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 DiscoveriesNational Heart, Lung, and Blood Institute

July 8, 2011Filippino Cardiovascular Summit

NHLBI Strategic Plan (2007): Three Goals

Goal 1 – From Form to FunctionTo 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 CausesTo 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 (1976-

2003) Cholesterol (1988-2004) Obesity (1998) Integrated Pediatric CV

Risk Reduction (pending release 2011)

• Asthma (1991-2007)

• 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: 1998

55

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, 2007

6

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

888

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

1010

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 8

+

+

+ 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 PanelEvidence Review on BP

Tx

Cholesterol PanelEvidence Review on

Cholesterol Tx

Obesity PanelEvidence Review on

Obesity Tx

131313

NHLBI Evidence Review and Guideline Development Process

14

Expert PanelSelected

External ReviewConducted;

Guidelines Revisedas Needed

Literature Searched

Studies Screened;Study Quality Rated;

Data Abstracted

Evidence TableFormulated;

Body of Evidence Summarized & Graded

Guidelines Disseminated,Implemented,

Evaluated

GradedRecommendations

Developed

Topic Area Identified

Critical Questions and I/E criteria

identified

151515

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 3rd 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

1919

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 EvidenceQuality 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 studiesHighly 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 studiesModerately 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 studiesLow certainty about the estimate of effect.

Low

20

NHLBI Evidence Quality Rating System

Grade Strength of Recommendation

AStrong recommendation High certainty that the net benefit is substantial. Benefits are much greater than risks/harms.

BModerate 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.

CWeak recommendation At least moderate certainty that the net benefit is small. Benefits may slightly outweigh risks/harms.

DRecommendation 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 reviewCQs = 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 2011

23

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

http://healthyweight. 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) 592-8573 Fax: (301) 592-8563 E-mail: NHLBIinfo@rover.nhlbi.nih.gov Internet: http://www.nhlbi.nih.gov Address: P.O. Box 30105 Bethesda, MD 20824-0105

Online Catalog: http://emall.nhlbihin.net

NHLBI Health Information Center

Thank you for your attention

36