- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07782645
Content Validation of a Questionnaire on Sports Activities in Children With Limb Amputation (VESAQ)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Demande
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Saint-Maurice, Demande, Frankrike, 94410
- Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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.
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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%.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Expert Consensus on VESAQ Questionnaire Items
Tidsram: Through completion of the three-round Delphi process, approximately 7 months
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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.
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Through completion of the three-round Delphi process, approximately 7 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Romane RP PIAUD, Institut Merle d'Aubigné
- Studiestol: Mathilde MC CARET, Hôpitaux Paris Est Val-de-Marne (HPEVM)
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VESAQ
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