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Methodological and ethical issues associated with health-related quality of life measurement in clinical trials

Investigators: Professor Mel Calvert, Dr Derek Kyte, Professor Heather Draper, Dr Jonathon Ives and others

Patient reported outcome measures (PROMs) enable researchers to assess the impact of interventions on the quality of patients’ lives. Properly collected and reported, they ought to help to inform doctors and patients in the future. The administration of PROs questionnaires in clinical trials raises ethical issues in relation to the choice and size of the questionnaires, how they are completed, when they are completed, and whether identifiable information collected as part of a clinical trial should be monitored as part of patient care and especially for ‘PRO alerts’ (indication that the patient’s quality of life has become extremely poor).

Professor Mel Calvert directs the Centre for Patient Reported Outcome Measures.


Kyte, D., Ives, J., Draper, H., Calvert, M. Current practices in patient reported outcome (PRO) data collection in clinical trials: a cross-sectional survey of UK trial staff and management. BMJ Open 2016;6:e012281. doi:10.1136/bmjopen-2016- 012281 (open access)

Kyte, D., Ives, J., Draper, H. Calvert, M. Management of patient reported outcomes (PRO) alerts in clinical trials: a cross sectional survey. PlosOne DOI:10.1371/journal.pone.0144658 January 19, 2016 pp.1-14 (open access)

Kyte, D., Duffy, H., Fletcher, B., Gheorghe, A., Mercieca-Bebber, R., King, M., Draper, H., Ives, J., Brundage, M.D., Blazeby, J., Calvert, M. Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols. PLOS One 2014 9(10) e110229 (open access)

Calvert, M., Kyte, D., Duffy, H., Gheorghe, A., Mercieca-Bebber, R., Ives, J., Draper, H., Brundage, M.D., Blazeby, J., King M. Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers PLOS One 9(10); e110216 (open access)

Kyte D, Ives J, Draper H, Keeley T, Calvert M Inconsistencies in Quality of Life Data Collection in Clinical Trials: A Potential Source of Bias? Interviews with Research Nurses and Trialists. PLoS ONE 8(10): e76625. doi:10.1371/journal.pone.0076625 (open access)

Kyte D, Draper H and Calvert, C. Patient report outcome alerts: ethical and logistical considerations in clinical Trials Journal of the American Medical Association 2013;310(12):1229-1230. doi:10.1001/jama.2013.277222. Associated with this paper, a letter was also published: Calvert, M., Draper, H., Kyte, D.(2014) Patient-reported outcome monitoring – reply JAMA2014;311(4):420-421. doi:10.1001/jama.2013.284330

Kyte, D, Draper H, Ives J, Liles C, Gheorghe A, Calvert M. Patient Reported Outcomes (PROs) in Clinical Trials: Is 'In-Trial' Guidance Lacking? A Systematic Review. – PLOS ONE 8(4): e60684 April 2013 DOI: 10.1371/journal.pone.0060684 (open access)