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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 886-893 |
| Number of pages | 8 |
| Journal | Annals of surgery |
| Volume | 277 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jun 1 2023 |
Funding
This study was supported by a grant from the Patient-Centered Outcomes Research Institute, PCORI Award (1409-240099). The funder was not involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The CODA Collaborative writing committee assumes responsibility for the content of this article. The views presented in this work are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute, its board of governors, or its methodology committee. Dr. Thea Price reports association with Kerecis as a key opinion leader, Acera for research and a key opinion leader, and Medline for research and as a key opinion leader. Dr. Brett Faine reports receiving grant support from SPERO Therapeutics. This study was supported by a grant from the Patient-Centered Outcomes Research Institute, PCORI Award (1409-240099).
Keywords
- Comparison of Outcomes of antibiotic Drugs and Appendectomy
- antibiotics
- appendectomy
- appendicitis
- clinical factors
- decisional regret
- dissatisfaction with treatment
- patient-reported outcomes
- sociodemographic factors
ASJC Scopus subject areas
- Surgery