Effectiveness and safety of out-of-hospital cardiac rehabilitation: protocol for a living systematic review
Creators: name: Reyes, María Ximena Rojas
name: Duarte-Díaz, Andrea
name: Rispau, Ariadna Auladell
name: López, Luz Angela Torres
Publisher: name: OSF Registries
Year: 2023
Subjects: subject: Medicine and Health Sciences
subject: Living systematic review
subject: cardiac rehabilitation
subject: living evidence synthesis
subject: systematic review protocol

description: TITLE: Effectiveness and safety of out-of-hospital cardiac rehabilitation: protocol for a living systematic review AUTHORS Andrea Duarte-Díaz ORCID: 0000-0002-4032-2974 Affiliations: Canary Islands Health Research Institute Foundation (FIISC), 38109 El Rosario, Spain; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), 38109 El Rosario, Spain; The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS). Yolanda Álvarez-Pérez ORCID: 0000-0002-6414-2863 Affiliations: Canary Islands Health Research Institute Foundation (FIISC), 38109 El Rosario, Spain; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), 38109 El Rosario, Spain; The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS). Amado Rivero-Santana ORCID: 0000-0002-5067-3196 Affiliations: Canary Islands Health Research Institute Foundation (FIISC), 38109 El Rosario, Spain; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), 38109 El Rosario, Spain; The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS). Lilisbeth Perestelo-Pérez ORCID: 0000-0002-6113-7313 Affiliations: Evaluation Unit (SESCS), Canary Islands Health Service (SCS), 38109 El Rosario, Spain; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), 38109 El Rosario, Spain; The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS). Mar Trujillo-Martín ORCID: 0000-0003-2276-2192 Affiliations: Canary Islands Health Research Institute Foundation (FIISC), 38109 El Rosario, Spain; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), 38109 El Rosario, Spain; The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS). AND The Living Evidence to Inform Health Decision program (LE-IHD) research group* CORRESPONDING AUTHOR: Andrea Duarte-Díaz Email address: andrea.duartediaz@sescs.es. Postal address: CS San Isidro, Camino Candelaria, 44, 1ª planta, 38109 - El Rosario, Santa Cruz de Tenerife. FUNDING SOURCES/SPONSORS The study is carrying out in the framework of activities developed by the Spanish Network of Agencies for Health Technology Assessment and Services for the National Health System (RedETS), commissioned and funded by the Ministry for Health of Spain. 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 * LE-IHD research group: María Ximena Rojas-Reyes, Iván Sola, Luz Angela Torres, Ariadna Auladell-Rispau. ABSTRACT Objective To provide a timely, rigorous, and continuously updated summary of the evidence available on the role of out-of-hospital cardiac rehabilitation for the treatment of patients with ischemic heart disease or heart failure. Methods Design This is a Living Evidence Synthesis that will start with a baseline synthesis report of the effects of the intervention on the main predefined outcomes. Based on its conclusions, we will set up a 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 for data extraction and methodological assessment 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 As part of the baseline synthesis, the estimates for all outcomes evaluated will be presented in GRADE evidence profiles. Regular updates will be reported and include a GRADE summary of findings tables with 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.