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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346279
• Other study ID #: Responsivität und MCID MSQPT
• Status: Completed
• Phase: N/A
• First received: January 20, 2015
• Last updated: January 24, 2015
• Start date: April 2011
• Est. completion date: October 2013

Study information

• Verified date: January 2015
• Source: Institut fuer Physiotherapieforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Questionnaires, EDSS, physical test
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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Institut fuer Physiotherapieforschung	Schweizer Physiotherapie Verband physioswiss, Schweizerische Multiple Sklerose Gesellschaft

References & Publications (5)

Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2(14):i-iv, 1-74. Review. — View Citation

Gold SM, Heesen C, Schulz H, Guder U, Mönch A, Gbadamosi J, Buhmann C, Schulz KH. Disease specific quality of life instruments in multiple sclerosis: validation of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS). Mult Scler. 2001 Apr;7(2):119-30. — View Citation

Learmonth YC, Paul L, McFadyen AK, Mattison P, Miller L. Reliability and clinical significance of mobility and balance assessments in multiple sclerosis. Int J Rehabil Res. 2012 Mar;35(1):69-74. doi: 10.1097/MRR.0b013e328350b65f. — View Citation

Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 Feb;61(2):102-9. doi: 10.1016/j.jclinepi.2007.03.012. Epub 2007 Aug 3. Review. — View Citation

Wyrwich KW, Norquist JM, Lenderking WR, Acaster S; Industry Advisory Committee of International Society for Quality of Life Research (ISOQOL). Methods for interpreting change over time in patient-reported outcome measures. Qual Life Res. 2013 Apr;22(3):475-83. doi: 10.1007/s11136-012-0175-x. Epub 2012 Apr 17. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Berg Balance Scale	14 Standardized tests, the Gold standard in Balance testing	20 minutes	No
Secondary	Hamburg Quality of Life Questionnaire in Multiple Sclerosis	Patient Reported Quality of Life Questionnaire	20 minutes	No
Secondary	Expanded Disability Status Scale	Gold standard in describing the status of MS	5 minutes	No
Secondary	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	No