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National Voluntary Consensus Standards for Patient Outcomes Summary of the Main Steering Committee meeting October 19-20, 2009 Steering Committee members present: Joyce Dubow, MUP (co-chair); Barbara Yawn, MD; Ted Gibbons, MD; Anne Deutsch, PhD, RN; Iver Juster, MD; Pauline McNulty, PhD; Burke Kealey, MD, FHM; Dianne Jewell, PT, DPT, PhD, CCS; Linda Groah RN, MSN, CNOR, FAAN; Ruben Amarasingham, MD, MBA; David Hopkins, MS, PhD; Patricia Haugen; Linda Gerbig, RN, MSPH (Oct 20. only) Steering Committee members participating via conference call: Lee Fleisher, MD (co-chair); Vanita Pindolia, PharmaD, BCPS; Brian Fillipo, MD, MMM, FACP; David Johnson, MD, FACP, FACG, FASGE; Linda Gerbig (Oct. 19 th only), RN, MSPH NQF Staff members present: Helen Burstin, MD, MPH; Reva Winkler, MD, MPH; Alexis Forman, MPH; Melissa Marinelarena, RN; Ian Corbridge, MPH, RN; Sarah Callahan; Bonnie Zell, MD, MS; Karen Pace, PhD, RN; Tom Valuck, MD, MHSA, JD; Emma Nochomovitz, MPH; Jensen Chiu, MHA There were three audience members present, all of whom belonged to NQF membership organizations. Co-chair Joyce Dubow, Committee opened the meeting and requested that the Steering Committee members introduce themselves, provide a brief background of their interests and experience and disclose any specific interests pertaining to the measures being evaluated. 1 After the introduction of the Committee members, National Quality Forum (NQF) staff, measure developers and audience members also introduced themselves. Orientation to NQF Dr. Helen Burstin, Senior Vice-President for Performance Measurement provided a brief overview of the project. She explained to the Committee that this particular project includes two additional Steering Committees for child health and mental health, as well as eight conditionspecific technical advisory panels (TAPs). Given that only a small number of measures have been submitted for review in this project so far, the Steering Committee was asked to draw on their knowledge of existing measures in the field and assist NQF staff in identifying and reaching out for those measures. Another important part of the project is to consider what important outcome measures would be useful for each condition area as well as cross-cutting. Introductory comments also included an explanation of the degree to which all members of the 1 Burke Kealey primary employment with HealthPartners medical group; Iver Juster employed by a subsidiary of Aetna, whose work related to clinical decision support has resulted in a number of measures submitted for NQF review; Anne Deutsch employment with the Rehabilitation Institute of Chicago; Dianne Jewell Board of Directors for the American Physical Therapy Association and employment with Virginia Commonwealth University; Ted Gibbons nominated by the American College of Cardiology; Pauline McNulty employed by Johnson and Johnson Pharmaceutical Services, LLC; Lee Fleisher unpaid member of surgery center for quality; Brian Fillipo employed by Connecticut Hospital Association; David Johnson Board of Trustees for American College of Gastroenterology NQF Steering Committee draft do not circulate

Committee have varied levels of experience in working with NQF and represent a wide variety of stakeholder interests. Dr. Reva Winkler, NQF Project Consultant and the outcomes project advisor, oriented the group to NQF s mission, strategic goals, and current processes for endorsing performance measures. The priorities and goals of the National Priorities Partnership were presented. NQF s strategic goals to improve quality measurement were discussed: driving high performance in healthcare delivery through the improvement of coordinated care, overall population health, patient safety, engagement of patients and families in health self-management, and eliminating waste while providing appropriate care at all levels; harmonizing 2 measures across sites and providers; promoting shared accountability and measurement across patient-focused episodes of care ; emphasizing outcome measures; shifting toward composite measures; and measuring social disparities that influence health at the population level. The Committee was advised NQF s main goals for this two day meeting, were to: orient the Steering Committee to NQF current and future activities; advise the Steering Committee on their role to reach project goals; establish the scope of the project by defining the types of outcome measures; and discuss the measure evaluation process. Orientation to the Outcomes Project Dr. Winkler described the goals of the project: Identify, evaluate and endorse additional outcome measures in more than 20 condition areas; Identify, evaluate and endorse cross-cutting (not condition-specific) measures; Identify gaps in existing outcome measures and make recommendations to fill those gaps. Further context for the project was provided through an explanation of the NQF Consensus Development Process (CDP) with detailed discussion of the role of the Steering Committee (SC), the project s Technical Advisory Panels (TAPs) and the role of the NQF staff. Specifically, the 2 Harmonization refers to the standardization of specifications for similar measures on the same topic (e.g., influenza immunization of patients in hospitals, nursing homes, etc.), or related measures for the same target population (e.g., eye exam and HbA1c for patients with diabetes), or definitions applicable to many measures (e.g., age designation for children) so that they are uniform or compatible, unless differences are dictated by the evidence. The dimensions of harmonization can include numerator, denominator, exclusions, and data source and collection instructions. The extent of harmonization depends on the relationship of the various measures and the evidence for the specific measure focus, as well as differences in data sources. 2

role of the SC is a Proxy for the NQF membership and to representthe wide variety of stakeholders; work with staff to achieve the project goals; evaluate candidate measures with input from Technical Advisory Panels and make recommendations to the NQF Membership on which measures should be endorsed. The TAPs provide additional clinical expertise to advise the SC by drafting preliminary evaluation of the sub-criteria on the standard measure evaluation criteria. The TAP chairs are members of the Steering Committee. NQF staff explained NQF s new online submission form, and lead a detailed discussion of NQF s standard measure evaluation criteria, revised in August 2008. Steering Committee discussion Members of the Committee raised a number of questions in response to their orientation to NQF s current work focused around four main themes: defining an outcome measure, barriers to meaningful outcome measurement, clarification of NQF s measure evaluation and maintenance processes, and the identification of guiding principles for future project work. Definitions and Scope In an effort to define the scope of this project, the Committee discussed the need for describing an outcome measure. NQF staff provided a straw man definition as a point of departure for this discussion by identifying Donobedian s definition of outcomes, which refers to changes (desirable and undesirable) in individuals and populations that are attributed to healthcare and a list of types of outcome measures, including the following: Patient function, symptoms, healthcare-related quality of life Intermediate clinical outcomes Patient experience with care Service utilization as proxy or potential efficiency indicated Non-mortality clinical morbidity Healthcare acquired events/complications Mortality The Committee suggested adding absenteeism, including missed days of school for children when their parents are ill, and patient knowledge (to expand upon the notion of patient experience) as potential additions to the list of types of outcome measures. Additionally, it was suggested that the definition of functional status should be expanded to includes both personal and role function. Several concepts related to the definition of an outcome measure and specifically, cross-cutting outcome measures were discussed in detail. While no formal definition of cross-cutting was identified, the Steering Committee agreed that a cross-cutting measure is non condition-specific. 3

Furthermore, the Committee agreed to continue to discuss this issue and create a formal definition for a cross-cutting measure. The overarching themes of this discussion included the need for further definition of the term healthcare as it relates to Donbedian s definition of an outcome; a desire to utilize terminology that emphasizes a patient-centered rather than systemcentered definition; and a close examination of the relationship between a process and an outcome. Challenges in outcome measurement The Committee identified several overarching issues and challenges in the measurement of outcomes, including the following: 1. measuring e change in health status; 2. capturing full episodes of care (complete trajectory of the disease),, including acute and chronic conditions, as well as multiple settings of care; 3. availability of adequate data, including obtaining data from EMRs 4. determining responsible or accountable entities; 5. categorizing, including and adjusting for comorbid conditions; 6. inconsistent age limits across measures; 7. appropriate risk adjustment; 8. identifying important outcome measures; and 9. identifying cross-cutting outcomes measures. NQF s measure evaluation and maintenance processes Several questions were raised regarding NQF s measure evaluation and maintenance processes. Some of the main issues that were addressed included the following: How measures without a steward might be considered for endorsment (e.g., gait speed) Tools to aid in transitioning to the use of Electronic Health Records (e.g..,the QDS data set) Establishing a shorter time frame for time-limited endorsed measures. Principles for evaluating outcome measures The Committee discussed several potential principles that may serve as a foundation for the project s future work evaluating outcome measures: Denominators should be specified as numbers of patients (rather than, e.g., the number of days, treatments, etc.) so that the interpretation is the percentage of patients with the outcome or received the care, etc. This is a more consumer- focused construct. election of risk adjustment variables and methods should be explained; threshold or benchmark values that are incorporated into measures should be supported by evidence; opportunities for pairing measures and/or subpopulation analysis should be identified; and 4

measures should include all populations at risk and exclusions should be supported by evidence/justified consider unintended consequences Identifying and Evaluating Candidate Outcomes Measures The Steering Committee was asked to assist NQF staff in identifying additional outcome measures. The following were suggested as potential sources for additional measures: Dartmouth Atlas Veteran s Health Administration ACOVE Assessing Care of Vulnerable Elderly Academy Health membership international measures NCCN National Comprehensive Cancer Network Committee members were asked to help solicit the submission of measures appropriate to this project. It was noted that the benefit of NQF endorsement includes a certain amount of preeminence, increases the likelihood that a measure will be more widely used, and allows a measure to be recognized at the national level. Next steps Dr. Winkler and Ms. Forman outlined the next activities for the Steering Committee: Schedule conference call(s) for the Technical Advisory Panels and determine specific dates for the April in-person Steering Committee in Washington, DC Webinar for introduction to risk adjustment for the Steering Committee and TAP members Ms. Dubow reiterated the importance for the SC to be present in person for the spring meeting as opposed to telephone. In addition, the Steering Committee was encouraged to continue to think about gaps in the NQF portfolio as it relates to outcome measures. Lastly, the group was asked to share any frameworks that will facilitate Steering Committee communication about the scope of the project, definitions, or measurement with the NQF staff. 5