Describing the characteristics, treatment pathways, outcomes, and costs of people with persistent noncancer pain managed by community pain clinics and generating an indicative estimate of cost-effectiveness: feasibility study protocol

Shiekha AlAujan,1 Saja AlMazrou,1 Roger D Knaggs,1,2 Rachel A Elliott11Division for Social Research in Medicines and Health, The School of Pharmacy, University of Nottingham, Nottingham, UK; 2Pharmacy Department and Pain Management Service, Nottingham University Hospitals NHS Trust, Nottingham, UKBackground: Low back pain (LBP) and fibromyalgia (FM), also known as chronic widespread pain (CWP), are highly prevalent chronic painful conditions that have substantial impact on patients, health care systems, and society. Diagnosis is complex and management strategies are associated with various levels of evidence for effectiveness and cost-effectiveness. Multidisciplinary pain services have been shown to be effective in some settings and therefore are recommended by clinical practice guidelines as a rational treatment option to manage these patients. Knowing that these services are resource intensive, evidence is needed to demonstrate their cost-effectiveness. This study aims to describe the management of patients with LBP and FM in two community pain clinics to derive an indicative estimate of cost-effectiveness compared with standard practice.Methods: This is a prospective observational multicenter study, using patient-level data. The data from this study will be combined with modelling of the long-term economic impact of community pain clinics in treating people with LBP and FM. Newly referred patients with LBP and FM who provide written consent will be included. We will collect data on functional disability, pain intensity, quality of life, and health resource utilization. Follow-up data at the 3- and 6-month points will be collected by patient-completed questionnaires and health care contact diaries. Health care resource use from diaries will be compared with patient electronic records to assess the agreement between these recording methods. Patient cohort characteristics, treatment pathways, resource use, and outcomes derived from this study will be integrated in a decision analysis model to assess the cost-effectiveness of community pain clinics compared with standard care. This feasibility study will address key methodological issues such as sample estimates and retention rate to inform the design of a future randomized controlled trial.Keywords: community pain clinics, back pain, fibromyalgia, cost-effectivenes