Center for the Study of Healthcare Provider Behavior Synthesizing Quality Improvement Research: Methodological & Empirical Challenges & Solutions Brian S. Mittman, PhD Center for the Study of Healthcare Provider Behavior VA Greater Los Angeles Healthcare System AcademyHealth Annual Research Meeting June 27, 2005 Co-authors Marjorie Pearson, PhD RAND Patricia Parkerton, PhD UCLA School of Public Health Nancy Takahashi, MPH VA Greater Los Angeles Healthcare System Nina Smith, MPH VA Greater Los Angeles Healthcare System Research synthesis in EBM Quantitative research synthesis (meta-analysis) is a foundation of evidence-based medicine (EBM) - combine, reconcile seemingly inconsistent findings - leverage small studies with limited power Although originating in education research, metaanalysis proved extremely useful–and has been extensively refined—in clinical research Research synthesis in other fields The value and power of meta-analysis in clinical research have prompted its application to healthcare quality improvement research, and renewed use in education, criminal justice and other areas of management, policy and behavioral/social research The core assumptions and requirements for metaanalysis are often adequately met in clinical research, but rarely in other fields Three key questions: - Which requirements are not met in QI research? - How serious are the gaps? - How should we respond? Framework and key source “Challenges of Summarizing Better Information for Better Health: The Evidence-based Practice Center Experience” Annals of Internal Medicine 142(12) Pt 2, June 21, 2005 Challenges in Systematic Reviews of … Complementary and Alternative Medicine Diagnostic Technologies Delivery, Organization and Financing of Health Care Drug Efficacy or Effectiveness Economic Analyses Educational Intervention Studies Treatment Harms Therapeutic Devices and Procedures Nonrandomized Studies Identifying and gathering evidence Publication bias − likelihood of preparation of manuscript − selective reporting of outcomes − likelihood of acceptance Types of evidence − dearth of RCTs − questionable value of observational evidence − limited, variable documentation of process, impact outcomes Variable reporting and coding Intervention (main effect) − insufficient specification of intervention − intervention flexibility (customization) − variability (skill dependence) Contextual factors (effect modifiers) − lack of recognition (attention) within protocol − lack of measurement − limited reporting even if measured (space constraints, exclusion from analysis) Heterogeneity of studies Equivalence of quality problems (diagnoses treated), i.e., comparability of “therapeutic aims” Intervention (main effect) − intervention flexibility (customization) − variability (skill dependence) − efficacy vs. effectiveness studies of QI programs Prevalence of intervention packages − separability of components; additive vs. interactive effects − comparability of unique packages Quality of evidence Threats to validity − contamination (patient-, clinician-, clinic-level randomization) − Hawthorne effects, expectation effects − short-term follow-up − limited or no blinding − PI role in intervention; intervention/evaluation team overlap − non-validated instruments − variability in assessment methods − other data/measurement flaws Quality of evidence (cont.) Use of non-RCT evidence − evolving quality standards for observational evidence − evolving standards for qualitative data Site selection, representativeness − Voluntary vs. random selection − QI site selection representativeness paradox: random selection = less representativeness Key problems Lack of clearly-defined, universally accepted concepts, terms for interventions, contextual factors, effects (process, outcome) Lack of quality standards and guidance for study designs, methods Lack of guidance in identifying (and measuring) key contextual factors Lack of standards for consistent reporting Evolving, developing methods for qualitative synthesis Short-term solutions: QUERI Research Synthesis Project Quantitative and qualitative synthesis of 54 VA-funded QI studies Data sources include public documents, confidential documents, in-depth interviews Evidence tables (and data collection forms) cover a wide range of intervention, contextual and outcome variables Long-term solutions Consensus efforts to establish: − shared definitions of key concepts and terms − quality standards and guidance for study designs, methods − list of key contextual factors − consistent measures of key contextual factors − reporting standards and templates Continued development of methods for qualitative synthesis