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Eur J Pediatr Surg 2024; 34(02): 128-136
DOI: 10.1055/a-2196-1887
Review Article

Development Methodology, Availability, and Implementation of Core Outcome Sets in Pediatric Surgery

Benjamin S.R. Allin  ‡   *
1   National Perinatal Epidemiology Unit, University of Oxford, Oxford, United Kingdom
,
George S. Bethell  ‡   *
2   University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, United Kingdom
,
Nigel J. Hall 
2   University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, United Kingdom
› Author Affiliations Funding G.S.B. was supported by National Institute for Health and Care Research (NIHR) Doctoral Fellowship: NIHR302541.
B.S.R.A. was supported by National Institute for Health and Care Research (NIHR) Health Services Delivery Research grant: NIHR127844.
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Abstract

Core outcome sets (COSs) provide a mechanism to guide researchers and clinicians when deciding which outcomes to report in research related to a specific clinical condition or intervention. The intention behind creating a COS for a specific condition is to improve the reporting of important and meaningful outcomes, thus enhancing the relevance of research. Additionally, a COS helps facilitate comparison of outcomes between different clinical studies and reduces research waste. In this paper, we discuss the availability of COSs in the field of pediatric general surgery. We provide an overview of the methodologies used to develop a COS, including common pitfalls, and finally, we discuss COS uptake and implementation. An understanding of all these aspects is important for researchers considering developing a new COS and for those reading research where a COS has been developed or used within a study. Failure to adequately appreciate the nuances of COS development, in particular, risks fundamental flaws that may jeopardize COS validity and subsequently hinder COS uptake and implementation.

Keywords

core outcome set - pediatric surgery - outcomes - evidence

* These authors contributed equally and retain the first authorship.




Publication History

Received: 16 October 2023

Accepted: 20 October 2023

Accepted Manuscript online:
23 October 2023

Article published online:
28 November 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Allin BSR, Irvine A, Patni N, Knight M. Variability of outcome reporting in Hirschsprung's disease and gastroschisis: a systematic review. Sci Rep 2016; 6 (01) 38969
    Google Scholar
  • 2 Prinsen CAC, Vohra S, Rose MR. et al. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials 2014; 15 (01) 247
    Google Scholar
  • 3 Williamson P, Clarke M. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative: its role in improving Cochrane Reviews. Cochrane Database Syst Rev 2012; (05) ED000041
    Google Scholar
  • 4 Williamson PR, Altman DG, Bagley H. et al. The COMET Handbook: version 1.0. Trials 2017; 18 (Suppl. 03) 280
    Google Scholar
  • 5 Williamson P, Altman D, Blazeby J, Clarke M, Gargon E. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy 2012; 17 (01) 1-2
    Google Scholar
  • 6 Kirkham JJ, Davis K, Altman DG. et al. Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLoS Med 2017; 14 (11) e1002447
    Google Scholar
  • 7 Kirkham JJ, Gorst S, Altman DG. et al; COS-STAP Group. Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement. Trials 2019; 20 (01) 116
    Google Scholar
  • 8 Kirkham JJ, Gorst S, Altman DG. et al. Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS Med 2016; 13 (10) e1002148
    Google Scholar
  • 9 COMET Initiative. 2013 ; (updated September 15, 2023). Accessed on September 15, 2023, at: http://www.comet-initiative.org
    Google Scholar
  • 10 Dodd S, Clarke M, Becker L, Mavergames C, Fish R, Williamson PR. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol 2018; 96: 84-92
    Google Scholar
  • 11 Boers M, Kirwan JR, Wells G. et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol 2014; 67 (07) 745-753
    Google Scholar
  • 12 Boers M, Idzerda L, Kirwan JR. et al. Toward a generalized framework of core measurement areas in clinical trials: a position paper for OMERACT 11. J Rheumatol 2014; 41 (05) 978-985
    Google Scholar
  • 13 Allin BSR, Bradnock T, Kenny S, Kurinczuk JJ, Walker G, Knight M. NETS1HD Collaboration. NETS1HD study: development of a Hirschsprung's disease core outcome set. Arch Dis Child 2017; 102 (12) 1143-1151
    Google Scholar
  • 14 Singendonk MMJ, Rexwinkel R, Steutel NF. et al. Development of a core outcome set for infant gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 2019; 68 (05) 655-661
    Google Scholar
  • 15 Rexwinkel R, van Berge Henegouwen VWA, Singendonk MMJ. et al; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition Motility Working Group. Development of a core outcome set for children aged 1-18 years with gastroesophageal reflux disease. J Pediatr 2022; 245: 129-134.e5
    Google Scholar
  • 16 Allin BSR, Hall NJ, Ross AR, Marven SS, Kurinczuk JJ, Knight M. NETS1G collaboration. Development of a gastroschisis core outcome set. Arch Dis Child Fetal Neonatal Ed 2019; 104 (01) F76-F82
    Google Scholar
  • 17 Sherratt FC, Eaton S, Walker E. et al. Development of a core outcome set to determine the overall treatment success of acute uncomplicated appendicitis in children: a study protocol. BMJ Paediatr Open 2017; 1 (01) e000151
    Google Scholar
  • 18 Sherratt FC, Allin BSR, Kirkham JJ. et al; Appendicitis Core Outcome Set Study Group. Core outcome set for uncomplicated acute appendicitis in children and young people. Br J Surg 2020; 107 (08) 1013-1022
    Google Scholar
  • 19 Bethell GS, Adams S, Johnson T, Hall NJ, Stanton MP. Laparoscopy uptake for paediatric appendicectomy: a comparison of general surgeons versus specialist paediatric surgeons in England from 1997 to 2015. Ann R Coll Surg Engl 2022; 104 (07) 538-542
    Google Scholar
  • 20 Knaapen M, Hall NJ, Moulin D. et al; Pediatric Appendicitis COS Development Group. International core outcome set for acute simple appendicitis in children: results of a systematic review, Delphi study, and focus groups with young people. Ann Surg 2022; 276 (06) 1047-1055
    Google Scholar
  • 21 Kersten CM, Hermelijn SM, Mullassery D. et al. The management of asymptomatic congenital pulmonary airway malformation: results of a European Delphi survey. Children (Basel) 2022; 9 (08) 1153
    Google Scholar
  • 22 Vergote S, De Bie FR, Duffy JMN. et al. Core outcome set for perinatal interventions for congenital diaphragmatic hernia. Ultrasound Obstet Gynecol 2023; 62 (03) 374-382
    Google Scholar
  • 23 Webbe JWH, Duffy JMN, Afonso E. et al. Core outcomes in neonatology: development of a core outcome set for neonatal research. Arch Dis Child Fetal Neonatal Ed 2020; 105 (04) 425-431
    Google Scholar
  • 24 Klerk DH, van Varsseveld OC, Offringa M. et al. Development of an international core outcome set for treatment trials in necrotizing enterocolitis-a study protocol. Trials 2023; 24 (01) 367
    Google Scholar
  • 25 Hassan L, Cortenraad SAM, Rosenberg CBM. et al. Protocol for the development of a core outcome set for the optimisation of treatment and follow-up of patients with an anorectal malformation (ARM): The ARM and OUtcome Review (ARMOUR)-project. BMJ Paediatr Open 2023; 7 (01) e001691
    Google Scholar
  • 26 Thomson D, Allin B, Long A-M, Bradnock T, Walker G, Knight M. Laparoscopic assistance for primary transanal pull-through in Hirschsprung's disease: a systematic review and meta-analysis. BMJ Open 2015; 5 (03) e006063
    Google Scholar
  • 27 Allin B, Ross A, Marven S, J Hall N, Knight M. Development of a core outcome set for use in determining the overall success of gastroschisis treatment. Trials 2016; 17: 360
    Google Scholar
  • 28 Allin B, Aveyard N, Campion-Smith T. et al. What evidence underlies clinical practice in paediatric surgery? A systematic review assessing choice of study design. PLoS ONE 2016; 11 (03) e0150864
    Google Scholar
  • 29 Allin B, Bradnock T, Kenny S, Walker G, Knight M. NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung's disease treatment. Trials 2016; 17 (01) 577
    Google Scholar
  • 30 Knaapen M, Hall NJ, van der Lee JH. et al; Paediatric Appendicitis COS development group. Establishing a core outcome set for treatment of uncomplicated appendicitis in children: study protocol for an international Delphi survey. BMJ Open 2019; 9 (05) e028861
    Google Scholar
  • 31 Hermelijn S, Kersten C, Mullassery D. et al; CONNECT study consortium COS development group, CONNECT study consortium COS development group. Development of a core outcome set for congenital pulmonary airway malformations: study protocol of an international Delphi survey. BMJ Open 2021; 11 (04) e044544
    Google Scholar
  • 32 Vergote S, De Bie F, Bosteels J. et al. Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia. Trials 2021; 22 (01) 158
    Google Scholar
  • 33 Maguire C, Tyack Z, Kimble RM. et al. What to measure in biliary atresia research: study protocol for developing a core outcome set. BMJ Open 2021; 11 (08) e047224
    Google Scholar