Feedback on the FDA's February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO measures.
I believe that the FDA guidelines have already had an impact in encouraging good practice in the use of PROs. There are, however, important improvements that need to be made to the guidelines, particularly in the use of health status and quality of life terminology. It is essential to distinguish between health status and quality of life and to use both terms. Nothing is to be gained and a great deal will be lost if the term quality of life (which has been misused as an umbrella term in the past) is abandoned and replaced with the term health status. Patients want us to consider their quality of life as well as their health. To abandon the term would be to forget about their quality of life and focus only on their health. Patients are well able to tell us what quality of life means to them and to rate the impact of a condition on their quality of life if we use individualised quality of life measures and individualised condition-specific quality of life measures to allow them to do so. Although my experience with PRO measures would support many of the recommendations in the guidelines there are others that I would not fully agree with or would contradict on the basis of my own research evidence. I have provided references to that research and hope that the FDA will feel able to do the same when they finalize their guidelines.
Bradley
Clare
C
Health Psychology Research, Royal Holloway, University of London, Egham, Surrey TW20 0EX, UK. c.bradley@rhul.ac.uk
D001294:Attitude to Health; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D017410:Practice Guidelines as Topic / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D011594:Psychometrics; D011788:Quality of Life; D012649:Self Concept; D018434:Sickness Impact Profile; D014481:United States; D014486:United States Food and Drug Administration