Multiple Sclerosis Clinical Trial
Official title:
Study to Evaluate the Responsiveness and Minimal Clinical Important Difference (MCID) of the 'Multiple Sclerosis Questionnaire for Physiotherapists' (MSQPT)
The aim of this survey is the evaluation of the responsiveness and the estimation of the MCID of the German and French Multiple Sclerosis Questionnaire for Physiotherapists, a self-rating Patient Reported Outcome questionnaire. This multicenter project uses a combined anchor and distribution based approach with multiple anchors to provide a range of MCID estimates or a single MCID for the reliable and valid Items, Activity and Participation group and the Total Score of the MSQPT, which should to be used as guidelines in daily practice.
The MSQPT is a highly reliable and valid questionnaire that was designed to be an aid for
physiotherapists to asses the course of treatment of Persons with MS (PwMS). The assessment
of the responsiveness of the MSQPT, which is so crucial for the evaluative value of an
instrument used in long time treatment of PwMS, is the focus of this study.
This multicenter study uses a convenience sample of 81 PwMS, who are in short or long term
treatment widespread over Switzerland. At baseline, the testers record age, gender, type of
MS and disease duration since diagnosis. The tests will be executed in the following order:
six-meter Timed Walking Test (6MTWT), nine-hole peg test (9HPT), Berg Balance Scale (BBS),
MSQPT, Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS), Expanded
Disability Status Scale (EDSS) and Transition Questionnaires for the Patient and the
treating physiotherapist. Finally the six-minute walk (6MWT) rest will be carried out. The
intervention with long term patients was planned every next 6 months after the baseline
testing (T1, T2 and T3). The short time patient will be tested at base line and after 3 to 4
months or at the end of the rehabilitation period (T1).
A standardized test protocol manual will be used by the experienced and trained testers.
Effect Size , Standardized Response Mean (SRM). Modified SRM (MSRM), Relative Efficiency
(RE), Sensitivity and Specificity and correlation estimates will describe the anchor based
responsiveness. The combined anchor and distribution based approach is used in search of a
MCID. The distribution based approach uses statistics like Standard Deviation, Standard
Error of Measurement and Minimal Detectable Change as indicators of MCID. The anchor based
approach uses global ratings of change out of the perspective of the patient and the
physiotherapist for different aspects of health: general health status, balance, walking
ability, arm function, fatigue, pain, amount of being active, participation in social life
and general impairment due to MS. Minimal change is defined as one to two gradient change on
the 9 point scale of the transition questions. The expected wide range of MCIDs will be
narrowed to a small range or single MCID by triangulation and selection of the MCID with
best selectivity and specificity.
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Observational Model: Cohort, Time Perspective: Prospective
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