Responder definition of the Multiple Sclerosis Impact Scale physical impact subscale for patients with physical worsening

Multiple Sclerosis Journal

Volumn 20, Issue 13, 2014, Pages 1753-1760

  Phillips, Glenn A ^a   Wyrwich, Kathleen W ^b   Guo, Shien ^b   Medori, Rossella ^a   Altincatal, Arman ^b   Wagner, Linda ^c   Elkins, Jacob ^a  

^a BIOGEN   (United States)

^b EVIDERA   (United States)

^c Envision Pharma Group   (United States)

Author keywords

Anchor based method; Distribution based method; MSIS 29; Multiple sclerosis; Patient reported outcomes; Physical worsening; Responder definition; SELECT

Indexed keywords

DACLIZUMAB; PLACEBO; DACLIZUMAB HYP; IMMUNOSUPPRESSIVE AGENT; MONOCLONAL ANTIBODY;

ADULT; ARTICLE; DRUG DOSE COMPARISON; EXPANDED DISABILITY STATUS SCALE; FEMALE; HUMAN; MALE; MULTIPLE SCLEROSIS; MULTIPLE SCLEROSIS IMPACT SCALE PHYSICAL IMPACT SUBSCALE; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT RESPONSE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; MAJOR CLINICAL STUDY; MULTIPLE SCLEROSIS IMPACT SCALE; PHYSICAL ACTIVITY; PHYSICAL IMPACT SUBSCALE; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RELIABILITY; VALIDITY; COMPLICATION; DISABILITY; DOSE RESPONSE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; SELF REPORT; SEVERITY OF ILLNESS INDEX;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; DISABILITY EVALUATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; SELF REPORT; SEVERITY OF ILLNESS INDEX;

EID: 84911409339     PISSN: 13524585     EISSN: 14770970     Source Type: Journal    
DOI: 10.1177/1352458514530489     Document Type: Article

References (30)

1. US Food and Drug Administration. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist 2009; 74: 65132-65133.
2. US Food and Drug Administration. Draft guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims; availability. Fed Regist 2006; 71: 5862-5863.
3. Wyrwich KW, Norquist JM, Lenderking WR, et al. Methods for interpreting change over time in patient-reported outcome measures. Qual Life Res 2013; 22: 475-483.
4. Hobart J, Lamping D, Fitzpatrick R, et al. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain 2001; 124: 962-973.
5. Gray O, McDonnell G and Hawkins S. Tried and tested: the psychometric properties of the multiple sclerosis impact scale (MSIS-29) in a population-based study. Mult Scler 2009; 15: 75-80.
6. Hobart JC, Riazi A, Lamping DL, et al. Improving the evaluation of therapeutic interventions in multiple sclerosis: development of a patient-based measure of outcome. Health Technol Assess 2004; 8(iii): 1-48.
7. Hobart JC, Riazi A, Lamping DL, et al. How responsive is the Multiple Sclerosis Impact Scale (MSIS-29)? A comparison with some other self report scales. J Neurol Neurosurg Psychiatry 2005; 76: 1539-1543.
8. Hoogervorst EL, Zwemmer JN, Jelles B, et al. Multiple Sclerosis Impact Scale (MSIS-29): relation to established measures of impairment and disability. Mult Scler 2004; 10: 569-574.
9. McGuigan C and Hutchinson M. The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure. J Neurol Neurosurg Psychiatry 2004; 75: 266-269.
10. Ramp M, Khan F, Misajon RA, et al. Rasch analysis of the Multiple Sclerosis Impact Scale MSIS-29. Health Qual Life Outcomes 2009; 7: 58. Published online June 22, 2009. doi: 10.1186/1477-7525-7-58.
11. Riazi A, Hobart JC, Lamping DL, et al. Multiple Sclerosis Impact Scale (MSIS-29): reliability and validity in hospital based samples. J Neurol Neurosurg Psychiatry 2002; 73: 701-704.
12. Costelloe L, O'Rourke K, McGuigan C, et al. The longitudinal relationship between the patient-reported Multiple Sclerosis Impact Scale and the clinician-assessed Multiple Sclerosis Functional Composite. Mult Scler 2008; 14: 255-258.
13. Ravnborg M, Blinkenberg M, Sellebjerg F, et al. Responsiveness of the Multiple Sclerosis Impairment Scale in comparison with the Expanded Disability Status Scale. Mult Scler 2005; 11: 81-84.
14. Riazi A, Hobart JC, Lamping DL, et al. Evidence-based measurement in multiple sclerosis: the psychometric properties of the physical and psychological dimensions of three quality of life rating scales. Mult Scler 2003; 9: 411-419.
15. Giordano A, Pucci E, Naldi P, et al. Responsiveness of patient reported outcome measures in multiple sclerosis relapses: the REMS study. J Neurol Neurosurg Psychiatry 2009; 80: 1023-1028.
16. Costelloe L, O'Rourke K, Kearney H, et al. The patient knows best: significant change in the physical component of the Multiple Sclerosis Impact Scale (MSIS-29 physical). J Neurol Neurosurg Psychiatry 2007; 78: 841-844.
17. Gold R, Giovannoni G, Selmaj K, et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet 2013; 381: 2167-2175.
18. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983; 33: 1444-1452.
19. Goldman MD, Motl RW and Rudick RA. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis. Ther Adv Neurol Disorders 2010; 3: 229-239.
20. Ware J, Jr, Kosinski M and Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220-233.
21. Norman GR, Sloan JA and Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003; 41: 582-592.
22. Robinson D Jr, Zhao N, Gathany T, et al. Health perceptions and clinical characteristics of relapsing-remitting multiple sclerosis patients: baseline data from an international clinical trial. Curr Med Res Opin 2009; 25: 1121-1130.
23. Walters SJ and Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 2005; 14: 1523-1532.
24. Mathias SD, Pritchard ML, Colwell HH, et al. What is the minimal clinically important difference and responsiveness of a patient-reported outcome questionnaire for metastatic colorectal cancer? Ann Oncol 2006; 17: Abstract no. 349P.
25. Revicki D, Hays RD, Cella D, et al. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol 2008; 61: 102-109.
26. Cella D, Eton DT, Fairclough DL, et al. What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol 2002; 55: 285-295.
27. Wyrwich KW, Nienaber NA, Tierney WM, et al. Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care 1999; 37: 469-478.
28. Wyrwich KW, Tierney WM and Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying changes in health-related quality of life. J Clin Epidemiol 1999; 52: 861-873.
29. Wyrwich KW, Tierney WM and Wolinsky FD. Using the standard error of measurement to identify important changes on the Asthma Quality of Life Questionnaire. Qual Life Res 2002; 11: 1-7.
30. Selmaj K, Havrdova E, Gold R, et al. Daclizumab HYP monotherapy improved health-related quality of life parameters in relapsing-remitting multiple sclerosis: findings of the SELECT trial. Neurology 2012; 78: P07.098.Pistotatet quunt et fugit volluptios