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Content Validation of a Questionnaire on Sports Activities in Children With Limb Amputation (VESAQ)

2026年8月20日 更新者:Hopitaux de Saint-Maurice

Content Validation of the VESAQ Questionnaire on Sports Activities in Children With Limb Amputation Using a Delphi Method

The VESAQ study aims to validate the content of a questionnaire designed to assess sports participation in children with limb amputation. Content validation was conducted using a three-round Delphi method involving a multidisciplinary panel of adult experts with professional or experiential expertise relevant to pediatric limb amputation, rehabilitation, prosthetic management, and adapted physical activity.

Children with limb amputation are the future target population of the questionnaire but did not participate in this content-validation study, and no individual medical data from pediatric patients were collected.

The Delphi process aimed to establish expert consensus on the relevance and clarity of the questionnaire content and to produce a final consensual version of the VESAQ.

調査の概要

状態

完了

条件

詳細な説明

The VESAQ (Questionnaire on Sports Activities in Children With Limb Amputation) was developed to provide a structured and multidimensional tool for assessing sports participation in children with limb amputation. The questionnaire addresses dimensions related to limb amputation, prosthetic devices when applicable, sports participation, functional limitations, barriers and facilitators, family, school and sports environments, the child's experience, and the support provided.

Content validation was conducted using a three-round Delphi process involving a multidisciplinary panel of adult experts with relevant professional or experiential expertise in the field of pediatric limb amputation, rehabilitation, prosthetic management, and adapted physical activity.

During the successive Delphi rounds, participants assessed proposed domains and questionnaire items using Likert scales and could provide qualitative comments and suggestions for reformulation. Following each round, responses were analyzed and the questionnaire was progressively revised to improve the clarity, relevance, and organization of its items.

Consensus was predefined as a median score of at least 4, an interquartile range of 1 or less, and an agreement rate of at least 70%. The first Delphi round focused on the main questionnaire domains, the second round evaluated the proposed items in greater detail, and the third round aimed to stabilize consensus and finalize the questionnaire.

A total of 26 experts were included in the study, of whom 23 participated through the end of the third Delphi round. Children with limb amputation did not participate in this content-validation study, and no individual medical data from pediatric patients were collected.

The objective of the study is to establish a final consensual version of the VESAQ based on the Delphi results. This content-validation phase is intended as a methodological step before subsequent studies evaluating the psychometric properties of the questionnaire, including its validity, reliability, reproducibility, and responsiveness to change.

研究の種類

観察的

入学 (実際)

26

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Demande
      • Saint-Maurice、Demande、フランス、94410
        • Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

Adult experts with professional or experiential expertise relevant to pediatric limb amputation, rehabilitation, prosthetic management, and adapted physical activity. Participants were recruited to form a multidisciplinary expert panel for the content validation of the VESAQ questionnaire using a three-round Delphi process.

説明

Inclusion Criteria:

  • Healthcare professionals or other specialists involved in the care or support of children with limb amputation, including physical and rehabilitation medicine physicians, physiotherapists, prosthetists and orthotists, occupational therapists, adapted physical activity professionals, and sports educators.
  • Patient experts.
  • At least one year of experience in the field of pediatrics, limb amputation, and/or prosthetic management.
  • Willingness to participate in the Delphi process and to provide informed consent and agree to confidentiality requirements

Exclusion Criteria:

  • Refusal or withdrawal of consent for the use of study data.
  • Non-participation in the Delphi rounds or prolonged disengagement from the Delphi process.
  • Conflict of interest related to the validation of the questionnaire, including authorship of the VESAQ or commercial involvement.
  • Minors.
  • Individuals under legal protection or unable to provide informed consent.

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
介入・治療
Multidisciplinary Expert Panel
Adult experts with professional or experiential expertise relevant to pediatric limb amputation, rehabilitation, prosthetic management, and adapted physical activity participated in a three-round Delphi process to assess the relevance and clarity of the VESAQ questionnaire content and establish expert consensus.
Participants completed three successive Delphi rounds to evaluate the domains and items of the VESAQ questionnaire. Items were rated using Likert scales for relevance and clarity, with the possibility of providing qualitative comments and suggestions for reformulation. After each round, responses were analyzed using predefined consensus criteria, and the questionnaire was progressively revised. Consensus was defined as a median score of at least 4, an interquartile range of 1 or less, and an agreement rate of at least 70%.

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
Expert Consensus on VESAQ Questionnaire Items
時間枠:Through completion of the three-round Delphi process, approximately 7 months
Expert consensus on the content of the VESAQ questionnaire, assessed using Likert-scale ratings. Consensus for an item was defined as a median rating of at least 4, an interquartile range of 1 or less, and an agreement rate of at least 70%, with agreement defined as the proportion of ratings of 4 or higher.
Through completion of the three-round Delphi process, approximately 7 months

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:Romane RP PIAUD、Institut Merle d'Aubigné
  • スタディチェア:Mathilde MC CARET、Hôpitaux Paris Est Val-de-Marne (HPEVM)

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 (実際)

2025年9月28日

一次修了 (実際)

2026年4月9日

研究の完了 (実際)

2026年4月9日

試験登録日

最初に提出

2026年8月20日

QC基準を満たした最初の提出物

2026年8月20日

最初の投稿 (実際)

2026年8月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月24日

QC基準を満たした最後の更新が送信されました

2026年8月20日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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