Pediatric Core Outcome Set for AMC: An International Multi-Stakeholder Consensus Study

Multiphasic development of a core outcome set specifically for pediatric AMC, with contributions from international clinicians, caregivers and individuals with lived experience.

Founded on a mixed methods approach in adherence with Core Outcome Set—STAndards for Development (COS-STAD) recommendations. The COS-STAR checklist will be utilized to ensure a complete and transparent reporting of the results for varied knowledge users.


Contributors

Naomi Zukerman

Supervised by Dr Noemi Dahan Oliel and Vasiliki Betty Darsaklis, Shriners Hospitals for Children Canada/ McGill University (Montreal, Quebec, Canada).

Further Study Information

Current Stage: Ongoing
Date: January 2025 - December 2026
Funding source(s): Shriners Hospitals for Children


Health Area

Disease Category: Child health

Disease Name: Arthrogryposis multiplex congenita (AMC)

Target Population

Age Range: 0 - 18

Sex: Either

Nature of Intervention: Rehabilitation

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Patient/ support group representatives
- Researchers
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Semi structured discussion
- Survey


Brief Overview of Phases:

Preliminary concepts were established based on a series of investigations involving clinicians, researchers, youth with AMC and their caregivers; Knowledge exchange day focus groups with clinicians and researchers (2016), interviews with clinicians and caregivers (2016), focus groups with AMC support group members (AMCSI 2017), and an international clinician survey for current clinical practices (Cachecho, 2021).

Over 30 pediatric outcome measures were then mapped to the ICF and to 16 consensus-based rehabilitation recommendations for children with AMC (Dahan-Oliel, Under Review 2025). Based on inclusion/ exclusion criteria, 5 outcome measures were selected to be reviewed by an expert panel consisting of international clinicians and individuals with lived experience.

In Phase 1, the expert panel was asked to evaluate the preliminary concepts, complete an initial appraisal of the selected outcome measures, and recommend additional measures if needed.

Phase 2 will entail detailed item mapping of the selected outcome measures by expert clinicians using ICF principles and Cosmin Guidelines.

For Phase 3, based on the initial clinical consultation and ICF mapping, a core outcome set will be defined, in conjunction with the 11 COS-STAD guidelines.

From this point, Phase 4 will consist of a combination of Modified Delphi rounds, expert panel meetings (up to 3), and focus groups. Invited participants in the Delphi rounds will represent clinical and lived experience from a diverse international group (varying levels of severity, geographical locations and practice contexts). From this phase, we expect to formulate a COS for children with AMC as well as potential methods for dissemination/ knowledge translation to best reach varied communities.

Finally, Phase 5 will introduce an external panel for appraisal of core outcome set via COS-STAD guidelines.

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