BMJ 1998;317:1191-1194 ( 31 October )

Papers

Reporting on quality of life in randomised controlled trials: bibliographic study

Caroline Sanders, research assistant,  Matthias Egger, reader in social medicine and epidemiology,  Jenny Donovan, senior lecturer in health and health care,  Deborah Tallon, research assistant,  Stephen Frankel, professor of epidemiology and public health medicine. 

Department of Social Medicine, University of Bristol, Canynge Hall, Bristol BS8 2PR

Correspondence to: Ms Sanders Caroline.Sanders{at}bristol.ac.uk

Objectives: To examine the frequency and quality of reporting on quality of life in randomised controlled trials.
Design: Search of the Cochrane Controlled Trials Register 1980 to 1997 to identify trials from all disciplines, from oncology, and from cardiovascular medicine that reported on quality of life. Assessment of abstracts from articles published from 1993 to 1996. Assessment of a sample of full reports with a standardised instrument.
Main outcome measures: Prevalence of reporting on quality of life. Conditions and interventions studied in trials reporting on quality of life. Quality of reporting on quality of life.
Results: During 1980-97 reporting on quality of life increased from 0.63% to 4.2% for trials from all disciplines, from 1.5% to 8.2% for cancer trials, and from 0.34% to 3.6% for cardiovascular trials. Of 364 abstracts, 65% reported on drug interventions. Of a sample of 67 full reports, authors of 48 (72%) used 62 established quality of life instruments. In 15 reports (22%) authors developed their own measures, and in 2 (3%) methods were unclear. Response rates were given in 38 (57%), and complete reporting on all items and scales occurred in 31 (46%).
Conclusions: Less than 5% of all randomised controlled trials reported on quality of life, and this proportion was below 10% even for cancer trials. A plethora of instruments was used in different studies, and the reporting of methods and results was often inadequate. Standards for the measurement and reporting of quality of life in clinical trials research need to be developed.


© BMJ 1998
Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to StumbleUpon StumbleUpon   Add to Technorati Technorati    What's this?

Relevant Articles

Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review
Despina G Contopoulos-Ioannidis, Anastasia Karvouni, Ioanna Kouri, and John P A Ioannidis
BMJ 2009 338: a3006. [Abstract] [Full Text] [PDF]

Reporting on quality of life in RCTs
Susan P Wright, Olivier Chassany, Jean François Bergmann, and Charles Caulin
BMJ 1999 318: 1142. [Extract] [Full Text]

Fifty years of randomised controlled trials
BMJ 1998 317: 0. [Full Text] [PDF]

Quality of life is rarely and poorly measured in randomised controlled trials
BMJ 1998 317: 0. [Full Text]

This article has been cited by other articles:

  • Phung, O. J, White, C M., Baker, W. L, Coleman, C. I (2009). Assessing the Usefulness of Health-Related Quality-of-Life Trials: A Clinician's Perspective Using Two COPD Examples. The Annals of Pharmacotherapy 43: 1496-1505 [Abstract] [Full text]  
  • Contopoulos-Ioannidis, D. G, Karvouni, A., Kouri, I., Ioannidis, J. P A (2009). Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ 338: a3006-a3006 [Abstract] [Full text]  
  • Joly, F., Vardy, J., Pintilie, M., Tannock, I. F. (2007). Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer. Ann Oncol 18: 1935-1942 [Abstract] [Full text]  
  • Girling, A. J, Lilford, R. J, Braunholtz, D. A, Gillett, W. R (2007). Sample-size calculations for trials that inform individual treatment decisions: a 'true-choice' approach. Clin Trials 4: 15-24 [Abstract]  
  • Ioannidis, J. P.A., Evans, S. J.W., Gotzsche, P. C., O'Neill, R. T., Altman, D. G., Schulz, K., Moher, D., for the CONSORT Group*, (2004). Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement. ANN INTERN MED 141: 781-788 [Abstract] [Full text]  
  • Peacock, A., Naeije, R., Galie, N., Reeves, J.T. (2004). End points in pulmonary arterial hypertension: the way forward. Eur Respir J 23: 947-953 [Abstract] [Full text]  
  • Efficace, F., Bottomley, A., Osoba, D., Gotay, C., Flechtner, H., D'haese, S., Zurlo, A. (2003). 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?. JCO 21: 3502-3511 [Abstract] [Full text]  
  • Engelmann, M. D.M, Pehrson, S. (2003). Quality of life in nonpharmacologic treatment of atrial fibrillation. Eur Heart J 24: 1387-1400 [Abstract] [Full text]  
  • McKevitt, C, Redfern, J, La-Placa, V, Wolfe, C D. (2003). Defining and using quality of life: a survey of health care professionals. Clin Rehabil 17: 865-870 [Abstract]  
  • Bottomley, A., Efficace, F., Thomas, R., Vanvoorden, V., Ahmedzai, S. H. (2003). Health-Related Quality of Life in Non-Small-Cell Lung Cancer: Methodologic Issues in Randomized Controlled Trials. JCO 21: 2982-2992 [Abstract] [Full text]  
  • Efficace, F., Bottomley, A., Levine, M. N., Ganz, P. A. (2002). Do Quality-of-Life Randomized Clinical Trials Support Clinicians in Their Decision-Making?. JCO 20: 4126-4127 [Full text]  
  • Walker, S. M., Goudas, L. C., Cousins, M. J., Carr, D. B. (2002). Combination Spinal Analgesic Chemotherapy: A Systematic Review. Anesth. Analg. 95: 674-715 [Full text]  
  • Goodacre, S, McCabe, C (2002). Being economical with the truth: how to make your idea appear cost effective. Emerg. Med. J. 19: 301-304 [Abstract] [Full text]  
  • Garratt, A., Schmidt, L., Mackintosh, A., Fitzpatrick, R. (2002). Quality of life measurement: bibliographic study of patient assessed health outcome measures. BMJ 324: 1417-1417 [Abstract] [Full text]  
  • Bottomley, A., Efficace, F., Fayers, P. M (2002). Standards are needed for quality of life clinical trials. BMJ 324: 1156-1156 [Full text]  
  • Bottomley, A. (2002). The Cancer Patient and Quality of Life. The Oncologist 7: 120-125 [Abstract] [Full text]  
  • Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gotzsche, P. C., Lang, T., for the CONSORT Group, (2001). The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration. ANN INTERN MED 134: 663-694 [Abstract] [Full text]  
  • Rovers, M M, Krabbe, P F M, Straatman, H, Ingels, K, van der Wilt, G-J, Zielhuis, G A (2001). Randomised controlled trial of the effect of ventilation tubes (grommets) on quality of life at age 1-2 years. Arch. Dis. Child. 84: 45-49 [Abstract] [Full text]  
  • MARSHALL, M., LOCKWOOD, A., BRADLEY, C., ADAMS, C., JOY, C., FENTON, M. (2000). Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia. Br. J. Psychiatry 176: 249-252 [Abstract] [Full text]  
  • Wright, S. P, Chassany, O., Bergmann, J. F., Caulin, C. (1999). Reporting on quality of life in RCTs. BMJ 318: 1142-1142 [Full text]  

Rapid Responses:

Read all Rapid Responses

Biases in measuring and reporting on quality of life in clinical trials
Chassany Olivier
bmj.com, 26 Nov 1998 [Full text]
Biases in measuring and reporting on quality of life in clinical trials
Oliver Chassany
bmj.com, 27 Nov 1998 [Full text]
Quality of life in clinical trials
Susan P Wright
bmj.com, 11 Dec 1998 [Full text]
Access jobs at BMJ Careers
Whats new online at Student BMJ