Publications by authors named "Michael Pencina"

364 Publications

Impact of train/test sample regimen on performance estimate stability of machine learning in cardiovascular imaging.

Sci Rep 2021 Jul 14;11(1):14490. Epub 2021 Jul 14.

University of California at Los Angeles, Los Angeles, CA, USA.

As machine learning research in the field of cardiovascular imaging continues to grow, obtaining reliable model performance estimates is critical to develop reliable baselines and compare different algorithms. While the machine learning community has generally accepted methods such as k-fold stratified cross-validation (CV) to be more rigorous than single split validation, the standard research practice in medical fields is the use of single split validation techniques. This is especially concerning given the relatively small sample sizes of datasets used for cardiovascular imaging. We aim to examine how train-test split variation impacts the stability of machine learning (ML) model performance estimates in several validation techniques on two real-world cardiovascular imaging datasets: stratified split-sample validation (70/30 and 50/50 train-test splits), tenfold stratified CV, 10 × repeated tenfold stratified CV, bootstrapping (500 × repeated), and leave one out (LOO) validation. We demonstrate that split validation methods lead to the highest range in AUC and statistically significant differences in ROC curves, unlike the other aforementioned approaches. When building predictive models on relatively small data sets as is often the case in medical imaging, split-sample validation techniques can produce instability in performance estimates with variations in range over 0.15 in the AUC values, and thus any of the alternate validation methods are recommended.
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http://dx.doi.org/10.1038/s41598-021-93651-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8280147PMC
July 2021

Competing Risks, Treatment Switching, and Informative Censoring.

JAMA Cardiol 2021 May 19. Epub 2021 May 19.

Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.

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http://dx.doi.org/10.1001/jamacardio.2021.1239DOI Listing
May 2021

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease.

N Engl J Med 2021 05 15;384(21):1981-1990. Epub 2021 May 15.

From Duke Clinical Research Institute, Duke University, Durham (W.S.J., H.M., L.M.W., M.J.P., M.T.R., H.R.R., L.H.C., A.G.S., L.G.B., B.G.H., D.F.H., L.G.Q., G.M.-G., A.F.H.), University of North Carolina at Chapel Hill, Chapel Hill (D.A.D.), and Wake Forest University School of Medicine, Winston-Salem (L.Z.) - all in North Carolina; Vanderbilt University Medical Center, Nashville (S.K., D.M., D.L.C., R.L.R.); Ochsner Health (M.B.E., R.N.R.) and Louisiana Public Health Institute (T.W.C., E.N.) - both in New Orleans; University of Kansas Medical Center, Kansas City (K.G.); University of Florida, Gainesville (R.D.A., C.J.P., E.M.H., B.R.M., E.A.S.); University of Pittsburgh Medical Center, Pittsburgh (S.K.J., K.M.M.), Penn State College of Medicine, Hershey (J.L.K.), and Temple University, Philadelphia (A.P.) - all in Pennsylvania; University of Iowa, Iowa City (S.G., D.R.); Medical College of Wisconsin, Milwaukee (J.W.), and Marshfield Clinic Research Institute, Marshfield (J.J.V.) - both in Wisconsin; Albert Einstein College of Medicine, Bronx (Y.H.G.), and Weill Cornell Medicine and New York-Presbyterian Hospital, New York (R.K.) - both in New York; Mayo Clinic, Rochester (V.L.R.), Essentia Health Heart and Vascular Center, Duluth (C.P.B.), and Allina Health and Minneapolis Heart Institute, Minneapolis (S.M.B.) - all in Minnesota; University of Utah School of Medicine (R.H.) and Intermountain Medical Center Heart Institute (K.U.K.) - both in Salt Lake City; University of Michigan, Ann Arbor (P.F.); Johns Hopkins University School of Medicine, Baltimore (D.E.F.); HealthCore, Wilmington, DE (K.H.); University of Chicago Medicine (T.S.P.) and Northwestern University Feinberg School of Medicine (D.J.F., F.S.A., A.M.K.) - both in Chicago; University of Nebraska Medical Center, Omaha (J.C.M., J.R.C.); University of California, Los Angeles, Los Angeles (D.S.B., G.C.F.), University of California, San Francisco, San Francisco (M.F.M., G.M.M.), and Stanford University School of Medicine, Stanford (R.A.H.) - all in California; University of Missouri School of Medicine, Columbia (L.R.W.); University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (F.A.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.M.A.); Chicago (D.R.D.); St. Joseph, MO (K.E.); Brighton, MI (J.G.M.); Columbia, TN (L.S.B.); Alachua, FL (D.N.Z.); Columbia, MD (T.E.M.); North Hills, CA (J.D.A.); and Metairie, LA (K.C.G.).

Background: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.

Methods: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis.

Results: A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]).

Conclusions: In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).
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http://dx.doi.org/10.1056/NEJMoa2102137DOI Listing
May 2021

Clinical reasoning and prevention of cardiovascular disease.

J Clin Lipidol 2021 May-Jun;15(3):394-398. Epub 2021 Apr 29.

Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Department of Medicine, McGill University Health Centre, Montreal, Quebec.

All the major lipid prevention guidelines agree that the 10-year risk of a cardiovascular event should be the primary method to select individuals for statin prevention of a cardiovascular event. They also all rely on LDL cholesterol (LDL-C) as the primary metric to monitor lipid lowering therapy. These two principles form the major instruments on which primary prevention of cardiovascular disease is based worldwide. Their application is based on decades of prospective observational studies and large numbers of randomized clinical trials. Their development and application are milestones in medical progress. But are there limits, which were unseen and unintended, that need to be identified and overcome so that cardiovascular prevention can improve? Based on new insights and old knowledge, this Viewpoint will apply Clinical Reasoning, the process by which we integrate all the relevant knowledge, including the knowledge we have gained from physiology, pathology, epidemiology, metabolism, experimental models of disease, and our clinical experience as well as the results of randomized clinical trials to the analysis of a single case to answer these questions. Moreover, this Viewpoint will challenge the universal practice of relating the clinical outcomes of the major successful lipid lowering trials to the decrease in LDL-C and argue that cardiovascular prevention should move from the Risk model to the Causal Benefit model. This Viewpoint will be framed around a single case because, as caregivers, we make decisions case by case and because, as caregivers, the individual is the true object of our concern.
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http://dx.doi.org/10.1016/j.jacl.2021.04.001DOI Listing
April 2021

Effects of hybrid comprehensive telerehabilitation on cardiopulmonary capacity in heart failure patients depending on diabetes mellitus: subanalysis of the TELEREH-HF randomized clinical trial.

Cardiovasc Diabetol 2021 05 13;20(1):106. Epub 2021 May 13.

1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.

Background: Type 2 diabetes mellitus (DM) is one of the most common comorbidities among patients with heart failure (HF) with reduced ejection fraction (HFrEF). There are limited data regarding efficacy of hybrid comprehensive telerehabilitation (HCTR) on cardiopulmonary exercise capacity in patients with HFrEF with versus those without diabetes.

Aim: The aim of the present study was to analyze effects of 9-week HCTR in comparison to usual care on parameters of cardiopulmonary exercise capacity in HF patients according to history of DM.

Methods: Clinically stable HF patients with left ventricular ejection fraction [LVEF] < 40% after a hospitalization due to worsening HF within past 6 months were enrolled in the TELEREH-HF (The TELEREHabilitation in Heart Failure Patients) trial and randomized to the HCTR or usual care (UC). Cardiopulmonary exercise tests (CPET) were performed on treadmill with an incremental workload according to the ramp protocol.

Results: CPET was performed in 385 patients assigned to HCTR group: 129 (33.5%) had DM (HCTR-DM group) and 256 patients (66.5%) did not have DM (HCTR-nonDM group). Among 397 patients assigned to UC group who had CPET: 137 (34.5%) had DM (UC-DM group) and 260 patients (65.5%) did not have DM (UC-nonDM group). Among DM patients, differences in cardiopulmonary parameters from baseline to 9 weeks remained similar among HCTR and UC patients. In contrast, among patients without DM, HCTR was associated with greater 9-week changes than UC in exercise time, which resulted in a statistically significant interaction between patients with and without DM: difference in changes in exercise time between HCTR versus UC was 12.0 s [95% CI - 15.1, 39.1 s] in DM and 43.1 s [95% CI 24.0, 63.0 s] in non-DM, interaction p-value = 0.016. Furthermore, statistically significant differences in the effect of HCTR versus UC between DM and non-DM were observed in ventilation at rest: - 0.34 l/min [95% CI - 1.60, 0.91 l/min] in DM and 0.83 l/min [95% CI - 0.06, 1.73 l/min] in non-DM, interaction p value = 0.0496 and in VE/VCO slope: 1.52 [95% CI - 1.55, 4.59] for DM vs. - 1.44 [95% CI - 3.64, 0.77] for non-DM, interaction p value = 0.044.

Conclusions: The benefits of hybrid comprehensive telerehabilitation versus usual care on the improvement of physical performance, ventilatory profile and gas exchange parameters were more pronounced in patients with HFrEF without DM as compared to patients with DM.

Trial Registration: ClinicalTrials.gov Identifier: NCT02523560. Registered 3rd August 2015. https://clinicaltrials.gov/ct2/show/NCT02523560?term=NCT02523560&draw=2&rank=1 . Other Study ID Numbers: STRATEGME1/233547/13/NCBR/2015.
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http://dx.doi.org/10.1186/s12933-021-01292-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8120915PMC
May 2021

Incremental Benefits of Machine Learning-When Do We Need a Better Mousetrap?

JAMA Cardiol 2021 Jun;6(6):621-623

Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1001/jamacardio.2021.0139DOI Listing
June 2021

An aetiology-based subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial.

ESC Heart Fail 2021 04 1;8(2):1263-1273. Epub 2021 Feb 1.

Telecardiology Center, National Institute of Cardiology, Warsaw, Poland.

Aims: The aim of our study was to analyse the benefits of a 9 week hybrid comprehensive telerehabilitation (HCTR) programme in heart failure (HF) patients according to aetiology, as a subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial.

Methods And Results: Overall, 555 (65.3%) patients with ischaemic (IS) and 295 (34.7%) patients with non-ischaemic (NIS) HF aetiology were randomized. There were no differences between the effect of HCTR and usual care (UC) on the primary outcome of number of days alive and out of the hospital in 26 months from the time of randomization in either aetiology (Wilcoxon-Mann-Whitney test), and no heterogeneity of effect between the aetiologies was noted (van Elteren test, P = 0.746). In Cox proportional hazards regression analysis, treatment was not independently associated with the secondary outcomes. For all-cause mortality, the adjusted hazard ratio for HCTR vs. UC was 0.90 (95% confidence interval, 0.54-1.51) in IS and 1.42 (95% confidence interval, 0.69-2.94) in NIS (P interaction = 0.316). Differences between HCTR and UC in terms of change in the 6 min walk test distance and cardiopulmonary exercise test time after 9 weeks reached statistical significance in the IS arm (P = 0.015 and P < 0.001, respectively), but not in the NIS arm; however, tests of heterogeneity indicated no statistically significant differences.

Conclusions: The trial showed no difference between HCTR and UC in the primary outcome of percentage of days alive and out of the hospital for either IS or NIS aetiology. Moreover, the magnitude of changes in the clinical and functional statuses of the HF patients did not differ by aetiology. HCTR might have had beneficial effects on the 6 min walk test distance and cardiopulmonary exercise test time after 9 weeks in the IS patients; however, the effect was not statistically significantly different from that observed in the NIS patients.
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http://dx.doi.org/10.1002/ehf2.13189DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006702PMC
April 2021

The Dose-Response Relationship Between Physical Activity and Cardiometabolic Health in Adolescents.

Am J Prev Med 2021 01;60(1):95-103

Duke Clinical Research Institute, Durham, North Carolina; Duke Center for Childhood Obesity Research, Duke University School of Medicine, Durham, North Carolina; Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina; Duke Children's Health and Discovery Initiative, Duke University School of Medicine, Durham, North Carolina.

Introduction: This study examines the dose-response relationship between moderate-to-vigorous physical activity and cardiometabolic measures in adolescents.

Methods: Cross-sectional spline analyses were performed using 2003-2016 National Health and Nutrition Examination Survey data among adolescents (aged 12-19 years, N=9,195) on objectively measured (2003-2006) and self-reported (2007-2016) weekly mean minutes of moderate-to-vigorous physical activity and cardiometabolic measures (systolic and diastolic blood pressure, total cholesterol, high-density lipoprotein, BMI, and cardiorespiratory fitness). Inflection points were determined for nonlinear relationships.

Results: For objective moderate-to-vigorous physical activity, female adolescents had significant nonlinear associations with inflection points at 90 minutes/week for BMI percentile and systolic blood pressure. Male adolescents had inflection points at 150 weekly minutes of objective activity for BMI percentile and cardiorespiratory fitness. BMI percentile was about 7% lower for female and male adolescents at 150 weekly minutes of objectively measured moderate-to-vigorous physical activity than at 0 minutes. For self-reported moderate-to-vigorous physical activity, inflection points were at 375 minutes/week (diastolic blood pressure for female adolescents) and 500 minutes/week (systolic blood pressure for male adolescents).

Conclusions: Among several significant dose-response relationships between physical activity and cardiometabolic health in adolescents, consistent and often nonlinear relationships were identified for BMI, with inflection points at 90-150 minutes of objective moderate-to-vigorous physical activity. Notable differences in associations and linearity were identified by sex and physical activity measure (objective or self-reported). These results support calls for any increase in physical activity among adolescents and suggest that recommendations closer to the adult guidelines of 150 weekly minutes of physical activity may be health promoting and more attainable for youth than the current recommendation of 420 weekly minutes.
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http://dx.doi.org/10.1016/j.amepre.2020.06.027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7769140PMC
January 2021

Remote Monitoring of Cardiac Implantable Electronic Devices in Patients Undergoing Hybrid Comprehensive Telerehabilitation in Comparison to the Usual Care. Subanalysis from Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomised Clinical Trial.

J Clin Med 2020 Nov 20;9(11). Epub 2020 Nov 20.

Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Division of Medical Sciences in Zabrze, Medical University of Silesia, 41-800 Zabrze, Poland.

Background: The impact of cardiac rehabilitation on the number of alerts in patients with remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is unknown. We compared alerts in RM and outcomes in patients with CIEDs undergoing hybrid comprehensive telerehabilitation (HCTR) versus usual care (UC).

Methods: Patients with heart failure (HF) after a hospitalization due to worsening HF within the last 6 months (New York Heart Association (NYHA) class I-III and left ventricular ejection fraction (LVEF) ≤40%) were enrolled in the TELEREH-HF study and randomised 1:1 to HCTR or UC. Patients with HCTR and CIEDs received RM (HCTR-RM). Patients with UC and CIEDs were offered RM optionally (UC-RM). Data from the initial 9 weeks of the study were analysed.

Results: Of 850 enrolled patients, 208 were in the HCTR-RM group and 62 in the UC-RM group. The HCTR-RM group was less likely to have alerts of intrathoracic impedance (TI) decrease ( < 0.001), atrial fibrillation (AF) occurrence ( = 0.031) and lower mean number of alerts per patient associated with TI decrease ( < 0.0001) and AF ( = 0.019) than the UC-RM group. HCTR significantly decreased the occurrence of alerts in RM of CIEDs, 0.360 (95%CI, 0.189-0.686; = 0.002), in multivariable regression analysis. There were two deaths in the HCTR-RM group (0.96%) and no deaths in the UC-RM group ( = 1.0). There were no differences in the number of hospitalised patients between the HCTR-RM and UC-RM group ( = 1.0).

Conclusions: HCTR significantly reduced the number of patients with RM alerts of CIEDs related to TI decrease and AF occurrence. There were no differences in mortality or hospitalisation rates between HCTR-RM and UC-RM groups.
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http://dx.doi.org/10.3390/jcm9113729DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7699808PMC
November 2020

Testing Clinical Prediction Models.

JAMA 2020 11;324(19):1998-1999

Department of Biostatistics & Bioinformatics, Duke University, Durham, North Carolina.

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http://dx.doi.org/10.1001/jama.2020.19392DOI Listing
November 2020

Impact of the COVID-19 pandemic on patterns of outpatient cardiovascular care.

Am Heart J 2021 01 1;231:1-5. Epub 2020 Nov 1.

Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Durham, NC, USA.

Background: The coronavirus disease 2019 (COVID-19) pandemic brought about abrupt changes in the way health care is delivered, and the impact of transitioning outpatient clinic visits to telehealth visits on processes of care and outcomes is unclear.

Methods: We evaluated ordering patterns during cardiovascular telehealth clinic visits in the Duke University Health System between March 15 and June 30, 2020 and 30-day outcomes compared with in-person visits in the same time frame in 2020 and in 2019.

Results: Within the Duke University Health System, there was a 33.1% decrease in the number of outpatient cardiovascular visits conducted in the first 15 weeks of the COVID-19 pandemic, compared with the same time period in 2019. As a proportion of total visits initially booked, 53% of visits were cancelled in 2020 compared to 35% in 2019. However, patients with cancelled visits had similar demographics and comorbidities in 2019 and 2020. Telehealth visits comprised 9.3% of total visits initially booked in 2020, with younger and healthier patients utilizing telehealth compared with those utilizing in-person visits. Compared with in-person visits in 2020, telehealth visits were associated with fewer new (31.6% for telehealth vs 44.6% for in person) or refill (12.9% vs 15.6%, respectively) medication prescriptions, electrocardiograms (4.3% vs 31.4%), laboratory orders (5.9% vs 21.8%), echocardiograms (7.3% vs 98%), and stress tests (4.4% vs 6.6%). When adjusted for age, race, and insurance status, those who had a telehealth visit or cancelled their visit were less likely to have an emergency department or hospital encounter within 30 days compared with those who had in-person visits (adjusted rate ratios (aRR) 0.76 [95% 0.65, 0.89] and aRR 0.71 [95% 0.65, 0.78], respectively).

Conclusions: In response to the perceived risks of routine medical care affected by the COVID-19 pandemic, different phenotypes of patients chose different types of outpatient cardiology care. A better understanding of these differences could help define necessary and appropriate mode of care for cardiology patients.
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http://dx.doi.org/10.1016/j.ahj.2020.10.074DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7604084PMC
January 2021

Calibration and Uncertainty in Neural Time-to-Event Modeling.

IEEE Trans Neural Netw Learn Syst 2020 Oct 29;PP. Epub 2020 Oct 29.

Models for predicting the time of a future event are crucial for risk assessment, across a diverse range of applications. Existing time-to-event (survival) models have focused primarily on preserving pairwise ordering of estimated event times (i.e., relative risk). We propose neural time-to-event models that account for calibration and uncertainty while predicting accurate absolute event times. Specifically, an adversarial nonparametric model is introduced for estimating matched time-to-event distributions for probabilistically concentrated and accurate predictions. We also consider replacing the discriminator of the adversarial nonparametric model with a survival-function matching estimator that accounts for model calibration. The proposed estimator can be used as a means of estimating and comparing conditional survival distributions while accounting for the predictive uncertainty of probabilistic models. Extensive experiments show that the distribution matching methods outperform existing approaches in terms of both calibration and concentration of time-to-event distributions.
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http://dx.doi.org/10.1109/TNNLS.2020.3029631DOI Listing
October 2020

Understanding Observational Treatment Comparisons in the Setting of Coronavirus Disease 2019 (COVID-19).

JAMA Cardiol 2020 09;5(9):988-990

Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1001/jamacardio.2020.1874DOI Listing
September 2020

Federal judge invalidates icosapent ethyl patents - but on the basis of a common statistical mistake.

Nat Biotechnol 2020 08;38(8):939-941

Duke University School of Medicine, Durham, NC, USA.

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http://dx.doi.org/10.1038/s41587-020-0616-yDOI Listing
August 2020

The Expected 30-Year Benefits of Early Versus Delayed Primary Prevention of Cardiovascular Disease by Lipid Lowering.

Circulation 2020 Sep 23;142(9):827-837. Epub 2020 Jul 23.

Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Department of Medicine, McGill University, Montreal, Quebec (G.T., A.D.S.).

Background: Lipid-lowering recommendations for prevention of atherosclerotic cardiovascular disease rely principally on estimated 10-year risk. We sought to determine the optimal time for initiation of lipid lowering in younger adults as a function of expected 30-year benefit.

Methods: Data from 3148 National Health and Nutrition Examination Survey (2009-2016) participants, age 30 to 59 years, not eligible for lipid-lowering treatment recommendation under the most recent US guidelines, were analyzed. We estimated the absolute and relative impact of lipid lowering as a function of age, age at initiation, and non-high-density lipoprotein cholesterol (HDL-C) level on the expected rates of atherosclerotic cardiovascular disease over the succeeding 30 years. We modeled expected risk reductions based on shorter-term effects observed in statin trials (model A) and longer-term benefits based on Mendelian randomization studies (model B).

Results: In both models, potential reductions in predicted 30-year atherosclerotic cardiovascular disease risk were greater with older age and higher non-HDL-C level. Immediate initiation of lipid lowering (ie, treatment for 30 years) in 40- to 49-year-old patients with non-HDL-C ≥160 mg/dL would be expected to reduce their average predicted 30-year risk of 17.1% to 11.6% (model A; absolute risk reduction [ARR], 5.5%) or 6.5% (model B; ARR 10.6%). Delaying lipid lowering by 10 years (treatment for 20 years) would result in residual 30-year risk of 12.7% (A; ARR 4.4) or 9.9% (B; ARR 7.2%) and delaying by 20 years (treatment for 10 years) would lead to expected mean residual risk of 14.6% (A; ARR 2.6%) or 13.9% (B; ARR 3.2%). The slope of the achieved ARR as a function of delay in treatment was also higher with older age and higher non-HDL-C level.

Conclusions: Substantial reduction in expected atherosclerotic cardiovascular disease risk in the next 30 years is achievable by intensive lipid lowering in individuals in their 40s and 50s with non-HDL-C ≥160 mg/dL. For many, the question of when to start lipid lowering might be more relevant than whether to start lipid lowering.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.045851DOI Listing
September 2020

The Dose-Response Relationship Between Physical Activity and Cardiometabolic Health in Young Adults.

J Adolesc Health 2020 08 19;67(2):201-208. Epub 2020 Jun 19.

Duke Clinical Research Institute, Durham, North Carolina; Duke Center for Childhood Obesity Research, Duke University School of Medicine, Durham, North Carolina; Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina; Children's Health and Discovery Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address:

Purpose: Guidelines recommend 150 minutes of weekly moderate-to-vigorous physical activity (MVPA) for all adults, although physical activity level correlation with cardiometabolic health is not well characterized for young adults. We determined the dose-response relationship of MVPA on measures of cardiometabolic health in young adults.

Methods: We examined young adults (aged 20-29 years; N = 5,395, 47.9% female) in the 2003-2016 National Health and Nutrition Examination Survey. Exposures were objective (accelerometer based) and self-reported weekly mean minutes of MVPA. Cardiometabolic outcome measures were body mass index (BMI), high-density lipoprotein (HDL), total cholesterol, systolic blood pressure, and diastolic blood pressure. The dose-response relationships were assessed with unadjusted spline analyses. Sex-stratified outcomes were modeled using multivariable linear regression with mean estimated change presented for 150-minute dose increases of MVPA.

Results: Among females, associations between objective activity and cardiometabolic measures were all linear. Compared with no activity, 150 minutes of objective activity was associated with a lower BMI (-1.37 kg/m) and total cholesterol (-4.89 mg/dL), whereas 150 minutes of self-reported activity was associated with a higher HDL (1 mg/dL) and lower diastolic blood pressure (-.42 mm Hg). Among males, an inflection point was identified in the dose-response curves for objective activity with BMI around 100 minutes. Compared with no activity, 150 self-reported minutes was associated with lower BMI (-.26 kg/m), higher HDL (.52 mg/dL), and lower total cholesterol (-1.35 mg/dL).

Conclusions: The dose-response relationships between physical activity and cardiometabolic markers in young adults were predominantly linear, supporting public health calls for any increase in physical activity in this population.
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http://dx.doi.org/10.1016/j.jadohealth.2020.04.021DOI Listing
August 2020

The Project Baseline Health Study: a step towards a broader mission to map human health.

NPJ Digit Med 2020 5;3:84. Epub 2020 Jun 5.

Duke University, School of Medicine, Durham, NC USA.

The Project Baseline Health Study (PBHS) was launched to map human health through a comprehensive understanding of both the health of an individual and how it relates to the broader population. The study will contribute to the creation of a biomedical information system that accounts for the highly complex interplay of biological, behavioral, environmental, and social systems. The PBHS is a prospective, multicenter, longitudinal cohort study that aims to enroll thousands of participants with diverse backgrounds who are representative of the entire health spectrum. Enrolled participants will be evaluated serially using clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, and other health-related measurements. An initial deeply phenotyped cohort will inform the development of a large, expanded virtual cohort. The PBHS will contribute to precision health and medicine by integrating state of the art testing, longitudinal monitoring and participant engagement, and by contributing to the development of an improved platform for data sharing and analysis.
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http://dx.doi.org/10.1038/s41746-020-0290-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275087PMC
June 2020

Overlap Weighting: A Propensity Score Method That Mimics Attributes of a Randomized Clinical Trial.

JAMA 2020 06;323(23):2417-2418

Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.

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http://dx.doi.org/10.1001/jama.2020.7819DOI Listing
June 2020

Prediction Models - Development, Evaluation, and Clinical Application.

N Engl J Med 2020 Apr;382(17):1583-1586

From the Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.J.P., B.A.G.); and the Department of Mathematics and Statistics, Boston University, Boston (R.B.D.).

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http://dx.doi.org/10.1056/NEJMp2000589DOI Listing
April 2020

Prevention of cardiovascular disease: time for a course correction.

Eur Heart J 2020 08;41(31):3016-3017

Duke University School of Medicine, Durham, NC, USA.

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http://dx.doi.org/10.1093/eurheartj/ehaa259DOI Listing
August 2020

Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial.

JAMA Cardiol 2020 05;5(5):598-607

Minneapolis Heart Institute, Minneapolis Heart Institute Foundation, Minneapolis.

Importance: Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question.

Objective: To report the rationale and design for a randomized clinical trial to determine the optimal dosage of aspirin to be used for secondary prevention of ASCVD, using an innovative research method.

Design, Setting, And Participants: This pragmatic, open-label, patient-centered, randomized clinical trial is being conducted in 15 000 patients within the National Patient-Centered Clinical Research Network (PCORnet), a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the United States. Patients with established ASCVD treated in routine clinical practice within the network are eligible. Patient recruitment began in April 2016. Enrollment was completed in June 2019. Final follow-up is expected to be completed by June 2020.

Interventions: Participants are randomized on a web platform in a 1:1 fashion to either 81 mg or 325 mg of aspirin daily.

Main Outcomes And Measures: The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke. The primary safety end point is hospitalization for major bleeding associated with a blood-product transfusion. End points are captured through regular queries of the health systems' common data model within the structure of PCORnet's distributed data environment.

Conclusions And Relevance: As a pragmatic study and the first interventional trial conducted within the PCORnet electronic data infrastructure, this trial is testing several unique and innovative operational approaches that have the potential to disrupt and transform the conduct of future patient-centered randomized clinical trials by evaluating treatments integrated in clinical practice while at the same time determining the optimal dosage of aspirin for secondary prevention of ASCVD.

Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.
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http://dx.doi.org/10.1001/jamacardio.2020.0116DOI Listing
May 2020

Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study.

Ann Allergy Asthma Immunol 2020 05 8;124(5):487-493.e1. Epub 2020 Jan 8.

Brigham and Women's Hospital, Division of Pulmonary and Critical Care Medicine, Boston, Massachusetts.

Background: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown.

Objective: We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols.

Methods: Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures.

Results: Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue."

Conclusion: Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures.

Clinical Trials Registration: pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).
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http://dx.doi.org/10.1016/j.anai.2019.12.027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188592PMC
May 2020

Using Propensity Score Methods to Create Target Populations in Observational Clinical Research.

JAMA 2020 02;323(5):466-467

Duke Clinical Research Institute, Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.

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http://dx.doi.org/10.1001/jama.2019.21558DOI Listing
February 2020

Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial.

JAMA Cardiol 2020 03;5(3):300-308

Department of Cardiac Rehabilitation and Noninvasive Electrocardiology, Institute of Cardiology, Warsaw, Poland.

Importance: Guidelines recommend exercise training as a component of heart failure management. There are large disparities in access to rehabilitation, and introducing hybrid comprehensive telerehabilitation (HCTR) consisting of remote monitoring of training at patients' homes might be an appealing alternative.

Objective: To assess whether potential improvements in quality-of-life outcomes after a 9-week HCTR intervention in patients with heart failure translate into improvement in clinical outcomes during extended 12 to 24 months of follow-up, compared with usual care.

Design, Setting, And Participants: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial is a multicenter, prospective, open-label, parallel-group randomized clinical trial that enrolled 850 patients with heart failure up to 6 months after a cardiovascular hospitalization with New York Heart Association levels I, II, or III and left ventricular ejection fraction of 40% or less. Patients from 5 centers in Poland were randomized 1:1 to HCTR plus usual care or usual care only and followed up for 14 to 26 months after randomization.

Interventions: During the first 9 weeks, patients underwent either an HCTR program (1 week in hospital and 8 weeks at home) or usual care with observation. The HCTR intervention encompassed telecare, telerehabilitation, and remote monitoring of implantable devices. No intervention occurred in the remaining study period.

Main Outcomes And Measures: The percentage of days alive and out of the hospital from randomization through the end of follow-up at 14 to 26 months.

Results: A total of 850 patients were enrolled, with 425 randomized to the HCTR group (377 male patients [88.7%]; mean [SD] age, 62.6 [10.8] years) and 425 randomized to usual care (376 male patients [88.5%]; mean [SD] age, 62.2 [10.2] years). The HCTR intervention did not extend the percentage of days alive and out of the hospital. The mean (SD) days were 91.9 (19.3) days in the HCTR group vs 92.8 (18.3) days in the usual-care group, with the probability that HCTR extends days alive and out of the hospital equal to 0.49 (95% CI, 0.46-0.53; P = .74) vs usual care. During follow-up, 54 patients died in the HCTR arm and 52 in the usual-care arm, with mortality rates at 26 months of 12.5% vs 12.4%, respectively (hazard ratio, 1.03 [95% CI, 0.70-1.51]). There were also no differences in hospitalization rates (hazard ratio, 0.94 [95% CI, 0.79-1.13]). The HCTR intervention was effective at 9 weeks, significantly improving peak oxygen consumption (0.95 [95% CI, 0.65-1.26] mL/kg/min vs 0.00 [95% CI, -0.31 to 0.30] mL/kg/min; P < .001) and quality of life (Medical Outcome Survey Short Form-36 questionnaire score, 1.58 [95% CI, 0.74-2.42] vs 0.00 [95% CI, -0.84 to 0.84]; P = .008), and it was well tolerated, with no serious adverse events during exercise.

Conclusions And Relevance: In this trial, the positive effects of a 9-week program of HCTR in patients with heart failure did not lead to the increase in percentage of days alive and out of the hospital and did not reduce mortality and hospitalization over a follow-up period of 14 to 26 months.

Trial Registration: ClinicalTrials.gov identifier: NCT02523560.
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http://dx.doi.org/10.1001/jamacardio.2019.5006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6865325PMC
March 2020

Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.

Am Heart J 2019 12 12;218:110-122. Epub 2019 Sep 12.

Duke University School of Medicine, Durham, NC.

Background: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes.

Methods: We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection.

Results: Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest.

Conclusions: Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.
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http://dx.doi.org/10.1016/j.ahj.2019.09.002DOI Listing
December 2019

The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement.

Ann Intern Med 2020 01 12;172(1):35-45. Epub 2019 Nov 12.

Leiden University Medical Center, Leiden, the Netherlands (E.W.S.).

Heterogeneity of treatment effect (HTE) refers to the nonrandom variation in the magnitude or direction of a treatment effect across levels of a covariate, as measured on a selected scale, against a clinical outcome. In randomized controlled trials (RCTs), HTE is typically examined through a subgroup analysis that contrasts effects in groups of patients defined "1 variable at a time" (for example, male vs. female or old vs. young). The authors of this statement present guidance on an alternative approach to HTE analysis, "predictive HTE analysis." The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risks with versus without the intervention, taking into account all relevant patient attributes simultaneously. The PATH (Predictive Approaches to Treatment effect Heterogeneity) Statement was developed using a multidisciplinary technical expert panel, targeted literature reviews, simulations to characterize potential problems with predictive approaches, and a deliberative process engaging the expert panel. The authors distinguish 2 categories of predictive HTE approaches: a "risk-modeling" approach, wherein a multivariable model predicts the risk for an outcome and is applied to disaggregate patients within RCTs to define risk-based variation in benefit, and an "effect-modeling" approach, wherein a model is developed on RCT data by incorporating a term for treatment assignment and interactions between treatment and baseline covariates. Both approaches can be used to predict differential absolute treatment effects, the most relevant scale for clinical decision making. The authors developed 4 sets of guidance: criteria to determine when risk-modeling approaches are likely to identify clinically important HTE, methodological aspects of risk-modeling methods, considerations for translation to clinical practice, and considerations and caveats in the use of effect-modeling approaches. The PATH Statement, together with its explanation and elaboration document, may guide future analyses and reporting of RCTs.
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http://dx.doi.org/10.7326/M18-3667DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7531587PMC
January 2020

The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration.

Ann Intern Med 2020 01 12;172(1):W1-W25. Epub 2019 Nov 12.

The PATH (Predictive Approaches to Treatment effect Heterogeneity) Statement was developed to promote the conduct of, and provide guidance for, predictive analyses of heterogeneity of treatment effects (HTE) in clinical trials. The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risk with versus without the intervention, taking into account all relevant patient attributes simultaneously, to support more personalized clinical decision making than can be made on the basis of only an overall average treatment effect. The authors distinguished 2 categories of predictive HTE approaches (a "risk-modeling" and an "effect-modeling" approach) and developed 4 sets of guidance statements: criteria to determine when risk-modeling approaches are likely to identify clinically meaningful HTE, methodological aspects of risk-modeling methods, considerations for translation to clinical practice, and considerations and caveats in the use of effect-modeling approaches. They discuss limitations of these methods and enumerate research priorities for advancing methods designed to generate more personalized evidence. This explanation and elaboration document describes the intent and rationale of each recommendation and discusses related analytic considerations, caveats, and reservations.
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http://dx.doi.org/10.7326/M18-3668DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7750907PMC
January 2020

Cardiovascular risk factor profiles in familial hypercholesterolemia patients with and without genetic mutation compared to a nationally representative sample of adults in a high-risk European country.

Am Heart J 2019 12 23;218:32-45. Epub 2019 Oct 23.

DCRI, Duke University School of Medicine, Durham, NC, USA.

Background: There is a paucity of data on the distribution of cardiovascular risk factors in patients with familial hypercholesterolemia (FH) as compared to the general population. The aim of the study was to compare cardiovascular risk factors in a cohort of FH patients to the representative sample of adults in Poland who represent a high-cardiovascular risk European region.

Methods: We compared the distribution of risk factors in 1,382 individuals with FH phenotype referred for genetic testing between 2006 and 2014 to the National Centre of Familial Hypercholesterolemia in Gdansk, Poland. The cohort was comprised of 637 positive FH(+) and 745 negative FH(-) patients who were compared to a nationally representative sample of 2,413 adults age 18-79, standardized by age and sex, from the NATPOL 2011 study (NATPOL). We analyzed patients' distribution of history of atherosclerotic cardiovascular disease (ASCVD) and standard risk factors including total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, triglycerides, systolic and diastolic blood pressure (SBP, DBP), body mass index, smoking, and diabetes.

Results: FH(+) patients (mean age 45.6 years) had the highest LDL-C of 241.7 mg/dL (95% CI 234.8-248.5) compared to 206.1 mg/dL (200.5-211.7) in FH(-) patients (mean age 48.2) and 126.2 mg/dL (124.8-127.6) in NATPOL. Mean SBP was the lowest in FH(+) patients at 128.7 mm Hg (126.7-130.7) compared to 133.4 mm Hg (132.6-134.3) in NATPOL and 134.4 mm Hg (132.3-136.5) in FH(-). No differences were found in the prevalence of diabetes and body mass index. Smoking was less common in FH(+) at 12.4% (9.4-15.4) compared to both FH(-) and NATPOL: 20.4% (16.6-24.1) and 28.4% (26.6-30.2), respectively. The prevalence of individuals with a history of ASCVD in both FH(+) and FH(-) was nearly 3-fold higher compared to NATPOL: 26% (21.8-30.1) and 26.6% (22.2-30.9) versus 9.5% (8.3-10.7), respectively.

Conclusions: The FH(+) patients had significantly higher mean LDL-C, but the levels of nonlipid factors were lower or similar compared to the other groups. Both FH(+) and FH(-) were characterized by a heavy burden of ASCVD. This suggests that cholesterol, and no other risk factors, is a key contributor to cardiovascular risk in patients with FH, especially those with genetic mutation.
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http://dx.doi.org/10.1016/j.ahj.2019.09.007DOI Listing
December 2019

Hybrid comprehensive telerehabilitation in heart failure patients (TELEREH-HF): A randomized, multicenter, prospective, open-label, parallel group controlled trial-Study design and description of the intervention.

Am Heart J 2019 11 22;217:148-158. Epub 2019 Aug 22.

University of Rochester Medical Center, Rochester, NY, United States.

Guidelines recommend exercise training as a component of heart failure (HF) management. There are large disparities in access to rehabilitation and introducing hybrid comprehensive telerehabilitation (TR) consisting of remote monitoring of training in patients' homes might be an optimal solution in Poland.

Purpose: The primary objective of the TELEREH-HF trial is to determine whether introducing TR will significantly increase days alive and out of hospital compared with usual care. The secondary objectives including assessment the effects of TR compared to usual care on all-cause and cardiovascular mortality and all-cause, cardiovascular and HF hospitalization. The tertiary analyses include: evaluation of the safety, effectiveness, quality of life, depression, anxiety, patients' acceptance of and adherence to TR.

Methods: The TELEREH-HF study is a randomized, multicenter, prospective, open-label, parallel group controlled trial in 850 HF patients after a hospitalization incident in NYHA I-III and LVEF≤40%. Patients were randomized to TR + usual care (TR group) or to usual care only (control group) and are followed for a maximum of 24 months. The TR group patients underwent a 9-week TR program consisting of an initial stage (1 week) conducted at hospital and a basic stage (8-week) home-based TR five times weekly.

Results: All patients were randomized and completed initial intervention in the TR group. The follow up of both groups is in progress.

Conclusion: The TELEREH-HF trial will provide novel data on the effects of telerhabilitation on hospitalization and mortality in HF patients, and on safety, quality of life, depression, anxiety and acceptance of and adherence to this intervention.
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http://dx.doi.org/10.1016/j.ahj.2019.08.015DOI Listing
November 2019