Evidence map›Paper›PMID 21824421›Full record

ArticleTrials2011

Can an online clinical data management service help in improving data collection and data quality in a developing country setting?

Maarten A Wildeman, Jeroen Zandbergen, Andrew Vincent, Camelia Herdini, Jaap M Middeldorp, Renske Fles, Otilia Dalesio, Emile van der Donk, I Bing Tan

Abstract read
In one paragraph

Article in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Trial
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  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
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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

9 authors.

Maarten A WildemanDepartment of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute- Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands. m.wildeman@nki.nl
Jeroen Zandbergen
Andrew Vincent
Camelia Herdini
Jaap M Middeldorp
Renske Fles
Otilia Dalesio
Emile van der Donk
I Bing Tan

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundData collection by electronic medical record (EMR) systems have been proven to be helpful in data collection for scientific research and in improving healthcare. For a multi-centre trial in Indonesia and the Netherlands a web based system was selected to enable all participating centres to easily access data. This study assesses whether the introduction of a clinical trial data management service (CTDMS) composed of electronic case report forms (eCRF) can result in effective data collection and treatment monitoring.

methodsData items entered were checked for inconsistencies automatically when submitted online. The data were divided into primary and secondary data items. We analysed both the total number of errors and the change in error rate, for both primary and secondary items, over the first five month of the trial.

resultsIn the first five months 51 patients were entered. The primary data error rate was 1.6%, whilst that for secondary data was 2.7% against acceptable error rates for analysis of 1% and 2.5% respectively.

conclusionThe presented analysis shows that after five months since the introduction of the CTDMS the primary and secondary data error rates reflect acceptable levels of data quality. Furthermore, these error rates were decreasing over time. The digital nature of the CTDMS, as well as the online availability of that data, gives fast and easy insight in adherence to treatment protocols. As such, the CTDMS can serve as a tool to train and educate medical doctors and can improve treatment protocols.

Indexed as

Developing CountriesElectronic Health RecordsInternetResearch DesignAutomationBiomarkers, TumorCarcinomaClinical Trials as TopicHerpesvirus 4, HumanHumansIndonesiaInformation ManagementMulticenter Studies as TopicNasopharyngeal CarcinomaNasopharyngeal NeoplasmsNetherlandsBiomarkers, Tumor

Identifiers

PMID21824421
PMCPMC3175171

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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.