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      Active close contact investigation of tuberculosis through computer-aided detection and stool Xpert MTB/RIF among people living in Oromia Region, Ethiopia (CADOOL Study): protocol for a prospective, cross-sectional study

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          Abstract

          Introduction

          Pulmonary tuberculosis (TB) is an infectious disease with high incidence in low-income countries (LICs); it remains one of the infectious diseases with the highest mortality in the world, especially in LICs. It is crucial to recognise and diagnose TB as soon as possible, but microbiological tests on sputum are not always sensitive enough. New methods for an early diagnosis of TB are needed. In this study, we will investigate the role of two different tests to detect TB in Ethiopia (where the prevalence of TB is high): molecular search for TB in stool samples with Xpert assay and detection of pulmonary TB signs on chest X-rays with CAD4TB technology.

          Methods and analysis

          A prospective diagnostic test accuracy study during TB active contact investigation will be conducted. In the referral hospital in Southwest Shoa Zone, Oromia Region, Ethiopia, patients with pulmonary TB and a sputum sample positive for Mycobacterium tuberculosis and household contacts of at least 4 years of age will be enrolled, with a target sample size of 231 patients. Trained staff will label household contacts as ‘possible TB’ cases or not according to their symptoms; when TB is possible, a stool Xpert and computer-aided detection on chest X-ray will be performed, alongside standard diagnostic methods, assessing the diagnostic accuracy of CAD4TB compared with Xpert MTB/RIF during TB contact investigation and the accuracy of stool Xpert compared with sputum Xpert.

          Ethics and dissemination

          This study has been approved by the Oromia Health Bureau Research Ethics Committee (ref no BFO/MBTFH/1-16/100023). All information obtained will be kept confidential. Selected investigators will have access to data, while international partners will sign a dedicated data protection agreement. Eligible participants will receive brief information about the study before being asked to participate and they will provide written informed consent. Results will be disseminated through peer-reviewed journals.

          Trial registration number

          NCT05818059.

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          Most cited references21

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            The REDCap consortium: Building an international community of software platform partners

            The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.
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              Tuberculosis.

              Tuberculosis (TB) is an airborne infectious disease caused by organisms of the Mycobacterium tuberculosis complex. Although primarily a pulmonary pathogen, M. tuberculosis can cause disease in almost any part of the body. Infection with M. tuberculosis can evolve from containment in the host, in which the bacteria are isolated within granulomas (latent TB infection), to a contagious state, in which the patient will show symptoms that can include cough, fever, night sweats and weight loss. Only active pulmonary TB is contagious. In many low-income and middle-income countries, TB continues to be a major cause of morbidity and mortality, and drug-resistant TB is a major concern in many settings. Although several new TB diagnostics have been developed, including rapid molecular tests, there is a need for simpler point-of-care tests. Treatment usually requires a prolonged course of multiple antimicrobials, stimulating efforts to develop shorter drug regimens. Although the Bacillus Calmette-Guérin (BCG) vaccine is used worldwide, mainly to prevent life-threatening TB in infants and young children, it has been ineffective in controlling the global TB epidemic. Thus, efforts are underway to develop newer vaccines with improved efficacy. New tools as well as improved programme implementation and financing are necessary to end the global TB epidemic by 2035.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2023
                21 December 2023
                : 13
                : 12
                : e074968
                Affiliations
                [1 ]departmentDepartment of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J) , Ringgold_9295University of Bari Aldo Moro , Bari, Italy
                [2 ]St Luke Catholic Hospital , Wolisso, Ethiopia
                [3 ]Ringgold_9295University of Bari Aldo Moro , Bari, Italy
                [4 ]departmentHealth Research Team , Ringgold_561051Oromia Regional Health Bureau , Addis Ababa, Ethiopia
                [5 ]Doctors with Africa CUAMM, Addis Ababa Coordination Office , Addis Ababa, Ethiopia
                [6 ]Doctors with Africa CUAMM , Padua, Italy
                [7 ]departmentMycobacterial Diseases Research , Ringgold_70605Armauer Hansen Research Institute , Addis Ababa, Ethiopia
                [8 ]departmentBiostatistics , University of Padova , Padua, Italy
                [9 ]Ringgold_70605Armauer Hansen Research Institute , Addis Ababa, Ethiopia
                Author notes
                [Correspondence to ] Dr Giacomo Guido; giacguido@ 123456gmail.com
                Author information
                http://orcid.org/0000-0001-5276-2603
                http://orcid.org/0009-0004-8783-7221
                Article
                bmjopen-2023-074968
                10.1136/bmjopen-2023-074968
                10749013
                38135314
                5f53950f-1492-4722-95b1-36c5ea2f405b
                © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 21 April 2023
                : 12 December 2023
                Funding
                Funded by: Agenzia Italiana per la Cooperazione allo Sviluppo (Italian Agency for Development Cooperation, AICS);
                Award ID: Determina n. 217 del 1/08/22
                Categories
                Infectious Diseases
                1506
                1706
                Protocol
                Custom metadata
                unlocked

                Medicine
                tuberculosis,infectious diseases,radiology & imaging,microbiology,molecular diagnostics
                Medicine
                tuberculosis, infectious diseases, radiology & imaging, microbiology, molecular diagnostics

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