Trial Participation and Outcomes Among English-Speaking and Spanish-Speaking Patients With Appendicitis Randomized to Antibiotics
Authors: Serrano Elina , Voldal Emily C. , Machado-Aranda David , DeUgarte Daniel A. , Kao Lillian , Drake Thurston , Winchell Robert , Cuschieri Joseph , Krishnadasan Anusha , Talan David A. , Siparsky Nicole , Ayoung-Chee Patricia , Self Wesley H. , McGonagill Patrick , Mandell Katherine A. , Liang Mike K. , Dodwad Shan-Jahan , Thompson Callie M. , Padilla Reynaldo M. , Fleischman Ross , Price Thea P. , Jones Alan , Bernardi Karla , Garcia Luis , Evans Heather L. , Sanchez Sabrina E. , Odom Stephen , Comstock Bryan A. , Heagerty Patrick J. , Lawrence Sarah O. , Monsell Sarah E. , Fannon Erin E.C. , Kessler Larry G. , Flum David R. , Davidson Giana H. ,   Writing Group for the CODA Collaborative, Abouzeid Mohamad , Alam Hasan B. , Arif Hikmatullah , Ballman Karla , Bennion Robert , Burris Debra , Carter Damien , Chen Formosa , Chung Bruce , Clark Sunday , Cooper Randall , Cuschieri Joseph , Deeney Kimberly , Dhanani Naila , Diflo Thomas , Fairfield Cathy , Farjah Farhood , Ferrigno Lisa , Foster Careen , Gerry Terilee , Gibbons Melinda , Guiden Mary , Haas Nathan , Hayes Lillian Adrianna , Hayward Alyssa , Hennessey Laura , Hernandez Miriam , Horvath Karen F. , Howell Erin C. , Hsu Cindy , Johnson Jeffrey , Johnsson Billie , Kim Dennis , Kim Daniel , Ko Tien C. , Lavallee Danielle C. , Lew Debbie , Mack Joseph , MacKenzie David , Maggi Jason , Marquez Stephanie , Martinez Ryan , McGrane Karen , Melis Marcovalerio , Miller Karen , Mireles Debbie , Moran Gregory J. , Morgan Dayna , Morris Arden , Moser Kelly M. , Mount Lauren , O'Connor Kathleen , Olavarria Oscar , Olbrich Norman , Osborn Scott , Owens Olga , Park Pauline , Parr Zoe , Parsons Charles S. , Pathmarajah Kavitha , Patki Deepti , Patton Joe H. , Peacock Rebekah K. , Pierce Kristyn , Pullar Kelsey , Putnam Brant , Rushing Amy , Sabbatini Amber , Saltzman Darin , Salzberg Matthew , Schaetzel Shaina , Schmidt Paul J , Shah Paresh , Shapiro Nathan I. , Sinha Prashant , Skeete Dionne , Skopin Elliott , Sohn Vance , Spence Lara H. , Steinberg Steven , Tichter Aleksandr , Tschirhart John , Tudor Brandon , Uribe Lisandra , VanDusen Heather , Wallick Julie , Weiss Meridith , Wells Sean , Wiebusch Abigail , Williams Estell J. , Winchell Robert J. , Wisler Jon , Wolfe Bruce , Wolff Erika , Yealy Donald M. , Yu Julianna 
Published: June 2023

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