Abstract：
Can early pregnancies be accurately and cost-effectively diagnosed and managed using a new medical computerized tool?
Compared to the standard clinical approach, retrospective implementation of the new medical software in a gynaecological emergency unit was correlated with more accurate diagnosis and more cost-effective management.
Early pregnancy complications are responsible for a large percentage of consultations, mostly in emergency units, with guidelines becoming complex and poorly known/misunderstood by practitioners.
A total of 780 gynaecological emergency consultations (446 patients), recorded between November 2018 and June 2019 in a tertiary university hospital, were retrospectively encoded in a new medical computerized tool. The inclusion criteria were a positive hCG test result, ultrasonographical visualization of gestational sac, and/or embryo corresponding to a gestational age of 14 weeks or less. Diagnosis and management suggested by the new computerized tool are named eDiagnoses, while those provided by a gynaecologist member of the emergency department staff are called medDiagnoses.
Usability was the primary endpoint, with accuracy and cost reduction, respectively, as secondary and tertiary endpoints. Identical eDiagnoses/medDiagnoses were considered as accurate. During follow-up visits, if the updated eDiagnoses and medDiagnoses became both identical to a previously discrepant eDiagnosis or medDiagnosis, this previous eDiagnosis or medDiagnosis was also considered as correct. Four double-blinded experts reviewed persistent discrepancies, determining the accurate diagnoses. eDiagnoses/medDiagnoses accuracies were compared using McNemar\'s Chi square test, sensitivity, specificity, and predictive values.
Only 1 (0.1%) from 780 registered medical records lacked data for full encoding. Out of the 779 remaining consultations, 675 eDiagnoses were identical to the medDiagnoses (86.6%) and 104 were discrepant (13.4%). From these 104, 60 reached an agreement during follow-up consultations, with 59 medDiagnoses ultimately changing into the initial eDiagnoses (98%) and only one discrepant eDiagnosis turning later into the initial medDiagnosis (2%). Finally, 24 remained discrepant at all subsequent checks and 20 were not re-evaluated. Out of these 44, the majority of experts agreed on 38 eDiagnoses (86%) and 5 medDiagnoses (11%, including four twin pregnancies whose twinness was the only discrepancy). No majority was reached for one discrepant eDiagnosis/medDiagnosis (2%). In total, the accuracy of eDiagnoses was 99.1% (675 + 59 + 38 = 772 eDiagnoses out of 779), versus 87.4% (675 + 1 + 5 = 681) for medDiagnoses (P < 0.0001). Calculating all basic costs of extra consultations, extra-medications, extra-surgeries, and extra-hospitalizations induced by incorrect medDiagnoses versus eDiagnoses, the new medical computerized tool would have saved 3623.75 Euros per month. Retrospectively, the medical computerized tool was usable in almost all the recorded cases (99.9%), globally more accurate (99.1% versus 87.4%), and for all diagnoses except twinning reports, and it was more cost-effective than the standard clinical approach.
The retrospective study design is a limitation. Some observed improvements with the medical software could derive from the encoding by a rested and/or more experienced physician who had a better ultrasound interpretation. This software cannot replace clinical and ultrasonographical skills but may improve the compliance to published guidelines.
This medical computerized tool is improving. A new version considers diagnosis and management of multiple pregnancies with their specificities (potentially multiple locations, chorioamnionicity). Prospective evaluations will be required. Further developmental steps are planned, including software incorporation into ultrasound devices and integration of previously published predictive/prognostic factors (e.g. serum progesterone, corpus luteum scoring).
No external funding was obtained for this study. F.B. and D.G. created the new medical software.
NCT03993015.
Compared to the standard clinical approach, retrospective implementation of the new medical software in a gynaecological emergency unit was correlated with more accurate diagnosis and more cost-effective management.
Early pregnancy complications are responsible for a large percentage of consultations, mostly in emergency units, with guidelines becoming complex and poorly known/misunderstood by practitioners.
A total of 780 gynaecological emergency consultations (446 patients), recorded between November 2018 and June 2019 in a tertiary university hospital, were retrospectively encoded in a new medical computerized tool. The inclusion criteria were a positive hCG test result, ultrasonographical visualization of gestational sac, and/or embryo corresponding to a gestational age of 14 weeks or less. Diagnosis and management suggested by the new computerized tool are named eDiagnoses, while those provided by a gynaecologist member of the emergency department staff are called medDiagnoses.
Usability was the primary endpoint, with accuracy and cost reduction, respectively, as secondary and tertiary endpoints. Identical eDiagnoses/medDiagnoses were considered as accurate. During follow-up visits, if the updated eDiagnoses and medDiagnoses became both identical to a previously discrepant eDiagnosis or medDiagnosis, this previous eDiagnosis or medDiagnosis was also considered as correct. Four double-blinded experts reviewed persistent discrepancies, determining the accurate diagnoses. eDiagnoses/medDiagnoses accuracies were compared using McNemar\'s Chi square test, sensitivity, specificity, and predictive values.
Only 1 (0.1%) from 780 registered medical records lacked data for full encoding. Out of the 779 remaining consultations, 675 eDiagnoses were identical to the medDiagnoses (86.6%) and 104 were discrepant (13.4%). From these 104, 60 reached an agreement during follow-up consultations, with 59 medDiagnoses ultimately changing into the initial eDiagnoses (98%) and only one discrepant eDiagnosis turning later into the initial medDiagnosis (2%). Finally, 24 remained discrepant at all subsequent checks and 20 were not re-evaluated. Out of these 44, the majority of experts agreed on 38 eDiagnoses (86%) and 5 medDiagnoses (11%, including four twin pregnancies whose twinness was the only discrepancy). No majority was reached for one discrepant eDiagnosis/medDiagnosis (2%). In total, the accuracy of eDiagnoses was 99.1% (675 + 59 + 38 = 772 eDiagnoses out of 779), versus 87.4% (675 + 1 + 5 = 681) for medDiagnoses (P < 0.0001). Calculating all basic costs of extra consultations, extra-medications, extra-surgeries, and extra-hospitalizations induced by incorrect medDiagnoses versus eDiagnoses, the new medical computerized tool would have saved 3623.75 Euros per month. Retrospectively, the medical computerized tool was usable in almost all the recorded cases (99.9%), globally more accurate (99.1% versus 87.4%), and for all diagnoses except twinning reports, and it was more cost-effective than the standard clinical approach.
The retrospective study design is a limitation. Some observed improvements with the medical software could derive from the encoding by a rested and/or more experienced physician who had a better ultrasound interpretation. This software cannot replace clinical and ultrasonographical skills but may improve the compliance to published guidelines.
This medical computerized tool is improving. A new version considers diagnosis and management of multiple pregnancies with their specificities (potentially multiple locations, chorioamnionicity). Prospective evaluations will be required. Further developmental steps are planned, including software incorporation into ultrasound devices and integration of previously published predictive/prognostic factors (e.g. serum progesterone, corpus luteum scoring).
No external funding was obtained for this study. F.B. and D.G. created the new medical software.
NCT03993015.
摘要：
目的：使用一种新的计算机化医疗工具能否准确且经济有效地诊断和管理早孕？
结论：与标准临床方法相比，新医疗软件在妇科急救室的回顾性实施与更准确的诊断和更具成本效益的管理相关.
背景：早孕并发症占咨询的比例很大，主要是在应急单位，指南变得复杂，从业者知之甚少/误解。
方法：总共780例妇科急诊咨询（446例患者），在2018年11月至2019年6月期间在一所三级大学医院记录，被回顾性地编码在一种新的医疗计算机化工具中。纳入标准是hCG测试结果阳性，妊娠囊的超声可视化，和/或对应于14周或更小的胎龄的胚胎。新的计算机化工具建议的诊断和管理被称为eDiagnoses，而由急诊科工作人员的妇科医生提供的那些被称为medDiagnoses。
方法：可用性是主要终点，准确性和成本降低，分别,作为二级和三级终点。相同的电子诊断/医学诊断被认为是准确的。在后续访问中，如果更新后的eDiagnoses和medDiagnoses与以前存在差异的eDiagnosis或medDiagnosis相同,以前的电子诊断或医学诊断也被认为是正确的。四位双盲专家审查了持续的差异，确定准确的诊断。使用McNemar卡方检验比较了eDiagnoses/medonses的准确性，灵敏度,特异性，和预测值。
结果：在780份登记的医疗记录中，只有1份（0.1%）缺乏完整编码的数据。在剩下的779次磋商中，675例eDiagnoses与medDiagnoses（86.6％）相同，104例差异（13.4％）。从这104个中，60个在后续磋商中达成了协议，59例medDiagnoses最终转变为最初的eDiagnoses(98%)，只有1例不同的eDiagnoses后来转变为最初的medDiagnoses(2%)。最后,在所有后续检查中，24项仍然存在差异，20项没有重新评估。在这44人中，大多数专家同意38次eDiagnoses(86%)和5次medDiagnoses(11%，包括四个双胞胎怀孕，其双胞胎是唯一的差异）。一项不一致的电子诊断/医学诊断(2%)没有达到大多数。总的来说,eDiagnoses的准确率为99.1%(779个中的675+59+38=772个eDiagnoses)，与治疗诊断的87.4%(675+1+5=681)相比(P<0.0001)。计算额外咨询的所有基本费用，额外的药物,额外的手术,以及由不正确的医疗诊断与诊断引起的额外住院，新的医疗计算机化工具每月可节省3623.75欧元。回顾过去,医学计算机化工具在几乎所有记录的病例中都可用(99.9%)，全球更准确(99.1%对87.4%)，除了孪生报告之外的所有诊断，并且比标准临床方法更具成本效益。
结论：回顾性研究设计是一个局限性。医疗软件的一些观察到的改进可以从具有更好超声解释的休息和/或更有经验的医师的编码中得出。该软件不能代替临床和超声检查技能，但可以提高对已发布指南的依从性。
结论：这种医疗计算机化工具正在改进。一个新的版本考虑了多胎妊娠的诊断和管理，其特殊性（可能是多个地点，绒毛膜羊膜性）。需要进行前瞻性评估。计划进一步的发展步骤，包括将软件整合到超声设备中，并整合先前发布的预测/预后因素(例如血清孕酮，黄体评分）。
背景：本研究未获得外部资助。F.B.和D.G.创建了新的医疗软件。
背景：NCT03993015。
结论：与标准临床方法相比，新医疗软件在妇科急救室的回顾性实施与更准确的诊断和更具成本效益的管理相关.
背景：早孕并发症占咨询的比例很大，主要是在应急单位，指南变得复杂，从业者知之甚少/误解。
方法：总共780例妇科急诊咨询（446例患者），在2018年11月至2019年6月期间在一所三级大学医院记录，被回顾性地编码在一种新的医疗计算机化工具中。纳入标准是hCG测试结果阳性，妊娠囊的超声可视化，和/或对应于14周或更小的胎龄的胚胎。新的计算机化工具建议的诊断和管理被称为eDiagnoses，而由急诊科工作人员的妇科医生提供的那些被称为medDiagnoses。
方法：可用性是主要终点，准确性和成本降低，分别,作为二级和三级终点。相同的电子诊断/医学诊断被认为是准确的。在后续访问中，如果更新后的eDiagnoses和medDiagnoses与以前存在差异的eDiagnosis或medDiagnosis相同,以前的电子诊断或医学诊断也被认为是正确的。四位双盲专家审查了持续的差异，确定准确的诊断。使用McNemar卡方检验比较了eDiagnoses/medonses的准确性，灵敏度,特异性，和预测值。
结果：在780份登记的医疗记录中，只有1份（0.1%）缺乏完整编码的数据。在剩下的779次磋商中，675例eDiagnoses与medDiagnoses（86.6％）相同，104例差异（13.4％）。从这104个中，60个在后续磋商中达成了协议，59例medDiagnoses最终转变为最初的eDiagnoses(98%)，只有1例不同的eDiagnoses后来转变为最初的medDiagnoses(2%)。最后,在所有后续检查中，24项仍然存在差异，20项没有重新评估。在这44人中，大多数专家同意38次eDiagnoses(86%)和5次medDiagnoses(11%，包括四个双胞胎怀孕，其双胞胎是唯一的差异）。一项不一致的电子诊断/医学诊断(2%)没有达到大多数。总的来说,eDiagnoses的准确率为99.1%(779个中的675+59+38=772个eDiagnoses)，与治疗诊断的87.4%(675+1+5=681)相比(P<0.0001)。计算额外咨询的所有基本费用，额外的药物,额外的手术,以及由不正确的医疗诊断与诊断引起的额外住院，新的医疗计算机化工具每月可节省3623.75欧元。回顾过去,医学计算机化工具在几乎所有记录的病例中都可用(99.9%)，全球更准确(99.1%对87.4%)，除了孪生报告之外的所有诊断，并且比标准临床方法更具成本效益。
结论：回顾性研究设计是一个局限性。医疗软件的一些观察到的改进可以从具有更好超声解释的休息和/或更有经验的医师的编码中得出。该软件不能代替临床和超声检查技能，但可以提高对已发布指南的依从性。
结论：这种医疗计算机化工具正在改进。一个新的版本考虑了多胎妊娠的诊断和管理，其特殊性（可能是多个地点，绒毛膜羊膜性）。需要进行前瞻性评估。计划进一步的发展步骤，包括将软件整合到超声设备中，并整合先前发布的预测/预后因素(例如血清孕酮，黄体评分）。
背景：本研究未获得外部资助。F.B.和D.G.创建了新的医疗软件。
背景：NCT03993015。
