Nonacademic Sites Research Articles

The National Institutes of Health COVID-19 Neuro Databank/Biobank: Creation and Evolution.

Diverse neurological conditions are reported associated with the SARS-CoV-2 virus; neurological symptoms are the most common conditions to persist after the resolution of acute infection, affecting 20% of patients 6 months after acute illness. The COVID-19 Neuro Databank (NeuroCOVID) was created to overcome the limitations of siloed small local cohorts to collect detailed, curated, and harmonized de-identified data from a large diverse cohort of adults with new or worsened neurological conditions associated with COVID-19 illness, as a scientific resource. A Steering Committee including US and international experts meets quarterly to provide guidance. Initial study sites were recruited to include a wide US geographic distribution; academic and non-academic sites; urban and non-urban locations; and patients of different ages, disease severity, and comorbidities seen by a variety of clinical specialists. The NeuroCOVID REDCap database was developed, incorporating input from professional guidelines, existing common data elements, and subject matter experts. A cohort of eligible adults is identified at each site; inclusion criteria are: a new or worsened neurological condition associated with a COVID-19 infection confirmed by testing. De-identified data are abstracted from patients' medical records, using standardized common data elements and five case report forms. The database was carefully enhanced in response to feedback from site investigators and evolving scientific interest in post-acute conditions and their timing. Additional US and international sites were added, focusing on diversity and populations not already described in published literature. By early 2024, NeuroCOVID included over 2,700 patient records, including data from 16 US and 5 international sites. Data are being shared with the scientific community in compliance with NIH requirements. The program has been invited to share case report forms with the National Library of Medicine as an ongoing resource for the scientific community. The NeuroCOVID database is a unique and valuable source of comprehensive de-identified data on a wide variety of neurological conditions associated with COVID-19 illness, including a diverse patient population. Initiated early in the pandemic, data collection has been responsive to evolving scientific interests. NeuroCOVID will continue to contribute to scientific efforts to characterize and treat this challenging illness and its consequences.

Outpatient administration of mosunetuzumab in US community practice settings: perspectives and learnings from the Phase II MorningSun study

Outpatient administration of mosunetuzumab in US community practice settings: perspectives and learnings from the Phase II MorningSun study

Complex implementation factors demonstrated when evaluating cost-effectiveness and monitoring racial disparities associated with [18F]DCFPyL PET/CT in prostate cancer men

Prostate cancer (PC) staging with conventional imaging often includes multiparametric magnetic resonance (MR) of the prostate, computed tomography (CT) of the chest, abdomen, and pelvis, and whole-body bone scintigraphy. The recent development of highly sensitive and specific prostate specific membrane antigen (PSMA) positron emission tomography (PET) has suggested that prior imaging techniques may be insufficiently sensitive or specific, particularly when evaluating small pathologic lesions. As PSMA PET/CT is considered to be superior for multiple clinical indications, it is being deployed as the new multidisciplinary standard-of-care. Given this, we performed a cost-effectiveness analysis of [18F]DCFPyL PSMA PET/CT imaging in the evaluation of PC relative to conventional imaging and anti-3-[18F]FACBC (18F-Fluciclovine) PET/CT. We also conducted a single institution review of PSMA PET/CT scans performed primarily for research indications from January 2018 to October 2021. Our snapshot of this period of time in our catchment demonstrated that PSMA PET/CT imaging was disproportionately accessed by men of European ancestry (EA) and those residing in zip codes associated with a higher median household income. The cost-effectiveness analysis demonstrated that [18F]DCFPyL PET/CT should be considered as an alternative to anti-3-[18F]FACBC PET/CT and standard of care imaging for prostate cancer staging. [18F]DCFPyL PET/CT is a new imaging modality to evaluate PC patients with higher sensitivity and specificity in detecting disease than other prostate specific imaging studies. Despite this, access may be inequitable. This discrepancy will need to be addressed proactively as the distribution network of the radiotracer includes both academic and non-academic sites nationwide.

AB-452642-2 COMPLICATIONS ASSOCIATED WITH CATHETER ABLATION OF ATRIAL FIBRILLATION IN CURRENT PRACTICE: INSIGHTS FROM A LARGE, REAL-WORLD COLLABORATION

Catheter ablation is a cornerstone treatment for symptomatic atrial fibrillation (AF) with major improvements in safety over time. However, rates of adverse events with use of current techniques in a contemporary quality-focused network remain undefined. Across a large, real-world sample, we sought to describe (1) rates of major, adverse events associated with catheter ablation of AF and (2) patient-level factors associated with complications. Utilizing the REAL-AF collaboration, a registry of contemporary AF ablation procedures with granular patient, procedural and follow-up data comprised of cases from over 50 operators across academic and non-academic sites, we evaluated all patients undergoing their first ablation procedure from January 2018 – June 2022. Risk-adjusted analyses were conducted to evaluate the relationship between patient factors and complications. Among 3144 patients (age 66.1 +/- 11.0 years, 42% female, 67.1% paroxysmal, 32.9% persistent) who underwent AF ablation, procedure-related complications (n =77) were identified in 65 patients (2.1%) with multiple complications occurring in 9 patients (0.2%). Most complications (n=70, 93.5%) occurred in the peri-procedural (within 30 days) period and 6.5% (n=5) after 30 days, the latter of which all represented vascular injuries (Figure). Major complications (18 of 72 peri-procedural complications, 25.0%) are defined, detailed, and associated data reported in the Figure. Unadjusted (16.0% without CHF vs. 33.3% with CHF, p = 0.045) and risk-adjusted (OR 2.8, 95% CI 1.03-7.60, p=0.045) analyses indicated history of CHF was associated with a composite outcome of major complications. Analyses of independent complications showed those who suffered from peri-procedural stroke (n=3) were of significantly greater age (77.3 +/- 5.5 years vs. 66.1 +/- 10.9 years, p=0.035). Risk-adjusted analyses showed history of vascular disease (OR 2.9, 95% CI 1.02-8.20, p=0.045) was associated with vascular injury (n=18). From 0-695 days post-procedure, 31 deaths occurred (unknown cause: 17, COVID-19 related: 4, heart failure: 2, cardiac arrest: 2). Major complications represent rare events among those undergoing AF ablation in current practice. Risk-adjusted analyses suggest a history of CHF is associated with major complications. Similarly, older age and a history of vascular disease are associated with stroke and vascular complications, respectively.

MP38-17 PROSTATE CANCER GRADE MIGRATION AND FACILITY-LEVEL TREATMENT TRENDS FOR LOW GRADE DISEASE

You have accessJournal of UrologyCME1 Apr 2023MP38-17 PROSTATE CANCER GRADE MIGRATION AND FACILITY-LEVEL TREATMENT TRENDS FOR LOW GRADE DISEASE Leonardo Borregales, Michael Tzeng, Ashwin Ramaswamy, Xiangmei Gu, Meenakshi Davuluri, Himanshu Nagar, and Jim Hu Leonardo BorregalesLeonardo Borregales More articles by this author , Michael TzengMichael Tzeng More articles by this author , Ashwin RamaswamyAshwin Ramaswamy More articles by this author , Xiangmei GuXiangmei Gu More articles by this author , Meenakshi DavuluriMeenakshi Davuluri More articles by this author , Himanshu NagarHimanshu Nagar More articles by this author , and Jim HuJim Hu More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.17AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Overtreatment of low-grade prostate cancer (PCa) reflect poor quality of care and prompted changes to guidelines over the past decade. Active surveillance (AS) is the preferred choice for low-grade PCa, due to excellent oncological safety and ability to mitigate the consequences of definitive treatment. Nonetheless, uptake of AS in the US continues to lag behind other healthcare systems, such as Sweden, where implementation for GG (Gleason grade group) 1 disease reached 74% by 2014.The lack of AS adoption has been attributed to significant heterogeneity in facility-level practice patterns in the US. Contemporary trends in GG1 PCa management can inform policymakers and guide future initiatives. We sought to characterize trends in the incidence of GG1 disease at biopsy and prostatectomy pathology and assess treatment variability by facility type. METHODS: Men with newly diagnosed PCa between 2010-2019 were identified in the National Cancer Database. Analysis of trends in GG distribution included 1,024,607 men in the biopsy cohort and 511,199 men in the RP cohort. Analysis of treatment trends (AS vs. RP, radiation therapy [RT], focal therapy [FT], or androgen deprivation therapy [ADT]) of localized GG1 PCa according to facility type included 249,585 men. Patients with unknown stage/grade, treatment, or facility type were excluded. Facility was defined as academic (academic/research program) vs. non-academic (community cancer program, comprehensive community cancer program, or integrated network cancer program). AS was defined per the NCDB variable “RX_SUMM_TREATMENT_STATUS” code 2(AS). Joinpoint Regression Program 4.9.0.1 was used for joinpoint analysis. RESULTS: From 2010-2019, GG1 PCa incidence significantly declined from 45% to 25% at biopsy and from 33% to 10% at RP pathology. Among academic sites, use of AS increased from 12% to 62% (AAPC=21%, 95% CI [19,22]), RP decreased from 61% to 25% (AAPC=-9.3%, 95%CI [-10, -8.5]), and RT from 25% to 12% (AAPC=-7.9%, 95%CI [-8.8, -7.0]). Similar trends were seen in nonacademic sites, AS increased from 5% to 49% (AAPC=28%, 95% CI [24,32]), RP decreased from 54% to 28% (AAPC=-6.9%, 95% CI [-8.7, -5.2]), and RT from 38% to 22% (AAPC=-5.9%, 95% CI [-6.6, -5.3]), p<0.001 for all trends. ADT and FT were scarcely utilized, with less than 1% of men receiving such therapies by 2019 at any level. CONCLUSIONS: Declines in the diagnosis and treatment of GG1 disease demonstrate a positive shift in PCa epidemiology and proper stewardship of PCa screening. Nonetheless, heterogeneity in AS utilization remains and reflects opportunities for improvement. Source of Funding: This work was supported by the National Institute of Health (R01 CA241758, R01 CA259173-01A1 to J.C.H); and Patient-Centered Outcomes Research Institute (CER-2019C1-15682, CER-2019C2- 17372 to J.C.H). J.C.H. and L.D.B, receive salary support from the Frederick J. and Theresa Dow Wallace Fund of the New York Community Trust, J.C.H, receives salary support from Prostate Cancer Challenge Award. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e531 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Leonardo Borregales More articles by this author Michael Tzeng More articles by this author Ashwin Ramaswamy More articles by this author Xiangmei Gu More articles by this author Meenakshi Davuluri More articles by this author Himanshu Nagar More articles by this author Jim Hu More articles by this author Expand All Advertisement PDF downloadLoading ...

Prostate cancer grade migration and facility-level treatment trends for grade group 1 disease.

Overdiagnosis and overtreatment of low-grade prostate cancer (PCa) reflect poor quality of care and prompted changes to guidelines over the past decade. We used the National Cancer Database to characterize Gleason Grade Group (GG)1 PCa diagnosis trends and assess facility-level treatment variability. Between 2010 and 2019, GG1 PCa incidence had a clinically and statistically significant decline, from 45% to 25% at biopsy and from 33% to 9.8% at radical prostatectomy (RP) pathology. Similarly, active surveillance (AS) uptake significantly increased to 49% and 62% among nonacademic and academic sites, respectively. Decreasing rates of definitive therapies were identified: among academic sites, RP decreased from 61.1% to 25.3% and radiation therapy (RT) from 25.2% to 12%, whereas among nonacademic sites, RP decreased from 53.6% to 28% and RT from 37.8% to 21.9% (Ptrend < .001). Declines in the diagnosis and treatment of low-grade disease demonstrate an encouraging shift in PCa epidemiology. However, heterogeneity in AS utilization remains and reflects opportunities for improvement.

The Quality of Online Information for the Treatment of Knee Osteoarthritis: A Google Study.

Introduction Affecting more than 30 million adults annually, osteoarthritis (OA) is the most common joint disorder in the United States. A variety of management options for knee OA exists, includingphysical therapy, weight loss, intra-articular corticosteroid injections, and total joint arthroplasty. With many treatments available, patients often utilize the internet to educate themselves about their condition and management options. The purpose of this study was to evaluate the quality, transparency, and readability of online information for the treatment of knee OA. Methods The search terms "knee," "arthritis," and "treatment" were entered into an incognito mode Google browser. Websites were classified by type (commercial, academic, nonacademic medical practice, government/patient advocacy, and other) and graded on content quality, transparency, and readability using the following scores, respectively: modified DISCERN, Journal of American Medical Association (JAMA) Benchmark, and Flesch-Kincaid (FK) grade level. Results Of the 95 websites evaluated, commercial (mean, 38.2) and academic (37.3) sites had the highest total DISCERN scores, which were significantly greater than nonacademic medical practice (31.8) and government/patient advocacy sites (33.4) (p≤0.035). Nonacademic medical practice sites had the lowest mean total DISCERN (31.8) and JAMA (1.47) scores and the highest FK grade level readability (9.5). There was a significant positive correlation between mean total DISCERN and JAMA scores (r=0.46, p<0.001). Conclusion The mean overall quality of websites regarding the treatment of OA was good as evidenced by greater modified DISCERN scores. However, website quality ranged from poor to excellent, indicating that some websites are still missing key information patients may find useful when assessing treatment options online.

Academics versus the Internet: Evaluating the readability of patient education materials for cerebrovascular conditions from major academic centers.

Background: Health literacy profoundly impacts patient outcomes as patients with decreased health literacy are less likely to understand their illness and adhere to treatment regimens. Patient education materials supplement in-person patient education, especially in cerebrovascular diseases that may require a multidisciplinary care team. This study aims to assess the readability of online patient education materials related to cerebrovascular diseases and to contrast the readability of those materials produced by academic institutions with those of non-academic sources.Methods: The readability of online patient education materials was analyzed using Flesch-Kincaid Grade Level (FKGL) and Flesch Reading Ease (FRE) assessments. Readability of academic-based online patient education materials was compared to nonacademic online patient education materials. Online patient education materials from 20 academic institutions and five sources from the web were included in the analysis.Results: Overall median FKGL for neurovascular-related patient online education documents was 11.9 (95% CI: 10.8–13.1), reflecting that they are written at a 12th grade level, while the median FRE was 40.6 (95% CI: 34.1–47.1), indicating a rating as “difficult” to read. When comparing academic-based online patient education materials to other internet sources, there was no significant difference in FRE and FKGL scores (P = 0.63 and P = 0.26 for FKGL and FRE, respectively).Conclusion: This study demonstrates that online patient education materials pertaining to cerebrovascular diseases from major academic centers and other nonacademic internet sites are difficult to understand and written at levels significantly higher than that recommended by national agencies. Both academic and nonacademic sources reflect this finding equally. Further study and implementation are warranted to investigate how improvements can be made.

Review: Queer Public History: Essays on Scholarly Activism, by Marc Stein

Review: <i>Queer Public History: Essays on Scholarly Activism</i>, by Marc Stein

Large multicenter randomized trials in autism: key insights gained from the balovaptan clinical development program

BackgroundAutism spectrum disorder (ASD) is a common and heterogeneous neurodevelopmental condition that is characterized by the core symptoms of social communication difficulties and restricted and repetitive behaviors. At present, there is an unmet medical need for therapies to ameliorate these core symptoms in order to improve quality of life of autistic individuals. However, several challenges are currently faced by the ASD community relating to the development of pharmacotherapies, namely in the conduct of clinical trials. Balovaptan is a V1a receptor antagonist that has been investigated to improve social communication difficulties in individuals with ASD. In this viewpoint, we draw upon our recent first-hand experiences of the balovaptan clinical development program to describe current challenges of ASD trials.Discussion pointsThe balovaptan trials were conducted in a wide age range of individuals with ASD with the added complexities associated with international trials. When summarizing all three randomized trials of balovaptan, a placebo response was observed across several outcome measures. Placebo response was predicted by greater baseline symptom severity, online recruitment of participants, and less experienced or non-academic trial sites. We also highlight challenges relating to selection of outcome measures in ASD, the impact of baseline characteristics, and the role of expectation bias in influencing trial results.ConclusionTaken together, the balovaptan clinical development program has advanced our understanding of the key challenges facing ASD treatment research. The insights gained can be used to inform and improve the design of future clinical trials with the collective aim of developing efficacious therapies to support individuals with ASD.

Exploring the Influence of Gender on Surgical Clerkship Grades and Test Scores: A Single Institution, Multisite Comparison

General surgery remains a male-dominated specialty. Women constitute 54% of medical students at the University of Washington, but only 3.4% of full professors within the Department of Surgery. Many believe surgical attrition and "the leaky pipeline" starts during medical school clerkships, but the exact deterrents remain undefined. This study examined the impact of gender on grading during the third-year surgical clerkship. Retrospective analysis of confidential final clerkship grades, examination scores and subjective clerkship grades was conducted. These were compared by gender, time period, and type of clerkship site. Chi-square analyses were performed. Clerkship sites across multiple academic (n = 6) and nonacademic (n = 14) locations. All third-year medical students undergoing a core surgical clerkship over 2 time periods-2007 to 2010 (period 1) and 2016 to 2019 (period 2)-were included. There were 539 medical students in period 1 and 792 in period 2. The percentage of women was stable over time (52.0% vs 54.2%, p = 0.43). Final clerkship grades of Honors increased significantly from period 1 to 2 (22.3% vs 44.3%, p < 0.0001) and was similarly distributed by gender (women: 21.4% vs 48.0%, p < 0.0001; men 23.2% vs 39.9%, p < 0.0001). Honors on examinations remained stable over time and did not differ by gender. Women earned more final clerkship honors than men at academic sites in period 2 (48.4% vs 30.9%, p < 0.001). This finding was not identified in period 1, nor at nonacademic sites. There was a significant increase in surgical clerkship honors over the past decade, independent of gender. Women attained more clinical and final clerkship honors than men and similar exam grades as time progressed, suggesting that gender bias in the subjective grading of women at this institution does not directly contribute to the loss of talented women as they progress from medical student to faculty within the department, with said gender imbalance not related to clerkship evaluations.

Factors associated with DCIS treatment patterns in a large cancer center network.

e18589 Background: There remains variability in management of DCIS, particularly with radiation therapy (RT) and hormone therapy (HT). Little is known about DCIS treatment patterns according to patient characteristics. We examined associations between patient characteristics, treating center location and DCIS therapy received. Methods: We performed a retrospective registry review of all patients diagnosed and treated with DCIS from 2018-2019, collected from the UPMC network, an NCI designated cancer center, serving western and central Pennsylvania. Demographics and administered treatments were compiled from cancer registry records. Descriptive statistics and logistic regression were used for analysis. Treatment centers throughout the network were dichotomized to academic (academic practice) or community (non-academic) sites, race was divided into two groups, Black and White/Other. Neighborhood deprivation index (NDI) was dichotomized to median level at &gt; = 59% vs. &lt; 59% and extremes &gt; = 75% vs. &lt; 75%. Results: A total of 941 patients treated for DCIS;29 patients were not eligible for surgery because of trial enrollment randomizing away from surgery. Of the remaining 912 patients, 506 patients were from academic sites and 406 patients from community sites. Median patient age was 63 years old (range: 24-90 years). There were no treatment differences noted for age, race, or NDI. For treatment, 80 patients refused recommended HT; 46 patients refused recommended RT. The likelihood of receiving RT was similar between academic and community sites (64.3% vs. 67.2%; p= 0.47). Of those having surgery, 25% had mastectomy (231 of 912), more likely at academic sites (29% vs. 21%; p= 0.0045). Among patients with lumpectomy, community patents had greater HT utilization than academic patients (82% vs. 68%; p &lt; 0.001), while ER status was not different. Conclusions: Within the UPMC network, variability in the management of DCIS did not differ based on age, race, or NDI. However, academic practice locations had higher levels of mastectomy, while greater HT utilization was observed in community sites. Further qualitative information is under examination from patients and clinicians to better understand how treatment decisions are framed and completed in the context of patient centered care for DCIS.

Quality and safety of coronary computed tomography angiography at academic and non-academic sites: insights from a large European registry (ESCR MR/CT Registry).

To compare the use of coronary computed tomography angiography (CCTA) between academic and non-academic sites across Europe over the last decade. We analyzed a large multicenter registry (ESCR MR/CT Registry) of stable symptomatic patients who received CCTA 01/2010-01/2020 at 47 (22%) academic and 165 (78%) non-academic sites across 19 European countries. We compared image quality, radiation dose, contrast-media-related adverse events, patient characteristics, CCTA findings, and downstream testing between academic and non-academic sites. Among 64,317 included patients (41% female; 60 ± 13 years), academic sites accounted for most cases in 2010-2014 (52%), while non-academic sites dominated in 2015-2020 (71%). Despite less contemporary technology, non-academic sites maintained low radiation doses (4.76 [2.46-6.85] mSv) with a 30% decline of high-dose scans ( > 7 mSv) over time. Academic and non-academic sites both reported diagnostic image quality in 98% of cases and low rate of scan-related adverse events (0.4%). Academic and non-academic sites examined similar patient populations (41% females both; age: 61 ± 14 vs. 60 ± 12 years; pretest probability for obstructive CAD: low 21% vs. 23%, intermediate 73% vs. 72%, high 6% both, CAD prevalence on CCTA: 40% vs. 41%). Nevertheless, non-academic sites referred more patients to non-invasive ischemia testing (6.5% vs. 4.2%) and invasive coronary angiography/surgery (8.5% vs. 5.6%). Non-academic and academic sites provide safe, high-quality CCTA across Europe, essential to successfully implement the recently updated guidelines for the diagnosis and management of chronic coronary syndromes. However, despite examining similar populations with comparable CAD prevalence, non-academic sites tend to refer more patients to downstream testing. • Smaller non-academic providers increasingly use CCTA to rule out obstructive coronary artery disease. • Non-academic and academic sites provide comparably safe, high-quality CCTA across Europe. • Compared to academic sites, non-academic sites tend to refer more patients to downstream testing.

Quality Improvement in Canadian Nephrology: Key Considerations in Ensuring Thoughtful Ethical Oversight.

Purpose of review:Quality improvement (QI) work is a cornerstone of health care, and a growing area within nephrology. With such growth comes the need to ensure that QI activities are implemented in an ethically responsible manner. The existing institutional research board (IRB) framework has largely focused on reviewing the ethical suitability of traditional research projects, and it can be challenging to know if QI initiatives require formal ethics oversight. Several tools have been developed to assist in distinguishing between the two, such as the “A pRoject Ethics Community Consensus Initiative” tool. Our objective was to demonstrate how QI is distinct from research, to outline how QI-focused IRB process is used across Canada, and to develop a practical aid for clinicians embarking on QI-related projects.Sources of information:Publicly available institutional Web sites from academic and select nonacademic sites across Canada.Methods:Institutional Web sites across all academic centers within Canada were examined to determine local QI-specific ethics review processes. We have provided examples of QI processes from select community sites. We have developed a tool to assist clinicians navigate the ethical challenges of QI projects and to determine whether their project may require ethics approval.Key findings:This overview of the considerations of the research ethics approval process helps clinicians to determine whether IRB approval is required for QI studies. Examples of the current ethical processes employed in both academic and community institutions across Canada demonstrate the variability between centers. We have included examples of fictional nephrology-oriented QI initiatives to illustrate when ethics approval may be considered, along with a flowchart. This summary highlights the opportunity for QI-specific IRB review processes to be standardized across Canada, along with the need for creation of a separate stream with dedicated expertise for QI project review.Limitations:We did not do a formal environmental scan of the QI IRB review process in all hospital institutions across Canada.

Uncomplicated Distal Radius Fractures: An Opportunity to Reduce Emergency Medicine Opioid Prescribing?

To assess emergency physician prescribing for simple extremity fractures-specifically, distal radius fractures-and describe the opportunity for reducing opioid prescribing. An electronic survey was distributed to 1238 emergency physicians employed by a nationwide practice serving 220 sites in 20 states. The survey presented two plain film views of a simple Colles fracture and asked: "For the last patient you discharged . . . with the above injury, which pain medications did you prescribe or recommend?" Responses were collected using a clickable checklist of common opioid and nonopioid pain medications. Respondents also specified the number of days covered by any prescription. We assessed associations between physician characteristics and opioid prescribing using the χ2 test, the Wilcoxon rank-sum test, and multivariable regression models. Responses were received from 447 (36%) physicians working in 18 states; 93% were trained in emergency medicine, 33% worked at academic sites, 68% had site volumes between 25,000 and 75,000, and the median experience was 10 (interquartile range 5-19) years. Overall, 92% (95% confidence interval 89%-95%) had prescribed an opioid for a median of 3 (interquartile range 3-4) days. The most commonly prescribed opioids were hydrocodone/acetaminophen (55%) and oxycodone/acetaminophen (20%). Physicians at academic sites prescribed opioids less frequently than those at nonacademic sites (88% vs 94%), but in multivariable regression there were no significant associations between physician characteristics and opioid prescribing. Emergency physicians commonly prescribe opioids for simple distal radius fractures. This represents a potential opportunity to reduce opioid prescribing.

Are trauma research programs in academic and non-academic centers measured by equal standards? A survey of 137 level I trauma centers in the United States

BackgroundAmerican College of Surgeons level I trauma center verification requires an active research program. This study investigated differences in the research programs of academic and non-academic trauma centers.MethodsA 28-question survey was administered to ACS-verified level I trauma centers in 11/12/2020–1/7/2021. The survey included questions on center characteristics (patient volume, staff size), peer-reviewed publications, staff and resources dedicated to research, and funding sources.ResultsThe survey had a 31% response rate: 137 invitations were successfully delivered via email, and 42 centers completed at least part of the survey. Responding level I trauma centers included 36 (86%) self-identified academic and 6 (14%) self-identified non-academic centers. Academic and non-academic centers reported similar annual trauma patient volume (2190 vs. 2450), number of beds (545 vs. 440), and years of ACS verification (20 vs. 14), respectively. Academic centers had more full-time trauma surgeons (median 8 vs 6 for non-academic centers) and general surgery residents (median 30 vs 7) than non-academic centers. Non-academic centers more frequently ranked trauma surgery (100% vs. 36% academic), basic science (50% vs. 6% academic), neurosurgery (50% vs. 14% academic), and nursing (33% vs. 0% academic) in the top three types of studies conducted. Academic centers were more likely to report non-profit status (86% academic, 50% non-academic) and utilized research funding from external governmental or non-profit grants more often (76% vs 17%).ConclusionsSurvey results suggest that academic centers may have more physician, resident, and financial resources available to dedicate to trauma research, which may make fulfillment of ACS level I research requirements easier. Structural and institutional changes at non-academic centers, such as expansion of general surgery resident programs and increased pursuit of external grant funding, may help ensure that academic and non-academic sites are equally equipped to fulfill ACS research criteria.

Recruitment and retention of participant and study partner dyads in two multinational Alzheimer\u2019s disease registration trials

BackgroundEarly study exit is detrimental to statistical power and increases the risk for bias in Alzheimer’s disease clinical trials. Previous analyses in early phase academic trials demonstrated associations between rates of trial incompletion and participants’ study partner type, with participants enrolling with non-spouse study partners being at greater risk.MethodsWe conducted secondary analyses of two multinational phase III trials of semagacestat, an oral gamma secretase inhibitor, for mild-to-moderate AD dementia.Cox’s proportional hazards regression model was used to estimate the relationship between study partner type and the risk of early exit from the trial after adjustment for a priori identified potential confounding factors. Additionally, we used a random forest model to identify top predictors of dropout.ResultsAmong participants with spousal, adult child, and other study partners, respectively, 35%, 38%, and 36% dropped out or died prior to protocol-defined study completion, respectively. In unadjusted models, the risk of trial incompletion differed by study partner type (unadjusted p value = 0.027 for test of differences by partner type), but in models adjusting for potential confounding factors, the differences were not statistically significant (p value = 0.928). In exploratory modeling, participant age was identified as the primary characteristic to explain the relationship between study partner type and the risk of failing to complete the trial. Participant age was also the strongest predictor of trial incompletion in the random forest model.ConclusionsAfter adjustment for age, no differences in the risk of incompletion were observed when comparing participants with different study partner types in these trials. Differences between our findings and the findings of previous studies may be explained by differences in trial phase, size, geographic regions, or the composition of academic and non-academic sites.

Assessing Readability of Patient Education Materials on Breast Reconstruction by Major US Academic Hospitals as Compared With Nonacademic Sites.

Women undergoing postmastectomy breast reconstruction face many complex choices. A myriad of online patient education materials exist to assist in decision making. Understanding of these materials, termed health literacy, affects surgical decision making and outcomes. The National Institutes of Health recommends writing patient education materials at a sixth- to seventh-grade reading level. The primary goal of this study was to assess readability of online breast reconstruction materials. Resources were collected from every academic hospital with a plastic surgery residency program, 97 in total. These data were compared with the top nonacademic Web sites ranked by search engine results, 14 in total. Materials were analyzed using 3 validated readability assessment scales: Coleman-Liau Index, SMOG (Simplified Measure of Gobbledygook) Readability Formula, and Flesch-Kincaid Grade Level. Average readability was analyzed, and results were compared using a 1-way analysis of variance to assess for significance between the different tools and a 2-sided t test to assess for significance between academic and nonacademic readability results. The mean readability scores across the academic programs were a Coleman-Liau Index of 13.38 (standard Deviation [SD] 2.81, 13th to 14th grade), Flesch-Kincaid Grade Level of 13.04 (SD = 3.9, 13th grade), and SMOG Readability of 13.64 (SD = 2.99, 13th to 14th grade). For the 14 nonacademic sites, results showed a Coleman-Liau Index of 11.93 (SD = 1.14, 12th grade), Flesch-Kincaid of 11.82 (SD = 2.33, 11th to 12th grade), and SMOG Readability of 10.91 (SD = 1.79, 11th grade). One-way analysis of variance demonstrated no significant differences in mean readability scores across the 3 readability tools used (academic F = 2.7804, P = 0.06; nonacademic F = 1.14, P = 0.33). Two-tailed t test results demonstrated that there was statistical significance between readability of the academic in comparison with nonacademic search engine results (t = 2.04, P = 0.04). Average readability across all Web sites were much higher than the recommended reading level, at a 13th to 14th grade reading level for academic institutions, and an 11th to 12th grade for nonacademic Web sites. Plastic surgeons may contribute to improving patient understanding and perioperative outcomes through revising patient education materials.

4R Care Delivery Program results: Impact of implementation metrics on patient self-management and 4R usefulness.

225 Background: We previously proposed a 4R care delivery model that facilitates teamwork and patient self-management (pSM) in cancer care (NCI ASCO Teams Project, Trosman JOP 2016). 4R (Right Info / Care / Patient / Time) enables patient and care team to manage complex care with an innovative 4R Care Sequence. We tested 4R at 10 US sites in a stepwise mode 2016-2019. Methods: Step 1 included 1 academic and 2 nonacademic sites; step 2 included 3 academic and 4 nonacademic sites. Patients with stage 0-III breast cancer received 4R Sequences (4R Cohort). We surveyed 4R and historical control cohorts of patients treated at the same sites pre-4R. We assessed the impact of implementation metrics on usefulness of 4R to the 4R cohort and on improvement of pSM in 4R cohort vs historical control cohort. Results: Survey response rates: 63%, 422/670 (4R cohort); 47%, 466/992 (control cohort). Three of the five implementation metrics significantly impacted patient usefulness of 4R (Table). Patients at step 2 sites; sites with a systematic care process; and sites with small practices reported significantly higher 4R usefulness than patients in the comparison subgroup within respective metrics. 4R usefulness was not affected by practice setting or availability of patient navigators. pSM was significantly improved between control and 4R cohorts along all implementation metrics (p &lt; .001), but the magnitude of incremental improvement between comparison subgroups varied across metrics (Table), with the largest increment associated with the program step metric. Conclusions: 4R is useful to patients across settings, with or without patient navigators. Stepwise design is effective in increasing 4R impact overtime. Future 4R Program will investigate an expanded array of implementation metrics and their influence on 4R outcomes. [Table: see text]

4R Care Delivery Program results: Impact of implementation metrics on patient self-management and 4R usefulness.

e14039 Background: We previously proposed a 4R care delivery model that facilitates teamwork and patient self-management (pSM) in cancer care (NCI ASCO Teams Project, Trosman JOP 2016). 4R (Right Info / Care / Patient / Time) enables patient and care team to manage complex care with an innovative 4R Care Sequence. We tested 4R at 10 US sites in a stepwise mode 2016-2019. Methods: Step 1 included 1 academic and 2 nonacademic sites; step 2 included 3 academic and 4 nonacademic sites. Patients with stage 0-III breast cancer received 4R Sequences (4R Cohort). We surveyed 4R and historical control cohorts of patients treated at the same sites pre-4R. We assessed the impact of implementation metrics on usefulness of 4R to the 4R cohort and on improvement of pSM in 4R cohort vs historical control cohort. Results: Survey response rates: 63%, 422/670 (4R cohort); 47%, 466/992 (control cohort). Three of the five implementation metrics significantly impacted patient usefulness of 4R (Table). Patients at step 2 sites; sites with a systematic care process; and sites with small practices reported significantly higher 4R usefulness than patients in the comparison subgroup within respective metrics. 4R usefulness was not affected by practice setting or availability of patient navigators. pSM was significantly improved between control and 4R cohorts along all implementation metrics (p &lt; .001), but the magnitude of incremental improvement between comparison subgroups varied across metrics (Table), with the largest increment associated with the program step metric. Conclusions: 4R is useful to patients across settings, with or without patient navigators. Stepwise design is effective in increasing 4R impact overtime. Future 4R Program will investigate an expanded array of implementation metrics and their influence on 4R outcomes. [Table: see text]