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 nonoperative
treatment pathway for the treatment of acute
uncomplicated appendicitis in children.
Methods: The economic substudy will use individuallevel
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 (CHU9D)
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