Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis
Writing Group for the CODA Collaborative, Charles S. Parsons, Stephen R. Odom, Randall Cooper, Katherine Fischkoff, Brant Putnam, Dennis Kim, Erin C. Howell, Lara H. Spence, Ross J. Fleischman, Erika M. Wolff, Farhood Farjah, Hikmatullah Arif, Kelsey Pullar, Laura Hennessey, Alyssa Hayward, Lillian Adrianna Hayes, Vance Y. Sohn, Bruce Chung, Damien Carter, David MacKenzie, Debra Burris, Joseph Mack, Terilee Gerry, Darin J. Saltzman, Debbie Mireles, Formosa Chen, Kavitha Pathmarajah, Paul J. Schmit, Robert S. Bennion, Melinda M. Gibbons, Bruce Wolfe, Elliott Skopin, Heather VanDusen, Kimberly Deeney, Mary Guiden, Meridith Weiss, Miriam Hernandez, Brandon Tudor, Careen Foster, Shaina Schaetzel, Arden M. Morris, Dayna Morgan, John Tschirhart, Julie A. Wallick, Katherine Mandell, Ryan Martinez, Sean Wells, Steven Steinberg, Jason Maggi, Kristyn Pierce, Marcovalerio Melis, Mohamad Abouzeid, Paresh Shah, Prashant Sinha, Cathy Fairfield, Dionne A. Skeete, Cindy Hsu, Krishnan Raghavendran, Nathan Haas, Norman Olbrich, Pauline Park, Hasan B. Alam, Deepti Patki, Rebekah K. Peacock, Donald M. Yealy, Debbie F. Lew, Karla Bernardi, Naila Dhanani, Oscar Olavarria, Stephanie Marquez, Tien C. Ko, Amber K. Sabbatini, Estell J. Williams, Karen Horvath, Zoe Parr, Karen F. Miller, Kelly M. Moser, Abigail Wiebusch, Julianna Yu, Scott Osborn, Billie Johnsson, Karla V. Ballman, Lauren Mount, Robert J. Winchell, Sunday Clark, Thomas Diflo, Kathleen O’Connor, Olga Owens, David A. Talan, Gregory J. Moran, Anusha Krishnadasan, Sarah E. Monsell, Brett Faine, Lisandra Uribe, Amy H. Kaji, Daniel A. DeUgarte, Wesley H. Self, Nathan I. Shapiro, Joseph Cuschieri
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.