In4medicine Inc, Bern, Switzerland.
Cantonal Hospital Baden, Baden, Switzerland.
J Med Internet Res. 2024 Jun 27;26:e58157. doi: 10.2196/58157.
Symptom-checkers have become important tools for self-triage, assisting patients to determine the urgency of medical care. To be safe and effective, these tools must be validated, particularly to avoid potentially hazardous undertriage without leading to inefficient overtriage. Only limited safety data from studies including small sample sizes have been available so far.
The objective of our study was to prospectively investigate the safety of patients' self-triage in a large patient sample. We used SMASS (Swiss Medical Assessment System; in4medicine, Inc) pathfinder, a symptom-checker based on a computerized transparent neural network.
We recruited 2543 patients into this single-center, prospective clinical trial conducted at the cantonal hospital of Baden, Switzerland. Patients with an Emergency Severity Index of 1-2 were treated by the team of the emergency department, while those with an index of 3-5 were seen at the walk-in clinic by general physicians. We compared the triage recommendation obtained by the patients' self-triage with the assessment of clinical urgency made by 3 successive interdisciplinary panels of physicians (panels A, B, and C). Using the Clopper-Pearson CI, we assumed that to confirm the symptom-checkers' safety, the upper confidence bound for the probability of a potentially hazardous undertriage should lie below 1%. A potentially hazardous undertriage was defined as a triage in which either all (consensus criterion) or the majority (majority criterion) of the experts of the last panel (panel C) rated the triage of the symptom-checker to be "rather likely" or "likely" life-threatening or harmful.
Of the 2543 patients, 1227 (48.25%) were female and 1316 (51.75%) male. None of the patients reached the prespecified consensus criterion for a potentially hazardous undertriage. This resulted in an upper 95% confidence bound of 0.1184%. Further, 4 cases met the majority criterion. This resulted in an upper 95% confidence bound for the probability of a potentially hazardous undertriage of 0.3616%. The 2-sided 95% Clopper-Pearson CI for the probability of overtriage (n=450 cases,17.69%) was 16.23% to 19.24%, which is considerably lower than the figures reported in the literature.
The symptom-checker proved to be a safe triage tool, avoiding potentially hazardous undertriage in a real-life clinical setting of emergency consultations at a walk-in clinic or emergency department without causing undesirable overtriage. Our data suggest the symptom-checker may be safely used in clinical routine.
ClinicalTrials.gov NCT04055298; https://clinicaltrials.gov/study/NCT04055298.
症状检查已成为自我分诊的重要工具，帮助患者确定医疗护理的紧迫性。为了安全有效，这些工具必须经过验证，特别是为了避免潜在的危险分诊而不会导致低效的过度分诊。迄今为止，只有来自包括小样本量在内的研究的有限安全性数据可用。
我们的研究目的是在大量患者样本中前瞻性地研究患者自我分诊的安全性。我们使用了基于计算机透明神经网络的症状检查器 SMASS（瑞士医疗评估系统；in4medicine，Inc）探路者。
我们在瑞士巴登州立医院进行了这项单中心前瞻性临床试验，共招募了 2543 名患者。急诊部的团队治疗紧急严重指数为 1-2 的患者，而紧急严重指数为 3-5 的患者则由普通医生在门诊就诊。我们将患者自我分诊的分诊建议与 3 个连续的跨学科医生小组（小组 A、B 和 C）的临床紧急程度评估进行了比较。使用 Clopper-Pearson CI，我们假设为了确认症状检查器的安全性，潜在危险分诊的概率的上限置信区间应低于 1%。潜在危险的分诊被定义为最后一个小组（小组 C）的专家中的所有（共识标准）或大多数（多数标准）都认为症状检查器的分诊“很可能”或“可能”危及生命或有害。
在 2543 名患者中，1227 名（48.25%）为女性，1316 名（51.75%）为男性。没有患者达到潜在危险分诊的共识标准。这导致上限 95%置信区间为 0.1184%。此外，有 4 例符合多数标准。这导致潜在危险分诊概率的上限 95%置信区间为 0.3616%。（450 例病例，17.69%）过度分诊的双侧 95% Clopper-Pearson CI 为 16.23%至 19.24%，远低于文献报告的数字。
该症状检查器被证明是一种安全的分诊工具，在门诊或急诊紧急咨询的真实临床环境中避免了潜在的危险分诊，而不会导致不必要的过度分诊。我们的数据表明，该症状检查器可以安全地用于临床常规。
ClinicalTrials.gov NCT04055298；https://clinicaltrials.gov/study/NCT04055298。
