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

Augestad, K. M., Berntsen, G., Lassen, K., Bellika, J. G., Wootton, R., Lindsetmo, R. O. and Study Group of Research Quality in Medical Informatics and Decision Support (SQUID) (2012) Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support. Journal of the American Medical Informatics Association, 19 1: 13-21. doi:10.1136/amiajnl-2011-000411


Author Augestad, K. M.
Berntsen, G.
Lassen, K.
Bellika, J. G.
Wootton, R.
Lindsetmo, R. O.
Study Group of Research Quality in Medical Informatics and Decision Support (SQUID)
Title Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support
Journal name Journal of the American Medical Informatics Association   Check publisher's open access policy
ISSN 1067-5027
1527-974X
Publication date 2012-01-01
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1136/amiajnl-2011-000411
Open Access Status DOI
Volume 19
Issue 1
Start page 13
End page 21
Total pages 9
Place of publication London, United Kingdom
Publisher B M J Group
Language eng
Subject 2718 Health Informatics
Formatted abstract
Introduction: The 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).

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

Result: 32 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.

Conclusion: The overall quality of reporting RCTs was low. There is a need to develop standards for reporting RCTs in medical informatics. 
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ
Additional Notes Published January/February 2012.

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: School of Medicine Publications
Centre for Online Health Publications
 
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