Developing a comparative effectiveness research agenda: The CONCERT experience David H. Au, MD MS Associate Professor of Medicine University of Washington and Investigator Health Services Research and Development VA Puget Sound Health Care System For the CONCERT Investigators
Disclosures Research Funding NHLBI, AHRQ, VA HSR&D Gilead Sciences Consultant Bosch No tobacco industry relationships
Disclaimer The views expressed here are those of the authors and do no necessarily reflect the position or policy of the Department of Veterans Affairs.
Overview How to identify a national comparative effectiveness research priority CONCERT as a model
What is comparative effectiveness? The conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in real world settings. Purpose is to improve health outcomes by developing and disseminating evidence based information to patients, clinicians, and other decision makers, responding to their expressed needs, about which interventions are most effective for patients under specific circumstances. Federal Coordinating Council for CER Draft Definition 2010
Who decides research priorities American Recovery and Reinvestment Act of 2009 Charge the IOM to identify CER priorities for the country IOM provide a priority list of CER topics Solicited ideas from stakeholders Received >1000 topics Prioritized ideas with input from stakeholders Top 100 CER priorities for the country
How did the ATS 3 pillars do? IOM top 100 priorities for CER search What didn t make it word search COPD none Asthma two shared decision making in chronic disease Integrated approach episodic care model children Lung one genetic, biomarkers for lung cancer Sleep, critical care none What made it CER of Acne treatments Migraine treatment on lost productivity Diagnostic imaging of radiologist vs non radiologist http://www.hrsonline.org/policy/legislationtakeaction/iom_report_cer_priorities.cfm Accessed 05/14/2011
Pillars of the ATS 2011 Research Deaths $$ Per Patient $$ Per Patient Disease Funding Per Disease Death COPD 101 Million 126,128 $ 811 $ 7 Hepatitis C 102 Million 12,000 $8,500 $ 23 Cardiovascular 2.1 Billion 864,280 $ 2,429 $ 26 Dis. Diabetes 1 Billion 72,449 $ 13,803 $ 42 Prostate Cancer 329 Million 28,372 $ 11,595 $ 219 HIV/AIDS 3.2 Billion 14,110 $ 225,656 $ 3,032 Breast Cancer 765 Million 41,210 $ 18,563 $4,238 West Nile Virus 41 Million 28 $1,464,285 $ 64,364 Clear we need better advocacy http://www.fairfoundation.org/factslinks.htm accessed 1/12/2010
Developing research agenda CONCERT Research agenda set by community of stakeholders Series of 4 topics distributed over 2 years May 2009 Chronic COPD care Care Coordination May 2010 Acute Care in COPD Transitions in care in COPD AHRQ/NHLBI R13 HS017894
Objectives of consensus conferences and network studies 1) To create an effectiveness & implementation research agenda that identifies and prioritizes opportunities to improve COPD care. 2) To accelerate the development of welldesigned multi center studies that evaluate the effectiveness and implementation of care in real world clinical settings. AHRQ/NHLBI R13 HS017894
Where to start? Identify the stakeholders Patients/patient advocacy groups Funders of health care Health quality Professional societies Research funders Academic institutions
Priorities in COPD Care Research 25 Active Participating Stakeholders
Development timeline Chronic COPD Care/Care Coordination Pre conference Consensus Conference Post Conference 3/23-3/31 4/3-4/17 4/24-5/6 5/13 5/21/09 5/22/09 Working Group (WG) 1 and WG 2 propose lists of Provisional Topics for research related to measuring or improving: 1. Chronic COPD care (WG 1) 2. Care coordination in COPD (WG 2). Provisional Topics sent to representatives of Stakeholders, Conference Speakers from Years 1 and 2, and External Advisory Committee to identify additional research topics. Revised Provisional Topics DUE 4/17/09. Revised Provisional Topics from each WG sent for initial prioritization/vote to Stakeholders and Conference Speakers ([Vote #1]; separate vote for each list of Provisional topics; Votes DUE 5/6/09) Briefing book with Ranked Provisional Topics distributed to conference participants Day 1 of Conference Speakers B. Celli (state of the art in COPD care); R. Mularski (Gaps in COPD care); M. Levine (Measuring quality/pqri); J. Range (Certification programs, Joint Commission); T. Lee (Epidemiology of complex medical patients/elderly with COPD); C. Boyd (Care of complex medical patients); M. Glasser (Caring for COPD in rural populations); F. Masoudi (Disease management) Day 2 of Consensus Conference Modified Delphi method used to develop/rank separate research agendas [Vote #2]: 1. Evaluating and improving chronic COPD care (morning session) 2. Evaluating and improving COPD care coordination (afternoon session) Draft research agenda (prepared by WG 1 and 2 cochairs). Reviewed by External Advisory Committee Comment period for Draft research agendas (review by Stakeholder organizations) Endorsement of final research agenda (by Stakeholder organizations) Stakeholders participating in the Consensus Conference: AHRQ, NHLBI, CMS, NIA, American Academy of Sleep Medicine, American Association of Cardiovascular and Pulmonary Rehabilitation, American Association of Respiratory Care, American College of Emergency Physicians, American College of Physicians, American Health Quality Association, American Public Health Association, American Thoracic Society, Canadian Association of Emergency Physicians Research Consortium, COPD Foundation/Alpha 1 Foundation, Joint Commission, Kaiser Permanente Center for Health Research, Respiratory Health Association of Metropolitan Chicago, Society of Critical Care Medicine, Society of Hospital Medicine, Wellpoint AHRQ/NHLBI R13 HS017894
Prioritized research agenda Chronic COPD Care AHRQ/NHLBI R13 HS017894
Prioritized research agenda COPD Care Coordination AHRQ/NHLBI R13 HS017894
Developing research agenda CONCERT Series of 4 topics distributed over 2 years May 2009 Chronic COPD care Care Coordination May 2010 Acute care in COPD Transitions in care in COPD Analytic Hierarchy Process Method to identify not only rank Insight stakeholder specific criteria for ranking AHRQ/NHLBI R13 HS017894
Analytic Hierarchy Process (AHP) Structure for complex decisions-making method Decision elements quantified Weighting of different criteria Rational framework Not prescriptive Grounded in psychology and math Widely employed
Implementation of AHP at the Consensus Conference Stakeholders created a provisional list of research topics Identify criteria to be used by stakeholders to rank research importance Uncertainty about effectiveness of interventions Impact on patient centered health outcomes in efficacy studies Quality of evidence in efficacy studies Variability in care in real world settings Societal cost Feasibility of effectiveness studies Results would informs healthcare in diverse settings For each criterion, attendees rank pairs of provisional research topics individually Aggregate individual ranks to create initial prioritization
Expressed importance weighting Intensity of Importance 1 No difference in importance Definition 2 Weak or slight difference in importance 3 4 Moderate difference in importance 5 6 Large difference in importance 7 8 9 Extreme difference in importance Adapted from Saaty. Int. J. Services Sciences, Vol. 1, No. 1, 2008
Hypothetical ranking of research topic for individual criteria Impact on Patient Centered Outcome in Efficacy studies Pulmonary Rehabilitation Oxygen LABA Topic Antibiotics Topic Steroid Topic LVRS Pulmonary Rehabilitation 1 2 (X) PR twice the impact of O2 3 (X) PR three times the impact of LABA 4 (X) PR four times the impact of Antibiotics 5 9 (X) PR nine times as preferable to LVRS Oxygen 1 1/3 Oxygen 1/3 the impact of LABA 4 3 7 LABA 1 4 5 6 Antibiotics 1 6 7 Steroids 1 3 LVRS 1
Prioritized research agenda Acute COPD Care May 21, 2010 Acute Care Consensus Conference Findings AHRQ/NHLBI R13 HS017894
Prioritized research agenda Transitions in COPD Care May 21, 2010 Acute Care Consensus Conference Findings AHRQ/NHLBI R13 HS017894
Post Conference of Stakeholders Continued involvement of stakeholders Throughout process of research question development Inform on how study could be disseminated within their organization How stakeholders may utilize the data generated How stakeholders may implement findings
Conclusion Need greater national advocacy for research Pulmonary, Sleep and Critical Illness Developing a CER research agenda involves a broad set of stakeholder End users of the results of the research study Integral part of process Developing and refining of research questions Process guarantees value to of the research to the end user
Questions?
Care Coordination Top 3 Priorities Disease management with multi-morbidity protocol strategies to identify CAD, CHF, OSA Pulmonary rehabilitation (model of coordination) interventions to increase access and delivery Depression and mental health management impact of screening / disease co-management AHRQ/NHLBI R13 HS017894
Methods - Summary Conference organizing committee and engaged a broad-base of 25 stakeholder groups patient advocacy groups, physician and nonphysician professional organizations, payers, quality improvement organizations, regulators, government stakeholders identified representatives Topic solicitation / synthesis / briefing book Modified Delphi consensus process One vote / organization pre moderated discussion One vote / organizations post forced rank order AHRQ/NHLBI R13 HS017894
Research priorities Spirometry for diagnosis and treatment compare implementation approaches in primary care Effectiveness study of pulmonary rehabilitation community versus hospital based program COPD guideline translation effectiveness Implementation of key components during periods of exacerbations AHRQ/NHLBI R13 HS017894