Unitat de Suport a la Recerca Terres de l'Ebre, IDIAP Jordi Gol, Barcelona, Catalunya, Spain.
Department of Pediatrics, Obstetrics and Gynecology, and Preventive Medicine, Universitat Autonoma de Barcelona, Barcelona, Catalunya, Spain.
BMJ Open. 2021 Feb 5;11(2):e043562. doi: 10.1136/bmjopen-2020-043562.
Fibromyalgia syndrome (FMS) imposes a high cost on society. The significant economic burden from the use of healthcare and, especially, social resources is a spur to revising the usual clinical care (UCC) and to improving treatment strategies. FMS has a deleterious effect on the quality of life (QOL) and productivity, which considerably increase the indirect costs to society. This study reports an economic evaluation comparing the cost and health benefits in a multicomponent intervention programme and UCC of patients with FMS who attend primary healthcare centres of the Gerència Territorial Terres de L'Ebre region of Catalonia, Spain. This article is linked to the pre-results of a randomised control trial study on the implementation of this intervention programme (ClinicalTrials.gov: NCT04049006).
A cost-utility analysis will be conducted from a societal perspective. Quality-adjusted life years will be calculated from the results of the SF-36 questionnaire, a QOL measurement instrument. Direct and indirect healthcare costs will be obtained from official prices and reports published by the Spanish Public Health Administration and the National Statistics Institute. The incremental cost-utility ratio will be estimated to compare the two healthcare practices. Deterministic sensitivity analysis will also be used to compare different cost scenarios, modifying the items with the highest weight in the cost composition.
The Clinical Research Ethics Committee of the IDIAPJGol Institute approved this study on 25 April 2018 (code P18/068) in accordance with the Helsinki/Tokyo Declaration. Information will be provided orally and in writing to participants, and their informed consent will be required. Participant anonymity will be guaranteed. The dissemination strategy includes publications in scientific journals and presentations in local and national media and at academic conferences. NCT04049006; Pre-results.
纤维肌痛综合征（fibromyalgia syndrome，FMS）给社会带来了沉重的负担。医疗保健费用的大量支出，尤其是社会资源的大量支出，促使人们修订常规临床护理（usual clinical care，UCC）并改进治疗策略。FMS会对生活质量（quality of life，QOL）和生产力产生不利影响，从而使社会的间接成本大大增加。本研究报告了一项经济评估，比较了西班牙加泰罗尼亚地区特伦蒂诺-埃布罗地区初级保健中心的 FMS 患者接受多组分干预方案和 UCC 的成本和健康效益。本文与该干预方案实施的随机对照试验研究的预结果相关（ClinicalTrials.gov：NCT04049006）。
将从社会角度进行成本效用分析。将从 SF-36 问卷的结果中计算出健康调整生命年，这是一种 QOL 测量工具。将从西班牙公共卫生管理局和国家统计局公布的官方价格和报告中获取直接和间接医疗保健成本。将估计增量成本效用比以比较两种医疗保健实践。还将进行确定性敏感性分析，以比较不同的成本方案，修改成本构成中权重最高的项目。
IDIAPJGol 研究所的临床研究伦理委员会于 2018 年 4 月 25 日根据赫尔辛基/东京宣言批准了这项研究（代码 P18/068）。将向参与者提供口头和书面信息，并要求他们签署知情同意书。参与者的匿名性将得到保证。传播策略包括在科学期刊上发表文章，以及在当地和国家媒体以及学术会议上进行演示。NCT04049006；预结果。
