Journal article
Self-selection vs Randomized Assignment of Treatment for Appendicitis
JAMA surgery, Vol.157(7), pp.598-607
05/25/2022
DOI: 10.1001/jamasurg.2022.1554
PMCID: PMC9134042
PMID: 35612859
Abstract
For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ.
To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment.
The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy.
Appendectomy vs antibiotics.
Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment.
Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, -1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup.
This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large.
ClinicalTrials.gov Identifier: NCT02800785.
Details
- Title: Subtitle
- Self-selection vs Randomized Assignment of Treatment for Appendicitis
- Creators
- Giana H Davidson - University of WashingtonSarah E Monsell - University of WashingtonHeather Evans - Harborview Medical CenterEmily C Voldal - University of WashingtonErin Fannon - University of WashingtonSarah O Lawrence - University of WashingtonAnusha Krishnadasan - Olive View-UCLA Medical CenterDavid A Talan - Olive View-UCLA Medical CenterBonnie Bizzell - University of WashingtonPatrick J Heagerty - University of WashingtonBryan A Comstock - University of WashingtonDanielle C Lavallee - University of WashingtonCassandra Villegas - Cornell UniversityRobert Winchell - Cornell UniversityCallie M Thompson - Vanderbilt University Medical CenterWesley H Self - Vanderbilt University Medical CenterLillian S Kao - The University of Texas Health Science CenterShah-Jahan Dodwad - The University of Texas Health Science CenterAmber K Sabbatini - University of WashingtonDavid Droullard - University of WashingtonDavid Machado-Aranda - Michigan MedicineMelinda Maggard Gibbons - Olive View-UCLA Medical CenterAmy H Kaji - Harbor–UCLA Medical CenterDaniel A DeUgarte - Harbor–UCLA Medical CenterLisa Ferrigno - University of Colorado HospitalMatthew Salzberg - University of Colorado HospitalKatherine A Mandell - Swedish Medical Center, Seattle, WashingtonNicole Siparsky - Rush University Medical CenterThea P Price - Rush University Medical CenterAnooradha Raman - Providence Regional Medical Center EverettJoshua Corsa - Providence Regional Medical Center EverettJon Wisler - The Ohio State University Wexner Medical CenterPatricia Ayoung-Chee - Tisch HospitalJesse Victory - Bellevue Hospital CenterAlan Jones - University of Mississippi Medical CenterMatthew Kutcher - University of Mississippi Medical CenterKaren McGrane - Madigan Army Medical CenterJulie Holihan - Lyndon Baines Johnson HospitalMike K Liang - Lyndon Baines Johnson HospitalJoseph Cuschieri - Harborview Medical CenterJeffrey Johnson - Henry Ford Health SystemKatherine Fischkoff - Columbia University Irving Medical CenterF Thurston Drake - Boston Medical CenterSabrina E Sanchez - Boston Medical CenterStephen R Odom - Beth Israel Deaconess Medical CenterLarry G Kessler - University of WashingtonDavid R Flum - University of WashingtonWriting Group for the CODA Collaborative
- Resource Type
- Journal article
- Publication Details
- JAMA surgery, Vol.157(7), pp.598-607
- DOI
- 10.1001/jamasurg.2022.1554
- PMID
- 35612859
- PMCID
- PMC9134042
- ISSN
- 2168-6254
- eISSN
- 2168-6262
- Language
- English
- Date published
- 05/25/2022
- Academic Unit
- Emergency Medicine; Internal Medicine
- Record Identifier
- 9984297149402771
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