Evidence map›Paper›PMID 21803926›Full record

SynthesisJournal of the American Medical Informatics Association : JAMIA

Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support.

K M Augestad, G Berntsen, K Lassen, J G Bellika, R Wootton, R O Lindsetmo, Study Group of Research Quality in Medical Informatics and Decision Support (SQUID)

Abstract readSystematic Review
In one paragraph

Synthesis in Journal of the American Medical Informatics Association : JAMIA. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 8 pooled it
–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

24 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  7. A systematic review of the implementation and impact of asthma protocols.BMC medical informatics and decision making · 2014
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  20. Meta-epidemiology.Epidemiology and health · 2014
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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

7 authors.

K M AugestadDepartment of Telemedicine and Integrated Care, University Hospital North Norway, Tromsø, Norway.
G Berntsen
K Lassen
J G Bellika
R Wootton
R O Lindsetmo
Study Group of Research Quality in Medical Informatics and Decision Support (SQUID)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe Consolidated Standards for Reporting Trials (CONSORT) were published to standardize reporting and improve the quality of clinical trials. The objective of this study is to assess CONSORT adherence in randomized clinical trials (RCT) of disease specific clinical decision support (CDS).

methodsA systematic search was conducted of the Medline, EMBASE, and Cochrane databases. RCTs on CDS were assessed against CONSORT guidelines and the Jadad score.

result32 of 3784 papers identified in the primary search were included in the final review. 181 702 patients and 7315 physicians participated in the selected trials. Most trials were performed in primary care (22), including 897 general practitioner offices. RCTs assessing CDS for asthma (4), diabetes (4), and hyperlipidemia (3) were the most common. Thirteen CDS systems (40%) were implemented in electronic medical records, and 14 (43%) provided automatic alerts. CONSORT and Jadad scores were generally low; the mean CONSORT score was 30.75 (95% CI 27.0 to 34.5), median score 32, range 21-38. Fourteen trials (43%) did not clearly define the study objective, and 11 studies (34%) did not include a sample size calculation. Outcome measures were adequately identified and defined in 23 (71%) trials; adverse events or side effects were not reported in 20 trials (62%). Thirteen trials (40%) were of superior quality according to the Jadad score (≥3 points). Six trials (18%) reported on long-term implementation of CDS.

conclusionThe overall quality of reporting RCTs was low. There is a need to develop standards for reporting RCTs in medical informatics.

Indexed as

Decision Support Systems, ClinicalGuideline AdherenceEvidence-Based MedicineGuidelines as TopicHumansMedical InformaticsPublishingQuality ControlRandomized Controlled Trials as TopicResearch Design

Identifiers

PMID21803926
PMCPMC3240766

What OpenQuestion holds

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LicenceCC BY-NC
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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.