Medical care
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Randomized trials aimed at improving the quality of medical care often randomize the provider. Such trials are frequently embedded in health care systems with available automated records, which can be used to enhance the design of the trial. ⋯ Challenges to compliance, expected small effects, and covariate imbalances are particularly likely in cluster-randomized trials of quality improvement interventions. When such trials are embedded in medical systems with available automated records, use of these data can enhance the design of the trial.
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Multicenter Study
Developing indicators of inpatient adverse drug events through nonlinear analysis using administrative data.
Because of uniform availability, hospital administrative data are appealing for surveillance of adverse drug events (ADEs). Expert-generated surveillance rules that rely on the presence of International Classification of Diseases, 9th Revision Clinical Modification (ICD-9-CM) codes have limited accuracy. Rules based on nonlinear associations among all types of available administrative data may be more accurate. ⋯ Hierarchically optimal classification tree analysis is a promising method for rapidly developing clinically meaningful surveillance rules for administrative data. The resultant model for drug-induced bleeding and anticoagulation problems may be useful for retrospective ADE screening and rate estimation.
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To evaluate the association of institutional residence and chronic disability with end-of-life Medicare utilization in 1989 and 1999. ⋯ Despite dramatic growth in hospice use, hospital and SNF utilization generally did not decline. Institutional residence, which is not usually included in analyses of Medicare claims, was strongly associated with utilization. This may affect the usefulness of claims-based efficiency indicators.
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The issues of weighing benefits and harms and of shared decision-making have become increasingly important in recent years. There is limited knowledge and lack of adequate data on the most transparent method of communicating the information. In this article we discuss examples of communicating benefits and harms for well-known therapeutics, illustrating that relative risk estimates are not helpful for communicating the chance of experiencing adverse events. ⋯ We conclude that consistently depicting benefit and harm information in frequencies can substantially improve the communication of benefits and harms. Investigators should be requested to provide frequency data along with relative risk information in the publication of their scientific findings. Currently, even in the highest impact medical journals, evidence of benefits and harms is not consistently presented in ways that facilitate accurate interpretation.
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Centralized administrative databases enable low-cost pragmatic randomized trials (PRTs) of drug effectiveness and safety. We simplified the PRT strategy by using designed delays (DD) to evaluate drug policies. ⋯ DD trials can be negotiated with policymakers. Low cost and simplicity of DD trials partly compensate for some limitations for evaluating drug safety and effectiveness. The ethics question of whether a DD is routine evaluation or research depends on its purpose and generalizability.