Evidence map›Paper›PMID 28250964›Full record

ArticleBMJ innovations2017

Open-source mobile digital platform for clinical trial data collection in low-resource settings.

Joris van Dam, Kevin Omondi Onyango, Brian Midamba, Nele Groosman, Norman Hooper, Jonathan Spector, Goonaseelan Colin Pillai, Bernhards Ogutu

Abstract read
In one paragraph

Article in BMJ innovations, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

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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

8 authors.

Joris van DamNovartis Institutes for BioMedical Research Inc , Cambridge, Massachusetts , USA.
Kevin Omondi OnyangoKenya Medical Research Institutes and Center for Research in Therapeutic Sciences Strathmore University , Nairobi , Kenya.
Brian MidambaKenya Medical Research Institutes and Center for Research in Therapeutic Sciences Strathmore University , Nairobi , Kenya.
Nele GroosmanDimagi , Cape Town , South Africa.
Norman HooperDimagi , Cape Town , South Africa.
Jonathan SpectorNovartis Institutes for BioMedical Research Inc , Cambridge, Massachusetts , USA.
Goonaseelan Colin PillaiNovartis AG , Basel , Switzerland.
Bernhards OgutuKenya Medical Research Institutes and Center for Research in Therapeutic Sciences Strathmore University , Nairobi , Kenya.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGovernments, universities and pan-African research networks are building durable infrastructure and capabilities for biomedical research in Africa. This offers the opportunity to adopt from the outset innovative approaches and technologies that would be challenging to retrofit into fully established research infrastructures such as those regularly found in high-income countries. In this context we piloted the use of a novel mobile digital health platform, designed specifically for low-resource environments, to support high-quality data collection in a clinical research study.

objectiveOur primary aim was to assess the feasibility of a using a mobile digital platform for clinical trial data collection in a low-resource setting. Secondarily, we sought to explore the potential benefits of such an approach.

methodsThe investigative site was a research institute in Nairobi, Kenya. We integrated an open-source platform for mobile data collection commonly used in the developing world with an open-source, standard platform for electronic data capture in clinical trials. The integration was developed using common data standards (Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model), maximising the potential to extend the approach to other platforms. The system was deployed in a pharmacokinetic study involving healthy human volunteers.

resultsThe electronic data collection platform successfully supported conduct of the study. Multidisciplinary users reported high levels of satisfaction with the mobile application and highlighted substantial advantages when compared with traditional paper record systems. The new system also demonstrated a potential for expediting data quality review. DISCUSSION AND

conclusionsThis pilot study demonstrated the feasibility of using a mobile digital platform for clinical research data collection in low-resource settings. Sustainable scientific capabilities and infrastructure are essential to attract and support clinical research studies. Since many research structures in Africa are being developed anew, stakeholders should consider implementing innovative technologies and approaches.

Indexed as

clinical researcheSourceGlobal HealthmHealthReverse Innovations

Identifiers

PMID28250964
PMCPMC5293854

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.