Nine years of comparative effectiveness research education and training: initiative supported by the PhRMA Foundation

The term comparative effectiveness research (CER) took center stage with passage of the American Recovery and Reinvestment Act (2009). The companion US$1.1 billion in funding prompted the launch of initiatives to train the scientific workforce capable of conducting and using CER. Passage of the Patient Protection and Affordable Care Act (2010) focused these initiatives on patients, coining the term ‘patient-centered outcomes research’ (PCOR). Educational and training initiatives were soon launched. This report describes the initiative of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) Foundation. Through provision of grant funding to six academic Centers of Excellence, to spearheading and sponsoring three national conferences, the PhRMA Foundation has made significant contributions to creation of the scientific workforce that conducts and uses CER/PCOR

Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review

Rapid improvements in hepatitis C virus (HCV) therapy have led to the approval of multiple oral direct-acting antiviral (DAA) regimens by the U.S. Food and Drug Administration (FDA) for treatment of chronic HCV infection

Chapter 3: Choosing the Important Outcomes for a Systematic Review of a Medical Test

In this chapter of the Evidence-based Practice Centers Methods Guide for Medical Tests, we describe how the decision to use a medical test generates a broad range of outcomes and that each of these outcomes should be considered for inclusion in a systematic review. Awareness of these varied outcomes affects how a decision maker balances the benefits and risks of the test; therefore, a systematic review should present the evidence on these diverse outcomes. The key outcome categories include clinical management outcomes and direct health effects; emotional, social, cognitive, and behavioral responses to testing; legal and ethical outcomes, and costs. We describe the challenges of incorporating these outcomes in a systematic review, suggest a framework for generating potential outcomes for inclusion, and describe the role of stakeholders in choosing the outcomes for study. Finally, we give examples of systematic reviews that either included a range of outcomes or that might have done so. The following are the key messages in this chapter: Consider both the outcomes that are relevant to the process of testing and those that are relevant to the results of the test.Consider inclusion of outcomes in all five domains: clinical management effects, direct test effects; emotional, social, cognitive and behavioral effects; legal and ethical effects, and costs.Consider to which group the outcomes of testing are most relevant.Given resource limitations, prioritize which outcomes to include. This decision depends on the needs of the stakeholder(s), who should be assisted in prioritizing the outcomes for inclusion

Impact of bariatric surgery on hypertensive disorders in pregnancy: retrospective analysis of insurance claims data

Objective To determine whether women who had a delivery after bariatric surgery have lower rates of hypertensive disorders in pregnancy compared with women who had a delivery before bariatric surgery

Preliminary Competencies for Comparative Effectiveness Research

The Clinical and Translational Science Award (CTSA) Workgroup for Comparative Effectiveness Research (CER) Education, Training, and Workforce Development identified a need to delineate the competencies that practitioners and users of CER for patient centered outcomes research, should acquire. With input from CTSA representatives and collaborators, we began by describing the workforce. We recognize the workforce that conduct CER and the end users who use CER to improve the health of individuals and communities. We generated a preliminary set of competencies and solicited feedback from the CER representatives at each member site of the CTSA consortium. We distinguished applied competencies (i.e., skills needed by individuals who conduct CER) from foundational competencies that are needed by the entire CER workforce, including end users of CER. Key competency categories of relevance to both practitioners and users of CER were: 1) Asking relevant research questions; 2) Recognizing or designing ideal CER studies; 3) Executing or using CER studies; 4) Using appropriate statistical analyses for CER; and 5) Communicating and disseminating CER study results to improve health. While CER is particularly broad concept, we anticipate that these preliminary, relatively generic competencies will be used in tailoring curricula to individual learners from a variety of programmatic perspectives

Risk of venous thromboembolism after total hip and knee replacement in older adults with comorbidity and co-occurring comorbidities in the Nationwide Inpatient Sample (2003-2006)

<p>Abstract</p> <p>Background</p> <p>Venous thromboembolism is a common, fatal, and costly injury which complicates major surgery in older adults. The American College of Chest Physicians recommends high potency prophylaxis regimens for individuals undergoing total hip or knee replacement (THR or TKR), but surgeons are reluctant to prescribe them due to fear of excess bleeding. Identifying a high risk cohort such as older adults with comorbidities and co-occurring comorbidities who might benefit most from high potency prophylaxis would improve how we currently perform preoperative assessment.</p> <p>Methods</p> <p>Using the Nationwide Inpatient Sample, we identified older adults who underwent THR or TKR in the U.S. between 2003 and 2006. Our outcome was VTE, including any pulmonary embolus or deep venous thrombosis. We performed multivariate logistic regression analyses to assess the effects of comorbidities on VTE occurrence. Comorbidities under consideration included coronary artery disease, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes, and cerebrovascular disease. We also examined the impact of co-occurring comorbidities on VTE rates.</p> <p>Results</p> <p>CHF increased odds of VTE in both the THR cohort (OR = 3.08 95% CI 2.05-4.65) and TKR cohort (OR = 2.47 95% CI 1.95-3.14). COPD led to a 50% increase in odds in the TKR cohort (OR = 1.49 95% CI 1.31-1.70). The data did not support synergistic effect of co-occurring comorbidities with respect to VTE occurrence.</p> <p>Conclusions</p> <p>Older adults with CHF undergoing THR or TKR and with COPD undergoing TKR are at increased risk of VTE. If confirmed in other datasets, these older adults may benefit from higher potency prophylaxis.</p

Provider-Level Variation and Determinants of Outpatient Generic Drug Prescribing in a Mixed-Payer Health Care System

Background/Aims: While 86% of all drugs in the United States are dispensed as generics, this rate is not uniform across all therapeutic classes and drug products. The role of the health care provider in influencing generic use is not well understood. We sought to quantify variation between providers and provider-specific determinants of generic prescribing in an outpatient setting. Methods: This was a cross-sectional analysis of electronic health record data from a mixed-payer health care system in northern California in 2013. We focused on 12 therapeutic classes that had the potential for suboptimal generic utilization, including stimulants, antidepressants, thyroids, vasodilators, vascular 5HT1 agonists, antiplatelets, sympathomimetics, smooth-muscle relaxers, eyes/ears/nose/throat drugs, estrogens, antigout agents and cardiac agents. Generic prescribing rates for each class were calculated, regardless of generic availability. For each class, we applied mixed-effect logit regression models with generic prescribed (yes/no) as the dependent variable and random effects (intercepts) for providers. Models included provider-level determinants: provider type (specialist vs. primary care), and continuous measures of average weekly prescription count and patient visits over the previous 3 months. We further adjusted for patient-level characteristics (age, sex, race/ethnicity, insurance, comorbidities, prescription burden). For each model we calculated the intraclass correlation (ICC) as a measure of random provider-level variation and adjusted odds ratio (OR) for provider-level fixed-effect covariates. Results: We identified 162,819 prescriptions in 2013 for 150,881 patients in the 12 therapeutic classes of interest. Generic prescribing rates across therapeutic classes ranged from 9.3% (sympathomimetics) to 95.1% (antidepressants). After controlling for provider and patient characteristics, significant between-provider variation in generic prescribing was observed; ICC ranged from 7.6% (vasodilators) to 72.9% (eyes/ears/nose/throat drugs). Specialists had lower odds of prescribing generic antidepressants than primary care providers (OR: 0.48), but higher odds of prescribing generic estrogens (OR: 1.55) and sympathomimetic agents (OR: 2.53). Across classes, a provider’s prescription volume or patient volume had little or no effect on generic prescribing. Conclusion: In this cross-sectional analysis of electronic health record data from a mixed-payer health system, we observed large heterogeneity across providers in outpatient generic prescribing for select therapeutic classes, even after accounting for patient characteristics. Health system initiatives may be warranted to better educate providers on generic prescribing