Reesa Laws

The DASH Diet, Sodium Intake and Blood Pressure Trial (DASH-Sodium): Rationale and Design

The DASH Diet, Sodium Intake and Blood Pressure Trial (DASH-Sodium) is a multicenter, randomized trial comparing the effects of 3 levels of sodium intake and 2 dietary patterns on blood pressure among adults with higher than optimal blood pressure or with stage 1 hypertension (120-159/80-95 mm Hg). The 2 dietary patterns are a control diet typical of what many Americans eat, and the DASH diet, which, by comparison, emphasizes fruits, vegetables, and low-fat dairy foods, includes whole grains, poultry, fish, and nuts, and is reduced in fats, red meat, sweets, and sugar-containing beverages. The 3 sodium levels are defined as higher (typical of current US consumption), intermediate (reflecting the upper limit of current US recommendations), and lower (reflecting potentially optimal levels). Participants are randomly assigned to 1 of the 2 dietary patterns using a parallel group design and are fed each of the 3 sodium levels using a randomized crossover design. The study provides participants with all of their food during a 2-week run-in feeding period and three 30-day intervention feeding periods. Participants attend the clinic for 1 meal per day, 5 days per week, and take home food for other meals. Weight is monitored and individual energy intake adjusted to maintain baseline weight. The primary outcome is systolic blood pressure measured at the end of each intervention feeding period. Systolic blood pressure is compared across the 3 sodium levels within each diet and across the 2 diets within each sodium level. If effects previously observed in clinical trials are additive, sodium reduction and the DASH diet together may lower blood pressure to an extent not as yet demonstrated for nonpharmacologic treatment. The DASH-Sodium results will have important implications for the prevention and treatment of high blood pressure.

Developing a data infrastructure for a learning health system: the PORTAL network

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings.

Efficacy of Chlorhexidine Varnish for the Prevention of Adult Caries A Randomized Trial

The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D1-2FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877).

Design of the Prevention of Adult Caries Study (PACS): A randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

BackgroundDental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited.Methods/DesignThe Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered.DiscussionThis new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States.Trial Registration NumberNCT00357877

Dietary quality assurance processes of the DASH-Sodium controlled diet study

A thorough quality assurance (QA) program upholds the integrity of nutrition research studies by yielding reliable data and results. Continually evaluating the implementation of a procedure against a goal and making adjustments when needed enhance the quality of a studys conduct and outcomes. Controlled diet studies require QA processes at various steps beginning with the screening of study participants, through diet preparation and delivery to data collection. Staff training and observations with monitoring activities, are important so tasks are completed according to protocol. When several clinical sites participate as partners in a controlled diet study, uniform procedures must be followed and a formal standardized QA program will assist. The Dietary Approaches to Stop Hypertension (DASH)-Sodium study employed such a program, described in this article, that included training staff, observing procedures, monitoring data for completeness and accuracy, evaluating processes, giving feedback, and documenting that tasks were done according to protocol. Furthermore, QA processes were used in the areas of participant screening, orientation, diet adherence, food procurement and preparation, and exit interviews. Other researchers may implement similar activities to ensure quality in their nutrition research programs.

The Community Health Applied Research Network (CHARN) Data Warehouse: a Resource for Patient-Centered Outcomes Research and Quality Improvement in Underserved, Safety Net Populations

Background: The Community Health Applied Research Network, funded by the Health Resources and Services Administration, is a research network comprising 18 Community Health Centers organized into four Research Nodes (each including an academic partner) and a data coordinating center. The network represents more than 500,000 diverse safety net patients across 11 states. Objective: The primary objective of this paper is to describe the development and implementation process of the CHARN data warehouse. Methods: The methods involved regulatory and governance development and approval, development of content and structure of the warehouse and processes for extracting the data locally, performing validation, and finally submitting data to the data coordinating center. Progress to Date: Version 1 of the warehouse has been developed. Tables have been added, the population and the years of electronic health records (EHR) have been expanded for Version 2. Conclusions: It is feasible to create a national, centralized data warehouse with multiple Community Health Center partners using different EHR systems. It is essential to allow sufficient time: (1) to develop collaborative, trusting relationships among new partners with varied technology, backgrounds, expertise, and interests; (2) to complete institutional, business, and regulatory review processes; (3) to identify and address technical challenges associated with diverse data environments, practices, and resources; and (4) to provide continuing data quality assessments to ensure data accuracy.

Improving Adherence to Cardiovascular Therapies: An Economic Evaluation of a Randomized Pragmatic Trial☆

OBJECTIVE Preplanned economic analysis of a pragmatic trial using electronic-medical-record-linked interactive voice recognition (IVR) reminders for enhancing adherence to cardiovascular medications (i.e., statins, angiotensin-converting enzyme inhibitors [ACEIs], and angiotensin receptor blockers [ARBs]). METHODS Three groups, usual care (UC), IVR, and IVR plus educational materials (IVR+), with 21,752 suboptimally adherent patients underwent follow-up for 9.6 months on average. Costs to implement and deliver the intervention (from a payer perspective) were tracked during the trial. Medical care costs and outcomes were ascertained using electronic medical records. RESULTS Per-patient intervention costs ranged from

Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory

9 to

Predictors of coronal caries progression in adults: results from the Prevention of Adult Caries Study

17 for IVR and from

C-B4-03: Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT): Implementing a Medication Adherence Intervention Using Health Information Technology

36 to