Electronic medical records (EMRs) have become a common source of data for outcomes research. This review discusses trends in EMR data use for outcomes research as well as strengths and limitations, and likely future developments to help optimize value and use of EMR data for outcomes research. EMR-based studies reporting treatment outcomes published between 2007 and 2012 were predominantly from the USA and Europe. There has been a substantial increase in the number of EMR-based outcomes studies published from 2007-2008 (n = 28) to 2010-2011 (n = 55). Many studies evaluated biometric and laboratory test outcomes in common chronic conditions. However, researchers are expanding the scope of evaluated diseases and outcomes using advanced techniques, such as natural language processing and linking EMRs to other patient-level data to overcome issues with missing data or data that cannot be accessed using standard queries. These advances will help to expand the scope and sophistication of outcomes research in the coming years.

The objective of the current study was to determine the cost-utility of pregabalin versus duloxetine for treating painful diabetic neuropathy (PDN) using a decision tree analysis. Literature searches identified clinical trials and real-world studies reporting the efficacy, tolerability, safety, adherence, opioid usage, health care utilization, and costs of pregabalin and duloxetine. The proportions of patients reported in the included studies were used to determine probabilities in the decision tree model. The base-case model included the Food and Drug Administration (FDA)-approved doses of pregabalin (300 mg/day) and duloxetine (60 mg/day), whereas "real-world" sensitivity analyses explored the effects over a range of doses (pregabalin 75-600 mg/day, duloxetine 20-120 mg/day). A 6-month time horizon and a US third-party payer perspective were chosen for the study. Outcomes from the model were expressed as cost per quality-adjusted life-year (QALY). In the base-case model, duloxetine cost less and was more effective than pregabalin (incremental cost -$187, incremental effectiveness 0.011 QALYs). Results from two real-world sensitivity analyses indicated that duloxetine cost $16,300 and $20,667 more per additional QALY than pregabalin. Using a decision tree model that incorporated both clinical trial and real-world data, duloxetine was a more cost-effective option than pregabalin in the treatment of PDN from the perspective of third-party payers.

Outcomes research studies use clinical and administrative data generated in the course of patient care or from patient surveys to examine the effectiveness of treatments. Health care providers need to understand the limitations and strengths of the real-world data sources used in outcomes studies to meaningfully use the results. This paper describes five types of databases commonly used in the United States for outcomes research studies, discusses their strengths and limitations, and provides examples of each within the context of pain treatment. The databases specifically discussed are generated from (1) electronic medical records, which are created from patient-provider interactions; (2) administrative claims, which are generated from providers' and patients' transactions with payers; (3) integrated health systems, which are generated by systems that provide both clinical care and insurance benefits and typically represent a combination of electronic medical record and claims data; (4) national surveys, which provide patient-reported responses about their health and behaviors; and (5) patient registries, which are developed to track patients with a given disease or exposure over time for specified purposes, such as population management, safety monitoring, or research.

In the European Union, 4.5 million people are estimated to have AF.2 Patients with untreated AF are at a 4-to 5-fold increased risk of stroke compared with those without the disease. Vitamin K antagonists (VKAs), such as warfarin, have been successfully used for many years to provide prophylaxis against stroke in patients with AF. A large meta-analysis of randomized trials showed that adjusted-dose warfarin reduced the incidence of stroke by 64%. 4 However, in a real-world analysis of Medicare patients with AF, the reduction in stroke with warfarin was lower than in the meta-analysis, at 27%. 5While effective, VKAs are associated with a number of limitations: they have numerous drug and food interactions; their effect is influenced by genetic factors; and they have a narrow therapeutic range, requiring frequent international normalized ratio (INR) monitoring and dose adjustments.6 As a result of these factors, there is considerable variability in the amount of time patients spend within the therapeutic range (INR, 2.0-3.0), which exposes them to stroke when they are below the range and bleeding when they are above the range.New anticoagulants have been developed to reduce the risk of stroke in patients with AF. These oral agents are direct inhibitors of single coagulation factors and include dabigatran, rivaroxaban, and apixaban.7 They meet the need for predictable anticoagulation with fixed dosing, without the need for laboratory monitoring. As may be expected, these anticoagulants are more expensive per unit than warfarin.7 However, the