Effectiveness and safety of out-of-hospital cardiac rehabilitation: protocol for a living systematic review
Creators: name: Rispau, Ariadna Auladell
name: Duarte-Díaz, Andrea
name: Reyes, María Ximena Rojas
Publisher: name: OSF Registries
Year: 2023
Subjects: subject: Medical Sciences
subject: Medicine and Health Sciences
subject: health decision-making
subject: healthtechnology
subject: living evidence

description: 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
This HTA report was commissioned and funded by the Ministry for Health of Spain in the framework of activities developed by the Spanish Network of Agencies for Health Technology Assessment and Services for the National Health System (RedETS). 
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 no conflicts of interest. 

* LE-IHD research group: María Ximena Rojas-Reyes; Iván Sola, Luz Angela Torres, Ariadna Auladell-Rispau.

How to cite this article: Duarte-Díaz A., Álvarez-Pérez Y., Rivero-Santana A., Perestelo-Pérez L., Trujillo-Martín M., The Living Evidence to Inform Health Decision program (LE-IHD) research group (2023) Effectiveness and safety of out-of-hospital cardiac rehabilitation: protocol for a living systematic review. Living Evidence to Inform Health Decisions program, Oct. 2023. OSF osf.io/xah7g

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 and randomized clinical trials. 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 and randomized controlled studies evaluating the effect of out-of-hospital cardiac rehabilitation (e.g., in primary and community care, home-based) versus hospital-based cardiac rehabilitation in patients with ischemic heart disease or heart failure. 
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. 

Key words: "Cardiac Rehabilitation"; "Ischemic Heart Disease"; "Coronary Artery Disease"; “Heart Failure”, "Systematic Review" “Living Evidence”.