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Background: The diagnostic performance of the high‐sensitivity troponin T (hs‐cTnT) 0/2‐h algorithm is unclear among U.S. emergency department (ED) patients with acute chest pain. Methods: A preplanned subgroup analysis of the STOP‐CP cohort study was conducted. Participants with 0‐ and 2‐h hs‐cTnT measures prospectively enrolled at eight U.S. EDs from January 2017 to September 2018 were stratified into rule‐out, observation, and rule‐in zones using the hs‐cTnT 0/2‐h algorithm alone and combined with the history, electrocardiogram, age, and risk factor (HEAR) score. The primary outcome was adjudicated 30‐day cardiac death or myocardial infarction (CDMI). The sensitivity and negative predictive value (NPV) of the 0/2‐h rule‐out zone and specificity and positive predictive value (PPV) of the rule‐in zone for 30‐day CDMI were calculated. Results: Of the 1307 patients accrued, 53.6% (700/1307) were male and 58.6% (762/1307) were White, with a mean ± SD age of 57.5 ± 12.7 years. At 30 days, CDMI occurred in 12.9% (168/1307) of participants. The 0/2‐h algorithm ruled out 61.4% (802/1307) of patients. Among rule‐out patients, 1.9% (15/802) experienced 30‐day CDMI, resulting in a sensitivity of 91.1% (95% confidence interval [CI] 85.7%–94.9%) and NPV of 98.1% (95% CI 96.9%–98.9%). The 0/2‐h algorithm ruled in 12.4% (162/1307) patients of whom 61.7% (100/162) experienced 30‐day CDMI. The rule‐in zone specificity was 94.6% (95% CI 93.1%–95.8%) and PPV was 61.7% (95% CI 53.8%–69.2%) for 30‐day CDMI. The 0/2‐h algorithm combined with HEAR score ruled out 30.7% (401/1307) of patients with a sensitivity and NPV for 30‐day CDMI of 98.2% (95% CI 94.9%–99.6%) and 99.3% (95% CI 97.8%–99.8%), respectively. Conclusions: The hs‐cTnT 0/2‐h algorithm ruled out most patients. With NPV of <99% for 30‐day CDMI, the hs‐cTnT 0/2‐h algorithm, many emergency physicians may not consider it safe to use for U.S. ED patients. When combined with a low‐risk HEAR score, NPV was >99% for 30‐day CDMI at the cost of reduced efficacy. [ABSTRACT FROM AUTHOR]

The diagnostic performance of the high‐sensitivity troponin T (hs‐cTnT) European Society of Cardiology (ESC) 0/1‐h algorithm in sex and race subgroups of US Emergency Department (ED) patients is unclear. A pre‐planned subgroup analysis of the STOP‐CP cohort study was conducted. Participants with 0‐ and 1‐h hs‐cTnT measures from eight US EDs (1/2017 to 9/2018) were stratified into rule‐out, observation, and rule‐in zones using the hs‐cTnT ESC 0/1 algorithm. The primary outcome was adjudicated 30‐day cardiac death or MI. The proportion with the primary outcome in each zone was compared between subgroups with Fisher's exact tests. The negative predictive value (NPV) of the ESC 0/1 rule‐out zone for 30‐day CDMI was calculated and compared between subgroups using Fisher's exact tests. Of the 1422 patients enrolled, 54.2% (770/1422) were male and 58.1% (826/1422) white with a mean age of 57.6 ± 12.8 years. At 30 days, cardiac death or myocardial infarction (MI) occurred in 12.9% (183/1422) of participants. Among patients stratified to the rule‐out zone, 30‐day cardiac death or MI occurred in 1.1% (5/436) of women versus 2.1% (8/436) of men (p =.40) and 1.2% (4/331) of non‐white patients versus 1.8% (9/490) of white patients (p =.58). The NPV for 30‐day cardiac death or MI was similar among women versus men (98.9% [95% confidence interval, CI: 97.3–99.6] vs. 97.9% [95% CI: 95.9–99.1]; p =.40) and among white versus non‐white patients (98.8% [95% CI: 96.9–99.7] vs. 98.2% [95% CI: 96.5–99.2]; p =.39). NPVs <99% in each subgroup suggest the hs‐cTnT ESC 0/1‐h algorithm may not be safe for use in US EDs. Trial Registration: High‐Sensitivity Cardiac Troponin T to Optimize Chest Pain Risk Stratification (STOP‐CP; ClinicalTrials.gov: NCT02984436; https://clinicaltrials.gov/ct2/show/NCT02984436). [ABSTRACT FROM AUTHOR]

Background: ST‐elevation myocardial infarction (STEMI) guidelines recommend an emergency medical services (EMS) first medical contact (FMC) to percutaneous coronary intervention (PCI) time of ≤90 min. The primary objective of this study was to evaluate the association between FMC to PCI time and mortality in rural STEMI patients. Methods: We conducted a cohort study of patients ≥18 years old with STEMI activations from January 2016 to March 2020. Data were obtained from a rural North Carolina Regional STEMI Data Registry, which included eight rural EMS agencies and three PCI centers, the National Cardiovascular Data Registry, and the EMS electronic health record. Prehospital and in‐hospital time intervals were digitally abstracted. The outcome of index hospitalization mortality was compared between patients who did and did not meet FMC to PCI time goal using Fisher's exact tests. Negative predictive value (NPV) for index hospitalization death was calculated with 95% confidence intervals (CIs). A receiver operating characteristic curve was constructed and an optimal FMC to PCI time goal was identified by maximizing NPV to prevent index hospitalization death. Results: Among 365 rural EMS STEMI patients, 30.1% (110/365) were female with a mean ± SD age of 62.5 ± 12.7 years. PCI was performed within the 90‐min time goal in 60.5% (221/365) of patients. Among these patients, 3% (11/365) died during initial STEMI hospitalization, with 1.4% (3/221) mortality in the group that met the 90‐minute time goal compared to 5.6% (8/144) in patients exceeding the time goal (p = 0.03). Meeting the 90‐min time goal yielded a 98.6% (95% CI 96.1%–99.7%) NPV for index death. A 78‐min FMC to PCI time was the optimal cut point, yielding a NPV for index mortality of 99.3% (95% CI 96.1%–100%). Conclusions: Death among rural patients with STEMI was four times more likely when they did not receive PCI within 90 min. [ABSTRACT FROM AUTHOR]

Background: Identifying and eliminating racial health care disparities is a public health priority. However, data evaluating race differences in emergency department (ED) chest pain care are limited. Methods: We conducted a secondary analysis of the High‐Sensitivity Cardiac Troponin T to Optimize Chest Pain Risk Stratification (STOP‐CP) cohort, which prospectively enrolled adults with symptoms suggestive of acute coronary syndrome without ST‐elevation from eight EDs in the United States from 2017 to 2018. Race was self‐reported by patients and abstracted from health records. Rates of 30‐day noninvasive testing (NIT), cardiac catheterization, revascularization, and adjudicated cardiac death or myocardial infarction (MI) were determined. Logistic regression was used to evaluate the association between race and 30‐day outcomes with and without adjustment for potential confounders. Results: Among 1454 participants, 42.3% (615/1454) were non‐White. At 30 days NIT occurred in 31.4% (457/1454), cardiac catheterization in 13.5% (197/1454), revascularization in 6.0% (87/1454), and cardiac death or MI in 13.1% (190/1454). Among Whites versus non‐Whites, NIT occurred in 33.8% (284/839) versus 28.1% (173/615; odds ratio [OR] 0.76, 95% confidence interval [CI] 0.61–0.96) and catheterization in 15.9% (133/839) versus 10.4% (64/615; OR 0.62, 95% CI 0.45–0.84). After covariates were adjusted for, non‐White race remained associated with decreased 30‐day NIT (adjusted OR [aOR] 0.71, 95% CI 0.56–0.90) and cardiac catheterization (aOR 0.62, 95% CI 0.43–0.88). Revascularization occurred in 6.9% (58/839) of Whites versus 4.7% (29/615) of non‐Whites (OR 0.67, 95% CI 0.42–1.04). Cardiac death or MI at 30 days occurred in 14.2% of Whites (119/839) versus 11.5% (71/615) of non‐Whites (OR 0.79 95% CI 0.57–1.08). After adjustment there was still no association between race and 30‐day revascularization (aOR 0.74, 95% CI 0.45–1.20) or cardiac death or MI (aOR 0.74, 95% CI 0.50–1.09). Conclusions: In this U.S. cohort, non‐White patients were less likely to receive NIT and cardiac catheterization compared to Whites but had similar rates of revascularization and cardiac death or MI. [ABSTRACT FROM AUTHOR]

Background: The HEART Pathway is a validated accelerated diagnostic protocol (ADP) for patients with possible acute coronary syndrome (ACS). This study aimed to compare the safety and effectiveness of the HEART Pathway based on patient rurality (rural vs. urban) or socioeconomic status (SES). Methods: We performed a preplanned subgroup analysis of the HEART Pathway Implementation Study. The primary outcomes were death or myocardial infarction (MI) and hospitalization at 30 days. Proportions were compared by SES and rurality with Fisher's exact tests. Logistic regression evaluated for interactions of ADP implementation with SES or rurality and changes in outcomes within subgroups. Results: Among 7245 patients with rurality and SES data, 39.9% (2887/7245) were rural and 22.2% were low SES (1607/7245). The HEART Pathway identified patients as low risk in 32.2% (818/2540) of urban versus 28.1% (425/1512) of rural patients (p = 0.007) and 34.0% (311/915) of low SES versus 29.7% (932/3137) high SES patients (p = 0.02). Among low‐risk patients, 30‐day death or MI occurred in 0.6% (5/818) of urban versus 0.2% (1/425) rural (p = 0.67) and 0.6% (2/311) with low SES versus 0.4% (4/932) high SES (p = 0.64). Following implementation, 30‐day hospitalization was reduced by 7.7% in urban patients (adjusted odds ratio [aOR] 0.76, 95% confidence interval [CI] 0.66–0.87), 10.6% in low SES patients (aOR 0.68, 95% CI 0.54–0.86), and 4.5% in high SES patients (aOR 0.83, 95% CI 0.73–0.94). However, rural patients had a nonsignificant 3.3% reduction in hospitalizations. Conclusions: HEART Pathway implementation decreased 30‐day hospitalizations regardless of SES and for urban patients but not rural patients. The 30‐day death or MI rate was similar among low‐risk patients. [ABSTRACT FROM AUTHOR]

Background: The HEART Pathway is a validated protocol for risk stratifying emergency department (ED) patients with possible acute coronary syndrome (ACS). Its performance in different age groups is unknown. The objective of this study is to evaluate its safety and effectiveness among older adults. Methods: A pre‐planned subgroup analysis of the HEART Pathway implementation study was conducted. This prospective interrupted time series accrued adult ED patients with possible ACS who were without ST‐elevation across three US sites from 11/2013–01/2016. After implementation, providers prospectively used the HEART Pathway to stratify patients as low‐risk or non‐low‐risk. Patients were classified as older adults (≥65 years), middle‐aged (46–64 years), and young (21–45 years). Primary safety and effectiveness outcomes were 30‐day death or MI and hospitalization at 30 days, determined from health records, insurance claims, and death index data. Fisher's exact test compared low‐risk proportions between groups. Sensitivity for 30‐day death or MI and adjusted odds ratios (aORs) for hospitalization and objective cardiac testing were calculated. Results: The HEART Pathway implementation study accrued 8474 patients, of which 26.9% (2281/8474) were older adults, 45.5% (3862/8474) middle‐aged, and 27.5% (2331/8474) were young. The HEART Pathway identified 7.4% (97/1303) of older adults, 32.0% (683/2131) of middle‐aged, and 51.4% (681/1326) of young patients as low‐risk (p < 0.001). The HEART Pathway was 98.8% (95% CI 97.1–100) sensitive for 30‐day death or MI among older adults. Following implementation, the rate of 30‐day hospitalization was similar among older adults (aOR 1.25, 95% CI 1.00–1.55) and cardiac testing increased (aOR 1.25, 95% CI 1.04–1.51). Conclusion: The HEART Pathway identified fewer older adults as low‐risk and did not decrease hospitalizations in this age group. [ABSTRACT FROM AUTHOR]

The article focuses on responding to concerns regarding troponin thresholds for myocardial infarction risk assessment, addressing issues such as the use of high-sensitivity cardiac troponin T (hs-cTnT) algorithms and the importance of chest pain timing in patient stratification. Topics include the diagnostic performance of the hs-cTnT 0/2-hour algorithm, sensitivity analysis based on chest pain onset time, and the influence of disease prevalence on reported negative predictive values.

Background: Despite negative troponins and nonischemic electrocardiograms (ECGs), patients at moderate risk for acute coronary syndrome (ACS) are frequently admitted. The objective of this study was to describe the major adverse cardiac event (MACE) rate in moderate‐risk patients and how it differs based on history of coronary artery disease (CAD). Methods: A secondary analysis of the HEART Pathway implementation study was conducted. This prospective interrupted time‐series study accrued adults with possible ACS from three sites (November 2013–January 2016). This analysis excluded low‐risk patients determined by emergency providers' HEART Pathway assessments. Non–low‐risk patients were further classified as high risk, based on elevated troponin measures or ischemic ECG findings or as moderate risk, based on HEAR score ≥ 4, negative troponin measures, and a nonischemic ECG. Moderate‐risk patients were then stratified by the presence or absence of prior CAD (MI, revascularization, or ≥70% coronary stenosis). MACE (death, myocardial infarction, or revascularization) at 30 days was determined from health records, insurance claims, and death index data. MACE rates were compared among groups using a chi‐square test and likelihood ratios (LRs) were calculated. Results: Among 4,550 patients with HEART Pathway assessments, 24.8% (1,130/4,550) were high risk and 37.7% (1715/4550) were moderate risk. MACE at 30 days occurred in 3.1% (53/1,715; 95% confidence interval [CI] = 2.3% to 4.0%) of moderate‐risk patients. Among moderate‐risk patients, MACE occurred in 7.1% (36/508, 95% CI = 5.1% to 9.8%) of patients with known CAD versus 1.4% (17/1,207, 95% CI = 0.9% to 2.3%) in patients without known prior CAD (p < 0.0001). The negative LR for 30‐day MACE among moderate‐risk patients without prior CAD was 0.08 (95% CI = 0.05 to 0.12). Conclusion: MACE rates at 30 days were low among moderate‐risk patients but were significantly higher among those with prior CAD. [ABSTRACT FROM AUTHOR]

Background: Supportive care interventions have demonstrated benefits for both informal and/or family cancer caregivers and their patients, but uptake generally is poor. To the authors' knowledge, little is known regarding the availability of supportive care services in community oncology practices, as well as engagement practices to connect caregivers with these services. Methods: Questions from the National Cancer Institute Community Oncology Research Program (NCORP)'s 2017 Landscape Survey examined caregiver engagement practices (ie, caregiver identification, needs assessment, and supportive care service availability). Logistic regression was used to assess the relationship between the caregiver engagement outcomes and practice group characteristics. Results: A total of 204 practice groups responded to each of the primary outcome questions. Only 40.2% of practice groups endorsed having a process with which to systematically identify and document caregivers, although approximately 76% were routinely using assessment tools to identify caregiver needs and approximately 63.7% had supportive care services available to caregivers. Caregiver identification was more common in sites affiliated with a critical access hospital (odds ratio [OR], 2.44; P =.013), and assessments were less common in safety‐net practices (OR, 0.41; P =.013). Supportive care services were more commonly available in the Western region of the United States, in practices with inpatient services (OR, 2.96; P =.012), and in practices affiliated with a critical access hospital (OR, 3.31; P =.010). Conclusions: Although many practice groups provide supportive care services, fewer than one‐half systematically identify and document informal cancer caregivers. Expanding fundamental engagement practices such as caregiver identification, assessment, and service provision will be critical to support recent calls to improve caregivers' well‐being and skills to perform caregiving tasks. Although many community oncology practice groups provide supportive care services, fewer than one‐half systematically identify and document informal cancer caregivers. Expanding fundamental engagement practices such as caregiver identification, assessment, and service provision will be critical to support recent calls to improve caregivers' well‐being and skills to perform caregiving tasks. [ABSTRACT FROM AUTHOR]

Aims A prospectively enrolled patient cohort was used to assess whether the prediction of CYP2D6 phenotype activity from genotype data could be improved by reclassification of diplotypes or alleles. Methods Three hundred and fifty-five patients receiving tamoxifen 20 mg were genotyped for CYP2D6 and tamoxifen metabolite concentrations were measured. The endoxifen : N-desmethly-tamoxifen metabolic ratio, as a surrogate of CYP2D6 activity, was compared across four diplotypes ( EM/IM, EM/PM, IM/IM, IM/PM) that are typically collapsed into an intermediate metabolizer (IM) phenotype. The relative metabolic activity of each allele type ( UM, EM, IM, and PM) and each EM and IM allele was estimated for comparison with the activity scores typically assigned, 2, 1, 0.5 and 0, respectively. Results Each of the four IM diplotypes have distinct CYP2D6 activity from each other and from the EM and PM phenotype groups (each P < 0.05). Setting the activity of an EM allele at 1.0, the relative activities of a UM, IM and PM allele were 0.85, 0.67 and 0.52, respectively. The activity of the EM alleles were statistically different ( P < 0.0001), with the CYP2D6*2 allele (scaled activity = 0.63) closer in activity to an IM than an EM allele. The activity of the IM alleles were also statistically different ( P = 0.014). Conclusion The current systems for translating CYP2D6 genotype into phenotype are not optimally calibrated, particularly in regards to IM diplotypes and the *2 allele. Additional research is needed to improve the prediction of CYP2D6 activity from genetic data for individualized dosing of CYP2D6 dependent drugs. [ABSTRACT FROM AUTHOR]

BACKGROUND The objective of the current study was to evaluate the effect of obesity on pretreatment quality of life (QoL) in gynecologic oncology patients. METHODS The authors analyzed collected data from an institution-wide cohort study of women with gynecologic cancers enrolled from August 2012 to June 2013. The Functional Assessment of Cancer Therapy-General, site-specific symptom scales, and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) global mental and physical health tools were administered. Survey results were linked to clinical data abstracted from medical records (demographics and comorbid conditions). Bivariate tests and multivariate linear regression models were used to evaluate factors associated with QoL scores. RESULTS A total of 182 women with ovarian, uterine, cervical, and vulvar/vaginal cancers were identified; of these, 152 (84%) were assessed before surgery. Mean body mass index was 33.5 kg/m2 and race included white (120 patients [79%]), black (22 patients [15%]), and other (10 patients [6.5%]). A total of 98 patients (64.5%) were obese (body mass index ≥30). On multivariate analysis, subscales for functional (17 vs 19; P = .04), emotional (16 vs 19; P = .008), and social (22 vs 24; P = .02) well-being as well as overall Functional Assessment of Cancer Therapy-General scores (77 vs 86; P = .002) and Patient-Reported Outcomes Measurement Information System global physical health scores (45 vs 49; P = .003) were found to be significantly lower in obese versus nonobese patients. CONCLUSIONS Before cancer treatment, obese patients with gynecologic malignancies appear to have worse baseline QoL than their normal-weight counterparts. Emerging models of QoL-based cancer outcome measures may disproportionately affect populations with a high obesity burden. The potential disparate impact of cancer therapy on longitudinal QoL in the obese versus nonobese patients needs to be evaluated. Cancer 2015;121:395-402. © 2014 American Cancer Society. [ABSTRACT FROM AUTHOR]

Multiple outcomes are often collected in applications where the quantity of interest cannot be measured directly or is difficult or expensive to measure. In a head and neck cancer study conducted at Dana-Farber Cancer Institute, the investigators wanted to determine the effect of clinical and treatment factors on unobservable dysphagia through collected multiple outcomes of mixed types. Latent variable models are commonly adopted in this setting. These models stipulate that multiple collected outcomes are conditionally independent given the latent factor. Mixed types of outcomes (e.g., continuous vs. ordinal) and censored outcomes present statistical challenges, however, as a natural analog of the multivariate normal distribution does not exist for mixed data. Recently, Lin et al. proposed a semiparametric latent variable transformation model for mixed outcome data; however, it may not readily accommodate event time outcomes where censoring is present. In this paper, we extend the work of Lin et al. by proposing both semiparametric and parametric latent variable models that allow for the estimation of the latent factor in the presence of measurable outcomes of mixed types, including censored outcomes. Both approaches allow for a direct estimate of the treatment (or other covariate) effect on the unobserved latent variable, greatly enhancing the interpretability of the models. The semiparametric approach has the added advantage of allowing the relationship between the measurable outcomes and latent variables to be unspecified, rendering more robust inference. The parametric and semiparametric models can also be used together, providing a comprehensive modeling strategy for complicated latent variable problems. Copyright © 2014 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]