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PURPOSE: Patients with advanced cancer often have unrealistic expectations about prognosis and treatment. This study assessed the effect of an oncology nurse-led primary palliative care intervention on illness expectations among patients with advanced cancer. METHODS: This study is a secondary analysis of a cluster-randomized trial of primary palliative care conducted at 17 oncology clinics. Adult patients with advanced solid tumors for whom the oncologist would not be surprised if died within 1 year were enrolled. Monthly visits were designed to foster realistic illness expectations by eliciting patient concerns and goals for their medical care and empowering patients and families to engage in discussions with oncologists about treatment options and preferences. Baseline and 3-month questionnaires included questions about life expectancy, treatment intent, and terminal illness acknowledgment. Odds of realistic illness expectations at 3 months were adjusted for baseline responses, patient demographic and clinical characteristics, and intervention dose. RESULTS: Among 457 primarily White patients, there was little difference in realistic illness expectations at 3 months between intervention and standard care groups: 12.8% v 11.4% for life expectancy (adjusted odds ratio [aOR] = 1.15; 95% CI, 0.59 to 2.22; P = .684); 24.6% v 33.3% for treatment intent (aOR = 0.76; 95% CI, 0.44 to 1.27; P = .290); 53.6% v 44.7% for terminal illness acknowledgment (aOR = 1.28; 95% CI, 0.81 to 2.00; P = .288). Results did not differ when accounting for variation in clinic sites or intervention dose. CONCLUSION: Illness expectations are difficult to change among patients with advanced cancer. Additional work is needed to identify approaches within oncology practices that foster realistic illness expectations to improve patient decision making.

Background Clinicians often cite a fear of giving up hope as a reason they defer advance care planning (ACP) among patients with advanced cancer. The objective of this study was to determine whether engagement in ACP affects hope in these patients. Methods This was a secondary analysis of a randomized controlled trial of primary palliative care in advanced cancer. Patients who had not completed ACP at baseline were included in the analysis. ACP was assessed in the forms of an end-of-life (EOL) conversation with one's oncologist and completion of a living will or advance directive (AD). Measurements were obtained at baseline and at 3 months. Hope was measured using the Herth Hope Index (HHI) (range, 12-48; higher scores indicate higher hope). Multivariate regression was performed to assess associations between ACP and hope, controlling for baseline HHI score, study randomization, patient age, religious importance, education, marital status, socioeconomic status, time since cancer diagnosis, pain/symptom burden (Edmonton Symptom Assessment System), and anxiety/depression score (Hospital Anxiety and Depression Scale)-all variables known to be associated with ACP and/or hope. Results In total, 672 patients with advanced cancer were enrolled in the overall study. The mean age was 69 ± 10 years, and the most common cancer types were lung cancer (36%), gastrointestinal cancer (20%) and breast/gynecologic cancers (16%). In this group, 378 patients (56%) had not had an EOL conversation at baseline, of whom 111 of 378 (29%) reported having an EOL conversation by 3 months. Hope was not different between patients who did or did not have an EOL conversation over the study period (mean ± standard deviation ∆HHI, 0.20 ± 5.32 vs -0.53 ± 3.80, respectively; P = .136). After multivariable adjustment, hope was significantly increased in patients who had engaged in an EOL conversation (adjusted mean difference in ∆HHI, 0.95; 95% CI, 0.08-1.82; P = .032). Similarly, of 216 patients (32%) without an AD at baseline, 67 (31%) had subsequently completed an AD. Unadjusted hope was not different between those who did and did not complete an AD (∆HHI, 0.20 ± 3.89 vs -0.91 ± 4.50, respectively; P = .085). After adjustment, hope was significantly higher in those who completed an AD (adjusted mean difference in ∆HHI, 1.31; 95% CI, 0.13-2.49; P = .030). Conclusions The current results demonstrate that hope is not decreased after engagement in ACP and indeed may be increased. These findings may provide reassurance to clinicians who are apprehensive about having these important and difficult conversations. Lay summary Many oncologists defer advance care planning (ACP) out of concern for giving up hope. This study demonstrates that hope is not decreased in patients who have engaged in ACP either as a conversation with their oncologists or by completing an advance directive. With this information, providers may feel more comfortable having these important conversations with their patients.

BACKGROUND: Fatigue has a major impact on health‐related quality of life (HR‐QOL) in Parkinson's disease (PD). OBJECTIVES: To determine whether demographic characteristics modify the relationship between fatigue and HR‐QOL. METHODS: Patients with PD in the Fox Insight study completed the Parkinson Fatigue Scale (PFS‐16) and Geriatric Depression Scale (GDS‐15). Linear regression examined the relationship between the PFS‐16 and Parkinson Disease Quality of Life, as modified by age, sex, and GDS‐15. RESULTS: A total of 1029 participants (44% female, mean age 67.4 years, and mean disease duration 4.6 years) were included in this analysis. Multivariable regression modeling demonstrated a negative effect modification for age (β = −0.07, P

Autosomal dominant polycystic kidney disease (ADPKD) is characterized by growth of kidney cysts and glomerular filtration rate (GFR) decline. Metformin was found to impact cystogenesis in preclinical models of polycystic disease, is generally considered safe and may be a promising candidate for clinical investigation in ADPKD. In this phase 2 two-year trial, we randomly assigned 97 patients, 18-60 years of age, with ADPKD and estimated GFR over 50 ml/min/1.73 m2, in a 1:1 ratio to receive metformin or placebo twice daily. Primary outcomes were medication safety and tolerability. Secondary outcomes included estimated GFR decline, and total kidney volume growth. Thirty-eight metformin and 39 placebo participants still received study product at 24-months. Twenty-one participants in the metformin arm reduced drug dose due to inability to tolerate, compared with 14 in the placebo arm (not significant). Proportions of participants experiencing serious adverse events was similar between the groups. The Gastrointestinal Symptoms Rating Scale score was low at baseline and did not significantly change over time. The annual change for estimated GFR was -1.71 with metformin and -3.07 ml/min/1.73m2 per year with placebo (mean difference 1.37 {-0.70, 3.44} ml/min/1.73m2), while mean annual percent change in height-adjusted total kidney volume was 3.87% in metformin and 2.16% per year in placebo, (mean difference 1.68% {-2.11, 5.62}). Thus, metformin in adults with ADPKD was found to be safe and tolerable while slightly reducing estimated GFR decline but not to a significant degree. Hence, evaluation of efficacy requires a larger trial, with sufficient power to detect differences in endpoints.

Background Readmissions following transcatheter aortic valve replacement (TAVR) are common but detailed analysis of cardiac and non-cardiac inpatient readmissions beyond thirty days to different levels of care are limited. Methods Our study population was 1,037 consecutive patients who underwent TAVR between 2011-2017 within a multi-hospital quaternary health system. A retrospective chart review was performed and readmissions were adjudicated and classified based on primary readmission diagnosis (cardiac versus noncardiac) and level of care [intensive care unit (ICU) admission vs. non-ICU admission]. Incidence, causes, and outcomes of readmissions to up to three years post procedure were evaluated. Results Of the 1,017 patients who survived their index hospitalization, there were readmissions due to noncardiac causes in 350 (34.4%) and cardiac causes in 208 (20.5%) during a mean 1.96 years of follow-up. The most common non-cardiac causes of readmission were sepsis/infection (14.3%), gastrointestinal (8.3%), and respiratory (4.8%), whereas heart failure (14.0%) and arrhythmias (4.6%) were the most common cardiac causes of readmission. A total of 191 (18.8%) patients were readmitted to the ICU and 372 patients (36.6%) were non-ICU readmissions. The risk of a noncardiac readmission was highest in the period immediately following TAVR (~4.5% per month) with an early high hazard phase that gradually declined over months. However, the risk of cardiac readmission remained stable at ~1% per month throughout. TAVR patients that were readmitted for any cause had markedly increased mortality; this was especially true for patients readmitted to an ICU. Conclusions In TAVR patients who survived their index hospitalization, non-cardiac readmissions were more prevalent than cardiac. The risk of readmission and subsequent mortality was highest immediately post-procedure and declined thereafter. Readmission to ICU portends the highest risk of subsequent death in this cohort. Patient baseline co-morbidities are an important consideration for TAVR patients and play a significant role in readmissions and outcomes.

ObjectivesFamily caregiver burden among older adults with advanced cancer remains poorly understood. We sought to (1) identify patient factors associated with caregiver burden and (2) examine how amount of time caregiving modifies these relationships.MethodsCross-sectional analysis of baseline data from a cluster-randomized palliative care intervention trial including patients with advanced cancer and their family caregivers, recruited from 17 oncology practices in Pennsylvania. Caregiver burden was measured using Zarit Burden Interview (ZBI-12; range 0-48). Patient factors included functional status (Eastern Cooperative Oncology Group), symptom burden (Edmonton Symptom Assessment Scale), anxiety and depression (Hospital Anxiety and Depression Scale), and quality of life (Functional Assessment of Chronic Illness Therapy - Palliative Care). Using adjusted multivariable regression, we analyzed (1) independent associations between patient factors and caregiver burden and (2) how weekly caregiving hours modified these relationships.ResultsAmong 441 patient-caregiver dyads, mean patient age was 70±10 and caregiver age was 62±13years. Most caregivers (59%) were patients' partners. Caregivers reported 44.5±53.5 average hours spent caregiving weekly; mean ZBI-12 scores were 10.3±7.3. Worse patient functional status (β=4.20, p&nbsp

BACKGROUND: Recent work suggests that dysregulated cellular metabolism may play a key role in the pathogenesis of autosomal dominant polycystic kidney disease (ADPKD). The TAME-PKD clinical trial is testing the safety, tolerability, and efficacy of metformin, a regulator of cell metabolism, in patients with ADPKD. This study investigates the cross-sectional association of urinary metabolic biomarkers with ADPKD severity among TAME-PKD trial participants at baseline. METHODS: Concentrations of total protein, targeted metabolites (lactate, pyruvate, succinate, and cAMP), and key glycolytic enzymes (pyruvate kinase M2 [PKM2], lactate dehydrogenase A [LDHA], and pyruvate dehydrogenase kinase 1 [PDK1]) were measured by ELISA, enzymatic assays, and immunoblotting in baseline urine specimens of 95 TAME-PKD participants. These analytes, normalized by urinary creatinine or osmolality to estimate excretion, were correlated with patients’ baseline height-adjusted total kidney volumes (htTKVs) by MRI and eGFR. Additional analyses were performed, adjusting for participants’ age and sex, using multivariable linear regression. RESULTS: Greater htTKV correlated with lower eGFR (r=−0.39; P=0.0001). Urinary protein excretion modestly correlated with eGFR (negatively) and htTKV (positively). Urinary cAMP normalized to creatinine positively correlated with eGFR. Among glycolytic enzymes, PKM2 and LDHA excretion positively correlated with htTKV, whereas PKM2 excretion negatively correlated with eGFR. These associations remained significant after adjustments for age and sex. Moreover, in adjusted models, succinate excretion was positively associated with eGFR, and protein excretion was more strongly associated with both eGFR and htTKV in patients

OBJECTIVE: Patient–oncologist therapeutic alliance is a foundation of quality cancer care, although there is limited research demonstrating its relationship with patient outcomes. We investigated the relationship between therapeutic alliance and patient quality of life with a secondary goal of determining whether the association varied by patients’ baseline level of psychological distress. METHODS: Cross-sectional analysis of baseline data from a randomized clinical trial of 672 patients with advanced cancer participating in a primary palliative care intervention trial. Patients completed baseline self-reported measures of therapeutic alliance (The Human Connection Scale, range: 16–64), overall quality of life (Functional Assessment of Cancer Therapy—Palliative Care, range: 0–184), and psychological distress (Hospital Anxiety and Depression Scale, range: 0–42). First, we determined the relationship between therapeutic alliance and quality of life using multivariable regression adjusting for confounders. We then examined if psychological distress was an effect modifier in this relationship by adding interaction effects of depression and anxiety symptoms on therapeutic alliance into the regression model. RESULTS: Patients reported high levels of therapeutic alliance (56.4 ± 7.4) and moderate quality of life (130.3 ± 25.5). Stronger therapeutic alliance was associated with better quality of life after adjusting for other confounding factors (β = 3.7, 95% confidence interval = 2.1, 5.3, p < 0.01). The relationship between therapeutic alliance and quality of life was generally consistent regardless of psychological distress. CONCLUSIONS: Collaborative, trusting relationships between patients with advanced cancer and their oncologists are associated with better patient quality of life. Future research should investigate the causal, longitudinal nature of these relationships.

Introduction Caregiver burden is high among caregivers of PD patients (CPD). Neuropsychiatric symptoms are leading contributors to CPD burden, but whether different symptoms differentially impact domains of caregiver burden is not known. Our objective was to examine which neuropsychiatric symptoms and demographic factors contribute to different domains of caregiver burden in PD. Methods This was a cross-sectional online survey study. Participants were recruited from the Fox Insight (FI) study and were eligible if they identified themselves as a CPD. The primary outcome was the Caregiver Burden Inventory (CBI) total score and its 5 sub-domain scores. The Neuropsychiatric Inventory Questionnaire (NPI-Q) assessed caregiver-reported neuropsychiatric symptoms in the care recipient. Multivariable linear regression models were used to characterize the associations between NPI-Q symptom severity scores and CBI scores. Covariates were caregiver age, sex, education, and caregiving duration. Results The sample consisted of 450 CPD, mean age 65.87 (SD 10.39) years, 74% females. After adjusting for covariates, CBI total score was predicted by NPI-Q total score (β = 1.96, p R2 = 39.2%. Anxiety severity had the largest effect size [standardized β (sβ) = 0.224] on the time-dependency domain, which was also associated with female sex (sβ = − 0.133) and age (sβ = 0.088). Severity of disinhibition (sβ = 0.218), agitation (sβ = 0.199), and female sex (sβ = 0.104) were associated with greater emotional burden. Conclusion Our findings indicate that demographic characteristics and specific neuropsychiatric symptoms contribute differentially to domains of caregiver burden. Tailored interventions to support CPD are needed.

PURPOSE: Providers have cited fear of taking away hope from patients as one of the principal reasons for deferring advance care planning (ACP). However, research is lacking on the relationship between ACP and hope. We sought to investigate the potential association between ACP and hope in advanced cancer. METHODS: This is a cross-sectional analysis of baseline data from a primary palliative care intervention trial. All patients had advanced solid cancers. Three domains of ACP were measured using validated questions to assess discussion with oncologists about end-of-life (EOL) planning, selection of a surrogate decision maker, and completion of an advance directive. Hope was measured using the Hearth Hope Index (HHI). Multivariable regression was performed, adjusting for variables associated with hope or ACP. RESULTS: A total of 672 patients were included in this analysis. The mean age was 69.3 ± 10.2 years; 54% were female, and 94% were White. Twenty percent of patients (132 of 661) reported having a discussion about EOL planning, 51% (342 of 668) reported completing an advance directive, and 85% (565 of 666) had chosen a surrogate. There was no difference in hope between patients who had and had not had an EOL discussion (adjusted mean difference in HHI, 0.55; P = .181 for adjusted regression), chosen a surrogate (adjusted HHI difference, 0.31; P = .512), or completed an advance directive (adjusted HHI difference, 0.11; P = .752). CONCLUSION: In this study, hope was equivalent among patients who had or had not completed 3 important domains of ACP. These findings do not support concerns that ACP is associated with decreased hope for patients with advanced cancer.

Background: This analysis describes associations between area deprivation and patient-reported outcomes among patients with advanced cancer. Methods: This is a cross-sectional analysis of baseline data from a multisite primary palliative care intervention trial. Participants were adult patients with advanced cancer. Patient-level area deprivation scores were calculated using the Area Deprivation Index (ADI). Quality of life and symptom burden were measured. Uni- and multivariate regressions estimated associations between area deprivation and outcomes of interest. Results: Among 672 patients, ∼0.5 (54%) were women and most (94%) were Caucasian. Mean age was 69.3±10.2 years. Lung (36%), breast (13%), and colon (10%) were the most common malignancies. Mean ADI was 64.0, scale of 1 (low)–100 (high). In unadjusted univariate analysis, Functional Assessment of Cancer Therapy—Palliative (p=0.002), Edmonton Symptom Assessment Scale (p=0.025) and the Hospital Anxiety and Depression Scale anxiety (p=0.003) and depression (p=0.029) scores were significantly associated with residence in more deprived areas (p=0.003). In multivariate analysis, controlling for patient-level factors, living in more deprived areas was associated with more anxiety (p=0.019). Conclusion: Higher ADI was associated with higher levels of anxiety among patients with advanced cancer. Geographic information could assist clinicians with providing geographically influenced social support strategies.

Objective The aim of the study was to evaluate the performance of nucleic acid amplification testing (NAAT) for the diagnosis of vulvovaginal candidiasis (VVC), bacterial vaginosis, and Trichomonas vaginalis. Methods A cross-sectional analysis of women with (n = 200) and without (n = 100) vulvovaginal symptoms was enrolled from outpatient gynecology offices and a vulvovaginal referral clinic. Vaginal swabs were analyzed by wet mount microscopy, yeast culture, Gram stain, T. vaginalis culture, and NAAT. Sensitivity and specificity analyses were performed. Results Among symptomatic women, the sensitivity of microscopy was 48.5% for VVC and 75% for T. vaginalis. Sensitivities of NAAT and culture for diagnosing VVC were 92.4% and 83.3%, respectively, whereas these methods were 100% and 93.8% for T. vaginalis. The sensitivity for bacterial vaginosis diagnosis by clinical criteria ("Amsel criteria"), Gram stain, and NAAT were 98.7%, 82.7%, and 78.7%, respectively. Test concordance rates were high between culture and NAAT for Candida species (91%) and between Gram stain and NAAT for the detection of bacterial vaginosis (88%). Among asymptomatic women, 20%-21% tested positive for bacterial vaginosis by Gram stain or NAAT, and 8%-13% were colonized with Candida species based on culture or NAAT. Conclusions Given the limitations of wet mount sensitivity for VVC and T. vaginalis, culture or NAAT testing should be considered when evaluating women with symptoms of vaginitis who test negative by microscopy. Although Amsel criteria accurately diagnosed bacterial vaginosis, NAAT is preferred for detection of T. vaginalis and performed similarly to culture for the diagnosis of VVC.

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) has been associated with metabolic disturbances characterized by downregulation of AMP-activated protein kinase (AMPK), a critical sensor of the cellular energy status. Therapeutic activation of AMPK by metformin could inhibit cyst enlargement by inhibition of both the mammalian target of rapamycin pathway and fluid secretion via the CFTR chloride channel. METHODS: We designed a phase-2, randomized, placebo-controlled, clinical trial to assess the safety, tolerability, and efficacy of metformin on total kidney volume in adults without diabetes (age 18–60 years) with ADPKD and eGFR of ≥50 ml/min per 1.73 m(2). There were no eligibility criteria relating to kidney volume. In addition to demographics and clinical/family history, baseline parameters included eGFR, total kidney and liver volumes measured by MRI, and patient-reported outcomes were ascertained by the Medical Outcomes Study Short Form-36, the Gastrointestinal Safety Rating Scale, and the HALT-PKD pain questionnaire. RESULTS: We successfully randomized 97 participants recruited from two university-based clinical sites in Baltimore and Boston. The mean age of participants was 41.9 years, 72% were female, and 94% of participants were White. The majority of study participants had early stage disease, with a mean eGFR of 86.8±19.0 ml/min per 1.73 m(2). Approximately half of the study participants (48%) were classified as high risk for progression (Mayo imaging classes 1C, 1D, or 1E). There was no correlation between kidney and/or liver size and health-related quality of life (HRQoL) or gastrointestinal symptom severity. CONCLUSIONS: We report successful recruitment in this ongoing, novel, clinical trial of metformin in ADPKD, with a study sample comprising patients with early stage disease and nearly a half of participants considered at high estimated risk for progression. Participants reported a low gastrointestinal symptom burden at baseline, and HRQoL similar to that of the general population, with no differences in symptoms or HRQoL related to organomegaly. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease (TAME), NCT02656017

Background: We evaluated subclinical cardiovascular disease in relation to lactation history among women with normotensive pregnancies and women with hypertensive pregnancies, a distinction not previously examined. Materials and Methods: The POUCHmoms study included 678 women from a pregnancy cohort who were followed 7–15 years after delivery. We measured blood pressure, lipid levels, carotid intima-media thickness (CIMT), and lactation duration for each live birth (LB) at follow-up. We categorized lactation as never

Importance Smoking is a key modifiable risk factor in the development and progression of peripheral artery disease, which often manifests as intermittent claudication (IC). Smoking cessation is a first-line therapy for IC, yet a minority of patients quit smoking prior to elective revascularization. Objective To assess if preprocedural smoking is associated with an increased risk of early postprocedural complications following elective open and endovascular revascularization. Design, Setting, and Participants This retrospective cohort study used nearest-neighbor (1:1) propensity score matching of 2011 to 2019 data from the Veterans Affairs Surgical Quality Improvement Program, including all cases with a primary diagnosis of IC and excluding emergent cases, primary procedures that were not lower extremity revascularization, and patients with chronic limb-threatening ischemia within 30 days of the intervention. All data were abstracted June 18, 2020, and analyzed from July 26, 2020, to June 30, 2021. Exposures Preprocedural cigarette smoking. Main Outcomes and Measures Any and organ system-specific (ie, wound, respiratory, thrombosis, kidney, cardiac, sepsis, and neurological) 30-day complications and mortality, overall and in prespecified subgroups. Results Of 14 350 included cases of revascularization, 14 090 patients (98.2%) were male, and the mean (SD) age was 65.7 (7.0) years. A total of 7820 patients (54.5%) were smoking within the preprocedural year. There were a total of 4417 endovascular revascularizations (30.8%), 4319 hybrid revascularizations (30.1%), and 5614 open revascularizations (39.1%). A total of 1594 patients (11.1%) had complications, and 57 (0.4%) died. Among 7710 propensity score-matched cases (including 3855 smokers and 3855 nonsmokers), 484 smokers (12.6%) and 34 nonsmokers (8.9%) experienced complications, an absolute risk difference (ARD) of 3.68% (95% CI, 2.31-5.06; P

Importance Guidelines recommend early specialty palliative care for all patients with advanced cancer, but most patients lack access to such services. Objective To assess the effect of CONNECT (Care Management by Oncology Nurses to Address Supportive Care Needs), a primary palliative care intervention delivered by oncology nurses, on patient outcomes. Design, setting, and participants This cluster randomized clinical trial of the CONNECT intervention vs standard care was conducted from July 25, 2016, to October 6, 2020. Participants were adult patients with metastatic solid tumors who were undergoing oncological care and for whom an oncologist would agree with the statement "would not be surprised if the patient died in the next year." The trial was conducted at 17 community oncology practices in western Pennsylvania. Data analyses adhered to the intention-to-treat principle. Interventions The CONNECT intervention included 3 monthly visits with an existing infusion room nurse who was trained to address symptoms, provide emotional support, engage in advance care planning, and coordinate care. Main outcomes and measures The primary outcome was quality of life. At baseline and 3 months, participants completed assessments of quality of life (Functional Assessment of Chronic Illness Therapy-Palliative care: score range, 0-184, with higher scores indicating better quality of life), symptom burden (Edmonton Symptom Assessment Scale: score range, 0-90, with higher scores indicating greater symptom burden), and mood symptoms (Hospital Anxiety and Depression Scale [HADS]: score range, 0-21, with higher scores indicating substantial anxiety and depression). Linear mixed-effects models were used to estimate adjusted mean differences in 3-month outcomes. Preplanned, intensity-adjusted analyses were conducted. Results A total of 672 patients were enrolled (mean [SD] age, 69.3 [10.2] years; 360 women [53.6%]). The mean (SD) number of CONNECT visits completed was 2.2 (1.0). At 3 months, no difference in mean (SD) quality-of-life score was found between the CONNECT and standard care groups (130.7 [28.2] vs 134.1 [28.1]; adjusted mean difference, 1.20; 95% CI, -2.75 to 5.15; P = .55). Similarly, there was no difference between groups in 3-month mean (SD) symptom burden (23.2 [16.6] vs 24.0 [16.1]; adjusted mean difference, -2.64; 95% CI, -5.85 to 0.58; P = .11) or mood symptoms (HADS depression subscale score: 5.1 [3.4] vs 4.8 [3.7], adjusted mean difference, -0.08 [95% CI, -0.71 to 0.57], P = .82; HADS anxiety subscale score: 5.7 [3.9] vs 5.4 [4.2], adjusted mean difference, -0.31 [95% CI, -0.96 to 0.33], P = .34). Intensity-adjusted analyses revealed a larger estimated treatment effect for patients who received a full dose (3 visits) of the CONNECT intervention. Conclusions and relevance This cluster randomized clinical trial found that a primary palliative care intervention that was delivered by oncology nurses did not improve patient-reported outcomes at 3 months. Primary palliative care interventions with a higher dose intensity may be beneficial for most patients with advanced cancer who lack access to palliative care specialists. Trial registration ClinicalTrials.gov Identifier: NCT02712229.

Author(s): Turgeon, Ricky D; Althouse, Andrew D; Cohen, Jordana B; Enache, Bogdan; Hogenesch, John B; Johansen, Michael E; Mehta, Raj; Meyerowitz-Katz, Gideon; Ziaeian, Boback; Hiremath, Swapnil

Underrepresented minorities have higher attrition from the professoriate and have experienced greater negative impacts of the COVID-19 pandemic. The purpose of this study was to compare the impact of COVID-19 on the lives of 196 early-career physician-scientists versus PhD researchers who are underrepresented in biomedical research. Participants in the Building Up study answered questions on the impact of the COVID-19 pandemic on their personal and professional lives, and a mixed-methods approach was used to conduct the analysis. While most participants experienced increases in overall stress (72% of PhD researchers vs 76% of physician-scientists), physician-scientists reported that increased clinical demands, research delays, and the potential to expose family members to SARS-CoV-2 caused psychological distress, specifically. PhD researchers, more than physician-scientists, reported increased productivity (27% vs 9%), schedule flexibilities (49% vs 25%), and more quality time with friends and family (40% vs 24%). Future studies should consider assessing the effectiveness of programs addressing COVID-19-related challenges experienced by PhD researchers and physician-scientists, particularly those from underrepresented backgrounds.

Background: Patient-reported outcomes in atrial fibrillation (AF) are increasingly used to evaluate treatment efficacy and as endpoints in clinical trials. Few studies have related patient-reported outcomes in AF to clinical events and outcomes. We examined the association between patient-reported outcomes and hospitalization risk in individuals with AF receiving care at a regional healthcare system. Methods and results: We related the AF Effect on QualiTy of Life (AFEQT), a validated measure (range 0–100) with higher scores indicating superior AF-specific patient-reported outcomes, to hospitalization events in a cohort with prevalent AF. We determined incidence rates for hospitalization events (all-cause, cardiac-, or AF-related) across quartiles of AFEQT scores. We used the Andersen-Gill method to account for multiple hospitalization events per individual and compared the risks of hospitalization across AFEQT quartiles in multivariable-adjusted models. In 339 individuals with AF (age 72.3 ± 10.1 years; 43% women) followed for median 2.6 years (range 0–3.4 years), we observed 417 total hospitalization events. We identified increased incidence rates of hospitalization with progressively decreased AFEQT quartile. Relative to those in the highest AFEQT quartile, individuals in the lowest AFEQT quartile had 3-fold greater risk of all-cause hospitalization (95% Confidence Interval [CI] 1.67–6.57, p < 0.001) and 5-fold greater risk of cardiac hospitalization (95% CI 1.66–13.80, p = 0.004). Conclusions: We identified a progressive association between patient-reported outcomes in AF and risk of hospitalization events. Our results underscore the relevance of patient-reported outcomes to clinical adversity and prognosis in AF.

BACKGROUND/OBJECTIVE: Smoking prevalence in patients with chronic pancreatitis [CP] is high. We aimed to understand lifetime history of smoking and cohort trends in CP patients to inform effective strategies for smoking cessation. METHOD: Data on 317 CP patients from the North American Pancreatitis Study 2 [NAPS2] Continuation and Validation Study and the NAPS2 Ancillary Study were analyzed. Smoking history was assessed for each phase of life from the onset of smoking to study enrollment. Data on second-hand smoke and drinking history were also collected. We compared demographic factors, drinking history, pain level and pancreas morphology by smoking status at age 25 (non-smoking

Background: Individuals with atrial fibrillation (AF) experience increased hospitalization. Income and education are major social determinants of health, but their contributions to hospitalization risk in AF have had limited investigation. We examined the associations between (1) annual income and (2) educational attainment with hospitalization in a cohort with prevalent AF. Hypothesis: We hypothesized that individuals with lower income or education would have an increased risk of hospitalization. Methods: In an institutional cohort with prevalent AF, we related annual income (≤$19,000/year; $20,000-49,000/year; $50,000-99,000/year; ≥$100,000/year) and educational attainment (high school/vocational; some college; bachelor's; graduate) to hospitalization events. We used the Anderson-Gill model to accommodate multiple events per participant in models adjusted for relevant covariates and co-adjusted for income or education. Results: In 339 individuals with AF (age 72.3±10.1 years; 43% women) followed for a median of 2.6 years (range 0-3.4), we observed 417 hospitalization events. We observed an increase in hospitalization risk as income or education level decreased ( Figure A and B ). Individuals with the lowest annual income had a 2.5-fold increased hospitalization risk compared to the highest (95% Confidence Interval [CI] 1.29-4.71). Individuals with the lowest education had a 2-fold increased hospitalization risk than those with the highest education (95% CI 0.87-3.11). Conclusion: We identified inverse relations between hospitalization risk in individuals with AF and their income or education. Our findings support the consideration of social factors to reduce hospitalization risk in individuals with AF

Background Patient success with atrial fibrillation (AF) requires adequate health literacy to understand the disease and rationale for treatment. We hypothesized that individuals receiving treatment for AF would have increased knowledge about AF and that such knowledge would be modified by education and income. Methods We enrolled adults with AF receiving anticoagulation at ambulatory clinic sites. Participants responded to survey items encompassing the definitions of AF and stroke, the rationale for anticoagulation, and an estimation of their annual stroke risk. We examined responses in relation to household income and education in multivariable-adjusted models. Results We enrolled 339 individuals (age 72.0 ± 10.1; 43% women) with predominantly lower annual income ($20–49,999, n = 99, 29.2%) and a range of educational attainment (high school or vocational, n = 117, 34.5%). Participants demonstrated moderate AF knowledge (1.7 ± 0.6; range 0–2) but limited knowledge about anticoagulation (1.3 ± 0.7; range 0–3) or stroke (1.5 ± 0.8; range 0–3). Income was not associated with improvement in AF (P = 0.32 for trend), anticoagulation (P = 0.27) or stroke knowledge (P = 0.26). Individuals with bachelor or graduate degree had greater AF (1.8 ± 0.5) and stroke (1.6 ± 0.8) knowledge relative to those with high school or vocational training (1.4 ± 0.7 and 1.2 ± 0.9; P ≪ 0.01, both estimates). Education was not associated with understanding the rationale for anticoagulation. Most participants (230, 68%) estimated their annual stroke risk as ≥15%. Conclusions We identified consistent, fundamental gaps in disease-specific knowledge in a cohort of adults receiving treatment for non-valvular AF. Improved patient understanding of this complex and chronic disease may enhance shared decision making, patient engagement, anticoagulation adherence, and clinical outcomes in AF.

BACKGROUND Some literature exists potentially linking proliferation signal inhibitors (PSIs) to venous thromboembolism (VTE). We sought to determine the impact of PSIs on development of VTE in heart transplant (HT) patients while controlling for other risk factors. METHODS The incidence and predisposing factors of VTE were analyzed in this retrospective review of patients >18 years who underwent HT January 2000 to October 2016. Re-transplants, multiorgan transplants, or patients that expired within 30 days post-HT were excluded. VTE incidence rates are reported as number of events per 100 person-years. Cox proportional hazards models were used to assess the relationship between PSI exposure (time-varying covariate) and VTE. RESULTS Of 561 HT recipients, 112 received PSIs, started a median of 1.5 years post-HT. There were 102 total VTE events: 78 in PSI-naive patients during 2,547 patient-years (3.0 events per 100 person-years) vs 24 in PSI-exposed patients during 544 patient-years (4.4 events per 100 person-years). Cox proportional hazards models with PSI exposure as a time-varying covariate indicated the increased risk was statistically significant (unadjusted hazard ratio [HR] 2.14, 95% confidence interval [CI] 1.31 to 3.49, p = 0.002). A VTE history was significantly associated with increased risk of VTE post-HT (HR 1.58, 95% CI 1.07 to 2.35, p = 0.022); however, the risk remained significant when adjusting for potential confounders, including previous VTE (HR 2.0, 95% CI 1.18 to 3.38, p = 0.010). CONCLUSIONS Exposure to PSIs is associated with a significant increase in risk for VTE even when controlling for other risk factors. When considering the use of PSI-based immunosuppression after HT, the risk of VTE over time should be weighed against the potential benefit.

Patients with nonspecific intraventricular conduction delay (IVCD) benefit less from cardiac resynchronization therapy (CRT) than patients with left bundle branch block (LBBB).The purpose of this study was to determine whether post-CRT outcome differences in patients with ischemic cardiomyopathy (ICM) relate to intrinsic QRS pattern and/or scar burden.We analyzed 393 consecutive ICM patients with left ventricular ejection fraction (LVEF) ≤35%, QRS duration120 ms, and LBBB or nonspecific IVCD who underwent single-photon emission computed tomography myocardial perfusion imaging and CRT-defibrillator implant. We compared scar burden; QRS duration; LVEF change; risk of death, transplant, or ventricular assist device; and risk of appropriate device shocks between LBBB and IVCD patients, using multivariable analyses to determine relative associations between QRS pattern vs scar burden and outcomes.Nonspecific IVCD is associated with greater scar burden and narrower baseline QRS duration than LBBB. IVCD patients demonstrated less QRS narrowing with CRT than LBBB patients, even when excluding IVCD patients with QRS duration150 ms. LVEF improved less in patients with IVCD vs LBBB, but only scar burden not QRS morphology or duration was associated with LVEF increase ≥5%. During 39-month follow-up, IVCD was associated with shorter survival free from transplant/ventricular assist device and shorter time to first appropriate device shock. Scar burden but not QRS morphology was independently associated with these outcomes on multivariate analysis.IVCD is associated with greater scar burden than LBBB in ICM CRT-defibrillator recipients. Scar burden, not QRS pattern, is independently associated with adverse clinical outcomes.

Driveline infection (DLI) is a cause of morbidity and mortality in patients with continuous-flow left ventricular assist devices (CF-LVADs). We hypothesized that an alternate dressing protocol would decrease the rate of DLIs.A retrospective review of CF-LVAD implants at a single institution from January 2010 to October 2015 was conducted. Patients were divided into implants before (group 1) and after (group 2) the introduction of the new protocol on September 1, 2012. Patients were followed until death, transplantation, change in dressing type, or 2 years. 153 patients were included: 61 in group 1 and 92 in group 2. Group 1 had fewer HVADs than group 2 (27.9% vs 71.7%; P.001) and more destination therapy, although the latter was not statistically significant (50.8% vs 34.8%; P = .118). At 24 months, the freedom from DLI was 53% in group 1 and 89% in group 2 (P = .01). Group 1 had a significantly greater risk of DLI than group 2 (incident rate ratio 3.18, 95% confidence interval 1.23-8.18; P = .016).Dramatic improvement in freedom from DLI at 2 years was achieved with a new driveline dressing protocol. This demonstrates that DLI rates can be improved with alternate percutaneous site care techniques in CF-LVAD patients.

Background Thoracic endovascular aortic repair is increasingly used in acute complicated type B aortic dissection. The objective of this study was to demonstrate evidence of aortic remodeling by using a Proximal ExTension to Induce COmplete ATtachment (PETTICOAT) system in patients with acute complicated type B aortic dissections. Methods From 2013 to 2016, 213 patients with type B aortic dissection were seen at our institution. A total of 33 of those patients underwent thoracic endografting for complicated acute type B aortic dissection. Of these patients, 12 underwent standard thoracic endovascular aortic repair (standard group), and 21 had an additional bare metal stent distal to the covered endograft (PETTICOAT group). Aortic dimensions were measured on the basis of on three-dimensional computed tomographic scans on discharge and at 6 months. Results There were no differences in baseline characteristics between the standard group and the PETTICOAT group. At 6 months, both the PETTICOAT and standard groups had significant change in aortic diameter, true lumen diameter, and true lumen ratio throughout the thoracoabdominal aorta demonstrating positive remodeling. The change in true lumen ratio was significantly greater at the level of the celiac artery with the PETTICOAT system when compared with the standard group. Conclusions The use of a PETTICOAT concept with an addition of a bare metal stent distal to the proximal thoracic endograft offers positive aortic remodeling in the thoracoabdominal aorta at 6 months.

Despite medical, dietary, and lifestyle recommendations and drug advancements, hypertension persists as among the most prevalent noncommunicable diseases in the US population, and control remains elusive. Uncontrolled hypertension may increase the risk of serious illness from various other health challenges, including cardiovascular and renal responses. Adoption of a healthy diet is a consistent core element of lifestyle modifications that are recommended for mitigation of hypertension. The dietary sodium-to-potassium ratio is recognized as having promising potential in the regulation of blood pressure. In fact, the understanding of the relation between this ratio and blood pressure was documented as a key evidence gap in the 2019 National Academies of Sciences, Engineering, and Medicine report that revised recommended intake levels for both sodium and potassium. Although notable animal and human evidence supports this point, fundamental to developing a specific dietary recommendation for a sodium-to-potassium ratio is a well-designed human intervention trial. The successful translatability of such a trial will require careful consideration of study elements, including the study population, duration, blood pressure measurement, and dietary intervention, among other factors. This paper addresses these decision points and serves as supporting documentation for a research group or organization with the interest and means to address this important data gap, which will undoubtedly be foundational for advancing dietary guidance and would inform the next iteration of Dietary Reference Intakes for sodium and potassium.

Author(s): Basir, Mir B; Pinto, Duane S; Ziaeian, Boback; Khandelwal, Akshay; Cowger, Jennifer; Suh, William; Althouse, Andrew | Abstract: BackgroundAcute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is associated with significant morbidity and mortality.MethodsWe provide an overview of previously conducted studies on the use of mechanical circulatory support (MCS) devices in the treatment of AMI-CS and difficulties which may be encountered in conducting such trials in the United States.ResultsWell powered randomized control trials are difficult to conduct in a critically ill patient population due to physician preferences, perceived lack of equipoise and challenges obtaining informed consent.ConclusionsWith growth in utilization of MCS devices in patients with AMI-CS, efforts to perform well-powered, randomized control trials must be undertaken.

The randomised controlled trial (RCT) is a powerful approach for testing the effectiveness of various clinical interventions. Cardiology often benefits from large RCTs, which may be used to inform practice decisions ranging from primary prevention to advanced cardiac disease and/or acute cardiac care. RCTs in cardiology often need to be quite large to test for meaningful effects on clinical outcomes, because effect sizes are typically modest and clinical outcomes may take several years to occur after treatment initiation. However, a variety of small clinical trials are also carried out in the biomedical research enterprise; these are often difficult to design and interpret, because the objectives and needs of small clinical trials are quite variable. Some are pilot trials that may be used to refine processes or as part of the planning in advance of a larger trial designed to test therapeutic efficacy. Some are first-in-human or proof-of-concept studies that, also, will eventually be followed by one or more larger trials to test therapeutic efficacy. Some are intended to be stand-alone trials that are small for other reasons. In this paper, we explore some key issues related to design and interpretation of small clinical trials in cardiology. We broadly classify small trials into 4 types: 1) pilot trials, 2) early-stage or proof-of-concept trials, 3) rare diseases or difficult-to-recruit populations, and 4) underpowered trials. For each, we describe the appropriate objectives, analysis, and interpretation.

INTRODUCTION: Although coexistence of alcohol-related liver disease (ALD) and pancreatitis (ALP) is seen in clinical practice, a clear understanding of the overlap between these diseases is lacking. Moreover, the relative risks for certain population groups have not been studied. We determined the prevalence and coexistence of ALD and ALP in patients with an alcohol use disorder using retrospective analysis of a large patient cohort from Western Pennsylvania. We specifically emphasized the analysis of underrepresented populations, including women and blacks. METHODS: We identified all unique patients who received care in UPMC health system during 2006–2017 with at least one International Classification of Diseases versions 9 and/or 10 codes for alcohol misuse, ALD and pancreatitis. We noted their sex, race and age of first diagnosis and duration of contact. RESULTS: Among 89,774 patients that fit our criteria, the prevalence of ALD, ALP and coexistent ALD and ALP in patients with alcohol misuse was 11.7%, 7.4% and 2.5%, respectively. Prevalence of ALP in ALD was 16.4%, and ALD in ALP was 33.1%. Prevalence of ALP in ALD was slightly more prevalent in women (18.6% vs. 15.6%, p < 0.001). Prevalence of ALP in ALD was 2–4 folds greater in blacks than other races. DISCUSSION: A sizeable fraction of patients with ALD or ALP has coexistent disease. This is the first study to identify that blacks are at a higher risk for ALP in the presence of ALD. Future studies should define the clinical impact of coexistent disease on clinical presentation and short- and long-term outcomes.

Background Cyclic vomiting syndrome (CVS) is an idiopathic disorder of gut-brain interaction characterized by recurrent bouts of nausea and vomiting. Although CVS negatively impacts quality of life (QOL), the determinants of impaired QOL among adult CVS sufferers are not fully understood. The unpredictability of CVS attacks may generate anticipatory anxiety and worsen quality of life in a substantial proportion of patients with CVS. Intolerance to uncertainty (IU) is a cognitive trait in which individuals experience distress when faced with unpredictable situations, particularly those with potentially negative consequences. Higher trait IU is a well-established vulnerability factor linked to the development of multiple psychiatric conditions, including anxiety. However, the extent to which higher IU is associated with impaired QOL in adults with CVS is not known. Methods To explore this issue, we surveyed 118 adult CVS patients and obtained demographic information, clinical features, reported healthcare utilization, and standardized assessments of IU, anxiety and panic, and QOL. Key results Adult CVS patients with higher IU did not report a greater frequency of CVS attacks or overall CVS-related healthcare utilization than those with lower IU. Yet, this group demonstrated substantially poorer physical and mental health-related QOL and higher rates of anxiety-spectrum disorders. Conclusions & inferences Higher degrees of IU are associated with increased anxiety and reduced QOL in patients with CVS. IU is a malleable cognitive trait that can be targeted by cognitive behavioral therapy (CBT). Our results suggest that some CVS patients may benefit from non-pharmacologic therapies such as CBT.

Pain burn-out during the course of chronic pancreatitis (CP), proposed in the 1980s, remains controversial, and has clinical implications. We aimed to describe the natural course of pain in a well-characterized cohort.We constructed the clinical course of 279 C P patients enrolled from 2000 to 2014 in the North American Pancreatitis Studies from UPMC by retrospectively reviewing their medical records (median observation period, 12.4 years). We assessed abdominal pain at different time points, characterized pain pattern (Type A [short-lived pain episodes] or B [persistent pain and/or clusters of recurrent severe pain]) and recorded information on relevant covariates.Pain at any time, at the end of follow-up, Type A pain pattern or B pain pattern was reported by 89.6%, 46.6%, 34% and 66% patients, respectively. In multivariable analyses, disease duration (time from first diagnosis of pancreatitis to end of observation) did not associate with pain - at last clinical contact (OR, 1.0, 95% CI 0.96-1.03), at NAPS2 enrollment (OR 1.02, 95% CI 0.96-1.07) or Type B pain pattern (OR 1.01, 95% CI 0.97-1.04). Patients needing endoscopic or surgical therapy (97.8 vs. 75.2%, p 0.001) and those with alcohol etiology (94.7 vs. 84.9%, p = 0.007) had a higher prevalence of pain. In multivariable analyses, invasive therapy associated with Type B pain and pain at last clinical contact.Only a subset of CP patients achieve durable pain relief. There is urgent need to develop new strategies to evaluate and manage pain, and to identify predictors of response to pain therapies for CP.

Introduction Primary care providers play a critical role in reducing patients' risk for cardiovascular disease, including providing dietary counseling. However, few physicians feel adequately trained to provide this counseling, and most internal medicine (IM) residencies do not offer nutrition education. Methods We created an interactive, case-based activity for IM residents to improve the delivery of nutrition counseling to patients with hypertension, hyperlipidemia, overweight, and obesity. The curriculum was given over two in-person small-group sessions facilitated by physician preceptors. It reviewed evidence for relevant dietary patterns, provided resources for dietary referrals, and allowed residents to practice counseling based on a patient's stage of behavioral change. Results Residents completed electronic surveys prior to curriculum implementation, immediately after, and 2 months after completion of the curriculum. Aggregate percent correct scores of knowledge questions improved significantly in the immediate postsurvey (n = 24 paired responses, p = .004). We also reviewed electronic health records of patients with body mass index ≥ 25, hypertension, or hyperlipidemia who were seen in our resident clinics 2 months prior (n = 503) and 2 months after (n = 473) curriculum delivery. Residents' documented nutrition counseling increased from 35% to 41% (odds ratio, 1.27; 95% CI, 0.97–1.67; p = .085). Discussion We demonstrated improved knowledge of nutrition interventions to reduce cardiovascular risk and reported improvement of resident-provided nutrition counseling for appropriate patients. This activity offers IM residents effective initial nutrition training for patients at risk for cardiovascular disease and is practical to implement as part of an ambulatory curriculum.

Well-designed randomized controlled trials have changed trauma resuscitation dramatically over the past few decades. Randomized controlled trials have established the effectiveness of permissive hypotension and the use of balanced blood product resuscitation to minimize mortality in traumatically injured patients. Together, these therapeutic concepts are termed “damage control resuscitation” and are now the standard of care for traumatically injured patients at risk of hemorrhagic shock and therefore trauma-induced coagulopathy.

Purpose Most older adults eligible for cardiac rehabilitation (CR) do not participate or participate with low frequency, although it is a standard of care for patients with cardiovascular disease (CVD). Identifying the barriers to older adult participation is key in improving CR efficacy. Methods A range of patient characteristics was analyzed in relation to on-site frequency of participation in a CR program by older adult patients. These characteristics included demographics and indications for referral, as well as CVD and non-CVD diagnoses. The prevalence of these characteristics was compared among three patient cohorts, ranging from high contact frequency to minimal contact frequency of on-site participation in CR. Results Among the three participation frequency cohorts, no differences were noted in demographic factors, indications for referral, or CVD diagnoses. However, patients with hearing impairment (OR = 4.15: 95% CI, 1.32-13.08) or visual impairment (OR = 4.11: 95% CI, 1.46-11.59) at time of enrollment were more likely to be found in the minimal contact cohorts than the moderate or high contact frequency cohorts. Conclusions Whereas differences in CVD had little bearing on frequency of CR participation in older patients, differences in hearing and visual impairment varied significantly. Patients with hearing and vision impairments attended less frequently. Sensory impairment has previously been demonstrated to impact health care utilization by older adults, but is rarely considered in the treatment of CVD or CR. As sensory impairments are extremely prevalent among geriatric patients, further study of these potential barriers to care might open possibilities for older adult participation in CR.

Background Failure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a major shortcoming of our cancer care delivery system. Methods A mixed-methods comparative effectiveness trial of in-person advance care planning (ACP) discussions versus web-based ACP is currently underway at oncology practices in Western Pennsylvania. Patients with advanced cancer and their caregivers are invited to enroll. Participants are randomized to either (1) in-person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool. The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs. Factors influencing ACP effectiveness are assessed via in-depth interviews with patients, caregivers and clinicians. Discussion This trial will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional written advance directives but entail very different investments of time and resources. It is innovative in using mixed methods to evaluate not only the comparative effectiveness of these approaches, but also the contexts and mechanisms influencing effectiveness. Data from this study will inform clinicians, payers and health systems seeking to adopt and scale the most effective and efficient ACP strategy in real-world oncology settings.

Purpose Current American Association of Cardiovascular and Pulmonary Rehabilitation guidelines rely primarily on cardiovascular disease (CVD)-centered metrics to stratify risk and guide care. Yet, contemporary CVD patients are often older and are more likely to have risks attributable to rudimentary functional impairments that can have disproportionate bearing on management and prognosis. In this study, we stratified risk using novel indices of physical function as well as traditional indices of CVD in patients enrolling in phase II cardiac rehabilitation (CR). We hypothesized that risk stratification (RS) using functional criteria would be nonconcordant with CVD RS in a significant number of patients, thus inferring the conceptual value of CR management priorities that are better tailored for distinctive functional risks in many patients. Methods This was a retrospective analysis of a comprehensive quality improvement database with 489 patients. Risk stratification using novel functional indices (ie, gait speed, Timed Up and Go, hand grip, sit to stand, tandem stand, and a 6-min walk test) was compared with RS using traditional CVD criteria. Results Using functional RS, 97 patients were determined to be high risk versus 235 at low risk. Using CVD RS in the same cohort, 227 patients had high risk versus 161 who had low risk. Functional RS was consistent with CVD RS only 42.9% of the time. Conclusion Functional RS and CVD RS varied in the same patients. Enhanced assessment of functional risks adds important prognostic refinement and greater potential to tailor exercise therapy, nutrition, and other CR caregiving priorities.

Background Available estimates of coexistent alcohol-related pancreatitis (ALP) and alcohol-related liver disease (ALD) vary widely, and factors that determine coexistent disease are largely unknown. We performed a systematic review of published literature with the primary aim to generate robust estimates for coexistent alcohol-related chronic pancreatitis (ACP) and alcohol-related cirrhosis (ALC). Methods We searched PubMed, EMBASE, and Web of Science databases from inception until February 2018. Studies included were those in English-language, sample size ≥25 and allowed calculation of the coexistent disease. Pooled estimates were calculated using a random-effects model approach. Results Twenty-nine (including 5 autopsy studies) of 2000 eligible studies met inclusion criteria. Only 6.9% included patients were female. Fifteen studies enabled calculation of ACP in ALC, and 11 for ALC in ACP. Pooled prevalence of ACP in ALC was 16.2% (95% CI 10.4–24.5) overall, and 15.5% (95% CI 8.0–27.7) when data were limited to clinical studies. Corresponding prevalence for ALC in ACP was 21.5% (95% CI 12.0–35.6) and 16.9% (95% CI 11.5–24.3), respectively. There was significant heterogeneity among studies (I2 – 65–92%). Pooled prevalence for ALP in ALD or ALD in ALP in clinical studies were 15.2% and 39%, respectively. None of the studies reported outcomes in patients with coexistent disease. Conclusion A sizeable fraction of patients with ACP or ALC have coexistent disease. Future studies should define the prevalence of coexistent disease in women and minority populations, and the consequences of coexistent disease on clinical presentation and short- and long-term outcomes.

Background & aims The natural history of groove pancreatitis is incompletely characterized. Published literature suggests a high rate of surgery. We describe the short- and long-term outcomes in a cohort of patients with groove pancreatitis treated at our institution. Methods Medical records of patients hospitalized in the University of Pittsburgh Medical Center system from 2000 to 2014 and diagnosed with groove pancreatitis based on imaging were retrospectively reviewed. Clinical presentation and outcomes during index admission and follow-up were recorded. Results Forty-eight patients with groove pancreatitis were identified (mean age 53.2 years, 79% male). Seventy-one percent were alcohol abusers and an equal number were cigarette smokers. Prior histories of acute and chronic pancreatitis were noted in 30 (62.5%) and 21 (43.8%), respectively. Forty-four (91.7%) met criteria for acute pancreatitis during their index admission. Alcohol was the most common etiology (68.8%). No patient experienced organ failure. The most frequent imaging findings were fat stranding in the groove (83.3%), duodenal wall thickening (52.1%), and soft tissue mass/thickening in the groove (50%). Over a mean follow-up of 5.0 years, seven (14.6%) required a pancreas-related surgery. Patients had a high burden of pancreatitis-related readmissions (68.8%, 69.4/100 patient-years). Incident diabetes and chronic pancreatitis were diagnosed in 5 (13.9% of patients at risk) and 8 (29.6% of patients at risk) respectively. Conclusions Groove pancreatitis has a wide spectrum of severity; most patients have mild disease. These patients have a high burden of readmissions and progression to chronic pancreatitis. A small minority requires surgical intervention.

Background Robotic mitral valve surgery has potential advantages in patient satisfaction and 30-day outcome. Cost concerns and repair durability limit wider adoption of robotic technology. This study examined detailed cost differences between robotic and sternotomy techniques in relation to outcomes and durability following robotic mitral program initiation. Methods Between April 2013 and October 2015, 30-day and 1-year outcomes of 328 consecutive patients undergoing robotic or sternotomy mitral valve repair or replacement by experienced surgeons were examined. Multivariable logistic regression informed propensity matching to derive a cohort of 182 patients. Echocardiographic follow-up was completed at 1 year in all robotic patients. Detailed activity-based cost accounting was applied to include direct, semidirect, and indirect costs with special respect to robotic depreciation, maintenance, and supplies. A quantitative analysis of all hospital costs was applied directly to each patient encounter for comparative financial analyses. Results Mean predicted risk of mortality was similar in both the robotic (n = 91) and sternotomy (n = 91) groups (0.9% vs 0.8%; P > .431). The total costs of robotic mitral operations were similar to those of sternotomy ($27,662 vs $28,241; P = .273). Early direct costs were higher in the robotic group. There was a marked increase in late indirect cost with the sternotomy cohort related to increased length of stay, transfusion requirements, and readmission rates. Robotic repair technique was associated with no echocardiographic recurrence greater than trace to only mild regurgitation at 1 year. Conclusions Experienced mitral surgeons can initiate a robotic program in a cost-neutral manner that maintains clinical outcome integrity as well as repair durability.

Background Deep hypothermic circulatory arrest (DHCA) is often avoided in patients with concomitant ascending aortic pathology when treating another cardiac disease to avoid increased risk of morbidity and mortality. We hypothesized that the use of DHCA with retrograde cerebral perfusion (RCP) does not add incremental risk to ascending aortic replacement alone in the setting of concomitant cardiac surgery. Methods A total of 408 ascending aortic ± hemiarch replacements and aortic (root), mitral, or tricuspid valve(s); coronary artery bypass grafting; or MAZE procedures were performed for concomitant cardiac disease. DHCA with RCP was used for all hemiarch replacements or the ascending aorta was replaced with an aortic cross-clamp proximal to the innominate artery. Propensity score matching was used to match similar ascending aorta patients versus hemiarch patients; the final propensity score–matched patients on age, sex, body mass index, previous heart surgery, preoperative aortic insufficiency, preoperative aortic stenosis, preoperative ejection fraction, and operative variables. Results Propensity score matching yielded 116 pairs of non-hemiarch patients versus 116 hemiarch patients. Within the propensity score–matched cohort, there were no differences in postoperative stroke (1.7% versus 3.4%; p = 0.41), new postoperative dialysis (6.0% versus 5.2%; p = 0.78), postoperative renal insufficiency (27.6% versus 19.8%; p = 0.16), 30-day mortality (2.6% versus 3.4%; p = 0.701), or 1-year mortality (4.3% versus 4.3%; p = 1.00) Conclusions Hemiarch replacement using DHCA with RCP does not increase the risk of operative complications compared with a normothermic, clamped-distal aortic anastomosis, and therefore its use should not be limited when planning complex multiprocedural reconstructions during elective ascending thoracic aortic replacement with concomitant cardiac surgery.

Background The aim of this study was to evaluate hospital readmission rates and clinical outcomes between bioprosthetic (bAVR) and mechanical (mAVR) aortic valve replacements (AVR). Methods Adults aged 50 years or older undergoing isolated or concomitant AVR between 2011 and 2017 were included. The primary outcome was 5-year hospital readmission. Multivariable logistic regression analysis was used to evaluate the risk-adjusted impact of bAVR versus mAVR on outcomes. Results A total of 2981 patients were included: 406 (14%) mAVR and 2575 (86%) bAVR. Mean follow-up was 2.9 ± 1.9 years. Operative mortality was comparable (4% bAVR vs 3% mAVR; P = 0.30). There was no risk-adjusted difference in 30-day (hazard ratio [HR] 1.32, P = 0.46), 1-year (HR 1.17, P = 0.52), or 5-year mortality (HR 0.99, P = 0.93). Aortic valve 5-year reoperation rates were comparable (1%, P = 0.32). Risk-adjusted hospital readmissions were similar at 30 days (14% vs 15%; P = 0.63), 1 year (30% vs 27%; P = 0.43), and 5 years (55% vs 53%; P = 0.83) in the bAVR and mAVR groups, respectively. Similar findings were demonstrated when evaluating readmissions for bleeding (5-year readmission: 8% bAVR vs 10% mAVR; P = 0.36). Conclusions In this analysis of over 2900 AVRs, readmissions within 5 years were comparable between groups at approximately 50%, with patients being at highest risk in the early postdischarge period. Readmissions for bleeding constituted a minority of all readmissions for both cohorts.

Objective Drowsy driving is a significant cause of traffic accidents and fatalities. Although previous reports have shown an association between race and drowsy driving, the reasons for this disparity remain unclear. Study design A cross-sectional analysis of responses from 193,776 White, Black, and Hispanic adults participating in the US Behavioral Risk Factor Surveillance System from 2009 to 2012 who answered a question about drowsy driving. Measurements Drowsy driving was defined as self-reporting an episode of falling asleep while driving in the past 30 days. All analyses were adjusted for age, sex, and medical comorbidities. Subsequent modeling evaluated the impact of accounting for differences in health care access, alcohol consumption, risk-taking behaviors, and sleep quality on the race–drowsy driving relationship. Results After adjusting for age, sex, and medical comorbidities, the odds ratio (OR) for drowsy driving was 2.07 (95% confidence interval [CI] 1.69-2.53) in Blacks and 1.80 (95% CI 1.51-2.15) in Hispanics relative to Whites. Accounting for health care access, alcohol use, and risk-taking behaviors had little effect on these associations. Accounting for differences in sleep quality resulted in a modest reduction in the OR for drowsy driving in Blacks (OR = 1.55, 95% CI 1.27-1.89) but not Hispanics (OR = 1.74, 95% CI 1.45-2.08). Conclusion US Blacks and Hispanics have approximately twice the risk of drowsy driving compared to whites. Differences in sleep quality explained some of this disparity in Blacks but not in Hispanics. Further research to understand the root causes of these disparities is needed.