Self-selection vs Randomized Assignment of Treatment for Appendicitis.

Autor:	Davidson GH; University of Washington, Seattle, Washington., Monsell SE; University of Washington, Seattle, Washington., Evans H; Harborview Medical Center, Seattle, Washington.; Medical University of South Carolina, Charleston, South Carolina., Voldal EC; University of Washington, Seattle, Washington., Fannon E; University of Washington, Seattle, Washington., Lawrence SO; University of Washington, Seattle, Washington., Krishnadasan A; Olive View UCLA Medical Center, Los Angeles, California., Talan DA; Olive View UCLA Medical Center, Los Angeles, California.; Ronald Reagan UCLA Medical Center, Los Angeles, California., Bizzell B; University of Washington, Seattle, Washington., Heagerty PJ; University of Washington, Seattle, Washington., Comstock BA; University of Washington, Seattle, Washington., Lavallee DC; University of Washington, Seattle, Washington.; BC Academic Health Science Network, Vancouver, British Columbia, Canada., Villegas C; Weill Cornell Medical Center, New York, New York., Winchell R; Weill Cornell Medical Center, New York, New York., Thompson CM; Vanderbilt University Medical Center, Nashville, Tennessee.; University of Utah, Salt Lake City, Utah., Self WH; Vanderbilt University Medical Center, Nashville, Tennessee., Kao LS; McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas., Dodwad SJ; McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas., Sabbatini AK; University of Washington, Seattle, Washington., Droullard D; University of Washington, Seattle, Washington., Machado-Aranda D; Michigan Medicine, Ann Arbor, Michigan., Gibbons MM; Olive View UCLA Medical Center, Los Angeles, California., Kaji AH; Harbor UCLA Medical Center, Los Angeles, California.; Statistical Editor, JAMA Surgery., DeUgarte DA; Harbor UCLA Medical Center, Los Angeles, California., Ferrigno L; UCHealth University of Colorado Hospital, Denver, Colorado., Salzberg M; UCHealth University of Colorado Hospital, Denver, Colorado., Mandell KA; Swedish Medical Center, Seattle, Washington., Siparsky N; Rush University Medical Center, Chicago, Illinois., Price TP; Rush University Medical Center, Chicago, Illinois., Raman A; Providence Regional Medical Center, Everett, Washington., Corsa J; Providence Regional Medical Center, Everett, Washington., Wisler J; The Ohio State University Wexner Medical Center, Columbus, Ohio., Ayoung-Chee P; Tisch Hospital NYU Langone Medical Center, New York, New York.; Grady Health, Morehouse School of Medicine, Atlanta, Georgia., Victory J; Bellevue Hospital Center NYU School of Medicine, New York, New York., Jones A; University of Mississippi Medical Center, Jackson, Mississippi., Kutcher M; University of Mississippi Medical Center, Jackson, Mississippi., McGrane K; Madigan Army Medical Center, Tacoma, Washington.; Mason General Hospital, Shelton, Washington., Holihan J; University of Texas Lyndon B. Johnson General Hospital, Houston, Texas., Liang MK; University of Texas Lyndon B. Johnson General Hospital, Houston, Texas.; University of Houston, HCA Healthcare, Kingwood, Texas., Cuschieri J; Harborview Medical Center, Seattle, Washington.; University of California, San Francisco, San Francisco, California., Johnson J; Henry Ford Health System, Detroit, Michigan., Fischkoff K; Columbia University Medical Center, New York, New York., Drake FT; Boston University Medical Center, Massachusetts., Sanchez SE; Boston University Medical Center, Massachusetts., Odom SR; Beth Israel Deaconess Medical Center, Boston, Massachusetts., Kessler LG; University of Washington, Seattle, Washington., Flum DR; University of Washington, Seattle, Washington.
Jazyk:	angličtina
Zdroj:	JAMA surgery [JAMA Surg] 2022 Jul 01; Vol. 157 (7), pp. 598-608.
DOI:	10.1001/jamasurg.2022.1554
Abstrakt:	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.
Databáze:	MEDLINE
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