Patient-reported outcomes (PROs) in dental clinical trials and product development: Introduction to scientific and regulatory considerations

Journal of Evidence-Based Dental Practice

Volumn 10, Issue 2, 2010, Pages 86-90

  Gwaltney, Chad J ^a  

^a BROWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; DENTISTRY; HUMAN; OUTCOME ASSESSMENT; PATIENT SATISFACTION;

CLINICAL TRIALS AS TOPIC; DENTISTRY; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SATISFACTION;

EID: 77954080086     PISSN: 15323382     EISSN: 15323390     Source Type: Journal    
DOI: 10.1016/j.jebdp.2010.02.001     Document Type: Article

References (16)

1. R.J. Willke, L.B. Burke, and P. Erickson Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels Control Clin Trials 25 2004 535 552
2. Food and Drug Administration (FDA). Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Dec 2009. US Department of Health and Human Services.
3. Committee for Medicinal Products for Human Use (CHMP). CHMP reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. EMEA/CHMP/EWP/139391/ 2004.
4. G.D. Slade, Measuring oral health and quality of life 1997 University of North Carolina, Dental Ecology Chapel Hill
5. R.R. Rubin, and M. Peyrot Psychometric properties of an instrument for assessing treatment satisfaction associated with pramlintide use Diabetes Educ 35 2009 136 146
6. EuroQol EuroQol - a new facility for the measurement of health-related quality of life. The EuroQol Group Health Policy 16 3 1990 199 208
7. American Psychological Association and the National Council on Measurement in Education Standards for Educational and Psychological Testing 2002 American Educational Research Association Washington, DC
8. J.C. Nunnally, and I.H. Bernstein Psychometric theory 3rd ed. 1994 McGraw-Hill New York
9. M.L. Rothman, P. Beltran, J.C. Cappelleri, J. Lipscomb, B. Teschendorf, J.A. Sloan the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group Patient-reported outcomes: conceptual issues Value Health 10 Suppl. 2 2007 S66 S75
10. G.B. Willis Cognitive interviewing 2004 Sage Thousand Oaks, CA
11. R.H. Dworkin, D.C. Turk, J.T. Farrar, J.A. Haythornthwaite, M.P. Jensen, and N.P. Katz Core outcome measures for chronic pain clinical trials: IMMPACT recommendations Pain 113 1-2 2005 9 19
12. J. Barden, S. Derry, H.J. McQuay, and R.A. Moore Single dose oral ketoprofen and dexketoprofen for acute postoperative pain in adults Cochrane Database Syst Rev 4 2009 CD007355
13. R.G. Walker, S. Cottrell, K. Sharp, R. Tripodi, K.M. Nicholls, and I. Fraser Conversion of cyclosporine to tacrolimus in stable renal allograft recipients: quantification of effects on the severity of gingival enlargement and hirsutism and patient-reported outcomes Nephrology 12 2007 607 614
14. C.P. Green, C.B. Porter, D.R. Bresnahan, and J.A. Spertus Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure J Am Coll Cardiol 35 2000 1245 1255
15. S.T. Chen, and D. Buser Clinical and esthetic outcomes of implants placed in postextraction sites Int J Oral Maxillofac Implants 24 Suppl 2009 186 217
16. T. Winning, I. Needleman, M. Rohlin, A. Carrassi, B. Chadwick, and K. Eaton Evidence-based care and the curriculum Eur J Dent Educ 12 Suppl 1 2008 48 63