Biological Therapy for Chronic Obstructive Pulmonary Disease (COPD): Efficacy and Safety.
Creators: name: López, Luz Angela Torres
name: Rispau, Ariadna Auladell
name: Morales, Olga Milena García
name: Reyes, María Ximena Rojas
Publisher: name: OSF Registries
Year: 2023
Subjects: subject: Medicine and Health Sciences
subject: Biological therapy
subject: Chronic Obstructive Pulmonary Disease
subject: living evidence synthesis
subject: living systematic review
subject: systematic review protocol

description: Title: Biological Therapy for Chronic Obstructive Pulmonary Disease (COPD): Efficacy and Safety. AUTHORS Olga Milena García Morales ORCID: 0000-0002-5293-5698 Affiliation: Departamento de medicina interna ,Fundación Santafé de Bogotá, Bogotá. Colombia. Daniel Poloni Affiliation:Hospital Naval Almirante, Viña del Mar, Región de Valparaíso, Chile. Luz Angela Torres-López ORCID: 0000-0002-5130-4659 Affiliation: Programa Living Evidence to Inform Health Decisions. Laura Díaz ORCID: 0000-0002-5293-5698 Affiliation: Departamento de medicina interna, Fundación Santafé de Bogotá, Bogotá, Colombia. Gerad Urrútia Cuch ORCID: 0000-0002-8850-0960 Affiliation: Centro Cochrane Iberoamericano - Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) - CIBERESP, Barcelona. España AND The Living Evidence to Inform Health Decision program (LE-IHD) research group* Corresponding author: Olga Milena García Morales Email address: olga.garcia@fsfb.org.co Postal address: Carrera 7 N 117-16, Bogotá, 110121. * María Ximena Rojas-Reyes, Patricia Gavín, Ariadna Auladell-Rispau Funding sources/sponsors 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: Authors declared no conflicts of interest ABSTRACT Background: The predominant airway inflammation in chronic obstructive pulmonary disease (COPD) is neutrophilic, although numerous studies have shown that eosinophilic inflammation contributes significantly to COPD. Eosinophilic COPD patients are characterized by a greater number of total exacerbations and higher hospitalization rates. Biological therapy targets multiple steps in eosinophilic inflammation, providing a promising approach to reduce exacerbation frequency and mortality. Objective To provide a timely, rigorous, and continuously updated summary of the evidence available about the role of biological therapy on patients with COPD. 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 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. An automated living search will be performed in relevant databases following high-standard procedures. Its results will be automatically incorporated into the L·OVE platform where two reviewers will then screen the titles and abstracts 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 and other trial registries. Study selection and data extraction For the baseline synthesis report, we will screen references identified up to July 30th 2023. Two reviewers will independently screen each study for eligibility, extract data, and assess its methodological quality using appropriate tools. For the baseline report, we will include systematic reviews and randomized controlled trials evaluating the effect of Biological therapy versus Usual Care in adult patients with COPD. Main outcomes defined as critical or important for decision making include exacerbation rate, exacerbation-free time, lung function, quality of life and adverse events. We will perform meta-analyses of the study’s results for each outcome of interest 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 As part of the baseline synthesis, as well as for 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. Keywords: Biological therapy, Chronic Obstructive Pulmonary Disease (COPD), systematic review, living evidence.