Département de Médecine d'Urgence, Angers University Hospital, Angers, France; UMR MitoVasc CNRS 6015-INSERM 1083, Health Faculty, Université Angers, Angers, France; FCRIN, INNOVTE, Angers, France.
Département de Médecine d'Urgence, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Bruxelles, Belgium.
Chest. 2021 Oct;160(4):1222-1231. doi: 10.1016/j.chest.2021.05.008. Epub 2021 May 15.
The Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection (HOME-CoV) rule is a checklist of eligibility criteria for home treatment of patients with COVID-19, defined using a Delphi method.
Is the HOME-CoV rule reliable for identifying a subgroup of COVID-19 patients with a low risk of adverse outcomes who can be treated at home safely?
We aimed to validate the HOME-CoV rule in a prospective, multicenter study before and after trial of patients with probable or confirmed COVID-19 who sought treatment at the ED of 34 hospitals. The main outcome was an adverse evolution, that is, invasive ventilation or death, occurring within the 7 days after patient admission. The performance of the rule was assessed by the false-negative rate. The impact of the rule implementation was assessed by the absolute differences in the rate of patients who required invasive ventilation or who died and in the rate of patients treated at home, between an observational and an interventional period after implementation of the HOME-CoV rule, with propensity score adjustment.
Among 3,000 prospectively enrolled patients, 1,239 (41.3%) demonstrated a negative HOME-CoV rule finding. The false-negative rate of the HOME-CoV rule was 4 in 1,239 (0.32%; 95% CI, 0.13%-0.84%), and its area under the receiver operating characteristic curve was 80.9 (95% CI, 76.5-85.2). On the adjusted populations, 25 of 1,274 patients (1.95%) experienced an adverse evolution during the observational period vs 12 of 1,274 patients (0.95%) during the interventional period: -1.00 (95% CI, -1.86 to -0.15). During the observational period, 858 patients (67.35%) were treated at home vs 871 patients (68.37%) during the interventional period: -1.02 (95% CI, -4.46 to 2.26).
A large proportion of patients treated in the ED with probable or confirmed COVID-19 have a negative HOME-CoV rule finding and can be treated safely at home with a very low risk of complications.
ClinicalTrials.gov; No.: NCT04338841; URL: www.clinicaltrials.gov.
SARS-CoV-2 感染患者的住院或门诊管理（HOME-CoV）规则是一种使用德尔菲方法定义的 COVID-19 患者居家治疗合格标准的清单。
HOME-CoV 规则是否可用于可靠识别具有低不良结局风险、可安全居家治疗的 COVID-19 患者亚组？
我们旨在通过前瞻性、多中心研究来验证该规则，该研究纳入了在 34 家医院急诊科就诊的疑似或确诊 COVID-19 患者，在试验前后进行。主要结局是患者入院后 7 天内发生不良转归，即需要有创通气或死亡。通过假阴性率评估规则的性能。通过倾向评分调整，比较实施 HOME-CoV 规则前后观察期和干预期的需要有创通气或死亡的患者比例以及居家治疗的患者比例的绝对差异，评估规则实施的影响。
在 3000 例前瞻性纳入的患者中，1239 例（41.3%）检测结果为 HOME-CoV 规则阴性。HOME-CoV 规则的假阴性率为 1239 例中的 4 例（0.32%；95%CI，0.13%-0.84%），其受试者工作特征曲线下面积为 80.9（95%CI，76.5-85.2）。在调整后的人群中，观察期内 1274 例患者中有 25 例（1.95%）发生不良转归，干预期内 1274 例患者中有 12 例（0.95%）发生不良转归：-1.00（95%CI，-1.86 至-0.15）。在观察期内，858 例患者（67.35%）居家治疗，干预期内 871 例患者（68.37%）居家治疗：-1.02（95%CI，-4.46 至 2.26）。
急诊科治疗的大量疑似或确诊 COVID-19 患者 HOME-CoV 规则检测结果为阴性，可安全居家治疗，并发症风险极低。
ClinicalTrials.gov；编号：NCT04338841；网址：www.clinicaltrials.gov。
