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Background: Invasive mechanical ventilation contributes to bronchopulmonary dysplasia (BPD), the most common complication of prematurity and the leading respiratory cause of childhood morbidity. Non-invasive ventilation (NIV) may limit invasive ventilation exposure and can be either synchronized or non-synchronized (NS). Pooled data suggest synchronized forms may be superior. Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) delivers NIV synchronized to the neural signal for breathing, which is detected with a specialized catheter. The DIVA (Diaphragmatic Initiated Ventilatory Assist) trial aims to determine in infants born 240/7–276/7 weeks’ gestation undergoing extubation whether NIV-NAVA compared to non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV) reduces the incidence of extubation failure within 5 days of extubation. Methods: This is a prospective, unblinded, pragmatic, multicenter phase III randomized clinical trial. Inclusion criteria are preterm infants 24–276/7 weeks gestational age who were intubated within the first 7 days of life for at least 12 h and are undergoing extubation in the first 28 postnatal days. All sites will enter an initial run-in phase, where all infants are allocated to NIV-NAVA, and an independent technical committee assesses site performance. Subsequently, all enrolled infants are randomized to NIV-NAVA or NS-NIPPV at extubation. The primary outcome is extubation failure within 5 days of extubation, defined as any of the following: (1) rise in FiO2 at least 20% from pre-extubation for > 2 h, (2) pH ≤ 7.20 or pCO2 ≥ 70 mmHg; (3) > 1 apnea requiring positive pressure ventilation (PPV) or ≥ 6 apneas requiring stimulation within 6 h; (4) emergent intubation for cardiovascular instability or surgery. Our sample size of 478 provides 90% power to detect a 15% absolute reduction in the primary outcome. Enrolled infants will be followed for safety and secondary outcomes through 36 weeks’ postmenstrual age, discharge, death, or transfer. Discussion: The DIVA trial is the first large multicenter trial designed to assess the impact of NIV-NAVA on relevant clinical outcomes for preterm infants. The DIVA trial design incorporates input from clinical NAVA experts and includes innovative features, such as a run-in phase, to ensure consistent technical performance across sites. Trial registration: , trial identifier , registered July 6, 2022. [ABSTRACT FROM AUTHOR]

Abstract Importance Objective Design and Setting and Participants Main Outcome Measures Results Conclusions and Relevance Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.To examine cancer clinical trial (CCT) participants’ perceptions of informed consent processes and variations in perceptions by cancer type.Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer (N = 334).Percentages satisfied with consent process and information provided; and assessing participation’s perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did—47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making. [ABSTRACT FROM AUTHOR]

In observational studies, the time origin of interest for time-to-event analysis is often unknown, such as the time of disease onset. Existing approaches to estimating the time origins are commonly built on extrapolating a parametric longitudinal model, which rely on rigid assumptions that can lead to biased inferences. In this paper, we introduce a flexible semiparametric curve registration model. It assumes the longitudinal trajectories follow a flexible common shape function with person-specific disease progression pattern characterized by a random curve registration function, which is further used to model the unknown time origin as a random start time. This random time is used as a link to jointly model the longitudinal and survival data where the unknown time origins are integrated out in the joint likelihood function, which facilitates unbiased and consistent estimation. Since the disease progression pattern naturally predicts time-to-event, we further propose a new functional survival model using the registration function as a predictor of the time-to-event. The asymptotic consistency and semiparametric efficiency of the proposed models are proved. Simulation studies and two real data applications demonstrate the effectiveness of this new approach. for this article are available online. [ABSTRACT FROM AUTHOR]

OBJECTIVES Compare patient characteristics by hospital discharge disposition (home without services, home with home healthcare (HHC) services, or post‐acute care (PAC) facilities). Examine timing and rates of 30‐day healthcare utilization (rehospitalization, emergency department (ED) visit, or observation (OBS) visit) and patient characteristics associated with rehospitalization by discharge location. DESIGN Retrospective analysis of hospital administrative and clinical data. SETTING AND PARTICIPANTS A total of 3,294 older adult inpatients discharged home with or without HHC services or to a PAC facility. MEASUREMENTS Patient‐level sociodemographic and clinical characteristics. Number of and time to occurrences of rehospitalization or ED/OBS visit within 30 days of hospital discharge. RESULTS: Most rehospitalizations and ED/OBS visits occurred within 14 days from hospital discharge. Patients who returned within 24 hours came mostly from inpatient rehabilitation facilities (IRFs). More intense levels of PAC services were linked with higher rehospitalization risk. However, specific predictors differed by discharge location. Being unemployed, being single, and having more comorbidities were most associated with rehospitalization in those who went home with or without services, whereas patients rehospitalized from IRFs were younger, with less chronic illness burden, but greater and recent functional decline. Those discharged with HHC services had more return ED/OBS visits. CONCLUSIONS: Although sicker patients were referred for more intense levels of PAC services, patients with greater chronic illness burden were still most often rehospitalized. In addition to unique patient differences, rehospitalizations from IRF within 24 hours suggest systems factors are contributory. Most return acute healthcare utilization occurred within 14 days; therefore, interventions should focus on smoothing transitions to all discharge locations. Because predictors of rehospitalization risk differed by discharge disposition, future research is necessary to study approaches aimed at matching patients' care needs with the most suitable PAC services at the right time. J Am Geriatr Soc 68:2279–2287, 2020. [ABSTRACT FROM AUTHOR]

Objective: To study the relationship between cancer patient/research participants' perceptions of communication with their research nurse and doctor and (1) participants' thoughts of dropping out from their cancer clinical trials (CCTs), (2) how informed they felt before and during their clinical trial participation, and (3) trust in their researchers. Methods: We surveyed 110 adult cancer patients who were enrolled in cancer clinical trials by using 15 modified items from the Medical Communication Competence Scale measuring information exchange and relational communication. Retention was measured by two items: ever thought about dropping out (yes/no) and likelihood of remaining enrolled in the clinical trial (5-point Likert item). We asked how well informed about the trial participants felt at enrollment, at the date they filled out the survey, and about changes in the trial. Results: Patient-participants with thoughts of dropping out from their CCTs rated their communication with research doctors lower than those who did not have thoughts of dropping out (4.14 versus 4.46, t = 2.22, p = 0.03). Patient-participants' intention to remain enrolled was correlated with more favorable scores on relational communication (such as contributing to a trusting relationship and showing compassion) with research doctors (r = 0.20, p = 0.04) and nurses (r = 0.25, p = 0.01). Communication with doctors was also associated with how informed patient-participants felt during their clinical trials. Conclusions: Relational communication with research doctors and nurses was significantly related to thoughts about remaining enrolled or dropping out of a clinical trial among adult participants in cancer treatment clinical trials. Practice Implications: Relational communication with cancer patients advances retention in research. [ABSTRACT FROM AUTHOR]

Abstract Objectives Although hospital clinicians strive to effectively refer patients who require post-acute care (PAC), their discharge planning processes often vary greatly, and typically are not evidence-based. Design Quasi-experimental study employing pre-/postdesign. Aimed at improving patient-centered discharge processes, we examined the effects of the Discharge Referral Expert System for Care Transitions (DIRECT) algorithm that provides clinical decision support (CDS) regarding which patients to refer to PAC and to what level of care (home care or facility). Setting and participants Conducted in 2 hospitals, DIRECT data elements were collected in the pre-period (control) but discharging clinicians were blinded to the advice and provided usual discharge care. During the postperiod (intervention), referral advice was provided within 24 hours of admission to clinicians, and updated twice daily. Propensity modeling was used to account for differences between the pre-/post patient cohorts. Measures Outcomes compared between the control and the intervention periods included PAC referral rates, patient characteristics, and same-, 7-, 14-, and 30-day readmissions or emergency department visits. Results Although 24%–25% more patients were recommended for PAC referral by DIRECT algorithm advice, the proportion of patients receiving referrals for PAC did not significantly differ between the control (3302) and intervention (5006) periods. However, the characteristics of patients referred for PAC services differed significantly and inpatient readmission rates decreased significantly across all time intervals when clinicians had DIRECT CDS compared with without. There were no differences observed in return emergency department visits. Largest effects were observed when clinicians agreed with the algorithm to refer (yes/yes). Conclusions/Implications Our findings suggest the value of timely, automated, discharge CDS for clinicians to optimize PAC referral for those most likely to benefit. Although overall referral rates did not change with CDS, the algorithm may have identified those patients most in need, resulting in significantly lower inpatient readmission rates. [ABSTRACT FROM AUTHOR]

Importance: Preterm infants must establish regular respirations at delivery. Sustained inflations may establish lung volume faster than short inflations.Objective: To determine whether a ventilation strategy including sustained inflations, compared with standard intermittent positive pressure ventilation, reduces bronchopulmonary dysplasia (BPD) or death at 36 weeks' postmenstrual age without harm in extremely preterm infants.Design, Setting, and Participants: Unmasked, randomized clinical trial (August 2014 to September 2017, with follow-up to February 15, 2018) conducted in 18 neonatal intensive care units in 9 countries. Preterm infants 23 to 26 weeks' gestational age requiring resuscitation with inadequate respiratory effort or bradycardia were enrolled. Planned enrollment was 600 infants. The trial was stopped after enrolling 426 infants, following a prespecified review of adverse outcomes.Interventions: The experimental intervention was up to 2 sustained inflations at maximal peak pressure of 25 cm H2O for 15 seconds using a T-piece and mask (n = 215); standard resuscitation was intermittent positive pressure ventilation (n = 211).Main Outcome and Measures: The primary outcome was the rate of BPD or death at 36 weeks' postmenstrual age. There were 27 prespecified secondary efficacy outcomes and 7 safety outcomes, including death at less than 48 hours.Results: Among 460 infants randomized (mean [SD] gestational age, 25.30 [0.97] weeks; 50.2% female), 426 infants (92.6%) completed the trial. In the sustained inflation group, 137 infants (63.7%) died or survived with BPD vs 125 infants (59.2%) in the standard resuscitation group (adjusted risk difference [aRD], 4.7% [95% CI, -3.8% to 13.1%]; P = .29). Death at less than 48 hours of age occurred in 16 infants (7.4%) in the sustained inflation group vs 3 infants (1.4%) in the standard resuscitation group (aRD, 5.6% [95% CI, 2.1% to 9.1%]; P = .002). Blinded adjudication detected an imbalance of rates of early death possibly attributable to resuscitation (sustained inflation: 11/16; standard resuscitation: 1/3). Of 27 secondary efficacy outcomes assessed by 36 weeks' postmenstrual age, 26 showed no significant difference between groups.Conclusions and Relevance: Among extremely preterm infants requiring resuscitation at birth, a ventilation strategy involving 2 sustained inflations, compared with standard intermittent positive pressure ventilation, did not reduce the risk of BPD or death at 36 weeks' postmenstrual age. These findings do not support the use of ventilation with sustained inflations among extremely preterm infants, although early termination of the trial limits definitive conclusions.Trial Registration: clinicaltrials.gov Identifier: NCT02139800. [ABSTRACT FROM AUTHOR]

Background: Symptom clusters among adults with atrial fibrillation have previously been identified but no study has examined the relationship between symptom clusters and outcomes. Aims: The purpose of this study was to identify atrial fibrillation-specific symptom clusters, characterize individuals with each cluster, and determine whether symptom cluster membership is associated with healthcare utilization. Methods: This was a cross-sectional secondary data analysis of 1501 adults from the Vanderbilt Atrial Fibrillation Registry with verified atrial fibrillation. Self-reported symptoms were measured with the University of Toronto Atrial Fibrillation Severity Scale. We used hierarchical cluster analysis (Ward's method) to identify clusters and dendrograms, pseudo F, and pseudo T-squared to determine the ideal number of clusters. Next, we used regression analysis to examine the association between cluster membership and healthcare utilization. Results: Males predominated (67%) and the average age was 58.4 years. Two symptom clusters were identified, a Weary cluster (3.7%, n=56, fatigue at rest, shortness of breath at rest, chest pain, and dizziness) and an Exertional cluster (32.7%, n=491, shortness of breath with activity and exercise intolerance). Several sociodemographic and clinical characteristics varied by symptom cluster group membership, including age, gender, atrial fibrillation type, body mass index, comorbidity status, and treatment strategy. Women were more likely to experience either cluster (p<0.001). The Weary cluster was associated with nearly triple the rate of emergency department utilization (incident rate ratio [IRR] 2.8, p<0.001) and twice the rate of hospitalizations (IRR 1.9, p<0.001). Conclusion: We identified two symptom clusters. The Weary cluster was associated with a significantly increased rate of healthcare utilization. [ABSTRACT FROM AUTHOR]

Abstract: Background: Symptoms drive healthcare use among adults with atrial fibrillation, but limited data are available regarding which symptoms are most problematic and which patients are most at‐risk. The purpose of this study was to: (1) identify clusters of patients with similar symptom profiles, (2) characterize the individuals within each cluster, and (3) determine whether specific symptom profiles are associated with healthcare utilization. Methods: We conducted a cross‐sectional secondary data analysis of 1,501 adults from the Vanderbilt Atrial Fibrillation Registry. Participants were recruited from Vanderbilt cardiology clinics, emergency department, and in‐patient services. Subjects included in our analysis had clinically verified atrial fibrillation and a completed symptom survey. Symptom and healthcare utilization data were collected with the University of Toronto Atrial Fibrillation Severity Scale. Latent class regression analysis was used to identify symptom clusters, with clinical and demographic variables included as covariates. We used Poisson regression to examine the association between latent class membership and healthcare utilization. Results: Participants were predominantly male (67%) with a mean age of 58.4 years (±11.9). Four latent classes were evident, including an Asymptomatic cluster (N = 487, 38%), Highly Symptomatic cluster (N = 142, 11%), With Activity cluster (N = 326, 25%), and Mild Diffuse cluster (N = 336, 26%). Highly Symptomatic membership was associated with the greatest rate of emergency department visits and hospitalizations (incident rate ratio 2.4, P < 0.001). Conclusions: Clinically meaningful atrial fibrillation symptom profiles were identified that were associated with increased rates of emergency department visits and hospitalizations. [ABSTRACT FROM AUTHOR]

Clinical endpoints measured in terms of duration, such as intensive care unit (ICU) length of stay (LOS), are widely used in randomized clinical trials (RCTs) and observational research. In analyses of patient-level data from a recent RCT, in which ICU LOS was the primary endpoint, and in administrative data, we showed that additional ICU time is often accrued by patients after they are deemed ready for discharge. This "immutable" time (which cannot plausibly be altered by interventions under study) varies by day, week, and year, adding on average one-third of a day to total LOS. We then used statistical simulations, informed by the administrative data and RCT, to assess the impact of immutable time on the measurement and statistical comparison of patients' ICU LOS. These simulations demonstrated that immutable time combines with clinically necessary ICU time (neither of which is likely to be normally distributed) to produce overall LOS distributions that might either mask true treatment effects or suggest false treatment effects relative to analyses of time to discharge readiness. The extent and direction of bias were complex functions of the statistical method used, mortality rates and distributions, and the magnitude of immutable time relative to intervention-associated reductions in LOS. [ABSTRACT FROM AUTHOR]

Background:The purpose of this article is to examine the extent to which cancer clinical trial participants assess the benefits and risks of research participation before enrollment.Methods:One hundred and ten oncology research participants enrolled in cancer clinical research in a large Northeastern cancer center responded to a self-administered questionnaire on perceptions about cancer clinical trials.Results:Of the participants, 51.6% reported they did not directly assess the benefits or risks. Educational level, age, employment, treatment options, insurance, and spiritual–religious beliefs were significantly associated with whether participants assessed risk and benefits. Those who felt well informed were more likely to have assessed the benefits and risks at enrollment than those who did not feel well informed (odds ratio [OR] = 3.92,p= .014); of those who did not assess the risks and benefits, 21% did not feel well informed at enrollment (p= .001). Those who agreed that the clinical trial helped pay the costs of the care had nearly three times the odds of not assessing risks and benefits compared to those who disagreed.Conclusion:Our findings have important implications for understanding the role of assessing risks and benefits in the research participation decisions of patients with cancer and call for further understanding of why participants are not assessing information believed to be essential for autonomous informed decisions. [ABSTRACT FROM PUBLISHER]

We extend a random pattern mixture joint model for longitudinal ordinal outcomes and informative dropouts. The patients are generalized to 'pattern' groups based on known covariates that are potentially surrogated for the severity of the underlying condition. The random pattern effects are defined as the latent effects linking the dropout process and the ordinal longitudinal outcome. Conditional on the random pattern effects, the longitudinal outcome and the dropout times are assumed independent. Estimates are obtained via the Expectation-maximization algorithm. We applied the model to the end-stage renal disease data. Anemia was found to be significantly affected by the baseline iron treatment when the dropout information was adjusted via the study model; as opposed to an independent or shared parameter model. Simulations were performed to evaluate the performance of the random pattern mixture model under various assumptions. Copyright © 2015 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: ICU readmissions are associated with increased mortality and costs; however, it is unclear whether these outcomes are caused by readmissions or by residual confounding by illness severity. An assessment of temporal changes in ICU readmission in response to a specific policy change could help disentangle these possibilities. We sought to determine whether ICU readmission rates changed after 2003 Accreditation Council for Graduate Medical Education Resident Duty Hours reform ("reform") and whether there were temporally corresponding changes in other ICU outcomes.Methods: We used a difference-in-differences approach using Project IMPACT (Improved Methods of Patient Information Access of Core Clinical Tasks). Piecewise regression models estimated changes in outcomes immediately before and after reform in 274,491 critically ill medical and surgical patients in 151 community and academic US ICUs. Outcome measures included ICU readmission, ICU mortality, and in-hospital post-ICU-discharge mortality.Results: In ICUs with residents, ICU readmissions increased before reform (OR, 1.5; 95% CI, 1.22-1.84; P < .01), and decreased after (OR, 0.85; 95% CI, 0.73-0.98; P = .03). This abrupt decline in ICU readmissions after reform differed significantly from an increase in readmissions observed in ICUs without residents at this time (difference-in-differences P < .01). No comparable changes in mortality were observed between ICUs with vs without residents.Conclusions: The changes in ICU readmission rates after reform, without corresponding changes in mortality, suggest that ICU readmissions are not causally related to other untoward patient outcomes. Instead, ICU readmission rates likely reflect operational aspects of care that are not patient-centered, making them less useful indicators of ICU quality. [ABSTRACT FROM AUTHOR]

The article discusses research on the changes in intensive care unit (ICU) readmission rates after the Accreditation Council for Graduate Medical Education (ACGME) Resident Duty Hours reform in 2003. Topics covered include the drop in the odds of postdischarge death, the inverse correlation between ICU readmissions and mortality after reform, and the voluntary participation of ICU in Project Improved Methods of Patient Information Access of Core Clinical Tasks (IMPACT).

Branching curves are a technique for modeling curves that change trajectory at a change (branching) point. Currently, the estimation framework is limited to independent data, and smoothing splines are used for estimation. This article aims to extend the branching curve framework to the longitudinal data setting where the branching point varies by subject. If the branching point is modeled as a random effect, then the longitudinal branching curve framework is a semiparametric nonlinear mixed effects model. Given existing issues with using random effects within a smoothing spline, we express the model as a B-spline based semiparametric nonlinear mixed effects model. Simple, clever smoothness constraints are enforced on the B-splines at the change point. The method is applied to Women's Health data where we model the shape of the labor curve (cervical dilation measured longitudinally) before and after treatment with oxytocin (a labor stimulant). Copyright © 2014 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The article discusses a study that determined the implications of varying decisions in forgoing therapies for sustaining life among intensive care unit (ICU) patients in the U.S. Reviewed were data of patients in 153 ICUs and the decisions to forgo life-sustaining therapy (DFLSTs) from 2001-2009. Results showed that factors affecting higher chances for DFLSTs among ICU patients in the U.S. include female sex, advanced age, white race and poor functional status.

Objective: Good quality indicators should have face validity, relevance to patients, and be able to be measured reliably. Beyond these general requirements, good quality indicators should also have certain statistical properties, including sufficient variability to identify poor performers, relative insensitivity to severity adjustment, and the ability to capture what providers do rather than patients' characteristics. We assessed the performance of candidate indicators of ICU quality on these criteria. Indicators included ICU readmission, mortality, several length of stay outcomes, and the processes of venous-thromboembolism and stress ulcer prophylaxis provision. Design: Retrospective cohort study Setting: One hundred thirty-eight U.S. ICUs from 2001-2008 in the Project IMPACT database. Patients: Two hundred sixty-eight thousand eight hundred twenty-four patients discharged from U.S. ICUs. Interventions: None. Measurements and Main Results: We assessed indicators' (1) variability across ICU-years; (2) degree of influence by patient vs. ICU and hospital characteristics using the Omega statistic; (3) sensitivity to severity adjustment by comparing the area under the receiver operating characteristic curve (AUC) between models including vs. excluding patient variables, and (4) correlation between risk adjusted quality indicators using a Spearman correlation. Large ranges of among-ICU variability were noted for all quality indicators, particularly for prolonged length of stay (4.7-71.3%) and the proportion of patients discharged home (30.6-82.0%), and ICU and hospital characteristics outweighed patient characteristics for stress ulcer prophylaxis (co, 0.43; 95% Cl, 0.34-0.54), venous thromboembolism prophylaxis (co, 0.57; 95% Cl, 0.53-0.61), and ICU readmissions (co, 0.69; 95% Cl, 0.52-0.90). Mortality measures were the most sensitive to severity adjustment (area under the receiver operating characteristic curve % difference, 29.6%); process measures were the least sensitive (area under the receiver operating characteristic curve % differences: venous thromboembolism prophylaxis, 3.4%; stress ulcer prophylaxis, 2.1%). None of the 10 indicators was clearly and consistently correlated with a majority of the other nine indicators. Conclusions: No indicator performed optimally across assessments. Future research should seek to define and operationalize quality in a way that is relevant to both patients and providers. [ABSTRACT FROM AUTHOR]

Background: Women undergoing abortion do psychologically well long-term. Little data, however, describe how women fare in the immediate 1-3 day post-abortion period, when interventions may be most impactful for those who need them. Methods: We conducted a cohort study of patients undergoing first and second trimester surgical abortion and scored self-reported responses regarding psychological well-being before and after abortion, plus anticipated post-procedural psychological coping. Results: Sixty-two of 148 patients had complete questionnaires. Average predicted psychological scores were 9.7% better than pre-procedural psychological states. Actual psychological coping scores improved by 38% over women's predictions. Women who scored poorly on pre-procedural psychological assessments were more likely to have post-procedural psychosocial concerns ( p=0.0376, r=0.2761). Conclusion: While most women approach their abortion with optimism, they actually fare even better psychologically than they predict they will during the 1-3 days following procedures. Poor scores on pre-procedural psychological assessments can identify women in need of additional support in the immediate post-abortion period. [ABSTRACT FROM AUTHOR]

Background Population-based ( PB) registries of type 1 diabetes mellitus ( T1DM) in children have been essential in determining the geographic, racial, and temporal patterns of the disease. There is a paucity of PB data on the prevalence of type 1 and type 2 diabetes ( T2DM) in youth. Methods The prevalence of diabetes in children was determined using a PB survey of the 628 schools in Philadelphia. Data obtained included type of diabetes, date of birth, race, gender, date of diagnosis, diabetes treatment, and most recent height and weight. Results The survey was completed by nurses at 510 schools (81% of schools) representing 252,896 children (70% of children in Philadelphia). Prevalence (per 1000) was computed. The survey identified 492 cases (355 T1DM, 88 T2DM, 49 type unknown). The overall prevalence of T1DM was 1.58 (0.73 White, 0.56 African American, 0.50 Hispanic); of T2DM was 0.35 (0.03 White, 0.28 African American, 0.05 Hispanic). Mean age at diagnosis was 8.6 and 11.9 years for T1DM and T2DM, respectively. The prevalence of T1DM was higher in boys- T2DM was higher in girls. Of children with T2DM, 25% were treated with insulin. BMI was ≥95th percentile in 20% of children weighed (10% of T1DM, 57% of T2DM). Conclusions Although the Philadelphia Pediatric Diabetes Registry is the longest ongoing US registry of its kind, these are the first PB diabetes prevalence data of children in Philadelphia. PB studies in schools are able to capture children with diabetes who are diagnosed and treated in a variety of settings. [ABSTRACT FROM AUTHOR]

Objective: To assess whether women with polycystic ovary syndrome (PCOS) follow the same age-related decline in IVF outcomes as women with tubal factor infertility over the reproductive life span. PCOS is characterized by increased ovarian reserve as assessed by antral follicle counts and anti-Miillerian hormone levels. It is unclear whether these surrogate markers of ovarian reserve reflect a true lengthening of the reproductive window. Design: Retrospective cohort. Setting: Not applicable. Patient(s): Women with PCOS and tubal factor infertility (42,286 cycles). Intervention(s): IVF. Main Outcome Measure(s): Pregnancy and live-birth rates. Result(s): The mean number of oocytes retrieved was higher in women with PCOS compared with in women with tubal factor (16.4 vs. 12.8; odds ratio [OR], 1.27; 95% confidence interval [CI], 1.25-1.29). The clinical pregnancy (42.5% vs. 35.8%; OR, 1.32; 95% CI, 1.27-1.38) and live-birth rates were also increased in women with PCOS (34.8% vs. 29.1o/0; OR, 1.30; 95% CI, 1.24-1.35). A similar rate of decline in clinical pregnancy and live-birth rates was noted in both groups (20-44 years). The implantation, clinical pregnancy, miscarriage, and live-birth rates were not significantly different for each year after age 40 in the two groups. Conclusion(s): Despite a higher oocyte yield in all age groups, women with PCOS over age 40 had similar clinical pregnancy and live-birth rates compared with women with tubal factor infertility. These findings suggest that the reproductive window may not be extended in PCOS and that patients with infertility should be treated in a timely manner despite indicators of high ovarian reserve. [ABSTRACT FROM AUTHOR]

Aims To determine how excessive daytime sleepiness (EDS) and impaired cognition contribute to health-related quality of life (HRQL) in heart failure (HF). Methods and results Adults with chronic HF were enrolled into a prospective cohort study. Data were obtained from 280 subjects enrolled from three sites in the northeastern USA; 242 completed the 6-month study. At baseline, cohorts with and without EDS were identified using the Epworth Sleepiness Scale. Each EDS group was further subdivided into those with and without impaired cognition using a battery of five neuropsychological tests. Two disease-specific measures, the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Functional Outcomes of Sleep Questionnaire (FOSQ), were used to measure HRQL. General linear modelling of square-transformed variables was used to test the hypothesis that cohort membership was a significant predictor of HRQL. At 6 months the remaining sample was 62.5 [standard deviation (SD) 12] years old, mostly male (63%), white (65%), and functionally compromised [72% New York Heart Association (NYHA) class III/IV]. The cohort with both EDS and impaired cognition had the lowest KCCQ overall summary score (60.5 ± 22.5) compared with the cohort without EDS or impaired cognition (74.6 ± 17.4, P ≤ 0.001). A similar effect was seen on the FOSQ (16.0 ± 2.8 vs. 18.5 ± 2.2, P < 0.001). Conclusion Impaired cognition alone did not explain poor HRQL, but the addition of EDS poses a significant risk for poor HRQL. Interventions designed to influence EDS may improve HRQL in this population. [ABSTRACT FROM AUTHOR]

The article discusses the results of a study that examines the association of extended embryo culture with preterm and very preterm deliveries, low birth weight or combination in neonates conceived through in vitro fertilization (IVF). The study showed increased risk for preterm delivery of singleton IVF births conceived after blastocyst transfer as compared with cleavage-stage transfer. It concludes that blastocyst transfer contributes to the perinatal morbidity associated with IVF conception.

The article discusses a study on the link between ovarian stimulation and risk of low birth weight in neonates born after in vitro fertilization (IVF). The study used the Society for Assisted Reproductive Technologies database to determine IVF-conceived neonates in the U.S. Neonates born after fresh embryo transfer had higher rates of low birth weight than those born after frozen embryo transfer. Neonates born after oocyte donation showed no difference in low birth weight for both IVF methods.

Little is known about intimate partner violence (IPV) and depression among low income, urban African American and Hispanic adolescent females. Interviews with 102 urban African American and Hispanic adolescent females examined physical abuse, emotional/verbal abuse, and threats, and their unique and combined associations with depression. One-quarter of the sample experienced all three types of abuse. Non-physical forms of IPV were significantly associated with depression. Some urban adolescent females from lower income households experience high rates of IPV. Physical and non-physical forms of IPV are important in understanding and responding to depression in this population. [ABSTRACT FROM AUTHOR]

Objective: To study the association of perinatal outcome and IVF transfer type in a group of infertility patients with standardized treatment and similar prognosis.Design: Retrospective cohort study.Setting: University-based infertility center, January 1998 to June 2006.Patient(s): Two hundred eighteen IVF pregnancies after fresh embryo transfer (ET); 122 IVF pregnancies after frozen ET.Intervention(s): Assessment of perinatal outcome in fresh versus frozen ET pregnancies.Main Outcome Measure(s): Pregnancy outcomes after fresh versus frozen embryo transfer (ET). Primary outcome was a composite of three events: preterm delivery, intrauterine growth restriction, or low birth weight. Secondary outcomes were subtypes of pregnancy loss. Associations were assessed using multivariate logistic regression.Result(s): The final sample included 340 pregnancies: 218 fresh and 122 frozen ETs. Singleton pregnancy was less likely after transfer of fresh embryos (odds ratio [OR] 0.39, 95% confidence interval [CI] 0.23-0.67), and pregnancies after fresh ET were more likely to end in first-trimester loss (OR 1.82, 95% CI 1.05-3.13). Composite adverse outcome after transfer of fresh (44.0%) versus frozen (32.6%) embryos was higher (OR 1.52, 95% CI 0.90-2.56) and was strongly associated with twin gestation (OR 23.82, 95% CI 11.16-50.82).Conclusion(s): Perinatal morbidity is higher in IVF pregnancies conceived after a fresh ET compared with a frozen ET. Although some differences are related to conception with twin gestations, these findings suggest that adverse outcomes may be related to differences in IVF procedures. [ABSTRACT FROM AUTHOR]

Abstract: Background: The study was conducted to test the feasibility of conducting a randomized controlled contraceptive trial in postpartum teens and to assess whether postpartum advanced supply of emergency contraception (EC) to teenaged mothers helps to prevent repeat pregnancies of close proximity. Study Design: We performed a randomized controlled trial of 50 postpartum teens at an urban academic medical center. Participants in the intervention arm received routine postpartum contraceptive care and advanced supply of one pack of EC pills with unlimited supply thereafter upon request. The routine care arm (RCA) received routine postpartum contraceptive care. We asked open-ended questions about how we might maximize study retention and implemented the participants'' requests in both arms. Results: Our retention rate was 78%. There were three (13%) pregnancies out of 23 participants in the intervention arm and eight (30%) pregnancies out of 27 participants in the RCA. The risk of pregnancy occurring in the intervention arm was 0.57 times that of the RCA (95% CI 0.20–1.60; p=.23). Conclusions: A randomized controlled trial of postpartum teens to receive and not to receive advanced supply of EC is both feasible and necessary. Our study provides preliminary data to suggest that advanced supply of EC may help decrease repeat teen pregnancies. [Copyright &y& Elsevier]

Objective • To compare the effects of 800 mg of valerian with a placebo on sleep quality and symptom severity in people with restless legs syndrome (RLS). Methods • A prospective, triple-blinded, randomized, placebo-controlled, parallel design was used to compare the efficacy of valerian with placebo on sleep quality and symptom severity in patients with RLS. Thirty-seven participants were randomly assigned to receive 800 mg of valerian or placebo for 8 weeks. The primary outcome of sleep was sleep quality with secondary outcomes including sleepiness and RLS symptom severity. Results • Data were collected at baseline and 8 weeks comparing use of valerian and placebo on sleep disturbances (Pittsburgh Sleep Quality index and Epworth Sleepiness Scale) and severity of RLS symptoms (International RLS Symptom Severity Scale) from 37 participants aged 36 to 65 years. Both groups reported improvement in RLS symptom severity and sleep. In a nested analysis comparing sleepy vs nonsleepy participants who received 800 mg of valerian (n=17), significant differences before and after treatment were found in sleepiness (P=.01) and RLS symptoms (P=.02). A strong positive association between changes in sleepiness and RLS symptom severity was found (P=.006). Conclusions • The results of this study suggest that the use of 800 mg of valerian for 8 weeks improves symptoms of RLS and decreases daytime sleepiness in patients that report an Epworth Sleepiness Scale (ESS) score of 10 or greater. Valerian may be an alternative treatment for the symptom management of RLS with positive health outcomes and improved quality of life. [ABSTRACT FROM AUTHOR]

This study examined the association between sexual relationship power, intimate partner violence, and condom use among African American and Hispanic urban girls. In this sample of 56 sexually active girls, 50% did not use condoms consistently and therefore were at higher risk for acquiring HIV or sexually transmitted diseases (STDs). Teens who experienced more intimate partner violence had a significantly higher likelihood of inconsistent condom use and therefore a greater risk for HIV/STDs. Girls' sense of sexual control in their relationships was not directly associated with inconsistent condom use but was inversely related to verbal and emotional abuse. Interventions aimed at reducing HIV/STD risk for adolescent girls need to address patterns of dominance and control in adolescent relationships as well as multiple forms of partner violence. This suggests the need for multilevel intervention approaches that promote girls' agency and multiple ways to keep girls safe from perpetrators of partner abuse. [ABSTRACT FROM AUTHOR]

Pattern-mixture models are frequently used for longitudinal data analysis with dropouts because they do not require explicit specification of the dropout mechanism. These models stratify the data according to time to dropout and formulate a model for each stratum. This usually results in underindentifiability, because we need to estimate many pattern-specific parameters even though the eventual interest is usually on the marginal parameter. In this article we extend this framework to a random pattern-mixture model, where the pattern-specific parameters are treated as nuisance parameters and modeled as random instead of fixed. The pattern is defined according to a surrogate for the dropout process. A constraint is then put on the pattern by linking it to the time to dropout using a random-effects survival model. We assume, conditional on the latent pattern effects, that the longitudinal outcome and the dropout process are independent. This model retains the robustness of the traditional pattern-mixture models, while avoiding the overparameterization problem. When we define each subject as a separate stratum, this model reduces to the shared parameter model. Maximum likelihood estimates are obtained using an EM Newton-Raphson algorithm. We apply the method to the depression data from the Prevention of Suicide in Primary Care Elderly Collaborative Trial (PROSPECT). We show when the dropout information is adjusted for under the proposed model, the treatment seems to reduce depression in the elderly. [ABSTRACT FROM AUTHOR]

We develop a joint model for the analysis of longitudinal and survival data in the presence of data clustering. We use a mixed effects model for the repeated measures that incorporates both subject- and cluster-level random effects, with subjects nested within clusters. A Cox frailty model is used for the survival model in order to accommodate the clustering. We then link the two responses via the common cluster-level random effects, or frailties. This model allows us to simultaneously evaluate the effect of covariates on the two types of responses, while accounting for both the relationship between the responses and data clustering. The model was motivated by a study of end-stage renal disease patients undergoing hemodialysis, where we wished to evaluate the effect of iron treatment on both the patients' hemoglobin levels and survival times, with the patients clustered by enrollment site. [ABSTRACT FROM AUTHOR]

There has been much debate about the relative merits of mixed effects and population-averaged logistic models. We present a different perspective on this issue by noting that the investigation of the relationship between these models for a given dataset offers a type of sensitivity analysis that may reveal problems with assumptions of the mixed effects and/or population-averaged models for clustered binary response data in general and longitudinal binary outcomes in particular. We present several datasets in which the following violations of assumptions are associated with departures from the expected theoretical relationship between these two models: 1) negative intra-cluster correlations; 2) confounding of the response–covariate relationship by cluster effects; and 3) confounding of autoregressive relationships by the link between baseline outcomes and subject effects. Under each of these conditions, the expected theoretical attenuation of the population-averaged odds ratio relative to the cluster-specific odds ratio does not necessarily occur. In all cases, the naive fitting of a random intercept logistic model appears to lead to bias. In response, the random intercept model is modified to accommodate negative intra-cluster correlations, confounding due to clusters, or baseline correlations with random effects. Comparisons are made with GEE estimation of population-averaged models and conditional likelihood estimation of cluster-specific models. Several examples, including a cross-over trial, a multicentre nonrandomized treatment study, and a longitudinal observational study are used to illustrate these modifications. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented which is concerned with research which investigated falls and head injuries in older patients in assisted living facilities.

Individualized prediction is a hallmark of clinical medicine and decision making. However, most existing prediction models rely on biomarkers and clinical outcomes available at a single time. This is in contrast to how health states progress and how physicians deliver care, which relies on progressively updating a prognosis based on available information. With the use of joint models of longitudinal and survival data, it is possible to dynamically adjust individual predictions regarding patient prognosis. This article aims to introduce the reader to the development of dynamic risk predictions and to provide the necessary resources to support their implementation and assessment, such as adaptable R code, and the theory behind the methodology. Furthermore, measures to assess the predictive performance of the derived predictions and extensions that could improve the predictions are presented. We illustrate personalized predictions using an online dataset consisting of patients with chronic liver disease (primary biliary cirrhosis). [ABSTRACT FROM AUTHOR]

Medicaid expansion's (ME) impact on postoperative outcomes after abdominal surgery remains poorly defined. We aimed to evaluate ME's effect on surgical morbidity, mortality, and readmissions in a state that expanded Medicaid (Virginia) compared to a state that did not (Tennessee) over the same time period. Virginia Surgical Quality Collaborative (VSQC) American College of Surgeons National Surgical Quality Improvement Program data for Medicaid, uninsured, and private insurance patients undergoing abdominal procedures before Virginia's ME (3/22/18-12/31/18) were compared with post-ME (1/1/19-12/31/19), as were corresponding non-ME state Tennessee Surgical Quality Collaborative (TSQC) data for the same 2018 and 2019 time periods. Postexpansion odds ratios for 30-d morbidity, 30-d mortality, and 30-d unplanned readmission were estimated using propensity score-adjusted logistic regression models. In Virginia, 4753 abdominal procedures, 2097 pre-ME were compared to 2656 post-ME. In Tennessee, 5956 procedures, 2484 in 2018 were compared to 3472 in 2019. VSQC's proportion of Medicaid population increased following ME (8.9% versus 18.8%, P < 0.001) while uninsured patients decreased (20.4% versus 6.4%, P < 0.001). Post-ME VSQC had fewer 30-d readmissions (12.2% versus 6.0%, P = 0.013). Post-ME VSQC Medicaid patients had significantly lower probability of morbidity (−8.18, 95% confidence interval: −15.52 ∼ −0.84, P = 0.029) and readmission (−6.92, 95% confidence interval: −12.56 ∼ −1.27, P = 0.016) compared to pre-ME. There were no differences in probability of morbidity or readmission in the TSQC Medicaid population between study periods (both P > 0.05); there were no differences in mortality between study periods in VSQC and TSQC patient populations (both P > 0.05). ME was associated with decreased 30-d morbidity and unplanned readmissions in the VSQC. Data-driven policies accounting for ME benefits should be considered. [ABSTRACT FROM AUTHOR]

Deep sternal wound infection (DSWI) is a rare complication associated with high mortality. Seasonal variability in surgical site infections has been demonstrated, however, these patterns have not been applied to DSWI. The purpose of this study was to assess temporal clustering of DSWIs. All cardiac surgery patients who underwent sternotomy were queried from a regional Society of Thoracic Surgeons database from 17 centers from 2001 to 2019. All patients with the diagnosis of DSWI were then identified. Cluster analysis was performed at varying time intervals (monthly, quarterly, and yearly) at the hospital and regional level. DSWI rates were calculated by year and month, and compared using mixed-effects negative binomial regression. A total of 134,959 patients underwent a sternotomy for cardiac surgery, of whom 469 (0.35%) developed a DSWI. Rates of DSWI per hospital across all years ranged from 0.12% to 0.69%. Collaborative-level rates of DSWIs were the greatest in September (0.44%) and the lowest in January (0.30%). Temporal clustering was not seen across seasonal quarters (high rate in preceeding quarter was not associated with a high rate in the next quarter) (P = 0.39). There were yearly differences across all institutions in the DSWI rates. A downward trend in DSWI rates was seen from 2001 to 2019 (P < 0.001). A difference among hospitals in the cohort was observed (P < 0.001). DSWI are a rare event within our region. Unlike other surgical site infection, there does not appear to be a seasonal pattern associated with DSWI. [ABSTRACT FROM AUTHOR]

A review of the article "Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial" by M.Y. Oncel is presented.

To compare comprehensive continence outcomes in patients receiving pelvic floor muscle training (PFMT) vs standard unsupervised home pelvic floor exercise therapy (UPFE). As part of the UVA prostatectomy functional outcomes program, participating patients complete a 12-month PFMT program under FPMRS specialist supervision. We performed a retrospective review of prospectively collected longitudinal outcomes in patients receiving PFMT vs UPFE through 12-month follow-up. Primary study outcome was ICIQ-MLUTS SUI domain score (SDS). Secondary outcomes included daily pad use (PPD), SUI Cure (SDS = 0), and quality of life score (IIQ-7). Multilevel mixed effects linear regression was used to model SDS over time. Analysis included 40 men. No difference in patient characteristics was seen in comparison of PFMT vs UPFE cohorts (P = NS, all comparisons). Mean predicted SDS was significantly better in the PFMT vs UPFE cohorts at 6-month (0.81 ± 0.21 vs 1.75 ± 0.34, respectively) (P =.014) and 12-month (0.72 ± 0.17 vs 1.67 ± 0.30, respectively) (P =.004) time points. At 12-month follow-up, 11 (55%) vs 4 (20%) patients reported absence of SUI in PFMT vs UPFE cohorts, respectively. Predicted probabilities of SUI cure in PFMT vs UPFE cohorts at 12 months were 0.52 ± 0.14 vs 0.23 ± 0.13, respectively (P =.14). At 12-month follow-up, the mean predicted PPD and IIQ score was 0.19 ± 0.10 vs 0.79 ± 0.33 and 2.86 ± 0.86 vs 2.55 ± 1.07 in PFMT vs UPFE cohorts, respectively (P = NS). In-person, FMPRS-directed PFMT is associated with improved SUI domain scores following robotic-assisted laparoscopic prostatectomy, a finding durable through 12-month follow-up. [ABSTRACT FROM AUTHOR]

We developed measures of benefits and burdens of research participation in cancer clinical trials using a sequential mixed methods design with a qualitative (n = 32) and quantitative sample (n = 110) of cancer clinical trial participants. Benefit–burden items (22 for benefits, 23 for burdens) were subsequently developed and assessed through cognitive interviewing for content, clarity, and meaning. Preliminary psychometric analyses support the internal consistency reliability and construct validity of Benefit (α = .90) and Burden (α = .87) research participation scales. Item response theory models supported the discrimination ability of the items on the scales. Participants who had thoughts of dropping out had lower Benefit scale scores (p < .001) and higher Burden scores (p < .001) than those who had no thoughts of dropping out, supporting construct validity. With further psychometric testing, the scale can be used to develop appropriate interventions to address recruitment and retention of human participants in clinical research. [ABSTRACT FROM AUTHOR]

Abstract: Of 1112 children with type 1 diabetes, dilated eye exams were performed in 717 (64%). Children were less likely to be screened for diabetic retinopathy (DR) if they were black (OR=1.6; p =0.005) or had poorer diabetes control (p =0.002). Those at greatest risk for DR were least likely to be screened. [Copyright &y& Elsevier]

Aim: To evaluate the impact peer counselling has on same-day desire for long-acting, reversible contraception (LARC) among adolescents attending a family planning clinic.Methods: A randomised, controlled trial of 110 adolescent females attending an outpatient clinic for contraception in 2013. Adolescents received either brief peer counselling about LARC with routine contraceptive counselling, or routine counselling alone. Bivariate analyses and multivariable logistic regression assessed the primary outcome of same-day desire for LARC and secondary outcomes of change in knowledge and attitudes regarding LARC.Results: Peer counselling was well received and 70% reported that it was helpful in contraceptive decision-making. Peer counselling did not affect same-day desire for LARC, however, adolescents who received the intervention were more likely to report increased knowledge and positive change in attitudes towards LARC (adjusted odds ratios: 6.6 (95% confidence interval: 2.0-22.0 and 6.4 (1.6-26.8), respectively). Factors positively associated with same-day LARC desire included greater reported peer contraceptive influence, peer use of LARC and social support. Twenty of the 36 adolescents who desired LARC at the end of their clinic visit did not receive one most commonly due to a need to schedule a specific appointment for the procedure and the need to return during a menstrual period for intrauterine device placement.Conclusion: While brief, point-of-care peer counselling is well received, and can increase adolescent knowledge and positive attitude about our most effective contraceptive methods, barriers to same-day LARC placement limit immediate use. [ABSTRACT FROM AUTHOR]

Introduction: Peripheral artery disease and cardiac disease are often comorbid conditions. Echocardiography is a diagnostic tool that can be performed preoperatively to risk stratify patients by a functional cardiac test. We hypothesized that ventricular dysfunction and valvular lesions were associated with an increased incidence of expanded major adverse cardiac events (Expanded MACE). Methods and materials: Retrospective cohort study from 2011 to 2020 including all patients from a major academic center who had vascular surgery and an echocardiographic study within two years of the index procedure. Results: 813 patients were included in the study; a majority had a history of smoking (86%), an ASA score of 3 (65%), and were male (68%). Carotid endarterectomy was the most common surgery (24%) and the least common surgery was open abdominal aortic aneurysm repair (5%). We found no significant association between the echocardiographic findings of left ventricular dysfunction, right ventricular dysfunction, or valvular lesions and the postoperative development of Expanded MACE. Conclusions: The preoperative echocardiographic findings of left ventricular dysfunction, right ventricular dysfunction and moderate to severe valvular lesions were not predictive of an increased incidence of postoperative Expanded MACE. We identified a significant association between RV dysfunction and post-operative dialysis that should be interpreted carefully due to the small number of outcomes. The transition from open to endovascular surgery and advances in perioperative management may have led to improved cardiovascular outcomes. Trial registration: Trial Registration:NCT04836702 (clinicaltrials.gov). https://www.google.com/search?client=firefox-b-d&q=NCT04836702. [ABSTRACT FROM AUTHOR]

Background: Myelodysplastic syndrome (MDS) is a marrow failure disease. As patients often require chronic transfusion, many develop red blood cell (RBC) alloimmunization or immune‐mediated platelet refractoriness. MDS represents a spectrum of diseases with specific categorizations and genetic abnormalities, and we set out to determine if these characteristics predispose patients to antibody formation. Study Design and Methods: A natural language search identified MDS patients with pre‐transfusion testing from 2015 to 2020. Marrow reports, cytogenetic results, and next‐generation sequencing panels were gathered. Transfusion history and testing were collected from the laboratory information system. Results: The group consisted of 226 biopsy‐proven MDS patients. The prevalence of RBC alloimmunization was 11.1% (25 of 226). Half (23 of 46) of all RBC alloantibodies were against Rh (C, c, E, e) and Kell (K) antigens. There was a relative enrichment for JAK2 positivity among the RBC alloimmunized group. A total of 7.1% (16 of 226) of patients had immune‐mediated platelet refractoriness and had increased transfusion requirements (p ≤ 0.01). No disease type or genetic abnormality was significantly associated with alloimmunization or immune‐mediated platelet refractoriness. Discussion: While JAK2 specific mutations were enriched among RBC alloimmunized patients, this association failed to reach statistical significance in our single‐center cohort. Further study using larger patient cohorts is warranted. Overall, this cohort of MDS patients had very similar RBC alloimmunization prevalence and anti‐RBC antibody specificities as other recent literature. Our data reinforce the finding that MDS patients are at greater risk for alloimmunization and support the use of extended phenotype matching for these at‐risk patients. [ABSTRACT FROM AUTHOR]

Supervised exercise is a common therapeutic intervention for patients with peripheral artery disease (PAD), however, the mechanism underlying the improvement in claudication symptomatology is not completely understood. The hypothesis that exercise improves microvascular blood flow is herein tested via temporally resolved magnetic resonance imaging (MRI) measurement of blood flow and oxygenation dynamics during reactive hyperemia in the leg with the lower ankle-brachial index. One hundred and forty-eight subjects with PAD were prospectively assigned to standard medical care or 3 mo of supervised exercise therapy. Before and after the intervention period, subjects performed a graded treadmill walking test, and MRI data were collected with Perfusion, Intravascular Venous Oxygen saturation, and T2* (PIVOT), a method that simultaneously quantifies microvascular perfusion, as well as relative oxygenation changes in skeletal muscle and venous oxygen saturation in a large draining vein. The 3-mo exercise intervention was associated with an improvement in peak walking time (64% greater in those randomized to the exercise group at follow-up, P < 0.001). Significant differences were not observed in the MRI measures between the subjects randomized to exercise therapy versus standard medical care based on an intention-to-treat analysis. However, the peak postischemia perfusion averaged across the leg between baseline and follow-up visits increased by 10% (P = 0.021) in participants that were adherent to the exercise protocol (completed >80% of prescribed exercise visits). In this cohort of adherent exercisers, there was no difference in the time to peak perfusion or oxygenation metrics, suggesting that there was no improvement in microvascular function nor changes in tissue metabolism in response to the 3-mo exercise intervention. [ABSTRACT FROM AUTHOR]