Defining a core outcome set for hypermobility spectrum disorders and hypermobile Ehlers-Danlos syndrome: A Delphi consensus study

The reported prevalence of hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos Syndrome (hEDS) is unclear due to complex presentations and lack of awareness amongst professionals, contributing to diagnostic and management uncertainties. Standardising an outcome measure to assess symptoms most important to patients should help determine the impact of interventions. This Delphi study aims to reach a consensus with stakeholders on the core outcome set for children and adults with HSD/hEDS. A three-round modified Delphi consensus study with a follow-up consensus meeting was used. Stakeholder groups consisted of (1) individuals with HSD/hEDS; (2) family/friends/carers and (3) healthcare professionals. Participants could belong to more than one stakeholder group. They rated 74 symptoms using a 9-point Likert scale: 1 “not important to 9 “critically important”. Symptoms achieving a consensus rating of?=?70.0% critical importance across all groups were included. In Round 1, 766 responses were received from 600 participants, reducing to 566 responses from 438 participants by Round 3, with 53 participating in the consensus meeting. Overall, 30 symptoms met the?=?70.0% critically important threshold to be included in the final core outcome set. These were categorised under the specialties of musculoskeletal and orthopaedics, social, pain, gynaecology and urology, negative affect, neurological, gastrointestinal and “other”. This study is the first to identify by consensus the core outcome set to be measured for patients with HSD/hEDS. The importance of these outcomes was confirmed by individuals living with the condition, their family, friends, carers and relevant healthcare professionals.

Contributors

Natalie L. Clark, Melissa Johnson, Amar Rangan, Lucksy Kottam, Andrea Hogarth, Sarah Scott & Katherine Swainston

Publication

Journal: Clinical Rheumatology
Volume: 43
Issue:
Pages: -
Year: 2024
DOI: 10.1007/s10067-024-07172-3

Further Study Information

Current Stage: Completed
Date: July 2023 - November 2024
Funding source(s): Stage 1 of this Delphi consensus study received a small internal £500 research grant from the co-author KS based at Newcastle University to support the five £100 vouchers to incentivise participants to complete the three rounds.


Health Area

Disease Category: Rheumatology

Disease Name: Hypermobility Spectrum Disorders, Ehlers-Danlos syndrome

Target Population

Age Range: 16

Sex: Either

Nature of Intervention: N/A

Stakeholders Involved

- Charities
- 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

This study aims to reach a consensus with key stakeholders of the COS that should be measured and reported for adults and children with HSD and EDS (Stage 1). Following this consensus, the study will then also aim to reach a consensus on the most appropriate measurement instruments for the COS (Stage 2).

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