Abstract Background This aim of this study was to provide an updated meta-analysis comparing antibiotic therapy with appendicectomy in adults (16 years or older) with uncomplicated acute appendicitis. Methods A search for randomized clinical trials comparing antibiotic therapy with appendicectomy in adults with uncomplicated acute appendicitis from inception to 3 October 2021 in MEDLINE, Embase and CENTRAL with no language constraints was performed. Studies were excluded if they included paediatric participants or those with complicated appendicitis. Data on complications of treatment, treatment efficacy (defined in the antibiotic group as not undergoing appendicectomy within 1 year of enrolment, versus surgery without complications or no negative histology in the appendicectomy group), readmissions, and length of stay (LOS) were presented. Results Eight RCTs involving 3203 participants (1613 antibiotics/1590 appendicectomy; 2041 males/1162 females) were included. There was no significant benefit of antibiotic treatment on complication rates (risk ratio (RR) 0.66, 95 per cent c.i. 0.41 to 1.04). Antibiotics had a reduced treatment efficacy compared with appendicectomy (RR 0.75, 95 per cent c.i. 0.63 to 0.89). Antibiotic treatment at 1 year was successful in 1016 of 1613 (62.9 per cent) participants. There was a six-fold increase in hospital readmissions within 1 year of enrolment in participants receiving antibiotic treatment (RR 6.28, 95 per cent c.i. 2.87 to 13.74). There was no difference in index admission LOS (mean difference 0.15 days (95 per cent c.i. −0.05 to 0.35)). Conclusions Earlier optimism regarding the benefits of antibiotic therapy for uncomplicated acute appendicitis does not persist at the same level now that further, large trials have been included. If antibiotic treatment is to be offered routinely as first-line therapy, patients should be counselled appropriately.

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Randomized clinical trials comparing antibiotic therapy with appendicectomy for uncomplicated acute appendicitis: meta-analysis

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.

Self-selection vs Randomized Assignment of Treatment for Appendicitis.

Failure of effective transitions of care following hospitalization can lead to excess days in the hospital, readmissions, and adverse events. Evidence identifies both patient and system factors that influence poor care transitions, yet health systems struggle to translate evidence into complex interventions that have a meaningful impact on care transitions. We report on our experience developing, pilot testing, and evaluating a complex intervention (Addressing Complex Transitions program, or ACT program) that aims to improve care transitions for complex patients. Following the Medical Research Council (MRC) framework, we engaged in iterative, stakeholder-driven work to develop a complex care intervention, assess feasibility and pilot methods, evaluate the intervention in practice, and facilitate ongoing implementation monitoring and dissemination. Patients receiving care from UW Medicine’s health system including 4 hospitals and 20-site Post-Acute Care network. Literature review and prospective data collection activities informed ACT program design. ACT program components include a tailored risk calculator that provides real-time scoring of transitions of care risk factors, a multidisciplinary team with the capacity to address complex barriers to safe transitions, and enhanced discharge workflows to improve care transitions for complex patients. Program evaluation metrics included estimated hospital days saved and program acceptance by care team members. During the 6-month pilot, 565 patients were screened and 97 enrolled in the ACT program. An estimated 664 hospital days were saved for the index admission of ACT program participants. Analysis of pre/post-hospital utilization for ACT program participants showed an estimated 3227 fewer hospital days after ACT program enrollment. Health systems need to address increasingly difficult challenges in care delivery. The use of evidence-based frameworks, such as the MRC framework, can guide systems to design complex interventions that respond to their local context and stakeholder needs.

/pdf/development-and-implementation-of-a-complex-health-system-4qegxkjw70.pdf

Development and Implementation of a Complex Health System Intervention Targeting Transitions of Care from Hospital to Post-acute Care

The need for patient decision aids in acute care settings.

Background: Multiple randomized controlled trials have shown that it is safe and effective to treat appendicitis with antibiotics or surgery. There are no tools available to assist surgeons and their patients in choosing the optimal treatment for each individual patient. Here we describe the development of a new decisions support tool (DST) for acute appendicitis and place it in the context of international guidelines for decision aid development. 

Methods: The stakeholder engagement and development process for the DST is described. The DST and its development process are placed in the context of the International Patient Decision Aid Standards (IPDAS) and the DEVELOPTOOLS checklist for a user-centered design process. 

Results: A diverse group of over 60 stakeholders were involved in the needs-assessment, development, and evaluation of the DST. The development process met 11/11 of the scored items on the DEVELOPTOOLS checklist. Of the 34 applicable IPDAS items, the current version of the DST meets 31 of them including 6/6 qualifying criteria, 6/6 certification criteria, and 18/22 quality criteria. 

Conclusions: The novel appendicitis DST was developed with the input of multiple stakeholders. The development process and the tool itself complies with best practices recommended by the IPDAS.

https://medrxiv.org/content/10.1101/2021.11.08.21266077v1.full.pdf

Development of a Decision Support Tool for Acute Appendicitis

/pdf/willingness-to-undergo-antibiotic-treatment-of-acute-2kawjexl89.pdf

Willingness to undergo antibiotic treatment of acute appendicitis based on risk of treatment failure.

Verbal Descriptions of the Probability of Treatment Complications Lead to High Variability in Risk Perceptions: A Survey Study

A Health Systems Framework for Evaluating Different Approaches to Predicting Readmission Risk

Introduction The Mediterranean diet is being studied as an alternative to surgery for common gastrointestinal conditions. However, dietary change can be challenging. “Nudges” – behavioral science strategies seeking to influence cognitive processes to promote good behaviors – may help. We conducted a pilot study evaluating the acceptability of the MediDiet, a behaviorally designed dietary intervention incorporating nudges and recommendations based on the Mediterranean Diet. Methods We conducted a three-phase pilot study involving parallel randomized surveys of U.S. adults. After completing a validated questionnaire assessing dietary consistency with a Mediterranean diet, participants were randomized to feedback containing no nudge versus nudge: peer comparison; peer comparison + positive affect induction; or default. Participants then rated their positive and negative emotions, motivation for dietary change, and interest in recipes. Responses were analyzed using baseline covariate-adjusted regression. Results Among 1,709 participants, 56% were men, 73% were White, and the mean age was 38. In response to dietary feedback, participants reported low negative emotions, high positive emotions, moderate motivation for dietary change and high interest in recipes. Nudges did not affect the extent of negative (p=0.104) or positive (p=0.34) emotions, motivation (p=0.139), or interest (p=0.86). In exploratory analyses, those with moderate and high consistency with the Mediterranean diet, with or without nudges, reported lower negative affect, greater positive affect, greater motivation, and greater interest in recipes, than the minimally consistent, no nudge group. Conclusion Delivering dietary feedback based on the Mediterranean diet using behavioral nudges was acceptable among U.S. adults, rousing positive reactions without triggering negative ones. As early evidence, this pilot study provides the basis for testing nudge-based dietary guidance among individuals with symptomatic gallstones, diverticulitis, and other gastrointestinal diseases. Highlights The MediDiet is being developed as a novel, behaviorally designed dietary intervention for the non-operative management of common gastrointestinal conditions including symptomatic gallstones and diverticulitis, classically managed with surgery. In this exploratory pilot study, delivering dietary feedback based on the Mediterranean diet using behavioral nudges was acceptable among U.S. adults. This foundational work will help serve as the basis for testing nudge-based dietary guidance among individuals with symptomatic gallstones, diverticulitis, and other gastrointestinal diseases, and ultimately conducting clinical trials to compare dietary interventions to surgical management for these conditions.

/pdf/applying-behavioral-nudges-in-a-dietary-comparator-for-4najfp6z16.pdf

Joshua M. Liao

Papers

Willingness to undergo antibiotic treatment of acute appendicitis based on risk of treatment failure.

Verbal Descriptions of the Probability of Treatment Complications Lead to High Variability in Risk Perceptions: A Survey Study

Development of a Decision Support Tool for Acute Appendicitis

A Health Systems Framework for Evaluating Different Approaches to Predicting Readmission Risk

Applying Behavioral Nudges in a Dietary Comparator for Surgical Trials: Developing the MediDiet