Chronic Headache Education and Self-management Study (CHESS) : Health Economics Analysis Plan [v2.0]

Abstract

Objective The Chronic Headache Education and Self-management Study (CHESS) is a multicomponent programme of interlocking studies funded by an NIHR programme grant to develop an education and self-management support intervention for people living with chronic headache (here in referred to as the CHESS intervention) and assess its clinical and cost- effectiveness in a randomised controlled trial. This analysis plan relates to the economic evaluation of the CHESS intervention using data from the two-arm multi-centre randomised controlled trial component of the CHESS programme. The within-trial economic evaluation will aim to estimate the cost-effectiveness of the CHESS intervention compared with best supportive care over the 12-month trial period of follow-up. The purpose of the health economics analysis plan is to outline an explicit framework of methods that will be used to analyse the health economic data in a robust manner. The document has been written based on information contained in the trial protocol version 3.7 dated on 19.Sep.2019. Background rationale Chronic headaches present a major problem both for the individual and society. Previous studies on supportive self-management interventions in this population have largely been small studies with short term follow-up, they often did not report clinically relevant outcomes, or were conducted in different healthcare systems therefore difficult to translate into an NHS setting. These studies also did not necessarily focus on chronic headache but rather looked at headache with no frequency specified. Based on the results of our systematic review there may be potential for large gain through a combination of self-management education and appropriate use of prophylaxis and management of medication overuse headache in a chronic headache population. In order to develop the evidence base needed for self-management intervention for chronic headache there needs to be a carefully developed, piloted and evaluated intervention package which has been supported by good qualitative work on understanding outcomes of interest. There is therefore the need for a robust clinical and cost-effectiveness trial within an NHS setting. Objectives The objective is to answer the question: Amongst adults with chronic headache arising from migraine, chronic tension type headache or medication overuse headache, is the provision of a self-management support programme in addition to best usual NHS care clinically and cost effective

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