Aims
To identify the minimum set of outcomes that should be collected in clinical practice and reported in research related to the care of children with idiopathic congenital talipes equinovarus (CTEV).
Methods
A list of outcome measurement tools (OMTs) was obtained from the literature through a systematic review. Further outcomes were collected from patients and families through a questionnaire and interview process. The combined list, as well as the appropriate follow-up timepoint, was rated for importance in a two-round Delphi process that included an international group of orthopaedic surgeons, physiotherapists, nurse practitioners, patients, and families. Outcomes that reached no consensus during the Delphi process were further discussed and scored for inclusion/exclusion in a final consensus meeting involving international stakeholder representatives of practitioners, families, and patient charities.
Results
In total, 39 OMTs were included from the systematic review. Two additional OMTs were identified from the interviews and questionnaires, and four were added after round one Delphi. Overall, 22 OMTs reached ‘consensus in’ during the Delphi and two reached ‘consensus out’; 21 OMTs reached ‘no consensus’ and were included in the final consensus meeting. In all, 21 participants attended the consensus meeting, including a wide diversity of clubfoot practitioners, parent/patient representative, and an independent chair. A total of 21 outcomes were discussed and voted upon; six were voted ‘in’ and 15 were voted ‘out’. The final COS document includes nine OMTs and two existing outcome scores with a total of 31 outcome parameters to be collected after a minimum follow-up of five years. It incorporates static and dynamic clinical findings, patient-reported outcome measures, and a definition of CTEV relapse.
Conclusion
We have defined a minimum set of outcomes to draw comparisons between centres and studies in the treatment of CTEV. With the use of these outcomes, we hope to allow more meaningful research and a better clinical management of CTEV.
Principal Investigator: Yael Gelfer, St. George's Healthcare NHS Trust, London, UK; and St George’s University of London, London, UK
Contributors:
Donato Giuseppe Leo, St George’s Healthcare NHS Trust, London, UK;
Deborah M. Eastwood, University College London; and Great Ormond Street Hospital, London, UK;
Daniel C. Perry, Oxford University, Oxford, UK; and University of Liverpool, Liverpool, UK; and Alder Hey Children’s Hospital, Liverpool, UK;
Aishling Russell, St George’s Healthcare NHS Trust, London, UK;
Anna Bridgens, St George’s Healthcare NHS Trust, London, UK
Disease Category: Orthopaedics & trauma
Disease Name: Clubfoot, Congenital talipes equinovarus (CTEV)
Age Range: 0 - 21
Sex: Either
Nature of Intervention: Management of care
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Interview
- Survey