FDA on PROMs: Two important points

BMJ (Online)

Volumn 341, Issue 7776, 2010, Pages 746-

  Rowen, D ^a   Carlton, J ^a   Brazier, J E ^a   Mulhern, B ^a   Palfreyman, S ^a   Stevens, K ^a   Tsuchiya, A ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; HEALTH STATUS; HUMAN; LETTER; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; REIMBURSEMENT; SCORING SYSTEM; NOTE; PATIENT SATISFACTION; UNITED STATES;

HEALTH STATUS; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SATISFACTION; PRACTICE GUIDELINES AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77957928820     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.c5454     Document Type: Letter

References (4)

1. Speight J, Barendse SM. FDA guidance on patient reported outcomes. BMJ 2010;340:c2921. (21 June.) [FREE Full text]
2. US Department of Health and Human Services Food and Drug Administration (FDA). Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. FDA, 2009.
3. National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal. 2008. www.nice.org.uk/aboutnice/howwework/ devnicetech/technologyappraisalprocessguides/ guidetothemethodsoftechnologyappraisal.jsp.
4. Brazier JE, Ratcliffe J, Salomon J, Tsuchiya A. Measuring and valuing health for economic evaluation. Oxford University Press, 2007.