P-404 Usability, accuracy and cost-effectiveness of “eDiagEPU”, a medical software for early pregnancies: a retrospective study
Authors: Blavier F , Grobet D , Duflos C , Rayssiguier R , Ranisavljevic N , Percier M. Duport , Rodriguez A , Blockeel C , Ribeiro S. Dos Santos , Faron G , Gucciardo L , Fuchs F 
Published: June 2022

Study question

Can early pregnancies be accurately and cost-effectively diagnosed and managed using a new medical computerised tool, named “eDiagEPU”?

Summary answer

Compared to the standard clinical approach, the retrospective implementation of “eDiagEPU” in a gynaecological emergency unit was correlated with sharper diagnoses and more cost-effective managements.

What is known already

Early pregnancies complications are responsible for a large percentage of consultations, mostly in emergency units. Moreover, clinical guidelines updates for the management of Intrauterine Pregnancies of Uncertain Viability (IPUV) have become increasingly complex and seem to be unknown or misunderstood by several practitioners. Specifically, a recently published prospective multinational survey revealed a limited knowledge regarding early pregnancy guidelines, with 69.0% of the participants reporting incorrect managements of IPUV and 86.6% misinterpreting the evolution of serum human chorionic gonadotropin (hCG).

In an attempt to aid practitioners with the diagnosis and management of early pregnancies, a software, named “eDiagEPU”, was developed.

Study design, size, duration

A total of 780 consultations, recorded between November 2018 and June 2019 in the gynaecological emergency unit of a tertiary university hospital, were retrospectively encoded in eDiagEPU. Positive hCG, ultrasonographical visualisation of gestational sac or/and embryo corresponding to a gestational age of 14 weeks gestation or less were the inclusion criteria.

Diagnoses and managements suggested by eDiagEPU are named “eDiagnoses”. The ones provided by a gynaecologist member of the emergency department staff are called “medDiagnoses”.

Participants/materials, setting, methods

Identical eDiagnosis and medDiagnosis were considered as correct (gold standard). During follow-up examinations, if they became both identical to a previous discrepant eDiagnosis or medDiagnosis, this previous eDiagnosis/medDiagnosis was considered as correct. Persistent discrepancies were reviewed by four double-blinded experts whose majority defined the correct eDiagnosis/medDiagnosis.

The accuracies of eDiagnoses/medDiagnoses were compared using McNemar’s Chi square test, computing diagnostic values (Sensitivity, Specificity, and predictive values) and 95% Confidence Intervals (CI). Cost reduction was also analysed.

Main results and the role of chance

Only one datum (0.1%) from 780 registered medical records was missing to process using “eDiagEPU”. Out of the 779 consultations that could be fully encoded until obtaining an eDiagnosis, 675 eDiagnoses were identical to the medDiagnoses (86.6%) and 104 discrepant (13.4%). From these 104, 60 reached an agreement during follow-up controls with 59 medDiagnoses finally changing into the initial eDiagnoses (98%) while only one discrepant eDiagnosis turning later into the initial medDiagnosis (2%). Finally, 24 remained discrepant at all subsequent checks and 20 were not reevaluated. Out of these 44 discrepancies without identical diagnoses/managements during follow-up controls, the double-blinded experts majority chose 38 eDiagnoses (86%) and 5 medDiagnoses (11%) including 4 twin pregnancies whose twinness was the only discrepancy. One discrepant eDiagnosis/medDiagnosis reached no majority (2%).

In total, eDiagnoses accuracy was 99.1% (675 + 59 + 38=772 eDiagnoses out of 779 final diagnoses), vs 87.4% (675 + 1 + 5=681) for medDiagnoses accuracy (p &lt; 0.0001). Calculating all basic costs of consultations, medications, surgeries and hospitalisations induced by medDiagnoses versus eDiagnoses, “eDiagEPU” would have saved 3 623.75 € per month.

Retrospectively, “eDiaEPU” was usable (99.9%), more accurate for each diagnosis except twinning report and more cost-effective than standard clinical approach.

Limitations, reasons for caution

The retrospective design is a limitation, as well as the quality of ultrasound interpretation. Some improvements could not derive exclusively from “eDiagEPU” but also from the encoding by a rested or more experienced physician. This software cannot replace clinical and ultrasonographical skills but can improve the diagnostic and therapeutic reasoning.

Wider implications of the findings

An improved “eDiagEPU” version, considering the diagnosis and management of multiple pregnancies with their specificities (potentially multiple locations, chorioamnionicity) has been developed. Prospective evaluations will be required. Further development steps are considered, including software incorporation into ultrasound devices and integration of previously published predictive/prognostic factors (serum progesterone, corpus luteum scoring...).

Trial registration number

NCT03993015