Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000154707
Ethics application status
Approved
Date submitted
23/06/2021
Date registered
31/01/2022
Date last updated
31/01/2022
Date data sharing statement initially provided
31/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Translation and validation of Victorian Institute of Sports Assessment for Gluteal Tendinopathy (VISA-G) questionnaire into Italian
Scientific title
Cross-cultural Adaptation and Measurement Properties of an Italian Version of the VISA-G questionnaire for Patients with Greater Trochanteric Pain Syndrome
Secondary ID [1] 304593 0
N/A
Universal Trial Number (UTN)
U1111-1267-0594
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
greater trochanteric pain syndrome 322494 0
Condition category
Condition code
Musculoskeletal 320135 320135 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 320136 320136 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The purpose of the current study was to translate the VISA-G from English into the Italian language (VISA-G-IT), to conduct a cross-cultural adaptation into the Italian context, assessing validity in the Italian context, and to evaluate the VISA-G-IT measurement properties.

Translation procedure for the VISA-G questionnaire
Beaton’s guidelines for the cross-cultural adaptation of self-reported measures were used (Beaton et al., 2000).
In brief:
1. Permission. The developer of the VISA-G Dr. Angie Fearon from University of Canberra was approached by e-mail to requiring both her authorization and her availability to collaborate on the translation process into Italian language of VISA-G questionnaire (Fearon et al., 2015). Dr. Fearon promptly responded by giving us her authorization and willingness to collaborate on our project.
2. Forward translation. The English version of VISA-G will be independently translated into Italian by 2 non-medical professional translators whose native language is English and by a physician whose native language is Italian. Neither of the nonmedical translators are aware of the concepts being investigated or had a medical background.
3. Forward translation - Reconciliation. The 3 Italian translations will be analyzed by a healthcare committee (1 physiatrist, 2 epidemiologists, 1 physiotherapist), which will first ensure that the translations took Italian cultural characteristics into consideration. Discrepancies will be resolved by consensus to achieve conceptual equivalence.
4. Back translation - data acquisition. This consensus version (Italian version 1) will be translated back into English by another non-medical professional translator whose native language is English and that will be blinded to the purpose of the questionnaire and had not seen the original VISA-G questionnaire.
5. Back translation - Reconciliation. The back translated version will be compared to the original version to ensure conceptual equivalence; the remaining discrepancies and ambiguities were resolved between the project manager (AC) and developer (AF)
6. Harmonization. The harmonization group consisted of the back - and forward-translators, and the health committee. At the end the team will agree upon the harmonized version of the Italian VISA-G (VISA-G-IT) questionnaire. All members of the harmonization group will approve the translated versions.
7. Cultural validation. After the committee will confirm the equivalence of the original version and the Italian version of the VISA-G (VISA-G-IT), and the developer will approve the translation, we will perform a pilot test on 10 subjects with a diagnose of GTPS and 10 gender- and age-matched healthy subjects. The main aim of this phase will be to determine whether the subjects understood the questions. Cognitive interviews of 10 patients with a diagnose of GTPS, 10 gender- and age-matched healthy subjects 10 and a researcher and two physiotherapists with relevant clinical experience will conduct to assess the harmonised version of the VISA-G-IT. A researcher trained in cognitive interviewing will conduct these face-to-face interviews maximum 24 hours after each interviewee will completes the VISA-G-IT questionnaire. The time required to complete the questionnaire will take a maximum of 10 minutes, while the interview time will take a maximum of 30 minutes. Each interviewee will be asked whether there were sentences that were difficult to understand. They will be asked what they thought each question meant. The meaning of the items and tasks, as well as the selected responses, will be discussed. This will ensure that the prefinal version will retain adequate equivalence in purpose. All questions should be considered easily understandable by all subjects.
8. Cultural validation - Harmonization. The results from the previous process will be reviewed, and a final version of the VISA-G-IT questionnaire prepared.
9. Final Translation. The version will be proofread and checked for spelling and grammar errors.
10. Assessment of psychometric properties of VISA-G-IT questionnaire. In this phase a sample of convenience will be recruited at a physiotherapy private practice in L'Aquila, Italy. Based on an expected reliability of 0.90, assuming a power of 0.80 and a significance level of
0.05, we calculated that a total sample size of 49 patients with a diagnose of GTPS and 49 gender- and age-matched healthy subjects will be required for the assessment of psychometric properties of VISA-G-IT.
Each patient and each healthy subject will be required to complete the VISA-G-IT and the Italian version of the Harris Hip Score questionnaire (HHS-IT) a first time (test) and then a second time after 3 days (re-test). These will allow to evaluate the psychometric properties (reliability and validity) of the VISA-G-IT questionnaire.
Intervention code [1] 320944 0
Not applicable
Comparator / control treatment
10 ealthy, gender- and age-matched subjects will be involved in a pilot study, with the aim of understanding whether the Italian version of the VISA-G questionnaire is well structured and understandable.
Furthermore, 49 healthy subjects will be involved in the measurement of the psychometric properties of the VISA-G-IT questionnaire.
Both groups of healthy subjects will be recruited from among those attending a gym adjacent to the physiotherapy center where patients diagnosed with GTPS will be recruited.
Control group
Active

Outcomes
Primary outcome [1] 328007 0
Internal consistency will be determined via Cronbach’s alpha with 0 indicating no internal
consistency and 1 corresponding to perfect internal consistency. Internal consistency is considered excellent when the Cronbach alpha equals or exceeds 0.80, adequate when it falls between 0.70 and 0.79, and inadequate when it is lower than 0.70.
Timepoint [1] 328007 0
Baseline
Primary outcome [2] 328008 0
Reproducibility (test-retest reliability) will be calculate by two-way random effects model (2.1), with single measures and absolute agreement ICC, The ICC score, which ranges from 0 to 1, with a value of 1 indicating perfect test-retest reliability, was interpreted as follows: excellent reliability, 0.75 or greater; moderate to good reliability, 0.74 to 0.40; poor reliability, less than 0.40.
Timepoint [2] 328008 0
Baseline (test) and 3 day after baseline (re-test)
Primary outcome [3] 328009 0
Construct Validity Construct validity indicates the extent to which the questionnaire scores correlate with those of other questionnaires intended to measure the same outcome.. Construct validity will be tested by determining the relationship between the overall VISA-G-IT score and the overall HHS score at the initial assessment. .Pearson correlation will be used to examine construct validity. The r values yield the degree of correlation between 2 scores. Pearson correlation coefficients will be interpreted as follows: 0.00 to 0.19, very weak correlation; 0.20 to 0.39, weak correlation; 0.40 to 0.69, moderate correlation; 0.70 to 0.89, strong correlation; 0.90 to 1, very strong correlation.
Timepoint [3] 328009 0
Baseline
Secondary outcome [1] 397227 0
Standard error of measurement (SEM) will be calculate by first creating a variable for the difference between the total VISA-G-IT score that we will obtain during the baseline and the second round (test score—retest score = Difference). We then will calculate the standard deviation (SD) and the SEM of the Difference in the VISA-G-IT (SD Difference), as suggested by the COSMIN guidelines.
Timepoint [1] 397227 0
Baseline (test) and 3 day after baseline (re-test)
Secondary outcome [2] 402246 0
Responsiveness. In this study, we will use 2 distribution-based methods: the effect size (ES) and the standardized response mean (SRM), as well as an anchor-based method, the receiver-operatingcharacteristic (ROC) curve, to assess the responsiveness of the VISA-G-IT and HHS-IT. Changes in the VISA-G-IT and HHS-IT scores following the rehabilitation treatment (6 week from baseline assessment) in comparison with baseline will be assessed using a paired t test. Moreover, at the end of rehabilitation treatment (6 week from baseline assessement), patients with GTPS will be asked: “How are you today compared with your first assessment?”. The 7 response options were (1) “very much worse,” (2) “much worse,” (3) “little worse,” (4) “no change,” (5) “little improved,” (6) “much improved,” and (7) “very much improved.” This measure of change will be used as our external criterion, in the absence of a gold standard, for the evaluation of responsiveness.
The ES will be calculated by dividing the mean change scores of the VISA-G-IT and HHS-IT by the standard deviation of their baseline scores. The SRM will calculated by dividing the mean change scores of the VISA-G-IT and HHS-IT by the standard deviation of their change scores. The ES and SRM scores will be interpreted as follows: 0.2 to 0.4, small; 0.5 to 0.8, moderate; greater than 0.8, large.
The ROC curve will be created by using different cut-off points for change scores, each with a given sensitivity (true positiverate) and specificity (true negative rate). The ROC curve will be constructed by plotting the sensitivity values on the y-axis and 1 minus the specificity values on the x-axis for the different change score values.
The ROC curve will be calculated based on the change in the questionnaire score and the global rating of change score. When plotting the ROC curve, the global rating of change, used as external criterion, will be dichotomized to identify those participants who will experience a clinically meaningful reduction in symptoms. We chose global change
cores of 5 or higher to represent important change and scores of 4 or lower to represent no change. We also will compute the area under the curve (AUC), which can will be interpreted as the probability of correctly identifying an improved patient from randomly selected pairs of patients who have and have not improved. An AUC of 1.0 indicates
perfect discrimination between these 2 health states. A questionnaire that does not discriminate more effectively than chance will have an AUC of 0.50. The AUC of the ROC curve was interpreted as follows: excellent, 0.90 or greater; adequate, 0.89 to 0.70; poor, less than 0.70.
Timepoint [2] 402246 0
Baseline and at the end of rehabilitation treatment (6 weeks from baseline)
Secondary outcome [3] 402247 0
Verbal feedback regarding patients' understanding of the VISA-G-IT questionnaire.
1)" whether there were sentences that were difficult to understand"
The principal investigator review the results from cognitive interview and will identify translation modifications necessary for improvement. Items and response options may will be reworded where respondents’ comments justify such changes
Timepoint [3] 402247 0
baseline
Secondary outcome [4] 402248 0
Verbal feedback regarding patients' understanding of the VISA-G-IT questionnaire.
2. "what they thought each question meant"
The principal investigator review the results from cognitive interview and will identify translation modifications necessary for improvement. Items and response options may will be reworded where respondents’ comments justify such changes
Timepoint [4] 402248 0
Baseline
Secondary outcome [5] 402249 0
Verbal feedback regarding patients' understanding of the VISA-G-IT questionnaire.
3. "the meaning of the items and tasks"
The principal investigator review the results from cognitive interview and will identify translation modifications necessary for improvement. Items and response options may will be reworded where respondents’ comments justify such changes
Timepoint [5] 402249 0
Baseline
Secondary outcome [6] 405552 0
minimal detectable change (MDC), representing the amount of score change beyond measurement error, will be calculate. The MDC represents a score ±1.96 times the SD Difference in the test–retest scores of the VISA-G-IT.
Timepoint [6] 405552 0
Baseline (test) and 3 day after baseline (re-test)

Eligibility
Key inclusion criteria
Subject with greater trochanteric pain syndrome
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Hip osteoarthritis,
Systemic inflammatory disease such as rheumatoid arthritis,
Lumbar spine nerve root findings,
History of lumbar spine or ipsilateral hip joint surgery,
Osteogenic disease such as Paget's disease,
Corticosteroid injection to the ipsilateral hip in the past 3 months,
Hip surgery.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Internal consistency of the will be assessed by means of the Cronbach alpha and 95% confidence intervals, using the data from the baseline questionnaire. Internal consistency is considered excellent when the Cronbach alpha equals or exceeds 0.80, adequate when it falls between 0.70 and 0.79, and inadequate when it is lower than 0.70.
Test-retest reliability will be assessed by The intraclass correlation coefficient (ICC) based on the 2-way random effects analysis of variance. The ICC score, which ranges from 0 to 1, with a value of 1 indicating perfect test-retest reliability, Construct validity was tested by determining the relationship between the overall VISA-G-I questionnaire score and
the overall Harris Hip Score.using the Pearson correlation coefficients in which with 0 indicating no correlation and 1 perfect correlation. Responsiveness will be assessed comparing the VISA-G-I score with a 7-Point Global Rating of Change scale (GROC) after six weeks, measuring the area under the receiver operating characteristics curve (ROC).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 23830 0
Italy
State/province [1] 23830 0

Funding & Sponsors
Funding source category [1] 308957 0
University
Name [1] 308957 0
University of L'Aquila
Country [1] 308957 0
Italy
Primary sponsor type
University
Name
University of L'Aquila
Address
Via Giuseppe Petrini - “Rita Levi Montalcini” Building (Delta 6) - 67100 Coppito-L'Aquila
Country
Italy
Secondary sponsor category [1] 309879 0
None
Name [1] 309879 0
N/A
Address [1] 309879 0
N/A
Country [1] 309879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308844 0
Internal Review Board of the University of L'Aquila
Ethics committee address [1] 308844 0
Ethics committee country [1] 308844 0
Italy
Date submitted for ethics approval [1] 308844 0
Approval date [1] 308844 0
27/03/2021
Ethics approval number [1] 308844 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112094 0
Prof Angelo Cacchio
Address 112094 0
Department of Life, Health & Environmental Sciences
University of L'Aquila
“Rita Levi Montalcini” Building (Delta 6) Via Giuseppe Petrini 67100 Coppito-L'Aquila
Country 112094 0
Italy
Phone 112094 0
+390862434747
Fax 112094 0
Email 112094 0
[email protected]
Contact person for public queries
Name 112095 0
Angelo Cacchio
Address 112095 0
Department of Life, Health & Environmental Sciences
University of L'Aquila
“Rita Levi Montalcini” Building (Delta 6) Via Giuseppe Petrini 67100 Coppito-L'Aquila
Country 112095 0
Italy
Phone 112095 0
+390862434747
Fax 112095 0
Email 112095 0
[email protected]
Contact person for scientific queries
Name 112096 0
Angelo Cacchio
Address 112096 0
Department of Life, Health & Environmental Sciences
University of L'Aquila
“Rita Levi Montalcini” Building (Delta 6) Via Giuseppe Petrini 67100 Coppito-L'Aquila
Country 112096 0
Italy
Phone 112096 0
+390862434747
Fax 112096 0
Email 112096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified participant information data will be available including a/ Baseline demographic information, b/VISA-G-IT questionnaire , c/ HHS-IT Questionnaire d/patient’s overall perceived treatment effectiveness based on 7-point Likert Scale
When will data be available (start and end dates)?
available with no end date
Available to whom?
Only researchers who provide a methodologically motivated and sound proposal, and not aimed at producing similar studies
Available for what types of analyses?
Purpose as agreed to by the prinicipal investigator
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.