Health economics and quality of life in a feasibility RCT of paediatric acute appendicitis: a protocol study

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 NHS. Investigating alternative treatment options offers not only the best prospect of enhancing the quality of care for patients but also 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 sub-study conducted alongside the CONTRACT feasibility RCT is to better understand and assess: (i) cost data collection tools and cost drivers by identifying patients’ pathways and (ii) patient Quality of Life (QoL) 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 sub-study will use individual-level data and will be conducted from the health system perspective over the study’s 6-month follow-up period. Micro-costing will include health resource and service use, while potential benefits acquired will be measured using the HRQoL measures, CHU-9D and EQ-5D-5L. We will assess the appropriateness of using the cost per QALY framework in the future RCT, as well as testing and identifying the most suitable HRQoL instrument.

Conclusions: The outcomes of the investigational economic sub-study 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 (EEACT) with an emphasis on costing methods of interventions taking place in secondary care settings.

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Identifiers

ORCID for Maria Chorozoglou: orcid.org/0000-0001-5070-4653

ORCID for Isabel Reading: orcid.org/0000-0002-1457-6532

ORCID for Nigel J. Hall: orcid.org/0000-0001-8570-9374

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