Evidence map›Paper›PMID 31593081›Full record

ArticleMedicine2019

Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care: A mixed methods study protocol.

Rosa Caballol Angelats, Alessandra Queiroga Gonçalves, Carina Aguilar Martín, Maria Cinta Sancho Sol, Gemma González Serra, Marc Casajuana, Noèlia Carrasco-Querol, José Fernández-Sáez, Maria Rosa Dalmau Llorca, Rosa Abellana and 2 more

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04049006 (Primary Care as a Promoter of the Quality of Life of Fibromyalgia Patients. Effectiveness and Cost-utility of a Complex Intervention Through a Randomized Clinical Trial), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04049006 nacompletednot on this map

Primary Care as a Promoter of the Quality of Life of Fibromyalgia Patients. Effectiveness and Cost-utility of a Complex Intervention Through a Randomized Clinical Trial

TypeinterventionalSponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaRan2019 to 2021Enrolled302ConditionsFibromyalgiaArmscomplex treatment
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Rosa Caballol AngelatsEquip d'Atenció Primària Tortosa Est, Institut Català de la Salut, Tortosa.
Alessandra Queiroga GonçalvesUnitat de Suport a la Recerca Terres de l'Ebre, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol).
Carina Aguilar MartínUnitat de Suport a la Recerca Terres de l'Ebre, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol).
Maria Cinta Sancho SolUnitat d'Expertesa en Sindromes de Sensibilització Central Terres de l'Ebre, Institut Català de la Salut, Tortosa, Tarragona.
Gemma González SerraUnitat d'Expertesa en Sindromes de Sensibilització Central Terres de l'Ebre, Institut Català de la Salut, Tortosa, Tarragona.
Marc CasajuanaFundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona.
Noèlia Carrasco-QuerolUnitat de Suport a la Recerca Terres de l'Ebre, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol).
José Fernández-SáezUnitat de Suport a la Recerca Terres de l'Ebre, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol).
Maria Rosa Dalmau LlorcaEquip d'Atenció Primària Tortosa Est, Institut Català de la Salut, Tortosa.
Rosa AbellanaDepartament de Fonaments Clínics, Facultat de Medicina, Universitat de Barcelona, Barcelona, Spain.
Anna BerengueraFundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona.
SensiTEbre group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFibromyalgia (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 registrationClinical-Trials.gov: NCT04049006.

Indexed as

Quality of LifeAdultCognitive Behavioral TherapyCombined Modality TherapyCost-Benefit AnalysisExercise TherapyFeasibility StudiesFemaleFibromyalgiaHealth Plan ImplementationHumansMaleOutcome and Process Assessment, Health CarePatient Acceptance of Health CarePatient CompliancePatient Education as Topic

Identifiers

PMID31593081
PMCPMC6799432

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.