A core outcome set for appendicitis: A consensus approach utilizing modified Delphi methodology.

BACKGROUND: Appendicitis is one of the most common pathologies encountered by general and acute care surgeons. The current literature is inconsistent, as it is fraught with outcome heterogeneity, especially in the area of nonoperative management. We sought to develop a core outcome set (COS) for future appendicitis studies to facilitate outcome standardization and future data pooling. METHODS: A modified Delphi study was conducted after identification of content experts in the field of appendicitis using both the Eastern Association for the Surgery of Trauma (EAST) landmark appendicitis articles and consensus from the EAST ad hoc COS taskforce on appendicitis. The study incorporated three rounds. Round 1 utilized free text outcome suggestions, then in rounds 2 and 3 the suggests were scored using a Likert scale of 1 to 9 with 1 to 3 denoting a less important outcome, 4 to 6 denoting an important but noncritical outcome, and 7 to 9 denoting a critically important outcome. Core outcome status consensus was defined a priori as >70% of scores 7 to 9 and <15% of scores 1 to 3. RESULTS: Seventeen panelists initially agreed to participate in the study with 16 completing the process (94%). Thirty-two unique potential outcomes were initially suggested in round 1 and 10 (31%) met consensus with one outcome meeting exclusion at the end of round 2. At completion of round 3, a total of 17 (53%) outcomes achieved COS consensus. CONCLUSION: An international panel of 16 appendicitis experts achieved consensus on 17 core outcomes that should be incorporated into future appendicitis studies as a minimum set of standardized outcomes to help frame future cohort-based studies on appendicitis. LEVEL OF EVIDENCE: Diagnostic Test or Criteria; Level V.

Surgeon Perspectives on Daily Presentation of Ethical Dilemmas: A Qualitative Study.

BACKGROUND: Surgeons encounter and navigate a unique set of ethical dilemmas. The American College of Surgeons (ACS) previously identified 6 core ethical issues central to the practice of surgery, but there have been no reports of the true range and complexity of ethical dilemmas encountered by surgeons in their daily practice. Qualitative research is well positioned to address this question. STUDY DESIGN: We conducted in-depth interviews with attending surgeons across multiple surgical subspecialties at a large, urban, academic medical center asking them to describe the most common ethical dilemmas they encounter in day-to-day practice. Interviews were recorded, transcribed, and coded according to a grounded theory, inductive approach. RESULTS: Thirty attending surgeons were interviewed, representing twelve different general surgery subspecialties. The majority of dilemmas identified pertained to 4 of the 6 ACS identified core ethical issues: professional obligations, competition of interests, truth telling, and end-of-life care. No participants described dilemmas relating to the themes of confidentiality or surrogate decision-making. Approximately one-third of participants identified ethical issues not well characterized by the ACS core principles, most often relating to the pressure to provide care that is not medically indicated. There was strong support for a formalized surgical ethics curriculum. CONCLUSIONS: Although the ACS-defined core ethical issues in surgery appropriately captured many ethical dilemmas identified by participants, surgeons described several scenarios not well characterized by these themes. A dedicated surgical ethics curriculum may help to better equip surgeons to navigate the ethical dilemmas they are likely to face in practice.

Trends in Comprehensive Thoracic Case Experience Among General Surgery Residents in the Modern Integrated Cardiothoracic Residency Era: Review of Twenty Years of Resident Case Logs.

BACKGROUND: Thoracic surgery training among general surgery residents in the United States is regulated by the Accreditation Council for Graduate Medical Education (ACGME) to ensure exposure to subspecialty fields during residency. Thoracic surgery training has changed over time with the placement of work hour restrictions, the emphasis on minimally invasive surgery, and increased subspecialization of training like integrated six-year cardiothoracic surgery programs. We aim to investigate how these changes over the past twenty years have affected thoracic surgery training among general surgery residents. METHODS: ACGME general surgery resident case logs from 1999 to 2019 were reviewed. Data included exposure to the thorax via thoracic, cardiac, vascular, pediatric, trauma, and alimentary tract procedures. Cases from the above categories were consolidated to determine the comprehensive experience. Descriptive statistics were performed over four 5-year Eras (Era 1:1999-2004, Era 2: 2004-2009, Era 3: 2009-2014, Era 4: 2014-2019). RESULTS: Between Era 1 and Era 4, there was an increase in thoracic surgery experience (37.6 ± 1.03 vs 39.3 ± .64; P = .006). The mean total thoracic experience for thoracoscopic, open, and cardiac procedures was 12.89 ± 3.76, 20.09 ± 2.33, and 4.98 ± 1.28, respectively. There was a difference between Era 1 and Era 4 in thoracoscopic (8.78 ± .961 vs 17.18 ± .75; P < .001) and open thoracic experience (22 ± .97 vs 17.06 ± .88; P < .001), and a decrease in thoracic trauma procedures (3.7 ± .06 vs 3.2 ± .32; P = .03). DISCUSSION: Over twenty years there has been a similar, to slight increase in thoracic surgery exposure among general surgery residents. The changes seen in thoracic surgery training reflect the overall movement of surgery towards minimally invasive surgery.

Annual Structured Communication Skills Training for Surgery Residents.

INTRODUCTION: There is no formalized communication curriculum for surgical training. The aim of this study is to determine the benefit of annual communication skill-building workshops for surgical residents over several years. METHODS: The general surgery and the integrated cardiothoracic surgery residents in a tertiary care, urban academic center participated in a 2-hour communication skill-building workshop each year from July 2017 to June 2021. Each participant was administered an anonymous pre-session and post-session survey with a 5-point Likert scale to assess their self-reported preparedness and their evaluation of the workshop. Survey responses were divided into three groups based on their experience in this workshop; no experience (Experience 0), 1 y of experience (Experience 1), and two or more years of experience (Experience 2+). They were compared among groups. RESULTS: Seventy-one surgical residents participated in the workshop generating 124 survey results (Experience 0, 71 [57.3%], Experience 1, 41 [33.1%], and Experience 2+, 12 [9.7%]). Self-reported preparedness scores improved for the overall group as well as for each experience group. While scores decreased significantly in the following years, they improved after each workshop. Scores were significantly better with more experience (4, interquartile range [IQR] 3-4 in Experience 0, 4, IQR 3-5 in Experience 1, 4, IQR 4-5 in Experience 2+, P < 0.001 between Experience 0 and Experience 1, P = 0.041 between Experience 1 and Experience 2+). All residents reported an overwhelmingly positive review of the curriculum. CONCLUSIONS: Yearly 2-hour communication skills practice increased surgical residents' self-reported preparedness, and the repetition helped the improvement. Annual workshops are important for residents to be more prepared for serious illness communication.

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.

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.

Reduction of Unnecessary Gastrostomy Tube Placement in Hospitalized Patients.

BACKGROUND: Many patients undergoing gastrostomy tube placement at one academic medical center were able to resume an oral diet prior to discharge or did not survive hospitalization. The objective of this study was to reduce placement of nonbeneficial gastrostomy tubes and to maintain or improve adherence to gastrostomy tube guidelines. METHODS: In February 2017 the Acute Care Surgery service began an initiative in which gastrostomy tube placement was deferred until the patient was deemed medically stable for discharge. This study retrospectively reviewed all patients who underwent percutaneous endoscopic gastrostomy (PEG) tube placement at Columbia University Irving Medical Center, January 2014-January 2017, prior to the intervention, and February 2017-December 2019, after the intervention. Primary outcomes included the proportion of patients undergoing PEG tube placement who resumed an oral diet or who died during the index hospital stay. Secondary outcomes included the timing of the PEG tube placement. RESULTS: PEGs were placed in 240 patients in the preintervention period and in 171 patients in the postintervention period. In the postintervention period, there was a lower percentage of patients resuming oral diet after PEG placement (17.1% vs. 7.6%, p = 0.0049), a lower duration between stroke diagnosis and PEG placement (mean of 21.0 days vs. 17,1 days, p = 0.0305), and a lower duration between PEG placement and hospital discharge (mean of 19.7 days vs. 13.6 days, p = 0.0035). CONCLUSION: Intentional delay in PEG placement until patients were medically stabilized and approaching discharge was associated with a reduction in unnecessary procedures and an overall reduction in the number of procedures, while maintaining alignment with clinical guidelines and avoiding delays in discharge attributable to the procedure.

In COVID-19 Patients Who Suffer In-Hospital Cardiac Arrest, Cardiopulmonary Resuscitation Outcomes May Be Impacted by Arrest Etiology and Local Pandemic Conditions.

OBJECTIVES: The utility and risks to providers of performing cardiopulmonary resuscitation after in-hospital cardiac arrest in COVID-19 patients have been questioned. Additionally, there are discrepancies in reported COVID-19 in-hospital cardiac arrest survival rates. We describe outcomes after cardiopulmonary resuscitation for in-hospital cardiac arrest in two COVID-19 patient cohorts. DESIGN: Retrospective cohort study. SETTING: New York-Presbyterian Hospital/Columbia University Irving Medical Center in New York, NY. PATIENTS: Those admitted with COVID-19 between March 1, 2020, and May 31, 2020, as well as between March 1, 2021, and May 31, 2021, who received resuscitation after in-hospital cardiac arrest. INTERVENTIONS: None. MEASUREMENT AND MAIN RESULTS: Among 103 patients with coronavirus disease 2019 who were resuscitated after in-hospital cardiac arrest in spring 2020, most self-identified as Hispanic/Latino or African American, 35 (34.0%) had return of spontaneous circulation for at least 20 minutes, and 15 (14.6%) survived to 30 days post-arrest. Compared with nonsurvivors, 30-day survivors experienced in-hospital cardiac arrest later (day 22 vs day 7; p = 0.008) and were more likely to have had an acute respiratory event preceding in-hospital cardiac arrest (93.3% vs 27.3%; p < 0.001). Among 30-day survivors, 11 (73.3%) survived to hospital discharge, at which point 8 (72.7%) had Cerebral Performance Category scores of 1 or 2. Among 26 COVID-19 patients resuscitated after in-hospital cardiac arrest in spring 2021, 15 (57.7%) had return of spontaneous circulation for at least 20 minutes, 3 (11.5%) survived to 30 days post in-hospital cardiac arrest, and 2 (7.7%) survived to hospital discharge, both with Cerebral Performance Category scores of 2 or less. Those who survived to 30 days post in-hospital cardiac arrest were younger (46.3 vs 67.8; p = 0.03), but otherwise there were no significant differences between groups. CONCLUSIONS: Patients with COVID-19 who received cardiopulmonary resuscitation after in-hospital cardiac arrest had low survival rates. Our findings additionally show return of spontaneous circulation rates in these patients may be impacted by hospital strain and that patients with in-hospital cardiac arrest preceded by acute respiratory events might be more likely to survive to 30 days, suggesting Advanced Cardiac Life Support efforts may be more successful in this subpopulation.

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.

Ethical Framework to Guide Decisions of Treatment Over Objection.

BACKGROUND: Whether to proceed with a medical intervention over the objection of a patient who lacks capacity is a common problem facing practitioners. Despite this, there is a notable gap in the literature describing how to proceed in such situations in an ethically rigorous and consistent fashion. We elaborate on the practical application of the 2018 Rubin and Prager 7-question algorithm for ethics consultations about treatment over objection and we describe the impact of each of the 7 questions. STUDY DESIGN: We retrospectively review a series of consultations at Columbia University Irving Medical Center between April 2017 and May 2020 for treatment over objection in adult patients determined to lack capacity. Outcomes about the final ethics recommendation and the assessment of each of the 7 questions are reported. The statistical analysis was designed to determine which of the 7 questions in the algorithm were most predictive of the final ethics recommendation. RESULTS: In our series, there was an ethics recommendation to proceed over the objection of a patient in 63% of consultations. Although all 7 questions were considered to be important to the ethical analysis of a patient's situation, the presence of logistical barriers to treatment and the imminence of harm to a patient without treatment emerged as the most significant drivers of the recommendation of whether to proceed over objection or not. CONCLUSIONS: Cases of treatment over objection in a patient lacking capacity are frequently encountered problems that require a careful balance of patient autonomy and a physician's duty of beneficence. The application of the Rubin and Prager 7-question algorithm reliably guides a care team through such a complex ethical dilemma.

COVID 19: Ethical dilemmas in human lives.

On 7 May 2020, Columbia University Global Centers hosted an online international symposium on ethical dilemmas during the COVID-19 pandemic. This interdisciplinary engagement between philosophers and Covid medical professionals reports the challenges as well as the discrepancies between ethical guidelines and reality. This collection of presentations identifies four key ethical dilemmas regarding responsibility, fairness, dignity and honouring death. In looking into accountability and consistency in medical humanities, it examines whether the contextuality of coronavirus across countries and cultures affected the ethical decision-making processes. This work aims to provide a seminal resource for the development of a high-quality roadmap in medical ethics for future health crises.

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.).

Clinical Ethics Consultations during the COVID-19 Pandemic Surge at a New York City Medical Center.

The COVID-19 pandemic swept through New York City swiftly and with devastating effect. The crisis put enormous pressure on all hospital services, including the clinical ethics consultation team. This report describes the recent experience of the ethics consultants and Columbia University Irving Medical Center during the COVID-19 surge and compares the case load and characteristics to the corresponding period in 2019. By reporting this experience, we hope to supplement the growing body of COVID-19 scientific literature and provide details of the human toll the virus took on our hospitals and communities. We also aim to highlight the role of the clinical ethics consultant as well as areas of policy and law that may need to be addressed in order to be better prepared for a future public health crisis.

Managing ICU surge during the COVID-19 crisis: rapid guidelines.

Given the rapidly changing nature of COVID-19, clinicians and policy makers require urgent review and summary of the literature, and synthesis of evidence-based guidelines to inform practice. The WHO advocates for rapid reviews in these circumstances. The purpose of this rapid guideline is to provide recommendations on the organizational management of intensive care units caring for patients with COVID-19 including: planning a crisis surge response; crisis surge response strategies; triage, supporting families, and staff.

Triage of Scarce Critical Care Resources in COVID-19 An Implementation Guide for Regional Allocation: An Expert Panel Report of the Task Force for Mass Critical Care and the American College of Chest Physicians.

Public health emergencies have the potential to place enormous strain on health systems. The current pandemic of the novel 2019 coronavirus disease has required hospitals in numerous countries to expand their surge capacity to meet the needs of patients with critical illness. When even surge capacity is exceeded, however, principles of critical care triage may be needed as a means to allocate scarce resources, such as mechanical ventilators or key medications. The goal of a triage system is to direct limited resources towards patients most likely to benefit from them. Implementing a triage system requires careful coordination between clinicians, health systems, local and regional governments, and the public, with a goal of transparency to maintain trust. We discuss the principles of tertiary triage and methods for implementing such a system, emphasizing that these systems should serve only as a last resort. Even under triage, we must uphold our obligation to care for all patients as best possible under difficult circumstances.