Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis

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.

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

“…However, English- and Spanish-speaking participants both reported fewer days of missed work in the antibiotic arm than the appendectomy arm. The similar number of days of missed work among Spanish-speaking participants with an active job and Spanish-speaking participants with a less active job suggests that there are factors contributing to the observed differences in days of work missed other than type of work …”

“…Sociodemographic characteristics were measured at baseline . Health literacy, employment status, and level of activity at work were assessed following previously described methods …”

“…16 Health literacy, employment status, and level of activity at work were assessed following previously described methods. 17 Study Participation Willingness to randomize was described by examining the number eligible and the number who declined to randomize. Twenty-eight people were excluded from this analysis due to missing preferred language.…”

Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes

“…Please tell us how much you agree with the following statements.” Participants could respond strongly agree, agree, neither agree nor disagree, disagree, or strongly disagree to the following 5 statements: “It was the right decision; I regret the choice that was made; I would go for the same choice if I had to do it over again; the choice did me a lot of harm; and the decision was a wise one.” The Decisional Regret Scale ranges from 0 (no regret) to 100 (high regret), which we dichotomized as high decisional regret (>50) or not high decisional regret (≤50), which was consistent with prior CODA secondary analyses. Additionally, participants were asked, “How satisfied are you with your treatment for appendicitis?” with the following response options: very dissatisfied, somewhat dissatisfied, somewhat satisfied, or very satisfied. This was also dichotomized into dissatisfaction (very dissatisfied or somewhat dissatisfied) or no dissatisfaction (other responses), which was consistent with prior CODA secondary analyses.…”

“…This was also dichotomized into dissatisfaction (very dissatisfied or somewhat dissatisfied) or no dissatisfaction (other responses), which was consistent with prior CODA secondary analyses. Previous analyses of the CODA data have shown that both dissatisfaction and high regret are uncommon and somewhat correlated ; to facilitate comparisons across belief groups with smaller sample sizes in this analysis, we defined a composite outcome for either high decisional regret or dissatisfaction at 30 days.…”