Medical care
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An evaluation of the effect of a healthcare intervention (or an exposure) must consider multiple possible outcomes, including the primary outcome of interest and other outcomes such as adverse events or mortality. The determination of the likelihood of benefit from an intervention, in the presence of other competing outcomes, is a competing risks problem. Although statistical methods exist for quantifying the probability of benefit from an intervention while accounting for competing events, these methods have not been widely adopted by clinical researchers. ⋯ CSH is the fundamental measure of outcome in competing risks problems. It is appropriate for evaluating treatment effects in the presence of competing events. Results of CSH analysis for primary and competing outcomes should always be reported even when EFS or CIF approaches are called for. EFS is appropriate for evaluating the composite effect of an intervention, only when combining different endpoints is clinically and biologically meaningful, and the treatment has similar effects on all event types. CIF is useful for evaluating the likelihood of benefit from an intervention over a meaningful period. CIF should be used for absolute risk calculations instead of the widely used complement of the Kaplan-Meier (1 - KM) estimator.
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Despite ethical implications, there are anecdotal reports of health practitioners withholding services from patients who do not pay their bills. We surveyed physicians about their attitudes and experiences regarding nonpaying patients. ⋯ A majority of primary care practitioners responding to our survey would be willing to withhold medical care from patients who do not pay their bills; some have actually done so despite ethical and legal mandates to the contrary. Physicians should be educated about the importance of the patient-physician relationship and their ethical obligations to patients.
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Comparative effectiveness research analyzes groups of patients and looks for associations between medical treatments and patient outcomes. To make meaningful comparisons of medical interventions, one must consider clinical heterogeneity of patient populations, intervention combinations, and outcomes. ⋯ PBE study designs address comparative effectiveness by creating a comprehensive set of patient, treatment, and outcome variables, and analyzing them to identify treatments associated with better outcomes for specific types of patients. PBE studies are an alternative to randomized controlled trials, well suited to determine what works best for specific patient types, and provide clinicians with a rational basis for treatment recommendations for individual patients. They provide a holistic picture of patients, treatments, and outcomes, with no preset limits to the number of variables that can be included. Such an approach is needed for high quality comparative effectiveness research.
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Defining comparative effectiveness research (CER) was the first order of business for the Institute of Medicine Committee on Initial Priorities for CER. The Institute of Medicine committee approached the task of defining CER by identifying the common theme in the 6 extant definitions. The definition follows: "Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. ⋯ Defining CER requires us to decide what we want from decisions about health care. Definitions also serve a bureaucratic function: they can set boundaries that delineate which research is eligible for CER program funding. Definitions--and the funding that advances their goals--can reshape the research environment.
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The Washington State workers' compensation agency funded a coverage with evidence development study to evaluate spinal cord stimulation (SCS) for chronic back and leg pain after spine surgery (failed back surgery syndrome). We previously published the study outcomes. We now report results from a second patient cohort; study costs; and industry, provider, and payer responses. ⋯ Coverage with evidence development studies may yield important information not apparent from randomized clinical trials concerning long-term risks and benefits of a therapy in clinical practice for specific subpopulations, but are likely to be met with criticism from interested parties.