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

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.

A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.

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.).

Functional outcomes after inpatient rehabilitation for trauma-improved but unable to return home.

BACKGROUND: Twenty-five percent of trauma patients are discharged to postacute care, indicating a loss of physical function and need for rehabilitation. The purpose of this study was to quantify the functional improvements in trauma patients discharged from inpatient rehabilitation facility (IRF) and identify predictors of improvement. MATERIALS AND METHODS: A retrospective cohort study of trauma patients aged ≥ 18 years were admitted to an IRF after discharge from a level-1 trauma center. Data included demographics, injury characteristics, hospital, and IRF course. The functional independence measure (FIM) was used to measure change in physical and cognitive function. RESULTS: There were 245 patients with a mean age of 55.8 years and mean injury severity score (ISS) of 14.7. Fall was the leading mechanism of injury (45.7%). On IRF admission, 50.7% of patients required moderate or greater assistance. On discharge, the mean intraindividual change in FIM score was 29.9; 85.4% of the patients improved by ≥1 level of functioning. Before injury, 99.6% of patients were living at home, but only 56.0% were discharged home from the IRF, despite 81.8% requiring minimal assistance at most (23.5% to skilled nursing; 19.7% readmitted). Increasing age and lower ISS were associated with less FIM improvement, and increasing ISS was associated with increased FIM improvement. CONCLUSIONS: More than 80% of the trauma patients experienced meaningful functional improvements during IRF admission. However, only half were discharged home, and a quarter required further institutional care. Further research is needed to identify the additional impediments to return to preinjury functioning.

Subway-Related Trauma: An Urban Public Health Issue with a High Case-Fatality Rate.

BACKGROUND: Between 1990 and 2003, there were 668 subway-related fatalities in New York City. However, subway-related trauma remains an understudied area of injury-related morbidity and mortality. OBJECTIVE: The objective of this study was to characterize the injuries and events leading up to the injuries of all patients admitted after subway-related trauma. METHODS: We conducted a retrospective case series of subway-related trauma at a Level I trauma center from 2001 to 2016. Descriptive epidemiology of patient demographics, incident details, injuries, and outcomes were analyzed. RESULTS: Over 15 years, 254 patients were admitted for subway-related trauma. The mean (standard error of the mean) age was 41 (1.0) years, 80% were male (95% confidence interval [CI] 74-84%) and median Injury Severity Score was 14 (interquartile range [IQR] 5-24). The overall case-fatality rate was 10% (95% CI 7-15%). The most common injuries were long-bone fractures, intracranial hemorrhage, and traumatic amputations. Median length of stay was 6 days (IQR 1-18 days). Thirty-seven percent of patients required surgical intervention. At the time of injury, 55% of patients (95% CI 49-61%) had a positive urine drug or alcohol screen, 16% (95% CI 12-21%) were attempting suicide, and 39% (95% CI 33-45%) had a history of psychiatric illness. CONCLUSIONS: Subway-related trauma is associated with a high case-fatality rate. Alcohol or drug intoxication and psychiatric illness can increase the risk of this type of injury.

Prolonged length of stay in delayed cholecystectomy is not due to intraoperative or postoperative contributors.

BACKGROUND: Previous studies have reported that same-day laparoscopic cholecystectomy for acute cholecystitis is superior to delayed elective cholecystectomy. Although this practice is ideal, it requires significant hospital resources, particularly for an underprivileged inner-city population at a large, municipal hospital. We sought to evaluate the implementation of same-day laparoscopic cholecystectomy in a large, municipal hospital and assess the possible benefits of decreasing preoperative length of stay (LOS), particularly its effect on operative time and length of stay in patients with acute cholecystitis. MATERIALS AND METHODS: This was a retrospective chart review of patients treated for symptomatic gallstone disease between September 2012 and November 2013. Medical records were reviewed, and relevant data points were collected. Univariate and multivariate regressions were performed to assess the correlation between time to operation (<36 h [no delay] or >36 h [delay]) and the main outcomes (operative time and total length of stay). Inclusion criteria were patients age ≥18 y who underwent same-admission cholecystectomy and had a diagnosis of cholecystitis on pathology. Eighty-eight patients met all inclusion criteria. RESULTS: The mean (standard deviation) preoperative LOS was 76.2 (±48.6) h, the mean operative time was 2.3 (±1.1) h, and the mean postoperative LOS was 60.3 (±60.1) h. The average total LOS was 136 (±79.8) h. Operative times and postoperative LOS were similar for patients in the delay and no delay groups. Patients with >36 h wait before surgery had a total length of stay twice as long as patients with <36 h wait (152 versus 83.3 h; P = 0.0005). These findings remained significant when adjusted for age, sex, radiologic findings, number of preoperative tests, and pathology. CONCLUSIONS: Increased preoperative LOS is not associated with a significant increase in operative time. However, it was associated with significantly increased length of stay. Further analysis is needed to explore the potential cost savings of decreasing preoperative LOS.

Drawing the Curtain Back on Injured Commercial Bicyclists.

OBJECTIVES: We determined the demographic characteristics, behaviors, injuries, and outcomes of commercial bicyclists who were injured while navigating New York City's (NYC's) central business district. METHODS: Our study involved a secondary analysis of prospectively collected data from a level 1 regional trauma center in 2008 to 2014 of bicyclists struck by motor vehicles. We performed univariable and multivariable logistic regression analyses. RESULTS: Of 819 injured bicyclists, 284 (34.7%) were working. Commercial bicyclists included 24.4% to 45.1% of injured bicyclists annually. Injured commercial bicyclists were more likely Latino (56.7%; 95% confidence interval [CI] = 50.7, 62.8 vs 22.7%; 95% CI = 19.2, 26.5). Commercial bicyclists were less likely to be distracted by electronic devices (5.0%; 95% CI = 2.7, 8.2 vs 12.7%; 95% CI = 9.9, 15.9) or to have consumed alcohol (0.7%; 95% CI = 0.9, 2.5 vs 9.5%; 95% CI = 7.2, 12.3). Commercial and noncommercial bicyclists did not differ in helmet use (38.4%; 95% CI = 32.7, 44.4 vs 30.8%; 95% CI = 26.9, 34.9). Injury severity scores were less severe in commercial bicyclists (odds ratio = 0.412; 95% CI = 0.235, 0.723). CONCLUSIONS: Commercial bicyclists represent a unique cohort of vulnerable roadway users. In NYC, minorities, especially Latinos, should be targeted for safety education programs.

Structure, process, and outcomes in skilled nursing facilities: understanding what happens to surgical patients when they cannot go home. A systematic review.

BACKGROUND: The surgical population is aging, and greater numbers of surgical patients are being discharged to skilled nursing facilities. Post-acute care is a poorly understood but very important aspect of our healthcare system. METHODS: This systematic review examines the current body of literature surrounding the structural, process of care, and outcomes measurements for patients in skilled nursing facilities. English language articles published between 1998 and 2011 that purposed to examine nursing facility structure, process of care, and/or outcomes were included. RESULTS & CONCLUSIONS: Abstracts (2129) were screened and 102 articles were reviewed in full. Twenty-nine articles were included in the qualitative synthesis. The role of the care setting and care delivery in contributing to outcomes has not been well studied, and no strong conclusions can be made. This area of care currently represents a "black box" to practicing surgeons. An understanding of these factors maybe instrumental to determining future directions for research to maximize positive outcomes for these patients.

Accuracy of Trauma Surgeons Prospective Estimation of the Injury Severity Score: A Pilot Study.

Injury Severity Score (ISS) has limited utility as a prospective predictor of trauma outcomes as it is currently scored by abstractors post-discharge. This study aimed to determine accuracy of ISS estimation at time of admission. Attending trauma surgeons assessed the Abbreviated Injury Scale of each body region for patients admitted during their call, from which estimated ISS (eISS) was calculated. The eISS was considered concordant to abstracted ISS (aISS) if both were in the same category: mild (<9), moderate (9-15), severe (16-25), or critical (>25). Ten surgeons completed 132 surveys. Overall ISS concordance was 52.2%; 87.5%, 30.8%, 34.8%, and 61.7% for patients with mild, moderate, severe, and critical aISS, respectively; unweighted k = .36, weighted k = .69. This preliminarily supports attending trauma surgeons' ability to predict severity of injury in real time, which has important clinical and research implications.

Value in Acute Care Surgery, Part 3: Defining Value in Acute Surgical Care - It Depends on the Perspective.

ABSTRACT: The prior articles in this series have focused on measuring cost and quality in acute care surgery. This third article in the series explains the current ways of defining value in acute care surgery, based on different stakeholders in the healthcare system - the patient, the healthcare organization, the payer and society. The heterogenous valuations of the different stakeholders require that the framework for determining high-value care in acute care surgery incorporates all viewpoints.

Pneumopericardium following severe thoracic trauma.

BACKGROUND: Traumatic pneumopericardium (PPC) is a rare clinical entity associated with chest trauma, resulting from a pleuropericardial connection in the presence of a pneumothorax, interstitial air tracking along the pulmonary perivascular sheaths from ruptured alveoli to the pericardium, or direct trachea-bronchial-pericardial communication.  Our objectives were to describe the modern management approach to PPC and to identify variables that could improve survival with severe thoracic injury. METHODS: We conducted a retrospective study of the trauma registry between 2015 and 2022 at a Level I verified adult trauma center for all patients with PPC. Demographics, injury patterns, and treatment characteristics were compared between blunt and penetrating trauma. This study focused on the management strategies and the physiologic status regarding PPC and the development of tension physiology. The main outcome measure was operative versus nonoperative management. RESULTS: Over a seven-year period, there were 46,389 trauma admissions, of which 488 patients had pneumomediastinum. Eighteen patients were identified with PPC at admission. Median age was 39.5 years (range, 18-77 years), predominantly male (n = 16, 89 %), Black (n = 12, 67 %), and the majority from blunt trauma (78 %). Half had subcutaneous emphysema on presentation while 39 % had recognizable pneumomediastinum on chest x-ray. Tube thoracostomy was the most common intervention in this cohort (89 %). Despite tube thoracostomy, tension PPC was observed in three patients, two mandating emergent pericardial windows for progression to tension physiology, and the remaining requiring reconstruction of a blunt tracheal disruption. The majority of PPC patients recovered with expectant management (83 %), and no deaths were directly related to PPC. CONCLUSIONS: Traumatic PPC is a rare radiographic finding with the majority successfully managed conservatively in a monitored ICU setting. These patients often have severe thoracic injury with concomitant injuries requiring thoracostomy alone; however, emergent surgical intervention may be required when PPC progresses to tension physiology to improve overall survival.

Best Case/Worst Case-ICU: protocol for a multisite, stepped-wedge, randomised clinical trial of scenario planning to improve communication in the ICU in US trauma centres for older adults with serious injury.

INTRODUCTION: Poor communication about serious injury in older adults can lead to treatment that is inconsistent with patient preferences, create conflict and strain healthcare resources. We developed a communication intervention called Best Case/Worst Case-intensive care unit (ICU) that uses daily scenario planning, that is, a narrative description of plausible futures, to support prognostication and facilitate dialogue among patients, their families and the trauma ICU team. This article describes a protocol for a multisite, randomised, stepped-wedge study to test the effectiveness of the intervention on the quality of communication (QOC) in the ICU. METHODS AND ANALYSIS: We will follow all patients aged 50 and older admitted to the trauma ICU for 3 or more days after a serious injury at eight high-volume level 1 trauma centres. We aim to survey one family or 'like family' member per eligible patient 5-7 days following their loved ones' admission and clinicians providing care in the trauma ICU. Using a stepped-wedge design, we will use permuted block randomisation to assign the timing for each site to begin implementation of the intervention and routine use of the Best Case/Worst Case-ICU tool. We will use a linear mixed-effects model to test the effect of the tool on family-reported QOC (using the QOC scale) as compared with usual care. Secondary outcomes include the effect of the tool on reducing clinician moral distress (using the Measure of Moral Distress for Healthcare Professionals scale) and patients' length of stay in the ICU. ETHICS AND DISSEMINATION: Institutional review board (IRB) approval was granted at the University of Wisconsin, and all study sites ceded review to the primary IRB. We plan to report results in peer-reviewed publications and national meetings. TRIAL REGISTRATION NUMBER: NCT05780918.

Blunt Traumatic Abdominal Wall Hernias: An Indicator for Emergent Laparotomy?

BACKGROUND: Traumatic abdominal wall hernias (TAWH) are relatively uncommon; however, the shearing force that results in fascial disruption could indicate an increased risk of visceral injury. The aim of our study was to evaluate whether the presence of a TAWH was associated with intra-abdominal injury requiring emergent laparotomy. METHODS: The trauma registry was queried over an 8-year period (7/2012-7/2020) for adult patients with blunt thoracoabdominal trauma diagnosed with a TAWH. Those patients who were identified with a TAWH and greater than 15 years of age were included in the study. Demographics, mechanism of injury, ISS, BMI, length of stay, TAWH size, type of TAWH repair, and outcomes were analyzed. RESULTS: Overall, 38,749 trauma patients were admitted over the study period, of which 64 (.17%) had a TAWH. Patients were commonly male (n = 42, 65.6%); the median age was 39 years (range 16-79 years) and a mean ISS of 21. Twenty-eight percent had a clinical seatbelt sign. Twenty-seven (42.2%) went emergently to the operating room, the majority for perforated viscus requiring bowel resection (n = 16, 25.0%), and 6 patients (9.4%) who were initially managed nonoperatively underwent delayed laparotomy. Average ventilator days was 14 days, with a mean ICU LOS of 14 days and mean hospital LOS of 18 days. About half of the hernias were repaired at the index operation, 6 of which were repaired primarily and 10 with mesh. CONCLUSION: The presence of a TAWH alone was an indication for immediate laparotomy to evaluate for intra-abdominal injury. In the absence of other indications for exploration, nonoperative management may be safe.

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.

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.

Data resources for evaluating the economic and financial consequences of surgical care in the United States.

ABSTRACT: Evaluating the relationship between health care costs and quality is paramount in the current health care economic climate, as an understanding of value is needed to drive policy decisions. While many policy analyses are focused on the larger health care system, there is a pressing need for surgically focused economic analyses. Surgical care is costly, and innovative technology is constantly introduced into the operating room, and surgical care impacts patients' short- and long-term physical and economic well-being. Unfortunately, significant knowledge gaps exist regarding the relationship between cost, value, and economic impact of surgical interventions. Despite the plethora of health care data available in the forms of claims databases, discharge databases, and national surveys, no single source of data contains all the information needed for every policy-relevant analysis of surgical care. For this reason, it is important to understand which data are available and what can be accomplished with each of the data sets. In this article, we provide an overview of databases commonly used in surgical health services research. We focus our review on the following five categories of data: governmental claims databases, commercial claims databases, hospital-based clinical databases, state and national discharge databases, and national surveys. For each, we present a summary of the database sampling frame, clinically relevant variables, variables relevant to economic analyses, strengths, weaknesses, and examples of surgically relevant analyses. This review is intended to improve understanding of the current landscape of data available, as well as stimulate novel analyses among surgical populations. Ongoing debates over national health policy reforms may shape the delivery of surgical care for decades to come. Appropriate use of available data resources can improve our understanding of the economic impact of surgical care on our health care system and our patients. LEVEL OF EVIDENCE: Regular Review, Level V.

Screening, Brief Intervention, and Referral to Treatment to Prevent Post-Traumatic Stress Disorder After Gunshot Wounds.

Screening, brief intervention, and referral to treatment (SBIRT) is an intervention originally developed to prevent and deter substance abuse. Adaptation of the SBIRT model to prevent post-traumatic stress disorder (PTSD) may potentially reduce acute stress symptoms after traumatic injury. We conducted a prospective randomized control study of adult patients admitted for gunshot wounds. Patients were randomized to intervention (INT) vs. treatment as usual (TAU) groups. INT received the newly developed SBIRT Intervention for Trauma Patients (SITP)-a 15-minute session with elements of cognitive behavioral therapy techniques. SITP took place during the index hospitalization; both groups had followup at 30 and 90 days at which time a validated PTSD screening tool, PCL-5, was administered. Most of the 46 participants were young (mean age = 30.5y), male (91.3%), and black (86.9%). At three-month follow-up, SBIRT and TAU patients had similar physical healing scores but the SBIRT arm showed reductions in PTSD symptoms.

Self-selection vs Randomized Assignment of Treatment for Appendicitis.

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.

Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis.

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.

Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis.

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.

Alcohol use by pedestrians who are struck by motor vehicles: how drinking influences behaviors, medical management, and outcomes.

BACKGROUND: Injuries to pedestrians struck by motor vehicles represent a significant public health hazard in large cities. The purpose of this study is to investigate the demographics of alcohol users who are struck by motor vehicles and to assess the effects of alcohol on pedestrian crossing patterns, medical management, and outcomes. METHODS: Data were prospectively collected between December 2008 to September 2010 on all pedestrians who presented to a Level I trauma center after being struck by a motor vehicle. Variables were obtained by interviewing patients, scene witnesses, first responders, and medical records. RESULTS: Pedestrians who used alcohol were less likely to cross the street in the crosswalk with the signal (22.6% vs. 64.7%) and more likely to cross either in the crosswalk against the signal (22.6% vs. 12.4%) or midblock (54.8% vs. 22.8%). Alcohol use was associated with more initial computed tomography imaging studies compared with no alcohol involvement. Alcohol use was associated with a higher Injury Severity Score (8.82 vs. 4.85; p < 0.001) and hospital length of stay (3.89 days vs. 1.82 days; p < 0.001) compared with those with no alcohol involvement. Patients who used alcohol had a lower average Glasgow Coma Scale score (13.80 vs. 14.76; p < 0.001) and a higher rate of head and neck, face, chest, abdomen, and extremity/pelvic girdle injuries (based on Abbreviated Injury Scale) than those with no alcohol involvement. CONCLUSION: Alcohol use is a significant risk factor for pedestrians who are struck by motor vehicles. These patients are more likely to cross the street in an unsafe manner and sustain more serious injuries. Traffic safety and injury prevention programs must address irresponsible alcohol use by pedestrians.