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Randomized Controlled Trial
. 2023 Jun 1;277(6):886-893.
doi: 10.1097/SLA.0000000000005458. Epub 2022 Jul 11.

Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort

Callie M Thompson  1   2 , Emily C Voldal  3 , Giana H Davidson  3 , Sabrina E Sanchez  4 , Patricia Ayoung-Chee  5   6 , Jesse Victory  7 , Mary Guiden  3 , Bonnie Bizzell  3 , Jacob Glaser  8 , Christopher Hults  8 , Thea P Price  9 , Nicole Siparsky  9 , Kristin Ohe  10 , Katherine A Mandell  10 , Daniel A DeUgarte  11 , Amy H Kaji  11 , Lisandra Uribe  12 , Lillian S Kao  13 , Krislynn M Mueck  13 , Farhood Farjah  3 , Wesley H Self  1 , Sunday Clark  4   14 , F Thurston Drake  4 , Katherine Fischkoff  15 , Elizaveta Minko  15 , Joseph Cuschieri  16   17 , Brett Faine  18 , Dionne A Skeete  18 , Naila Dhanani  19 , Mike K Liang  19   20 , Anusha Krishnadasan  12 , David A Talan  12   21 , Erin Fannon  3 , Larry G Kessler  3 , Bryan A Comstock  3 , Patrick J Heagerty  3 , Sarah E Monsell  3 , Sarah O Lawrence  3 , David R Flum  3 , Danielle C Lavallee  3   22 ; Writing Group for the CODA Collaborative
Collaborators, Affiliations
Randomized Controlled Trial

Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort

Callie M Thompson et al. Ann Surg. .

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.

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Conflict of interest statement

The authors report information from Price and Faine should read the remaining authors report no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Percent of participants in the randomized cohort with negative perceptions of treatment and impaired function, by treatment arm and 30-day appendectomy status for the antibiotics arm; percentages and 95% confidence intervals are pooled estimates from multiply imputed data sets.
FIGURE 2
FIGURE 2
Odds ratios for negative perceptions of treatment and impaired function, comparing antibiotics-assigned (overall and by 30-day appendectomy status) to appendectomy-assigned in the randomized cohort; ORs and 95% confidence intervals are pooled estimates from multiply imputed data sets.
See this image and copyright information in PMC

References

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