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Establishing a core outcome set for treatment of uncomplicated appendicitis in children: study protocol for an international Delphi survey

Establishing a core outcome set for treatment of uncomplicated appendicitis in children: study protocol for an international Delphi survey
Establishing a core outcome set for treatment of uncomplicated appendicitis in children: study protocol for an international Delphi survey
Introduction: appendicitis is a global disease affecting roughly 1 in every 12 people in the world, with the highest incidence between ages 10 and 19 years. To date, a wide variety of health outcomes have been reported in randomised controlled trials and meta-analyses evaluating treatments for appendicitis. This is especially the case in studies comparing non-operative treatment with operative treatment. A set of standard outcomes, to be reported in all future trials, is needed to allow for adequate comparison and interpretation of clinical trial results and to make data pooling possible. This protocol describes the development of such a global core outcome set (COS) to allow unified reporting of treatment interventions in children with acute uncomplicated appendicitis.

Methods and analysis: we use current international standard methodology for the development and reporting of this COS. Its development consists of three phases: (1) an update of the most recent systematic review on outcomes reported in uncomplicated paediatric appendicitis research to identify additional outcomes, (2) a three-step global Delphi study to identify a set of core outcomes for which there is consensus between parents and (paediatric) surgeons and (3) an expert meeting to finalise the COS and its definitions. Children and young people will be involved through their parents during phase 2 and will be engaged directly using a customised face-to-face approach.

Ethics and dissemination: the medical research ethics committee of the Academic Medical Center Amsterdam has approved the study. Each participating country/research group will ascertain ethics board approval. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at (international) conferences.

Trial registration number COMET registration: 1119.
2044-6055
1-9
Hall, Nigel
6919e8af-3890-42c1-98a7-c110791957cf
Knaapen, Max
794a6ae2-d3dc-4bae-a0f9-deea86550efb
Van Der Lee, J.
f60a360c-090d-41cd-93e5-ca16fd387e7d
Butcher, N.
23dd5e18-f85e-4bfc-99e0-45d81e13cc9d
Offringa, M
d15e3997-cb4d-408d-aa41-eb5b1aef1abf
Van Heurn, Ernest
3f67cfb3-da9a-484a-b2af-ce52bef6f97d
Bakx, R.
935964ca-c3bc-4403-9428-57ce19f26219
Gorter, R.
6f3fc84c-0969-4e87-9f1a-c7887cdf511b
Hall, Nigel
6919e8af-3890-42c1-98a7-c110791957cf
Knaapen, Max
794a6ae2-d3dc-4bae-a0f9-deea86550efb
Van Der Lee, J.
f60a360c-090d-41cd-93e5-ca16fd387e7d
Butcher, N.
23dd5e18-f85e-4bfc-99e0-45d81e13cc9d
Offringa, M
d15e3997-cb4d-408d-aa41-eb5b1aef1abf
Van Heurn, Ernest
3f67cfb3-da9a-484a-b2af-ce52bef6f97d
Bakx, R.
935964ca-c3bc-4403-9428-57ce19f26219
Gorter, R.
6f3fc84c-0969-4e87-9f1a-c7887cdf511b

Hall, Nigel, Knaapen, Max, Van Der Lee, J., Butcher, N., Offringa, M, Van Heurn, Ernest, Bakx, R. and Gorter, R. (2019) Establishing a core outcome set for treatment of uncomplicated appendicitis in children: study protocol for an international Delphi survey. BMJ Open, 9 (5), 1-9. (doi:10.1136/bmjopen-2018-028861).

Record type: Article

Abstract

Introduction: appendicitis is a global disease affecting roughly 1 in every 12 people in the world, with the highest incidence between ages 10 and 19 years. To date, a wide variety of health outcomes have been reported in randomised controlled trials and meta-analyses evaluating treatments for appendicitis. This is especially the case in studies comparing non-operative treatment with operative treatment. A set of standard outcomes, to be reported in all future trials, is needed to allow for adequate comparison and interpretation of clinical trial results and to make data pooling possible. This protocol describes the development of such a global core outcome set (COS) to allow unified reporting of treatment interventions in children with acute uncomplicated appendicitis.

Methods and analysis: we use current international standard methodology for the development and reporting of this COS. Its development consists of three phases: (1) an update of the most recent systematic review on outcomes reported in uncomplicated paediatric appendicitis research to identify additional outcomes, (2) a three-step global Delphi study to identify a set of core outcomes for which there is consensus between parents and (paediatric) surgeons and (3) an expert meeting to finalise the COS and its definitions. Children and young people will be involved through their parents during phase 2 and will be engaged directly using a customised face-to-face approach.

Ethics and dissemination: the medical research ethics committee of the Academic Medical Center Amsterdam has approved the study. Each participating country/research group will ascertain ethics board approval. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at (international) conferences.

Trial registration number COMET registration: 1119.

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Accepted/In Press date: 17 April 2019
Published date: 22 May 2019

Identifiers

Local EPrints ID: 431093
URI: http://eprints.soton.ac.uk/id/eprint/431093
ISSN: 2044-6055
PURE UUID: 179de61b-01de-4080-af8a-46263eabb0ce
ORCID for Nigel Hall: ORCID iD orcid.org/0000-0001-8570-9374

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Date deposited: 23 May 2019 16:30
Last modified: 16 Mar 2024 04:06

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Contributors

Author: Nigel Hall ORCID iD
Author: Max Knaapen
Author: J. Van Der Lee
Author: N. Butcher
Author: M Offringa
Author: Ernest Van Heurn
Author: R. Bakx
Author: R. Gorter

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