Watch out, watch out, the FDA are about

Developmental Medicine and Child Neurology

Volumn 50, Issue 6, 2008, Pages 408-409

  Cano, Stefan J ^a   Hobart, Jeremy C ^b  

^a PENINSULA MEDICAL SCHOOL   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CHILDHOOD DISEASE; CLINICAL ASSESSMENT TOOL; CLINICAL STUDY; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDLINE; MULTIPLE SCLEROSIS; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; PSYCHOLOGICAL RATING SCALE; PSYCHOMETRY; PUBLISHING; SHORT FORM 36;

CHILD; CHILD DEVELOPMENT; CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; FATIGUE; HEALTH PLANNING GUIDELINES; HEALTH STATUS; HUMANS; PATIENT CARE; PSYCHOMETRICS; QUESTIONNAIRES; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 43949087240     PISSN: 00121622     EISSN: 14698749     Source Type: Journal    
DOI: 10.1111/j.1469-8749.2008.00408.x     Document Type: Article

References (10)

1. Hobart JC, Cano SJ, Zajicek J, Thompson A. Ratingscales as outcome measures for clinical trials in neurology: Problems, solutions, and recommendations. Lancet Neurol 2007; 6: 1094-1105.
2. Food and Drug Administration. Patient reported outcome measures: Use in medical product development to support labelling claims, Food and Drug Administration, 2006: http://www.fda.gov/CDER/GUIDANCE/5460dft.pdf (accessed 4th March 2008).
3. Revicki D. FDA draft guidance and health-outcomes research. Lancet 2007; 369: 540-42.
4. European Medicines Agency. Reflection paper on the regulatory guidance for the use of the health-related quality of life (HRQL) measures in the evaluation of medicinal products. London: European Medicines Agency, 2006: http://www.emea.europa.eu/pdfs/human/ewp/13939104en.pdf (accessed 4th March 2008).
5. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey manual and interpretation guide. Boston, Massachusetts: Nimrod Press, 1993.
6. Hobart JC, Freeman J, Lamping D, Fitzpatrick R, Thompson A. The SF-36 in multiple sclerosis: Why basic assumptions must be tested. J Neurol Neurosurg Psychiatry 2001; 71: 363-70.
7. Jenkinson C, Hobart JC, Chandola T, Fitzpatrick R, Peto V, Swash M. Use of the short form health survey (SF-36) in patients with amyotrophic lateral sclerosis: Tests of data quality, score reliability, response rate and scaling assumptions. J Neurol 2002; 249: 178-83.
8. Hobart JC, Williams L, Moran K, Thompson A. Quality of life measurement after stroke: Uses and abuses of the SF-36. Stroke 2002; 33: 1348-56.
9. Cano SJ, Thompson A, Fitzpatrick R, Bhatia K, Warner TT, Hobart JC. Evidence-based guidelines for using the Short Form 36 in cervical dystonia. Mov Disord 2007; 22: 122-26.
10. Hagell P, Törnqvist AL, Hobart JC. Testing the SF-36 in Parkinson's disease: Implications for reporting rating scale data. J Neurol 2008; 255: 246-54.