Defining an Outcome Measures Framework for Global Surgery
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1 Defining an Outcome Measures Framework for Global Surgery Richard Gliklich MD Leffenfeld Professor of Otology and Laryngology, Harvard Medical School Surgeon, Mass Eye and Ear; Massachusetts General Hospital Principal Investigator: Outcome Measures Framework; Registry of Patient Registries; Registries for Evaluating Patient Outcomes: A User s Guide (1 st, 2 nd, 3 rd editions) for Agency for Healthcare Research and Quality (AHRQ) Lancet Commission for Global Surgery, 17 January 2014
2 Structures, Processes, Outcomes From:
3 Outcomes Metrics: Overview How will the outcomes be used? How will (or can) you obtain data? Which outcomes to measure (and how to find them)?
4 Outcomes Metrics: Overview How will the outcomes be used? Design with the end in mind Start with the purpose(s), it will define everything else Understand the stakeholders and decisionmakers
5 Outcomes Metrics: Overview How will the outcomes be used? How will (or can) you obtain data? Starting with the Ideal Real-world constraints-resources, data availability, followup, etc.
6 Measuring Outcomes-the Registries Model Patient /clinical data registries have become the standard for measuring outcomes for surgery on a global basis A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s). Gliklich RE, Dreyer NA: Registries for Evaluating Patient Registries: A User s Guide: Agency for Healthcare Research and Quality publication No. 07-EHC001. Rockville, MD. April 2007 (2 nd Edition September 2010; 3 rd Edition February 2014). Available online through
7 Timeline (T) Quality Assurance Pa;ents +/-sampling Reports Enrollment, Demography, Risk factors, Ini;al Evalua;on Ongoing treatments, intermediate outcomes Outcomes, Final disposi;on The Ideal Registry for Outcomes Assessment Collects uniform, clinically rich data including risk factors, treatments and outcomes at key points for a particular disease or procedure From multiple sources (doctors, patients, hospitals) and across care settings (practices, hospitals, home) Leverages HIT systems through interoperability and data sets from other sources through linkage Uses standardized methods to assure representative patient sample, data quality (accuracy, validity, meaning, completeness) and comparability (risk adjustment) Adapted from: Gliklich RE, Dreyer NA: Registries for Evaluating Patient Registries: A User s Guide: Agency for Healthcare Research and Quality Rockville, MD. September 2010
8 Outcomes Metrics: Overview How will the outcomes be used? How will (or can) you obtain data? Which outcomes to measure (and how to find them)? Should be meaningful, collectable and standardized whenever possible
9 What to Measure: IOM Crossing the Quality Chasm Six aims that health care system must fulfill to deliver quality care Safe Effective Efficient Timely Patient centered Equitable Access to safe surgery when needed with financial protection Dr. John Meara Lancet Commission on Global Surgery
10 Finding the right measures Development and applicability of the Outcome Measures Framework 2010, U.S. AHRQ and NLM - lack of standardized outcomes measurement a major impediment to collecting, sharing and comparing outcomes data Outcome Measures Framework (OMF) project, a part of the Registry of Patient Registries, launched to promote development of a common model and repository > Facilitate the use of common metrics, data fields and definitions in similar health conditions Hundreds of stakeholders-patient, physicians, payers, government agencies, societies-convened in multiple condition-focused meetings.
11 An Outcome Measures Framework Par;cipant Characteris;cs Treatments Outcomes Disease Characteris;cs Provider Characteris;cs Gliklich RE, et al. Outcome Measures Framework Design Document. Agency for Healthcare Research and Quality. In press. Gliklich RE et al. Challenges in Developing an Outcome Measures Framework for Patient Registries. Value in Health, 2013:16:A1-A
12 Framework Data Element Categories Par;cipant Characteris;cs - Demographics - Gene<cs - Family/Par<cipant History - Func<onal/performance status - Health Behaviors - Environmental Exposures Disease Characteris;cs - Diagnosis - Risk Factors - Staging Systems - Gene<cs of Disease tissue or infectious agent - Biomarkers - Comorbidity/Symptoms - Assessments/scales - Labs, radiology and imaging Provider Characteristics - Training/experience - Geography - Practice setting: academic vs. community Treatment - Treatment type Surgical Medical Devices Alternative - Treatment intent Outcomes Survival - Overall mortality - Disease free survival Disease Response - Recurrence - Progression Events of Interest - Adverse events - Exacerba<ons Pa;ent- Reported Outcomes - - Physical func<oning - - Quality of Life - - Other Health System U;liza;on - Inpa<ent hospitaliza<on - Office visits - ER visits - Addi<onal procedures - Produc<vity/absenteeism - Direct cost Gliklich RE, et al. Outcome Measures Framework Design Document. Agency for Healthcare Research and Quality. In press. Gliklich RE et al. Challenges in Developing an Outcome Measures Framework for Patient Registries. Value in Health, 2013:16:A1-A298.
13 Search for Outcome Measures Outcome Measure Attributes 13
14 Finding Outcome Measures Patient Reported Outcomes Selection Criteria 14
15 General concepts in designing/ implementing metrics General Considerations > Design measurement with respect to its major purposes > Select data sources, populations, comparison groups > Determine whether sampling is needed > Identify possible sources of bias (systematic error) and address them to the extent that is practical and achievable Data Elements > Select based on importance and relationship to the primary outcome > Consider data collection burden and incremental costs for collection > Whenever possible, use established standards and common data definitions or validated instruments > Weigh pros/cons of using patient identifiers > Use pilot testing to assess feasibility and burden as well as reliability, validity, and potential for missing data Adapted from Gliklich RE, Dreyer NA: Registries for Evaluating Patient Outcomes: A User s Guide, Agency for Healthcare Research and Quality. Sept 2010.
16 Thank you More information on how to select metrics see > Gliklich RE, Dreyer NA: Registries for Evaluating Patient Outcomes: A User s Guide, 2 nd Edition (3 rd Edition to be published soon): %20ed%20final%20to%20Eisenberg% pdf Contact Information > Rich Gliklich MD: Richard_gliklich@meei.harvard.edu
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