Emerging Methods in Comparative Effectiveness and Safety

BACKGROUND: Interest in new methods for comparative effectiveness, drug and patient safety, and related studies is burgeoning. The advent of Medicare Part D for outpatient prescription drugs has drawn significant attention to the need for efficient ways to monitor the potential benefits and harms of pharmaceuticals. These trends prompted the Effective Health Care program at the Agency for Healthcare Research and Quality and its DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) network to examine innovative approaches for such investigations through an invitational symposium in June 2006. RESULTS: Conference papers covered numerous points about ways to structure both interventional and database-oriented studies, particularly those concerned with adverse drug events, to avoid bias in those studies, and to apply advanced statistical tools to exploit the information from these studies to their fullest. Of particular importance are: (1) using new types of experimental designs, including cluster randomization, delayed designs, pragmatic trials, and practice-based investigations that incorporate the natural variation of data from routine clinical practice; (2) finding efficient ways to use different types of databases-eg, Department of Veterans Affairs files, Centers for Disease Control and Prevention surveillance files, Medicaid claims data, and state hospital data-for examining initiation, persistence, and adherence, and the benefits and adverse events of pharmaceutical use; and (3) inventing or refining ways to decrease the threats to validity of analyses relying on administrative or other observational data, particularly through propensity scoring, inverse probability weighting, risk adjustment, and direct or indirect methods for synthesizing comparative effectiveness information

Agency (philosophy) · Alternative medicine · Comparative effectiveness research · Data science · Health care · Inverse probability weighting · Medicaid · Observational study · Propensity score matching · Veterans Affairs · Advanced Causal Inference Techniques · Computer Science · Health Systems, Economic Evaluations, Quality of Life · Medicine · Pharmacovigilance and Adverse Drug Reactions

• Medicare Part D Data

  Leslie Greenwald, Leslie M Greenwald•Medical Care•2007

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• Designed Delays Versus Rigorous Pragmatic Trials

  Malcolm Maclure, Bruce Carleton et al.•Medical Care•2007

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• Comparison of Meta-Analytic Results of Indirect, Direct, and Combined Comparisons of Drugs for Chronic Insomnia in Adults

  Ben W Vandermeer, Ben Vandermeer et al.•Medical Care•2007

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• Using Propensity Scores Subclassification to Estimate Effects of Longitudinal Treatments

  Jodi B Segal, Michael Griswold et al.•Medical Care•2007

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• A Simulation-Based Evaluation of Methods to Estimate the Impact of an Adverse Event on Hospital Length of Stay

  Matthew H Samore, Shuying Shen et al.•Medical Care•2007

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• Practice-Based Evidence Study Design for Comparative Effectiveness Research

  Susan D Horn, Julie Gassaway•Medical Care•2007

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• Design of Cluster-Randomized Trials of Quality Improvement Interventions Aimed at Medical Care Providers

  Robert J Glynn, M Alan Brookhart et al.•Medical Care•2007

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• Developing Indicators of Inpatient Adverse Drug Events Through Nonlinear Analysis Using Administrative Data

  Jonathan R Nebeker, Paul R Yarnold et al.•Medical Care•2007

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• Evaluation and Overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project (Neiss-Cades)

  Michael A Jhung, Daniel S Budnitz et al.•Medical Care•2007

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• Cluster Randomized Trials

  Kathleen M Mazor, James E Sabin et al.•Medical Care•2007

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• Out-of-Pocket Pharmacy Expenditures for Veterans Under Medicare Part D

  Randall Rupper, Randall W Rupper et al.•Medical Care•2007

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• Use of Propensity Score Technique to Account for Exposure-Related Covariates

  John D Seeger, Tobias Kurth et al.•Medical Care•2007

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• Creating and Synthesizing Evidence With Decision Makers in Mind

  David C Atkins, David Atkins•Medical Care•2007

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• Using Inverse Probability-Weighted Estimators in Comparative Effectiveness Analyses With Observational Databases

  Lesley H Curtis, Bradley G Hammill et al.•Medical Care•2007

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• The Medical License Number Accurately Identifies the Prescribing Physician in a Large Pharmacy Claims Database

  M Alan Brookhart, J Avorn et al.•Medical Care•2007

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• Assessment of Adherence to and Persistence on Disease-Modifying Antirheumatic Drugs (DMARDs) in Patients With Rheumatoid Arthritis

  Carlos G Grijalva, Cecilia P Chung et al.•Medical Care•2007

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• Studying Prescription Drug Use and Outcomes With Medicaid Claims Data

  Stephen Crystal, Ayse Akincigil et al.•Medical Care•2007

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• The Utility of Administrative Data for Measuring Adherence to Cancer Surveillance Care Guidelines

  Gregory S Cooper, Lonni Schultz et al.•Medical Care•2007

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• Did the Medicare Inpatient Rehabilitation Facility Prospective Payment System Result in Changes in Relative Patient Severity and Relative Resource Use

  Susan M Paddock, José J Escarce et al.•Medical Care•2007

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• Evaluating the Validity of an Instrumental Variable Study of Neuroleptics

  M Alan Brookhart, Jeremy A Rassen et al.•Medical Care•2007

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• Increasing Levels of Restriction in Pharmacoepidemiologic Database Studies of Elderly and Comparison With Randomized Trial Results

  Sebastian Schneeweiss, Amanda R Patrick et al.•Medical Care•2007

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• Adjustments for Unmeasured Confounders in Pharmacoepidemiologic Database Studies Using External Information

  Til Stürmer, Robert J Glynn et al.•Medical Care•2007

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• Methodologic Challenges to Studying Patient Safety and Comparative Effectiveness

  Brian L Strom•Medical Care•2007

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• Improving Depiction of Benefits and Harms

  Artyom Sedrakyan, Chuck Shih•Medical Care•2007

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• Heterogeneity and the Interpretation of Treatment Effect Estimates From Risk Adjustment and Instrumental Variable Methods

  John M Brooks, Elizabeth A Chrischilles•Medical Care•2007

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• Real-Time Vaccine Safety Surveillance for the Early Detection of Adverse Events

  Tracy A Lieu, Martin Kulldorff et al.•Medical Care•2007

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• Does the Patient's Payer Matter in Hospital Patient Safety

  Jan P Clement, Richard C Lindrooth et al.•Medical Care•2007

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