Psychometric Evaluation of the Short Patient Evaluation Questionnaire

Patient Reported Outcomes Clinical Trial

Official title:

A Prospective Multi Center Prospective Cross-sectional and Longitudinal Study to Evaluate the Psychometric Properties of the Short Patient Evaluation Questionnaire

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03871920
• Other study ID #: SPEQ
• Status: Not yet recruiting
• Start date: June 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: March 2019
• Source: Institut fuer Physiotherapieforschung
• Contact: Nico van der Maas
• Phone: +41764373695
• Email: ipforschung[@]sunrise.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Persons older than 18 years, that are in physical therapy treatment.

• Persons must be able to read and understand German.

Exclusion criteria

• Grave cognitive changes

• Bedridden patients

• Grave comorbidities that may interfere with the treatment with physical therapy

Related Conditions & MeSH terms

• Patient Reported Outcomes

Intervention

Other:
• physical therapy treatment
any treatment chosen by treating physiotherapist

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Nanco van der Maas	HES-SO Valais-Wallis, University Hospital Inselspital, Berne, University of Bern

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smallest sum of the proportions of misclassification	By defining a cut-off value at the smallest sum of the proportions of misclassification, the investigators will define Minimal Important Difference	up to 30 weeks
Other	Distribution based Minimal Important Difference	MID is defined for all items and the sum of item scores as 0.5 Standard Deviation, Standard Error Measurement and Minimal Detectable Change at the 95% confidence interval	up to 30 weeks
Other	Anchor based Minimal Important Difference	MID is defined for item 2, 3 and the sum of items scores as the average change between T1 and T2 for the subset of patients with a minimal change as determined by the transition question.	up to 30 weeks
Primary	Test Retest reliability of SPEQ	Intra-Class Correlation coefficient (using a two way random effects model)	up to 30 weeks
Primary	Accuracy of the SPEQ	analysis of accuracy of SPEQ to detect patients who changed in transition question with ROC analysis	up to 30 weeks
Primary	Criterion Validity	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)	up to 30 weeks
Secondary	Inner consistancy	The inner consistency will be calculated with ordinal alpha.	up to 30 weeks
Secondary	Construct validity of the SPEQ	Categorial principle component analysis of SPEQ will be performed to asses the construct validity of the SPEQ.	up to 30 weeks
Secondary	Responsiveness of the SPEQ	Sensitivity to change will be evaluated using Effect Size, Standardized Mean, Modified standardized Mean and Relative efficiency.	up to 30 weeks
Secondary	Validity of the SPEQ as assessed using Spearman correlations with scores of other previously validated measures	The validity of the SPEQ was determined by calculating Spearman correlations between SPEQ and scores of previously validated measures (EQ-5D-5L, SF-12 and SPQ). Scores >0.6 were considered indicative of high validity.	up to 30 weeks