Chinese Systolic Hypertension Trial (1988～1993)A Collaborative Study of 31 Medical Centres in China Collaborating Centre (Syst-China)

INSTRUCTIONThetrialwasdesignedtotesttheeffectofanti-hypertensivetreatmenton:(1)mortalityandmor-bidityrate1(2)qualityoflifeofthisgroupofpa-tlents.METHoDSSamPlingandRecruitment.2l3osubjectswithsystolichypertensionwereselectedfrom31centersinChina.Allparticipantsmetthefollowingcriteria:(l)Age6O-79years;(2)SBP>16OmmHg;(3)DBP<95mmHg[";(4)hypertensionstageland2l(5)collaboration;(6)lackofrheumaticheartdiseaseorotheraorticinsufficiency1(7)absenceofdissectinganeurysmlormyocardiaIinfarctionwi…     

The Impact of Patient Self-Testing of Prothrombin Time for Managing Anticoagulation: Rationale and Design of VA Cooperative Study #481—The Home INR Study (THINRS)

Background: Anticoagulation (AC) with warfarin reduces the risk of thromboembolism (TE) in a variety of applications, yet despite compelling evidence of the value and importance of high quality AC, warfarin remains underused, and dosing is often suboptimal. Approaches to improve AC quality include (1) an AC service (ACS), which allows the physician to delegate day-to-day details of AC management to another provider dedicated to AC care, and (2) incorporating into the treatment plan patient self-testing (PST) under which, after completing a training program, patients perform their own blood testing (typically, using a finger-stick blood analyzer), have dosage adjustments guided by a standard protocol, and forward test results, dosing and other information to the provider. Studies have suggested that PST can improve the quality of AC and perhaps lower TE and bleed rates.The purpose of Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) #481, “The Home INR Study” (THINRS) is to compare AC management with frequent PST using a home monitoring device to high quality AC management (HQACM) implemented by an ACS with conventional monitoring of prothrombin time by international normalized ratio (INR) on major health outcomes. PST in THINRS involves use of an INR monitoring device that is FDA approved for home use.Study design: Sites are VA Medical Centers where the ACS has an active roster of more than 400 patients. THINRS includes patients with atrial fibrillation (AF) and/or mechanical heart valve (MHV) expected to be anticoagulated indefinitely.THINRS has two parts. In Part 1, candidates for PST are evaluated for 2 to 4 weeks for their ability to use home monitoring devices. In Part 2, individuals capable of performing PST are randomized to (1) HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes, or (2) PST with testing every week and as indicated for out of range values, medication/clinical changes.The primary outcome measure is event rates, defined as the percent of patients who have a stroke, major bleed, or die. Secondary outcomes include total time in range (TTR), other events (myocardial infarction (MI), non-stroke TE, minor bleeds), competence and compliance with PST, satisfaction with AC, AC associated quality of life (QOL), and cost-effectiveness.To assess the effect of PST frequency on TTR and other outcomes, at selected sites patients randomized to perform PST are assigned one of three test frequencies (weekly, twice weekly, or once every four weeks).Support for this research was provided by: The Department of Veterans Affairs, Cooperative Studies Program (125), 810 Vermont Ave NW, Washington, DC 20420.     

The Effect of Verapamil on Left Ventricular Remodelling and Diastolic Function after Acute Myocardial Infarction (The Verapamil Infarction Study on Remodelling and Relaxation—VISOR)

The VISOR is a double blind, randomized, placebo-controlled study aimed to assess the effects of early and prolonged administration of verapamil on the left ventricular geometry and diastolic function in patients with anterior acute myocardial infarction treated with thrombolysis. Patients with heart failure or ejection fraction < 45% were excluded. Within 12 hours from starting thrombolysis, 70 patients were given verapamil (5 mg/hour intravenously for the first 24 hours, followed by 120 mg t.i.d. perorally for 6 months) or equivalent placebo. Echocardiograms were performed on admittance, before discharge, after 3 months and 6 months. The following parameters were calculated: left ventricular volumes, ejection fraction, sphericity index, early (E) and late (A) transmitral peak flow velocities and time-velocity integrals with their ratios, deceleration time and half-time of E, isovolumic relaxation time (IVRT), and non-invasive time constant of ventricular relaxation (). The basal and the last available parameters were considered for statistical analysis. The effects of the treatment on the left ventricular volumes, ejection fraction, and sphericity index were not statistically relevant. Conversely, a reduction of E/A ratio (P < .05) and increases of A integral (P < .01), deceleration time and half-time E, IVRT and (P < .05) were found in the placebo group and not in the verapamil group. No significant changes in the blood pressure, heart rate, PQ interval, and biochemical parameters were observed in the two groups. In conclusion, in patients with a thrombolysed anterior acute myocardial infarction and preserved systolic function, verapamil can prevent alterations of the diastolic function in absence of effect on ventricular remodelling, and has a good safety profile.     

The Gendered Nature of Filial Piety — A Study among Chinese Canadians

This paper examines the modern face of filial piety enactment among Chinese families living away from their homeland. It empirically assesses filial piety practices among a random sample of diasporic Chinese Canadians, by studying the role of sons, daughters and spouses in providing assistance with basic activities of daily living, instrumental activities of daily living and perceptions of support; the relative contribution of the traditional Chinese caring unit (son plus daughter-in-law) with assistance provided; whether source of assistance changes when amount of care is taken into account, when the gendered nature of tasks is taken into account and when controlling for other factors in multivariate analyses. N = 2,272 Chinese seniors (age 55+) living in seven cities across Canada. The findings reveal that, among these diasporic Chinese, patterns found in other Chinese societies are evident in their tendency to live with children, even when the spouse is still living, and the involvement of sons and the son/daughter-in-law unit in providing care. However, similar to recent findings for China, daughters and spouses are involved in all 3 areas of support examined and importantly, their involvement increases as more assistance is provided while that from sons decreases, notably in terms of IADL. The participation of daughters-in-law tends to be lower than that of either sons or daughters. The involvement of spouses increases for perceived or emotional support. The findings suggest a blending of Chinese and Canadian patterns of care and are discussed in terms of the changing but still gendered nature of care. The data for this study were part of a larger project funded by the Social Sciences and Humanities Research Council of Canada. The first author was a co-investigator on that project.     

A Randomized Study of Defibrillator Lead Implantations in the Right Ventricular Mid-Septum versus the Apex: The SEPTAL Study(τ)

Impact of Recalls on ICD Utilization . Introduction: The study was designed to evaluate the feasibility and performance of right ventricular (RV) mid‐septal versus apical implantable defibrillator (ICD) lead placement. Methods and Results: SEPTAL is a randomized, noninferiority trial, which randomly assigned patients to implantation of ICD leads in the RV mid‐septum versus apex, with a primary objective of comparing the implant success rate of implant at each site, based on strict electrical predefined criteria. We also compared the (1) pacing lead characteristics, (2) rates of appropriate and inappropriate ICD therapies, and (3) all‐cause mortality between the 2 sites at 1 year. The trial enrolled 215 patients (mean age = 59.7 ± 12.4 years, mean LVEF = 34.0 ± 14.2%, 84.2% men), of whom 148 (68.8%) presented with ischemic heart disease. The ICD indication was primary prevention in 117 patients (54.4%). The lead was successfully implanted in 96/107 patients (89.7%) assigned to the RV mid‐septum, and in 99/108 (91.7%) assigned to the apex (ns). The 1‐year rate of lead‐related adverse events was similar in both groups. A total of 8 first inappropriate ICD therapies (7.9%) were delivered in the RV mid‐septal group, versus 8 (7.8%) in the apical group (ns), while first appropriate therapies were delivered to 22 (21.4%) and 24 patients (23.8%), respectively (ns). All‐cause mortality was 7.9% in the RV mid‐septal versus 2.9% in the RV apical group (ns). Conclusion: This study confirmed the technical feasibility and noninferior performance of ICD leads implanted in the RV mid‐septum versus the apex. (J Cardiovasc Electrophysiol, Vol. 23, pp. 853‐860, August 2012)     

Glucose regulation and pain in older people—The Helsinki Birth Cohort Study

AimsTo assess if individuals with diabetes or prediabetes report more pain or have increased use of pain medication compared to normoglycaemic individuals.MethodsUsing cross-sectional data, we studied 928 men and 1075 women from the Helsinki Birth Cohort Study in 2001–2004 at a mean age of 61.5 years. Glucose regulation was assessed with a 2-h 75 g oral glucose tolerance test, and applying World Health Organization criteria, participants were defined as having normoglycaemia, prediabetes (impaired fasting glucose or impaired glucose tolerance), newly diagnosed diabetes or previously diagnosed diabetes. Self-reported pain intensity and interference during the previous 4 weeks was estimated using the RAND 36-Item Health Survey 1.0. Information on use of pain medication during the past 12 months was obtained from the Social Insurance Institution of Finland.ResultsThere was no difference in pain intensity or interference between glucose regulation groups for neither men nor women after adjusting for covariates (age, body mass index, education years, Beck Depression Inventory and physical activity). In addition, use of pain medication was similar between glucose regulation groups.ConclusionsAlthough pain is a common symptom in the general population, impairments in glucose regulation alone does not seem to increase pain among older individuals.     

The Challenges of Chronic Obstructive Pulmonary Diseases (COPD)—A Perspective

Chronic Obstructive Pulmonary Disease (COPD) is an inflammatory disease, primarily caused by cigarette smoke, which will soon become the third leading cause of death globally. Despite the importance of the problem, our real understanding of the biological underpinnings of COPD remains incomplete. Consequently, our first-line therapies, while helpful, are not yet as effective as they need to be. In this review, we will focus on these challenges and more, including the role of impaired tissue repair and adaptive immunity in disease pathogenesis, determining who may be at risk, describing COPD phenotypes and potential biomarkers. New ideas for chronic disease management and prevention of exacerbations will also be discussed. While much remains to be accomplished, meeting these challenges will bring rewards because what we learn will have implications for the understanding and treatment of chronic inflammatory diseases beyond COPD.     

Epidemiology and disease outcome in inflammatory bowel disease:observations from the European Collaborative Study

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Carotid intima–media thickness value distributions in The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil)

Objective

Carotid intima–media thickness (IMT) is a noninvasive measurement of early atherosclerosis. Most IMT studies have involved populations with low rates of racial blending. The aim of the present article is to describe IMT value distributions and analyze the influence of sex and race on IMT values in a large Brazilian sample, a setting with a high rate of racial admixture.

Methods

The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) is a multicenter cohort of 15,105 adult (aged 35–74 years) civil servants in six Brazilian cities. Baseline assessment included IMT measurements in both common carotid arteries. Race was self-reported. We studied the association between sex and race with IMT values using multiple linear regression models. We conducted analyses in all and low-risk individuals, defined as those without classical cardiovascular risk factors.

Results

We analyzed complete IMT data from 10,405 ELSA-Brasil participants. We present nomograms by age for all and low-risk individuals, stratified by sex and race. We found that men had significantly higher maximal IMT values compared with women (β = 0.058; P < 0.001). This association remained for low-risk individuals (β = 0.027; P = 0.001). In addition, Brown and White individuals had lower maximal IMT values compared with Black individuals for all (β = −0.034 and β = −0.054, respectively; P < 0.001) and low-risk individuals (β = −0.027; P = 0.013 and β = −0.035; P < 0.001, respectively).

Conclusion

We found significantly higher IMT values in men. We found significantly higher IMT values in Black individuals than White and Brown individuals. These results persisted when analyses were restricted to low-risk individuals.     

Maternal and paternal family history of diabetes in second-degree relatives and metabolic outcomes at age 5–6 years: The ABCD Study

AimTo investigate whether children with a family history of diabetes (FHD) in second-degree relatives (grandparents, aunts/uncles) are at increased risk of developing obesity and diabetes, and whether the risk differs between maternal or paternal transmission.MethodsIn the multiethnic population-based cohort Amsterdam-Born Children and Their Development (ABCD) Study, body mass index (BMI), waist-to-height ratio (WHR), fat percentage (fat%), fasting glucose and C-peptide in 5- or 6-year-old children with no second-degree FHD (n = 2226) were compared with children with maternal-only (n = 353), paternal-only (n = 281) or both maternal and paternal (n = 164) second-degree FHD. Children of diabetic mothers or fathers were excluded.ResultsNone of the children in any of our FHD categories differed in body composition after adjusting for maternal, paternal and childhood lifestyle covariates. However, children with both maternal and paternal second-degree FHD had increased C-peptide levels (0.03 nmol, 95% CI: 0.01–0.05) compared with those in the other three study groups. Results were similar when analyses were restricted to only the Dutch children.ConclusionChildren with FHD in second-degree relatives on both maternal and paternal sides already have higher C-peptide levels at an early age. This might be the result of a double burden of a shared obesogenic lifestyle, or of more diverse diabetogenic genes compared to children without FHD or with only FHD in one side of the family. In any case, second-degree FHD could be used as a public-health screening tool to identify children at risk of adverse metabolic outcomes and of possible future disease.     

At-Home Versus In-Clinic INR Monitoring: A Cost–Utility Analysis from The Home INR Study (THINRS)

Background

Effective management of patients using warfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST.

Objective

To perform a cost–utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency.

Patients/Interventions

In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n?=?1465) or monthly in-clinic testing (n?=?1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n?=?116) or PST twice weekly (n?=?118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up.

Results

PST and HQACM participants were similar with regard to gender, age, and CHADS₂ score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, ?$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions.

Conclusion

Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

     

Association of physical activity and sedentary time with structural brain networks—The Maastricht Study

We assessed whether objectively measured low- and high-intensity physical activity (LPA and HPA) and sedentary time (ST) were associated with white matter connectivity, both throughout the whole brain and in brain regions involved in motor function. In the large population-based Maastricht Study (n = 1715, age 59.6 ± 8.1 (mean ± standard deviation) years, and 48% women), the amounts of LPA, HPA, and ST were objectively measured during 7 days by an activPAL accelerometer. In addition, using 3T structural and diffusion MRI, we calculated whole brain node degree and node degree of the basal ganglia and primary motor cortex. Multivariable linear regression analysis was performed, and we report standardized regression coefficients (stβ) adjusted for age, sex, education level, wake time, diabetes status, BMI, office systolic blood pressure, antihypertensive medication, total-cholesterol-to-HDL-cholesterol ratio, lipid-modifying medication, alcohol use, smoking status, and history of cardiovascular disease. Lower HPA was associated with lower whole brain node degree after full adjustment (stβ [95%CI] = − 0.062 [− 0.101, − 0.013]; p = 0.014), whereas lower LPA (stβ [95%CI] = − 0.013 [− 0.061, 0.034]; p = 0.580) and higher ST (stβ [95%CI] = − 0.030 [− 0.081, 0.021]; p = 0.250) was not. In addition, lower HPA was associated with lower node degree of the basal ganglia after full adjustment (stβ [95%CI] = − 0.070 [− 0.121, − 0.018]; p = 0.009). Objectively measured lower HPA, but not lower LPA and higher ST, was associated with lower whole brain node degree and node degree in specific brain regions highly specialized in motor function. Further research is needed to establish whether more HPA may preserve structural brain connectivity.

     

The cost burden of diabetes mellitus: the evidence from Germany—the CoDiM Study

Aims/hypothesis The aim of this study was to identify the health care costs of diabetic patients in Germany in 2001, focusing on the influence of age, sex, and type of treatment.Subjects and methods Annual direct costs of medical care and indirect costs of inability to work and early retirement in diabetic subjects were compared with costs of age- and sex-matched non-diabetic control subjects. The analysis was based on routine health care data from a random sample (18.75%) taken from a database of 1.9 million insured persons. Incremental differences in medical and national expenditure between subjects with and without diabetes were calculated.Results Annual direct mean costs per diabetic patient were €5,262, and indirect costs were €5,019. In the control group, mean direct and indirect costs were €2,755 and €3,691, respectively. Analysis of cost components revealed that the high costs associated with the care of diabetic patients could be largely attributed to inpatient care and overall medication costs. Hypoglycaemic drugs amounted to only one-quarter of the medication costs. The total health care costs were correlated with the type of treatment. Direct excess costs increased with increasing age in insulin-treated patients, but were unaffected by age in patients receiving other types of treatment.Conclusions/interpretation The Costs of Diabetes Mellitus (CoDiM) study is the first comprehensive study to provide estimates of costs associated with diabetes care in Germany. Direct costs of diabetic patients account for 14.2% of total health care costs, which includes the proportion that specifically accounts for diabetes-related costs (6.8%).Electronic Supplementary Material Supplementary material is available for this article at     

Use of Subcutaneous Enoxaparin Compared to Intravenous Heparin and Oral Phenprocoumon in the Setting of Cardioversion—The ACE Study (Anticoagulation in Cardioversion Using Enoxaparin)

The mode and duration of anticoagulation in the setting of cardioversion of atrial fibrillation-either with or without guidance by transesophageal echocardiography (TEE)-is still an unresolved issue. Oral anticoagulation with warfarin or phenprocoumon is frequently used but may be associated with an increased risk of bleeding complications or, conversely, episodes of undercoagulation. Moreover, it takes several days to reach full anticoagulation with oral compounds. This phase may be covered with intravenous heparin but this requires prolonged hospitalization. Low-molecular weight heparin is an attractive alternative as it not only provides a safe and predictable level of anticoagulation with few side effects but can also be administered safely on an outpatient basis. In addition, anticoagulation monitoring is usually unnecessary. The ACE study (Anticoagulation in Cardioversion using Enoxaparin) compared the safety and efficacy of subcutaneous enoxaparin with intravenous heparin/oral phenprocoumon before and after cardioversion (stratified to TEE guidance or no TEE guidance). This article summarizes the study rationale and design. The results will be published shortly.