Responsiveness and Minimal Clinical Important Difference of the Multiple Sclerosis Questionnaire for Physiotherapists

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study to Evaluate the Responsiveness and Minimal Clinical Important Difference (MCID) of the 'Multiple Sclerosis Questionnaire for Physiotherapists' (MSQPT)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Questionnaires, EDSS, physical test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosed MS, who are in physiotherapeutic treatment because of MS, older than 18 year, must be able to read the MSQPT by himself, native language German or French, EDSS score of less or equal 6.5 Exclusion Criteria: Acute episode of MS, grave cognitive changes, bedfast patient, distinct fatigue, able to perform less than 2 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons in physical therapy treatment<br>Questionnaires (MSQPT, HAQUAMS, Transition Questionnaire for Patient and treating physiotherapist), physical tests (9HPT, 6MTWT, BBS, 6MWT), EDSS | Other: Questionnaires, EDSS, physical test<br>* 6 Meter timed walking test, Nine Hole Peg Test, Berg balance Scale, MSQPT, HAQUAMS, Transition Questionnaire for Patients, Transition Questionnaire for Therapists, EDSS, 6 Minute Walking Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis Questionnaire for Physical Therapists | Items 'Taking a Shower', 'Getting in and out of a car', 'Walking distance' and Walking Time', Activity Group, Participation Group, Total Sum of Items | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Meter Timed Walking Test | Walking 6 Meter, static start, walking at normal speed with or without an walking aid, average of three repetitions | 3 to 20 seconds | 
| Nine Hole Peg Test | Putting as fast as possible nine pegs, one after the other, in nine holes and put them back, one after the other, in the container, best of 2 repetitions | up to 5 minutes | 
| Berg Balance Scale | 14 Standardized tests, the Gold standard in Balance testing | 20 minutes | 
| Hamburg Quality of Life Questionnaire in Multiple Sclerosis | Patient Reported Quality of Life Questionnaire | 20 minutes | 
| Expanded Disability Status Scale | Gold standard in describing the status of MS | 5 minutes | 
| 6 Minutes Walking Test | Walking 6 minutes as far the person can walk, static start, walking at normal speed with or without walking aid | 6 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Rehabilitation, Questionnaire, Patient-Reported Outcome, Responsiveness, Minimal Important Clinical Difference