL, Straus SE, Richardson WS, Rosenber W, Haynes RB. Medicina basada en la evidencia [Evidence-Based Medicine]. Hardcourt: Madrid; 2001.Google Scholar
- 40.Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. N Engl J Med 2005;353:1114–23.Google Scholar
- 48.Kaiser C, Brunner-La Rocca HP, Buser PT, Bonetti PO, Osswald S, Linka A, et al. Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitats Trial. Lancet 2005;366:921–9.PubMedCrossRefGoogle Scholar
- 49.Thatcher N, Chang A, Parikh P, Rodrigues Pereira J, Ciuleanu T, von Pawel J, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study. Lancet 2005;366:1527–37.PubMedCrossRefGoogle Scholar
- 50.Nitz UA, Mohrmann S, Fischer J, Lindemann W, Berdel WE, Jackisch C, et al. Comparison of rapidly cycled tandem high-dose chemotherapy plus peripheral-blood stem-cell support versus dose-dense conventional chemotherapy for adjuvant treatment of high-risk breast cancer: results of a multicentre phase III trial. Lancet 2005;366:1935–44.PubMedCrossRefGoogle Scholar
- 61.Kim J, Morris CB, Schulman KA. The role of the Food and Drug Administration in pharmacoeconomic evaluation during the drug development process. Drug Inf J 2000;34:1207–13.Google Scholar
- 68.Rivero-Arias O, Campbell H, Gray A, Fairbank J, Frost H, Wilson-MacDonald J. Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial. BMJ 2005;330:1239–43.PubMedCrossRefGoogle Scholar