Department of Emergency Medicine, Ronald Reagan UCLA Medical Center, Los Angeles, California.
Department of Emergency Medicine, Olive View-UCLA Medical Center, Los Angeles, California.
JAMA Netw Open. 2022 Jul 1;5(7):e2220039. doi: 10.1001/jamanetworkopen.2022.20039.
In the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial, which found antibiotics to be noninferior, approximately half of participants randomized to receive antibiotics had outpatient management with hospital discharge within 24 hours. If outpatient management is safe, it could increase convenience and decrease health care use and costs.
To assess the use and safety of outpatient management of acute appendicitis.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study, which is a secondary analysis of the CODA trial, included 776 adults with imaging-confirmed appendicitis who received antibiotics at 25 US hospitals from May 1, 2016, to February 28, 2020.
Participants randomized to antibiotics (intravenous then oral) could be discharged from the emergency department based on clinician judgment and prespecified criteria (hemodynamically stable, afebrile, oral intake tolerated, pain controlled, and follow-up confirmed). Outpatient management and hospitalization were defined as discharge within or after 24 hours, respectively.
Outcomes compared among patients receiving outpatient vs inpatient care included serious adverse events (SAEs), appendectomies, health care encounters, satisfaction, missed workdays at 7 days, and EuroQol 5-dimension (EQ-5D) score at 30 days. In addition, appendectomy incidence among outpatients and inpatients, unadjusted and adjusted for illness severity, was compared.
Among 776 antibiotic-randomized participants, 42 (5.4%) underwent appendectomy within 24 hours and 8 (1.0%) did not receive their first antibiotic dose within 24 hours, leaving 726 (93.6%) comprising the study population (median age, 36 years; range, 18-86 years; 462 [63.6%] male; 437 [60.2%] White). Of these participants, 335 (46.1%; site range, 0-89.2%) were discharged within 24 hours, and 391 (53.9%) were discharged after 24 hours. Over 7 days, SAEs occurred in 0.9 (95% CI, 0.2-2.6) per 100 outpatients and 1.3 (95% CI, 0.4-2.9) per 100 inpatients; in the appendicolith subgroup, SAEs occurred in 2.3 (95% CI, 0.3-8.2) per 100 outpatients vs 2.8 (95% CI, 0.6-7.9) per 100 inpatients. During this period, appendectomy occurred in 9.9% (95% CI, 6.9%-13.7%) of outpatients and 14.1% (95% CI, 10.8%-18.0%) of inpatients; adjusted analysis demonstrated a similar difference in incidence (-4.0 percentage points; 95% CI, -8.7 to 0.6). At 30 days, appendectomies occurred in 12.6% (95% CI, 9.1%-16.7%) of outpatients and 19.0% (95% CI, 15.1%-23.4%) of inpatients. Outpatients missed fewer workdays (2.6 days; 95% CI, 2.3-2.9 days) than did inpatients (3.8 days; 95% CI, 3.4-4.3 days) and had similar frequency of return health care visits and high satisfaction and EQ-5D scores.
These findings support that outpatient antibiotic management is safe for selected adults with acute appendicitis, with no greater risk of complications or appendectomy than hospital care, and should be included in shared decision-making discussions of patient preferences for outcomes associated with nonoperative and operative care.
ClinicalTrials.gov Identifier: NCT02800785.
在比较抗生素药物和阑尾切除术（CODA）试验的结果中，发现抗生素非劣效，大约一半随机接受抗生素治疗的参与者在 24 小时内接受门诊管理并出院。如果门诊管理是安全的，它可以增加便利性，并减少医疗保健的使用和成本。
评估急性阑尾炎门诊管理的使用和安全性。
设计、地点和参与者：本队列研究是 CODA 试验的二次分析，纳入了 2016 年 5 月 1 日至 2020 年 2 月 28 日在美国 25 家医院接受影像学证实的阑尾炎并接受抗生素治疗的 776 名成年人。
随机接受抗生素（静脉然后口服）治疗的参与者可以根据临床医生的判断和预设标准（血流动力学稳定、不发热、可耐受口服摄入、疼痛控制和随访确认）从急诊室出院。门诊管理和住院治疗分别定义为 24 小时内或之后出院。
接受门诊和住院治疗的患者之间的比较结果包括严重不良事件（SAE）、阑尾切除术、医疗保健就诊、满意度、7 天缺勤天数和 30 天的 EuroQol 5 维度（EQ-5D）评分。此外，还比较了门诊和住院患者的阑尾切除术发生率，未经调整和根据疾病严重程度调整后。
在 776 名接受抗生素随机分组的参与者中，42 名（5.4%）在 24 小时内接受了阑尾切除术，8 名（1.0%）在 24 小时内未接受首剂抗生素治疗，726 名（93.6%）构成了研究人群（中位数年龄 36 岁；范围 18-86 岁；462 [63.6%]为男性；437 [60.2%]为白人）。在这些参与者中，335 名（46.1%；站点范围 0-89.2%）在 24 小时内出院，391 名（53.9%）在 24 小时后出院。在 7 天内，每 100 名门诊患者中发生 0.9（95%CI，0.2-2.6）例 SAE，每 100 名住院患者中发生 1.3（95%CI，0.4-2.9）例 SAE；在阑尾结石亚组中，每 100 名门诊患者中发生 2.3（95%CI，0.3-8.2）例 SAE，每 100 名住院患者中发生 2.8（95%CI，0.6-7.9）例 SAE。在此期间，每 100 名门诊患者中发生 9.9%（95%CI，6.9%-13.7%）例阑尾切除术，每 100 名住院患者中发生 14.1%（95%CI，10.8%-18.0%）例阑尾切除术；调整分析显示，发病率存在相似差异（-4.0 个百分点；95%CI，-8.7 至 0.6）。在 30 天内，每 100 名门诊患者中发生 12.6%（95%CI，9.1%-16.7%）例阑尾切除术，每 100 名住院患者中发生 19.0%（95%CI，15.1%-23.4%）例阑尾切除术。门诊患者缺勤天数较少（2.6 天；95%CI，2.3-2.9 天），住院患者缺勤天数较多（3.8 天；95%CI，3.4-4.3 天），门诊患者就诊频率和满意度、EQ-5D 评分相似。
这些发现支持对选定的急性阑尾炎成年患者进行门诊抗生素管理是安全的，与住院治疗相比，并发症或阑尾切除术的风险没有增加，并且应该纳入与非手术和手术治疗相关的患者偏好结果的共同决策讨论中。
ClinicalTrials.gov 标识符：NCT02800785。
