Feedback on the FDA's February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO me
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Open Access
Commentary
Feedback on the FDA's February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO measures Clare Bradley* Address: Health Psychology Research, Royal Holloway, University of London, Egham, Surrey TW20 0EX, UK Email: Clare Bradley* - [email protected] * Corresponding author
Published: 09 October 2006 Health and Quality of Life Outcomes 2006, 4:78
doi:10.1186/1477-7525-4-78
Received: 19 July 2006 Accepted: 09 October 2006
This article is available from: http://www.hqlo.com/content/4/1/78 © 2006 Bradley; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract 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 finalise their guidelines.
Introduction The US Department of Health and Human Services Food and Drug Administration (FDA) made public in February 2006 a document entitled 'Guidance for Industry PatientReported Outcome Measures: Use in Medical Product Development to Support Labeling Claims DRAFT GUIDANCE'. I have a particular interest in this draft guidance as I specialise in the design, development and use of PRO measures and license them for use in clinical trials, other research and routine clinical practice. My measures include:
• the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in its status (DTSQs) and change (DTSQc) forms [1-6] and related measures for other conditions including the HIVTSQ, RTSQ, RetTSQ, GHerpTSQ, ThyTSQ [7-12], and the newly designed DTSQ-Teen and DTSQ-Parent. The DTSQs and DTSQc are fully linguistically validated in
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