Trial Participation and Outcomes Among English-Speaking and Spanish-Speaking Patients With Appendicitis Randomized to Antibiotics

Abstract

ImportanceSpanish-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.ObjectiveTo 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 ParticipantsThis 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.InterventionRandomization to a 10-day course of antibiotics or appendectomy.Main Outcomes and MeasuresTrial 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.ResultsAmong 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 RelevanceA 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 RegistrationClinicalTrials.gov Identifier: NCT02800785

Antibiotics or Appendectomy for Vulnerable Populations

“…Therefore, in terms of disability, the results suggest that Spanish-speaking participants benefit relatively more from antibiotics than English-speaking participants. Eighty-three percent of Spanish speakers reported poverty-level income compared with 22% of English speakers . Poverty-associated poor health and nutrition may have contributed to differences in recovery.…”

“…To the Editor In their Invited Commentary addressing the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial’s secondary analysis of its Spanish-speaking cohort, Peck and coauthors noted that in the appendectomy arm, Spanish-speaking patients missed 8 more workdays than English-speaking patients, which they asserted in the original text “suggests Spanish-speaking patients might do better with surgery from the onset.” However, when outcomes are compared between treatment groups, we see that Spanish-speaking participants who got urgent appendectomy missed substantially more work over 30 days than those treated with antibiotics, a mean time of 14.19 days (95% CI, 12.55-15.83) vs 6.69 days (95% CI, 5.51-7.87), respectively . This 7.50-day difference favoring antibiotics is greater than the between-group difference for the entire CODA population, 3.47 days at 90 days (mean, 8.73 vs 5.26 days, respectively) .…”

“…Another CODA trial secondary analysis found that, compared with hospitalization, outpatient nonoperative management of patients judged stable for discharge after an initial parenteral dose of a long-acting antibiotic regimen (with an oral antibiotic prescription) was safe and associated with 1 less day of lost work but no more appendectomies or return visits over the next 7 days . Out-of-pocket costs particularly affect people who are uninsured or underinsured and can be financially catastrophic; 53% of CODA’s Spanish speakers lacked commercial, Medicare, or Medicaid insurance compared with 18% of English speakers . The cost of outpatient antibiotic management would be projected to be significantly less than routine hospitalization and surgery, even taking into account some later care for recurrences.…”