COVID-19 pandemic effects: Examining prenatal internalizing symptoms and infant temperament.

For pregnant women, the COVID-19 pandemic has resulted in unprecedented stressors, including uncertainty regarding prenatal care and the long-term consequences of perinatal infection. However, few studies have examined the role of this adverse event on maternal wellbeing and infant socioemotional development following the initial wave of the pandemic when less stringent public health restrictions were in place. The current study addressed these gaps in the literature by first comparing prenatal internalizing symptoms and infant temperament collected after the first wave of the pandemic to equivalent measures in a pre-pandemic sample. Second, associations between prenatal pandemic-related stress and infant temperament were examined. Women who were pregnant during the COVID-19 pandemic endorsed higher pregnancy-specific anxiety relative to the pre-pandemic sample. They also reported greater infant negative emotionality and lower positive affectivity and regulatory capacity at 2 months postpartum. Prenatal infection stress directly predicted infant negative affect. Both prenatal infection and preparedness stress were indirectly related to infant negative emotionality through depression symptoms during pregnancy and at 2 months postpartum. These results have implications for prenatal mental health screening procedures during the pandemic and the development of early intervention programs for infants born to mothers during this adverse event.

Whole-Genome Sequencing to Characterize Monogenic and Polygenic Contributions in Patients Hospitalized With Early-Onset Myocardial Infarction.

BACKGROUND: The relative prevalence and clinical importance of monogenic mutations related to familial hypercholesterolemia and of high polygenic score (cumulative impact of many common variants) pathways for early-onset myocardial infarction remain uncertain. Whole-genome sequencing enables simultaneous ascertainment of both monogenic mutations and polygenic score for each individual. METHODS: We performed deep-coverage whole-genome sequencing of 2081 patients from 4 racial subgroups hospitalized in the United States with early-onset myocardial infarction (age ≤55 years) recruited with a 2:1 female-to-male enrollment design. We compared these genomes with those of 3761 population-based control subjects. We first identified individuals with a rare, monogenic mutation related to familial hypercholesterolemia. Second, we calculated a recently developed polygenic score of 6.6 million common DNA variants to quantify the cumulative susceptibility conferred by common variants. We defined high polygenic score as the top 5% of the control distribution because this cutoff has previously been shown to confer similar risk to that of familial hypercholesterolemia mutations. RESULTS: The mean age of the 2081 patients presenting with early-onset myocardial infarction was 48 years, and 66% were female. A familial hypercholesterolemia mutation was present in 36 of these patients (1.7%) and was associated with a 3.8-fold (95% CI, 2.1-6.8; P<0.001) increased odds of myocardial infarction. Of the patients with early-onset myocardial infarction, 359 (17.3%) carried a high polygenic score, associated with a 3.7-fold (95% CI, 3.1-4.6; P<0.001) increased odds. Mean estimated untreated low-density lipoprotein cholesterol was 206 mg/dL in those with a familial hypercholesterolemia mutation, 132 mg/dL in those with high polygenic score, and 122 mg/dL in those in the remainder of the population. Although associated with increased risk in all racial groups, high polygenic score demonstrated the strongest association in white participants ( P for heterogeneity=0.008). CONCLUSIONS: Both familial hypercholesterolemia mutations and high polygenic score are associated with a >3-fold increased odds of early-onset myocardial infarction. However, high polygenic score has a 10-fold higher prevalence among patients presents with early-onset myocardial infarction. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00597922.

Pregnancy and postpartum antidepressant use moderates the effects of sleep on depression.

This study examined the course of antidepressant use, sleep quality, and depression severity from pregnancy through 6-month postpartum in women with and without a depressive disorder during pregnancy. Women (N = 215) were interviewed during pregnancy, 1- and 6-month postpartum. Mixed linear models were used to examine the longitudinal course and inter-relationships for the time-varying variables of antidepressant use, subjective sleep quality, and depression severity. Pregnant women with a depressive disorder who did not use antidepressants had more variable depression severity over time with improvements in depression severity by 6-month postpartum. In contrast, the depression severity of their medicated counterparts remained stable and high throughout. Pregnant women without a depressive disorder had worse sleep quality when using antidepressants compared with when they were not. Antidepressant use significantly strengthened the magnitude of the effect of sleep quality on depression severity in women with a depressive disorder during pregnancy. When prenatally depressed women use antidepressants, their sleep disturbance is more highly linked to depression severity than when they do not. Furthermore, antidepressants are not adequately treating the sleep disturbance of these women or their remitted counterparts, leaving both groups vulnerable to significant negative mental and physical health outcomes.

Assessing the reliability of self-reported weight for the management of heart failure: application of fraud detection methods to a randomised trial of telemonitoring.

BACKGROUND: Since clinical management of heart failure relies on weights that are self-reported by the patient, errors in reporting will negatively impact the ability of health care professionals to offer timely and effective preventive care. Errors might often result from rounding, or more generally from individual preferences for numbers ending in certain digits, such as 0 or 5. We apply fraud detection methods to assess preferences for numbers ending in these digits in order to inform medical decision making. METHODS: The Telemonitoring to Improve Heart Failure Outcomes trial tested an approach to telemonitoring that used existing technology; intervention patients (n = 826) were asked to measure their weight daily using a digital scale and to relay measurements using their telephone keypads. First, we estimated the number of weights subject to end-digit preference by dividing the weights by five and comparing the resultant distribution with the uniform distribution. Then, we assessed the characteristics of patients reporting an excess number of weights ending in 0 or 5, adjusting for chance reporting of these values. RESULTS: Of the 114,867 weight readings reported during the trial, 18.6% were affected by end-digit preference, and the likelihood of these errors occurring increased with the number of days that had elapsed since trial enrolment (odds ratio per day: 1.002, p < 0.001). At least 105 patients demonstrated end-digit preference (14.9% of those who submitted data); although statistical significance was limited, a pattern emerged that, compared with other patients, they tended to be younger, male, high school graduates and on more medications. Patients with end-digit preference reported greater variability in weight, and they generated an average 2.9 alerts to the telemonitoring system over the six-month trial period (95% CI, 2.3 to 3.5), compared with 2.3 for other patients (95% CI, 2.2 to 2.5). CONCLUSIONS: As well as overshadowing clinically meaningful changes in weight, end-digit preference can lead to false alerts to telemonitoring systems, which may be associated with unnecessary treatment and alert fatigue. In this trial, end-digit preference was common and became increasingly so over time. By applying fraud detection methods to electronic medical data, it is possible to produce clinically significant information that can inform the design of initiatives to improve the accuracy of reporting. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT00303212 March 2006.

Perinatal hair cortisol concentrations linked to psychological distress and unpredicted birth complications.

Maternal well-being and stress during the perinatal period have been hypothesized to influence birth outcomes and the postnatal development of offspring. In the present study, we explored whether hair cortisol concentration (HCC) was related to symptoms of psychological distress during the perinatal period and with unpredicted birth complications (UBCs). Surveys measuring symptoms of perceived stress, state/trait anxiety, and depression were collected from 53 participants (mean age = 31.1, SD = 4.04; 83% Caucasian, 17% other races) during the third trimester and again at two and six months after birth, 24.5% of which reported UBCs. In a subset of participants, we measured HCC in hair samples collected during the third trimester (27-39 weeks) and six months after birth. Compared to participants reporting normal births, those reporting UBCs had significantly elevated composite stress, anxiety, and depression (SAD) scores two months after birth, but scores decreased by six months postpartum. During the third trimester, HCC was positively associated with reported SAD scores, and HCC was elevated in participants reporting birth complications. Logistic regression showed HCC, but not SAD scores, predicted UBCs (p = 0.023, pseudo R2= 19.7%). Repeated measures MANOVA showed HCC varied over the perinatal period depending on both SAD scores reported at two months postpartum and the experience of UBCs; but when SAD scores reported at six months postpartum were included in the model, the association between HCC and SAD scores and the influence of UBCs was diminished. Although generalizability is limited by our relatively small, homogeneous sample, findings support a positive association between reported psychological distress and HCC during pregnancy and at two months postpartum. We also report a novel finding that chronically elevated cortisol concentrations during pregnancy were related to the risk of UBCs and remain elevated through the early postpartum period, suggesting the importance of monitoring both psychological distress and HCC during the perinatal period.

Leveraging machine learning to study how temperament scores predict pre-term birth status.

Background: Preterm birth (birth at <37 completed weeks gestation) is a significant public heatlh concern worldwide. Important health, and developmental consequences of preterm birth include altered temperament development, with greater dysregulation and distress proneness. Aims: The present study leveraged advanced quantitative techniques, namely machine learning approaches, to discern the contribution of narrowly defined and broadband temperament dimensions to birth status classification (full-term vs. preterm). Along with contributing to the literature addressing temperament of infants born preterm, the present study serves as a methodological demonstration of these innovative statistical techniques. Study design: This study represents a metanalysis conducted with multiple samples (N = 19) including preterm (n = 201) children and (n = 402) born at term, with data combined across investigations to perform classification analyses. Subjects: Participants included infants born preterm and term-born comparison children, either matched on chronological age or age adjusted for prematurity. Outcome measures: Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R VSF) was completed by mothers, with factor and item-level data considered herein. Results and conclusions: Accuracy estimates were generally similar regardless of the comparison groups. Results indicated a slightly higher accuracy and efficiency for IBQR-VSF item-based models vs. factor-level models. Divergent patterns of feature importance (i.e., the extent to which a factor/item contributed to classification) were observed for the two comparison groups (chronological age vs. adjusted age) using factor-level scores; however, itemized models indicated that the two most critical items were associated with effortful control and negative emotionality regardless of comparison group.

Telemonitoring in patients with heart failure.

BACKGROUND: Small studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established. METHODS: We randomly assigned 1653 patients who had recently been hospitalized for heart failure to undergo either telemonitoring (826 patients) or usual care (827 patients). Telemonitoring was accomplished by means of a telephone-based interactive voice-response system that collected daily information about symptoms and weight that was reviewed by the patients' clinicians. The primary end point was readmission for any reason or death from any cause within 180 days after enrollment. Secondary end points included hospitalization for heart failure, number of days in the hospital, and number of hospitalizations. RESULTS: The median age of the patients was 61 years; 42.0% were female, and 39.0% were black. The telemonitoring group and the usual-care group did not differ significantly with respect to the primary end point, which occurred in 52.3% and 51.5% of patients, respectively (difference, 0.8 percentage points; 95% confidence interval [CI], -4.0 to 5.6; P=0.75 by the chi-square test). Readmission for any reason occurred in 49.3% of patients in the telemonitoring group and 47.4% of patients in the usual-care group (difference, 1.9 percentage points; 95% CI, -3.0 to 6.7; P=0.45 by the chi-square test). Death occurred in 11.1% of the telemonitoring group and 11.4% of the usual care group (difference, -0.2 percentage points; 95% CI, -3.3 to 2.8; P=0.88 by the chi-square test). There were no significant differences between the two groups with respect to the secondary end points or the time to the primary end point or its components. No adverse events were reported. CONCLUSIONS: Among patients recently hospitalized for heart failure, telemonitoring did not improve outcomes. The results indicate the importance of a thorough, independent evaluation of disease-management strategies before their adoption. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00303212.).

Associations between mothers' and fathers' depression and anxiety prior to birth and infant temperament trajectories over the first year of life: Evidence from diagnoses and symptom severity.

BACKGROUND: Developmental shifts in infant temperament predict distal outcomes including emerging symptoms of psychopathology in childhood. Thus, it is critical to gain insight into factors that shape these developmental shifts. Although parental depression and anxiety represent strong predictors of infant temperament in cross-sectional research, few studies have examined how these factors influence temperament trajectories across infancy. METHODS: We used latent growth curve modeling to examine whether mothers' and fathers' anxiety and depression, measured in two ways - as diagnostic status and symptom severity - serve as unique predictors of developmental shifts in infant temperament from 3 to 12 months. Participants included mothers (N = 234) and a subset of fathers (N = 142). Prior to or during pregnancy, both parents were assessed for lifetime diagnoses of depression and anxiety as well as current severity levels. Mothers rated their infants' temperament at 3, 6, and 12 months of age. RESULTS: Mothers' depression and anxiety primarily predicted initial levels of temperament at 3 months. Controlling for mothers' symptoms, fathers' depression and anxiety largely related to temperament trajectories across infancy. Lifetime diagnoses and symptom severities were associated with distinct patterns. LIMITATIONS: Infant temperament was assessed using a parent-report measure. Including an observational measure would provide a more comprehensive picture of the infants' functioning. CONCLUSIONS: These results indicate that mothers' and fathers' mental health are uniquely associated with infant temperament development when measured using diagnostic status and/or symptom severity. Future studies should examine whether these temperament trajectories mediate intergenerational transmission of risk for depression and anxiety.

Prenatal internalizing symptoms as a mediator linking maternal adverse childhood experiences with infant temperament.

BACKGROUND: Maternal adverse childhood experiences are known to significantly influence offspring development. However, mediators linking maternal early-life adversity with infant temperament remain largely unknown. AIMS: The current study investigated whether prenatal internalizing symptoms mediate the association between maternal adverse childhood experiences and infant temperament at two months. Maternal sensitivity/responsiveness during the postpartum period was also examined as a moderator of these associations. STUDY DESIGN: We used a repeated-measures design, with self-report measures administered during pregnancy. Self-report and observational data were also collected at 2 months postpartum. SUBJECTS: The study included a community sample of 64 pregnant women and their infants. OUTCOME MEASURES: Participants completed measures assessing their early-life adversity and current depression/anxiety symptoms. At two months postpartum, mothers reported on their infant's temperament and participated in a parent-child interaction task designed to assess maternal sensitivity/responsiveness. RESULTS AND CONCLUSIONS: Maternal adverse childhood experiences indirectly predicted poor self-regulation during early infancy via prenatal internalizing symptoms. Maternal sensitivity/responsiveness was also found to moderate the association between maternal adverse childhood experiences and certain aspects of infant regulatory capacity and positive affectivity at two months. This research has implications for mental health screening procedures during pregnancy and the development of early intervention programs.

Using machine learning to understand age and gender classification based on infant temperament.

Age and gender differences are prominent in the temperament literature, with the former particularly salient in infancy and the latter noted as early as the first year of life. This study represents a meta-analysis utilizing Infant Behavior Questionnaire-Revised (IBQ-R) data collected across multiple laboratories (N = 4438) to overcome limitations of smaller samples in elucidating links among temperament, age, and gender in early childhood. Algorithmic modeling techniques were leveraged to discern the extent to which the 14 IBQ-R subscale scores accurately classified participating children as boys (n = 2,298) and girls (n = 2,093), and into three age groups: youngest (< 24 weeks; n = 1,102), mid-range (24 to 48 weeks; n = 2,557), and oldest (> 48 weeks; n = 779). Additionally, simultaneous classification into age and gender categories was performed, providing an opportunity to consider the extent to which gender differences in temperament are informed by infant age. Results indicated that overall age group classification was more accurate than child gender models, suggesting that age-related changes are more salient than gender differences in early childhood with respect to temperament attributes. However, gender-based classification was superior in the oldest age group, suggesting temperament differences between boys and girls are accentuated with development. Fear emerged as the subscale contributing to accurate classifications most notably overall. This study leads infancy research and meta-analytic investigations more broadly in a new direction as a methodological demonstration, and also provides most optimal comparative data for the IBQ-R based on the largest and most representative dataset to date.

Strategies for reducing the door-to-balloon time in acute myocardial infarction.

BACKGROUND: Prompt reperfusion treatment is essential for patients who have myocardial infarction with ST-segment elevation. Guidelines recommend that the interval between arrival at the hospital and intracoronary balloon inflation (door-to-balloon time) during primary percutaneous coronary intervention should be 90 minutes or less. However, few hospitals meet this objective. We sought to identify hospital strategies that were significantly associated with a faster door-to-balloon time. METHODS: We surveyed 365 hospitals to determine whether each of 28 specific strategies was in use. We used hierarchical generalized linear models and data on patients from the Centers for Medicare and Medicaid Services to determine the association between hospital strategies and the door-to-balloon time. RESULTS: In multivariate analysis, six strategies were significantly associated with a faster door-to-balloon time. These strategies included having emergency medicine physicians activate the catheterization laboratory (mean reduction in door-to-balloon time, 8.2 minutes), having a single call to a central page operator activate the laboratory (13.8 minutes), having the emergency department activate the catheterization laboratory while the patient is en route to the hospital (15.4 minutes), expecting staff to arrive in the catheterization laboratory within 20 minutes after being paged (vs. >30 minutes) (19.3 minutes), having an attending cardiologist always on site (14.6 minutes), and having staff in the emergency department and the catheterization laboratory use real-time data feedback (8.6 minutes). Despite the effectiveness of these strategies, only a minority of hospitals surveyed were using them. CONCLUSIONS: Several specific hospital strategies are associated with a significant reduction in the door-to-balloon time in the management of myocardial infarction with ST-segment elevation.

Analysis of predicted loss-of-function variants in UK Biobank identifies variants protective for disease.

Less than 3% of protein-coding genetic variants are predicted to result in loss of protein function through the introduction of a stop codon, frameshift, or the disruption of an essential splice site; however, such predicted loss-of-function (pLOF) variants provide insight into effector transcript and direction of biological effect. In >400,000 UK Biobank participants, we conduct association analyses of 3759 pLOF variants with six metabolic traits, six cardiometabolic diseases, and twelve additional diseases. We identified 18 new low-frequency or rare (allele frequency < 5%) pLOF variant-phenotype associations. pLOF variants in the gene GPR151 protect against obesity and type 2 diabetes, in the gene IL33 against asthma and allergic disease, and in the gene IFIH1 against hypothyroidism. In the gene PDE3B, pLOF variants associate with elevated height, improved body fat distribution and protection from coronary artery disease. Our findings prioritize genes for which pharmacologic mimics of pLOF variants may lower risk for disease.

Achieving rapid door-to-balloon times: how top hospitals improve complex clinical systems.

BACKGROUND: Fewer than half of patients with ST-elevation acute myocardial infarction (STEMI) are treated within guideline-recommended door-to-balloon times; however, little information is available about the approaches used by hospitals that have been successful in improving door-to-balloon times to meet guidelines. We sought to characterize experiences of hospitals with outstanding improvement in door-to-balloon time during 1999-2002. METHODS AND RESULTS: We performed a qualitative study using in-depth interviews (n=122) with clinical and administrative staff at 11 hospitals that were participating with the National Registry of Myocardial Infarction and had median door-to-balloon times of < or =90 minutes during 2001-2002, representing substantial improvement since 1999. Data were organized with the use of NUD-IST 4 (Sage Publications Software) and were analyzed by the constant comparative method of qualitative data analysis. Eight themes characterized hospitals' experiences: commitment to an explicit goal to improve door-to-balloon time motivated by internal and external pressures; senior management support; innovative protocols; flexibility in refining standardized protocols; uncompromising individual clinical leaders; collaborative teams; data feedback to monitor progress and identify problems and successes; and an organizational culture that fostered resilience to challenges or setbacks in improvement efforts. CONCLUSIONS: Several themes characterized the experiences of hospitals that had achieved notable improvements in their door-to-balloon times. By distilling the complex and diverse experiences of organizational change into its essential components, this study provides a foundation for future efforts to elevate clinical performance in the hospital setting.

An administrative claims model suitable for profiling hospital performance based on 30-day mortality rates among patients with heart failure.

BACKGROUND: A model using administrative claims data that is suitable for profiling hospital performance for heart failure would be useful in quality assessment and improvement efforts. METHODS AND RESULTS: We developed a hierarchical regression model using Medicare claims data from 1998 that produces hospital risk-standardized 30-day mortality rates. We validated the model by comparing state-level standardized estimates with state-level standardized estimates calculated from a medical record model. To determine the stability of the model over time, we used annual Medicare cohorts discharged in 1999-2001. The final model included 24 variables and had an area under the receiver operating characteristic curve of 0.70. In the derivation set from 1998, the 25th and 75th percentiles of the risk-standardized mortality rates across hospitals were 11.6% and 12.8%, respectively. The 95th percentile was 14.2%, and the 5th percentile was 10.5%. In the validation samples, the 5th and 95th percentiles of risk-standardized mortality rates across states were 9.9% and 13.9%, respectively. Correlation between risk-standardized state mortality rates from claims data and rates derived from medical record data was 0.95 (SE=0.015). The slope of the weighted regression line from the 2 data sources was 0.76 (SE=0.04) with intercept of 0.03 (SE=0.004). The median difference between the claims-based state risk-standardized estimates and the chart-based rates was <0.001 (25th percentile=-0.003; 75th percentile=0.002). The performance of the model was stable over time. CONCLUSIONS: This administrative claims-based model produces estimates of risk-standardized state mortality that are very good surrogates for estimates derived from a medical record model.

An administrative claims model suitable for profiling hospital performance based on 30-day mortality rates among patients with an acute myocardial infarction.

BACKGROUND: A model using administrative claims data that is suitable for profiling hospital performance for acute myocardial infarction would be useful in quality assessment and improvement efforts. We sought to develop a hierarchical regression model using Medicare claims data that produces hospital risk-standardized 30-day mortality rates and to validate the hospital estimates against those derived from a medical record model. METHODS AND RESULTS: For hospital estimates derived from claims data, we developed a derivation model using 140,120 cases discharged from 4664 hospitals in 1998. For the comparison of models from claims data and medical record data, we used the Cooperative Cardiovascular Project database. To determine the stability of the model over time, we used annual Medicare cohorts discharged in 1995, 1997, and 1999-2001. The final model included 27 variables and had an area under the receiver operating characteristic curve of 0.71. In a comparison of the risk-standardized hospital mortality rates from the claims model with those of the medical record model, the correlation coefficient was 0.90 (SE=0.003). The slope of the weighted regression line was 0.95 (SE=0.007), and the intercept was 0.008 (SE=0.001), both indicating strong agreement of the hospital estimates between the 2 data sources. The median difference between the claims-based hospital risk-standardized mortality rates and the chart-based rates was <0.001 (25th and 75th percentiles, -0.003 and 0.003). The performance of the model was stable over time. CONCLUSIONS: This administrative claims-based model for profiling hospitals performs consistently over several years and produces estimates of risk-standardized mortality that are good surrogates for estimates from a medical record model.

Randomized trial of Telemonitoring to Improve Heart Failure Outcomes (Tele-HF): study design.

BACKGROUND: Telemonitoring, the use of communication technology to monitor clinical status, is gaining attention as a strategy to improve the care of patients with heart failure. A system of frequent monitoring could alert clinicians to early heart failure decompensation, providing the opportunity for intervention before patients become severely ill and require hospitalization. Moreover, patients' participation in a daily monitoring program could have a favorable effect on their health behaviors. The literature on telemonitoring for heart failure, however, is quite limited. METHODS AND MATERIALS: Telemonitoring to Improve Heart Failure Outcomes (Tele-HF) is a randomized, controlled, trial designed to compare an automated, daily symptom, and self-reported weight monitoring intervention with usual care in reducing (all-cause) hospital readmissions and mortality among patients recently hospitalized with decompensated heart failure. The intervention will be implemented and all outcomes will be assessed over a 6-month period. The purpose of the intervention is to collect information about symptoms, clinical status and weight and to engage participants in their own self-care. Participants are recruited from general cardiology, heart failure specialty, and primary care practices across the United States. CONCLUSIONS: The results of this study may inform future policy decisions regarding implementation of telemonitoring in treatment of heart failure.

Telemonitoring for patients with chronic heart failure: a systematic review.

BACKGROUND: Telemonitoring, the use of communication technology to remotely monitor health status, is an appealing strategy for improving disease management. METHODS AND RESULTS: We searched Medline databases, bibliographies, and spoke with experts to review the evidence on telemonitoring in heart failure patients. Interventions included: telephone-based symptom monitoring (n = 5), automated monitoring of signs and symptoms (n = 1), and automated physiologic monitoring (n = 1). Two studies directly compared effectiveness of 2 or more forms of telemonitoring. Study quality and intervention type varied considerably. Six studies suggested reduction in all-cause and heart failure hospitalizations (14% to 55% and 29% to 43%, respectively) or mortality (40% to 56%) with telemonitoring. Of the 3 negative studies, 2 enrolled low-risk patients and patients with access to high quality care, whereas 1 enrolled a very high-risk Hispanic population. Studies comparing forms of telemonitoring demonstrated similar effectiveness. However, intervention costs were higher with more complex programs (8383 dollars per patient per year) versus less complex programs (1695 dollars per patient per year). CONCLUSION: The evidence base for telemonitoring in heart failure is currently quite limited. Based on the available data, telemonitoring may be an effective strategy for disease management in high-risk heart failure patients.

Impact of Telemonitoring on Health Status.

BACKGROUND: Although noninvasive telemonitoring in patients with heart failure does not reduce mortality or hospitalizations, less is known about its effect on health status. This study reports the results of a randomized clinical trial of telemonitoring on health status in patients with heart failure. METHODS AND RESULTS: Among 1521 patients with recent heart failure hospitalization randomized in the Tele-HF trial (Telemonitoring to Improve Heart Failure Outcomes), 756 received telephonic monitoring and 765 usual care. Disease-specific health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within 2 weeks of discharge and at 3 and 6 months. Repeated measures linear regression models were used to assess differences in KCCQ scores between patients assigned to telemonitoring and usual care over 6 months. The baseline characteristics of the 2 treatment arms were similar (mean age, 61 years; 43% female and 39% black). Over the 6-month follow-up period, there was a statistically significant, but clinically small, difference between the 2 groups in their KCCQ overall summary and subscale scores. The average KCCQ overall summary score for those receiving telemonitoring was 2.5 points (95% confidence interval, 0.38-4.67; P=0.02) higher than usual care, driven primarily by improvements in symptoms (3.5 points; 95% confidence interval, 1.18-5.82; P=0.003) and social function (3.1 points; 95% confidence interval, 0.30-6.00; P=0.03). CONCLUSIONS: Telemonitoring results in statistically significant, but clinically small, improvements in health status when compared with usual care. Given that the KCCQ was a secondary outcome, the benefits should be confirmed in future studies. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00303212.

Patients with depressive symptoms have lower health status benefits after coronary artery bypass surgery.

BACKGROUND: Depression is an established independent prognostic factor for mortality, readmission, and cardiac events after CABG surgery. However, limited data exist on whether depression influences functional outcomes after CABG. METHODS AND RESULTS: We followed 963 patients who underwent first CABG between February 1999 and February 2001. At baseline and at 6 months after CABG, we interviewed patients to assess depressive symptoms using the Geriatric Depression Scale (GDS) and physical function using the Short Form-36 Physical Component Scale (PCS). The patient's physical function was considered improved if the PCS score increased > or =5 points at 6 months. Patients with high GDS scores were younger, were more often female, and had worse physical function and higher comorbidity than patients with low GDS scores. Rates of improvement in physical function were 60.1% for a GDS score <5 (below 75th percentile), 49.8% for a GDS score between 5 and 9 (75th to 90th percentile), and 39.7% for a GDS score > or =10 (> or =90th percentile; P=0.002 for the trend). Depressive symptoms remained a significant independent predictor of lack of functional improvement after adjustment for severity of coronary artery disease, angina class, baseline PCS score, and medical history. A GDS score > or =10 was a stronger inverse risk factor for functional improvement after CABG than such traditional measures of disease severity as previous myocardial infarction, heart failure on admission, history of diabetes, and left ventricular ejection fraction. CONCLUSIONS: Higher levels of depressive symptoms at the time of CABG are a strong risk factor for lack of functional benefits 6 months after CABG.

A randomized outpatient trial of a decision-support information technology tool.

BACKGROUND: Decision-support information technology is often adopted to improve clinical decision making, but it is rarely rigorously evaluated. Congress mandated the evaluation of Problem-Knowledge Couplers (PKC Corp, Burlington, Vt), a decision-support tool proposed for the Department of Defense's new health information network. METHODS: This was a patient-level randomized trial conducted at 2 military practices. A total of 936 patients were allocated to the intervention group and 966 to usual care. Couplers were applied before routine ambulatory clinic visits. The primary outcome was quality of care, which was assessed based on the total percentage of any of 24 health care quality process measures (opportunities to provide evidence-based care) that were fulfilled. Secondary outcomes included medical resources consumed within 60 days of enrollment and patient and provider satisfaction. RESULTS: There were 4639 health care opportunities (2374 in the Coupler group and 2265 in the usual-care group), with no difference in the proportion of opportunities fulfilled (33.9% vs 30.7%; P = .12). Although there was a modest improvement in performance on screening/preventive measures, it was offset by poorer performance on some measures of acute care. Coupler patients used more laboratory and pharmacy resources than usual-care patients (logarithmic mean difference, 71 dollars). No difference in patient satisfaction was observed between groups, and provider satisfaction was mixed. CONCLUSION: This study provides no strong evidence to support the utility of this decision-support tool, but it demonstrates the value of rigorous evaluation of decision-support information technology.