Patients at the Center: Guidelines for Effectiveness Carolyn M. Clancy, MD Director Agency for Healthcare Research and Quality New York Academy of Medicine Conference on E-GAPPS New York, NY – December 10, 2012

What We Know “The truth is that for a large part of medical practice, we don’t know what works. But we pay for it anyway.” H. Gilbert Welch, MD Geisel School of Medicine at Dartmouth Testing What We Think We Know. New York Times - August 19, 2012

Health System Transformation: Current and Future CurrentFuture Variable quality; expensive, wasteful Consistently better quality; lower cost, more efficient Pay for volume Pay for quality Pay for transactions Care-based episodes Quality assessment based on provider and setting (process) Quality assessment based on patient experience (outcomes)

Patients at the Center: Guidelines for Effectiveness Making the Case: Health Care Quality and Disparities Making the Case: Health Care Quality and Disparities Learning More about What We Know Learning More about What We Know The Role of Guidelines The Role of Guidelines Questions Questions

CDC Population health and the role of community based interventions to improve health NIH AHRQ Long-term and system-wide improvement of health care quality and effectiveness Biomedical Research to prevent, diagnose and treat disease HHS Organizational Focus

AHRQ 2011 National Healthcare Quality and Disparities Reports Overall, improvement in the quality of care remains suboptimal Overall, improvement in the quality of care remains suboptimal Few disparities in quality are getting smaller Few disparities in quality are getting smaller Quality of care varies not only across types of care but also across parts of the country Quality of care varies not only across types of care but also across parts of the country

Progress is Uneven Toward National Priority Areas 2011 Findings: 2011 Findings: – Health care quality and access are suboptimal, especially for minority and low-income groups – Quality is improving; access and disparities are not – Urgent attention needed to ensure continued improvement in quality and progress on reducing disparities for services, geographic areas and populations, including: Diabetes care and adverse events Diabetes care and adverse events Disparities in cancer screening and access to care Disparities in cancer screening and access to care States in the South States in the South Reports include evidence of progress toward priorities identified in National Quality Strategy and HHS Plan to Reduce Racial and Ethnic Health Disparities

Quality Is Improving Slowly Nearly 60 percent of health care quality measures tracked showed improvement Nearly 60 percent of health care quality measures tracked showed improvement However, the median rate of change was 2.5 percent per year However, the median rate of change was 2.5 percent per year AHRQ 2011 National Healthcare Quality and Disparities Reports Quality measures that are improving, not changing or worsening, overall and for select populations

Few Disparities in Quality of Care Are Getting Smaller Few disparities in quality showed significant improvement. Few disparities in quality showed significant improvement. The number of disparities that were getting smaller exceeded the number that were getting larger The number of disparities that were getting smaller exceeded the number that were getting larger AHRQ 2011 National Healthcare Quality and Disparities Reports Quality measures for which disparities related to age, race, ethnicity and income are improving, not changing or worsening

New York: Overall Quality vs. All States = Most Recent Year = Baseline Year Performance Meter: All Measures Very Weak Weak Average Strong Very Strong National Healthcare Quality Report, State Snapshots

New York Snapshot: Quality Measures MeasurePerformance Adult admissions—diabetes, short-term complications Better than average CABG deaths in hospital Average Deaths per 1,000 admissions in low- mortality DRGs Worse than average National Healthcare Quality Report, State Snapshots

National Quality Strategy: Three Broad Aims Better Care Improve the overall quality, by making health care more patient-centered, reliable, accessible and safe Healthy People/ Healthy Communities Healthy People/ Healthy Communities Improve the health of the U.S. population by supporting proven interventions to address behavioral, social and environmental determinants of health, in addition to delivering higher-quality care Affordable Care Reduce the cost of quality health care for individuals, families, employers and government Created Under the Affordable Care Act

There Has Been Considerable Progress: For Example… Unprecedented national investment in health care research, access, delivery Unprecedented national investment in health care research, access, delivery Funding for data infrastructure, new evidence, dissemination of best practices Funding for data infrastructure, new evidence, dissemination of best practices Wider opportunities for patient- centered outcomes research and quality improvement Wider opportunities for patient- centered outcomes research and quality improvement

Patients at the Center: Guidelines for Effectiveness Making the Case: Health Care Quality and Disparities Making the Case: Health Care Quality and Disparities Learning More about What We Know Learning More about What We Know The Role of Guidelines The Role of Guidelines Questions Questions

Research that Addresses Patient Outcomes Patient-centeredness may be the most challenging of all 6 domains of quality, because it is so difficult to define and measure Patient-centeredness may be the most challenging of all 6 domains of quality, because it is so difficult to define and measure But, it is also likely the most important, because it includes elements of all other domains But, it is also likely the most important, because it includes elements of all other domains Patient-Centeredness: The final frontier?

Implementing Evidence- Based Treatment Decisions Which treatments work, for which patients, and what are the trade-offs? Which treatments work, for which patients, and what are the trade-offs? – Patient-centered outcomes research informs decisions by providing evidence and information on effectiveness, benefits and harms How can evidence-based improvements be translated and shared with providers, patients? How can evidence-based improvements be translated and shared with providers, patients? – Effective Health Care Clinician and Consumer Summaries – Continuing Medical Education – Center for Medicare and Medicaid Innovation; AHRQ Innovation Exchange

Until Recently, Few Tools to Get From Evidence to Practice AHRQ is working to: AHRQ is working to: – Translate scientific advances into actual clinical practice – Translate scientific advances into usable information for clinicians and for patients – Deliver information in the right places at the right time

The Patient-Centered Outcomes Research Trust Fund and AHRQ Provides funding for AHRQ to disseminate research findings of the Institute and other government-funded research, train and build capacity for research Provides funding for AHRQ to disseminate research findings of the Institute and other government-funded research, train and build capacity for research – Up to 20% of Patient-Centered Outcomes Research Trust Fund can be used to support research capacity building and dissemination activities

Patients at the Center: Guidelines for Effectiveness Making the Case: Health Care Quality and Disparities Making the Case: Health Care Quality and Disparities Learning More about What We Know Learning More about What We Know The Role of Guidelines The Role of Guidelines Questions Questions

National Guideline Clearinghouse Originally a public/private partnership with the American Medical Association and American Association of Health Plans Originally a public/private partnership with the American Medical Association and American Association of Health Plans Emphasis on transferring evidence- based knowledge to health care professionals Emphasis on transferring evidence- based knowledge to health care professionals NGC went live 12/15/98 NGC went live 12/15/98

Facts About NGC More than 2,300 guideline summaries from 275 organizations More than 2,300 guideline summaries from 275 organizations More than 30 guideline comparisons (syntheses) More than 30 guideline comparisons (syntheses) More than 6,500 citations in the annotated bibliography More than 6,500 citations in the annotated bibliography More than 63,000 subscribers to the “What’s New” service More than 63,000 subscribers to the “What’s New” service

New, Updated, and Withdrawn Guidelines

IOM Reports

What’s In a Definition? IOM 2009 Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances IOM 2011 Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options

NGC: Next Steps & Time Estimates – IOM Trustworthiness 1Q 2013 Announce Revised Inclusion Criteria 2Q 2013 Apply Inclusion Criteria to New and Updated Guidelines (“Grandfather”) 3Q Q Q Q Q Q Q Months Develop, Test Approach to Indicating Extent to Which Guidelines Adhere to IOM Standards Inclusion Criteria Begin Phased Implementation of Approach Extent Adherence to IOM Calendar Year Timeline for AHRQ and NGC actions involving IOM Standards for Developing Trustworthy Guidelines

A Matter of Trust Systematic review of the existing evidence Systematic review of the existing evidence Developed by multidisciplinary panel of experts Developed by multidisciplinary panel of experts Consider patient subgroups and preferences Consider patient subgroups and preferences Explicit and transparent process Explicit and transparent process Clear explanation of relationships between alternative care options and health outcomes Clear explanation of relationships between alternative care options and health outcomes Reconsidered and revised as appropriate Reconsidered and revised as appropriate Measures of CPG Trustworthiness

Eight Standards for Developing Trustworthy CPGs Establishing transparency Establishing transparency Management of conflict of interest Management of conflict of interest Guideline development group composition Guideline development group composition Clinical practice guideline– systematic review intersection Clinical practice guideline– systematic review intersection Establishing evidence foundations for and rating strength of recommendations Establishing evidence foundations for and rating strength of recommendations Articulation of recommendations Articulation of recommendations External review External review Updating Updating

Implications for Clinical Practice Guidelines CPGs must comprise actionable statements CPGs must comprise actionable statements Future CPGs will be embedded in information systems  collaborations with human factors, engineers, others Future CPGs will be embedded in information systems  collaborations with human factors, engineers, others CPGs are about both ‘what’ – and ‘how’ CPGs are about both ‘what’ – and ‘how’ Improved quality supply chain links CPGs, quality measures and data sources Improved quality supply chain links CPGs, quality measures and data sources

Eisenberg Center Symposium: September 2012 What do we do when new evidence challenges conventional wisdom? What do we do when new evidence challenges conventional wisdom? – When evidence challenges established clinical practice – Consumers receiving mixed messages – Media focus on emerging research, conflict rather than established practice Conclusions Conclusions – Clear and concise messages! – Transparency in generating evidence and recommendations – Ongoing stakeholder input; work with trusted sources – “Meeting people where they are at”

The “Quality Supply Chain” Significant activity recently on provider performance measurement Significant activity recently on provider performance measurement Less clear is the basis for existing measures Less clear is the basis for existing measures Health IT sometimes considered a silver bullet Health IT sometimes considered a silver bullet – Digitized data “self- assembles” – Clinical decision support

USPSTF: New Steps Designed to Increase Transparency The Task Force now requests public comment throughout the recommendation process The Task Force now requests public comment throughout the recommendation process USPSTF is also developing stakeholder groups USPSTF is also developing stakeholder groups Organizations and individuals are encouraged to sign up for the Task Force listserv to receive updates on the latest activities Organizations and individuals are encouraged to sign up for the Task Force listserv to receive updates on the latest activities New Product for Consumers

The final Recommendation and supporting Evidence Report are posted on the Task Force Web site. Final Recommendations also are made available through electronic tools, peer-reviewed journals, and consumer guides. The Task Force reviews all comments, addresses them as appropriate, and creates a final Recommendation. Members vote to ratify the final Recommendation. The draft Recommendation is posted on the USPSTF Web site for public comment. The Evidence Report is finalized and published. The draft Evidence Report is posted on the USPSTF Web site for public comment. (Future Step in 2013) The EPC reviews all comments, addresses them as appropriate, and creates a final Evidence Report. Using the final Research Plan, the research team at the EPC independently gathers and reviews the available published evidence and creates a draft Evidence Report. The draft Evidence Report is critiqued by external national subject matter experts. The draft Research Plan is posted on the USPSTF Web site for public comment. The Task Force and EPC review all comments, address them as appropriate, and create a final Research Plan. Task Force members work with researchers from an Evidence-based Practice Center (EPC) to create a draft Research Plan that guides the recommendation process. Develop Research Plan Public Comment Opportunity Develop Evidence ReportPublic Comment Opportunity Task Force members discuss the Evidence Report and deliberate on the effectiveness of the service. Based on the discussion, Task Force members create a draft Recommendation. Develop Recommendation Public Comment Opportunity Finalize Recommendation Publish & Disseminate Final Recommendation Recommendation Process

Key Considerations Guidelines will remain central to the provision of safe, high- quality care Guidelines will remain central to the provision of safe, high- quality care Much of the measurement enterprise is “evolving” Much of the measurement enterprise is “evolving” Collective interest in using guidelines that reflect the profession’s knowledge and authority Collective interest in using guidelines that reflect the profession’s knowledge and authority Disparate stakeholders must be engaged Disparate stakeholders must be engaged The patient always comes first! The patient always comes first!

Questions? AHRQ Mission To improve the quality, safety, efficiency, and effectiveness of health care for all Americans AHRQ Vision As a result of AHRQ's efforts, American health care will provide services of the highest quality, with the best possible outcomes, at the lowest cost