self selection vs randomized assignment of treatment for appendicitis

• < Previous

Home > SURGERY > SURGERY_ARTICLES > 593

Surgery Articles

Self-selection vs randomized assignment of treatment for appendicitis.

Giana H. Davidson Sarah E. Monsell Heather Evans Emily C. Voldal Erin Fannon Sarah O. Lawrence Anusha Krishnadasan David A. Talan Bonnie Bizzell Patrick J. Heagerty Bryan A. Comstock Danielle C. Lavallee Cassandra Villegas Robert Winchell Callie M. Thompson Wesley H. Self Lillian S. Kao Shah-Jahan Dodwad Amber K. Sabbatini David Droullard David Machado-Aranda Melinda Maggard Gibbons Amy H. Kaji Daniel A. DeUgarte Lisa Ferrigno Matthew Salzberg Katherine A. Mandell Nicole Siparsky Thea P. Price Anooradha Raman Joshua Corsa Jon Wisler Patricia Ayoung-Chee Jesse Victory Alan Jones Matthew Kutcher Karen McGrane Julie Holihan Mike K. Liang Joseph Cuschieri Jeffrey Johnson , Henry Ford Health Follow Katherine Fischkoff F. Thurston Drake Sabrina E. Sanchez Stephen R. Odom Larry G. Kessler David R. Flum

Recommended Citation

Davidson GH, Monsell SE, Evans H, Voldal EC, Fannon E, Lawrence SO, Krishnadasan A, Talan DA, Bizzell B, Heagerty PJ, Comstock BA, Lavallee DC, Villegas C, Winchell R, Thompson CM, Self WH, Kao LS, Dodwad SJ, Sabbatini AK, Droullard D, Machado-Aranda D, Gibbons MM, Kaji AH, DeUgarte DA, Ferrigno L, Salzberg M, Mandell KA, Siparsky N, Price TP, Raman A, Corsa J, Wisler J, Ayoung-Chee P, Victory J, Jones A, Kutcher M, McGrane K, Holihan J, Liang MK, Cuschieri J, Johnson J, Fischkoff K, Drake FT, Sanchez SE, Odom SR, Kessler LG, and Flum DR. Self-selection vs Randomized Assignment of Treatment for Appendicitis. JAMA Surg 2022.

Document Type

Publication date, publication title.

Importance: 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.

Objective: 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.

Design, Setting, and Participants: 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.

Interventions: Appendectomy vs antibiotics.

Main Outcomes and Measures: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment.

Results: 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.

Conclusions and Relevance: 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.

Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

ePublication

ePub ahead of print

Since June 24, 2022

Advanced Search

• Notify me via email or RSS
• Collections
• Disciplines
• Henry Ford Hospital Medical Journal

Author Corner

Home | About | FAQ | My Account | Accessibility Statement

Privacy Copyright