The outcomes of Perthes ’ disease of the hip: a study protocol for the development of a core outcome set

This study aims to summarise the outcomes used in clin ical research of interventions for Perthes’ disease and define a set of core outcomes (COS) to ensure that the variables of primary importance are measured and reported in future research studies investigating Perthes’ disease.MethodsA systematic review of the current literature will be used to identify a list of outcomes reported in previous studies. Additional important outcomes will be sought by interviewing a group of children with Perthes ’ disease, adults who were treated with the disease in infancy and parents of children with the disease. This list will then be evaluated by experts in Perthes’ disease using a Delphi survey divided into two rounds to ascertain the importance of each outcome. The final outcomes list obtained fro m the Delphi survey will be then discussed during a consensus meeting of representative key stakeholders in order to define the COS to be reported in future clinical trials related to Perthes’ disease.DiscussionThe absence of high-quality research and clear guidelines concerning the management of Perthes ’ disease is, at least in part, due to the difficulties in the comparing the results from previous studies. The development of a COS seeks to standardise outcomes collected in future research studies to enable comparisons between studies to be made and to facilitate meta-analyses of results.Trial registrationCore Outcome Measures in Effectiveness Trials Initiative (COMET),1003. R...
Source: Trials - Category: Research Source Type: clinical trials