Rapid Sistematic Review Protocol: "Utilization records of implantable medical devices for cardiology use: A Rapid Literature Review"
Creators: name: Patrícia Véras Marrone
name: Rebello Pinho Dias Scoton, Maria Lídia
name: Santos, Milana
name: MASSAIA, IRINEU FRANCISCO DELFINO
name: Dias, Eduardo Mario
Publisher: name: Zenodo
Year: 2024
Subjects: cardiac implanted electronic device (CIED)
cardiovascular implantable devices use
heart failure
heart-assist devices
national cardiovascular data registries
cardiovascular disease statistics
cardiac implant registries

description: Utilization records of implantable medical devices for cardiology use: A Rapid Literature Review

 Zenodo Registry Protocol

 Team: 

·         Patrícia Véras Marrone, patriciam@websetorial.com.br, ORCID: 0000-0001-5631-5587

·         Maria Lídia Rebello Pinho Dias Scoton, e-mail: lidiadias@pea.usp.br, ORCID: 0000-0002-7651-3991

·         Milana Lima dos Santos, e-mail: milanals@usp.br , ORCID: 0000-0003-2680-5141

·         Irineu Francisco Delfino Massaia: e-mail: irineu.massaia@gmail.com, ORCID: 0000-0001-5584-9245

·         Eduardo Mario Dias, e-mail: emdias@pea.usp.br , ORCID: 0000-0002-2104-1747

 Corresponding author: 

 Patrícia Véras Marrone: patriciam@websetorial.com.br

Competing interests:

 The authors have no competing interests to declare.

Background

An implantable medical device (IMD) is defined as “any medical product that is either durably inserted into the human body (i.e., for 30 days or more) or used to replace an epithelial surface that is neither a drug nor a biological product. IMDs include a wide variety of products that range from intraocular lenses to hip prostheses and include life-supporting implants, such as pacemakers, heart valves, and defibrillators. Their use has become increasingly common in maintaining and improving patients' health in many medical fields.” (Pibouleau and Chevret, 2013[1])

In Brazil, no parameters are being collected to understand the national level of usage of cardiovascular implantable devices (C-IMD) to allow comparison with other countries and help to understand which products need to be further promoted to improve access to the population.

 Purpose of the rapid review

The objective of this paper is to scope findings, advanced in the academic literature, related to platforms and registries of C-IMD’s usage indicators and parameters. This information will guide Brazilian health system stakeholders to interpret the access of C-IMD’s access to cure or control cardiopathies.

 Research questions

The structured questions based on the PCC acronym are described in Questions 1 and 2 PCC structured question

P Problem: Identification of “cardiovascular implantable devices (C-IMD)” usage indicators recorded from national databases, statistics or reports.

C Concept: Framework to help to create benchmarks and parameters to compare Brazilian usage or access of cardiovascular implantable devices (C-IMD) with other countries.

C Context: “cardiovascular implantable devices (C-IMD)” for cardiovascular health conditions usage or access (in any country).

 With input from the team of investigators and collaborators from the University of São Paulo and Brazilian Association of Importers and Distributors of Health Products – ABRAIDI (stakeholder), the following four research questions were formulated:


1.       Are there national registries and databases that can serve as a benchmark for Brazilian cardiovascular implantable devices (C-IMD) industry stakeholders?

2.       Which are the current aspects taken into consideration in the scientific reference literature for analyzing usage or access of “Implantable Medical Devices” applied to cardiovascular health conditions?

 Methods

This rapid review will be carried out according to the Smela, 2023 proposed methodology for carrying out rapid reviews.

Search Strategy

A comprehensive search strategy for identifying published papers that met the inclusion criteria was constructed with support from experienced researchers (PM). The following structured search strategies were used in database searches and constructed using PubMed MeSH terms and Boolean operators.

The following databases were searched: PubMed, Google Scholar and IEEE Xplore.

Period: From 2014 to 2024

MedLine and Embase (PubMed): (implantable medical device) AND (national statistics) NOT (contraceptive AND tooth AND dental AND  breast AND arthroplasty AND contraceptive AND  hip AND  joint AND spine AND knee AND neck AND shoulder AND ankle) = // 960 results

 IEEE Xplorer: "Abstract":"implantable medical devices" AND ("Full Text & Metadata": statistics)

 Filters Applied: Journals Conferences Books = 26 resultados

Google Scholar: "Implantable medical device" AND national statistics. NOT (contraceptive AND tooth AND dental AND  breast AND arthroplasty AND contraceptive AND  hip AND  joint AND spine AND knee AND neck AND shoulder AND ankle) = 622 Results

https://scholar.google.com.br/scholar?as_q=implantable+medical+device&as_epq=national+statistics&as_oq=&as_eq=joint+tooth+knee+breast+contraceptive+spine+neck+hip+shoulder+ankle+arthoplasty&as_occt=any&as_sauthors=&as_publication=&as_ylo=2014&as_yhi=2024&hl=pt-BR&as_sdt=0%2C5

Consultation period on Google Scholar: from August  19 to  21,  2024

Selection Criteria

Inclusion and exclusion criteria were developed at the outset of the review.

The inclusion criteria were: a) primary and secondary studies, b) articles that directly or indirectly answered the research questions, c) studies that referred to implantable medical device coefficients applied to heart disease, national, continental or professional association databases.

Congress abstracts, letters, and editorials, full-text unavailability and studies presenting subjects were excluded. Cohort studies will be excluded, i.e. observational epidemiological studies that set out to observe a previously defined population, for example in a hospital or group of hospitals, or even in a country, in order to estimate the incidence of a specific disease or phenomenon related to health or illness when will deal with consecutive periods without identifying a year and often do not cover the whole country, but rather a sample.

Selection of studies

The selection will be carried out with the support of excel spreadsheets.

Two reviewers will independently (PM and MLS) evaluate each title and abstract of the identified records to make the selection. The selection of titles and abstracts will be tested concurrently by three investigators (PM, MLD, MLS), independently, on 5% of the records.

The decisions will be compared and discussed to resolve inconsistencies before proceeding. The titles and abstracts of the remaining 95% of the records were then analyzed by a single researcher (PM). The full texts of all articles identified as potentially relevant will be retrieved and eligibility will be assessed against the inclusion and exclusion criteria (by PM).

This process will be reviewed in 20% of cases (MLS). The studies that will raise doubts about inclusion will be submitted to analysis by (PM) for a second analysis of (MLS) respecting the review criteria. Selection was carried out using Excel spreadsheets.

Disagreements will be resolved by consensus or, when necessary, a third reviewer will be involved (IFDM).

A PRISMA flowchart will be included to present research results and the process of screening and eligibility of studies for inclusion.

In the full-text phase, a table listing excluded studies references from this review and the main reason(s) for exclusion will be presented.

Extraction of study information and graphics

An extraction spreadsheet will be developed and tested with calibration between the researchers. A data extraction form will be developed and tested. It extracted summary information about the study: author, country, period and the database it referenced as the source of the information on use.

The extraction will be performed by two reviewers independently. Disagreements will be resolved by consensus and a third reviewer will be engaged if necessary.

Charting, Extracting, and Tabulating the Data

Key pieces of information from papers selected for inclusion in the rapid review will be charted by the researchers using a data charting form (like a data extraction form used in systematic reviews).

The main parameters and indicators of C-IMD usage from the articles selected for inclusion in the rapid review will be recorded by the researchers using a data recording form (similar to a data extraction form used in systematic reviews).

These key aspects or concepts, identified a priori, included the following information will be extracted and recorded: Whether the article was assessed; Selected or Excluded; Reason for selection or exclusion; Main results; Conclusion; Variables used (including sources of information) to arrive at the findings or arguments presented were also extracted, when they were presented. When there was no data available for a category, it was indicated in the extraction table as “not informed”.

The included studies were identified according to the availability of annual data and comparable population territories.

 Risk of bias analysis

The analysis of the risk of bias was based on the assessment of the type of study, classifying them as: opinion, observational, and e





[1] https://www.sciencedirect.com/science/article/abs/pii/S089543561000185X