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Protocol
Health economics and quality of life in a feasibility RCT of paediatric acute appendicitis: a protocol study
  1. Maria Chorozoglou1,
  2. Isabel Reading2,
  3. Simon Eaton3,
  4. Natalie Hutchings4,
  5. Nigel J Hall5,6
  1. 1Southampton Health Technology Assessment Centre (SHTAC), Faculty of Medicine, University of Southampton, Southampton, UK
  2. 2Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK
  3. 3Developmental Biology & Cancer Programme, UCL Great Ormond Street Institute of Child Health, London, UK
  4. 4Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, UK
  5. 5Department of Paediatric Surgery and Urology, Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK
  6. 6University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK
  1. Correspondence to Maria Chorozoglou; M.Chorozoglou{at}soton.ac.uk

Abstract

Background Acute appendicitis is one of the most common acute surgical emergencies in children and accounts for an annual cost of approximately £50 million to the National Health Service. Investigating alternative treatment options offers the best prospect of enhancing the quality of care for patients and potential opportunities for cost savings through better allocative efficiency. A feasibility randomised controlled trial (RCT) comparing a non-operative treatment pathway with appendicectomy for children with acute uncomplicated appendicitis is underway (CONTRACT feasibility RCT).

Aims The prime objective of this economic substudy conducted alongside the CONTRACT feasibility RCT is to better understand and assess: (1) cost data collection tools and cost drivers by identifying patients’ pathways and (2) patient quality of life by assessing alternative paediatric health-related quality of life (HRQoL) instruments. Outcomes from this study will inform a future efficacy RCT assessing the effectiveness and cost-effectiveness of non-operative treatment pathway for the treatment of acute uncomplicated appendicitis in children.

Methods The economic substudy will use individual-level data and will be conducted from the health system perspective over the study’s 6-month follow-up period. Microcosting will include health resource and service use, while potential benefits acquired will be measured using the HRQoL measures, Child Health Utility 9D (CHU-9D) and Euroqol-5 dimensions and 5 levels (EQ-5D-5L). We will assess the appropriateness of using the cost per quality-adjusted life year framework in the future RCT, as well as testing and identifying the most suitable HRQoL instrument.

Conclusions The outcomes of the investigational economic substudy will be used to inform the design of our future definitive RCT. However, the result from this economic study will also provide a detailed description and account of the issues inherent in paediatric Economic Evaluations Alongside Clinical Trials with an emphasis on costing methods of interventions taking place in secondary care settings.

Trial registration number ISRCTN1583043.

  • health economics
  • paediatric surgery
  • costing

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjpo-2018-000347

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    Footnotes

    • Contributors The lead health economist (MC) designed the Health Economic Analysis Plan and prepared this manuscript; the lead statistician (IR) contributed to the design of the study; the principal investigator (NH) is involved in all aspects of the study; all coauthors contributed to the preparation and approval of this manuscript.

    • Funding The authors acknowledge funding received from the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Board (14/192/90).

    • Competing interests None declared.

    • Patient consent Patient/parent/gardian consent obtained.

    • Ethics approval The study, including the economic substudy, has been approved by the South Central – Hampshire A Research Ethics Committee (16/SC/0596).

    • Provenance and peer review Not commissioned; internally peer reviewed.