Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT03871920
Status:
UNKNOWN
Last Update Posted:
2019-03-12
First Post:
2017-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychometric Evaluation of the Short Patient Evaluation Questionnaire
Sponsor:
Nanco van der Maas
Organization:
Study Overview
Official Title:
A Prospective Multi Center Prospective Cross-sectional and Longitudinal Study to Evaluate the Psychometric Properties of the Short Patient Evaluation Questionnaire
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Responsiveness will be evaluated analyzing the correlations between SPEQ and criterion and hypothesis testing of change of scores (Cosmin). Furthermore we will calculate the several traditional statistics; Effect Size, Standardized Response Mean, Modified Standardized Response Mean and relative efficiency between SPEQ and the criterion; distribution based Minimal Important Change estimates will be calculated with 0.5 Standard Deviation, Standard Error Measurement and Minimal Detectable Change at the 95% confidence interval; the mean between T0 and T1 values are anchor-based MID estimates. The range of anchor and distribution based MIC estimates will be analysed by Receiver Operating Characteristics curves. The result of the analysis provides an estimate that will be compared to the MID estimate of the criterion validity approach. Finally the threshold for clinical relevant change for the items and the sum of scores of the SPEQ will be determined.
The investigators expect the SPEQ to be a reliable, valid and responsive patient rated outcome assessment that can be used in the evaluation of the results of physiotherapy treatment.
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.
Responsiveness will be evaluated analyzing the correlations between SPEQ and criterion and hypothesis testing of change of scores (Cosmin). Furthermore we will calculate the several traditional statistics; Effect Size, Standardized Response Mean, Modified Standardized Response Mean and relative efficiency between SPEQ and the criterion; distribution based Minimal Important Change estimates will be calculated with 0.5 Standard Deviation, Standard Error Measurement and Minimal Detectable Change at the 95% confidence interval; the mean between T0 and T1 values are anchor-based MID estimates. The range of anchor and distribution based MIC estimates will be analysed by Receiver Operating Characteristics curves. The result of the analysis provides an estimate that will be compared to the MID estimate of the criterion validity approach. Finally the threshold for clinical relevant change for the items and the sum of scores of the SPEQ will be determined.
The investigators expect the SPEQ to be a reliable, valid and responsive patient rated outcome assessment that can be used in the evaluation of the results of physiotherapy treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: