Jacobs Institute of Women's Health
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Penile microbiomes have important implications for HIV susceptibility and broader reproductive health
No full textAddressing Health Equity with a Focus on Education, Health Concerns across Specialties and Clinical Trial Enrollment
No full textSizing in lung transplantation: principles, practices and ideas for the future
No full textLung transplantation (LTx) is an important treatment option for many end-stage lung diseases. The goal of LTx is to restore pulmonary physiology (gas exchange and respiratory system mechanics) towards normal, so that LTx recipients can experience an improved quality of life and live significantly longer. An optimized approach to donor-to-recipient size matching is a strategy to increase opportunities for successful transplants and optimize outcomes. In this review we discuss relevant pulmonary gas exchange and respiratory systems mechanics principles as a framework to optimize donor-to-recipient size matching and LTX-recipient management. The predicted total lung capacity (pTLC) is a refined estimate of organ size utilizing regression equations to calculate lung size based on height, sex and age. In general, irrespective of the underlying lung disease the chest cavity is reverse remolding back towards normal size in most recipients. The parameter that can reflect the sizing goal to restore physiology towards normal is the recipient pTLC. A pragmatic size matching metric is the donor-to-recipient pTLC-ratio. Significant undersizing based on the pTLC-ratio is a risk factor for complications and lower LTx survival. If significant changes to the LTx candidate\u27s chest cavity size occur (as can occur in severe restrictive lung disease or severe emphysema), or if the chest cavity cannot reverse remodel towards normal, it is important to consider additional donor-to-recipient sizing metrics. In addition to the recipient\u27s measured actual total lung capacity imaging-based metrics can be considered. Chest X-ray and computer tomography based volumetric analyses can provide information facilitating a successful LTx
Management of Patients With Mild Cognitive Impairment in the Era of Anti-Amyloid Therapy: A Worldwide Neurology Survey
No full textBACKGROUND AND OBJECTIVES: The aim of this study was to explore practice patterns in managing mild cognitive impairment (MCI). The investigation and management of MCI is considered important because it offers the opportunity to potentially stave off conversion to dementia. However, there are few data on current practices/approaches in this area, especially worldwide; such data can help identify potential disparities and anticipate adoption of new therapies. METHODS: We performed a worldwide electronic survey of neurology practitioners through the Practice Current section of Neurology® Clinical Practice with clinical and practice-related questions in November 2019-August 2021 and repeated it in May-October 2023 after the FDA\u27s approval of aducanumab and lecanemab but before the approval of donanemab. Clinical questions addressed access to and utilization of diagnostic investigations, pharmacologic and nonpharmacologic management of MCI, and (in 2023) attitudes toward novel anti-amyloid agents. Responses were compared using the Fisher exact test and multivariable logistic regression adjusted for region, regional income, year of survey response, years in practice, and number of cognitive patients seen annually. RESULTS: We received 1,257 responses from 95 countries, including 237 cognitive subspecialists and 464 respondents from low-/middle-income countries. On multivariable analysis, cognitive subspecialists were more likely than other practitioners to investigate MCI with a lumbar puncture (aOR 1.90, 95% CI 1.32-2.73), luorodeoxyglucose-PET (FDG-PET) (aOR 1.45, 95% CI 1.00-2.10) and to offer pharmacotherapy if investigations suggested neurodegeneration (aOR 1.92, 95% CI 1.29-2.85). Regionally, respondents from Europe, Latin America, and Asia were more likely than those from the United States/Canada to order FDG-PET (e.g., Europe: aOR 2.38, 95% CI 1.29-4.39) and amyloid PET (Europe: aOR 3.30, 95% CI 1.85-5.87), controlling for reported access to these tests. Pharmacologic and nonpharmacologic approaches were comparable between cognitive subspecialists and other respondents. Despite concerns about safety (77.1% expressed being somewhat or very concerned), attitudes toward prescribing new anti-amyloid agents were similar among all respondents, reflecting a generally favorable attitude (e.g., 62% would prescribe anti-amyloid therapy if it was available). DISCUSSION: Our results highlight practice differences among cognitive subspecialists and other practitioners worldwide in the management of MCI. Attitudes toward anti-amyloid therapy indicate cautious optimism, with concerns about side effects but a general interest to prescribe
Obstructive sleep apnea, glycemic control, and cardiovascular risk in young adults with youth-onset type 2 diabetes: results from the TODAY study
No full textSTUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a common comorbidity in type 2 diabetes and has been associated with poor glycemic control, but few data exist in youth-onset type 2 diabetes. We evaluated the prevalence of OSA and its associations with metabolic control and cardiovascular risk in young adults with pediatric type 2 diabetes. METHODS: OSA presence and severity was assessed by polysomnography in 114 participants in the TODAY Study (Treatment Options for type 2 Diabetes in Adolescents and Youth) (mean: age 23.5 years, diabetes duration 10 years, BMI 35.3 kg/m). HbA1c, β-cell function, and diabetes-related complications were collected in the TODAY cohort. Adjusted regression models evaluated relationships between OSA and outcomes. RESULTS: The prevalence of OSA in TODAY was 38.6%. OSA was not associated with HbA1c, loss of metabolic control, or diabetes-related complications in this cohort. CONCLUSIONS: Despite nearly 10 years of poorly controlled diabetes, young adults with youth-onset type 2 diabetes had a moderate prevalence of OSA. Severity of OSA was not associated with loss of glycemic control or diabetes-related complications in the TODAY cohort. The prevalence of OSA was lower than that reported in adults with prediabetes/early type 2 diabetes. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: TODAY Study; Identifier: NCT00081328
Sociodemographic, Clinical, and Psychosocial Predictors of Short- and Long-term Study Retention in Diabetes Prevention Program (DPP) Outcomes Study (DPPOS)
No full textOBJECTIVE: Success of longitudinal studies depends on retention of participants. We examined characteristics as predictors of retention among participants with prediabetes and type 2 diabetes (T2D) in the Diabetes Prevention Program (DPP) and the follow-up DPP Outcomes Study. RESEARCH DESIGN AND METHODS: A total of 3,234 adults at high risk of T2D joined the DPP (1996-1999, mean age 51 ± 10 years). They were randomized to lifestyle, metformin, or placebo intervention, and then followed through 2020. Logistic regression models estimated the association between baseline sociodemographic, clinical and psychosocial characteristics (life events, family functioning, social support), and short-term retention (∼3 years). Cox proportional hazards models, censoring at death, estimated the association between baseline and time-varying characteristics and time to dropout over the entire 20 years of follow-up. RESULTS: Among surviving participants (n = 3,218), 93% were retained after 3 years, and 75% of those surviving remained engaged over 20 years. Younger age was associated with dropout during DPP and over 20 years of follow-up. Female sex, non-White race/ethnicity, employment, and lack of baseline depressive symptoms were associated with better long-term retention. Over time, better health state (SF-36) (hazard ratio [HR]: 0.89 per 0.1 point; 95% CI: 0.83-0.95) was associated with retention. Greater BMI (HR: 1.06 per 5 kg/m2; 95% CI: 1.00-1.12), more recent life events (HR: 1.08; 95% CI: 1.02-1.14), and depressive symptoms (HR: 1.11 per 5 points; 95% CI: 1.05-1.18) were associated with reduced retention. Among adults 45-59 years of age at baseline, development of T2D was associated with better retention (HR: 0.75; 95% CI: 0.58-0.97). CONCLUSIONS: Twenty-year retention of a racially and geographically diverse cohort with prediabetes is possible. Retention was associated with age, psychosocial factors, T2D development, and BMI
Interrater reliability between surgeons and pediatric emergency providers in the cervical spine assessment of injured children
No full textBACKGROUND: Cervical spine injury (CSI) is uncommon in children but an important consideration during trauma evaluation. The Pediatric Emergency Care Applied Research Network (PECARN) derived and validated a CSI prediction rule to guide cervical spine imaging decisions in children after blunt trauma. Our objective was to determine the interrater reliability between EM providers and surgeons for history and physical examination findings used to evaluate children for CSI after blunt trauma. METHODS: This was a planned secondary analysis of a prospective, observational multicenter study that enrolled children aged 0 year to 17 years evaluated for blunt trauma in 18 PECARN emergency departments (EDs). We collected data on injury mechanisms, history and physical examination findings, imaging ordered, and suspicion of CSI from EM and surgery providers. Kappa, prevalence, and bias-adjusted kappa (PABAK) were used to compare interrater reliability of variables associated with CSI. RESULTS: Surgeons cared for 8,041 of the 22,430 children enrolled in the parent study. About 18.6% (1494/8041) had data collection forms completed by both EM providers and surgeons and were included in the analysis. Agreement between EM and surgery providers per kappa was moderate (kappa 0.41-0.6) to substantial (kappa 0.61-0.8), while PABAK analyses showed substantial to almost perfect agreement for variables in the PECARN CSI prediction rule. There was agreement between EM and surgery providers in overall clinical suspicion for CSI in 64.2% (959/1494) of patients. Retrospective application of the PECARN Rule indicated that ED and surgical provider assessments would have led to the same imaging decision in 73.7% (1101/1494) of patients. CONCLUSION: We identified moderate to substantial agreement between EM providers and surgeons for clinical findings that comprise the PECARN Cervical Spine Injury Prediction Rule. Agreement between providers during shared decision-making will strengthen the use of the prediction rule and may lead to decreased cervical spine imaging in EDs. LEVEL OF EVIDENCE: Prognostic and Epidemiologic; Level II
Nonglycemic and Glycemic Risk Factors for Painful Neuropathic Symptoms and for Distal Symmetrical Polyneuropathy (DSPN) in the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study
No full textOBJECTIVE: The clinical presentation, symptoms, and signs of neuropathy vary substantially. We determined whether painful neuropathic symptoms and distal symmetrical polyneuropathy (DSPN) were associated with different risk factors in a longitudinal study of Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study (DPP/DPPOS) participants. RESEARCH DESIGN AND METHODS: We assessed neuropathy in 1,779 DPP/DPPOS participants ∼21 years after DPP randomization. Symptoms were assessed using the Michigan Neuropathy Screening Instrument (MNSI) questionnaire and signs using pinprick, vibration, and monofilament testing. We defined four mutually exclusive neuropathy phenotypes: 1) no symptoms or signs of DSPN, 2) neuropathic pain without signs, 3) other neurologic symptoms without pain or signs, and 4) DSPN (MNSI questionnaire score ≥4 or any signs). We used multinomial logistic regression models to compare nonglycemic and glycemic risk factors among participants to better understand risk factors associated with painful neuropathic symptoms and DSPN. RESULTS: Among the participants, 501 (28%) had no symptoms or signs, 144 (8%) had painful neuropathic symptoms without signs, and 473 (27%) had DSPN. Compared with participants with neither symptoms nor signs, those with painful neuropathic symptoms were more likely to be women, to have greater weight, and lower estimated glomerular filtration rate. Painful symptoms were not associated with glycemia. In contrast, DSPN, when compared with painful symptoms, was associated with older age, White race, and glycemic exposure. CONCLUSIONS: In this cohort, risk factors for painful neuropathic symptoms and DSPN differed. Improved recognition of painful neuropathic symptoms and better consensus on diagnostic criteria may facilitate research into their causes, prevention, and treatment
Laryngectomy and Overall Survival in cT4b Laryngeal Squamous Cell Carcinoma
No full textOBJECTIVE: To compare surgical and non-surgical definitive treatment in cT4b laryngeal squamous cell carcinoma (LSCC). METHODS: The 2004-2019 National Cancer Database (NCDB) was queried for patients with cT4b LSCC (N = 871). Patients undergoing definitive treatment with (1) laryngectomy + radiotherapy (RT)/chemoradiotherapy (CRT), RT alone, or (3) CRT were included in Kaplan-Meier and Cox survival analyses. RESULTS: Of 207 patients undergoing definitive treatment, 41 (19.8%) underwent laryngectomy + RT/CRT therapy and 166 (80.2%) underwent primary RT/CRT. Among patients undergoing laryngectomy + RT/CRT, 15 (39.5%) remained pT4b and 9 (22.1%) had positive margins. There were no documented mortalities within 90 days of laryngectomy. Nodal (79.3% vs. 79.9%, p = 0.038) and distant (30.7% vs. 0.0%, p \u3c 0.001) metastasis were associated with decreased odds of undergoing definitive treatment. Five-year overall survival (OS) of laryngectomy + RT/CRT and definitive RT/CRT was 39% and 22%, respectively (p = 0.005). Laryngectomy + RT/CRT (aHR: 0.54, 95% CI: 0.35-0.84) was associated with higher OS than definitive RT/CRT (p = 0.006). A separate cohort of 2807 patients with cT4a tumors was created; cT4a and cT4b (HR: 1.34, 95% CI: 0.89-2.02, p = 0.165) tumors had similar OS. CONCLUSIONS: A minority of patients with cT4b LSCC underwent definitive treatment. Laryngectomy + RT/CRT therapy was safe and associated with higher OS than definitive RT/CRT, despite the high rate of PSM. In the absence of clinical trial data, appropriately selected patients with cT4b LSCC may benefit from laryngectomy
Multiple micronutrient supplementation for maternal anemia prevention (MMS-MAP): an individually randomized trial of higher-dose iron (60 mg, 45 mg) compared to low-dose iron (30 mg) in multiple micronutrient supplements in pregnancy
No full textBACKGROUND: Antenatal multiple micronutrient supplementation (MMS) has been shown to be more effective than iron-folic acid (IFA) alone in reducing adverse pregnancy and birth outcomes. However, there is a concern that MMS containing 30 mg of iron may be less effective in reducing maternal anemia compared to IFA supplements containing 60 mg of iron. This poses a clinical and programmatic dilemma for countries with a high burden of maternal anemia (\u3e 40% prevalence) where the World Health Organization (WHO) recommends using IFA with 60 mg of iron. METHODS/DESIGN: We will conduct an individually randomized, quadruple-blind superiority trial of daily antenatal MMS in Dar es Salaam, Tanzania (n = 6381 pregnant women). Participants will be randomized to receive a daily MMS regimen during pregnancy containing 60 mg iron, 45 mg iron, or 30 mg iron at a ratio of 1:1:1. The trial participants, outcome assessors (research staff and care providers), investigators, trial statistician, and data analysts will be blinded. Pregnant women will be enrolled in the trial before 20 weeks of gestation and will receive the randomized MMS regimen from enrollment until the time of pregnancy outcome/delivery. The primary outcome is maternal third-trimester moderate or severe anemia (Hb \u3c 10.0 g/dL). The proportion of women who have moderate or severe anemia at 32 weeks of gestation will be compared between MMS containing 60 mg iron versus MMS containing 30 mg iron, as well as MMS containing 45 mg iron versus MMS containing 30 mg iron. Secondary outcomes include maternal hemoglobin concentration, anemia, maternal iron deficiency, and maternal iron deficiency anemia at 32 weeks gestation and 6 weeks postpartum; preeclampsia, antepartum bleeding, postpartum hemorrhage, maternal peripartum infection, pregnancy-related death, symptoms consistent with depression, fatigue, and maternal malaria during pregnancy and 42 days following; fetal death, stillbirth, birth weight, low birthweight, gestational age at birth, preterm birth, birthweight for gestational age, and small-for-gestational age birth; infant hemoglobin concentrations, infant iron status, neonatal death, and infant death at 6 weeks of age; and maternal side effects. Relative risks for binomial outcomes and mean differences for continuous outcomes and their 95% confidence intervals will be calculated for all the primary and secondary outcomes. DISCUSSION: This study will produce causal evidence on whether MMS containing 60 or 45 mg of iron is superior to MMS containing 30 mg of iron in reducing maternal anemia and improving other important maternal and infant health outcomes. The findings of this study will inform Tanzania and similar contexts on the optimal formulation of MMS as many countries begin transitioning from IFA to MMS. TRIAL REGISTRATION: ClinicalTrials.gov NCT06079918. Registered on 2023-10-06. TRIAL STATUS: The trial is recruiting. We report protocol version 1.7 dated March 2, 2025. Recruitment started with the first patient enrolled on March 3, 2025. At the submission of this manuscript on April 10, 2025, 111 participants have been randomized. Recruitment is ongoing and should be completed by December 2026