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Randomized Controlled Trial
. 2022 Jul 1;5(7):e2220039.
doi: 10.1001/jamanetworkopen.2022.20039.

Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis

Writing Group for the CODA Collaborative; David A Talan  1   2 , Gregory J Moran  2 , Anusha Krishnadasan  2 , Sarah E Monsell  3 , Brett A Faine  4 , Lisandra Uribe  2 , Amy H Kaji  5 , Daniel A DeUgarte  6 , Wesley H Self  7 , Nathan I Shapiro  8 , Joseph Cuschieri  9   10 , Jacob Glaser  11 , Pauline K Park  12 , Thea P Price  13 , Nicole Siparsky  13 , Sabrina E Sanchez  14 , David A Machado-Aranda  12 , Jesse Victory  15 , Patricia Ayoung-Chee  16   17 , William Chiang  10 , Joshua Corsa  11 , Heather L Evans  9   18 , Lisa Ferrigno  19 , Luis Garcia  20 , Quinton Hatch  21 , Marc D Horton  22 , Jeffrey Johnson  23 , Alan Jones  24 , Lillian S Kao  25 , Anton Kelly  26 , Daniel Kim  27 , Matthew E Kutcher  28 , Mike K Liang  29   30 , Nima Maghami  26 , Karen McGrane  14 , Elizaveta Minko  31 , Cassandra Mohr  25 , Miriam Neufeld  14 , Joe H Patton  23 , Colin Rog  19   22 , Amy Rushing  32   33 , Amber K Sabbatini  34 , Matthew Salzberg  35 , Callie M Thompson  36   37 , Aleksandr Tichter  38   39 , Jon Wisler  32 , Bonnie Bizzell  27 , Erin Fannon  27 , Sarah O Lawrence  27 , Emily C Voldal  3 , Danielle C Lavallee  27   40 , Bryan A Comstock  3 , Patrick J Heagerty  3 , Giana H Davidson  27 , David R Flum  27 , Larry G Kessler  41
Collaborators, Affiliations
Randomized Controlled Trial

Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis

Writing Group for the CODA Collaborative et al. JAMA Netw Open. .

Abstract

Importance: 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.

Objective: 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.

Exposures: 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.

Main outcomes and measures: 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.

Results: 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.

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT02800785.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Moran reported receiving grant support from Allergan, ContraFect, and Nabriva outside the submitted work. Dr Faine reported receiving grant support from Spero Therapeutics outside the submitted work. Dr Self reported receiving payment to his institution for his participation in this study during the conduct of the study. Dr Cuschieri reported receiving personal fees from Faraday Pharmaceuticals outside the submitted work and serving as an American College of Surgeons verification reviewer. Dr Park reported receiving grant support from Bristol Myers Squibb and Atox Bio outside the submitted work. Dr Price reported serving as a key opinion leader for Kerecis, Acera, and MEDLINE. Dr McGrane reported serving as an active-duty US Army officer employed by the US government (any views expressed do not represent the views of the US Army or the US Department of Defense). Dr Neufeld reported receiving grants from the National Institutes of Health outside the submitted work. Dr Evans reported receiving advisory board fees from Tetraphase Pharmaceuticals. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Time to Emergency Department (ED) Discharge of Sequentially Enrolled Participants Randomized to Receive Antibiotics at 25 US Comparison of Outcomes of Antibiotic Drugs and Appendectomy Trial Sites
Figure 2.
Figure 2.. Cumulative Incidence of Appendectomy Through 30 Days in the Antibiotic Group by Emergency Department (ED) Discharge Within 24 Hours or Later
Figure 3.
Figure 3.. Overall Appendectomy Rate Through 7 Days and Proportion of Participants Randomized to Receive Antibiotics Who Were Discharged From the Emergency Department Within 24 Hours by Investigative Site
See this image and copyright information in PMC

References

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