Novant Health

The regulations are evolving, for example EMA Annex 1, earlier versions did not mention trends, the current draft version mentions it 23 times. WHO, and FDA also talk about trending, root cause analysis, investigation, and using the data for these purposes. PDA technical report 13, the new revision, even states that automation for data management for environmental mentoring is "essential". Trending the data is now a regulatory requirement but what trends should we use, and when? This presentation will include a review of key regulations as they relate to the need to use our data for trending including how often and what events should trigger trending, root cause analysis, and investigations. Also, which trend tools should we use for the different contamination control processes, cut off method, Control charts (Shewhart, etc.), Quantiles, Percentiles, Weibull Distribution, Scatter plot, Regression analysis for slope (upward/downward trends).The last 20 years we have been collecting data and regulations like Annex 11/21 CFR part 11, and more recently the data integrity guidelines, have facilitated that the data is accurate and reliable. Now this regulatory evolution is mandating the use of the data for the betterment of our processes, process control, product quality and patient safety.

Esophageal cancer (EC) is the third leading cause of cancer-related morbidity and mortality in Malawi. Given limited imaging capacity and high costs, staging is not routinely performed. One proposed staging algorithm is to first evaluate for metastatic disease using low-cost chest radiography (CXR) and abdominal ultrasound (US) followed by confirmatory computerized tomography (CT) of the chest and abdomen if no metastases identified on initial screening. The feasibility of this approach is unknown for EC in sub–Saharan Africa and was studied in the context of a larger prospective observational cohort study of EC in Malawi. From 2021 to 2022, EC patients at Kamuzu Central Hospital in Lilongwe, Malawi enrolled in the Treatment Outcomes of Esophageal Cancer in Malawi (TOEC-M) study were recruited. Participants were scheduled for a CXR, US, and CT scan as part of this sub-study. Participant characteristics, completion rates, imaging findings, and barriers to completion were documented. For participants undergoing all three imaging studies, sensitivity and specificity were calculated. Of 150 patients in TOEC-M, 67 (44.7%) enrolled in this sub-study. Mean age was 55.4 years and 50.8% were males. The majority had mid-esophageal (38 [56.7%]) squamous cell carcinomas (54 [80.6%]). CXR was completed in 54 (80.6%) study participants, US in 43 (64.2%), CT chest in 29 (43.3%), and CT abdomen in 24 (35.8%). Sixteen (23.9%) completed all studies and 4 (6.0%) did not undergo any imaging. Of the 63 patients that were imaged, metastatic disease was identified in 18 (28.6%) by any modality. Positive findings were identified on 3 (5.6%) CXRs, 4 (9.3%) US, and 18 (62.1%) CTs, most frequently liver masses followed by lung nodules and adenopathy. Barriers to imaging completion included participant functional status and scanner availability. As access to EC treatment modalities expands, feasible and accurate staging will become increasingly important to guide clinical management. Our results suggest that CXR and US may serve as useful initial tools for assessing metastatic disease. In patients not medically fit for oncologic treatment, positive findings on CXR and US may allow CT to be deferred. Barriers to implementation of a pragmatic stepwise staging algorithm identified in this study can inform future research and care for patients with EC in similar resource-limited settings.

Point-of-care ultrasound (POCUS) has seen growing integration into family medicine over the past decade, to the point that POCUS competency is now moving toward inclusion in board eligibility. In parallel, excitement and interest around POCUS are growing at the medical student and residency levels. With its wide array of practical applications in the outpatient setting, POCUS invites us to imagine what family medicine could look like if ultrasound truly became "the new stethoscope" and a routine part of care. This commentary highlights how POCUS can be used accurately and efficiently for abdominal aortic aneurysm (AAA) screening, avoid unnecessary emergency department visits by ruling out deep vein thrombosis (DVT), and change management of soft tissue infections by detecting abscesses. Together, these examples illustrate how POCUS can enhance care in the family medicine clinic.

ABSTRACTObjectives:The purpose was to report pre–COVID-19 and post–COVID-19 trends in training and job searches for recent orthopaedic trauma fellowship graduates. The pandemic occurred within the survey period, so the aim was to evaluate the pandemic's effects, particularly regarding training and jobs. It was hypothesized that the pandemic and other societal changes that occurred during the survey period had broad-reaching effects on graduate medical education and job selection for graduating traumatologists, including fewer surgical repetitions, strained interviews, and altered trends in job characteristic prioritization extending beyond the pandemic.Design:Cross-sectional survey.Setting:Orthopaedic Trauma Association (OTA/AO) surveys.Participants:Orthopaedic surgeons who graduated from United States (US) trauma fellowships from 2017 to 2023 were eligible.Main Outcome Measurement:A 56-question survey was emailed to recent trauma fellowship graduates assessing training, job searches, and job types selected.Results:In total, 240/600 (40%) orthopaedic surgeons who graduated from US trauma fellowships from 2017 to 2023 participated. Most (68%) trained at academic level 1 trauma fellowships. Of 2020–2023 graduates, 52% reported lighter caseloads, while 27% felt telehealth made their clinical experience less valuable. Many (42%) reported fewer jobs. Sought-after job characteristics included 51–70 work hours/wk (63%), 4–6 night-calls/month (36%), and 401–500 cases/year (27%). The most common salary was $501,000–$600,000/y (22%).Conclusion:For trauma fellows, COVID-19 resulted in training disadvantages, including fewer hands-on experiences, and job search obstacles, including less employment opportunities and compensation. Recognizing trends in recently graduated traumatologists will help maximize training and enhance professional satisfaction for young surgeons.Level of Evidence:V.