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Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

Hanel, Ricardo A; Cortez, Gustavo M; Lopes, Demetrius Klee; Nelson, Peter Kim; Siddiqui, Adnan H; Jabbour, Pascal; Mendes Pereira, Vitor; István, Istvan Szikora; Zaidat, Osama O; Bettegowda, Chetan; Colby, Geoffrey P; Mokin, Maxim; Schirmer, Clemens M; Hellinger, Frank R; Given, Curtis; Krings, Timo; Taussky, Philipp; Toth, Gabor; Fraser, Justin F; Chen, Michael; Priest, Ryan; Kan, Peter; Fiorella, David; Frei, Donald; Aagaard-Kienitz, Beverly; Diaz, Orlando; Malek, Adel M; Cawley, C Michael; Puri, Ajit S; Kallmes, David F
BACKGROUND:The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale. METHODS:PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated. RESULTS:As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series. CONCLUSIONS:The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture. TRIAL REGISTRATION/BACKGROUND:NCT02186561.
PMID: 35292570
ISSN: 1759-8486
CID: 5373722

Antiracism CoaliTION in Pain Research (ACTION-PR): Guiding Principles for Equity in Reporting [Editorial]

Hood, Anna M; Morais, Calia A; Aroke, Edwin N; Booker, Staja Q; Campbell, Lisa C; Campbell, Claudia M; Goodin, Burel R; Janevic, Mary R; Kapos, Flavia P; Mathur, Vani A; Merriwether, Ericka N; Letzen, Janelle E
PMID: 36460609
ISSN: 1528-8447
CID: 5374952

Zoom Objective Structured Clinical Exams: Virtually the same as the real thing?

Desai, Purnahamsi V; Howell, Heather B; McGrath, Meaghan; Ramsey, Rachel; Lebowitz, Jonathan; Trogen, Brit; Cha, Christine; Pierce, Kristyn A; Zabar, Sondra
OBJECTIVE:Objective structured clinical exams (OSCE) are used to train and assess resident foundational family-centered communication skills incorporating key stakeholders. In 2020 encounters were conducted virtually. We sought to compare standardized patient (SP) and family faculty (FF) assessment across OSCE and virtual OSCE (VOSCE) formats. METHODS:The intern classes of 2019 and 2020 completed a live OSCE and VOSCE respectively where they disclosed an error to an SP. The 10 minute encounter was observed by an FF and facilitator followed by a 20 minute debrief. The SP and FF completed a behavioral checklist to evaluate skill mastery. RESULTS:Eighteen (90%) of the 20 interns completed the encounter each year. Total mastery scores were significantly higher for SP assessment than for FF assessment in both OSCE [68% vs 46% (z=-3.005, p<.05)] and VOSCE formats [68% vs 53% (z=-2.105, p<0.05)]. Total mastery scores of SPs across OSCE and VOSCE formats did not significantly differ, nor did FF scores based on evaluation format. CONCLUSIONS:Our current experience suggests VOSCEs are a viable alternative to in person sessions given the comparable assessment across the two modalities. The ease of participating in virtual sessions may provide a way to more easily partner with key stakeholders.
PMID: 36400337
ISSN: 1876-2867
CID: 5372182

Do Appetite Traits Mediate the Link between Birth Weight and Later Child Weight in Low-Income Hispanic Families?

Vandyousefi, Sarvenaz; Messito, Mary Jo; Scott, Marc A; Gross, Rachel S
PMID: 36255444
ISSN: 2153-2176
CID: 5360372

Using Resident-Sensitive Quality Measures Derived From Electronic Health Record Data to Assess Residents' Performance in Pediatric Emergency Medicine

Smirnova, Alina; Chahine, Saad; Milani, Christina; Schuh, Abigail; Sebok-Syer, Stefanie S; Swartz, Jordan; Wilhite, Jeffrey A; Kalet, Adina; Durning, Steven J; Lombarts, Kiki M J M H; van der Vleuten, Cees P M; Schumacher, Daniel J
PURPOSE/OBJECTIVE:Traditional quality metrics do not adequately represent the clinical work done by residents and, thus, cannot be used to link residency training to health care quality. This study aimed to determine whether electronic health record (EHR) data can be used to meaningfully assess residents' clinical performance in pediatric emergency medicine using resident-sensitive quality measures (RSQMs). METHOD/METHODS:EHR data for asthma and bronchiolitis RSQMs from Cincinnati Children's Hospital Medical Center, a quaternary children's hospital, between July 1, 2017, and June 30, 2019, were analyzed by ranking residents based on composite scores calculated using raw, unadjusted, and case-mix adjusted latent score models, with lower percentiles indicating a lower quality of care and performance. Reliability and associations between the scores produced by the 3 scoring models were compared. Resident and patient characteristics associated with performance in the highest and lowest tertiles and changes in residents' rank after case-mix adjustments were also identified. RESULTS:274 residents and 1,963 individual encounters of bronchiolitis patients aged 0-1 as well as 270 residents and 1,752 individual encounters of asthmatic patients aged 2-21 were included in the analysis. The minimum reliability requirement to create a composite score was met for asthma data (α = 0.77), but not bronchiolitis (α = 0.17). The asthma composite scores showed high correlations (r = 0.90-0.99) between raw, latent, and adjusted composite scores. After case-mix adjustments, residents' absolute percentile rank shifted on average 10 percentiles. Residents who dropped by 10 or more percentiles were likely to be more junior, saw fewer patients, cared for less acute and younger patients, or had patients with a longer emergency department stay. CONCLUSIONS:For some clinical areas, it is possible to use EHR data, adjusted for patient complexity, to meaningfully assess residents' clinical performance and identify opportunities for quality improvement.
PMID: 36351056
ISSN: 1938-808x
CID: 5357362

The Real-World Effectiveness and Safety of Ustekinumab in the Treatment of Crohn's Disease: Results from the SUCCESS Consortium

Johnson, Amanda M; Barsky, Maria; Ahmed, Waseem; Zullow, Samantha; Galati, Jonathan; Jairath, Vipul; Narula, Neeraj; Peerani, Farhad; Click, Benjamin H; Coburn, Elliot S; Dang, ThucNhi Tran; Gold, Stephanie; Agrawal, Manasi; Garg, Rajat; Aggarwal, Manik; Mohammad, Danah; Halloran, Brendan; Kochhar, Gursimran S; Todorowski, Hannah; Ud Din, Nabeeha Mohy; Izanec, James; Teeple, Amanda; Gasink, Chris; Muser, Erik; Ding, Zhijie; Swaminath, Arun; Lakhani, Komal; Hogan, Dan; Datta, Samit; Ungaro, Ryan C; Boland, Brigid S; Bohm, Matthew; Fischer, Monika; Sagi, Sashidhar; Afzali, Anita; Ullman, Thomas; Lawlor, Garrett; Baumgart, Daniel C; Chang, Shannon; Hudesman, David; Lukin, Dana; Scherl, Ellen J; Colombel, Jean-Frederic; Sands, Bruce E; Siegel, Corey A; Regueiro, Miguel; Sandborn, William J; Bruining, David; Kane, Sunanda; Loftus, Edward V; Dulai, Parambir S
OBJECTIVE:We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patients with Crohn's disease (CD). METHODS:This study utilized a retrospective, multicenter, multinational, consortium of UST-treated CD patients. Data included patient demographics, disease phenotype, disease activity, treatment history, and concomitant medications. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remission were assessed using time-to-event and clinical predictors were assessed by multivariate Cox proportional hazard analyses. Serious infections and adverse events were defined as those requiring hospitalization or treatment discontinuation. RESULTS:A total of 1113 patients (51.8% female, 90% prior anti-TNF exposure) were included, with a median follow-up of 386 days. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remission at 12 months were 40%, 32%, 39%, and 30%, respectively. Biologic-naïve patients achieved significantly higher rates of clinical and endoscopic remission at 63% and 55%, respectively. On multivariable analyses, prior anti-TNF (HR, 0.72; 95% CI, 0.49-0.99) and vedolizumab exposure (HR, 0.65; 95% CI, 0.48-0.88) were independently associated with lower likelihoods of achieving endoscopic remission. In patients who experienced loss of remission, 77/102 (75%) underwent dose optimization, and 44/77 (57%) achieved clinical response. An additional 152/681 (22.3%) patients were dose optimized as a result of primary non- or incomplete response to UST, of whom 40.1% (61/152) responded. Serious infections occurred in 3.4% of patients, while other non-infectious adverse events [lymphoma (n=1), arthralgia (n=6), rash (n=6), headache (n=3), hepatitis (n=3), hair loss (n=3), neuropathy (n=1), and vasculitis (n=1)] occurred in 2.4% of patients. CONCLUSIONS:UST represents a safe and effective treatment option for CD, with 40% of patients from a highly refractory cohort achieving clinical remission by 12 months. The greatest treatment effect of UST was seen in bio-naive patients, and dose escalation may recapture clinical response.
PMID: 36191274
ISSN: 1572-0241
CID: 5361632

Does exercise training improve exercise tolerance, quality of life, and echocardiographic parameters in patients with heart failure with preserved ejection fraction? A systematic review and meta-analysis of randomized controlled trials

Lin, Billy; Siskin, Matthew; Wang, Binhuan; Natarajan, Sundar
Patients with heart failure with preserved ejection fraction (HFpEF) often experience dyspnea, decreased exercise tolerance, and decreased quality of life (QOL). Exercise training is a promising non-pharmacological treatment, with some improvement in exercise tolerance and QOL in HFpEF patients in randomized controlled trials (RCTs). We conducted a systematic review and meta-analysis of RCTs examining the effect of exercise therapy on exercise tolerance, QOL, and echocardiographic parameters in patients with HFpEF. Article database search of PubMed, Embase, and Cochrane Central Register of Controlled Trials identified 15 publications representing 579 unique patients. Results are presented as weighted mean difference (WMD) with 95% confidence intervals (CI). Exercise training (compared to control) demonstrated a significant improvement in exercise tolerance as measured by peak absolute VO2 (WMD [95% CI] = 164.67 [65.54, 263.79] mL/min), peak relative VO2 (WMD [95% CI] = 1.85 [0.98, 2.73] mL/min/kg), workload (WMD [95% CI] = 12.92 [4.67, 21.17] W), exercise time (WMD [95% CI] = 2.05 [1.57, 2.53] min), anaerobic threshold (WMD [95% CI] = 170.31 [35.40, 305.22] mL/min/kg), and 6-min walk test distance (WMD [95% CI] = 32.77 [20.72, 44.83] m); in QOL as measured by Short Form (SF-36) physical functioning domain (WMD [95% CI] = 9.95 [2.85, 17.05]) and SF-36 vitality domain (WMD [95% CI] = 6.24 [0.15, 12.34]); and in the echocardiographic measure of LVESD (WMD [95% CI] =  - 0.16 [- 0.28, - 0.04] cm). In conclusion, we found after systematic review and meta-analysis of RCTs that exercise therapy improves exercise tolerance and physical-related quality of life measures.
PMID: 36334160
ISSN: 1573-7322
CID: 5358902

SEE the DIFFerence: Reducing Unnecessary C. difficile Orders Through Clinical Decision Support in a Large, Urban Safety-Net System

Krouss, Mona; Israilov, Sigal; Alaiev, Daniel; Tsega, Surafel; Talledo, Joseph; Chandra, Komal; Zaurova, Milana; Manchego, Peter Alacron; Cho, Hyung J
BACKGROUND:Clostridioides difficile (C. difficile) is a hospital-acquired infection. Overtesting for C. difficile leads to false positive results due to a high rate of asymptomatic colonization, resulting in unnecessary and harmful treatment for patients. METHODS:This was a quality improvement initiative to decrease the rate of inappropriate C. difficile testing across 11 hospitals in an urban, safety-net setting. Three best practice advisories were created, alerting providers of recent laxative administration within 48 hours, a recent positive test within 14 days, and a recent negative test within 7 days. The outcome measures were the number of C. difficile tests per 1000 patient days, as well as the rate of hospital onset C. difficile infection was compared pre- and post-intervention. The process measures included the rate of removal of the C. difficile test from the best practice advisory, as well as the subsequent 24-hour re-order rate. RESULTS:The number of C. difficile tests decreased by 27.3% from 1.1 per 1000 patient days pre-intervention (May 25, 2020-May 24, 2021) to 0.8 per 1000 patient days post-intervention, (May 25, 2021 to March 25, 2022), p<0.001. When stratified by hospital, changes in testing ranged from an increase of 12.5% to a decrease of 60.0%. Analysis among provider type showed higher behavior change among attendings than compared to trainees or advanced practice providers. There was a 12.1%, non-significant decrease in C. difficile rates from pre-intervention, 0.33 per 1000 patient days compared to post-intervention, 0.29 per 1000 patient days, p=0.32. CONCLUSION/CONCLUSIONS:Using only an electronic health record intervention, we successfully decreased C. difficile orders after 72 hours of admission in a large, safety-net system. Variation existed among hospitals and by provider type.
PMID: 36370868
ISSN: 1527-3296
CID: 5357752

Association between jail-based methadone or buprenorphine treatment for opioid use disorder and overdose mortality after release from New York City jails 2011-2017

Lim, Sungwoo; Cherian, Teena; Katyal, Monica; Goldfeld, Keith S; McDonald, Ryan; Wiewel, Ellen; Khan, Maria; Krawczyk, Noa; Braunstein, Sarah; Murphy, Sean M; Jalali, Ali; Jeng, Philip J; MacDonald, Ross; Lee, Joshua D
BACKGROUND AND AIMS/OBJECTIVE:Opioid overdose is a leading cause of death during the immediate time after release from jail or prison. Most jails in the United States do not provide methadone and buprenorphine treatment for opioid use disorder (MOUD), and research in estimating its impact in jail settings is limited. We aimed to test the hypothesis that in-jail MOUD is associated with lower overdose mortality risk post-release. DESIGN, SETTING AND PARTICIPANTS/METHODS:Retrospective, observational cohort study of 15 797 adults with opioid use disorder who were released from New York City jails to the community in 2011-17. They experienced 31 382 incarcerations and were followed up to 1 year. MEASUREMENTS/METHODS:The primary outcomes were death caused by accidental drug poisoning and all-cause death. The exposure was receipt of MOUD (17 119 events) versus out-of-treatment (14 263 events) during the last 3 days before community reentry. Covariates included demographic, clinical, behavioral, housing, healthcare utilization, and legal characteristics variables. We performed multivariable, mixed-effect Cox regression analysis to test association between in-jail MOUD and deaths. FINDINGS/RESULTS:A majority were male (82%) and their average age was 42 years. Receiving MOUD was associated with misdemeanor charges, being female, injection drug use, and homelessness. During 1 year post-release, 111 overdose deaths occurred, and crude death rates were 0.49 and 0.83 per 100 person-years for in-jail MOUD and out-of-treatment groups, respectively. Accounting for confounding and random effects, in-jail MOUD was associated with lower overdose mortality risk (adjusted hazard ratio = 0.20, 95% CI = 0.08-0.46), and all-cause mortality risk (adjusted hazard ratio = 0.22, 95% CI = 0.11-0.42) for the first month post-release. CONCLUSIONS:Methadone and buprenorphine treatment for opioid use disorder during incarceration was associated with an 80% reduction in overdose mortality risk for the first month post-release.
PMID: 36305669
ISSN: 1360-0443
CID: 5359662

Bridging the Gap from Student to Doctor: Developing Coaches for the Transition to Residency

Winkel, Abigail Ford; Gillespie, Colleen; Park, Agnes; Branzetti, Jeremy; Cocks, Patrick; Greene, Richard E; Zabar, Sondra; Triola, Marc
BACKGROUND/UNASSIGNED:A lack of educational continuity creates disorienting friction at the onset of residency. Few programs have harnessed the benefits of coaching, which can facilitate self-directed learning, competency development, and professional identity formation, to help ease this transition. OBJECTIVE/UNASSIGNED:To describe the process of training faculty Bridge Coaches for the Transition to Residency Advantage (TRA) program for interns. METHODS/UNASSIGNED:Nineteen graduate faculty educators participated in a coaching training course with formative skills assessment as part of a faculty development program starting in January 2020. Surveys (n = 15; 79%) and a focus group (n = 7; 37%) were conducted to explore the perceived impact of the training course on coaching skills, perceptions of coaching, and further program needs during the pilot year of the TRA program. RESULTS/UNASSIGNED:Faculty had strong skills around establishing trust, authentic listening, and supporting goal-setting. They required more practice around guiding self-discovery and following a coachee-led agenda. Faculty found the training course to be helpful for developing coaching skills. Faculty embraced their new roles as coaches and appreciated having a community of practice with other coaches. Suggestions for improvement included more opportunities to practice and receive feedback on skills and additional structures to further support TRA program encounters with coaches. CONCLUSIONS/UNASSIGNED:The faculty development program was feasible and had good acceptance among participants. Faculty were well-suited to serve as coaches and valued the coaching mindset. Adequate skills reinforcement and program structure were identified as needs to facilitate a coaching program in graduate medical education.
PMID: 36351566
ISSN: 1087-2981
CID: 5357372