Warning: Undefined array key "mm" in /www/wwwroot/www.ai-bt.com/si.php on line 10 Deprecated: trim(): Passing null to parameter #1 ($string) of type string is deprecated in /www/wwwroot/www.ai-bt.com/si.php on line 10 The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval.

Literature DB >> 18580868

The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval.

L B Burke¹, D L Kennedy, P H Miskala, E J Papadopoulos, A M Trentacosti.

Abstract

Patient-reported outcome (PRO) measures provide an important perspective on how patients feel and function that cannot be adequately captured by clinical measures. A PRO is any report that comes directly from a patient about a health condition or its treatment without interpretation of the patient's response by a clinician or anyone else.

Entities: Species

Mesh：

Year: 2008 PMID： 18580868 DOI： 10.1038/clpt.2008.128

Source DB: PubMed Journal: Clin Pharmacol Ther ISSN： 0009-9236 Impact factor: 6.875

Keyword Cloud
Cited

32 in total

Review 1. ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials.

Authors: Andrea M Barsevick; Charles S Cleeland; Donald C Manning; Ann M O'Mara; Bryce B Reeve; Jane A Scott; Jeff A Sloan
Journal: J Pain Symptom Manage Date: 2010-06 Impact factor: 3.612

Review 2. Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development.

Authors: Catherine Copley-Merriman; Susan Zelt; Marci Clark; Ari Gnanasakthy
Journal: Patient Date: 2017-04 Impact factor: 3.883

Review 3. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles.

Authors: Michael Camilleri; Lin Chang
Journal: Gastroenterology Date: 2008-10-09 Impact factor: 22.682

4. Psychometric evaluation of patient-reported outcomes in irritable bowel syndrome randomized controlled trials: a Rome Foundation report.

Authors: Brennan Spiegel; Michael Camilleri; Roger Bolus; Viola Andresen; William D Chey; Sheri Fehnel; Allen Mangel; Nicholas J Talley; William E Whitehead
Journal: Gastroenterology Date: 2009-08-23 Impact factor: 22.682

5. Validity of average, minimum, and maximum end-of-day recall assessments of pain and fatigue.

Authors: Arthur A Stone; Joan E Broderick; Joseph E Schwartz
Journal: Contemp Clin Trials Date: 2010-07-08 Impact factor: 2.226

6. The impact of physical complaints, social environment, and psychological functioning on IBS patients' health perceptions: looking beyond GI symptom severity.

Authors: Jeffrey M Lackner; Gregory D Gudleski; Elyse R Thakur; Travis J Stewart; Gary J Iacobucci; Brennan Mr Spiegel
Journal: Am J Gastroenterol Date: 2014-01-14 Impact factor: 10.864

The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval.

Review 1. ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials.

Review 2. Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development.

Review 3. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles.

4. Psychometric evaluation of patient-reported outcomes in irritable bowel syndrome randomized controlled trials: a Rome Foundation report.

5. Validity of average, minimum, and maximum end-of-day recall assessments of pain and fatigue.

6. The impact of physical complaints, social environment, and psychological functioning on IBS patients' health perceptions: looking beyond GI symptom severity.

Review 7. Psychosocial Mediators of Change and Patient Selection Factors in Oral Immunotherapy Trials.

8. A conceptual and disease model framework for osteoporotic kyphosis.

9. The impact of itch symptoms in psoriasis: results from physician interviews and patient focus groups.

10. Patient reported outcomes: looking beyond the label claim.