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1.
Cancer ; 2021 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-34787930

RESUMO

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.

2.
JCO Oncol Pract ; : OP2100573, 2021 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-34767474

RESUMO

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.

3.
J Clin Transl Sci ; 5(1): e174, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34721892

RESUMO

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.

4.
Am J Prev Cardiol ; 7: 100201, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34611640

RESUMO

Objective: Social determinants contribute to adverse outcomes in cardiovascular and non-cardiovascular conditions. However, their investigation in atrial fibrillation (AF) remains limited. We examined the associations between annual income and educational attainment with risk of hospitalization in individuals with AF receiving care in a regional health care system. We hypothesized that individuals with lower income and lower education would have an increased risk of hospitalization. Methods: We enrolled a cohort of individuals with prevalent AF from an ambulatory setting. We related annual income (≤$19,999/year; $20,000-49,000/year; $50,000-99,999/year; ≥$100,000/year) and educational attainment (high school/vocational; some college; Bachelor's; graduate) to hospitalization events in multivariable-adjusted Cox proportional hazards models, using the Andersen-Gill model to account for the potential of participants to have multiple events. Results: 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 hospitalization events. We identified an association between both income and educational attainment and hospitalization risk. In multivariable-adjusted analyses which included educational attainment individuals in the lowest annual income category (≤19,999/year) had 2.0-fold greater hospitalization risk than those in the highest (≥100,000/year; 95% Confidence Interval [CI] 1.08-4.09; p = 0.03). In multivariable-adjusted analyses without adjustment for income, those in the lowest educational attainment category (high school/vocational) had a 2-fold increased risk of hospitalization relative to the highest (graduate-level; 95% CI 1.12-3.54, p = 0.02). However, this association between education and events was attenuated with further adjustment for income (95% CI 0.97-3.15, p = 0.06). Conclusions: We identified relationships between income and education and prospective risk of hospitalization risk in AF. Our findings support the consideration of social determinants in evaluating and treating socioeconomically disadvantaged individuals with AF to reduce hospitalization risk.

5.
JAMA Cardiol ; 2021 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-34613348

RESUMO

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 < .001). Compared with nonsmokers, any complication was higher for smokers following endovascular revascularization (26 [4.3%] vs 52 [2.1%]; ARD, 2.19%; 95% CI, 0.77-3.60; P = .003), hybrid revascularization (204 [17.3%] vs 163 [14.1%]; ARD, 3.18%; 95% CI, 0.23-6.13; P = .04), and open revascularization (228 [15.4%] vs 153 [10.3%]; ARD, 5.18%; 95% CI, 2.78-7.58; P < .001). Compared with nonsmokers, respiratory complications were higher for smokers following endovascular revascularization (20 [1.7%] vs 6 [0.5%]; ARD, 1.17%; 95% CI, 0.35-2.00; P = .009), hybrid revascularization (33 [2.8%] vs 10 [0.9%]; ARD, 1.93%; 95% CI, 0.85-3.02; P = .001), and open revascularization (32 [2.2%] vs 19 [1.3%]; ARD, 0.89%; 95% CI, 0-1.80; P = .06). Wound complications and graft failure were higher for smokers compared with nonsmokers following open interventions (wound complications: 146 [9.9%] vs 87 [5.8%]; ARD, 4.05%; 95% CI, 2.12-5.99; P < .001; graft failure: 33 [2.2%] vs 11 [0.7%]; ARD, 1.50%; 95% CI, 0.63-2.37; P = .001). In a sensitivity analysis, compared with active smokers (n = 5173; smoking within 2 weeks before the procedure), the risk of any complication was decreased by 65% for never smokers (n = 1197; adjusted odds ratio, 0.45; 95% CI, 0.34-0.59) and 29% for former smokers (n = 4755; cessation more than 1 year before the procedure; adjusted odds ratio, 0.71; 95% CI, 0.61-0.83; P = .001 for interaction). Conclusions and Relevance: In this cohort study, more than half of patients with IC were smoking prior to elective revascularization, and complication risks were higher across all modalities of revascularization. These findings stress the importance of smoking cessation to optimize revascularization outcomes.

6.
JAMA Intern Med ; 181(11): 1451-1460, 2021 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-34515737

RESUMO

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.

7.
Cardiovasc Diagn Ther ; 11(4): 1002-1012, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34527523

RESUMO

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.

8.
Am J Prev Cardiol ; 8: 100252, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34541565

RESUMO

Background: Women have worse patient-reported outcomes in atrial fibrillation (AF) than men, but the reasons remain poorly understood. We investigated how comorbid conditions, treatment, social factors, and their modification by sex would attenuate sex-specific differences in patient-reported outcomes in AF. Methods: In a cohort with prevalent AF we measured patient-reported outcomes with the Short-Form-12 (SF-12, an 8-domain quality of life measure), and the AF Effect on QualiTy of Life (AFEQT), an instrument specific to AF, both with range 0-100 and higher scores indicating superior outcomes. We examined sex-specific differences in patient-reported outcomes in multivariable-adjusted regression analyses incorporating demographics, comorbid conditions, treatment, social factors, and their sex-based modification. Results: In 339 individuals (age 72±10, 45% women), women (vs. men) reported worse physical functioning on the SF-12 (49.7±39.0 versus 65.0±34.0), social functioning (69.8±31.8 versus 79.7±25.8), and mental health (67.4±20.2 versus 75.0±18.6). These differences were attenuated with adjustment for comorbid conditions and depression. Women had worse composite AFEQT scores (73.8±18.4 versus 78.5±16.6) and symptoms and treatment scores than men with differences remaining significant after multivariable adjustment. There were not significant interactions by sex and the array of covariates when examining differences in patient-reported outcomes between women and men. Conclusions: We identified sex-specific differences in patient-reported outcomes assessed with general and AF-specific measures. Compared to men, women with AF reported worse overall health-related quality of life, even after consideration of both relevant covariates and their modification by sex. Our research indicates the importance of consideration of sex-based inequities when evaluating patient-reported outcomes in AF.

10.
Can J Cardiol ; 37(9): 1428-1437, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34252567

RESUMO

Adaptive trials hold great promise to enhance the evidence base supporting medical interventions. In this review, we will describe the basic principles of an adaptive trial and the different types of adaptive trials, show examples of adaptive trials, and conclude with the advantages and challenges of different types of adaptive trials. While regulatory bodies have expressed a desire to see more adaptive trials, resistance in the community remains. We hope that this review helps to build greater acceptance of the concept of adaptive trial design.

11.
Kidney360 ; 2(5): 795-808, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-34316721

RESUMO

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 <43 years old. Conclusions: Proteinuria correlated with ADPKD severity, and urinary excretion of PKM2 and LDHA correlated with ADPKD severity at baseline in the TAME-PKD study population. These findings are the first to provide evidence in human urine samples that upregulated glycolytic flux is a feature of ADPKD severity. Future analysis may reveal if metformin treatment affects both disease progression and the various urinary metabolic biomarkers in patients throughout the study.

12.
Kidney Int ; 100(3): 684-696, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34186056

RESUMO

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.


Assuntos
Cistos , Metformina , Rim Policístico Autossômico Dominante , Adulto , Progressão da Doença , Taxa de Filtração Glomerular , Humanos , Rim , Metformina/efeitos adversos , Rim Policístico Autossômico Dominante/tratamento farmacológico
13.
Am Heart J Plus ; 22021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34151309

RESUMO

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.

14.
Dig Dis Sci ; 2021 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-33961195

RESUMO

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.

15.
Circulation ; 144(4): e70-e91, 2021 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-34032474

RESUMO

Statistical analyses are a crucial component of the biomedical research process and are necessary to draw inferences from biomedical research data. The application of sound statistical methodology is a prerequisite for publication in the American Heart Association (AHA) journal portfolio. The objective of this document is to summarize key aspects of statistical reporting that might be most relevant to the authors, reviewers, and readership of AHA journals. The AHA Scientific Publication Committee convened a task force to inventory existing statistical standards for publication in biomedical journals and to identify approaches suitable for the AHA journal portfolio. The experts on the task force were selected by the AHA Scientific Publication Committee, who identified 12 key topics that serve as the section headers for this document. For each topic, the members of the writing group identified relevant references and evaluated them as a resource to make the standards summarized herein. Each section was independently reviewed by an expert reviewer who was not part of the task force. Expert reviewers were also permitted to comment on other sections if they chose. Differences of opinion were adjudicated by consensus. The standards presented in this report are intended to serve as a guide for high-quality reporting of statistical analyses methods and results.

16.
Neurogastroenterol Motil ; 33(12): e14159, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33830558

RESUMO

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.

17.
Can J Cardiol ; 37(9): 1332-1339, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33775881

RESUMO

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.

18.
Int J Drug Policy ; 94: 103202, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33765514

RESUMO

BACKGROUND: There are important differences in medical cannabis laws across the U.S.. However, prior studies investigating the effect of medical cannabis laws on outcomes disregard this heterogeneity. Findings from the body of literature using a simple dichotomous assessment of whether a particular state has enacted a medical cannabis law are equivocal or conflicting. To advance the science, a national advisory group of experts in medical cannabis developed and utilized a systematic methodology, the "medicalization of cannabis laws standardized scale" (MCLaSS), to characterize and quantify state laws' degree of medicalization, the extent to which medical cannabis is treated similarly to pharmaceutical medications. METHODS: We conducted a systematic review of state-level medical cannabis laws in the U.S. Using the novel MCLaSS, we calculated seven domain scores (patient-clinician relationship, manufacturing and testing, product labeling, types of products, supply and dose limit, prescription drug monitoring program, and dispensing practices) and a summary score for each state which had enacted medical cannabis laws as of July 2019. RESULTS: There is substantial heterogeneity in the degree of medicalization of states' medical cannabis laws, as demonstrated by the MCLaSS summary score, which ranged from 23 (least medicalized) to 86 (most medicalized). CONCLUSION: This methodology will advance the evidence base about the impact of medical cannabis laws on patient and public health outcomes, which is urgently needed to ensure the development of policies that minimize the risks and maximize the benefits of medical cannabis.


Assuntos
Cannabis , Maconha Medicinal , Programas de Monitoramento de Prescrição de Medicamentos , Humanos , Legislação de Medicamentos , Políticas , Estados Unidos
19.
Pancreatology ; 21(3): 649-657, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33674197

RESUMO

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.


Assuntos
Dor Abdominal/etiologia , Pancreatite Crônica/fisiopatologia , Dor Abdominal/diagnóstico , Dor Abdominal/epidemiologia , Adulto , Idoso , Progressão da Doença , Feminino , Humanos , Modelos Logísticos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Medição da Dor , Pancreatite Crônica/terapia , Estudos Retrospectivos , Índice de Gravidade de Doença , Fatores de Tempo
20.
Health Equity ; 5(1): 8-16, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33564735

RESUMO

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.

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