ArticleHealth and quality of life outcomes2006
Feedback on the FDA's February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO measures.
Article in Health and quality of life outcomes, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Systematic literature review and evaluation of patient reported outcome measures (PROMs) for asthma and related allergic diseases.Primary care respiratory journal : journal of the General Practice Airways Group · 2012Pooled it
- Choosing appropriate patient-reported outcomes instrument for glaucoma research: a systematic review of vision instruments.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2011Pooled it
- Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study.Diabetic medicine : a journal of the British Diabetic Association · 2011 · on this mapTrial
- Patient-Reported Outcomes Measurement Information System as a Clinical Tool for Capturing the Patient Perspective in Pediatric Inflammatory Bowel Disease: A Narrative Review.Children (Basel, Switzerland) · 2024Review
- A nomogram based on a patient-reported outcomes measure: predicting the risk of readmission for patients with chronic heart failure.Health and quality of life outcomes · 2020Observational
- Article
- GC-PROM: validation of a patient-reported outcomes measure for Chinese patients with gastric cancer.BMC cancer · 2020Article
- CHF-PROM: validation of a patient-reported outcome measure for patients with chronic heart failure.Health and quality of life outcomes · 2018Article
- Treatment satisfaction in type 2 diabetes patients taking empagliflozin compared with patients taking glimepiride.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2016Article
- Patient-reported outcome measures in inflammatory bowel disease.Canadian journal of gastroenterology & hepatology · 2014Review
- Health-related quality of life assessment in prospective trials of systemic cytotoxic chemotherapy for metastatic castration-resistant prostate cancer: which instrument we need?Medical oncology (Northwood, London, England) · 2011Article
- Health-related quality of life and quality of life in type 2 diabetes: relationships in a cross-sectional study.The patient · 2009Article
- Patient-reported outcomes measurement and management with innovative methodologies and technologies.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2007Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
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 finalize their guidelines.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.