Core Outcome Measures in Effectiveness Trials

Towards developing a core outcome set for the assessment of Congenital Talipes Equinovarus (CTEV)

General Information

Congenital Talipes Equinovarus (CTEV) or Clubfoot is one of the most common congenital foot abnormalities worldwide, occurring in around 1 in 1000 live births. Although some quantitative measures exist to assess the severity of clubfoot at birth (ie. Pirani score, Dimeglio score) - there is no clear definition on what is a ‘corrected’ and ‘relapsed’ clubfoot. There is a wide variety of reporting standards in the literature, and sometimes a complete absence of clear definition around corrected and relapsed clubfeet.

This systematic review aims to establish a core outcome set (COS) on the definition of CTEV at birth, at correction and at relapse. A COS is defined as “the minimum that should be measured and reported in all clinical trials of a specific condition, and are also suitable for use in clinical audit or research other than randomised trials”

We feel this will be helpful to establish a global consistency in the way Clubfoot is assessed and reported in the global literature, and subsequently improve the quality of research done in this important area.

Principal Investigator: Yael Gelfer, St. George's Hospital Paediatric Orthopaedic Department, London, UK

Contributors: Katie Hughes and Andreas Fontalis, St. George's Hospital Paediatric Orthopaedic Department, London, UK

Further Study Information

Current Stage:
March 2018 - August 2018
Funding source(s):

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Congenital talipes equinovarus (CTEV)

Target Population

Age Range
0 - 21


Nature / type of Intervention


Systematic review

A systematic review of current literature on CTEV to assess the current definition of CTEV at birth, at correction and at relapse.

Stakeholders Involved


Study Type

Systematic review of outcomes measured in trials

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