Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force

Value in Health

Volumn 18, Issue 6, 2015, Pages 741-752

  Walton, Marc K ^a   Powers, John H ^b   Hobart, Jeremy ^c   Patrick, Donald ^d   Marquis, Patrick ^e   Vamvakas, Spiros ^f   Isaac, Maria ^f   Molsen, Elizabeth ^g   Cano, Stefan ^h   Burke, Laurie B ^i,j  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

^c PLYMOUTH UNIVERSITY PENINSULA SCHOOLS OF MEDICINE AND DENTISTRY   (United Kingdom)

^d UNIVERSITY OF WASHINGTON   (United States)

^e Modus Outcomes   (United States)

^f EUROPEAN MEDICINES AGENCY   (United Kingdom)

^g International Society for Pharmacoeconomics and Outcomes Research   (United States)

^h Modus Outcomes   (United Kingdom)

ⁱ LORA Group   (United States)

^j UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

more..

Author keywords

clinical outcome assessment; concept of interest; context of use; treatment benefit

Indexed keywords

ARTICLE; CLINICAL ASSESSMENT; CLINICAL TRIAL (TOPIC); CONTROLLED CLINICAL TRIAL (TOPIC); HUMAN; MEASUREMENT; OUTCOME ASSESSMENT; OUTCOMES RESEARCH; PATIENT ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; STANDARDIZATION; BIOASSAY; CLASSIFICATION; CONSENSUS; CONVALESCENCE; DAILY LIFE ACTIVITY; EMOTION; HEALTH CARE QUALITY; HEALTH SERVICES RESEARCH; HEALTH STATUS; NOMENCLATURE; STANDARDS; TREATMENT OUTCOME;

ACTIVITIES OF DAILY LIVING; CLINICAL TRIALS AS TOPIC; CONSENSUS; EMOTIONS; ENDPOINT DETERMINATION; HEALTH SERVICES RESEARCH; HEALTH STATUS; HUMANS; PROCESS ASSESSMENT (HEALTH CARE); RECOVERY OF FUNCTION; TERMINOLOGY AS TOPIC; TREATMENT OUTCOME;

EID: 84942293174     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2015.08.006     Document Type: Article

References (38)

1. G.M. Johansson, and C.K. Hager Measurement properties of the Motor Evaluation Scale for Upper Extremity in Stroke patients (MESUPES) Disabil Rehabil 34 2012 288 294
2. W.J. Coster, S.M. Haley, L.H. Ludlow, and et al. Development of an applied cognition scale to measure rehabilitation outcomes Arch Phys Med Rehabil 85 2004 2030 2035
3. K. Burk, S.R. Schulz, and J.B. Schulz Monitoring progression in Friedreich ataxia (FRDA): the use of clinical scales J Neurochem 126 Suppl. 1 2013 118 124
4. K. Howard, P. Berry, J. Petrillo, and et al. Development of the Shortness of Breath with Daily Activities questionnaire (SOBDA) Value Health 15 2012 1042 1050
5. L. Padua, A. Evoli, I. Aprile, and et al. Myasthenia gravis outcome measure: development and validation of a disease-specific self-administered questionnaire Neurol Sci 23 2012 59 68
6. P.A. Merkel, P.J. Clements, J.D. Reveille, and et al. Current status of outcome measure development for clinical trials in systemic sclerosis: report from OMERACT 6 J Rheumatol 30 2003 1630 1647
7. B. Brown, S.P. McKenna, M. Solomon, and et al. The patient-reported impact of scars measure: development and validation Plast Reconstr Surg 125 2010 1439 1449
8. P. Marquis, K.E. Lasch, L. Delgado-Herrera, and et al. Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome Clin Transl Gastroenterol 5 2014 e59
9. R. Aabenhus, H. Thorsen, V. Siersma, and J. Brodersen The development and validation of a multidimensional sum-scaling questionnaire to measure patient-reported outcomes in acute respiratory tract infections in primary care: the acute respiratory tract infection questionnaire Value Health 16 2013 987 992
10. D.J. Drobes, and S.E. Thomas Assessing craving for alcohol Alcohol Res Health 23 1999 179 186
11. D.A. Gold An examination of instrumental activities of daily living assessment in older adults and mild cognitive impairment J Clin Exp Neuropsychol 34 2012 11 34
12. J.C. Hobart, S.J. Cano, J.P. Zajicek, and A.J. Thompson Rating scales as outcome measures for clinical trials in neurology: problems, solutions, and recommendations Lancet Neurol 6 2007 1094 1105
13. J. Paltamaa, T. Sarasoja, E. Leskinen, and et al. Measures of physical functioning predict self-reported performance in self-care, mobility, and domestic life in ambulatory persons with multiple sclerosis Arch Phys Med Rehabil 88 2007 1649 1657
14. J. Hobart Rating scales for neurologists J Neurol Neurosurg Psychiatry 74 Suppl. IV 2003 iv22 iv26
15. C.R. Charman, A.J. Venn, and H.C. Williams The patient-oriented eczema measure Arch Dermatol 140 2004 1513 1519
16. C.B. Terwee, W. Bouwmeester, S.I. van Elsland, and et al. Instruments to assess physical activity in patients with osteoarthritis of the hip or knee: a systematic review of measurement properties Osteoarthritis Cartilage 19 2011 620 633
17. C.B. Terwee, L.B. Mokkink, M.P.M. Steultjens, and J. Dekker Performance based methods for measuring the physical function of patients with osteoarthritis of the hip or knee: a systematic review of measurement properties Rheumatology 45 2006 890 902
18. S.J. Cano, J.C. Hobart, P.E. Hart, and et al. International Cooperative Ataxia Rating Scale (ICARS): appropriate for studies of Friedreich's ataxia? Mov Disord 20 2005 1585 1591
19. P.I. Spuls, L.L.A. Lecluse, M.N.F. Poulsen, and et al. How good are clinical severity and outcome measures for psoriasis? Quantitative evaluation in a systematic review J Invest Dermatol 130 2010 933 943
20. E. Croarkin, J. Janoff, and C. Barnes Evidence-based rating of upper extremity motor function tests used for people following a stroke Phys Ther 84 2004 62 74
21. M. Rothman, L. Burke, P. Erickson, and et al. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report Value Health 12 2009 1075 1083
22. D.L. Patrick, L.B. Burke, C.J. Gwaltney, and et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force Report: part 1-eliciting concepts for a new PRO instrument Value Health 14 2011 967 977
23. D.L. Patrick, L.B. Burke, C.J. Gwaltney, and et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force Report: part 2-assessing respondent understanding Value Health 14 2011 978 988
24. US Food and Drug Administration. Patient-reported outcome measures: use in medical product development to support labeling claims. 2009. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064981.htm [Accessed July 20, 2014].
25. L.S. Matza, D. Patrick, A.W. Riley, and et al. Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO Good Research Practices for the Assessment of Children and Adolescents Task Force Value Health 16 2013 461 479
26. L.B. Mokkink, C.B. Terwee, D.L. Patrick, and et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes J Clin Epidemiol 63 2010 737 745
27. J.C. Hobart, D.L. Lamping, and A.J. Thompson Evaluating neurological outcome measures: the bare essentials J Neurol Neurosurg Psychiatry 60 1996 127 130
28. V.A. Scholtes, C.B. Terwee, and R.W. Poolman What makes a measurement instrument valid and reliable? Injury 42 2011 236 240
29. US Food and Drug Administration. Clinical Outcome Assessment Qualification Program. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm. [Accessed May 13, 2015].
30. J. Freeman, R. Walters, W. Ingram, and et al. Evaluating change in mobility in people with multiple sclerosis: relative responsiveness of four clinical measures Mult Scler 19 2013 1632 1639
31. B. Post, M.P. Merkus, R.M.A. de Bie, and et al. Unified Parkinson's disease rating scale motor examination: are ratings of nurses, residents in neurology, and movement disorders specialists interchangeable? Mov Disord 20 2005 1577 1584
32. D. Wild, S. Eremenco, I. Mear, and et al. Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient Reported Outcomes Translation & Linguistic Validation Good Research Practices Task Force Report Value Health 12 2009 430 440
33. D. Wild, A. Grove, M. Martin, and et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR Task Force for Translation and Cultural Adaptation Value Health 8 2005 94 104
34. S.J. Coons, C.J. Gwaltney, R.D. Hays, and et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force Report Value Health 12 2009 419 429
35. S. Eremenco, S.J. Coons, J. Paty, and et al. PRO data collection in clinical trials using mixed modes: report of the ISPOR PRO Mixed Modes Good Research Practices Task Force Value Health 17 2014 501 516
36. Biomarkers Definitions Working Group Biomarkers and surrogate endpoints: preferred definitions and conceptual framework Clin Pharmacol Ther 69 2001 89 95
37. M. Schmitter-Edgecombe, C. McAlister, and A. Weakley Naturalistic assessment of everyday functioning in individuals with mild cognitive impairment: the day-out task Neuropsychology 5 2012 631 641
38. T.J. Quinn, J. Dawson, M.R. Walters, and K.R. Lees Functional outcome measures in contemporary stroke trials Int J Stroke 4 2009 200 205