Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care

Abstract

Introduction:Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS).Methods and analysis:A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l’Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. Analysis: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out.Ethics and dissemination:This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals.Trial registration:Clinical-Trials.gov: NCT04049006.

Cost–utility analysis of a multicomponent intervention for fibromyalgia syndrome in primary care versus usual clinical practice: study protocol for an economic evaluation of a randomised control trial

“…This study aims to perform a CUA on an MI consisting of health education, physical activity, and cognitive-behavioural therapy, for patients with FMS compared with their treatment under usual clinical care (UCC), 33 provided within the 11 primary care centres of the Gerència Territorial Terres de L’Ebre of the Institut Català de la Salut, Spain. The results of this economic assessment are expected to support the evidence of the randomised clinical trial (RCT) related to this project 34 (ClinicalTrials.gov: NCT04049006). 35 It is hoped that this new proposed intervention will reinforce the UCC, enhance patients’ QOL, and promote the efficient allocation of health and social resources.…”

Інформаційне Забезпечення Доказового Ведення Пацієнтів З Ураженнями Кістково-М’язової Системи В Первинній Ланці Охорони Здоров’я

“…The results allowed Whittaker G.A. et al (2019) to establish a GC benefit while comparing them to either autologous blood injection or pain-reducing foot orthoses in the short term (0-6 weeks), but not in the medium term (7-12 weeks). As to the longer term (13-52 weeks), GCs were less effective than dry needle or plateletrich plasma injections.…”

“…Next paper from the «Primary care» TRIP category is written by Dakin P. et al (2019); it presents the doubleblind RCT results on «efficacy, tolerability, and joint safety» of using fasinumab, i.e. anti-nerve growth factor monoclonal antibody, for moderate-to-severe hip or knee pain related to OA with an inadequate response or intolerance to analgetics.…”

“…The website announced an update of the 2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada, the protocol for a «systematic reviewing of direct evidence on the effectiveness and acceptability of screening adults 40 years and older in primary care to reduce fragility fractures and related mortality and morbidity, and indirect evidence on the accuracy of fracture risk prediction tools» [40]. Its authors Gates M. et al (2019) noted they had conducted their search of primary sources in a number of EBM computer databases (the Cochrane Library, Medline, Embase, PsycINFO), as well as in the 'grey' literature complemented by the manual searches, using «a liberal-accelerated approach» and a risk of bias assessment. They indicated age, sex and menopausal status as the subgroups of interest.…”

Assessing the benefits on quality of life of a multicomponent intervention for fibromyalgia syndrome in primary care: patients’ and health professionals’ appraisals: a qualitative study protocol

“…gov: NCT04049006). 49 The contents of each MI session and other details of the design are fully described in the published protocol of the RCT study. 50…”