Effectiveness and safety of deep brain stimulation in severe and treatment-resistant obsessive-compulsive disorder
Creators: name: Triñanes, Yolanda
name: López, Luz Angela Torres
name: Rispau, Ariadna Auladell
name: Reyes, María Ximena Rojas
Publisher: name: OSF Registries
Year: 2023
Subjects: subject: Medicine and Health Sciences
subject: Living Evidence Synthesis
subject: deep brain stimulation
subject: living evidence
subject: obsessive-compulsive disorder
subject: protocol
subject: systematic review

description: Title Effectiveness and safety of deep brain stimulation in severe and treatment-resistant obsessive-compulsive disorder En adultos con trastorno obsesivo-compulsivo grave y resistente al tratamiento, se debe dar estimulación cerebral profunda comparado con no dar? AUTHORS: Yolanda Triñanes Pego ORCID: 0000-0003-0717-4604 Affiliation: Scientific and Technical Advice Unit, Avalia-t. Health Knowledge Agency (ACIS), Spain. Patricia Gómez Salgado ORCID: [0000-0002-3835-0028] Affiliation: Scientific and Technical Advice Unit, Avalia-t. Health Knowledge Agency (ACIS), Spain. Janet Puñal Rioboó ORCID: 0000-0003-4519-004X Affiliation: Scientific and Technical Advice Unit, Avalia-t. Health Knowledge Agency (ACIS), Spain. María del Carmen Maceira Rozas ORCID: 0000-0001-8656-2992 Affiliation: Scientific and Technical Advice Unit, Avalia-t. Health Knowledge Agency (ACIS), Spain. AND The Living Evidence to Inform Health Decision program (LE-IHD) research group* Corresponding author: Yolanda Triñanes Pego Email address: yolanda.trinanes.pego@sergas.es Postal address: Edificio Administrativo San Lázaro s/n Santiago de Compostela (A Coruña). Spain. 15781 * LE-IHD research group: María Ximena Rojas-Reyes; Luz Angela Torres, Ariadna Auladell-Rispau. Funding sources/sponsors The development of this report is commissioned by the Health Knowledge Agency (ACIS), Santiago de Compostela, Spain, without external funding. This work is being developed as part of the project “Strengthening decision-making capacity in the Spanish Health System through living evidence: An innovative framework” that received funding from the Spanish Government through the “Plan Estatal de Investigación Científica y Técnica y de Innovación-Acción Estratégica en Salud. Co-funded by FONDOS FEDER. Instituto de Salud Carlos III (ISC-III), Madrid, Spain. Grant PI21/01564; 2021 call. The funders and institutions did not take any part in the development of this study. Conflicts of interest: The authors declare have no conflicts of interest Key words: "Obsessive-Compulsive Disorder; "Deep Brain Stimulation"; "Systematic Review" ABSTRACT Objective To provide a rigorous and updated synthesis of the evidence available on the role of Deep Brain Stimulation for the treatment of patients with severe and treatment-resistant obsessive- compulsive disorder. Methods Design This is a Living Evidence synthesis, which will start with a baseline synthesis report of the effects of the Deep Brain Stimulation on the severity of symptoms, psychological, social, and professional functioning, quality of life, cognitive functioning, and adverse events in patients with severe and treatment-resistant obsessive-compulsive disorder. Based on its conclusions, we will set up the living evidence approach, and the evidence monitoring will begin. Evidence identification The evidence identification, screening, and selection will be supported by technological enablers developed by the Epistemonikos Foundation and included in its "Living Overview of Evidence (L.OVE) platform. The team maintaining the L·OVE platform will devise the literature search aimed to identify systematic reviews, randomized clinical trials, and non-randomized studies (e.g cohort and case-control studies). An automated living search will be performed in all databases following high-standard procedures. The results of the literature searches will be automatically incorporated into the L·OVE platform where two reviewers will then screen the titles and abstracts of classified references against selection criteria. We will continuously monitor the evidence by performing daily searches and a monthly screening of the retrieved references. To support the screening and monitoring, we will use an automatic classifier based on artificial intelligence (AI) algorithm and other technologies, that excludes references with a low probability of being relevant when appropriate. Additionally, every three months we will manually search for ongoing studies in the International Clinical Trials Registry Platform trial registries. Study selection and data extraction Two reviewers will independently screen each study for eligibility, extract data, and assess its methodological quality using appropriate tools. For the baseline synthesis report, we will include systematic reviews, randomized and non-randomized studies evaluating the effect of Deep Brain Stimulation in comparison to sham stimulation, treatment as usual, or ablative surgery in patients with severe and refractory obsessive-compulsive disorder. We will perform meta-analyses of the study’s results when pertinent. We will assess the certainty of the evidence for each outcome by applying the GRADE approach. These findings will be used to refine the parameters for setting up the living evidence approach. Living evidence approach We will continuously monitor the evidence for 12 months. If a new study is identified as eligible, we will follow the same procedures described above prior to updating the metanalysis of the outcomes reported. We will follow a systematic and reproducible process for taking decisions related to incorporating or postponing the incorporation of new studies, updating of conclusions or recommendations this synthesis informs and for periodically reviewing the question to define its continuation, changes, or withdrawal of the living mode. The question will withdraw according to predefined specific criteria. Results For the baseline synthesis and the subsequent synthesis updates, the estimates for all outcomes evaluated will be presented in the GRADE summary of findings tables. Regular updates will include key messages on changes in the evidence synthesis conclusions. We will resubmit new complete updates every time the conclusions change or whenever there are substantial updates for the main outcomes of interest.