24 results on '"Talan DA"'
Search Results
2. Antibiotics or Appendectomy for Vulnerable Populations.
- Author
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Talan DA, Machado-Aranda D, and Saltzman D
- Subjects
- Humans, Appendectomy, Vulnerable Populations, Treatment Outcome, Anti-Bacterial Agents therapeutic use, Appendicitis surgery
- Published
- 2024
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3. 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.
- Author
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Serrano E, Voldal EC, Machado-Aranda D, DeUgarte DA, Kao L, Drake T, Winchell R, Cuschieri J, Krishnadasan A, Talan DA, Siparsky N, Ayoung-Chee P, Self WH, McGonagill P, Mandell KA, Liang MK, Dodwad SJ, Thompson CM, Padilla RM, Fleischman R, Price TP, Jones A, Bernardi K, Garcia L, Evans HL, Sanchez SE, Odom S, Comstock BA, Heagerty PJ, Lawrence SO, Monsell SE, Fannon EEC, Kessler LG, Flum DR, and Davidson GH
- Subjects
- Adult, Humans, Male, Quality of Life, Appendectomy statistics & numerical data, Language, Anti-Bacterial Agents therapeutic use, Appendicitis drug therapy, Appendicitis surgery
- 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.
- Published
- 2023
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4. Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.
- Author
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Thompson CM, Voldal EC, Davidson GH, Sanchez SE, Ayoung-Chee P, Victory J, Guiden M, Bizzell B, Glaser J, Hults C, Price TP, Siparsky N, Ohe K, Mandell KA, DeUgarte DA, Kaji AH, Uribe L, Kao LS, Mueck KM, Farjah F, Self WH, Clark S, Drake FT, Fischkoff K, Minko E, Cuschieri J, Faine B, Skeete DA, Dhanani N, Liang MK, Krishnadasan A, Talan DA, Fannon E, Kessler LG, Comstock BA, Heagerty PJ, Monsell SE, Lawrence SO, Flum DR, and Lavallee DC
- Subjects
- Humans, Perception, Treatment Outcome, Anti-Bacterial Agents therapeutic use, Appendectomy, Appendicitis drug therapy, Appendicitis surgery
- Abstract
Objective: To compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days., Summary Background Data: The Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes., Methods: We focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations., Results: The pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret., Conclusions: Overall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals., Trial Registration: Clinicaltrials.gov Identifier: NCT02800785., Competing Interests: The authors report information from Price and Faine should read the remaining authors report no conflicts of interest., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)
- Published
- 2023
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5. Management of Acute Uncomplicated Appendicitis.
- Author
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Talan DA and Salminen P
- Subjects
- Humans, Anti-Bacterial Agents therapeutic use, Length of Stay, Acute Disease, Appendectomy, Appendicitis surgery, Appendicitis drug therapy
- Published
- 2023
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6. Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes: A Secondary Analysis of the CODA Randomized Clinical Trial.
- Author
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Zhang IY, Voldal EC, Davidson GH, Liao JM, Thompson CM, Self WH, Kao LS, Cherry-Bukowiec J, Raghavendran K, Kaji AH, DeUgarte DA, Gonzalez E, Mandell KA, Ohe K, Siparsky N, Price TP, Evans DC, Victory J, Chiang W, Jones A, Kutcher ME, Ciomperlik H, Liang MK, Evans HL, Faine BA, Neufeld M, Sanchez SE, Krishnadasan A, Comstock BA, Heagerty PJ, Lawrence SO, Monsell SE, Fannon EEC, Kessler LG, Talan DA, and Flum DR
- Subjects
- Humans, Male, Adult, Anti-Bacterial Agents therapeutic use, Appendectomy, Treatment Outcome, Surveys and Questionnaires, Appendicitis drug therapy, Appendicitis surgery, Appendicitis complications
- Abstract
Importance: A patient's belief in the likely success of a treatment may influence outcomes, but this has been understudied in surgical trials., Objective: To examine the association between patients' baseline beliefs about the likelihood of treatment success with outcomes of antibiotics for appendicitis in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial., Design, Setting, and Participants: This was a secondary analysis of the CODA randomized clinical trial. Participants from 25 US medical centers were enrolled between May 3, 2016, and February 5, 2020. Included in the analysis were participants with appendicitis who were randomly assigned to receive antibiotics in the CODA trial. After informed consent but before randomization, participants who were assigned to receive antibiotics responded to a baseline survey including a question about how successful they believed antibiotics could be in treating their appendicitis., Interventions: Participants were categorized based on baseline survey responses into 1 of 3 belief groups: unsuccessful/unsure, intermediate, and completely successful., Main Outcomes and Measures: Three outcomes were assigned at 30 days: (1) appendectomy, (2) high decisional regret or dissatisfaction with treatment, and (3) persistent signs and symptoms (abdominal pain, tenderness, fever, or chills). Outcomes were compared across groups using adjusted risk differences (aRDs), with propensity score adjustment for sociodemographic and clinical factors., Results: Of the 776 study participants who were assigned antibiotic treatment in CODA, a total of 425 (mean [SD] age, 38.5 [13.6] years; 277 male [65%]) completed the baseline belief survey before knowing their treatment assignment. Baseline beliefs were as follows: 22% of participants (92 of 415) had an unsuccessful/unsure response, 51% (212 of 415) had an intermediate response, and 27% (111 of 415) had a completely successful response. Compared with the unsuccessful/unsure group, those who believed antibiotics could be completely successful had a 13-percentage point lower risk of appendectomy (aRD, -13.49; 95% CI, -24.57 to -2.40). The aRD between those with intermediate vs unsuccessful/unsure beliefs was -5.68 (95% CI, -16.57 to 5.20). Compared with the unsuccessful/unsure group, those with intermediate beliefs had a lower risk of persistent signs and symptoms (aRD, -15.72; 95% CI, -29.71 to -1.72), with directionally similar results for the completely successful group (aRD, -15.14; 95% CI, -30.56 to 0.28)., Conclusions and Relevance: Positive patient beliefs about the likely success of antibiotics for appendicitis were associated with a lower risk of appendectomy and with resolution of signs and symptoms by 30 days. Pathways relating beliefs to outcomes and the potential modifiability of beliefs to improve outcomes merit further investigation., Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.
- Published
- 2022
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7. Result Interpretation in Nonoperative Management of Uncomplicated Appendicitis.
- Author
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Minneci PC, Talan DA, and Deans KJ
- Subjects
- Humans, Appendectomy, Anti-Bacterial Agents therapeutic use, Treatment Outcome, Acute Disease, Appendicitis diagnosis, Appendicitis therapy, Appendicitis complications, Laparoscopy
- Published
- 2022
- Full Text
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8. Association of Appendicitis Incidence With Warmer Weather Independent of Season.
- Author
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Simmering JE, Polgreen LA, Talan DA, Cavanaugh JE, and Polgreen PM
- Subjects
- Acute Disease, Adult, Aged, Cohort Studies, Humans, Incidence, Male, Medicare, Seasons, United States epidemiology, Weather, Appendicitis epidemiology
- Abstract
Importance: Acute appendicitis is a common cause of abdominal pain and the most common reason for emergency surgery in several countries. Increased cases during summer months have been reported., Objective: To investigate the incidence of acute appendicitis by considering local temperature patterns in geographic regions with different climate over several years., Design, Setting, and Participants: This cohort study used insurance claims data from the MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefits Database from January 1, 2001, to December 31, 2017. The cohort included individuals at risk for appendicitis who were enrolled in US insurance plans that contribute data to the MarketScan databases. Cases of appendicitis in the inpatient, outpatient, and emergency department settings were identified using International Classification of Diseases, Ninth Revision, Clinical Modification or International Statistical Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes. Local weather data were obtained for individuals living in a metropolitan statistical area (MSA) from the Integrated Surface Database. Associations were characterized using a fixed-effects generalized linear model based on a negative binomial distribution. The model was adjusted for age, sex, and day of week and included fixed effects for year and MSA. The generalized linear model was fit with a piecewise linear model by searching each 0.56 °C in temperature for change points. To further isolate the role of temperature, observed temperature was replaced with the expected temperature and the deviation of the observed temperature from the expected temperature for a given city on a given day of year. Data were analyzed from October 1, 2021, to July 31, 2022., Main Outcomes and Measures: The primary outcome was the daily number of appendicitis cases in a given city stratified by age and sex, with mean temperature in the MSA over the previous 7 days as the independent variable., Results: A total of 450 723 744 person-years at risk and 689 917 patients with appendicitis (mean [SD] age, 35 [18] years; 347 473 male [50.4%] individuals) were included. Every 5.56 °C increase in temperature was associated with a 1.3% increase in the incidence of appendicitis (incidence rate ratio [IRR], 1.01; 95% CI, 1.01-1.02) when temperatures were 10.56 °C or lower and a 2.9% increase in incidence (IRR, 1.03; 95% CI, 1.03-1.03) for temperatures higher than 10.56 °C. In terms of temperature deviations, a higher-than-expected temperature increase greater than 5.56 °C was associated with a 3.3% (95% CI, 1.0%-5.7%) increase in the incidence of appendicitis compared with days with near-0 deviations., Conclusions and Relevance: Results of this cohort study observed seasonality in the incidence of appendicitis and found an association between increased incidence and warmer weather. These results could help elucidate the mechanism of appendicitis.
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- 2022
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9. Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis.
- Author
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Talan DA, Moran GJ, Krishnadasan A, Monsell SE, Faine BA, Uribe L, Kaji AH, DeUgarte DA, Self WH, Shapiro NI, Cuschieri J, Glaser J, Park PK, Price TP, Siparsky N, Sanchez SE, Machado-Aranda DA, Victory J, Ayoung-Chee P, Chiang W, Corsa J, Evans HL, Ferrigno L, Garcia L, Hatch Q, Horton MD, Johnson J, Jones A, Kao LS, Kelly A, Kim D, Kutcher ME, Liang MK, Maghami N, McGrane K, Minko E, Mohr C, Neufeld M, Patton JH, Rog C, Rushing A, Sabbatini AK, Salzberg M, Thompson CM, Tichter A, Wisler J, Bizzell B, Fannon E, Lawrence SO, Voldal EC, Lavallee DC, Comstock BA, Heagerty PJ, Davidson GH, Flum DR, and Kessler LG
- Subjects
- Acute Disease, Adult, Anti-Bacterial Agents therapeutic use, Appendectomy adverse effects, Cohort Studies, Female, Humans, Male, Outpatients, Appendicitis complications, Appendicitis surgery
- Abstract
Importance: In the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial, which found antibiotics to be noninferior, approximately half of participants randomized to receive antibiotics had outpatient management with hospital discharge within 24 hours. If outpatient management is safe, it could increase convenience and decrease health care use and costs., Objective: To assess the use and safety of outpatient management of acute appendicitis., Design, Setting, and Participants: This cohort study, which is a secondary analysis of the CODA trial, included 776 adults with imaging-confirmed appendicitis who received antibiotics at 25 US hospitals from May 1, 2016, to February 28, 2020., Exposures: Participants randomized to antibiotics (intravenous then oral) could be discharged from the emergency department based on clinician judgment and prespecified criteria (hemodynamically stable, afebrile, oral intake tolerated, pain controlled, and follow-up confirmed). Outpatient management and hospitalization were defined as discharge within or after 24 hours, respectively., Main Outcomes and Measures: Outcomes compared among patients receiving outpatient vs inpatient care included serious adverse events (SAEs), appendectomies, health care encounters, satisfaction, missed workdays at 7 days, and EuroQol 5-dimension (EQ-5D) score at 30 days. In addition, appendectomy incidence among outpatients and inpatients, unadjusted and adjusted for illness severity, was compared., Results: Among 776 antibiotic-randomized participants, 42 (5.4%) underwent appendectomy within 24 hours and 8 (1.0%) did not receive their first antibiotic dose within 24 hours, leaving 726 (93.6%) comprising the study population (median age, 36 years; range, 18-86 years; 462 [63.6%] male; 437 [60.2%] White). Of these participants, 335 (46.1%; site range, 0-89.2%) were discharged within 24 hours, and 391 (53.9%) were discharged after 24 hours. Over 7 days, SAEs occurred in 0.9 (95% CI, 0.2-2.6) per 100 outpatients and 1.3 (95% CI, 0.4-2.9) per 100 inpatients; in the appendicolith subgroup, SAEs occurred in 2.3 (95% CI, 0.3-8.2) per 100 outpatients vs 2.8 (95% CI, 0.6-7.9) per 100 inpatients. During this period, appendectomy occurred in 9.9% (95% CI, 6.9%-13.7%) of outpatients and 14.1% (95% CI, 10.8%-18.0%) of inpatients; adjusted analysis demonstrated a similar difference in incidence (-4.0 percentage points; 95% CI, -8.7 to 0.6). At 30 days, appendectomies occurred in 12.6% (95% CI, 9.1%-16.7%) of outpatients and 19.0% (95% CI, 15.1%-23.4%) of inpatients. Outpatients missed fewer workdays (2.6 days; 95% CI, 2.3-2.9 days) than did inpatients (3.8 days; 95% CI, 3.4-4.3 days) and had similar frequency of return health care visits and high satisfaction and EQ-5D scores., Conclusions and Relevance: These findings support that outpatient antibiotic management is safe for selected adults with acute appendicitis, with no greater risk of complications or appendectomy than hospital care, and should be included in shared decision-making discussions of patient preferences for outcomes associated with nonoperative and operative care., Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.
- Published
- 2022
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10. Self-selection vs Randomized Assignment of Treatment for Appendicitis.
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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
- Subjects
- Adult, Female, Humans, Patient Selection, Research Design, Treatment Outcome, Anti-Bacterial Agents therapeutic use, Appendectomy, Appendicitis complications, Appendicitis drug therapy, Appendicitis surgery
- Abstract
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.
- Published
- 2022
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11. Diagnosis and Management of Acute Appendicitis.
- Author
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Talan DA
- Subjects
- Acute Disease, Humans, Appendicitis diagnosis, Appendicitis surgery
- Published
- 2022
- Full Text
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12. Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis.
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Monsell SE, Voldal EC, Davidson GH, Fischkoff K, Coleman N, Bizzell B, Price T, Narayan M, Siparsky N, Thompson CM, Ayoung-Chee P, Odom SR, Sanchez S, Drake FT, Johnson J, Cuschieri J, Evans HL, Liang MK, McGrane K, Hatch Q, Victory J, Wisler J, Salzberg M, Ferrigno L, Kaji A, DeUgarte DA, Gibbons MM, Alam HB, Scott J, Kao LS, Self WH, Winchell RJ, Villegas CM, Talan DA, Kessler LG, Lavallee DC, Krishnadasan A, Lawrence SO, Comstock B, Fannon E, Flum DR, and Heagerty PJ
- Subjects
- Adult, Anti-Bacterial Agents therapeutic use, Appendectomy adverse effects, Cohort Studies, Female, Humans, Male, Treatment Outcome, Appendicitis complications, Appendicitis drug therapy, Appendicitis surgery, Appendix
- Abstract
Importance: Use of antibiotics for the treatment of appendicitis is safe and has been found to be noninferior to appendectomy based on self-reported health status at 30 days. Identifying patient characteristics associated with a greater likelihood of appendectomy within 30 days in those who initiate antibiotics could support more individualized decision-making., Objective: To assess patient factors associated with undergoing appendectomy within 30 days of initiating antibiotics for appendicitis., Design, Setting, and Participants: In this cohort study using data from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial, characteristics among patients who initiated antibiotics were compared between those who did and did not undergo appendectomy within 30 days. The study was conducted at 25 US medical centers; participants were enrolled between May 3, 2016, and February 5, 2020. A total of 1552 participants with acute appendicitis were randomized to antibiotics (776 participants) or appendectomy (776 participants). Data were analyzed from September 2020 to July 2021., Exposures: Appendectomy vs antibiotics., Main Outcomes and Measures: Conditional logistic regression models were fit to estimate associations between specific patient factors and the odds of undergoing appendectomy within 30 days after initiating antibiotics. A sensitivity analysis was performed excluding participants who underwent appendectomy within 30 days for nonclinical reasons., Results: Of 776 participants initiating antibiotics (mean [SD] age, 38.3 [13.4] years; 286 [37%] women and 490 [63%] men), 735 participants had 30-day outcomes, including 154 participants (21%) who underwent appendectomy within 30 days. After adjustment for other factors, female sex (odds ratio [OR], 1.53; 95% CI, 1.01-2.31), radiographic finding of wider appendiceal diameter (OR per 1-mm increase, 1.09; 95% CI, 1.00-1.18), and presence of appendicolith (OR, 1.99; 95% CI, 1.28-3.10) were associated with increased odds of undergoing appendectomy within 30 days. Characteristics that are often associated with increased risk of complications (eg, advanced age, comorbid conditions) and those clinicians often use to describe appendicitis severity (eg, fever: OR, 1.28; 95% CI, 0.82-1.98) were not associated with odds of 30-day appendectomy. The sensitivity analysis limited to appendectomies performed for clinical reasons provided similar results regarding appendicolith (adjusted OR, 2.41; 95% CI, 1.49-3.91)., Conclusions and Relevance: This cohort study found that presence of an appendicolith was associated with a nearly 2-fold increased risk of undergoing appendectomy within 30 days of initiating antibiotics. Clinical characteristics often used to describe severity of appendicitis were not associated with odds of 30-day appendectomy. This information may help guide more individualized decision-making for people with appendicitis.
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- 2022
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13. Antibiotics versus Appendectomy for Acute Appendicitis - Longer-Term Outcomes.
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Davidson GH, Flum DR, Monsell SE, Kao LS, Voldal EC, Heagerty PJ, Fannon E, Lavallee DC, Bizzell B, Lawrence SO, Comstock BA, Krishnadasan A, Winchell RJ, Self WH, Thompson CM, Farjah F, Park PK, Alam HB, Saltzman D, Moran GJ, Kaji AH, DeUgarte DA, Salzberg M, Ferrigno L, Mandell KA, Price TP, Siparsky N, Glaser J, Ayoung-Chee P, Chiang W, Victory J, Chung B, Carter DW, Kutcher ME, Jones A, Holihan J, Liang MK, Faine BA, Cuschieri J, Evans HL, Johnson J, Patton JH, Coleman N, Fischkoff K, Drake FT, Sanchez SE, Parsons C, Odom SR, Kessler LG, and Talan DA
- Subjects
- Acute Disease, Appendicitis complications, Humans, Lithiasis complications, Anti-Bacterial Agents therapeutic use, Appendectomy statistics & numerical data, Appendicitis drug therapy, Appendicitis surgery
- Published
- 2021
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14. Treatment of Acute Uncomplicated Appendicitis.
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Talan DA and Di Saverio S
- Subjects
- Acute Disease, Adult, Analgesics therapeutic use, Anti-Bacterial Agents adverse effects, Appendicitis diagnostic imaging, Appendix diagnostic imaging, Appendix pathology, Female, Humans, Lithiasis diagnostic imaging, Patient Participation, Practice Guidelines as Topic, Anti-Bacterial Agents therapeutic use, Appendectomy adverse effects, Appendicitis drug therapy, Appendicitis surgery
- Published
- 2021
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15. A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.
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Flum DR, Davidson GH, Monsell SE, Shapiro NI, Odom SR, Sanchez SE, Drake FT, Fischkoff K, Johnson J, Patton JH, Evans H, Cuschieri J, Sabbatini AK, Faine BA, Skeete DA, Liang MK, Sohn V, McGrane K, Kutcher ME, Chung B, Carter DW, Ayoung-Chee P, Chiang W, Rushing A, Steinberg S, Foster CS, Schaetzel SM, Price TP, Mandell KA, Ferrigno L, Salzberg M, DeUgarte DA, Kaji AH, Moran GJ, Saltzman D, Alam HB, Park PK, Kao LS, Thompson CM, Self WH, Yu JT, Wiebusch A, Winchell RJ, Clark S, Krishnadasan A, Fannon E, Lavallee DC, Comstock BA, Bizzell B, Heagerty PJ, Kessler LG, and Talan DA
- Subjects
- Absenteeism, Administration, Intravenous, Adult, Anti-Bacterial Agents adverse effects, Appendicitis complications, Appendix pathology, Fecal Impaction, Female, Health Status, Hospitalization statistics & numerical data, Humans, Laparoscopy, Male, Middle Aged, Postoperative Complications epidemiology, Quality of Life, Surveys and Questionnaires, Treatment Outcome, Anti-Bacterial Agents therapeutic use, Appendectomy statistics & numerical data, Appendicitis drug therapy, Appendicitis surgery, Appendix surgery
- Abstract
Background: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis., Methods: We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith., Results: In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50)., Conclusions: For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.)., (Copyright © 2020 Massachusetts Medical Society.)
- Published
- 2020
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16. Cancer of the appendix and nonoperative treatment of appendicitis shared decision making.
- Author
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Talan DA
- Subjects
- Appendectomy, Decision Making, Humans, Neoplasm Recurrence, Local, Appendiceal Neoplasms, Appendicitis
- Published
- 2019
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17. Methods of conservative antibiotic treatment of acute uncomplicated appendicitis: A systematic review.
- Author
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Talan DA, Saltzman DJ, DeUgarte DA, and Moran GJ
- Subjects
- Acute Disease, Adolescent, Adult, Appendectomy, Appendicitis diagnosis, Child, Child, Preschool, Drug Administration Schedule, Female, Guideline Adherence, Humans, Male, Middle Aged, Recurrence, Retreatment, Anti-Bacterial Agents therapeutic use, Appendicitis drug therapy, Conservative Treatment methods
- Abstract
Background: Meta-analyses and a recent guideline acknowledge that conservative management of uncomplicated appendicitis with antibiotics can be successful for patients who wish to avoid surgery. However, guidance as to specific management does not exist., Methods: PUBMED and EMBASE search of trials describing methods of conservative treatment was conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines., Results: Thirty-four studies involving 2,944 antibiotic-treated participants were identified. The greatest experience with conservative treatment is in persons 5 to 50 years of age. In most trials, imaging was used to confirm localized appendicitis without evidence of abscess, phlegmon, or tumor. Antibiotics regimens were generally consistent with intra-abdominal infection treatment guidelines and used for a total of 7 to 10 days. Approaches ranged from 3-day hospitalization on parenteral agents to same-day hospital or ED discharge of stable patients with outpatient oral antibiotics. Minimum time allowed before response was evaluated varied from 8 to 72 hours. Although pain was a common criterion for nonresponse and appendectomy, analgesic regimens were poorly described. Trials differed in use of other response indicators, that is, white blood cell count, C-reactive protein, and reimaging. Diet ranged from restriction for 48 hours to as tolerated. Initial response rates were generally greater than 90% and most participants improved by 24 to 48 hours, with no related severe sepsis or deaths. In most studies, appendectomy was recommended for recurrence; however, in several, patients had antibiotic retreatment with success., Conclusion: While further investigation of conservative treatment is ongoing, patients considering this approach should be advised and managed according to study methods and related guidelines to promote informed shared decision-making and optimize their chance of similar outcomes as described in published trials. Future studies that address biases associated with enrollment and response evaluation, employ best-practice pain control and antibiotic selection, better define cancer risk, and explore longer time thresholds for response, minimized diet restriction and hospital stays, and antibiotic re-treatment will further our understanding of the potential effectiveness of conservative management., Level of Evidence: Systematic review, level II.
- Published
- 2019
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18. Questionable Assumptions Provided in Nonoperative Treatment of Appendicitis Survey.
- Author
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Talan DA
- Subjects
- Anti-Bacterial Agents, Appendectomy, Humans, Patient Preference, Surveys and Questionnaires, Appendicitis
- Published
- 2018
- Full Text
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19. Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial: a protocol for the pragmatic randomised study of appendicitis treatment.
- Author
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Davidson GH, Flum DR, Talan DA, Kessler LG, Lavallee DC, Bizzell BJ, Farjah F, Stewart SD, Krishnadasan A, Carney EE, Wolff EM, Comstock BA, Monsell SE, Heagerty PJ, Ehlers AP, DeUgarte DA, Kaji AH, Evans HL, Yu JT, Mandell KA, Doten IC, Clive KS, McGrane KM, Tudor BC, Foster CS, Saltzman DJ, Thirlby RC, Lange EO, Sabbatini AK, and Moran GJ
- Subjects
- Acute Disease, Humans, Linear Models, Quality of Life, Research Design, Treatment Outcome, United States, Anti-Bacterial Agents therapeutic use, Appendectomy, Appendicitis therapy
- Abstract
Introduction: Several European studies suggest that some patients with appendicitis can be treated safely with antibiotics. A portion of patients eventually undergo appendectomy within a year, with 10%-15% failing to respond in the initial period and a similar additional proportion with suspected recurrent episodes requiring appendectomy. Nearly all patients with appendicitis in the USA are still treated with surgery. A rigorous comparative effectiveness trial in the USA that is sufficiently large and pragmatic to incorporate usual variations in care and measures the patient experience is needed to determine whether antibiotics are as good as appendectomy., Objectives: The Comparing Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial for acute appendicitis aims to determine whether the antibiotic treatment strategy is non-inferior to appendectomy., Methods/analysis: CODA is a randomised, pragmatic non-inferiority trial that aims to recruit 1552 English-speaking and Spanish-speaking adults with imaging-confirmed appendicitis. Participants are randomised to appendectomy or 10 days of antibiotics (including an option for complete outpatient therapy). A total of 500 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary analytic outcome is quality of life (measured by the EuroQol five dimension index) at 4 weeks. Clinical adverse events, rate of eventual appendectomy, decisional regret, return to work/school, work productivity and healthcare utilisation will be compared. Planned exploratory analyses will identify subpopulations that may have a differential risk of eventual appendectomy in the antibiotic treatment arm., Ethics and Dissemination: This trial was approved by the University of Washington's Human Subjects Division. Results from this trial will be presented in international conferences and published in peer-reviewed journals., Trial Registration Number: NCT02800785., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
- Published
- 2017
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20. Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.
- Author
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Talan DA, Saltzman DJ, Mower WR, Krishnadasan A, Jude CM, Amii R, DeUgarte DA, Wu JX, Pathmarajah K, Morim A, and Moran GJ
- Subjects
- Administration, Intravenous, Adolescent, Adult, Aged, Appendicitis epidemiology, Cefdinir, Child, Cost-Benefit Analysis, Drug Therapy, Combination, Ertapenem, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Outpatients, Pain epidemiology, Pilot Projects, Quality of Life, Severity of Illness Index, Treatment Outcome, United States epidemiology, Young Adult, Anti-Bacterial Agents administration & dosage, Appendectomy statistics & numerical data, Appendicitis therapy, Cephalosporins administration & dosage, Metronidazole administration & dosage, beta-Lactams administration & dosage
- Abstract
Study Objective: Randomized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics-first is safe. No trial has evaluated outpatient treatment and no US randomized trial has been conducted, to our knowledge. This pilot study assessed feasibility of a multicenter US study comparing antibiotics-first, including outpatient management, with appendectomy., Methods: Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were randomized to appendectomy or intravenous ertapenem greater than or equal to 48 hours and oral cefdinir and metronidazole. Stable antibiotics-first-treated participants older than 13 years could be discharged after greater than or equal to 6-hour emergency department (ED) observation with next-day follow-up. Outcomes included 1-month major complication rate (primary) and hospital duration, pain, disability, quality of life, and hospital charges, and antibiotics-first appendectomy rate., Results: Of 48 eligible patients, 30 (62.5%) consented, of whom 16 (53.3%) were randomized to antibiotics-first and 14 (46.7%) to appendectomy. Median age was 33 years (range 9 to 73 years), median WBC count was 15,000/μL (range 6,200 to 23,100/μL), and median computed tomography appendiceal diameter was 10 mm (range 7 to 18 mm). Of 15 antibiotic-treated adults, 14 (93.3%) were discharged from the ED and all had symptom resolution. At 1 month, major complications occurred in 2 appendectomy participants (14.3%; 95% confidence interval [CI] 1.8% to 42.8%) and 1 antibiotics-first participant (6.3%; 95% CI 0.2% to 30.2%). Antibiotics-first participants had less total hospital time than appendectomy participants, 16.2 versus 42.1 hours, respectively. Antibiotics-first-treated participants had less pain and disability. During median 12-month follow-up, 2 of 15 antibiotics-first-treated participants (13.3%; 95% CI 3.7% to 37.9%) developed appendicitis and 1 was treated successfully with antibiotics; 1 had appendectomy. No more major complications occurred in either group., Conclusion: A multicenter US trial comparing antibiotics-first to appendectomy, including outpatient management, is feasible to evaluate efficacy and safety., (Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)
- Published
- 2017
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21. Nonoperative Management of Appendicitis: Avoiding Hospitalization and Surgery.
- Author
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Talan DA, Moran GJ, and Saltzman DJ
- Subjects
- Adult, Appendectomy, Hospitalization, Humans, Randomized Controlled Trials as Topic, Appendicitis
- Published
- 2017
- Full Text
- View/download PDF
22. Patient perspectives on antibiotics for appendicitis at one hospital.
- Author
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Kadera SP, Mower WR, Krishnadasan A, and Talan DA
- Subjects
- Adolescent, Adult, Aged, Appendicitis surgery, Female, Humans, Male, Middle Aged, Prospective Studies, Young Adult, Anti-Bacterial Agents therapeutic use, Appendectomy psychology, Appendicitis drug therapy, Health Knowledge, Attitudes, Practice, Patient Preference statistics & numerical data
- Abstract
Background: Appendicitis has long been considered a progressive inflammatory condition best treated by prompt appendectomy. Recently, several trials comparing initial treatment with antibiotics alone to appendectomy suggest that antibiotic therapy may be a safe option in select patients. However, little is known about patients' understanding of appendicitis, prioritized outcomes, and treatment preferences., Materials and Methods: We conducted a prospective, observational survey at a Los Angeles County public hospital emergency department. Trained study coordinators recorded the following data on each subject: basic knowledge of appendicitis, past surgical and antibiotic history, and medical illness outcome priorities. Participants were then educated about appendicitis and were told that studies had demonstrated that appendicitis can be treated safely with antibiotics alone. Subjects were then surveyed as to their preference for urgent surgery or antibiotics alone in a hypothetical scenario of acute uncomplicated appendicitis., Results: Of 129 subjects interviewed, 56 (43%) correctly defined appendicitis, and 69 (53%) identified the treatment for appendicitis as surgery. When presented with a hypothetical acute appendicitis scenario, 57% chose antibiotics over surgery. Persons with previous appendectomy and parents of minors more often chose antibiotics alone, 74% and 63%, respectively. Dying was the most frequently cited and highest-ranked concern about medical illness., Conclusions: Our results demonstrate that, among persons at one US public hospital, understanding of appendicitis is poor. Once presented with background information about appendicitis and being informed that antibiotics can safely treat appendicitis, many people would prefer an antibiotic approach over appendectomy. Death is the most prioritized concern., (Copyright © 2016 Elsevier Inc. All rights reserved.)
- Published
- 2016
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23. Evidence for an Antibiotics-First Strategy for Uncomplicated Appendicitis in Adults: A Systematic Review and Gap Analysis.
- Author
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Ehlers AP, Talan DA, Moran GJ, Flum DR, and Davidson GH
- Subjects
- Adult, Appendectomy, Appendicitis diagnosis, Appendicitis surgery, Humans, Treatment Outcome, Anti-Bacterial Agents therapeutic use, Appendicitis drug therapy
- Published
- 2016
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24. The bacteriology of gangrenous and perforated appendicitis--revisited.
- Author
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Bennion RS, Baron EJ, Thompson JE Jr, Downes J, Summanen P, Talan DA, and Finegold SM
- Subjects
- Adolescent, Adult, Appendicitis complications, Appendix pathology, Bacteria, Aerobic classification, Bacteria, Anaerobic classification, Bacteriological Techniques, Female, Gangrene, Humans, Intestinal Perforation etiology, Intestinal Perforation microbiology, Male, Middle Aged, Specimen Handling, Appendicitis microbiology, Appendix microbiology, Bacteria, Aerobic isolation & purification, Bacteria, Anaerobic isolation & purification
- Abstract
By using optimum sampling, transport, and culture techniques in patients with gangrenous or perforated appendicitis, we recovered than has previously been reported. Thirty patients older than 12 years with histologically documented gangrenous or perforated appendicitis had peritoneal fluid, appendiceal tissue, and abscess contents (if present) cultured. Appendiceal tissue was obtained so as to exclude the lumen. A total of 223 anaerobes and 82 aerobic or faculatative bacteria were recovered, an average of 10.2 different organisms per specimen. Twenty-one different genera and more than 40 species were encountered. Bacteroides fragilis group and Escherichia coli were isolated from almost all specimens. Within the B. fragilis group, eight species were represented. Other frequent isolates included Peptostreptococcus (80%), Pseudomonas (40% [P. aeruginosa, 23.3%, other Pseudomonas spp., 16.7%]), B. splanchnicus (40%), B. intermedius (36.7%), and Lactobacillus (36.7%). Interestingly a previously undescribed fastidious gram-negative anaerobic bacillus was isolated from nearly one half of all patients. This organism was found to have low DNA homology (by dot blot) with the known organisms most closely resembling it.
- Published
- 1990
- Full Text
- View/download PDF
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