Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support
- K M Augestad1,2,
- G Berntsen1,
- K Lassen2,4,
- J G Bellika1,3,
- R Wootton1,
- R O Lindsetmo2,4,
- Study Group of Research Quality in Medical Informatics and Decision Support (SQUID)
- 1Department of Telemedicine and Integrated Care, University Hospital North Norway, Tromsø, Norway
- 2Department of Gastrointestinal Surgery, University Hospital North Norway, Tromsø, Norway
- 3Department of Computer Science, University of Tromsø, Tromsø, Norway
- 4Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway
- Correspondence to Dr Knut Magne Augestad, Department of Telemedicine and Integrated Care, University Hospital North Norway, 9037 Breivika, Tromsø, Norway;
Contributors Study concept and design: KMA and GB. Acquisition of data: GB and KMA. Analysis and interpretation of data: KMA, GB, RW, and KL. Drafting of the manuscript: KMA. Critical revision of the manuscript for important intellectual content: KMA, GB, KL, JGB, RW, and ROL. Statistical analysis: KMA and GB. Administrative, technical, and material support: KMA and GB. Study supervision: KMA, GB, JGB, and RW. KMA had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
- Received 31 May 2011
- Accepted 29 June 2011
- Published Online First 29 July 2011
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.
- Clinical decision support
- medical Informatics
- disease surveillance
- clinical decision support systems
Funding The Norwegian Health Authorities Research Fund supported this survey (grant number 40614).
Competing interests None.
Ethics approval No patients were involved in the survey and thus approval by the hospital IRB board was not required.
Provenance and Peer review Not commissioned; externally peer reviewed.
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