Search

Purpose: To develop reference charts that describe normative quadriceps strength recovery after total knee arthroplasty (TKA) as measured by handheld dynamometry (HHD).Materials and Methods: We con...

Background Risk prediction models for time-to-event outcomes play a vital role in personalized decision-making. A patient’s biomarker values, such as medical lab results, are often measured over time but traditional prediction models ignore their longitudinal nature, using only baseline information. Dynamic prediction incorporates longitudinal information to produce updated survival predictions during follow-up. Existing methods for dynamic prediction include joint modeling, which often suffers from computational complexity and poor performance under misspecification, and landmarking, which has a straightforward implementation but typically relies on a proportional hazards model. Random survival forests (RSF), a machine learning algorithm for time-to-event outcomes, can capture complex relationships between the predictors and survival without requiring prior specification and has been shown to have superior predictive performance. Methods We propose an alternative approach for dynamic prediction using random survival forests in a landmarking framework. With a simulation study, we compared the predictive performance of our proposed method with Cox landmarking and joint modeling in situations where the proportional hazards assumption does not hold and the longitudinal marker(s) have a complex relationship with the survival outcome. We illustrated the use of the RSF landmark approach in two clinical applications to assess the performance of various RSF model building decisions and to demonstrate its use in obtaining dynamic predictions. Results In simulation studies, RSF landmarking outperformed joint modeling and Cox landmarking when a complex relationship between the survival and longitudinal marker processes was present. It was also useful in application when there were several predictors for which the clinical relevance was unknown and multiple longitudinal biomarkers were present. Individualized dynamic predictions can be obtained from this method and the variable importance metric is useful for examining the changing predictive power of variables over time. In addition, RSF landmarking is easily implementable in standard software and using suggested specifications requires less computation time than joint modeling. Conclusions RSF landmarking is a nonparametric, machine learning alternative to current methods for obtaining dynamic predictions when there are complex or unknown relationships present. It requires little upfront decision-making and has comparable predictive performance and has preferable computational speed.

Cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder is a rare neurodevelopmental disorder characterized by infantile-onset refractory epilepsy, profound developmental delays, and cerebral visual impairment. Although there is evidence that the presence of cerebral visual impairment in CDKL5 deficiency disorder is common, the potential impact of cerebral visual impairment severity on developmental attainment has not been explored directly. Focusing on a cohort of 46 children with CDKL5 deficiency disorder, examination features indicative of cerebral visual impairment were quantified and compared to developmental achievement. The derived cerebral visual impairment severity score was inversely correlated with developmental attainment, bolstering the supposition that cerebral visual impairment severity may provide a useful early biomarker of disease severity and prognosis. This study demonstrates the utility of a cerebral visual impairment score to better capture the range of cerebral visual impairment severity in the CDKL5 deficiency disorder population and further elucidates the interaction between cerebral visual impairment and developmental outcomes.

PURPOSE: Studies based on administrative databases show that infant pyeloplasty is associated with minority race/ethnicity but lack clinical data that may influence treatment. Our objective was to identify clinical and demographic factors associated with pyeloplasty in infants from three large tertiary centers. METHODS: We reviewed infants with unilateral Society for Fetal Urology (SFU) grade 3-4 hydronephrosis seen at three tertiary centers from 2/1/2018-9/30/2019. Patients were excluded if > 6 months old or treated surgically prior to the initial visit. Outcomes were: pyeloplasty < age 1 year and SFU grade on most recent ultrasound (US) within the first year. Covariables included: age at the initial visit, race/ethnicity, treating site, insurance type, febrile UTI, and initial imaging findings. Univariable and multivariable analyses were performed using log-rank tests and Cox proportional hazards models, respectively. RESULTS: 197 patients met study criteria; 19.3% underwent pyeloplasty. Pyeloplasty was associated with: treating site (p=0.03), SFU 4 on initial US (p =0.001), MAG-3 (p 20 minutes (p < 0.001) in patients undergoing a MAG-3 (n=107). MAG-3 (p

Purpose: Up to 1.8% of youth identify as transgender; many will be treated with a gonadotropin-releasing hormone agonist (GnRHa). The impact of GnRHa on insulin sensitivity and body composition in transgender youth is understudied. We aimed to evaluate differences in insulin sensitivity and body composition in transgender youth on GnRHa therapy compared with cisgender youth. Methods: Transgender participants were matched to cisgender participants on age, body mass index, and sex assigned at birth. Transgender males (n=9, ages 10.1–16.0 years) on GnRHa (mean±standard deviation duration of exposure: 20.9±19.8 months) were compared with cisgender females (n=14, ages 10.6–16.2). Transgender females (n=8, ages 12.6–16.1) on GnRHa (11.3±7 months) were compared with cisgender males (n=17, ages 12.5–15.5). Differences in insulin sensitivity (1/[fasting insulin], homeostatic model of insulin resistance [HOMA-IR]), glycemia (hemoglobin A1C [HbA1c], fasting glucose), and body composition (dual-energy X-ray absorptiometry) were evaluated using a mixed linear regression model. Results: Transgender males had lower 1/fasting insulin and higher HOMA-IR (p=0.031, p=0.01, respectively), fasting glucose (89±4 vs. 79±13 mg/dL, p=0.012), HbA1c (5.4±0.2 vs. 5.2±0.2%, p=0.039), and percent body fat (36±7 vs. 32±5%, p=0.042) than matched cisgender females. Transgender females had lower 1/fasting insulin and higher HOMA-IR (p=0.028, p=0.035), HbA1c (5.4±0.1% vs. 5.1±0.2%, p=0.007), percent body fat (31±9 vs. 24±10%, p=0.002), and lower percent lean mass (66±8 vs. 74±10%, p

Objective:Children with infantile spasms may develop Lennox-Gastaut syndrome. The diagnostic criteria for Lennox-Gastaut syndrome are vague, and many experts use varying combinations of the following criteria for diagnosis: paroxysmal fast activity on electroencephalography (EEG), slow spike and wave on EEG, developmental delay, multiple seizure types, and nocturnal tonic seizures. Our objective was to determine the prevalence of Lennox-Gastaut syndrome in a high-risk cohort of children with a history of infantile spasms and the characteristics of infantile spasms that were associated with the diagnosis of Lennox-Gastaut syndrome.Methods:Children with infantile spasms who were diagnosed and treated at Children’s Hospital Colorado between 2012 and 2018 were included. Lennox-Gastaut syndrome was defined as having 3 of 5 of the following characteristics: paroxysmal fast activity, slow spike and wave, current developmental delay, multiple seizure types, or tonic seizures. Descriptive statistics were performed using median and interquartile range. Univariable analysis was performed with Pearson chi-square, Fisher exact, or the Kruskal-Wallis test.Results:Ninety-seven children met inclusion criteria, and 36% (35/97) met criteria for Lennox-Gastaut syndrome. Developmental delay and history of seizures prior to the onset of infantile spasms were identified as risk factors for the development of Lennox-Gastaut syndrome ( P = .003) as was poor response to first treatment for spasms ( P = .004). Children with an unknown etiology of infantile spasms were less likely to develop Lennox-Gastaut syndrome ( P = .019). Eighty percent (28/35) of the children who met Lennox-Gastaut syndrome criteria lacked a documented diagnosis.Conclusions:Thirty-six percent of children with infantile spasms met criteria for Lennox-Gastaut syndrome. Risk factors for development of Lennox-Gastaut syndrome were developmental delay and seizures prior to the onset of infantile spasms and poor response to first treatment for infantile spasms. Children with an unknown etiology of infantile spasms were less likely to develop Lennox-Gastaut syndrome. Eighty percent of the children who met our criteria were not given a documented diagnosis of Lennox-Gastaut syndrome, which highlights the fact that many children may not be receiving a diagnosis of Lennox-Gastaut syndrome. We recommend establishing clear guidelines for the diagnosis of Lennox-Gastaut syndrome to ensure that the diagnosis is being made accurately.

INTRODUCTION: People with Down syndrome have health risks that require specific lifelong preventive healthcare. With increasing life expectancy, people with Down syndrome also face health conditions typical of their unaffected peers and thus need coordinated healthcare. The purpose of this study is to describe rates of age/gender- and Down syndrome-specific preventive healthcare activities among adolescents and adults with Down Syndrome. METHODS: Using Medicaid claims (2006–2010) in California, Colorado, Michigan, and Pennsylvania, the cohort was defined as people with Down syndrome aged ≥12 years seen by primary care providers and enrolled in Medicaid for ≥45 of 60 months without dual Medicare enrollment (n=3,501). Age focus-consistent primary care providers were defined as having a focus concordant with a patient’s age: 12–17 years, child or mixed focus; ≥26 years, adult or mixed focus; 18–25 years, any focus. Differences in healthcare activities were evaluated using Pearson’s chi-square, Fisher’s exact, and Kruskal-Wallis tests. Analyses were performed in 2015–2017. RESULTS: Seventy-nine percent of the cohort had an age focus-consistent primary care provider. However, 40% of adults aged ≥26 years received care from child-focused primary care provider. Only 43% with an age focus-consistent provider had ≥1 well examination (age focus-inconsistent primary care provider: 35%, p

Cystic fibrosis and other chronic lung disease clinical trials often use time to first pulmonary exacerbation (PEx) or total PEx count as endpoints. The use of these outcomes may fail to capture patterns or timing of multiple exacerbations and how covariates influence the risk of future exacerbations. Analysis of gap times between PEx provides a useful framework to understand risks of subsequent events, particularly to assess if there is a temporary increase in a hazard of a subsequent PEx following the occurrence of a PEx. This may be useful for estimating the amount of time needed to follow patients after a PEx and predicting which patients are more likely to have multiple PEx. We propose a smoothed hazard for gap times to account for elevated hazards after exacerbations. A simulation study was conducted to explore model performance and was able to appropriately estimate parameters in all situations with an underlying change point with independent or correlated recurrent events. Models with different change-point structures and trends are compared using Early Pseudomonas Infection Control (EPIC) observational study data, using a quasi-likelihood modification of the Akaike information criterion; a model with a change-point provided a better fit than a model without one. The analysis suggests that the change point may be 1.8 years (SE 0.09) after the end of a PEx. Models including covariates in the hazard function revealed that having one or two copies of the

Objective: In a randomized trial, we aimed to evaluate the efficacy of cosyntropin injectable suspension, 1 mg/mL, compared to vigabatrin for infantile spasms syndrome. An additional arm was included to assess the efficacy of combination therapy (cosyntropin and vigabatrin) compared with cosyntropin monotherapy. Methods: Children (2 months to 2 years) with new-onset infantile spasms syndrome and hypsarhythmia were randomized into 3 arms: cosyntropin, vigabatrin, and cosyntropin and vigabatrin combined. Daily seizures and adverse events were recorded, and EEG was repeated at day 14 to assess for resolution of hypsarhythmia. The primary outcome measure was the composite of resolution of hypsarhythmia and absence of clinical spasms at day 14. Fisher exact test was used to compare outcomes. Results: 37 children were enrolled and 34 were included in the final efficacy analysis (1 withdrew prior to treatment and 2 did not return seizure diaries). Resolution of both hypsarhythmia and clinical spasms was achieved in in 9 of 12 participants (75%) treated with cosyntropin, 1/9 (11%) vigabatrin, and 5/13 (38%) cosyntropin and vigabatrin combined. The primary comparison of cosyntropin versus vigabatrin was significant (64% [95% confidence interval 21, 82], P

Background Pulmonary exacerbations (PEx) are important contributors to morbidity and mortality in cystic fibrosis (CF). Understanding risk factors for PEx is critical to improve treatment; pulmonary exacerbations also serve as an important outcome in CF clinical trials. Current risk estimates generally only evaluate time to the first PEx. Methods accounting for multiple exacerbations during the observation period could provide more power to detect significant risk factors. Methods The Early Pseudomonas Infection Control (EPIC) Observational Study enrolled participants between 2004 and 2006 who were ≤ 12 years of age and negative for Pseudomonas aeruginosa. First and multiple event analyses were used to investigate risk factors for pulmonary exacerbations. Results We evaluated a total of 5129 PEx from 1734 CF patients in the EPIC study. Multiple event analysis identified 2 more factors associated with occurrence of PEx compared to first event analysis. After adjusting for multiple factors, the following were associated with higher occurrence of PExs: female gender, older age at enrollment, household cigarette smoke exposure, increased cough at the most recent encounter, having used antibiotics since the previous encounter, a positive culture for any CF organism at the most recent encounter, and having had a PEx in the last 30 days. Conclusions Multiple event analyses use all PEx events and may identify more risk factors for PEx than analysis of time to first PEx. We have provided an example of how to apply this type of analysis and how to interpret estimates in the context of the EPIC study.

Background : Hospitalized children have high rates of tobacco smoke exposure; parents who smoke may be receptive to interventions during their child's hospitalization. Objective : We tested the efficacy of a smoking cessation intervention for parents of hospitalized children. Methods : We conducted a randomized, single-blind clinical trial from 12/14-5/18 at the Children's Hospital Colorado. Hospitalized children who had a parent who smoked tobacco were eligible. Intervention: Intervention participants received motivational interviewing sessions, 2 weeks of nicotine replacement therapy; both groups received referral to the Quitline Consenting parents completed a questionnaire; urine was collected from the child for measurement of cotinine. Our primary outcome was: 1) increase in reporting “no one is allowed to smoke anywhere” in the home (smoke-free home rule). Additional outcomes included: 2) change in child's cotinine from baseline to 1 year, and 3) parental quitting at 1 year. Data were analyzed using Chi-square and t-tests for bivariable data, and multivariable logistic and linear regression. Results : Of 1641 eligible families approached, 252 were randomized (15%); 149 families had follow-up data at 12 months (59%). In the adjusted analysis, there was no difference between the groups in smoke free home rules, or child cotinine level; in an intention-to-treat analysis, 15% in the intervention group vs. 8% of controls reported quit (p=0.07). Conclusions : A smoking cessation intervention can be delivered to parents of hospitalized children. While hospitalization provides an opportunity to help parents quit smoking, more efficient and effective engagement strategies are needed to optimize tobacco control success.

Context As many as 1.8% of adolescents identify as transgender and many more seek care, yet the impact of gender-affirming hormone therapy (GAHT) on cardiometabolic health is unknown. Objective To determine insulin sensitivity and body composition among transgender females (TF) and males (TM) on estradiol or testosterone, compared with cisgender females (CF) and males (CM). Design Pilot, cross-sectional study conducted from 2016–2018. Setting Academic regional transgender referral center. Participants Transgender adolescents on either testosterone or estradiol for at least 3 months were recruited. Nineteen TM were matched to 19 CM and 42 CF on pubertal stage and body mass index (BMI). Eleven TF were matched to 23 CF and 13 TF to 24 CM on age and BMI. Main Outcome Measures 1/[fasting insulin] and body composition (dual-energy x-ray absorptiometry). Results Total body fat was lower in TM than CF mean ± SD: (29% ± 7% vs 33% ± 7%; P = 0.002) and higher than in CM (28% ± 7% vs 24% ± 9%; P = 0.047). TM had higher lean mass than CF (68% ± 7% vs 64% ± 7%, P = 0.002) and lower than CM (69% ± 7% vs 73% ± 8%; P = 0.029). Insulin sensitivity was not different between the groups. TF had lower body fat than CF (31% ± 7% vs 35% ± 8%; P = 0.033) and higher than CM (28% ± 6% vs 20% ± 10%; P = 0.001). TF had higher lean mass than CF (66% ± 6% vs 62% ± 7%; P = 0.032) and lower than CM (69% ± 5% vs 77% ± 9%; P = 0.001). TF were more insulin resistant than CM (0.078 ± 0.025 vs 0.142 ± 0.064 mL/μU; P = 0.011). Conclusions Transgender adolescents on GAHT have significant differences in body composition compared with cisgender controls, with a body composition intermediate between BMI-matched CMs and CFs. These changes in body composition may have consequences for the cardiometabolic health of transgender adolescents. ClinicalTrials.gov NCT02550431

BACKGROUND: There is a need for new strategies to improve the success of obesity treatment within the primary care setting. OBJECTIVE: To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care. DESIGN: Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital. PARTICIPANTS: From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention. INTERVENTIONS: Medical weight management tools—partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program—for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months. MAIN MEASURES: The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss. KEY RESULTS: Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p

OBJECTIVES: To evaluate trends and factors associated with mode of delivery in the rural Southwest Trifinio region of Guatemala. METHODS: We conducted a retrospective analysis of self-reported antepartum factors and postpartum outcomes recorded in a quality improvement database among 430 women enrolled in a home-based maternal healthcare program between June 1, 2015 and August 1, 2017. RESULTS: Over the study period, the rates of cesarean delivery (CD) increased (from 30% to 45%) and rates of vaginal delivery (VD) decreased (70% to 55%) while facility-based delivery attendance remained stable around 70%. Younger age (23.5 years for VD versus 21.6 years for CD, p < 0.001), nulliparity (25.1% for VD versus 45.0% for CD, p < 0.001), prolonged/obstructed labor (2.4% for VD versus 55.6% for CD, p < 0.001), and fetal malpresentation (0% for VD versus 16.3% CD, p < 0.001) significantly influenced mode of delivery in univariate analysis. The leading indications for CD were labor dysfunction (47.5%), malpresentation (14.5%), and prior cesarean delivery (19.8%). The CD rate among the subpopulation of term, nulliparous women with singleton pregnancies in vertex presentation also increased from 20% of all CD in 2015, to 38% in 2017. CONCLUSIONS: Among low-income women from rural Guatemala, the CD rate has increased above the World Health Organization (WHO) recommendations in a period of 3 years. Additional research on the factors affecting this trend are essential to guide interventions that might improve the appropriateness of CD, and to determine if reducing or stabilizing rates is necessary.

Introduction There is overlap in the electroclinical features of many childhood epilepsy syndromes, especially those presenting with multiple seizure types, such as epilepsy with myoclonic-atonic seizures (EMAS) and Lennox-Gastaut syndrome (LGS). This study aimed to determine the frequency of diagnosis switching and the factors influencing epilepsy syndrome diagnosis in a cohort of children with possible EMAS, as well as to explore the relationship between epilepsy syndrome diagnoses, key electroclinical features, and clinically relevant outcomes. Methods This is a cross-sectional retrospective chart review of children treated at the Children’s Hospital of Colorado with a potential diagnosis of EMAS. Results There were 77 patients that met eligibility criteria, including 39% (n = 30) with an initial diagnosis of EMAS and 74% (n = 57) with a final diagnosis of EMAS. On average, for the 65% of patients who received more than one epilepsy diagnosis, the first, second, and third diagnoses were received within one year, three years, and ten years after epilepsy onset, respectively. Final diagnosis was significantly related to obtaining at least a six-month period of seizure freedom, p = 0.03. Classic LGS traits, including paroxysmal fast activity, slow spike-and-wave, and tonic seizures were present in 50% of the overall cohort, although a minority of these patients had a final diagnosis of LGS. However, the presence of more LGS traits was associated with a higher likelihood of ongoing seizures. Adjusted for age of epilepsy onset, seizure freedom was half as likely for every additional LGS trait observed (0.49[0.31, 0.77], p = 0.002). Conclusion Current epilepsy syndrome classification has reduced applicability due to overlapping features. This results in diagnosis switching and limited prognostic value for patients with an overlapping clinical phenotype. Future studies should attempt to stratify patients based not only on epilepsy syndrome diagnosis, but also on the presence of various electroclinical traits to more accurately predict outcome.

Objective he purpose of this study will be to determine the efficacy of error-manipulation gait training (error-augmentation or error-correction) to improve step length symmetry and secondary health outcomes in veterans with unilateral nontraumatic transtibial amputation (TTA). Methods This will be a 3-arm, parallel, assessor-blinded, randomized controlled trial, with baseline, postintervention, and 3-month follow-up assessments in a VA Geriatric Research Education and Clinical Center. Participants are 54 US military veterans ranging in age from 50 to 85 years with a unilateral transtibial nontraumatic amputation. Participants will be randomized into 1 of 3 groups: error-augmentation training (EAT), error-correction training (ECT), or supervised walking (CTL). Each group will complete 8 split-belt treadmill walking training sessions of 25 minutes each over 4 weeks. The EAT group will walk with belts moving at asymmetrical speeds. The ECT group will walk to the cadence of a metronome and the split belts moving at symmetrical speeds. The CTL group will walk with symmetrical belt speeds and without feedback. Step length symmetry is the primary outcome and will be assessed using an asymmetry index during overground walking. Secondary outcomes include lower extremity joint work during treadmill walking, 6-Minute Walk Test performance, daily step count, participant-perceived disability, and residual-limb integumentary health. Outcomes will be assessed at preintervention, 1-week postintervention (primary endpoint), and 13 weeks postintervention. Impact This study protocol focuses on an understudied area of rehabilitation for patients with nontraumatic unilateral TTA who have high levels of spatiotemporal gait asymmetry and mobility impairment. The results of this study will inform future implementation of clinical gait training interventions to improve spatiotemporal gait symmetry and long-term health and disability outcomes in patients with nontraumatic unilateral TTA.

Background: Studies of transgender adults on gender affirming hormone therapy have shown increased rates of cardiovascular events (myocardial infarction and stroke) and features of metabolic syndrome including increased body mass index (BMI, transgender males) and dyslipidemia (transgender males and females). Studies in youth are limited by mostly small, single-center studies. With 1.8% of adolescents identifying as transgender, and increasing referral rates to gender clinics for care, more information is needed to better inform clinicians, patients and families about potential health risks in this cohort. PEDSnet, a pediatric Learning Health System, captures data from some of the largest pediatric care institutions in the U.S. We aimed to evaluate differences in diagnoses related to metabolic syndrome or cardiometabolic risk among youth with a diagnosis of gender dysphoria compared to matched cisgender controls. Methods: All youth with a diagnosis of gender dysphoria (n=4,177) and at least one outpatient encounter were extracted from the PEDSnet database (6 sites, years 2009-2019) and propensity-score matched on 7 variables (year of birth, age at last visit, site, race, ethnicity, insurance status, duration in database) to 4 controls without gender dysphoria (n=16,664). The odds of having a diagnosis of overweight/obesity, hypertension, dyslipidemia, dysglycemia, liver dysfunction, polycystic ovary syndrome (PCOS) or metabolic syndrome, was examined using generalized estimating equations with an interaction term for sex (as listed in the chart). Results: Of the transgender youth, 66% were female sex, 73% were white race, 9% were of Hispanic ethnicity, and 61% had private insurance. The control group was similar: 67% female sex, 72% white, 9% Hispanic, and 61% had private insurance. Transgender youth and controls both had on average 7 years duration in the database and were 16.2 years old at last visit. Transgender youth had higher odds of dyslipidemia (OR: 1.6 [95% CI: 1.3, 1.8], p

BACKGROUND Group visits can support health behavior change and self-efficacy. In primary care, an advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement. OBJECTIVE To determine whether the ENgaging in Advance Care Planning Talks (ENACT) group visits intervention improves ACP documentation and readiness in older adults. METHODS This randomized clinical trial was conducted among geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019. Participants randomized to ENACT group visits (n = 55) participated in two 2-hour sessions with discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos). Participants randomized to the control arm (n = 55) received the Conversation Starter Kit and a Medical Durable Power of Attorney form by mail. The primary outcomes included presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR) at 6 months, and a secondary outcome was ACP readiness (validated four-item ACP Engagement Survey) at 6 months. RESULTS Participants were a mean of 77 years old, 60% female, and 79% white. At 6 months, 71% of ENACT participants had an advance directive in the EHR (26% higher) compared with 45% of control arm participants (P

Introduction: Pediatric early warning scores (PEWS) identify hospitalized children at risk for deterioration. Manual calculation is prone to human error. Electronic health records (EHRs) enable automated calculation, removing human error. This study’s objective was to compare the accuracy of automated EHR-based PEWS calculation (AutoPEWS) to manual calculation and evaluate the non-inferiority of AutoPEWS in predicting deterioration. Methods: We performed a retrospective cohort study inclusive of non-intensive care unit inpatients at a freestanding children’s hospital over 4.5 months in Fall 2018. AutoPEWS mapped the historical manual PEWS scoring rubric to frequently used EHR documentation. We determined accuracy by comparing the expected respiratory subset score based on the current respiratory rate to the actual respiratory score of AutoPEWS and the manual PEWS. The agreement was determined using kappa statistics. We used predicted probabilities from a generalized linear mixed model to calculate areas under the curve for each combination of scores (AutoPEWS, manual) and deterioration outcome (rapid response team activation, unplanned intensive care unit transfer, critical deterioration event). We compared the adjusted difference in areas under the curves between the scores. Non-inferiority was defined as a difference of

OBJECTIVE To examine the impact of a 1-year pragmatic obesity trial on primary care providers' (PCPs) perspectives of treatment. METHODS PCPs from four intervention clinics (PCP-I) and five control clinics (PCP-C) completed pre- and postintervention surveys on weight-loss counseling, comfort discussing obesity treatments, and perceived effectiveness of interventions; questions were rated on 0 to 10 Likert scales. Only PCP-I received patient updates and education about obesity management. RESULTS Eighty PCPs completed preintervention surveys (pre: 71% female, 71% physicians); 82 PCPs completed postintervention surveys (post: 66% female, 70% physicians). PCPs were most comfortable discussing exercise before and after the trial (pre PCP-C: 8.22 [1.44], mean [standard deviation (SD)]; post PCP-C: 8.37 [1.24]; P = 0.8; pre/post PCP-I: 7.88 [1.51] vs. 7.80 [1.71]; P = 0.3). PCPs were initially least comfortable discussing phentermine/topiramate extended release (ER) but developed significantly more comfort after the trial, to a greater degree among PCP-I (pre/post PCP-C: 2.86 [2.66] vs. 3.73 [2.72], P < 0.001; pre/post PCP-I: 4.00 [2.57] vs. 6.17 [2.27], P < 0.001). After the trial, both PCPs rated exercise significantly less effective for weight loss, with a greater decrease in effectiveness rations among PCP-I (pre/post PCP-C: 7.73 [1.94] vs. 6.93 [2.35], P = 0.017; pre/post PCP-I: 6.27 [2.69] vs. 5.15 [2.31], P = 0.001). Both PCPs rated phentermine (pre/post PCP-C: 5.03 [2.05] vs. 5.50 [2.12], P = 0.002; pre/post PCP-I: 5.70 [1.64] vs. 6.83 [1.18], P = 0.001) and phentermine/topiramate ER (pre/post PCP-C: 3.91 [2.33] vs. 5.47 [2.54], P < 0.001; pre/post PCP-I: 5.58 [2.21] vs. 7.02 [1.47], P < 0.001) significantly more effective after the trial, though ratings were higher among PCP-I. CONCLUSIONS PCPs initially overvalued exercise and undervalued weight-loss medications. PCPs exposed to education and experience gave higher comfort and effectiveness ratings to weight-loss medications.

To illustrate and document the tenuous connection between the Wilcoxon–Mann–Whitney (WMW) procedure and medians, its relationship to mean ranks is first contrasted with the relationship of a t-test...

Context Little is known about the health of transgender adults in the United States, a growing population. There have been no large reports examining differences in health status and cardiometabolic disease in subgroups of transgender adults [female-to-male (FTM), male-to-female (MTF), and gender nonconforming (GNC)] in the United States. Objective Compare the health status and prevalence of cardiometabolic disease among specific subgroups of transgender adults (FTM, MTF, GNC) with those of cisgender adults in the United States. Design Secondary data analysis based on the 2015 Behavioral Risk Factor Surveillance System survey. Setting The 22 states in the United States that asked about transgender identity. Participants Noninstitutionalized adults age ≥18 years who reside in the United States, identified through telephone-based methods. Main Outcome Measures Data were extracted for respondents who answered the transgender identity question. Weighted percentages are given for all measures. Adjusted odds ratios (ORs) are reported for health status and cardiometabolic disease measures. Results FTM adults have a higher odds of being uninsured than both cisgender women [OR 3.8; 95% confidence interval (CI), 2.1 to 7.1] and cisgender men (OR 2.5; 95% CI, 1.4 to 4.7). MTF adults have a higher odds of reporting myocardial infarction than cisgender women (OR 2.9; 95% CI, 1.6 to 5.3) but not cisgender men. Conclusions There are significant differences in health status measures and cardiometabolic health between subgroups of transgender adults and cisgender adults. There is a need for additional research to understand the societal and medical (e.g., hormone therapy) effects on these outcomes., There are differences in health status and cardiometabolic health among subgroups of transgender adults compared with cisgender adults on the 2015 Behavioral Risk Factor Surveillance System survey.

OBJECTIVES: To prospectively validate and refine the 5-item "CRASH" screening tool for identifying older drivers needing a behind-the-wheel (BTW) test. DESIGN: Prospective observational study. SETTING: Geriatric and internal medicine primary care clinics affiliated with a tertiary care hospital and a local BTW program. PARTICIPANTS: Cognitively intact drivers aged 65 and older (N = 315). MEASUREMENTS: Participants completed baseline questionnaire (including CRASH tool) and assessments and BTW test (evaluator blinded to questionnaire results) and participated in 1-month telephone follow-up. Analysis included descriptive statistics and examination of predictive ability of the CRASH tool to discriminate normal (pass) from abnormal (conditional pass or fail) on the BTW test, with logistic regression and CART techniques for tool refinement. RESULTS: Two hundred sixty-six participants (84%) had a BTW test; of these, 17% had a normal rating and 83% an abnormal rating. Forty-five percent of those with an abnormal score were advised to limit driving under particular conditions. Neither the CRASH tool nor its individual component variables were significantly associated with the summary BTW score; in refined models with other variables, the best-performing tool had approximately 67% sensitivity and specificity for an abnormal BTW score. Most participants found the BTW test useful and were willing to pay a median of $50. At 1-month follow-up, no participants had stopped driving. CONCLUSION: The CRASH screening tool cannot be recommended for use in clinical practice. FINDINGS on older adults' perceived utility of the BTW test and the stability of driving patterns at 1-month follow-up could be useful for future research studies and for design of older driver programs.© 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society. Language: en

Hospital readmissions are viewed as a mark of inferior health care quality and are penalized. Unplanned postoperative readmission reason and timing after lung resection are not well understood. We examine related, unplanned readmissions after thoracoscopic versus open anatomic lung resections to identify opportunities to improve patient care.We analyzed the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data set, 2012 to 2015, characterizing 30-day related, unplanned postoperative readmissions after anatomic lung resections for primary lung cancer. Risk-adjusted comparison of readmission after thoracoscopic and open resection was performed using propensity matching.Patients (n = 9,510) underwent anatomic lung resections; 4,935 (51.9%) were thoracoscopic resections and 4,575 (48.1%) were open resections. Of the thoracoscopic patients, 10.9% experienced one or more complications, versus 19.4% of patients with open resection (p0.0001). Of the thoracoscopic patients 5.5% experienced related, unplanned readmissions versus 7.2% of the patients with open resection (p0.001). 24.8% of complications after thoracoscopic approach occurred after discharge, versus 15.5% after open approach (p0.0001). Timing of unplanned readmission was similar for both groups. The propensity-matched odds ratio of risk of readmission after thoracoscopic versus open resection was 1.16 (95% confidence interval, 0.949 to 1.411, p = 0.15).Open anatomic lung resections for primary lung cancer had nearly twice the complication rate but only a slightly higher readmission rate than thoracoscopic resection. More complications occurred after discharge after thoracoscopic than open resections. Most readmissions occurred within 2 weeks after both thoracoscopic and open resections. Risk-adjusted comparison identified no statistically significant difference in risk of related, unplanned readmission after thoracoscopic versus open resections. Future studies should focus on identification of processes of care to decrease complications and unplanned readmissions after lung cancer resection.

Dravet syndrome is an intractable childhood epilepsy syndrome most often associated with an SCN1A mutation. In our clinical practice, several patients with Dravet syndrome were noted to have short stature and endocrine dysfunction. This has not been reported in the literature. Our study aim was to describe growth measurements and endocrine abnormalities in children with Dravet syndrome.A retrospective chart review was performed at a single institution. Eligibility criteria included clinical and genetic (SCN1A) diagnosis of Dravet syndrome. Records were reviewed for height and weight measurements and serologic evidence of endocrine abnormality, as well as patient demographics, anti-seizure medication, and family history. Age and gender specific trend of height and weight measurements, using z-scores, were compared to CDC growth curves (Centers for Disease Control and Prevention [1]).Sixty-eight children were identified, 46% male, age 1-21 years, taking an average of 2.9 anti-seizure medications per patient. Mean growth parameter measurements were significant for decrease in height z-score of 0.10 (p=0.001) and decrease in weight z-score of 0.09 (p=0.01) for every year increase in age, such that with increasing age the cohort moved farther away from the mean. The average group height and weight z-score, at age 8, was -0.45 and -0.09, respectively. After adjusting for age, neither gender, family history, or anti-seizure medication was associated with height or weight z-score. Serologic endocrine results were available for 26 children (38%). This identified low insulin-like growth factor 1 (IGF-1) in 7/15 and low testosterone in 2/10. Two children received growth hormone supplementation. TSH testing was abnormal10% of the time.Comorbidities in children with Dravet syndrome may involve more systems than previously reported. We report a cohort of children with Dravet syndrome with reduced height and weight growth trend, as well as a subset with endocrine dysfunction evidenced by low IGF-1 and testosterone levels. Additional prospective research is needed to further define the significance of this relationship.

Obstructive sleep apnea (OSA) affects up to 26% of US adults, is often undiagnosed, and increases perioperative morbidity. We hypothesized that patients screened on the day of surgery as moderate/high risk for OSA (S-OSA) present similar perioperative respiratory complications, hospital use, and mortality than patients with previously diagnosed OSA (D-OSA). Second, we hypothesized that both OSA groups have more respiratory complications than No-OSA patients.The electronic medical database from 1 academic and 2 community hospitals was retrospectively queried to identify adults undergoing nonemergent inpatient surgery (January 1, 2012, to December 31, 2014). Based on the day-of-surgery preoperative assessment and STOP-BANG (Snoring, Tiredness, Observed apnea during sleep, high blood Pressure, Body mass index35, Age50 years, thick Neck, Gender male) score, they were classified as D-OSA, S-OSA, or No-OSA. Perioperative respiratory events and interventions, hospital use, and mortality were measured. The primary outcome composite (adverse respiratory events [AREs]) included perioperative hypoxemic events and difficult airway management. Hypoxemic event was defined as peripheral saturation of oxygen (SpO2)90% by continuous pulse oximetry for ≥3 minutes, or if validated and/or manually entered into the medical chart. Hypoxemia was classified as mild (lowest SpO2 86%-89%) or moderate/severe (lowest SpO2 ≤85%). Secondary outcomes included postoperative respiratory interventions, intensive care unit admission, hospital length of stay, and 30-day and 1-year all-cause mortality. Outcomes were compared using linear and logistic regression analyses.A total of 28,912 patients were assessed: 3432 (11.9%) D-OSA; 1546 (5.3%) S-OSA; and 23,934 (82.8%) No-OSA patients. At least 1 ARE was present in 68.0% of S-OSA; 71.0% of D-OSA; and 52.1% of No-OSA patients (unadjusted P.001), primarily ≥1 moderate/severe hypoxemic event after discharge from the postanesthesia care unit (PACU; 39.9% in S-OSA; 39.5% in D-OSA; and 27.1% in No-OSA patients). S-OSA patients compared to D-OSA patients presented lower rates of moderate/severe hypoxemia in the PACU but similar intraoperatively and postoperatively, higher difficult mask ventilation rates, and similar difficult intubation reports. After adjusting for demographic, health, and surgical differences and hospital type, the likelihood of ≥1 ARE was not different in S-OSA and D-OSA patients (adjusted odds ratio 0.90 [99% confidence interval, 0.75-1.09]; P = .15). S-OSA patients compared to D-OSA patients had significantly increased postoperative reintubation, mechanical ventilation, direct intensive care unit admission after surgery, hospital length of stay, and 30-day all-cause mortality.Patients classified as S-OSA have similar rates of AREs to D-OSA patients, but increased postoperative respiratory interventions, hospital use, and 30-day all-cause mortality. These worse postoperative outcomes in S-OSA patients than D-OSA patients could reflect the lack of awareness and appropriate management of this bedside S-OSA diagnosis after PACU discharge. Multidisciplinary interventions are needed for these high-risk patients.

Panel counts are often encountered in longitudinal, such as diary, studies where individuals are followed over time and the number of events occurring in time intervals, or panels, is recorded. This article develops methods for situations where, in addition to the counts of events, a mark, denoting a measure of severity of the events, is recorded. In many situations there is an association between the panel counts and their marks. This is the case for our motivating application that studies the effect of two hormone therapy treatments in reducing counts and severities of vasomotor symptoms in women after hysterectomy/ovariectomy. We model the event counts and their severities jointly through the use of shared random effects. We also compare, through simulation, the power of testing for the treatment effect based on such joint modeling and an alternative scoring approach, which is commonly employed. The scoring approach analyzes the compound outcome of counts times weighted severity. We discuss this approach and quantify challenges which may arise in isolating the treatment effect when such a scoring approach is used. We also show that the power of detecting a treatment effect is higher when using the joint model than analysis using the scoring approach. Inference is performed via Markov chain Monte Carlo methods.

Background Counseling to reduce access to lethal means such as firearms and medications is recommended for suicidal adults but does not routinely occur. We developed the Web-based Lock to Live (L2L) decision aid to help suicidal adults and their families choose options for safer home storage. Objective This study aimed to test the feasibility and acceptability of L2L among suicidal adults in emergency departments (EDs). Methods At 4 EDs, we enrolled participants (English-speaking, community-dwelling, suicidal adults) in a pilot randomized controlled trial. Participants were randomized in a 13:7 ratio to L2L or control (website with general suicide prevention information) groups and received a 1-week follow-up telephone call. Results Baseline characteristics were similar between the intervention (n=33) and control (n=16) groups. At baseline, many participants reported having access to firearms (33/49, 67%), medications (46/49, 94%), or both (29/49, 59%). Participants viewed L2L for a median of 6 min (IQR 4-10 min). L2L also had very high acceptability; almost all participants reported that they would recommend it to someone in the same situation, that the options felt realistic, and that L2L was respectful of values about firearms. In an exploratory analysis of this pilot trial, more participants in the L2L group reported reduced firearm access at follow-up, although the differences were not statistically significant. Conclusions The L2L decision aid appears feasible and acceptable for use among adults with suicide risk and may be a useful adjunct to lethal means counseling and other suicide prevention interventions. Future large-scale studies are needed to determine the effect on home access to lethal means. Trial Registration ClinicalTrials.gov NCT03478501; https://clinicaltrials.gov/ct2/show/NCT03478501

BACKGROUND Counseling to reduce access to lethal means such as firearms and medications is recommended for suicidal adults but does not routinely occur. We developed the Web-based Lock to Live (L2L) decision aid to help suicidal adults and their families choose options for safer home storage. OBJECTIVE This study aimed to test the feasibility and acceptability of L2L among suicidal adults in emergency departments (EDs). METHODS At 4 EDs, we enrolled participants (English-speaking, community-dwelling, suicidal adults) in a pilot randomized controlled trial. Participants were randomized in a 13:7 ratio to L2L or control (website with general suicide prevention information) groups and received a 1-week follow-up telephone call. RESULTS Baseline characteristics were similar between the intervention (n=33) and control (n=16) groups. At baseline, many participants reported having access to firearms (33/49, 67%), medications (46/49, 94%), or both (29/49, 59%). Participants viewed L2L for a median of 6 min (IQR 4-10 min). L2L also had very high acceptability; almost all participants reported that they would recommend it to someone in the same situation, that the options felt realistic, and that L2L was respectful of values about firearms. In an exploratory analysis of this pilot trial, more participants in the L2L group reported reduced firearm access at follow-up, although the differences were not statistically significant. CONCLUSIONS The L2L decision aid appears feasible and acceptable for use among adults with suicide risk and may be a useful adjunct to lethal means counseling and other suicide prevention interventions. Future large-scale studies are needed to determine the effect on home access to lethal means. CLINICALTRIAL ClinicalTrials.gov NCT03478501; https://clinicaltrials.gov/ct2/show/NCT03478501

Background Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. Methods This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. Discussion A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town which is about an hour away by vehicular travel. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within 3 months of childbirth. The potential implications of this study include that nurses may be able to be trained to safely provide contraceptives, including placing implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period. Trial registration Clinicaltrials.gov, NCT04005391. Retrospectively registered on 1 July 2019.

Background Few cluster-randomized trials have been performed in rural Guatemala. Our objective was to describe the feasibility, recruitment and retention in our cluster-randomized trial. Methods In our cluster-randomized trial, a range of contraceptives were brought to mothers’ homes in rural Guatemala. Results Of 173 women approached, 33 were excluded. Of the 140 eligible women, 127 (91%) consented to participate. Of the 87 women who should have been assessed for the primary outcome, three were lost to follow-up, which represents a retention rate of 97%. Conclusions Nurses who are both clinical providers and study staff can feasibly conduct research, which leads to high enrollment and retention rates.

Background Tacrolimus (TAC) is an immunosuppressant drug given to kidney transplant recipients post-transplant to prevent antibody formation and kidney rejection. The optimal therapeutic dose for TAC is poorly defined and therapy requires frequent monitoring of drug trough levels. Analyzing the association between TAC levels over time and the development of potentially harmful de novo donor specific antibodies (dnDSA) is complex because TAC levels are subject to measurement error and dnDSA is assessed at discrete times, so it is an interval censored time-to-event outcome. Methods Using data from the University of Colorado Transplant Center, we investigated the association between TAC and dnDSA using a shared random effects (intercept and slope) model with longitudinal and interval censored survival sub-models (JM) and compared it with the more traditional interval censored survival model with a time-varying covariate (TVC). We carried out simulations to compare bias, level and power for the association parameter in the TVC and JM under varying conditions of measurement error and interval censoring. In addition, using Markov Chain Monte Carlo (MCMC) methods allowed us to calculate clinically relevant quantities along with credible intervals (CrI). Results The shared random effects model was a better fit and showed both the average TAC and the slope of TAC were associated with risk of dnDSA. The simulation studies demonstrated that, in the presence of heavy interval censoring and high measurement error, the TVC survival model underestimates the association between the survival and longitudinal measurement and has inflated type I error and considerably less power to detect associations. Conclusions To avoid underestimating associations, shared random effects models should be used in analyses of data with interval censoring and measurement error. Electronic supplementary material The online version of this article (10.1186/s12874-019-0773-1) contains supplementary material, which is available to authorized users.

ContextUp to 1.8% of adolescents identify as transgender and many more seek care, yet the impact of gender affirming hormone therapy (GAHT) on cardiometabolic health is unknown.ObjectiveTo determine insulin sensitivity and body composition among transgender females (TF) and males (TM) on estradiol or testosterone, compared to cisgender females (CF) and males (CM).DesignPilot, cross-sectional study conducted from 2016-2018.Setting. Academic regional transgender referral center.ParticipantsTransgender adolescents on either testosterone or estradiol for at least 3 months were recruited. Nineteen TM were matched to 19 CM and 42 CF on pubertal stage and body mass index (BMI). Eleven TF were matched to 23 CF and 13 TF to 24 CM on age and BMI.Main Outcome Measure(s)1/[fasting insulin] and body composition (dual-energy absorptiometry, DXA).ResultsTotal body fat was lower in TM than CF (29±7 vs. 33±7%, p=0.002) and higher than CM (28±7 vs. 24±9%, p=0.047). TM had higher lean mass than CF (68±7 vs. 64±7%, p=0.002) and lower than CM (69± vs. 73±8%, p=0.029). Insulin sensitivity was not different between the groups.TF had lower body fat than CF (31±7 vs. 35±8%, p=0.033) and higher than CM (28±6 vs. 20±10, p=0.001). TF had higher lean mass than CF (66±6 vs. 62±7%, p=0.032) and lower than CM (69±5 vs. 77±9%, p=0.001). TF were more insulin resistant than CM (0.078±0.025 vs. 0.142±0.064, p=0.011).ConclusionsTransgender adolescents on GAHT have significant differences in body composition compared to cisgender controls, with a body composition intermediate between BMI-matched cisgender males and females. These changes in body composition may have consequences for the cardiometabolic health of transgender adolescents.PrecisTransgender youth on gender affirming hormone therapy have differences in their percent fat and lean mass compared to cisgender (non-transgender) youth.

Background and Objectives: Among youth, 0.7% identify as transgender. Markers of cardiometabolic health and body composition in transgender youth undergoing gender-affirming hormone therapy have not been rigorously studied. Our objectives were to evaluate differences in body composition, insulin sensitivity, lipid profile, and aspartate and alanine aminotransferases (AST, ALT) in male-to-female (MTF) youth treated with estradiol (E2) compared to non-transgender female (FC) and male controls (MC). Methods: Fourteen MTF E2-treated (mean + SD E2 dose 1.5 + 1.0 mg/day, duration 1 + 0.8 years) participants (aged 14.5-19.4 years) were compared to BMI percentile-category-matched and age-matched (within 1 year) FC (n=23, aged 14.2-18.3) and MC (n=24, aged 14.5-19.8). Three MTF participants were also on a gonadotropin releasing-hormone analogue (GnRHa) for suppression of endogenous testicular function. Participants had fasted morning laboratory testing and body composition measured by dual-energy X-ray absorptiometry (DXA). Differences (mean + SD) in body composition, insulin sensitivity (estimated from 1/[fasting insulin]), lipids, leptin, AST, ALT and blood pressure (BP) were evaluated using a mixed linear regression model with a random effect for the matched set. A spearman correlation was performed to evaluate for a correlation between 1/[fasting insulin] and % lean mass. Results: MTF vs. FC: Total testosterone was higher in MTF vs. FC (224 + 182 vs. 43 + 10 ng/dL, respectively, p

Importance Pediatric transplant recipients are at risk for vaccine-preventable infections owing to immunosuppression, suboptimal response to vaccines before and after transplant, and potential underimmunization if transplant occurred early in life. However, the incidence and burden of illness from vaccine-preventable infections in this population is unknown. Objectives To evaluate in pediatric solid organ transplant recipients the number of hospitalizations for vaccine-preventable infections in the first 5 years after transplant and to determine the associated morbidity, mortality, and costs. Design, Setting, and Participants A retrospective cohort study from January 1, 2004, to December 31, 2011, with 5 years of follow-up per participant (unless they died during the study period). The participants of this multicenter study through the Pediatric Health Information System were solid organ transplant recipients who were younger than 18 years at the time of transplant. Analysis began in July 2017. Exposures Transplant. Main Outcomes and Measures Hospitalizations for a vaccine-preventable infection during the first 5 years after transplant were ascertained usingInternational Classification of Diseases, Ninth Revision, andInternational Statistical Classification of Diseases and Related Health Problems, Tenth Revision, clinical modification diagnosis codes. Data were collected on clinical care, outcomes, and costs during these hospitalizations. Results Of 6980 transplant recipients identified, there were 3819 boys (54.7%), and the mean (SD) age at transplant was 8 (6.2) years. Overall, 1092 patients (15.6%) had a total of 1471 cases of vaccine-preventable infections. There were 187 of 1471 cases (12.7%) that occurred during transplant hospitalization. The case fatality rate was 1.7% for all infections. Excluding infections that occurred during transplant hospitalization (when all patients go to the intensive care unit), 213 of 1257 patients (17.0%) were hospitalized with a vaccine-preventable infection requiring intensive care. In multivariable analysis, age younger than 2 years at time of transplant and receipt of a lung, heart, intestine, or multivisceral organ were positively associated with increased risk of a hospitalization from a vaccine-preventable infection.Transplant hospitalizations complicated by vaccine-preventable infections were $120 498 more expensive (median cost) than transplant hospitalizations not complicated by vaccine-preventable infections. Conclusions and Relevance Hospitalization for vaccine-preventable infections occurred in more than 15% of solid organ transplant recipients in the first 5 years after transplant at a rate of up to 87 times higher than in the general population. There was significant morbidity, mortality, and costs from these infections, demonstrating the importance of immunizing all transplant candidates and recipients. Further research on improving immunization delivery, preventing nosocomial infections, and monitoring response to vaccines in the transplant population is needed.

CDKL5 Deficiency Disorder: Relationship Between Genotype, Epilepsy, Cortical Visual Impairment, and Development Demarest ST, Olson HE, Moss A, et al. Epilepsia. 2019;60(8):1733-1742. doi:10.1111/epi.16285. Epub 2019 Jul 16. PMID: 31313283Objective:The cyclin-dependent kinase-like 5 (CDKL5) gene is a known cause of early-onset developmental and epileptic encephalopathy, also known as CDKL5 deficiency disorder (CDD). We sought to (1) provide a description of seizure types in patients with CDD, (2) provide an assessment of the frequency of seizure-free periods and cortical visual impairment, (3) correlate these features with genotype and gender, and (4) correlate these features with developmental milestones.Methods:This is a cohort study of patients with CDD. Phenotypic features were explored and correlated with gene variant grouping and gender. A developmental score was created based on achieving 7 primary milestones. Phenotypic variables were correlated with the developmental score to explore markers of better developmental outcomes. Multivariate linear regression was used to account for age at last visit.Results:Ninety-two patients with CDD were seen during the enrollment period. Eighteen (19%) were male; median age at the last visit was 5 years (interquartile range: 2.0-11.0). Eighty-one percent of patients developed epileptic spasms, but only 47% of those also had hypsarrhythmia. Previously described hypermotor-tonic-spasms sequence was seen in only 24% of patients, but 56% of patients had seizures with multiple phases (often tonic and spasms). Forty-three percent of patients experienced a seizure-free period ranging from 1 to >12 months, but only 6% were still seizure-free at the last visit. Cortical visual impairment was present in 75% of all CDD patients. None of these features was associated with genotype group or gender. Cortical visual impairment was correlated with reduced milestone achievement after adjusting for age at the last visit and a history of hypsarrhythmia.Significance:The most common seizure types in CDD are epileptic spasms (often without hypsarrhythmia) and tonic seizures that may cluster together. Cortical visual impairment is a common feature in CDD and is correlated with achieving fewer milestones.

OBJECTIVE To develop parsimonious prediction models for postoperative mortality, overall morbidity, and 6 complication clusters applicable to a broad range of surgical operations in adult patients. SUMMARY BACKGROUND DATA Quantitative risk assessment tools are not routinely used for preoperative patient assessment, shared decision making, informed consent, and preoperative patient optimization, likely due in part to the burden of data collection and the complexity of incorporation into routine surgical practice. METHODS Multivariable forward selection stepwise logistic regression analyses were used to develop predictive models for 30-day mortality, overall morbidity, and 6 postoperative complication clusters, using 40 preoperative variables from 2,275,240 surgical cases in the American College of Surgeons National Surgical Quality Improvement Program data set, 2005 to 2012. For the mortality and overall morbidity outcomes, prediction models were compared with and without preoperative laboratory variables, and generic models (based on all of the data from 9 surgical specialties) were compared with specialty-specific models. In each model, the cumulative c-index was used to examine the contribution of each added predictor variable. C-indexes, Hosmer-Lemeshow analyses, and Brier scores were used to compare discrimination and calibration between models. RESULTS For the mortality and overall morbidity outcomes, the prediction models without the preoperative laboratory variables performed as well as the models with the laboratory variables, and the generic models performed as well as the specialty-specific models. The c-indexes were 0.938 for mortality, 0.810 for overall morbidity, and for the 6 complication clusters ranged from 0.757 for infectious to 0.897 for pulmonary complications. Across the 8 prediction models, the first 7 to 11 variables entered accounted for at least 99% of the c-index of the full model (using up to 28 nonlaboratory predictor variables). CONCLUSIONS Our results suggest that it will be possible to develop parsimonious models to predict 8 important postoperative outcomes for a broad surgical population, without the need for surgeon specialty-specific models or inclusion of laboratory variables.