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Related Concept Videos

Guidelines for Writing Outcome01:11

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When developing expected outcomes for a patient care plan, the nurse should adhere to the following recommendations:
Patient outcomes reflect the patient's response to the goal rather than what the nurse aims to achieve. Terminology should be observable and measurable to avoid the reader's interpretation. The desired outcome should be realistic and achievable in the designated care timeframe. Expected outcomes should align with adjunctive therapies. The outcome should enhance care...
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The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool
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Defining reliable disability outcomes in multiple sclerosis.

Tomas Kalincik1, Gary Cutter2, Tim Spelman3

  • 11 Department of Medicine, University of Melbourne, Melbourne, Australia 2 Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia tomas.kalincik@unimelb.edu.au.

Brain : a Journal of Neurology
|September 12, 2015
PubMed
Summary
This summary is machine-generated.

Disease modifying therapy for multiple sclerosis aims to prevent irreversible disability. Shorter confirmation periods for disability progression in clinical trials may overestimate permanent disability accumulation by up to 30%.

Keywords:
clinical trialdisabilityoutcome measuresprognosisrelapse

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Area of Science:

  • Neurology
  • Clinical Trials
  • Biostatistics

Background:

  • Preventing irreversible disability is a primary goal of multiple sclerosis (MS) disease-modifying therapies.
  • Current MS clinical trials often use Expanded Disability Status Scale (EDSS) progression confirmed over 3-6 months, but its sensitivity and stability are not fully understood.

Purpose of the Study:

  • To evaluate various criteria for disability progression in multiple sclerosis.
  • To assess the sensitivity, stability, and determinants of different disability progression metrics.
  • To determine the impact of confirmation period length on the accuracy of disability progression assessment.

Main Methods:

  • Analysis of 48 disability progression criteria using the global MSBase cohort study data (16,636 patients, 112,584 patient-years).
  • Evaluation of progression rates, event persistence over five years, and determinants of progression and regression.
  • Testing definitions for baseline disability, progression magnitude, long-term irreversibility, and event confirmation periods.

Main Results:

  • Progression rates varied significantly (0.41-1.14 events/10 years), influenced most by the confirmation interval length.
  • Concordance among tested progression criteria was low (17.3%).
  • Disability regression occurred in 11-34% of events within five years. Longer confirmation periods (12-24 months) significantly increased event persistence (80-89%).

Conclusions:

  • Disability outcomes based on 3-6 month confirmed progression may overestimate permanent disability accumulation by up to 30%.
  • This overestimation can lead to spurious results in short-term clinical trials, particularly in younger patients or those with relapsing-remitting MS.
  • Extending the confirmation period for disability progression enhances the stability and accuracy of assessing permanent disability in multiple sclerosis.