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      Point-of-Care Approaches for Meningitis Diagnosis in a Low-Resource Setting (Southwestern Uganda): Observational Cohort Study Protocol of the “PI-POC” Trial

      , BSc, MSc, PhD 1 , 2 , , , MD 3 , , MD 1 , , MSc 4 , , PhD 5 , , MSc 4 , , MD, PhD 6 , , MD 3 , , MSc 7 , , MD 3 , 8 , , PhD 5 , , MD 3 , 8 , , BSc, MSc, PhD 7 , 9 , , PhD 3 , 4 , , PhD 2 , , PhD, MD 2 , , MD 3 , 4 , , BSc, MD, PhD 1
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      JMIR Research Protocols
      JMIR Publications
      global health, central nervous system infections, pediatrics, diagnostics, low-resource settings, meningitis, Uganda, children

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          A timely differential diagnostic is essential to identify the etiology of central nervous system (CNS) infections in children, in order to facilitate targeted treatment, manage patients, and improve clinical outcome.


          The Pediatric Infection-Point-of-Care (PI-POC) trial is investigating novel methods to improve and strengthen the differential diagnostics of suspected childhood CNS infections in low-income health systems such as those in Southwestern Uganda. This will be achieved by evaluating (1) a novel DNA-based diagnostic assay for CNS infections, (2) a commercially available multiplex PCR-based meningitis/encephalitis (ME) panel for clinical use in a facility-limited laboratory setting, (3) proteomics profiling of blood from children with severe CNS infection as compared to outpatient controls with fever yet not severely ill, and (4) Myxovirus resistance protein A (MxA) as a biomarker in blood for viral CNS infection. Further changes in the etiology of childhood CNS infections after the introduction of the pneumococcal conjugate vaccine against Streptococcus pneumoniae will be investigated. In addition, the carriage and invasive rate of Neisseria meningitidis will be recorded and serotyped, and the expression of its major virulence factor (polysaccharide capsule) will be investigated.


          The PI-POC trial is a prospective observational study of children including newborns up to 12 years of age with clinical features of CNS infection, and age-/sex-matched outpatient controls with fever yet not severely ill. Participants are recruited at 2 Pediatric clinics in Mbarara, Uganda. Cerebrospinal fluid (for cases only), blood, and nasopharyngeal (NP) swabs (for both cases and controls) sampled at both clinics are analyzed at the Epicentre Research Laboratory through gold-standard methods for CNS infection diagnosis (microscopy, biochemistry, and culture) and a commercially available ME panel for multiplex PCR analyses of the cerebrospinal fluid. An additional blood sample from cases is collected on day 3 after admission. After initial clinical analyses in Mbarara, samples will be transported to Stockholm, Sweden for (1) validation analyses of a novel nucleic acid–based POC test, (2) biomarker research, and (3) serotyping and molecular characterization of S. pneumoniae and N. meningitidis.


          A pilot study was performed from January to April 2019. The PI-POC trial enrollment of patients begun in April 2019 and will continue until September 2020, to include up to 300 cases and controls. Preliminary results from the PI-POC study are expected by the end of 2020.


          The findings from the PI-POC study can potentially facilitate rapid etiological diagnosis of CNS infections in low-resource settings and allow for novel methods for determination of the severity of CNS infection in such environment.

          Trial Registration

          ClinicalTrials.gov NCT03900091; https://clinicaltrials.gov/ct2/show/NCT03900091

          International Registered Report Identifier (IRRID)


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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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            Is Open Access

            STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration

            Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www.equator-network.org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports.
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              Laboratory medicine in Africa: a barrier to effective health care.

              Providing health care in sub-Saharan Africa is a complex problem. Recent reports call for more resources to assist in the prevention and treatment of infectious diseases that affect this population, but policy makers, clinicians, and the public frequently fail to understand that diagnosis is essential to the prevention and treatment of disease. Access to reliable diagnostic testing is severely limited in this region, and misdiagnosis commonly occurs. Understandably, allocation of resources to diagnostic laboratory testing has not been a priority for resource-limited health care systems, but unreliable and inaccurate laboratory diagnostic testing leads to unnecessary expenditures in a region already plagued by resource shortages, promotes the perception that laboratory testing is unhelpful, and compromises patient care. We explore the barriers to implementing consistent testing within this region and illustrate the need for a more comprehensive approach to the diagnosis of infectious diseases, with an emphasis on making laboratory testing a higher priority.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                November 2020
                4 November 2020
                : 9
                : 11
                : e21430
                [1 ] Department of Global Public Health Karolinska Institutet Stockholm Sweden
                [2 ] Division of Nanobiotechnology Department of Protein Science KTH Royal Institute of Technology, SciLifeLab Stockholm Sweden
                [3 ] Department of Paediatrics and Child Health Faculty of Medicine Mbarara University of Science and Technology Mbarara Uganda
                [4 ] MSF Epicentre Mbarara Research Centre Mbarara Uganda
                [5 ] Division of Affinity Proteomics Department of Protein Science KTH Royal Institute of Technology, SciLifeLab Stockholm Sweden
                [6 ] Department of Women's and Children's Health, International Maternal and Child Health Uppsala University Uppsala Sweden
                [7 ] Department of Microbiology, Tumor, and Cell Biology BioClinicum Karolinska University Hospital Stockholm Sweden
                [8 ] Holy Innocents Children’s Hospital Mbarara Uganda
                [9 ] SCELSE Nanyang Technological University Singapore Singapore
                Author notes
                Corresponding Author: Giulia Gaudenzi giulia.gaudenzi@ 123456ki.se
                Author information
                ©Giulia Gaudenzi, Elias Kumbakumba, Reza Rasti, Deborah Nanjebe, Pedro Réu, Dan Nyehangane, Andreas Mårtensson, Milly Nassejje, Jens Karlsson, John Mzee, Peter Nilsson, Stephen Businge, Edmund Loh, Yap Boum II, Helene Andersson-Svahn, Jesper Gantelius, Juliet Mwanga-Amumpaire, Tobias Alfvén. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.11.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 15 June 2020
                : 20 July 2020
                : 9 September 2020
                : 13 September 2020

                global health,central nervous system infections,pediatrics,diagnostics,low-resource settings,meningitis,uganda,children


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