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

Introduction 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...

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Main Authors: Anna Berenguera, Victoria Mailen Arfuch, Rosa Caballol Angelats, Carina Aguilar Martín, Noèlia Carrasco-Querol, Maria Cinta Sancho Sol, Gemma González Serra, Immaculada Fusté Anguera, Alessandra Queiroga Gonçalves, José Fernández Sáez, Marc Casajuana
Format: Article
Language:English
Published: BMJ Publishing Group 2021-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/2/e043562.full
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author Anna Berenguera
Victoria Mailen Arfuch
Rosa Caballol Angelats
Carina Aguilar Martín
Noèlia Carrasco-Querol
Maria Cinta Sancho Sol
Gemma González Serra
Immaculada Fusté Anguera
Alessandra Queiroga Gonçalves
José Fernández Sáez
Marc Casajuana
author_facet Anna Berenguera
Victoria Mailen Arfuch
Rosa Caballol Angelats
Carina Aguilar Martín
Noèlia Carrasco-Querol
Maria Cinta Sancho Sol
Gemma González Serra
Immaculada Fusté Anguera
Alessandra Queiroga Gonçalves
José Fernández Sáez
Marc Casajuana
author_sort Anna Berenguera
collection DOAJ
description Introduction 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).Method and analysis 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.Ethics and dissemination 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.Trial registration number: NCT04049006; Pre-results.
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spelling doaj-art-7dca73f0b2d34d6b84f16468eafb3b982024-11-17T05:30:12ZengBMJ Publishing GroupBMJ Open2044-60552021-02-0111210.1136/bmjopen-2020-043562Cost–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 trialAnna Berenguera0Victoria Mailen Arfuch1Rosa Caballol Angelats2Carina Aguilar Martín3Noèlia Carrasco-Querol4Maria Cinta Sancho Sol5Gemma González Serra6Immaculada Fusté Anguera7Alessandra Queiroga Gonçalves8José Fernández Sáez9Marc Casajuana10Central Research Unit, IDIAP Jordi Gol, Barcelona, Catalunya, SpainUnitat de Suport a la Recerca Terres de l’Ebre, IDIAP Jordi Gol, Barcelona, Catalunya, SpainEquip d’Atenció Primària Tortosa Est, Institut Català de la Salut, Tortosa, Catalonia, Spain3 Unitat de Suport a la Recerca Terres de l’Ebre, Fundació Institut Universitari per a la Recerca al’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Tortosa, SpainUnitat de Suport a la Recerca Terres de l’Ebre, IDIAP Jordi Gol, Barcelona, Catalunya, SpainUnitat d’Expertesa en Sindromes de Sensibilització Central Terres de l’Ebre, Institut Català de la Salut, Tortosa, Catalonia, SpainUnitat de Suport a la Recerca Terres de l’Ebre, IDIAP Jordi Gol, Barcelona, Catalunya, SpainEquip d’Atenció Primària Tortosa Est, Institut Català de la Salut, Tortosa, Catalonia, Spain3 Unitat de Suport a la Recerca Terres de l’Ebre, Fundació Institut Universitari per a la Recerca al’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Tortosa, SpainUnitat de Suport a la Recerca Terres de l’Ebre, IDIAP Jordi Gol, Barcelona, Catalunya, SpainCentral Research Unit, IDIAP Jordi Gol, Barcelona, Catalunya, SpainIntroduction 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).Method and analysis 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.Ethics and dissemination 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.Trial registration number: NCT04049006; Pre-results.https://bmjopen.bmj.com/content/11/2/e043562.full
spellingShingle Anna Berenguera
Victoria Mailen Arfuch
Rosa Caballol Angelats
Carina Aguilar Martín
Noèlia Carrasco-Querol
Maria Cinta Sancho Sol
Gemma González Serra
Immaculada Fusté Anguera
Alessandra Queiroga Gonçalves
José Fernández Sáez
Marc Casajuana
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
BMJ Open
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/11/2/e043562.full
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