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

2015年7月22日 更新者:Frederic Balg、Université de Sherbrooke
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.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

観察的

入学 (実際)

34

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

The "Test of the Pre-final version" will be performed using subjects with no ankle osteoarthritis who will answer the questionnaire and evaluate their comprehension of each item.

Patients with isolated ankle degenerative changes at the orthopaedic outpatient clinic of the Centre Hospitalier Universitaire de Sherbrooke (CHUS) will be used to validate the questionnaire. Patients have 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 will be excluded.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
Control
Healthy subjects (without ankle osteoarthritis) for validation of translation
ankle OA
Ankle osteoarthritis patients to ensure validity of translated scale

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Reliability
時間枠:1 week
test-retest of AOS-Fr
1 week
Criterion validity
時間枠:1 day
Correlation of AOS-Fr and SF-36 and WOMAC scores
1 day
Construct validity
時間枠:1 day
Correlation of AOS-Fr and single heel-lift
1 day

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Frédéric Balg, MD、Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke
  • 主任研究者:Magalie Angers, MD、Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年9月1日

一次修了 (実際)

2015年1月1日

研究の完了 (実際)

2015年1月1日

試験登録日

最初に提出

2015年7月22日

QC基準を満たした最初の提出物

2015年7月22日

最初の投稿 (見積もり)

2015年7月24日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年7月24日

QC基準を満たした最後の更新が送信されました

2015年7月22日

最終確認日

2015年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 09-130

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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