-
1.
Does the Implantable Cardioverter-Defibrillator Benefit Vary With the Estimated Proportional Risk of Sudden Death in Heart Failure Patients?
Levy, WC, Li, Y, Reed, SD, Zile, MR, Shadman, R, Dardas, T, Whellan, DJ, Schulman, KA, Ellis, SJ, Neilson, M, et al
JACC. Clinical electrophysiology. 2017;(3):291-298
Abstract
BACKGROUND Prediction of which heart failure patients are most likely to die of sudden death vs. non-sudden death is an important factor in determining who will benefit the most from an ICD. OBJECTIVE We developed the Seattle Proportional Risk Model (SPRM) to estimate the proportion of total mortality due to sudden death. We prospectively validated the model in HF-ACTION and tested whether the ICD benefit varied with the SPRM. METHODS Among 2331 patients enrolled, 1947 patients were retained for analysis over a median follow-up of 2.5 years. The SPRM was calculated using age, gender, diabetes, BMI, SBP, EF, NYHA, sodium, creatinine, and digoxin use. RESULTS ICD use (ICD or CRT-D) was present prior to death in 1204 patients (62%). SPRM was predictive of sudden death vs. non-sudden death in those without an ICD (P=0.002). The hazard ratio representing ICD versus no ICD was 0.63 for all-cause mortality (P=0.0002). The ICD benefit varied with the SPRM for all-cause mortality (P=0.001), with a greater benefit in those with a higher conditional probability of sudden death. CONCLUSIONS In an ambulatory NYHA II-IV HF population and EF ≤35%, the SPRM was predictive of the proportional risk of sudden vs. non-sudden death. ICDs were associated with a decreased risk of all-cause mortality by 37% and the ICD benefit varied with the SPRM. The SPRM may have utility in risk stratifying patients for a primary prevention ICD.
-
2.
Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity.
Clifton, RG, Evans, M, Cahill, AG, Franks, PW, Gallagher, D, Phelan, S, Pomeroy, J, Redman, LM, Van Horn, L, ,
Obesity (Silver Spring, Md.). 2016;(2):305-13
Abstract
OBJECTIVE The Lifestyle Interventions for Expectant Moms (LIFE-Moms) Consortium is designed to determine, in pregnant women with overweight or obesity, whether various behavioral and lifestyle interventions reduce excessive gestational weight gain (GWG) and subsequent adverse maternal and neonatal outcomes and obesity in offspring. The design and planning process of the LIFE-Moms Consortium is described. METHODS The LIFE-Moms Consortium is a collaboration among seven clinical centers, a Research Coordinating Unit, and the NIH designed to support each clinical center's conduct of a separate trial of a unique intervention. Specific common measures, procedures, and eligibility criteria are consistent across the seven trials allowing data to be combined in exploratory analyses and/or compared readily. RESULTS Numerous committees and working groups were created to define common measures and outcomes during pregnancy and through 1 year postpartum, develop Consortium policies, and oversee progress of the trials. The primary outcome for the Consortium is excessive GWG. Secondary outcomes include maternal, neonatal, and infant anthropometric measures, physical activity, sleep, and complications of pregnancy and delivery. CONCLUSIONS A multi-center consortium of independent, lifestyle interventions with common measures and outcomes may enhance the ability to identify promising interventions for improving outcomes in pregnant women and their offspring.
-
3.
Using prophylactic antioxidants to prevent noise-induced hearing damage in young adults: a protocol for a double-blind, randomized controlled trial.
Gilles, A, Ihtijarevic, B, Wouters, K, Van de Heyning, P
Trials. 2014;:110
Abstract
BACKGROUND During leisure activities young people are often exposed to excessive noise levels resulting in an increase of noise-induced symptoms such as hearing loss, tinnitus and hyperacusis. Noise-induced tinnitus is often perceived after loud music exposure and provides an important marker for overexposure as a temporary threshold shift that is often not experienced by the individual itself. As oxidative stress plays an important role in the pathogenesis of noise-induced hearing loss, the use of antioxidants to prevent hearing damage has recently become the subject of research. METHODS This study proposes a randomized, double-blind, placebo-controlled crossover trial to assess the effects of a prophylactic combination of N-acetylcysteine (600 mg) and magnesium (200 mg) prior to leisure noise exposure in young adults. The primary outcome measure is the tinnitus loudness scored by a visual analogue scale (VAS). Secondary outcome measures are the differences in audiological measurements for the antioxidant treatments compared to placebo intake. Audiological testing comprising of pure tone audiometry including frequencies up to 16 kHz, distortion product otoacoustic emissions, transient-evoked otoacoustic emissions and speech-in-noise testing will be performed prior to and within 7 hours after noise exposure. By use of a mixed effects statistical model, the effects of antioxidants compared to placebo intake will be assessed. DISCUSSION As adolescents and young adults often do not use hearing protection while being exposed to loud music, the use of preventive antioxidant intake may provide a useful and harmless way to prevent noise-induced hearing damage in this population. Furthermore, when exposed to hazardous noise levels the protection provided by hearing protectors might not be sufficient to prevent hearing damage and antioxidants may provide additive otoprotective effects. Previous research mainly focused on occupational noise exposure. The present study provides a protocol to assess the usefulness of antioxidants during leisure noise activities. TRIAL REGISTRATION The present protocol is registered at ClinicalTrials.gov: NCT01727492.
-
4.
Recruitment results among families contacted for an obesity prevention intervention: the Obesity Prevention Tailored for Health Study.
Ghai, NR, Reynolds, KD, Xiang, AH, Massie, K, Rosetti, S, Blanco, L, Martinez, MP, Quinn, VP
Trials. 2014;:463
Abstract
BACKGROUND Overweight and obesity are serious threats to health and increase healthcare utilization and costs. The Obesity Prevention Tailored for Health (OPT) study was designed to test the effectiveness of a family-based intervention targeting diet and physical activity. We describe the results of efforts to recruit parents and children enrolled in a large managed-care organization into the OPT study. METHODS Parents with 10- to 12-year-old children were randomly selected from the membership of Kaiser Permanente Southern California, a large integrated health plan, and contacted between June 2010 and November 2011. We describe recruitment outcomes and compare characteristics of parents and children who did and did not participate. Information was collected from calls with parents and through the administrative and electronic medical records of the health plan. RESULTS Of the 4,730 parents contacted, 16.1% expressed interest in participation (acceptors), 28.8% declined participation (refusers), 4.7% were ineligible, and, even after multiple attempts, we were unable to reach 50.4%. Slightly less than half of the acceptors (n = 361) were ultimately randomized to receive either the OPT program plus usual care or usual care alone (7.6% of all parents initially contacted). There were not any significant differences between acceptors who were or were not randomized. Overall, we found that acceptors were more likely to be female parents, have overweight/obese children, and higher utilization of outpatient visits by parents and children compared with refusers and those we were unable to reach. We found no differences in recruitment outcomes by body mass index or comorbidity score of the parents, level of physical activity of the parents and children, education of the parents, or household income. CONCLUSIONS Recruiting parents and children into an obesity prevention program in a healthcare setting proved to be challenging and resource-intensive. Barriers and incentives for participation in obesity prevention programs need to be identified and addressed. Concern for the weight of their children may motivate parents to participate in family-based lifestyle interventions; however, the healthcare setting may be more relevant to weight-related treatment than to primary prevention. TRIAL REGISTRATION NUMBER ISRCTN06248443, 30 January 2014.
-
5.
Quantifying cardiometabolic risk using modifiable non-self-reported risk factors.
Marino, M, Li, Y, Pencina, MJ, D'Agostino, RB, Berkman, LF, Buxton, OM
American journal of preventive medicine. 2014;(2):131-40
-
-
Free full text
-
Abstract
BACKGROUND Sensitive general cardiometabolic risk assessment tools of modifiable risk factors would be helpful and practical in a range of primary prevention interventions or for preventive health maintenance. PURPOSE To develop and validate a cumulative general cardiometabolic risk score that focuses on non-self-reported modifiable risk factors such as glycosylated hemoglobin (HbA1c) and BMI so as to be sensitive to small changes across a span of major modifiable risk factors, which may not individually cross clinical cut-off points for risk categories. METHODS We prospectively followed 2,359 cardiovascular disease (CVD)-free subjects from the Framingham offspring cohort over a 14-year follow-up. Baseline (fifth offspring examination cycle) included HbA1c and cholesterol measurements. Gender-specific Cox proportional hazards models were considered to evaluate the effects of non-self-reported modifiable risk factors (blood pressure, total cholesterol, high-density lipoprotein cholesterol, smoking, BMI, and HbA1c) on general CVD risk. We constructed 10-year general cardiometabolic risk score functions and evaluated its predictive performance in 2012-2013. RESULTS HbA1c was significantly related to general CVD risk. The proposed cardiometabolic general CVD risk model showed good predictive performance as determined by cross-validated discrimination (male C-index=0.703, 95% CI=0.668, 0.734; female C-index=0.762, 95% CI=0.726, 0.801) and calibration (lack-of-fit chi-square=9.05 [p=0.338] and 12.54 [p=0.128] for men and women, respectively). CONCLUSIONS This study presents a risk factor algorithm that provides a convenient and informative way to quantify cardiometabolic risk on the basis of modifiable risk factors that can motivate an individual's commitment to prevention and intervention.
-
6.
Docosahexaenoic acid supplementation, vascular function and risk factors for cardiovascular disease: a randomized controlled trial in young adults.
Singhal, A, Lanigan, J, Storry, C, Low, S, Birbara, T, Lucas, A, Deanfield, J
Journal of the American Heart Association. 2013;(4):e000283
Abstract
BACKGROUND A high consumption of omega-3 long-chain polyunsaturated fatty acids, and particularly docosahexaenoic acid (DHA), has been suggested to reduce the risk of cardiovascular disease (CVD). However, while DHA supplementation may have benefits for secondary prevention, few studies have investigated the role of DHA in the primary prevention of CVD. Here, we tested the hypothesis that DHA supplementation improves endothelial function and risk factors for CVD. METHODS AND RESULTS Healthy volunteers (n=328), aged 18 to 37 years, were randomly assigned to 1.6 g DHA/day (from a microalgae source) together with 2.4 g/day carrier oil (index group) or to 4.0 g/day olive oil (control) (both given in eight 500-mg capsules/day for 16 weeks). Flow-mediated endothelium-dependent vasodilation (FMD) of the brachial artery (primary outcome) was measured before and after the intervention (n=268) using high-resolution vascular ultrasound. FMD was the same in both groups at randomization (mean, SD; 0.27, 0.1 mm), but postintervention was higher in the control group (0.29, 0.1 mm) compared with the DHA-supplemented group (0.26, 0.1 mm; mean difference -0.03 mm; 95% CI -0.005 to -0.06 mm; P=0.02). Of other outcomes, only triglyceride (mean difference -28%, 95% CI -40% to -15%; P<0.0001) and very low-density lipoprotein concentrations were significant lower in DHA-supplemented individuals compared with controls. CONCLUSIONS DHA supplementation did not improve endothelial function in healthy, young adults. Nevertheless, lower triglyceride concentrations with DHA supplementation was consistent with previous reports and could have benefits for the prevention of CVD.
-
7.
A novel approach to cardiovascular health by optimizing risk management (ANCHOR): behavioural modification in primary care effectively reduces global risk.
Cox, JL, Vallis, TM, Pfammatter, A, Szpilfogel, C, Carr, B, O'Neill, BJ
The Canadian journal of cardiology. 2013;(11):1400-7
Abstract
BACKGROUND Primary care is well positioned to facilitate cardiovascular risk improvement and reduce future cardiovascular disease (CVD) burden. METHODS The efficacy of risk factor screening, behavioural counselling, and pharmacological treatment to lower CVD risk was assessed via a prospective pre- and postintervention health risk assessment, individualized intervention with behaviour modification, risk factor treatment, and linkage to community programs, with 1-year follow-up and final health risk assessment. Primary outcome was the proportion of subjects with moderate and high baseline Framingham Risk Score (FRS) reducing their risk by 10% and 25%, respectively; the secondary end point was the proportion dropping ≥ 1 risk category. RESULTS Patients were enrolled (N = 1509) from March 2006 through October 2008 and 72% completed the study. This analysis focuses on 563 subjects with moderate or high baseline FRS, and excluded 325 low-risk patients and 205 with established CVD or diabetes mellitus. Median age was 56 years, 57.7% were female. The primary outcome was achieved in 31.8% (N = 112; 95% confidence interval [CI], 26.9%-36.6%) of moderate risk FRS participants and 47.9% (N = 101; 95% CI, 41.2%-54.6%) of high-risk participants. The secondary outcome was achieved by 37.2% (N = 210; 95% CI, 33.2%-41.2%). Prevalence of metabolic syndrome fell from 79.2% (N = 446; 95% CI, 75.9%-82.6%) at entry to 52.8% (N = 303; 95% CI, 48.7%-56.9%) at study end. Significant improvements in all modifiable risk factors occurred through lifestyle modification. CONCLUSIONS Global cardiovascular risk can be effectively decreased via lifestyle changes informed by readiness to change assessment and individualized counselling targeting specific behaviours. TRIAL REGISTRATION ClinicalTrials.gov number NCT01620996.
-
8.
Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial.
Sanchez, A, Silvestre, C, Sauto, R, Martínez, C, Grandes, G, ,
BMC family practice. 2012;:109
Abstract
BACKGROUND The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. METHODS/DESIGN This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. DISCUSSION The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice.
-
9.
Rational Prescribing in Primary Care (RaPP-trial). A randomised trial of a tailored intervention to improve prescribing of antihypertensive and cholesterol-lowering drugs in general practice [ISRCTN48751230].
Fretheim, A, Oxman, AD, Treweek, S, Bjørndal, A
BMC health services research. 2003;(1):5
Abstract
BACKGROUND The underlying reasons for differences between clinical practice and systematically developed guidelines vary from one clinical problem to another. It is therefore logical to tailor strategies to support the implementation of guidelines to address identified barriers to change. The objective of this trial is to evaluate the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease. METHODS/DESIGN Unblinded, cluster-randomised trial. 150 general practices will be recruited from two geographical areas in Norway, and randomised to the intervention or control group (passive dissemination of guidelines). Outcomes will be measured for all eligible patients seen in the participating practices during one year after the intervention. A multifaceted intervention has been tailored to address identified barriers to change. Key components are an educational outreach visit with audit and feedback, and computerised reminders. Pharmacists will conduct the visits. During the outreach visit the main recommendations will be presented and software will be installed that links to the electronic medical record systems used in the participating practices. The software will perform an audit that will be fed back during the visit, present pop-up reminders for patients with high blood pressure or cholesterol, and provide a cardiovascular risk calculator and patient education material. The main outcomes are the proportions of 1) first time prescriptions for hypertension where thiazides are not prescribed, 2) patients not assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and 3) patients treated for hypertension or high cholesterol for three months or more who have not achieved recommended treatment goals.
-
10.
The diabetes prevention program and its global implications.
Molitch, ME, Fujimoto, W, Hamman, RF, Knowler, WC, ,
Journal of the American Society of Nephrology : JASN. 2003;(7 Suppl 2):S103-7
-
-
Free full text
-
Abstract
Type 2 diabetes affects over 150 million adults worldwide and this figure is expected to double over the next 25 yr. This increase will be accompanied by a marked increase in the number of patients with ESRD due to diabetes. We hypothesized that a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes We randomly assigned 3234 nondiabetic persons with elevated fasting and postload plasma glucose concentrations to placebo, metformin (850 mg twice daily), or a lifestyle-modification program with the goals of at least a 7% weight loss and at least 150 min of physical activity per week. The mean age of the participants was 51 yr, and the mean body mass index was 34.0 kg/m(2); 68% were women, and 45% were members of non-Caucasian racial/ethnic groups. The average follow-up was 2.8 yr. The incidence of diabetes was 11.0, 7.8, and 4.8 cases per 100 person-years in the placebo, metformin, and lifestyle groups, respectively. The lifestyle intervention reduced the incidence of diabetes by 58% (95% CI: 48 to 66%) and metformin by 31% (95% CI: 17 to 43%), compared with placebo; the lifestyle intervention was significantly more effective than metformin. In conclusion, lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk and the lifestyle intervention was more effective than metformin. Because the lifestyle changes worked equally in all racial/ethnic groups in the Diabetes Prevention Program, they should be applicable to high-risk populations worldwide and may be able to reduce the projected progressive rise in the incidence of diabetes and the expected increase in ESRD.