Jacobs Institute of Women's Health
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The Diabetes Prevention Program and Its Outcomes Study: NIDDK\u27s Journey Into the Prevention of Type 2 Diabetes and Its Public Health Impact
No full textThe current-day epidemic of type 2 diabetes, largely driven by increased adiposity and reduced physical activity in the setting of genetic susceptibility, is a major public health challenge. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) presciently proposed the Diabetes Prevention Program (DPP), a multicenter randomized clinical trial, designed by investigators in conjunction with NIDDK staff and initiated in 1996. The primary goal of DPP was to determine whether an intensive lifestyle intervention (ILS) or metformin in comparison with placebo would reduce the development of diabetes in a high-risk population with prediabetes. After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated efficacy of both interventions. In 2002, an extension of the DPP study, the Diabetes Prevention Program Outcomes Study (DPPOS), was initiated for examination of the longer-term course and consequences of diabetes prevention. Over 21 years of median total follow-up, in comparison with the placebo group, cumulative diabetes incidence was reduced by 24% and 17% in the original ILS and metformin groups, respectively, with median increases in diabetes-free survival of 3.5 and 2.5 years/person. During long-term follow-up, there were no significant effects of the original DPP interventions on microvascular or cardiovascular outcomes. However, compared with prevalence of microvascular outcomes among participants who progressed to diabetes, prevalence among those who did not progress was significantly lower. Longer-term follow-up of the cohort continues with examination of relationships between diabetes and prediabetes and an expanded array of diabetes- and aging-related morbidities
Modifiable Risk Factors for Complications Following Surgical Treatment of Tibial Tubercle Fracture
No full textBACKGROUND: Tibial tubercle fractures (TTF) commonly occur in an athletic adolescent population and typically require operative reduction and fixation. Surgical techniques and postoperative restrictions are varied, with limited knowledge on factors that may affect outcome. We hypothesize that surgical technique and postoperative rehabilitation protocol can affect risk of postoperative complications following surgical treatment of TTF. METHODS: Retrospective review was conducted including all consecutive surgically treated TTF at a single level 1 pediatric trauma center between January 2010 and December 2022. Patients were excluded for skeletal dysplasia, \u3c10 weeks of follow-up, or periosteal avulsion only. They were classified into accelerated (postoperative weight-bearing and motion allowed within 21 d) or conservative (did not meet accelerated criteria) groups. Postoperative complications were recorded and graded by the modified Clavien-Dindo (C-D) classification. Univariate and multivariate logistic regression analysis were used to investigate factors associated with C-D grade II and III complications. RESULTS: Totally, 183 knees (177 patients) met criteria for analysis. Median follow-up was 27.3 weeks. Fifty-three knees (29%) qualified for the accelerated group and 129 knees (71%) were conservative. Initial postoperative casting was performed in 38% of the conservative group compared with 1.9% in the accelerated group (P\u3c0.001). Overall complication rate was 44.3% (81/183), with 33.3% (61/183) being a grade II or III complication. The most common complication was symptomatic implant (19.7%). There were 4 cases of fracture displacement and 1 case of implant displacement, all occurring in the conservative group. In multivariate analysis female sex (OR: 4.9), initial postoperative casting (OR: 2.6), and lower BMI percentile (OR: 1.02) were independently associated with higher grade II and III complication rate, while distal repair of the avulsed periosteum was associated with lower rate (OR: 0.26). CONCLUSION: Postoperative casting and repair of the distal periosteal avulsion are modifiable treatment decisions impacting risk of complications following surgical treatment of TTF. Decreasing variability in care, including implementing an accelerated rehabilitation protocol, may improve outcomes. LEVEL OF EVIDENCE: Level III
Experiences of Team Collaboration in Primary Care-Based Delivery of Opioid Use Disorder Treatment
No full textTeam-based models of care delivery are increasingly utilized to address co-occurring mental health and/or substance use conditions. However, little is known about how team-based models function among primary care teams delivering treatment for opioid use disorder (OUD). The research team conducted qualitative interviews with a sample of multidisciplinary, primary care team members delivering OUD treatment using the collaborative care model (CoCM). Providers were recruited from 13 diverse United States (U.S.) clinics participating in a multisite hybrid effectiveness-implementation trial. Interviews were audio recorded and professionally transcribed. All transcripts were double-coded using a coding schema informed by relational coordination theory. Thirty-five team members completed an interview, including 14 primary care providers (PCPs), 13 behavioral health care managers (BHCM), and eight consulting psychiatric providers (CPP). Four themes emerged: (1) team-based work increases shared knowledge about patients; (2) team members leverage one another\u27s relationships with patients to increase treatment engagement; (3) team collaboration is enhanced when BHCMs have opportunities and space to connect informally with PCPs; and (4) increased mutual respect between team members is needed to maximize patient engagement efforts. Team-based models may enhance patient engagement in OUD care by increasing the volume of patient contacts and augmenting therapeutic alliances
Serum fibrinogen is not elevated in patients with myasthenia gravis
No full textMyasthenia gravis (MG) is an autoimmune, autoantibody-mediated disease characterized by fatigable weakness of skeletal muscles. MG is a heterogeneous disease that currently lacks a robust biomarker for diagnosing all subtypes. Residual serum fibrinogen was found to be elevated 1000-fold in patients with MG in one study and posited to represent a universal diagnostic biomarker for MG. We set out to confirm elevated serum fibrinogen in patients with all subtypes of MG. We employed multiple methodologies to compare fibrinogen levels between MG patients and controls, using samples from independent cohorts. With enzyme-linked immunosorbent assay (ELISA), fibrinogen levels in sera from MG patients were not significantly different from controls. And in plasma samples, MG patients had a significantly lower amount of fibrinogen compared to controls. Using liquid chromatography-mass spectrometry (LC-MS), the abundance of serum fibrinogen-α was not elevated in patients compared to controls, and patients had a significantly lower abundance of serum fibrinogen-ß and fibrinogen-γ compared to controls. Our results do not support serum fibrinogen to be a diagnostic biomarker for MG and underscore the need for replication of novel findings to ensure our common goal of identifying effective biomarkers for MG
Implementation of adolescent HIV screening in two urban pediatric emergency departments in the United States
No full textOBJECTIVES: Routine, opt-out HIV screening of adolescents and youth (AY) is recommended in the United States in all healthcare settings, including emergency departments (EDs), however, data on ED-based HIV screening among AY remains limited. We aimed to describe the implementation and outcomes of a routine HIV AY screening program in two pediatric EDs in Washington, DC. METHODS: This was a cross-sectional prospective study of an opt-out HIV point-of-care testing (POCT) program of AY aged 13-24 years at a tertiary-based pediatric ED and community-based pediatric ED in Washington DC from March 2009 to February 2019. Descriptive statistics were used to analyze annual program performance by numbers of eligible AY seen, approached, tested, and new HIV identified. One-time ED staff survey collected barriers to HIV screening. RESULTS: During the 10-year period, out of 191,107 AY seen in ED, 21.9% (n=41,913) were approached for HIV POCT, of which 58.7% were tested (n=24,599); 23 new HIV infections (0.09% of tested AY) were identified. A higher proportion of AY were approached at the community-based ED compared to the tertiary-based ED (58.5% vs. 11.4%). The tertiary-based ED experienced a decline in AY approached after shifting the task from designated testers to ED staff. Among 179 surveyed ED staff, the most common barriers to HIV POCT included forgetting to offer the test (41.9%), lack of time (33.0%) and discomfort when approaching parents/guardians (15.6%). CONCLUSIONS: The rate of new HIV diagnoses among screened AY ED patients was \u3c0.1%, however, less than one-quarter of eligible AY were approached for testing. The staff-run HIV POCT model was successful in the lower acuity community-based pediatric ED, while the larger tertiary-based pediatric ED performed well only with the support of dedicated testers. Future studies are necessary to identify the optimal implementation strategy for sustainable ED-based AY HIV screening in the US
Feasibility of a virtual safety officer in detecting PPE donning and doffing violations
No full textA safety officer (SO) can assist healthcare workers in minimizing respiratory transmission of communicable diseases through verification of compliance with safety protocols, such as appropriately donning and doffing personal protective equipment (PPE). This project sought to determine if observation of PPE donning and doffing for detection of protocol violations by a virtual safety officer (VSO) was a feasible option to improve the safety of the workplace. Five healthcare workers with experience serving as safety officers were enrolled in a feasibility study in which they observed actors donning and doffing PPE in-person and noted errors using a curated checklist for documentation. One month later, the same participants viewed recordings of the in-person sessions and again recorded errors for seven trials. Five hundred and twenty-three responses recorded from the SOs across the in-person and virtual trials aligned 88.7% of the time. SOs were more accurate in the virtual setting than in the in-person setting (87.6% vs. 82.4%, respectively). However, Cohen\u27s kappa showed lower inter-rater reliability when observing virtually than in-person, especially in the doffing steps of the protocol. A VSO may be a feasible option when assessing whether participants can correctly follow PPE donning and doffing protocols. Future work includes incorporating real-time observation, 360-degree cameras, virtual reality (VR), and augmented reality (AR) to increase visualization, thereby increasing inter-rater reliability
Defining methodologic and other core competencies for PhD-level training in epidemiology
No full textIn this manuscript, we present the results of a series of workshops convened in conjunction with the 2023 Society for Epidemiologic Research (SER) annual meeting. The overall objective of the workshops was to develop a set of core competencies for PhD students in epidemiology. The topics presented in the lists of competencies are organized using a framework similar to many graduate programs in epidemiology, proceeding from basic to advanced topics. Given the breadth of substantive topics in the fields of epidemiology and public health, this list of competencies focuses on methodologic topics that are relevant to all students, regardless of research interest. The final topic lists were developed based on discussions including a large and diverse group of epidemiologists with different areas of expertise. By creating this resource, we aim to facilitate training of future generations of epidemiologists
Practice Patterns in Management of Low- to Intermediate-Grade Salivary Gland Carcinoma: A Multi-Institutional Study
No full textOBJECTIVES: To characterize practice patterns and outcomes in the management of low- and intermediate-grade salivary gland carcinoma prior to the existence of treatment guidelines. METHODS: Analysis of a registry of patients who underwent parotid and submandibular gland resections for low-and intermediate-grade carcinomas between 2010 and 2019. RESULTS: Of all 786 patients included in the study, 726 (92%) had preoperative imaging and 653 (83%) had preoperative biopsy. Of the 729 patients with parotid gland cancer, the majority underwent superficial (n = 384, 53%) or total (n = 254, 35%) parotidectomy. In patients with facial nerve preservation, total parotidectomy was associated with a significant increase in transient facial weakness (72/177 (41%) vs. 82/311 (26%), RR 0.65, 95% CI 0.50-0.84, p \u3c 0.05) and permanent facial nerve weakness (23/176 (13%) vs. 16/301 (5%), RR 0.41, 95% CI 0.22-0.75, p \u3c 0.05) compared to superficial parotidectomy. Adjuvant radiation therapy (RT) was delivered to 285 (36%) patients. The proportion of patients receiving adjuvant RT declined significantly over the time period from 2015 to 2019 compared to 2010 to 2014 at 162/504 (32%) and 123/282 (44%), respectively (RR 0.74, 95% CI 0.61-0.89, p \u3c 0.05). When comparing the time periods from 2015 to 2019 and 2010 to 2014, there was no significant difference in local control rates (RR 0.52, 95% CI 0.26-1.04, p = 0.06) or regional control rates (RR 0.75, 95% CI 0.26-2.13, p = 0.58). CONCLUSIONS: Management of low- and intermediate-grade salivary cancer from 2010 to 2019 was variable, which is expected given the rarity and heterogeneity of the disease and the lack of treatment guidelines prior to 2021. Most patients with parotid malignancies underwent superficial or total parotidectomy. The extent of parotidectomy had an impact on facial nerve function outcomes. Delivery of adjuvant radiation trended down with time. The data presented here will support dissemination of the guidelines and provide data that could inform future trials. LEVEL OF EVIDENCE: 2b
HIV biomedical prevention knowledge, attitudes, and behaviors among U.S. women enrolled in a longitudinal cohort study 2014-2019
No full textBACKGROUND: Pre-exposure prophylaxis (PrEP) was approved for use in the US in 2012 and cross-sectional analyses show low uptake among women. However, use of PrEP over time has not been characterized in women. Longitudinal assessments are needed to characterize PrEP use and eligibility. METHODS: We conducted a nested cross-sectional survey (April 2014-October 2015) to assess post-exposure prophylaxis (PEP)/PrEP knowledge, attitudes, and PEP/PrEP use among cisgender women without HIV enrolled in the Women\u27s Interagency HIV Study (WIHS). As few women reported PEP/PrEP use we assessed willingness to use PEP/PrEP. Longitudinally, we determined PrEP use and eligibility based on CDC guidance using semi-annual self-reported risk behaviors collected from 2014 to 2019. We used logistic regression to identify factors associated with willingness to use PrEP. RESULTS: Among the 716 women who completed the survey the median age was 46 years (IQR 38, 53) and 72% were Black. At baseline, 43% (n = 46/108) of PrEP-eligible women self-identified as medium-high risk for HIV while 8% (n = 47/593) of non-eligible women believed they were at high risk. 36% (n = 264/731) of women were eligible for PrEP at some point between 2014 and 2019. However, only 3% (n = 22/731) of women reported PrEP use. Older age (aOR 0.97 95% CI 0.95-0.99) and ambivalence/shame (aOR 0.37 95% CI 0.16-0.90) were associated with lower willingness to use PrEP. Belief that PrEP prevents HIV infection (aOR 27.03 95% CI 9.68-75.46) and self/healthcare provider-initiated HIV testing in the prior 2-years (aOR 1.76 95% CI 1.15-2.68) were associated with willingness to use PrEP. CONCLUSIONS: PrEP uptake among women remains low despite availability and willingness to take PrEP. Eligibility for PrEP varied over time and self-perception of risk was not always congruent with guidelines. Continued efforts are needed to identify those that would benefit from HIV prevention services during routine medical care and develop interventions to increase PrEP prescribing and use
Physical Activity, Mentorship, and Mental Health in Adolescents Living in Washington, DC: Teens Run DC
No full textBACKGROUND: Mental health is a serious concern among US adolescents. We examined the role of a combined running/mentorship program, Teens Run DC (TRDC), on self-reported indicators of mental health in high-school students (N = 291) living in Washington, DC. METHODS: The TRDC program was offered in 10 high schools across 7 DC wards between 2010 and 2018. We used a quasi-experimental design within each school to determine the relation between dose of the TRDC program, and indicators of depression, and social connectedness in students who did and did not participate in the program. Data were collected at the beginning and end of each school year, using the Center for Epidemiological Studies Depression in Children scale and the Hemingway Social Connectedness scale. Mixed-effect regression modeling examined the dose-response relationship between participation dose and mental health scores. RESULTS: High school students who completed at least 2 years of TRDC lowered their Center for Epidemiological Studies Depression in Children scale score by 6 points (β = -5.9; 95% CI, -10.7 to -1.0) and had a 69% lower odds of developing symptoms of clinical depression (odds ratios = 0.31; 95% CI, 0.23 to 0.42), compared with students receiving less than one year. Similarly, students with 2 or more years of TRDC increased their overall Hemingway Social Connectedness score by 8 points (β = 7.9; 95% CI, 0.65 to 15.1), relative to those with less than one year of exposure. The benefits of TRDC were especially pronounced in female students. CONCLUSION: These findings indicate that a running/mentoring program has substantial mental health benefits for high school students and this is particularly so for teenage girls