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. 2018 Jul 13;19(1):374.
doi: 10.1186/s13063-018-2695-3.

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

Donato Giuseppe Leo  1 , Wei Yee Leong  2 , Tina Gambling  3 , Andrew Long  4 , Rebecca Murphy  1 , Helen Jones  1 , Daniel Christopher Perry  5
Affiliations

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

Donato Giuseppe Leo et al. Trials. .

Abstract

Background: Perthes' disease is an idiopathic osteonecrosis of a developmental hip that is most frequent in Northern Europe. Currently, the absence of a common set of standardised outcomes makes comparisons between studies of different interventions challenging. This study aims to summarise the outcomes used in clinical 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.

Methods: A 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 from 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.

Discussion: The 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 registration: Core Outcome Measures in Effectiveness Trials Initiative (COMET), 1003 . Registered on 20 July 2017. Prospero International Prospective Register of Systematic Reviews, CRD 42017069742 . Registered on 10 July 2017.

Keywords: Consensus outcomes; Core outcomes set; Delphi; Legg-calve-Perthes’ disease; Perthes’ disease.

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Conflict of interest statement

Ethics approval and consent to participate

Consultation with the Health Research Authority deemed this study a service evaluation project with no requirement for ethical approval (reference 60/89/81).

Competing interests

None of the authors has any competing interests. Any competing interests relating to any external reviewers will be declared in the final report. All correspondence should be sent to the team lead(s).

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schematic of the interview process
Fig. 2
Fig. 2
Schematic summary of Delphi Survey Process
See this image and copyright information in PMC

References

    1. Perry DC, Skellorn PJ, Bruce CE. The lognormal age of onset distribution in Perthes’ disease: an analysis from a large well-defined cohort. J Bone Joint Surg Br. 2016;98(5):710–114. doi: 10.1302/0301-620X.98B5.36453. - DOI - PubMed
    1. Perry DC, Bruce CE, Pope D, Dangerfield P, Platt MJ, Hall AJ. Comorbidities in Perthes’ disease: a case control study using the general practice research database. J Bone Joint Surg Br. 2012;94(12):1684–1689. doi: 10.1302/0301-620X.94B12.29974. - DOI - PubMed
    1. Perthes’ WO. Disease in Norway a prospective study on 425 patients. Acta Orthop Suppl. 2009;80(333):1–44. - PubMed
    1. Perry D, Bruce C. Hip disorders in childhood. Surgery. 2011;29(4):181–186.
    1. Perry D, Hall A. The epidemiology and etiology of Perthes’ disease. Orthop Clin. 2011;42(3):279–283. doi: 10.1016/j.ocl.2011.03.002. - DOI - PubMed

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