A Prospective Multi Center Prospective Cross-sectional and Longitudinal Study to Evaluate the Psychometric Properties of the Short Patient Evaluation Questionnaire
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 250
- Primary Endpoint
- Test Retest reliability of SPEQ
Study Overview
Brief Summary
It is important for physiotherapy in general and for the individual physio-therapist to demonstrate the result of the interventions in physiotherapy. The new short (4 items) generic questionnaire Short Patient Evaluation Questionnaire SPEQ was especially developed for use in private practices to answer the main questions for evaluation of treatment. This research project aims at evaluating the reliability, validity and responsiveness of the SPEQ and at providing an estimate for Minimal Important Difference MID that may be used as threshold for clinical relevant changes.
Detailed Description
In this study the investigators evaluate the reliability, validity and responsiveness of the SPEQ and providing an estimate for Minimal Important Difference MID. They will use a longitudinal multicenter design with an adequate sample size of n=250 for validity and n=80 for reliability evaluation. Private practices and the Department of Physiotherapy of the Inselspital, Bern University Hospital, will participate in the study.
Reliability will be evaluated in a test-retest setting and with ordinal alpha. The SPEQ will be compared to the Euroqual-5-Dimensions-5-Levels (EQ-5D-5L), Short Form 12 (SF-12) and Patient Satisfaction Questionnaire (PSQ) to evaluate the validity. Responsiveness will be evaluated using a criterion validity approach and hypothesis testing of the correlation between SPEQ and the other questionnaires. In addition, the investigators will calculate ES, Standardized Response Mean (SRM), Modified SRM (MSRM) and relative efficiency between SPEQ and the criterions. For MID estimates, they use a combined anchor and distribution based approach. The anchors for the items are provided by the T0- and T1-questionnaire.
Patients will be recruited by the treating physiotherapists and provide written informed consent. At baseline, they will complete the T0-questionnaire, SF-12 and EQ-5D-5L. At the end of treatment or after 6 month of treatment for persons in long term treatment, the patients will fill out SPEQ, the T1-questionnaire, SF-12, EQ-5D-5L, and the PSQ. Two to seven days after the second test series, a subset of patients(n=80) will be asked to answer the SPEQ questions again by telephone.
Descriptive statistics will describe missing data, distribution of data over scale levels, frequency, floor and ceiling effects. Scaling will be tested by comparing pearson and spearman correlations and effect size (ES) for ordinal data and for metric data. Independence will be evaluated with the Mann-Whitney U test. The assumptions for building a sum of score will be evaluated comparing and assessing the spearman correlations and a categorical principle component analysis of the matrix of the 4 items of the SPEQ.
The reliability will be evaluated. Correlations between the SPEQ and the criterions EQ-5D-5L, SF-12 and PSQ will demonstrate validity.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Test Retest reliability of SPEQ
Time Frame: up to 30 weeks
Intra-Class Correlation coefficient (using a two way random effects model)
Accuracy of the SPEQ
Time Frame: up to 30 weeks
analysis of accuracy of SPEQ to detect patients who changed in transition question with ROC analysis
Criterion Validity
Time Frame: up to 30 weeks
The validity will be assessed using hypothesis testing of correlations (between SPEQ and existing previously validated measures). The SPEQ has a sufficient criterion validity, if these correlations are at least moderate (rho\>0.5)
Secondary Outcomes
- Responsiveness of the SPEQ(up to 30 weeks)
- Inner consistancy(up to 30 weeks)
- Construct validity of the SPEQ(up to 30 weeks)
- Validity of the SPEQ as assessed using Spearman correlations with scores of other previously validated measures(up to 30 weeks)
Investigators
Nanco van der Maas
Principle investigator
Institut fuer Physiotherapieforschung