Cristin-resultat-ID: 862924
Sist endret: 18. november 2014 00:00
NVI-rapporteringsår: 2012
Resultat
Vitenskapelig oversiktsartikkel/review
2012

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

Bidragsytere:
  • Knut Magne Augestad
  • Gro Berntsen
  • Kristoffer Lassen
  • Johan Gustav Bellika
  • Richard Wootton og
  • Rolv-Ole Lindsetmo

Tidsskrift

Om resultatet

Importkilder

Finansiering

Beskrivelse

  • Engelsk

Tittel

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

Sammendrag

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.

Bidragsytere