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The MSIS-29 and SF-36 as outcomes in secondary progressive MS trials.
Strijbis, Eva Mm; Repovic, Pavle; Mostert, Jop; Bowen, James D; Uitdehaag, Bernard Mj; Cutter, Gary; Koch, Marcus W.
Afiliação
  • Strijbis EM; Department of Neurology, MS Center Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
  • Repovic P; Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, WA, USA.
  • Mostert J; Department of Neurology, Rijnstate Hospital, Arnhem, The Netherlands.
  • Bowen JD; Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, WA, USA.
  • Uitdehaag BM; Department of Neurology, MS Center Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
  • Cutter G; Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, USA.
  • Koch MW; Departments of Clinical Neurosciences and Community Health Sciences, University of Calgary, Calgary, AB, Canada.
Mult Scler ; 28(10): 1606-1619, 2022 09.
Article em En | MEDLINE | ID: mdl-35876467
ABSTRACT

BACKGROUND:

Patient-reported outcome measures (PROMs) are often used in clinical research, but little is known about their performance as longitudinal outcomes.

METHODS:

We used data from ASCEND, a large SPMS trial (n = 889), to investigate changes on the Short Form Health Survey 36 (SF-36 v2) and the Multiple Sclerosis Impact Scale (MSIS-29) over 2 years of follow-up.

RESULTS:

PROM scores changed little over the 2 years of follow-up. In contrast to physical disability measures, there was no consistent trend in PROM change significant worsening occurred about as often as improvement. Using a 6-month confirmation reduced the number of both worsening and improvement events without altering their relative balance. There was no clear difference in worsening events in groups based on population characteristics, nor was there a noticeable effect using different thresholds for clinically significant change.

CONCLUSION:

We found little consistent change in MSIS-29 and SF-36 over 2 years of follow-up in people with SPMS. Our findings show a disconnect between disability worsening and PROM change in this population. Our findings raise caution about the use of these PROMs as primary outcome measures in SPMS trials and call for a critical reappraisal of the longitudinal use of these measures in SPMS trials.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article