The NHLBI Division for the Application of Research Discoveries (DARD): Translating Science into Practice Karen A. Donato, S.M. Acting Deputy Director, Division for the Application of Research Discoveries National Heart, Lung, and Blood Institute July 8, 2011 Filippino Cardiovascular Summit

NHLBI Strategic Plan (2007): Three Goals Goal 1 – From Form to Function To improve understanding of the molecular and physiological basis of health and disease and to use that understanding to develop improved approaches to disease diagnosis, treatment, and prevention. Goal 2 – From Function to Causes To improve understanding of the clinical mechanisms of disease and thereby enable better prevention, diagnosis, and treatment. Goal 3 – From Causes to Cures To generate an improved understanding of the processes involved in translating research into practice and use that understanding to enable improvements in public health and to stimulate further scientific discovery. 2

DARD Efforts In Translation in Clinical Health-care Settings 3

NHLBI Clinical Practice Guidelines Cardiovascular Dz prevention  Hypertension ( )  Cholesterol ( )  Obesity (1998)  Integrated Pediatric CV Risk Reduction (pending release 2011) Asthma ( ) Sickle Cell Disease (in progress) 4

Joint National Committee on Prevention, Detection, Evaluation, & Treatment of High Blood Pressure (JNC) JNC 7: 2003 JNC 6: 1997 JNC 5: 1992 JNC 4: 1988 JNC 3: 1984 JNC 2: 1980 JNC 1: 1976 Detection, Evaluation, &Treatment of High Blood Cholesterol in Adults (ATP, Adult Treatment Panel) ATP III Update: 2004 ATP III: 2002 ATP II: 1993 ATP I: 1988 Clinical Guidelines on the Identification, Evaluation, & Treatment of Overweight and Obesity in Adults Obesity 1: History of NHLBI CVD Adult Clinical Guidelines

Cardiovascular Prevention Guidelines New Directions New directions for CV guidelines derived from recommendations by several groups: NHLBI Cardiovascular Disease Thought Leaders  June 17, 2005 NHLBI Clinical Guidelines Users and Developers  March 7, 2006 NHLBI Guidelines Leadership Group (Stakeholder Representation)  November 15,

 Update guidelines on BP, cholesterol, and obesity  Use systematic evidence review process  Use evidence & recommendations grading  Standardize and coordinate approaches  Develop consistent recommendations for lifestyle & risk assessment  Create an integrated CV risk reduction guideline  Individual risk factor guidelines + lifestyle and risk assessment + additional CVD prevention approaches  Develop an improved approach to implementation  Write guidelines clearly so they are more implementable  Emphasize user needs: primary care, specialists, patients,  Develop and disseminate materials & tools  Develop an evidence-based implementation plan  Create a National Program to Reduce Cardiovascular Risk Cardiovascular Prevention Guidelines New Directions 7

88 8 New NHLBI Approach to CV Guideline Development  Evidence-based approach, using systematic reviews and graded recommendations  Standardized coordinated approach to blood pressure, cholesterol, and overweight/obesity guideline updates  Crosscutting work groups to develop consistent recommendations on lifestyle, risk assessment, and implementation  Development of an integrated CVD risk reduction guideline  Integrate the individual risk factor guidelines + additional CVD risk issues + lifestyle and risk assessment  Evidence-based approach to implementation; emphasize user needs and implementability  Primary care, specialists, and patients/consumers  User friendly with clear focused messages

99  Call for Nomination: Dec 17, 2007 to Feb 1, 2008  Over 440 nominations, 350 nominees  Major inputs from GLG organizations and their membership and general public  Expert Panel Composition  Diversity and balance of expertise  Diversity of demographics  Conflict of interest management 9 New NHLBI Approach to CV Guideline Development

10 NHLBI CVD Guidelines: Panels & Workgroups Chairs/Co-Chairs Panels:  High blood cholesterol/dyslipidemia (ATP IV)  Neil Stone, MD; Alice Lichtenstein, DSc  High blood pressure (JNC-8)  Paul James, MD; Suzanne Oparil, MD  Obesity/Overweight (Obesity II)  Michael Jensen, MD; Donna Ryan, MD  Integrated clinical guideline for CVD risk reduction  Sidney C. Smith, Jr., MD Workgroups:  Risk Assessment  David Goff, Jr., MD, PhD; Donald M. Lloyd-Jones, MD, ScD  Lifestyle  Robert Eckel, MD; John Jakicic, PhD  Implementation  Thomas Pearson, MD, PhD; Wiley Chan, MD 10

NHLBI Director DARD Director DARD Project Team SAIC and RTI Support Contracts Clinical Guidelines Executive Committee Expert Panel for the Integrated CVD Guideline Development Expert Panel for Cholesterol Update Expert Panel for Hypertension Update Expert Panel for Obesity Update Risk Assessment Lifestyle/Nutrition/PA Implementation/System/IT/ Informatics Cross-Cutting Workgroups 11 NHLBI Clinical Guidelines for CV Risk Reduction: Organizational Structure

Products: Evidence Reviews *Same for all Guidelines Products: Updated RF Guidelines Implementation Plan JNC Approach to writing guidelines (e.g., GLIA ) ATP IV CVD Risk Factor List* Risk Assessment Approach for Cholesterol Heart Healthy Diet & Physical Activity* Modifications for Chol Approach to writing guidelines (e.g., GLIA) OBESITY 2 CVD Risk Factors List* Risk Assessment Approach for Obesity Heart Healthy Diet & Physical Activity* Modifications for Obesity Approach to writing guidelines (e.g., GLIA) CVD Risk Factor List* Risk Assessment Approach for BP Heart Healthy Diet & Physical Activity* Modifications for BP Implementation WG Evidence Review on implementation approaches Product: Integrated CVD Risk Reduction Guideline Product: Evidence-based Implementation Plan + Approach to patient: Risk assessment, Lifestyle, BP, Chol, Obesity, Mult RFs, Other Risk Reduction Topics (e,g., Aspirin, Smoking, HRT) Integrated Panel Evidence Review on multiple RFs Lifestyle WG Evidence Review on Lifestyle Issues Risk Assessment WG Evidence Review & Risk Prediction Model Project Map Implementation WG Evidence-informed Guidance Lifestyle WG Evidence Review on Diet & Physical Activity Risk Assessment WG Evidence Review & Risk Prediction Model Blood Pressure Panel Evidence Review on BP Tx Cholesterol Panel Evidence Review on Cholesterol Tx Obesity Panel Evidence Review on Obesity Tx

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NHLBI Evidence Review and Guideline Development Process 14 Expert Panel Selected External Review Conducted; Guidelines Revised as Needed Literature Searched Studies Screened; Study Quality Rated; Data Abstracted Evidence Table Formulated; Body of Evidence Summarized & Graded Guidelines Disseminated, Implemented, Evaluated Graded Recommendations Developed Topic Area Identified Critical Questions and I/E criteria identified

15  Step 1 – Develop critical questions (CQs)  Step 2 – Establish study inclusion & exclusion criteria  Step 3 – Search literature for relevant studies  Step 4 – Rate the quality of each included study  Step 5 – Abstract study data  Step 6 – Create evidence tables for each study  Step 7 – Summarize the evidence for each CQ Evidence Review and Guideline Development Process

Critical Questions and I/E Criteria  Critical Question in PICOTS format  Population  Intervention/Exposure  Control/Comparator  Outcomes  Time frame  Setting  Inclusion/ Exclusion criteria:  Selecting types of studies (e.g., observational, RCTs)  Identifying subgroups  Defining specific outcomes 16

 Systematic search of the literature for each critical question using inclusion/exclusion criteria  Initial screen of citations by title and abstracts, followed by full-text review  All articles reviewed for inclusion independently by two trained reviewers  If the reviewers do not agree about inclusion status, a 3 rd reviewer with content and methodological expertise reviews and adjudicates. If uncertainty remains, the article is included. 17 Literature Review Process

Rating the Quality of Individual Studies  The quality of each “included” study is rated by two independent reviewers  Good, Fair, Poor  If the raters do not agree, a 3rd rater with content and methodological expertise reviews and adjudicates  Standardized NHLBI rating instruments with pre-specified criteria:  Controlled intervention studies (e.g., RCTs)  Observational studies (cohort, cross-sectional, case-control)  Systematic reviews and meta-analyses 18

19 Evidence-Based Review and Guideline Development Process  Step 8 – Review and grade the body of evidence for each critical question (or subquestion)  Step 9 – Draft graded recommendations (assure grade is aligned with quality and strength of evidence)  Step 10 – Release draft recommendations for public comment, with invitations for review  Step 11 – Review comments and revise recommendations as needed  Step 12 – Combine recommendations into guidelines  Step 13 – Disseminate and implement guidelines 19

Type of Evidence Quality Rating Well-designed, well-executed RCTs that adequately represent populations to which results are applied and directly assess effects on health outcomes Well conducted meta-analyses of such studies Highly certain about the estimate of effect. High RCTs with minor limitations affecting confidence in, or applicability of, results; Well-designed, well-executed nonrandomized controlled studies and well- designed, well-executed observational studies Well conducted meta-analyses of such studies Moderately certain about the estimate of effect. Moderate RCTs with major limitations Nonrandomized controlled studies and observational studies with major limitations affecting confidence in, or applicability of, the results Uncontrolled clinical observations without an appropriate comparison group (e.g., case series, case reports) Physiological studies in humans Meta-analyses of such studies Low certainty about the estimate of effect. Low 20 NHLBI Evidence Quality Rating System

Grade Strength of Recommendation A Strong recommendation High certainty that the net benefit is substantial. Benefits are much greater than risks/harms. B Moderate recommendation Reasonable certainty that the net benefit is moderate to substantial or there is high certainty that the net benefit is moderate. Benefits are greater than risks/harms. C Weak recommendation At least moderate certainty that the net benefit is small. Benefits may slightly outweigh risks/harms. D Recommendation against At least moderate certainty that it has no net benefit or that risks/harms outweigh benefits. E Expert opinion Net benefit is unclear. Balance of benefits and harms cannot be determined because of no evidence, insufficient evidence, or conflicting evidence, but the panel thought it was important to provide clinical guidance and make a recommendation. Further research is recommended. N No recommendation for or against Net benefit is unclear. Balance of benefits and harms cannot be determined because of no evidence, insufficient evidence, or conflicting evidence, and the panel thought no recommendation should be made. Further research is recommended. 21 NHLBI Recommendation Strength

Conceptual Plan for Converting Evidence-Based Recommendations into Guideline Documents SR = systematic review CQs = critical questions

Integrated Guideline on CV Risk Reduction in Children and Adolescents Topics:  Screening for risk factors  Family history  Nutrition and diet  Physical activity  Tobacco exposure  High blood pressure  Lipids and lipoproteins  Overweight and obesity  Diabetes and other conditions  Risk factor clustering and the metabolic syndrome To be released in

CVD Risk Reduction Guideline in Children/Adolescents: Implementation Purpose: To facilitate maximal adoption of the pediatric CV guideline to integrate assessment and treatment of CV risk factors into routine care by pediatric care providers Approaches:  Understand the needs of pediatric care providers through formative research  Create strategies and tools to facilitate application of the guideline in the care of children and adolescents  Evaluate strategies and tools in practice settings to determine effectiveness and to enhance the tool kit  Embed the tool kit into practice improvement projects to produce large-scale practice adoption

25 Professional Education Materials

nhlbi.nih.gov

DARD Efforts in Translation for Community Settings and Reducing Health Disparities 27

Goal: To employ the Community Health Worker (CHW) model to improve CV health in low-income and high-risk communities to reduce health disparities Objectives: To train and equip CHWs to conduct culturally sensitive heart health education To use evidence-based curricula and other resources developed by NHLBI To improve knowledge and attitudes, and promote health behaviors and adherence that promote CV health CHW Initiative – Goal and Objectives 28

Community Health Worker (CHW) Initiative to Reduce Health Disparities Latinos  Salud para su Corazón (Your Heart, Your Life) (14 U.S. sites)  DARD-PAHO collaboration (3 sites - Guatemala, Chile, Argentina) African Americans  With Every Heartbeat is Life (12 U.S. sites) American Indian and Alaska Native  Honoring the Gift of Heart Health (14 U.S. sites) Filipinos  Healthy Heart, Healthy Family (2 U.S. sites) 29

History and Status of CHW Initiative  Background  Created in 1994 to promote heart health and reduce disparities  First curriculum was for Spanish-speaking Latinos  Strategies  CHW training, community education, screening, lifestyle, and clinical management (in some sites)  Engagement of community partners to sustain the projects  Evaluations  Process evaluation of 7 sites in 2001  Current evaluations to: Determine program effectiveness Evaluate specific strategies Determine future directions 30

We Can!® A National Education Program to Help Children and Families Maintain a Healthy Weight! 31 S.M.A.R.T NIH Science  Curricula  Local Partnerships  Local Media  Outreach Events Communities  Federal  Clinical Non-profit  Media  Corporate Partnerships Media  Web  Print  Television We Can!™ media coverage: estimated reach of 1.4 billion 4 NIH Institutes (NHLBI, NIDDK, NICHD, NCI) 43 partners including CDC, HRSA, PCPFS, DOI (NPS, FWS), Action for Healthy Kids, Subway, et al. About 1500 Community Sites in 50 states, District of Columbia, Puerto Rico, Northern Mariana Islands, 11 countries

We Can! ® Sites 32

43 We Can! Partners 33

Implementing Clinical Guidelines: Improving Patient Outcomes Guideline Implementation (Simons-Morton, 2005) Patient Health Insurance & Government Performance measures (e.g.,HEDIS) Accreditation (JCAHO) Insurance reimbursement (p4p) Clinical Institutions CME, academic detailing Services & appointments Patient monitoring & feedback Reminders, charting cues, eHR Provider incentives Patients Knowledge Behaviors Tx Adherence Risk Factors Clinicians Screening & diagnoses Treatments & procedures Advice & counseling Referrals 34

Phone: (301) Fax: (301) Internet: Address: P.O. Box Bethesda, MD Online Catalog: NHLBI Health Information Center

Thank you for your attention 36