Diagnoses supported by a computerised diagnostic decision support system versus conventional diagnoses in emergency patients (DDX-BRO): a multicentre, multiple-period, double-blind, cluster-randomised, crossover superiority trial

Abstract

Background: Diagnostic error is a frequent and clinically relevant health-care problem. Whether computerised diagnostic decision support systems (CDDSSs) improve diagnoses is controversial, and prospective randomised trials investigating their effectiveness in routine clinical practice are scarce. We hypothesised that diagnoses made with a CDDSS in the emergency department setting would be superior to unsupported diagnoses.

Methods: This multicentre, multiple-period, double-blind, cluster-randomised, crossover superiority trial was done in four emergency departments in Switzerland. Eligible patients were adults (aged ≥18 years) presenting with abdominal pain, fever of unknown origin, syncope, or non-specific symptoms. Emergency departments were randomly assigned (1:1) to one of two predefined sequences of six alternating periods of intervention or control. Patients presenting during an intervention period were diagnosed with the aid of a CDDSS, whereas patients presenting during a control period were diagnosed without a CDDSS (usual care). Patients and personnel assessing outcomes were masked to group allocation; treating physicians were not. The primary binary outcome (false or true) was a composite score indicating a risk of reduced diagnostic quality, which was deemed to be present if any of the following occurred within 14 days: unscheduled medical care, a change in diagnosis, an unexpected intensive care unit admission within 24 h if initially admitted to hospital, or death. We assessed superiority of supported versus unsupported diagnoses in all consenting patients using a generalised linear mixed effects model. All participants who received any study treatment (including control) and completed the study were included in the safety analysis. This trial is registered with ClinicalTrials.gov (NCT05346523) and is closed to accrual.

Findings: Between June 9, 2022, and June 23, 2023, 15 845 patients were screened and 1204 (591 [49·1%] female and 613 [50·9%] male) were included in the primary efficacy analysis. The median age of participants was 53 years (IQR 34-69). Diagnostic quality risk was observed in 100 (18%) of 559 patients with CDDSS-supported diagnoses and 119 (18%) of 645 with unsupported diagnoses (adjusted odds ratio 0·96 [95% CI 0·71-1·3]). 94 (7·8%) patients suffered a serious adverse event, none related to the study.

Interpretation: Use of a CDDSS did not reduce the occurrence of diagnostic quality risk compared with the usual diagnostic process in adults presenting to emergency departments. Future research should aim to identify specific contexts in which CDDSSs are effective and how existing CDDSSs can be adapted to improve patient outcomes.

Funding: Swiss National Science Foundation and University Hospital Bern.