Burns in South Asia: Outcomes from South Asian Burn Registry (SABR).

BACKGROUND: South Asian region contributes 59 % to the global mortality due to burns. However, we find a paucity of literature on the outcomes of burns from low- and middle-income countries (LMICs). South Asian Burn Registry (SABR) is a facility-based burns registry that collected data on in-patient burn care. This study assesses factors associated with mortality, length of hospital stay at the burns center, and functional status of burn patients. METHODS: Prospective data was collected from two specialized public sector burn centers between September 2014 - January 2015 from Bangladesh and Pakistan. Multivariable logistic, linear, and ordinal logistic regression was conducted to assess factors associated with inpatient-mortality, length of hospital stay, and functional status at discharge, respectively. RESULTS: Data on 883 patients was analyzed. Increased association with mortality was observed with administration of blood product (OR:3, 95 % CI:1.18-7.58) and nutritional support (OR:4.32, 95 % CI:1.55-12.02). Conversely, antibiotic regimens greater than 8 days was associated with decreased mortality (OR:0.1, 95 % CI:0.03-0.41). Associated increase in length of hospital stay was observed in patients with trauma associated with their burn injury, history of seizures (CE:47.93, 95 % CI 12.05-83.80), blood product (CE:22.09, 95 % CI:0.83-43.35) and oxygen administration (CE:23.7, 95 % CI:7.34-40.06). Patients who developed sepsis (OR:6.89, 95 % CI:1.92-24.73) and received blood products during hospitalization (OR:2.55, 95 % CI:1.38- 4.73) were more likely to have poor functional status at discharge. CONCLUSION: This study identified multiple factors associated with worse clinical outcomes for burn patients in South Asia. Understanding these parameters can guide targeted efforts to improve the process and quality of burn care in LMICs.

Exploring medical and nursing students' perceptions about a patient safety course: a qualitative study.

BACKGROUND: Educating health professionals on patient safety can potentially reduce healthcare-associated harm. Patient safety courses have been incorporated into medical and nursing curricula in many high-income countries and their impact has been demonstrated in the literature through objective assessments. This study aimed to explore student perceptions about a patient safety course to assess its influence on aspiring health professionals at a personal level as well as to explore differences in areas of focus between medical and nursing students. METHODS: A dedicated patient safety course was introduced for year III medical and year II and IV nursing students at the Aga Khan University (2021-2022). As part of a post-course assessment, 577 participating students (184 medical and 393 nursing) wrote reflections on the course, detailing its influence on them. These free-text responses were thematically analyzed using NVivo. RESULTS: The findings revealed five major themes: acquired skills (clinical, interpersonal), understanding of medical errors (increased awareness, prevention and reduction, responding to errors), personal experiences with patient safety issues, impact of course (changed perceptions, professional integrity, need for similar sessions, importance of the topic) and course feedback (format, preparation for clinical years, suggestions). Students reported a lack of baseline awareness regarding the frequency and consequences of medical errors. After the course, medical students reported a perceptional shift in favor of systems thinking regarding error causality, and nursing students focused on human factors and error prevention. The interactive course format involving scenario-based learning was deemed beneficial in terms of increasing awareness, imparting relevant clinical and interpersonal skills, and changing perspectives on patient safety. CONCLUSIONS: Student perspectives illustrate the benefits of an early introduction of dedicated courses in imparting patient safety education to aspiring health professionals. Students reported a lack of baseline awareness of essential patient safety concepts, highlighting gaps in the existing curricula. This study can help provide an impetus for incorporating patient safety as a core component in medical and nursing curricula nationally and across the region. Additionally, patient safety courses can be tailored to emphasize areas identified as gaps among each professional group, and interprofessional education can be employed for shared learning. The authors further recommend conducting longitudinal studies to assess the long-term impact of such courses.

Assessment of Patient Safety in a Low-Resource Health Care System: Proposal for a Multimethod Study.

BACKGROUND: The high prevalence of adverse events (AEs) globally in health care delivery has led to the establishment of many guidelines to enhance patient safety. However, patient safety is a relatively nascent concept in low- and middle-income countries (LMICs) where health systems are already overburdened and underresourced. This is why it is imperative to study the nuances of patient safety from a local perspective to advocate for the judicious use of scarce public health resources. OBJECTIVE: This study aims to assess the status of patient safety in a health care system within a low-resource setting, using a multipronged, multimethod approach of standardized methodologies adapted to the local setting. METHODS: We propose purposive sampling to include a representative mix of public and private, rural and urban, and tertiary and secondary care hospitals, preferably those ascribed to the same hospital quality standards. Six different approaches will be considered at these hospitals including (1) focus group discussions on the status quo of patient safety, (2) Hospital Survey on Patient Safety Culture, (3) Hospital Consumer Assessment of Healthcare Providers and Systems, (4) estimation of incidence of AEs identified by patients, (5) estimation of incidence of AEs via medical record review, and (6) assessment against the World Health Organization's Patient Safety Friendly Hospital Framework via thorough reviews of existing hospital protocols and in-person surveys of the facility. RESULTS: The abovementioned studies collectively are expected to yield significant quantifiable information on patient safety conditions in a wide range of hospitals operating within LMICs. CONCLUSIONS: A multidimensional approach is imperative to holistically assess the patient safety situation, especially in LMICs. Our low-budget, non-resource-intensive research proposal can serve as a benchmark to conduct similar studies in other health care settings within LMICs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50532.

Factors associated with emergency department disposition among burn injury patients: Analysis of prehospital and emergency care characteristics using South Asia Burn Registry (SABR) data.

INTRODUCTION: Improvement in burn injury data collections and the quality of databanks has allowed meaningful study of the epidemiologic trends in burn care. The study assessed factors associated with disposition of burn injury patients from emergency department accounting for pre-hospital care and emergency care. METHODS: This prospective observational pilot study of the South Asia Burn Registry project was conducted at selected public sector burn centers in Bangladesh and Pakistan (September 2014 - January 2015). All age groups with an initial presentation to the burn centers were enrolled. Descriptive and regression analysis is presented. RESULTS: A total of 2749 patients were enrolled. The mean age was 21.7 ± 18.0 years, 55.3% were males, and about a quarter were children < 5 years. About 46.9% of the females were housewives. Scald burns were common among children (67.6%) while flame burns were common among adults (44.3%). About 75% of patients were brought in via non-ambulance mode of transport. More than 55% of patients were referrals from other facilities or clinics. The most common first aid given pre-hospital was the use of water or oil. About 25% were admitted for further care. The adjusted odds of being admitted compared to being sent home were highest for children < 5 yrs, those with higher total body surface area burnt, having arrived via ambulance, scald and electrical burn, having an associated injury and inhalational injury. CONCLUSION: The study provides insight into emergency burn care and associated factors that influenced outcomes for patients with burn injuries.

Surgical management of 1- to 2-cm neuroendocrine tumors of the appendix: Appendectomy or right hemicolectomy?

BACKGROUND: The surgical management of 1- to 2-cm neuroendocrine tumors of the appendix is an area of debate. We analyzed the clinical outcomes of appendectomy and compared them to right hemicolectomy. METHODS: We queried the National Cancer Database to identify patients treated for 1- to 2-cm ANETs from 2004 to 2018. Patients were stratified by surgical approach (appendectomy vs. hemicolectomy). Multivariable models were used to identify factors associated with the choice of surgical approach and the association between surgical approach and overall survival. RESULTS: Of the 3,189 patients we included, 1,573 (49.3%) underwent right hemicolectomy and 1,616 (50.7%) appendectomy. The appendectomy rate increased from 37.7% in 2004 to 58.9% in 2018. On multivariable analysis, patients with grade 2 and 3 tumors were less likely to undergo appendectomy alone (odds ratio = 0.41, 95% confidence interval = 0.26-0.66). Longer travel distance was associated with a higher likelihood of undergoing appendectomy (odds ratio = 2.52, 95% confidence interval = 1.15-5.51). After adjusting for tumor grade, appendectomy alone had similar survival to hemicolectomy (hazard ratio = 1.03, 95% confidence interval = 0.67-1.59). CONCLUSION: In this updated analysis of the National Cancer Database, right hemicolectomy was not associated with improved overall survival compared to appendectomy alone for 1- to 2-cm neuroendocrine tumors of the appendix. Although patients with grade 2 or 3 tumors are more likely to undergo right hemicolectomy, this procedure may not improve their treatment or overall outcome.

The effect of surgical timing in nonmetastatic melanoma.

BACKGROUND AND OBJECTIVES: There is no consensus guidelines on the best timing to perform Sentinel lymph node biopsy (SLNB) in high-risk melanoma patients. We aimed to understand the impact of surgical timing on nodal upstaging in patients with cutaneous melanoma. METHODS: We queried the National Cancer Database from 2004 to 2018 for patients with T2-T4, N0, M0 melanomas, who underwent melanoma excision and nodal surgery. We included patients who underwent surgery within 2-19 weeks postdiagnosis. We aimed to determine the association of surgical delay (weeks) with nodal positivity. RESULTS: A total of 53 355 patients were included, of whom 20.9% had positive lymph nodes. Patients underwent surgery at a median of 5 (4-7) weeks after diagnosis. The rate of positive nodes increased with increased weeks to surgery (line of best-fit slope = 0.38). Multivariable regression analysis identified an association between time to surgery and nodal positivity (2.4% increased risk per week, p < 0.05). Our analysis showed significantly increased likelihood of nodal positivity beginning 9 weeks after diagnosis (odds ratio [OR] = 1.3, p < 0.05). Furthermore, patients with T2-3 tumors had a significant increase in nodal positivity with increased time to surgery (OR = 1.03 per week, p < 0.001). However, no significant trend in nodal positivity was identified for patients with T4 melanomas (OR = 1.01 per week, p = 0.596). CONCLUSION: Surgery within 9 weeks of melanoma diagnosis was not associated with increased likelihood of nodal positivity. These data can guide clinical conversations regarding the importance of surgical timing for melanoma.

Incorporating Patient Safety and Quality Course Into the Nursing Curriculum: An Assessment of Student Gains.

BACKGROUND: Training nursing students on quality and patient safety (PS) is crucial to ensuring safe healthcare practices given the key role nurses play on the healthcare team. The aim of this study was to evaluate the impact of quality and PS course on the knowledge, and system thinking of students at different stages of the undergraduate nursing course. METHODS: A 4.5-day quality improvement and PS course was conducted at the Aga Khan University School of Nursing and Midwifery for 146 second- and 139 fourth-year students. Students' knowledge, self-assessment of knowledge and skills, and system thinking were assessed using pretest and posttest. RESULTS: Of the total of 20 points, the course significantly improved students' knowledge by a mean of 4.91 points for second-year students (95% confidence interval [CI], 4.32-5.51) and 3.46 points for fourth-year students (95% CI, 2.90-4.02) between pretest and posttest. For systems thinking, the Systems Thinking Scale scores increased by 0.41 points (95% CI, 0.29-0.52) for second-year students and 0.33 points (95% CI, 0.22-0.44) for fourth-year students out of the total of 5 points. The self-assessment scores significantly increased on postcourse assessment for second (P < 0.05) and fourth-year students (P < 0.001). Positive experience reported by students in the narrative reflections complemented these results. CONCLUSIONS: There was a significant increase in nursing students' knowledge, self-efficacy, and system thinking after participating in this short PS course. Replication at a national level may improve safety knowledge and skills among nursing students with subsequent gains in the safety of healthcare delivery in Pakistan.

The impact of community medical camps on medical students and graduates' education.

Objectives: To investigate the impact of volunteering at community medical camps on medical students' and graduates' clinical and soft skills, knowledge of community health, and future career goals. METHODS: The cross-sectional pilot study was conducted at the Aga Khan University Hospital, Karachi from July to October 2020, and comprised medical students or trainees who had attended at least one medical camp in a community-based setting organised by any of the two non-governmental organisations who collaborated in the study. Responses were obtained through a self-reported online survey from the participants. Data was analyzed using SPSS 25. RESULTS: Of the 52 subjects, there were 25(48.9%) males and 27(51.9%) females with overall mean age 25.4±3.8 years. Majority of the participants 35(67.3%) had attended a private first-tier medical school while 17(32.7%) had attended other local medical schools. Overall, 40(76.9%) subjects reported improved community knowledge, , 44(84.6%) had experiential learning and confidence in outpatient management, and 49(94%) had improved soft skills. Besides, 21(40.4%) participants agreed to have been influenced to pursue a career in primary care, and 25(48.1%) reported a direct impact on their choice of career specialty. Compared to males, females reported improved awareness and alertness (p=0.016), increased confidence approaching communities (p=0.032), and increased compassion towards patient care (p=0.047). CONCLUSIONS: Community-based medical camps had an overall positive impact on volunteering medical students.

Predictors of sentinel lymph node metastasis in very thin invasive melanomas.

BACKGROUND: Melanomas < 0.8 mm in Breslow depth have less than a 5% risk for nodal positivity. Nonetheless, nodal positivity is prognostic for this group. Early identification of nodal positivity may improve the outcomes for these patients. OBJECTIVES: To determine the degree to which ulceration and other high-risk features predict sentinel lymph node (SLN) positivity for very thin melanomas. METHODS: The National Cancer Database was reviewed from 2012 to 2018 for patients with melanoma with Breslow thickness < 0.8 mm. Data were analysed from 7 July 2022 through to 25 February 2023. Patients were excluded if data regarding their ulceration status or SLN biopsy (SLNB) performance were unknown. We analysed patient, tumour and health system factors for their effect on SLN positivity. Data were analysed using χ2 tests and logistic regressions. Overall survival (OS) was compared by Kaplan-Meier analyses. RESULTS: Positive nodal metastases were seen in 876 (5.0%) patients who underwent SLNB (17 692). Factors significantly associated with nodal positivity on multivariable analysis include lymphovascular invasion [odds ratio (OR) 4.5, P < 0.001], ulceration (OR 2.6, P < 0.001), mitoses (OR 2.1, P < 0.001) and nodular subtype (OR 2.1, P < 0.001). Five-year OS was 75% and 92% for patients with positive and negative SLN, respectively. CONCLUSIONS: Nodal positivity has prognostic significance for very thin melanomas. In our cohort, the rate of nodal positivity was 5% overall in these patients who underwent SLNB. Specific tumour factors (e.g. lymphovascular invasion, ulceration, mitoses, nodular subtype) were associated with higher rates of SLN metastases and should be used to guide clinicians in choosing which patients will benefit from SLNB.

Patient and provider factors predict non-surgical management for complex upper gastrointestinal cancers.

BACKGROUND: Surgery is the only potentially curative treatment for non-metastatic upper gastrointestinal cancers. We analyzed patient and provider characteristics associated with non-surgical management. METHODS: We queried the National Cancer Database for patients with upper gastrointestinal cancers from 2004 to 2018 who underwent surgery, refused surgery, or for whom surgery was contraindicated. Multivariate logistic regression identified factors associated with surgery being refused or contraindicated, and Kaplan-Meier curves assessed survival. RESULTS: We identified 249,813 patients based on our selection criteria-86.3% had surgery, 2.4% refused, and for 11.3%, surgery was contraindicated. Median overall survival was 48.2 months for patients who underwent surgery versus 16.3 and 9.4 months for the refusal and contraindicated groups. Medical and non-medical factors predicted both surgery refusals and contraindications, such as increasing age (odds ratio = 1.07 and 1.03, respectively, P < .001), Black race (odds ratio = 1.72 and 1.45, P < .001), comorbidities (Charlson-Deyo score 2+, odds ratio = 1.18 and 1.66, P < .001), low socioeconomic status (odds ratio = 1.70 and 1.40, P < .001), no health insurance (odds ratio = 3.26 and 2.34, P < .001), community cancer programs (odds ratio = 1.43 and 1.40, P < .001), low volume facilities (odds ratio = 1.82 and 1.52, P < .001), and stage 3 disease (odds ratio = 1.51 and 6.50, P < .001). On subset analysis (excluding patients age >70, Charlson-Deyo score 2+, and stage 3 cancer), non-medical predictors of both outcomes were similar. CONCLUSION: Refusal of and medical contraindications for surgery profoundly impact overall survival. The same factors (ie, race, socioeconomic status, hospital volume, and hospital type) predict these outcomes. These findings suggest variation and potential bias that may exist between physicians and patients discussing cancer surgery.

Adjuvant Chemotherapy Is Associated with Improved Survival for Stage III Colon Cancer When Initiated Beyond 8 Weeks.

BACKGROUND: The National Comprehensive Cancer Network (NCCN) guidelines recommend adjuvant chemotherapy (AC) within 6-8 weeks of surgical resection for patients with stage III colon cancer. However, postoperative complications or prolonged surgical recovery may affect the receipt of AC. The aim of this study was to assess the utility of AC for patients with prolonged postoperative recovery. METHODS: We queried the National Cancer Database (2010-2018) for patients with resected stage III colon cancer. Patients were categorized as having either normal or prolonged length of stay (PLOS: >7 days, 75th percentile). Multivariable Cox proportional hazard regression and logistic regressions were used to identify factors associated with overall survival and receipt of AC. RESULTS: Of the 113,387 patients included, 30,196 (26.6%) experienced PLOS. Of the 88,115 (77.7%) patients who received AC, 22,707 (25.8%) initiated AC more than 8 weeks after surgery. Patients with PLOS were less likely to receive AC (71.5% vs. 80.0%, OR: 0.72, 95%CI=0.70-0.75) and displayed inferior survival (75 vs. 116 months, HR: 1.39, 95%CI=1.36-1.43). Receipt of AC was also associated with patient factors such as high socioeconomic status, private insurance, and White race (p<0.05 for all). AC within and after 8 weeks of surgery was associated with improved survival for patients with both normal LOS and PLOS (normal LOS: <8 weeks HR: 0.56, 95% CI: 0.54-0.59, >8 weeks HR: 0.68, 95% CI: 0.65-0.71; PLOS: <8 weeks HR: 0.51, 95% CI: 0.48-0.54, >8 weeks HR: 0.63, 95% CI 0.60-0.67). AC was associated with significantly improved survival if initiated up to 15 weeks postoperatively (normal LOS: HR: 0.72, 95%CI=0.61-0.85; PLOS: HR: 0.75, 95%CI=0.62-0.90), and very few patients (<3.0%) initiated AC beyond this time. CONCLUSION: Receipt of AC for stage III colon cancer may be affected by surgical complications or otherwise prolonged recovery. Timely and even delayed AC (>8 weeks) are both associated with improved overall survival. These findings highlight the importance of delivering guideline-based systemic therapies, even after complicated surgical recovery.

Understanding Factors Leading to Surgical Attrition for "Resectable" Gastric Cancer.

OBJECTIVES: We used a novel combined analysis to evaluate various factors associated with failure to surgical resection in non-metastatic gastric cancer. METHODS: We identified factors associated with the receipt of surgery in publicly available clinical trial data for gastric cancer and in the National Cancer Database (NCDB) for patients with stages I-III gastric adenocarcinoma. Next, we evaluated variable importance in predicting the receipt of surgery in the NCDB. RESULTS: In published clinical trial data, 10% of patients in surgery-first arms did not undergo surgery, mostly due to disease progression and 15% of patients in neoadjuvant therapy arms failed to reach surgery. Effects related to neoadjuvant administration explained the increased attrition (5%). In the NCDB, 61.7% of patients underwent definitive surgery. In a subset of NCDB patients resembling those enrolled in clinical trials (younger, healthier, and privately insured patients treated at high-volume and academic centers) the rate of surgery was 79.2%. Decreased likelihood of surgery was associated with advanced age (OR 0.97, p < 0.01), Charlson-Deyo score of 2+ (OR 0.90, p < 0.01), T4 tumors (OR 0.39, p < 0.01), N+ disease (OR 0.84, p < 0.01), low socioeconomic status (OR 0.86, p = 0.01), uninsured or on Medicaid (OR 0.58 and 0.69, respectively, p < 0.01), low facility volume (OR 0.64, p < 0.01), and non-academic cancer programs (OR 0.79, p < 0.01). CONCLUSION: Review of clinical trials shows attrition due to unavoidable tumor and treatment factors (~ 15%). The NCDB indicates non-medical patient and provider characteristics (i.e., age, insurance status, facility volume) associated with attrition. This combined analysis highlights specific opportunities for improving potentially curative surgery rates.

Measuring the patient safety culture at a tertiary care hospital in Pakistan using the Hospital Survey on Patient Safety Culture (HSOPSC).

BACKGROUND: Patient safety is a top priority for many healthcare organisations worldwide. However, most of the initiatives aimed at the measurement and improvement of patient safety culture have been undertaken in developed countries. The purpose of this study was to measure the patient safety culture at a tertiary care hospital in Pakistan using the Hospital Survey on Patient Safety Culture (HSOPSC). METHODS: The HSOPSC was used to measure the patient safety culture across 12 dimensions at Aga Khan University Hospital, Karachi. 2,959 individuals, who had been working at the hospital, were administered the HSOPSC in paper form between June and September 2019. RESULTS: The response rate of the survey was 50%. In the past 12 months, 979 respondents (33.1%) had submitted at least one event report. Results showed that the personnel viewed the patient safety culture at their hospital favourably. Overall, respondents scored highest in the following dimensions: 'feedback and communication on error' (91%), 'organisational learning and continuous improvement' (85%), 'teamwork within units' (83%), 'teamwork across units' (76%). The dimensions with the lowest positive per cent scores included 'staffing' (40%) and 'non-punitive response to error' (41%). Only the reliability of the 'handoffs and transitions', 'frequency of events reported', 'organisational learning' and 'teamwork within units' was higher than Cronbach's alpha of 0.7. Upon regression analysis of positive responses, physicians and nurses were found to have responded less favourably than the remaining professional groups for most dimensions. CONCLUSION: The measurement of safety culture is both feasible and informative in developing countries and could be broadly implemented to inform patient safety efforts. Current data suggest that it compares favourably with benchmarks from hospitals in the USA. Like the USA, high staff workload is a significant safety concern among staff. This study lays the foundation for further context-specific research on patient safety culture in developing countries.

Average treatment effect of facility hepatopancreatobiliary malignancy case volume on survival of patients with nonoperatively managed hepatobiliary malignancies.

BACKGROUND: Surgical volume-outcome relationships have been described for a variety of procedures. There is scant literature on total institutional volume and outcomes in patients who are nonoperatively managed. We examined the average treatment effect of total hepatopancreatobiliary malignancy case volume on survival outcomes of patients with nonresected hepatobiliary malignancies. METHODS: We identified patients with hepatopancreatobiliary malignancies [pancreatic adenocarcinoma, pancreatic neuroendocrine neoplasms, hepatocellular carcinoma, biliary tract cancers] within the National Cancer Database (2004-2018). We determined percentile thresholds based on the total annual hepatopancreatobiliary malignancy case volume. We then identified nonoperatively managed patients with hepatocellular carcinoma or biliary tract cancers. We used inverse probability-weighted Cox regression to estimate the effect of facility volume on overall survival. RESULTS: We identified 710,988 patients with hepatopancreatobiliary malignancies. Total annual hepatopancreatobiliary malignancy case volume of 32, 71, and 177 cases/year corresponded to the 25th, 50th, and 75th percentiles. A total of 96,420 with hepatocellular carcinoma and 52,627 patients with biliary tract cancers were managed nonoperatively. In patients with hepatocellular carcinoma or biliary tract cancer, treatment at ≥25th, ≥50th, and ≥75th percentile facilities was associated with improved median, 1-, 2-, and 3-year overall survival compared with treatment at lower-percentile facilities. On inverse probability-weighted Cox analysis, treatment at higher-percentile facilities resulted in a lower hazard of death. Consistent findings were observed in patients with early or intermediate/advanced hepatocellular carcinoma or metastatic biliary tract cancers. CONCLUSION: Patients with nonoperatively managed hepatocellular carcinoma or biliary tract cancer who receive treatment at higher-volume facilities have improved survival outcomes. These data suggest regionalization of care for patients with hepatocellular carcinoma or biliary tract cancer to high-volume centers may improve survival.

Defining Facility Volume Threshold for Optimization of Short- and Long-Term Outcomes in Patients Undergoing Resection of Perihilar Cholangiocarcinoma.

BACKGROUND: We determined the minimum threshold (Tmin) of annual facility case volume to optimize outcomes for patients with resected perihilar cholangiocarcinoma. METHODS: We identified patients with localized perihilar cholangiocarcinoma who underwent resection within the National Cancer Database (2010-2017). We used marginal structural logistic regression models to estimate the average treatment effect of receiving care in facilities meeting/exceeding Tmin on 90-day mortality and other postoperative outcomes. RESULTS: A total of 2471 patients underwent resection for perihilar cholangiocarcinoma at 471 facilities. There was no effect of total hepatopancreatobiliary, surgical hepatopancreatobiliary, total hepatobiliary, surgical hepatobiliary, or total perihilar cholangiocarcinoma case volume on 90-day mortality. A Tmin of seven perihilar cholangiocarcinoma resections/year resulted in lower odds of 90-day mortality (IP-weighted OR = 0.49, 95% CI: 0.66-0.87). A total of two facilities met the Tmin. Patients receiving treatment at Tmin facilities had lower odds of length of stay ≥ 7 days (IP-weighted OR = 0.85, 95% CI: 0.75-0.97) and positive surgical resection margins (IP-weighted OR = 0.40, 95% CI: 0.47-0.55). Additionally, undergoing surgery at Tmin facilities resulted in higher (≥ 4 nodes) lymph node yields (IP-weighted OR = 1.94, 95% CI: 1.21-3.11) but no change in the odds of nodal positivity. There was no effect of undergoing surgery at Tmin facilities on 30-day mortality or re-admission. CONCLUSIONS: Resection of perihilar cholangiocarcinoma is infrequently performed at a high number of facilities. A Tmin of ≥ 7 resections/year resulted in lower 90-day mortality and improved postoperative outcomes. Our data suggest that regionalization of care for patients with perihilar cholangiocarcinoma could potentially improve outcomes in the USA.

Trends in Melanoma Phase 3 Clinical Trials since 2010: Is there Hope for Advanced Melanoma Therapies beyond Approved Treatment Mechanisms?

BACKGROUND: Several drugs and treatment modalities are under investigation to improve current melanoma therapy options. This review profiles the trends in clinical trial investment in late-stage melanoma, and anticipates what changes are expected in melanoma treatment, with a focus on exploratory drug mechanisms. METHODS: We reviewed nine international clinical trial databases for registered, interventional, and phase 3 cutaneous melanoma clinical trials since 2010. RESULTS: 73 trials studied drug therapies in late-stage (stage III and IV) melanoma. Exploratory mechanisms were investigated in 32% (23/73) of the late-stage melanoma drug therapy trials. Most exploratory drug trials include immunotherapy drug mechanisms (15/23 trials). Two exploratory mechanisms showed promise: the anti-LAG3 antibody, relatlimab, and the hapten modified vaccine, MVax. Many (52%) trials of exploratory mechanisms are ongoing including the use of adoptive cell transfer immunotherapies, dendritic cell vaccine therapy, and histone deacetylase (HDAC) inhibitors, among others. CONCLUSIONS: Since most clinical trials focus on previously approved drug mechanisms, it is likely that paradigm-changing treatments will involve these therapies being used in new treatment contexts or combinations. Only 2 exploratory drug mechanisms studied since 2010 have achieved promising results in the phase 3 setting, though many other trials are ongoing at this time.

Incorporating Patient Safety and Quality Into the Medical School Curriculum: An Assessment of Student Gains.

BACKGROUND: Global efforts are being made to improve health care standards and the quality of care provided. It has been shown through research that the introduction of patient safety (PS) and quality improvement (QI) concepts in the medical curriculum prepares medical students to face future challenges in their professional careers. PURPOSE: This study aimed to evaluate how a brief course on QI and PS affects the knowledge, efficacy, and system thinking of medical students. METHODS: A 5-day QI and PS intervention course was implemented at the Aga Khan University medical college for 98 third-year medical students in March 2021. This weeklong course of lectures, interactive sessions, and hands-on skill workshops was conducted before the students began their clinical rotations. Students' knowledge, self-efficacy, and system thinking were assessed with pretest and posttest. Students were also asked to write personal reflections and fill out a satisfaction survey at the end of the intervention. RESULTS: Comparisons of pretest and posttest scores showed that the course significantly improved students' knowledge by a mean of 2.92 points (95% confidence interval, 2.30-3.53; P < 0.001) and system thinking by 0.16 points (95% confidence interval, 0.03-0.29; P = 0.018) of the maximum scores of 20 and 5 points, respectively. The students' self-assessment of PS knowledge also reflected statistically significant increases in all 9 domains ( P < 0.001). Students reported positive experiences with this course in their personal reflections. CONCLUSIONS: The medical students exhibited increases in knowledge, self-efficacy, and system thinking after this weeklong intervention. The design of the course can be modified as needed and implemented at other institutions in low- and middle-income countries. A targeted long-term assessment of knowledge and attitudes is needed to fully evaluate the impact of this course.

Liver Transplantation as a Curative Approach for Patients With Nonresectable Colorectal Liver Metastases.

OBJECTIVES: Liver transplant is emerging as a potential treatment option for patients with isolated colorectal liver metastasis. In this review article, we analyzed the published literature on liver transplant outcomes in such patients. MATERIALS AND METHODS: Four prospective studies documenting the clinical outcomes in patients with colorectal liver metastasis who underwent liver transplant were analyzed to study the feasibility of liver transplant in such patients. RESULTS: The SECA-II trial demonstrated the highest overall survival of 100%, 83%, and 83% at 1, 3, and 5 years, respectively, and disease-free survival of 53%, 44%, and 35%, respectively, with a narrow inclusion criterion. Conversely, extended criteria for selection and donors in arm D of the same trial resulted in median overall survival and disease-free survival of 18 and 4 months, respectively. CONCLUSIONS: Liver transplant provided more prolonged overall survival compared with other therapeutic modalities. Patients with isolated colorectal liver metastasis of less aggressive biology, good performance status, at least 6 weeks of chemotherapy, low clinical risk scores, and negative nodal disease should be considered for patient selection. Moreover, exclusion criteria consisting of patients with the right-sided primary tumor, less than 3 years to liver transplant after diagnosis, and elevation of carbohydrate antigen (CA19-9) in the presence of BRAF mutation should be explored.

Disparities in treatment and survival for patients with isolated colorectal liver metastases.

BACKGROUND: Surgical resection improves survival for patients with isolated colorectal liver metastasis. National studies on the disparities related to this topic are limited; therefore, we investigated factors that affect surgical treatment and survival. METHODS: We queried the National Cancer Database (2010-2017) for patients with isolated synchronous colorectal liver metastasis. Multivariable logistic regression and Cox proportional hazard regressions were used to identify factors associated with surgical resection, treatment at high-volume facilities, and overall survival. RESULTS: Of 34,050 patients with isolated colorectal liver metastasis, surgical resection (n = 7,810; 23.0%) was more likely among patients who were of high socioeconomic status (odds ratio = 1.16; 95% confidence interval, 1.04-1.31), traveled long distance for treatment (odds ratio = 1.48; 95% confidence interval, 1.31-1.66), and were treated at high-volume facilities (odds ratio = 4.86; 95% confidence interval, 14.45-5.30). Black patients were less likely to undergo resection (odds ratio = 0.75; 95% confidence interval, 0.69-0.82). Treatment at high-volume facility was more common among patients who were Black (odds ratio = 1.14; 95% confidence interval, 1.07-1.21), were of high socioeconomic status (socioeconomic status index 7: odds ratio = 1.21; 95% confidence interval, 1.11-1.31), and traveled long distance (odds ratio = 4.03; 95% confidence interval, 3.63-4.48) and less likely for nonmetropolitan residents and those of low socioeconomic status (P < .05). Patients of high socioeconomic status and those who traveled long distance, were treated at high-volume facilities, underwent surgical resection, and received perioperative chemotherapy had an associated survival advantage (P < .05 for all), whereas Black race was associated with poorer overall survival (P < .05). CONCLUSION: Nonmedical patient factors, such as race, socioeconomic status, and geography, are associated with treatment and survival for isolated colorectal liver metastases. Disparities persist after adjusting for surgical resection and treatment facility. These barriers must be addressed to improve care for vulnerable cancer patients.