Evidence map›Paper›PMID 40774717›Full record

ArticleBMJ open2025

Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol.

Maria Del Mar Castro, Horeya M Ismail, Carlos Alberto Montenegro-Quiñonez, Elena Ivanova Reipold, Sonjelle Shilton, Claudia Denkinger, Seda Yerlikaya

Abstract read
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Maria Del Mar CastroDepartment of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany maria.castro@uni-heidelberg.de.ORCID http://orcid.org/0000-0002-0485-2919
Horeya M IsmailDepartment of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Carlos Alberto Montenegro-QuiñonezDepartment of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Elena Ivanova ReipoldFIND, Geneva, Switzerland.
Sonjelle ShiltonFIND, Geneva, Switzerland.ORCID http://orcid.org/0000-0003-1569-8758
Claudia DenkingerDepartment of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Seda YerlikayaDepartment of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNovel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when shifting testing tasks from highly controlled settings like centralised laboratories to people with minimal training. Applying usability and human factors engineering principles can reduce the challenges related to human errors. Despite existing frameworks and tools, the practical application of usability guidelines remains variable across different settings. METHODS AND ANALYSIS: This scoping review protocol outlines a systematic investigation of current practices in assessing the usability of novel diagnostics, particularly POC tests for infectious diseases intended for use in low-income and middle-income countries. The review will analyse original research studies of all designs and product dossiers that report on the usability evaluation or validation of a diagnostic test for an infectious disease. A qualitative synthesis of the data extracted from the articles will be conducted. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Joanna Briggs Institute guidelines for this scoping review. ETHICS AND DISSEMINATION: No ethical approval is required because individual patient data will not be included. The findings will be disseminated through publication in a peer-reviewed journal.

Indexed as

Communicable DiseasesPoint-of-Care SystemsPoint-of-Care TestingHumansResearch DesignScoping Reviews as TopicDiagnostic microbiologyMolecular diagnosticsPatient-Centered CarePrimary CareTask Performance

Identifiers

PMID40774717
PMCPMC12336581

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.