J Am Med Inform Assoc - Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support.

Tópicos

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Resumo

TRODUCTION: 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. 181702 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.

Resumo Limpo

troduct consolid standard report trial consort publish standard report improv qualiti clinic trial object studi assess consort adher random clinic trial rct diseas specif clinic decis support cdsmethod systemat search conduct medlin embas cochran databas rcts cds assess consort guidelin jadad scoreresult paper identifi primari search includ final review patient physician particip select trial trial perform primari care includ general practition offic rcts assess cds asthma diabet hyperlipidemia common thirteen cds system implement electron medic record provid automat alert consort jadad score general low mean consort score ci median score rang fourteen trial clear defin studi object studi includ sampl size calcul outcom measur adequ identifi defin trial advers event side effect report trial thirteen trial superior qualiti accord jadad score point six trial report longterm implement cdsconclus overal qualiti report rcts low need develop standard report rcts medic informat

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