Cross-cultural Adaptation and Validation of the Ankle Osteoarthritis Scale (AOS) for Use in French-speaking Populations

Ankle Osteoarthritis Clinical Trial

Official title:

Cross-cultural Adaptation and Validation of the Ankle Osteoarthritis Scale (AOS) for Use in French-speaking Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508233
• Other study ID #: 09-130
• Status: Completed
• Phase: N/A
• First received: July 22, 2015
• Last updated: July 22, 2015
• Start date: September 2009
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministère santé et services sociaux du Québec
• Study type: Observational

Clinical Trial Summary

Many recent randomised multi-centre trials have used the AOS and the involvement of the French-speaking population is limited by the absence of a French version. The goal of our study was to develop a French version and validate the psychometric properties to assure equivalence to the English original.

Description:

Power and sample size calculation The required number of patients has been estimated based on qualities to assess. The reproducibility (test-retest) of the questionnaire is one of the main properties and assess the lower acceptable limit is .85. However, knowing that the reproducibility of the English version was .97, the investigators estimated that the French version would be at least .90. A sample of 10 patients would be sufficient to obtain a power of 99% with a reproducibility of .901,9. Regarding validity, the investigators wish to obtain a statistically significant correlation with the three selected tests. The investigators hypothesized that the lowest correlation between the AOS-Fr and the SF-36 questionnaire would provide the lowest correlation, because the SF-36 is not specific to ankle OA. By estimating an average correlation of .50, 30 patients are required to obtain a significant correlation with a power of 80% and p < .051,9.

Translation The study was approved by a local ethics committee (protocol #09-130). Following the guidelines for the cross cultural adaptation process written by the American Association of Orthopaedic Surgeons (AAOS) in 2000, the translation was performed using this six-step process 2: 1) Initial translation; 2) Synthesis; 3) Back translation; 4) Expert committee; 5) Test of the Pre-final version; and 6) Submission of document to the developer. For the "Initial translation", two independent translators whose mother tongue was French translated the scale from English to French. The second step of "Synthesis" required these two translators to meet, discuss and compose a synthesised version of the AOS. Two independent translators, blind to the original scale, whose mother tongue was English, translated the synthesised version back to English. An "Expert committee" composed of a linguist, two orthopaedic surgeons and the four translators revised the whole process and consolidated the pre-final version. The "Test of the Pre-final version" was performed using 60 subjects, with no ankle osteoarthritis, who answered the questionnaire and evaluated their comprehension of each item. From the data collected in this step, some sections of the test were changed to improve comprehension and readability. For the final step the investigators submitted the corrected version to Dr. Charles Saltzman, the developer of the English version, who approved its translation and use (Supplementary data 1).

Evaluation of psychometric properties In order to validate the use of the French AOS version, the investigators set out to evaluate the psychometric properties of the test on ankle osteoarthritis patients using the same process as the original study validating the English version of the AOS 6. Patients with isolated ankle degenerative changes at the orthopaedic outpatient clinic of the Centre Hospitalier Universitaire de Sherbrooke (CHUS) were included. To be included, patients had to consider French as their mother tongue and be able to read and write in French. Patients under 18 years old and those with additional foot and/or ankle pathologies were excluded.

At the first visit, socio-demographic data (age, sex, BMI, occupation) and pertinent past medical history (Diabetes, neuropathy, ankle or foot fractures)) were collected and patients were asked to perform single heel lift tests of both affected and unaffected side. The participants completed three questionnaires: AOS-French version, SF-36, and WOMAC. Criterion validity was assessed by comparing the AOS to the WOMAC and the SF-36 scores. Construct validity was established by the examination of the correlation between the AOS scores and the single heel lift test. Finally, to measure test-retest reliability, the patient was asked to complete the AOS a second time and a small questionnaire detailing any modification to the treatment (shoes, orthotics, medication, surgery, injection) one week following the first visit and return it by mail. Any modification to their treatment between the completion of the two AOS questionnaires would nullify the test-retest reliability, so these patients would be excluded in the analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Healthy subjects

Inclusion Criteria:

• 18 years of age and over

• French as their mother tongue

• able to read and write in French

Exclusion Criteria:

• foot and/or ankle pathologies

OA group

Inclusion Criteria:

• 18 years of age and over

• isolated ankle degenerative changes

• French as their mother tongue

• able to read and write in French

Exclusion Criteria:

• additional foot and/or ankle pathologies

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Osteoarthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability	test-retest of AOS-Fr	1 week	No
Primary	Criterion validity	Correlation of AOS-Fr and SF-36 and WOMAC scores	1 day	No
Primary	Construct validity	Correlation of AOS-Fr and single heel-lift	1 day	No