Patient Reported OutcomesNCT03871920
Psychometric Evaluation of the Short Patient Evaluation Questionnaire
An observational study of Patient Reported Outcomes, run by Nanco van der Maas.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Reported Outcomes
- What is being tested?
- physical therapy treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of the regular patient in full age in physical therapy treatment without a grave other health problems, that may interfere with the result of the treatment with physiotherapy
Who may be able to join
- Persons older than 18 years, that are in physical therapy treatment.
- Persons must be able to read and understand German.
Who cannot join
- Grave cognitive changes
- Bedridden patients
- Grave comorbidities that may interfere with the treatment with physical therapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Multi Center Prospective Cross-sectional and Longitudinal Study to Evaluate the Psychometric Properties of the Short Patient Evaluation Questionnaire
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.
Read the 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.
- Conditions
- Patient Reported Outcomes
- Being tested
- physical therapy treatment
- Keywords
- Physiotherapy, outcomes, therapy quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy treatmentOther
any treatment chosen by treating physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| intervention | any kind of condition treated by physiotherapists, physical therapy treatment is chosen by treating physiotherapist Receives: Other: physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Retest reliability of SPEQ
Intra-Class Correlation coefficient (using a two way random effects model)
Measured: up to 30 weeks
Accuracy of the SPEQ
analysis of accuracy of SPEQ to detect patients who changed in transition question with ROC analysis
Measured: up to 30 weeks
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)
Measured: up to 30 weeks
Secondary outcomes (4)
Inner consistancy
The inner consistency will be calculated with ordinal alpha.
Measured: up to 30 weeks
Construct validity of the SPEQ
Categorial principle component analysis of SPEQ will be performed to asses the construct validity of the SPEQ.
Measured: up to 30 weeks
Responsiveness of the SPEQ
Sensitivity to change will be evaluated using Effect Size, Standardized Mean, Modified standardized Mean and Relative efficiency.
Measured: up to 30 weeks
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.
Measured: up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Reported OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanco van der Maas
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, HES-SO Valais-Wallis, University of Bern
- Responsible party
- Sponsor-investigator, Nanco van der Maas, Institut fuer Physiotherapieforschung
- Investigators
- Nico van der Maas, Principal investigator, Institut für Physiotherapieforschung gmbh, Biel, SwitzerlandMartin Verra, PHD, Principal investigator, Institute of physiotherapy, Insel university hospital, Bern, SwitzerlandRoger Hilfiger, MSc., Principal investigator, HES-SO Valais/Wallis, Leukerbad, SwitzerlandAngela Balsimann Schwarz, MSc., Principal investigator, Bern university of applied sciences, Health professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871920
- Sponsor's protocol ID
- SPEQ
- Status last verified
- Mar 2019
- First submitted
- 15 Aug 2017
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi Center Prospective Cross-sectional and Longitudinal Study to Evaluate the Psychometric Properties of the Short Patient Evaluation Questionnaire
- ClinicalTrials.gov ID
- NCT03871920
- Acronym / sponsor ID
- SPEQ
- Conditions
- Patient Reported Outcomes
- Keywords
- Physiotherapy, outcomes, therapy quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Nanco van der MaasUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, HES-SO Valais-Wallis, University of Bern
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | – | Other: physical therapy treatmentany kind of condition treated by physiotherapists, physical therapy treatment is chosen by treating physiotherapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of the regular patient in full age in physical therapy treatment without a grave other health problems, that may interfere with the result of the treatment with physiotherapy
Key inclusion criteria (2 listed)
- Persons older than 18 years, that are in physical therapy treatment.
- Persons must be able to read and understand German.
Key exclusion criteria (3 listed)
- Grave cognitive changes
- Bedridden patients
- Grave comorbidities that may interfere with the treatment with physical therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapy treatmentany treatment chosen by treating physiotherapist | Other | intervention |
Primary outcome
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)
4 secondary outcomes
Inner consistancy
Time frame: up to 30 weeks
Construct validity of the SPEQ
Time frame: up to 30 weeks
Responsiveness of the SPEQ
Time frame: up to 30 weeks
Validity of the SPEQ as assessed using Spearman correlations with scores of other previously validated measures
Time frame: up to 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nico van der Maas principal investigator
Institut für Physiotherapieforschung gmbh, Biel, Switzerland
Martin Verra, PHD principal investigator
Institute of physiotherapy, Insel university hospital, Bern, Switzerland
Roger Hilfiger, MSc. principal investigator
HES-SO Valais/Wallis, Leukerbad, Switzerland
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Reported Outcomes, run by Nanco van der Maas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nico van der Maas (+41764373695, ipforschung@sunrise.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Retest reliability of SPEQ (time frame: up to 30 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.