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Comment
. 2023 Sep 1;158(9):901-908.
doi: 10.1001/jamasurg.2023.2277.

Trial Participation and Outcomes Among English-Speaking and Spanish-Speaking Patients With Appendicitis Randomized to Antibiotics: A Secondary Analysis of the CODA Randomized Clinical Trial

Elina Serrano  1   2 , Emily C Voldal  1   2 , David Machado-Aranda  3 , Daniel A DeUgarte  4 , Lillian Kao  5 , Thurston Drake  6 , Robert Winchell  7 , Joseph Cuschieri  8   9 , Anusha Krishnadasan  10 , David A Talan  10   11 , Nicole Siparsky  12 , Patricia Ayoung-Chee  13   14   15 , Wesley H Self  16 , Patrick McGonagill  17 , Katherine A Mandell  12 , Mike K Liang  18   19 , Shan-Jahan Dodwad  5 , Callie M Thompson  16   20 , Reynaldo M Padilla  10 , Ross Fleischman  4 , Thea P Price  21 , Alan Jones  22 , Karla Bernardi  18 , Luis Garcia  17 , Heather L Evans  8   23 , Sabrina E Sanchez  6 , Stephen Odom  24 , Bryan A Comstock  1 , Patrick J Heagerty  1 , Sarah O Lawrence  1 , Sarah E Monsell  1 , Erin E C Fannon  1 , Larry G Kessler  1 , David R Flum  1 , Giana H Davidson  1 ; Writing Group for the CODA Collaborative
Collaborators, Affiliations
Comment

Trial Participation and Outcomes Among English-Speaking and Spanish-Speaking Patients With Appendicitis Randomized to Antibiotics: A Secondary Analysis of the CODA Randomized Clinical Trial

Elina Serrano et al. JAMA Surg. .

Abstract

Importance: Spanish-speaking participants are underrepresented in clinical trials, limiting study generalizability and contributing to ongoing health inequity. The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial intentionally included Spanish-speaking participants.

Objective: To describe trial participation and compare clinical and patient-reported outcomes among Spanish-speaking and English-speaking participants with acute appendicitis randomized to antibiotics.

Design, setting, and participants: This study is a secondary analysis of the CODA trial, a pragmatic randomized trial comparing antibiotic therapy with appendectomy in adult patients with imaging-confirmed appendicitis enrolled at 25 centers across the US from May 1, 2016, to February 28, 2020. The trial was conducted in English and Spanish. All 776 participants randomized to antibiotics are included in this analysis. The data were analyzed from November 15, 2021, through August 24, 2022.

Intervention: Randomization to a 10-day course of antibiotics or appendectomy.

Main outcomes and measures: Trial participation, European Quality of Life-5 Dimensions (EQ-5D) questionnaire scores (higher scores indicating a better health status), rate of appendectomy, treatment satisfaction, decisional regret, and days of work missed. Outcomes are also reported for a subset of participants that were recruited from the 5 sites with a large proportion of Spanish-speaking participants.

Results: Among eligible patients 476 of 1050 Spanish speakers (45%) and 1076 of 3982 of English speakers (27%) consented, comprising the 1552 participants who underwent 1:1 randomization (mean age, 38.0 years; 976 male [63%]). Of the 776 participants randomized to antibiotics, 238 were Spanish speaking (31%). Among Spanish speakers randomized to antibiotics, the rate of appendectomy was 22% (95% CI, 17%-28%) at 30 days and 45% (95% CI, 38%-52%) at 1 year, while in English speakers, these rates were 20% (95% CI, 16%-23%) at 30 days and 42% (95% CI 38%-47%) at 1 year. Mean EQ-5D scores were 0.93 (95% CI, 0.92-0.95) among Spanish speakers and 0.92 (95% CI, 0.91-0.93) among English speakers. Symptom resolution at 30 days was reported by 68% (95% CI, 61%-74%) of Spanish speakers and 69% (95% CI, 64%-73%) of English speakers. Spanish speakers missed 6.69 (95% CI, 5.51-7.87) days of work on average, while English speakers missed 3.76 (95% CI, 3.20-4.32) days. Presentation to the emergency department or urgent care, hospitalization, treatment dissatisfaction, and decisional regret were low for both groups.

Conclusions and relevance: A high proportion of Spanish speakers participated in the CODA trial. Clinical and most patient-reported outcomes were similar for English- and Spanish-speaking participants treated with antibiotics. Spanish speakers reported more days of missed work.

Trial registration: ClinicalTrials.gov Identifier: NCT02800785.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Serrano reported grants from the Patient-Centered Outcomes Research Institute (1409-24099) and the National Institute of Diabetes and Digestive and Kidney Diseases (T32 training grant; award T32DK070555) during the conduct of the study. Dr Evans reported advisory board fees from Crely outside the submitted work. Dr Fannon reported contract fees from the University of Washington and the Patient-Centered Outcomes Research Institute during the conduct of the study. Dr Flum reported contract fees from University of Washington and the Patient-Centered Outcomes Research Institute (1409-24099) during the conduct of the study. Dr. Liao reported personal fees from the Kaiser Permanente Washington Health Research Institute; honoraria from Wolters Kluwer, the Journal of Clinical Pathways, and the American College of Physicians; and grants from the National Institute of Aging; all outside of the submitted work. Dr. Thompson reported serving as a reviewer for the Shriner’s Research Fund and receiving personal fees from UpToDate. Dr Price reported association with Kerecis, Acera, and Medline as a key opinion leader. Dr Evans reported advisory board fees from Tetraphase Pharmaceuticals. No other disclosures were reported.

Comment on

References

    1. US Census Bureau . Language spoken at home, 2019: 5-year American Community Survey estimates. Accessed May 18, 2023. https://data.census.gov/cedsci/table?q=Language%20&tid=ACSST5Y2019.S1601.... https://data.census.gov/cedsci/table?q=ACSDT5Y2019.B16001&tid=ACSDT5Y201...
    1. Rumbaut RG, Massey DS. Immigration and language diversity in the United States. Daedalus. 2013;142(3):141-154. doi:10.1162/DAED_a_00224 - DOI - PMC - PubMed
    1. Ponce NA, Hays RD, Cunningham WE. Linguistic disparities in health care access and health status among older adults. J Gen Intern Med. 2006;21(7):786-791. doi:10.1111/j.1525-1497.2006.00491.x - DOI - PMC - PubMed
    1. Divi C, Koss RG, Schmaltz SP, Loeb JM. Language proficiency and adverse events in US hospitals: a pilot study. Int J Qual Health Care. 2007;19(2):60-67. doi:10.1093/intqhc/mzl069 - DOI - PubMed
    1. John-Baptiste A, Naglie G, Tomlinson G, et al. . The effect of English language proficiency on length of stay and in-hospital mortality. J Gen Intern Med. 2004;19(3):221-228. doi:10.1111/j.1525-1497.2004.21205.x - DOI - PMC - PubMed

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