Association between Covid-19 sources of information, beliefs, and vaccination rates: an EU-wide survey.

BACKGROUND: Misinformation hampers vaccine uptake. The European Union (EU) employed a coordinated effort to curb misinformation during the Covid-19 pandemic. In this context, we investigated relationships between sources of information, vaccine safety/effectiveness, satisfaction with government vaccination strategy, and vaccination intent. METHODS: We used cross-sectional survey data (May 2021) from Flash Eurobarometer 494, a population-adjusted dataset comprised of a representative sample of those ≥15 years from 27 EU nations. We employed a latent class analysis to create clusters of information sources as the independent variable and beliefs in vaccine safety/efficacy, satisfaction with government vaccination strategy, and vaccine intent as four outcome variables. We first estimated the association between source clusters and each of the first three outcomes separately. Then, using these three as intermediate variables, we employed structural equation modeling to estimate the relationship between sources and vaccine intent. We adjusted for individual and country-level variables. RESULTS: Among 23 012 respondents, four clusters of information sources emerged: (1) national authorities/health professionals (n = 9602; 42%), (2) mostly health professionals (6184; 27%), (3) mixed (n = 1705; 17%) and (4) social media/family/friends (n = 5524; 24%). Using cluster (3) as the referent, we found decreasing odds of beliefs in vaccine safety/effectiveness, satisfaction and vaccine intent across clusters (1), (2) and (4), respectively. Demographics played a role. CONCLUSION: In the context of the Covid pandemic, these results provide the first EU-wide estimates of the association between sources of information about vaccine safety/effectiveness, satisfaction and vaccine intent. The coordinated approach promulgated by the EU to minimize misinformation provides a model for managing future pandemics.

Persistence and switching patterns of oral migraine prophylactic medications among patients with chronic migraine: A retrospective claims analysis.

Background Migraine prevention guidelines recommend oral prophylactic medications for patients with frequent headache. This study examined oral migraine preventive medication (OMPM) treatment patterns by evaluating medication persistence, switching, and re-initiation in patients with chronic migraine (CM). Methods A retrospective US claims analysis (Truven Health MarketScan® Databases) evaluated patients ≥18 years old diagnosed with CM who had initiated an OMPM between 1 January, 2008 and 30 September, 2012. Treatment persistence was measured at six and 12 months' follow-up. Time-to-discontinuation was assessed for each OMPM and compared using Cox regression models. Among those who discontinued, the proportion that switched OMPMs within 60 days or re-initiated treatment between 61 to 365 days, and their associated persistence rates, were also assessed. Results A total of 8707 patients met the inclusion/exclusion criteria. Persistence to the initial OMPM was 25% at six months and 14% at 12 months. Based on Kaplan-Meier curves, a sharp decline of patients discontinuing was observed by 30 days, and approximately half discontinued by 60 days. Similar trends in time-to-discontinuation were seen following the second or third OMPM. Amitriptyline, gabapentin, and nortriptyline had significantly higher likelihood of non-persistence compared with topiramate. Among patients who discontinued, 23% switched to another prophylactic and 41% re-initiated therapy within one year. Among patients who switched, persistence was between 10 to 13% and among re-initiated patients, persistence was between 4 to 8% at 12 months. Conclusions Persistence to OMPMs is poor at six months and declines further by 12 months. Switching between OMPMs is common, but results indicate that persistence worsens as patients cycle through various OMPMs.

Making pharmacogenomic-based prescribing alerts more effective: A scenario-based pilot study with physicians.

To facilitate personalized drug dosing (PDD), this pilot study explored the communication effectiveness and clinical impact of using a prototype clinical decision support (CDS) system embedded in an electronic health record (EHR) to deliver pharmacogenomic (PGx) information to physicians. We employed a conceptual framework and measurement model to access the impact of physician characteristics (previous experience, awareness, relative advantage, perceived usefulness), technology characteristics (methods of implementation-semi-active/active, actionability-low/high) and a task characteristic (drug prescribed) on communication effectiveness (usefulness, confidence in prescribing decision), and clinical impact (uptake, prescribing intent, change in drug dosing). Physicians performed prescribing tasks using five simulated clinical case scenarios, presented in random order within the prototype PGx-CDS system. Twenty-two physicians completed the study. The proportion of physicians that saw a relative advantage to using PGx-CDS was 83% at the start and 94% at the conclusion of our study. Physicians used semi-active alerts 74-88% of the time. There was no association between previous experience with, awareness of, and belief in a relative advantage of using PGx-CDS and improved uptake. The proportion of physicians reporting confidence in their prescribing decisions decreased significantly after using the prototype PGx-CDS system (p=0.02). Despite decreases in confidence, physicians perceived a relative advantage to using PGx-CDS, viewed semi-active alerts on most occasions, and more frequently changed doses toward doses supported by published evidence. Specifically, sixty-five percent of physicians reduced their dosing, significantly for capecitabine (p=0.002) and mercaptopurine/thioguanine (p=0.03). These findings suggest a need to improve our prototype such that PGx CDS content is more useful and delivered in a way that improves physician's confidence in their prescribing decisions. The greatest increases in communication effectiveness and clinical impact of PGx-CDS are likely to be realized through continued focus on content, content delivery, and tailoring to physician characteristics.

Cost-effectiveness of a computerized provider order entry system in improving medication safety ambulatory care.

BACKGROUND: Computerized provider order entry (CPOE) is the process of entering physician orders directly into an electronic health record. Although CPOE has been shown to improve medication safety and reduce health care costs, these improvements have been demonstrated largely in the inpatient setting; the cost-effectiveness in the ambulatory setting remains uncertain. OBJECTIVE: The objective was to estimate the cost-effectiveness of CPOE in reducing medication errors and adverse drug events (ADEs) in the ambulatory setting. METHODS: We created a decision-analytic model to estimate the cost-effectiveness of CPOE in a midsized (400 providers) multidisciplinary medical group over a 5-year time horizon- 2010 to 2014-the time frame during which health systems are implementing CPOE to meet Meaningful Use criteria. We adopted the medical group's perspective and utilized their costs, changes in efficiency, and actual number of medication errors and ADEs. One-way and probabilistic sensitivity analyses were conducted. Scenario analyses were explored. RESULTS: In the base case, CPOE dominated paper prescribing, that is, CPOE cost $18 million less than paper prescribing, and was associated with 1.5 million and 14,500 fewer medication errors and ADEs, respectively, over 5 years. In the scenario that reflected a practice group of five providers, CPOE cost $265,000 less than paper prescribing, was associated with 3875 and 39 fewer medication errors and ADEs, respectively, over 5 years, and was dominant in 80% of the simulations. CONCLUSIONS: Our model suggests that the adoption of CPOE in the ambulatory setting provides excellent value for the investment, and is a cost-effective strategy to improve medication safety over a wide range of practice sizes.

Statins in the prevention of dementia and Alzheimer's disease: a meta-analysis of observational studies and an assessment of confounding.

BACKGROUND: Studies demonstrate the potential for statins to prevent dementia and Alzheimer's disease (AD), but the evidence is inconclusive. OBJECTIVE: Conduct a meta-analysis to estimate any benefit of statins in preventing dementia and examine the potential effect of study design and confounding on the benefit of statins in dementia. A secondary goal is to explore factors that may elucidate the mechanisms by which statins exert their potentially beneficial effect. METHODS: Performed systematic literature review to identify relevant publications. Relative risk (RR) estimates were pooled using both fixed and random effect models. Studies were stratified by study design and potential confounding factors. RESULTS: The pooled results for all-type dementia suggest that use of statins is associated with a lower RR of dementia when compared to non-statin users (random effects model: RR 0.82 (95%CI [0.69, 0.97]). The pooled results for AD also suggested a lower RR with statin user compared to non-statin users in random effects models (RR: 0.70, 95% CI [0.60, 0.83]). Study design and methods used to address biases may influence the results. CONCLUSION: These pooled results suggest that statins may provide a slight benefit in the prevention of AD and all-type dementia. This benefit observed in both disease states should be interpreted with caution as observational studies are subject to bias, and it is possible that the slight benefit observed may disappear when these biases are addressed in a well-designed randomized controlled trial.

Comparative efficacy of oral pharmaceuticals for the treatment of chronic peripheral neuropathic pain: meta-analysis and indirect treatment comparisons.

OBJECTIVE: Neuropathic pain is generally chronic and challenging to treat. Studies often ignore chronicity by reporting short-duration outcomes and fail to account for medication tolerability. We assessed efficacy of oral medications on chronic peripheral neuropathic pain. METHODS: Relevant published, English-language, randomized controlled trials administering oral medications for peripheral neuropathic pain were identified through MEDLINE (1966 to Dec 1, 2012), EMBASE (1980 to December 2012), the Cochrane Library Databases (through December 2012), and the Oxford Pain Relief Database (through 2012). Included studies reported end point pain or pain reduction from baseline on an 11-point scale (0-10); had active treatment ≥ 12 weeks; reported an intention-to-treat analysis, and had 5-point quality score ≥ 3. Abstracted information included patient characteristics, neuropathic pain condition, drug and dosage arms, adverse events rates causing dropout, and secondary measures (50% pain improvement, global improvement, and sleep interference). Primary outcome meta-analysis, stratified by drug and dosage, was followed by an indirect treatment comparison adjusting for study dropouts due to adverse events. RESULTS: Seventeen studies comprised of 5,975 subjects, totaling 38 active trial arms evaluating 7 drugs, and 17 drug-dosing combinations met inclusion criteria. Mean pain reduction over placebo ranked highest for duloxetine 120 mg (1.17 95% CI 0.77, 1.58) and pregabalin 600 mg (1.11 95% CI 0.77, 1.45). The Indirect treatment comparison showed largest effect size for duloxetine at 120 and 60 mg followed by pregabalin 600 mg. CONCLUSIONS: Pregabalin and duloxetine had the largest beneficial effects for chronic peripheral neuropathic pain. In the absence of head-to-head trials, meta-analysis and indirect treatment comparisons inform best practice clinical decision-making.

Exploring Providers' Perception to Naloxone Education for Opioid Overdose After Receiving Academic Detailing at the U.S. Department of Veterans Affairs.

Introduction: The U.S. Department of Veterans Affairs (VA), in partnership with the Opioid Overdose Education and Naloxone Distribution (OEND) Program, implemented the National Academic Detailing Service to deliver naloxone education to providers with patients at-risk for opioid-related overdose. Methods: We administered a 26-item online survey to VA providers to explore their perceptions about prescribing naloxone for opioid overdose emergencies and their experience with academic detailing between August 2017 and April 2018. Responses were analyzed using descriptive statistics to (1) explore their current perceptions of naloxone prescribing and their experience with academic detailing, (2) identify differences across provider types [primary care providers (PCP), specialists, and others], and (3) assess perceived naloxone prescribing behavior change after an academic detailing visit. Results: Providers (N = 137) indicated that they were practicing at a level that was consistent with VA goals to promote take-home naloxone to reverse opioid-related overdose events. Average domain scores were similar across PCP, specialist, and other provider types. Specialists reported a higher average attitude domain score (+.56, P = .011) and perceived barriers domain score (+.82, P = .009) than PCPs. Most providers agreed that they prescribed naloxone more frequently due to academic detailing (53%) and indicated that they synthesized information from the academic detailer to change their naloxone prescribing practice (60%). Discussion: VA providers' perceptions of take-home naloxone were aligned with current evidence-based practice. Moreover, providers reported increasing their naloxone prescribing and synthesizing OEND-related information after an academic detailing interaction. Understanding providers' perceptions can be used to improve and enhance the academic detailing program's effectiveness.

Patient-centred outcomes of imaging tests: recommendations for patients, clinicians and researchers.

BACKGROUND: Imaging tests are one of the most frequently used diagnostic modalities in healthcare, but the benefits of their direct impacts on clinical decision-making have been countered by concerns that they can be overused. Assessing the relative value of imaging tests has largely focused on measures of test accuracy, which overlooks more comprehensive benefits and risks of imaging tests, particularly their impact on patient-centred outcomes (PCOs). We present the findings of the Patient Reported Outcomes of Diagnostics (PROD) research study in response to a methodological gap in the area of diagnostic test comparative effectiveness research. METHODS: Over a 3-year period, the PROD Study engaged with multiple stakeholders to identify existing conceptual models related to PCOs for imaging testing, conducted primary research and evidence synthesis, and developed consensus recommendations to describe and categorise PCOs related to imaging testing. RESULTS: The PROD framework categorises PCOs from imaging studies within four main domains: information or knowledge yielded, physical impact, emotional outcomes and test burden. PCOs interact with each other and influence effects across domains, and can be modified by factors related to the patient, clinical situation, healthcare team and the testing environment. CONCLUSIONS: Using PCOs to inform healthcare decision-making will require ways of collating and presenting information on PCOs in ways that can inform patient-provider decision-making, and developing methods to determine the relative importance of outcomes (including test accuracy) to one another.

Microvascular Benefits of New Antidiabetic Agents: A Systematic Review and Network Meta-Analysis of Kidney Outcomes.

CONTEXT: Diabetic kidney disease affects nearly one-third of US adults with prevalent type 2 diabetes mellitus (T2DM). The use of new antidiabetic medications in the prevention and treatment of diabetic kidney disease is a growing area of research interest. OBJECTIVE: We sought to characterize the risk of developing a composite kidney outcome among patients receiving a new antidiabetic medication of the SGLT-2i, GLP-1ra, and DPP-4i drug classes. METHODS: We conducted a systematic literature search in MEDLINE to identify randomized trials observing kidney safety endpoints associated with the use of new antidiabetic medications. Two independent reviewers selected the 7 eligible studies for analysis. Included studies were published between January 2013 and March 2020, conducted with adult participantss, published full-text in English, and observed composite kidney outcomes. A network meta-analysis was conducted within a Bayesian framework using a fixed-effects model with uninformative priors. RESULTS: A qualitative assessment of transitivity was conducted to ensure similar distribution of potential modifiers across studies. Included studies were generally comparable in mean age, glycated hemoglobin A1c (HbA1c), and mean duration of T2DM at baseline. MAIN CONCLUSIONS: Compared with placebo, dapagliflozin was associated with the greatest reduction in risk of developing the composite kidney outcome (hazard ratio 0.53; 95% credible interval, 0.43-0.66) followed by empagliflozin, canagliflozin, semaglutide, and liraglutide. Linagliptin did not show a significant reduction in risk of the outcome. LIMITATIONS: This analysis was limited by the scarcity of data for kidney safety endpoints in large, randomized clinical trials. Although the heterogeneity statistic was low, there are slight differences in study design and baseline demographic characteristics across trials.

Communication Training, Adverse Events, and Quality Measures: 2 Retrospective Database Analyses in Washington State Hospitals.

OBJECTIVE: Washington State's HealthPact program was launched in 2011 as part of AHRQ's Patient Safety and Medical Liability Reform initiative. HealthPact delivered interdisciplinary communication training to health-care professionals with the goal of enhancing safety. We conducted 2 exploratory, retrospective database analyses to investigate training impact on the frequency of adverse events (AEs) and select quality measures across 3 time frames: pretraining (2009-2011), transition (2012), and posttraining (2013). METHODS: Using administrative data from Washington State's Comprehensive Hospital Abstract Reporting System (CHARS) and clinical registry data from the Surgical Care and Outcomes Assessment Program (SCOAP), we compared proportions of AEs and quality measures between HealthPact (n = 4) and non-HealthPact (n = 93-CHARS; n = 48-SCOAP) participating hospitals. Risk ratios enabled comparisons between the 2 groups. Multivariable logistic regression enabled investigation of the association between training and the frequency of AEs. RESULTS: Approximately 9.4% (CHARS) and 7.7% (SCOAP) of unique patients experienced 1 AE or greater. In CHARS, the odds of a patient experiencing an AE in a HealthPact hospital were initially (pretraining) higher than in a non-HealthPact hospital (odds ratio [OR], 1.13; 95% confidence interval [CI], 1.10-1.17), lower in transition (OR, 0.80; 95% CI, 0.76-0.83) and posttraining (OR, 0.72; 95% CI, 0.69-0.75) periods. In SCOAP, ORs were consistently lower in HealthPact hospitals: pretraining (OR, 0.87; 95% CI, 0.80-0.95), transition (OR, 0.75; 95% CI, 0.70-0.81), and posttraining (OR, 0.63; 95% CI, 0.58-0.68). The proportion of at-risk patients that experienced each individual AE was low (<1%) throughout. Adherence to quality measures was high. CONCLUSIONS: Interprofessional communication training is an area of intense activity nationwide. A broad-based training initiative may play a role in mitigating AEs.

Prescriber and staff perceptions of an electronic prescribing system in primary care: a qualitative assessment.

BACKGROUND: The United States (US) Health Information Technology for Economic and Clinical Health Act of 2009 has spurred adoption of electronic health records. The corresponding meaningful use criteria proposed by the Centers for Medicare and Medicaid Services mandates use of computerized provider order entry (CPOE) systems. Yet, adoption in the US and other Western countries is low and descriptions of successful implementations are primarily from the inpatient setting; less frequently the ambulatory setting. We describe prescriber and staff perceptions of implementation of a CPOE system for medications (electronic- or e-prescribing system) in the ambulatory setting. METHODS: Using a cross-sectional study design, we conducted eight focus groups at three primary care sites in an independent medical group. Each site represented a unique stage of e-prescribing implementation - pre/transition/post. We used a theoretically based, semi-structured questionnaire to elicit physician (n = 17) and staff (n = 53) perceptions of implementation of the e-prescribing system. We conducted a thematic analysis of focus group discussions using formal qualitative analytic techniques (i.e. deductive framework and grounded theory). Two coders independently coded to theoretical saturation and resolved discrepancies through discussions. RESULTS: Ten themes emerged that describe perceptions of e-prescribing implementation: 1) improved availability of clinical information resulted in prescribing efficiencies and more coordinated care; 2) improved documentation resulted in safer care; 3) efficiencies were gained by using fewer paper charts; 4) organizational support facilitated adoption; 5) transition required time; resulted in workload shift to staff; 6) hardware configurations and network stability were important in facilitating workflow; 7) e-prescribing was time-neutral or time-saving; 8) changes in patient interactions enhanced patient care but required education; 9) pharmacy communications were enhanced but required education; 10) positive attitudes facilitated adoption. CONCLUSIONS: Prescribers and staff worked through the transition to successfully adopt e-prescribing, and noted the benefits. Overall impressions were favorable. No one wished to return to paper-based prescribing.

Assessing attitudes toward electronic prescribing adoption in primary care: a survey of prescribers and staff.

BACKGROUND: Using survey instruments to assess physicians' attitudes toward electronic health record (EHR) adoption has been an ongoing area of research. No instrument has emerged for widespread use. OBJECTIVE: We used a theoretically-based, 37-question survey instrument to assess attitudes toward electronic (e-) prescribing adoption in the context of an existing EHR. Our objective was to elicit information to inform strategies to maximise adoption. METHODS: The instrument assesses attitudes in four domains: finesse, intent to use technology, perceived usefulness and perceived ease of use. Two additional questions ask about computer use at home and self-assessed computer knowledge. We administered the instrument to prescribers and staff at three primary care sites between 2005 and 2007. Each site represented a unique transition from paper-based or partial (Phase 1) to full (Phase 2) e-prescribing use. RESULTS: Fifty-nine prescribers (82% response) and 58 staff (50% response) completed the survey. At the paper-based site, domain scores increased significantly from Phase 1 to Phase 2 for intent to use technology for both prescribers (4.8 to 5; P<0.04) and staff (4 to 5; P<0.03); and for perceived usefulness for staff (3.7 to 4.6; P<0.02). For prescribers, significant associations (P<0.05) were found between computer use at home for professional use and each domain score; and between computer knowledge and three of the four domains. Self-assessed computer knowledge was consistently rated as intermediate, vs novice or expert. CONCLUSIONS: Domain scores improved. Prescribers' self-assessment of computer use at home and computer knowledge predicted attitudes toward adoption. This instrument may be useful in tailoring strategies for successful adoption.

Providers' perceptions on barriers and facilitators to prescribing naloxone for patients at risk for opioid overdose after implementation of a national academic detailing program: A qualitative assessment.

BACKGROUND: Academic detailing is an educational outreach program that aligns providers' prescribing with evidence-based practice. The U.S. Department of Veterans Affairs (VA) Opioid Overdose Education and Naloxone Distribution (OEND) Program partnered with the VA Pharmacy Benefits Management National Academic Detailing Service to deliver naloxone education to providers who cared for patients at risk of opioid overdose. In this pilot study, we interviewed providers' who received academic detailing to capture their perceptions of facilitators and barriers to prescribing naloxone. OBJECTIVE: To identify providers' perceptions of facilitators and barriers to prescribing naloxone for patients at risk for opioid overdose after implementation of a national academic detailing program. METHODS: This was a hybrid inductive-deductive qualitative pilot using semi-structured interviews with VA providers to explore constructs associated with facilitators and barriers to prescribing take-home naloxone to patients at risk for opioid overdose from August 2017 to April 2018. RESULTS: Eleven participants were interviewed, six physicians, three clinical psychiatric pharmacists, and two nurse practitioners. Participants identified patient-level barriers (social stigma and lack of homeless patient support), poor data integration, and burden of data validation as barriers to prescribing naloxone. However, they also identified patient lists, repeat visits, and face-to-face/one-on-one video conferencing visits as important facilitators for naloxone prescribing. CONCLUSIONS/IMPORTANCE: Academic detailing will need to address issues of social stigma regarding naloxone, educate providers about existing support systems for homeless veterans, and develop tools for data integration to improve naloxone access for veterans at risk for an opioid overdose.

Strategies to optimize medication use in the physician group practice: the role of the clinical pharmacist.

OBJECTIVES: To (1) describe the role of clinical pharmacists in providing population-based pharmaceutical care as employees of a physician group practice, (2) describe the strategies used by pharmacists to optimize medication use, (3) quantify improvements in care, and (4) illustrate the calculations used to quantify cost savings. SETTING: Community-based, multispecialty, physician group practice located in the north Puget Sound area between 2003 and 2007. PRACTICE DESCRIPTION: Using four cornerstones (evidence-based medicine, therapeutic interchange, academic detailing, and a local pharmacy and therapeutics committee), the pharmacists provided population-based pharmaceutical care, leading generic switches, target drug programs, and prescription to over-the-counter medication switches. They also led disease management programs, managed drug recalls, implemented electronic health records, negotiated budgets with health plans, and led patient assistance programs and prior authorization programs to improve patient satisfaction. PRACTICE INNOVATION: Implementing these strategies from the vantage point of a physician group presents a seldom-realized employment opportunity for pharmacists. MAIN OUTCOME MEASURES: The impact of these strategies is measured by process, use, and clinical outcomes metrics. These, in turn, are linked to incentive payments in the pay-for-performance environment or to a lowered per member, per month cost in the capitated environment. RESULTS: In 2006-2007, 71% of our hypertensive patients received generic agents compared with a network average for receiving generic agents of 43%, while the proportion of patients with controlled blood pressure increased from 45% to 60%. We saved $450,000 in inpatient costs for deep venous thrombosis. CONCLUSION: Clinical pharmacists employed in a physician group practice can optimize medication use, improve care, and reduce costs.

Implementation evaluation of academic detailing on naloxone prescribing trends at the United States Veterans Health Administration.

OBJECTIVE: Academic detailing in partnership with the Opioid Overdose Education and Naloxone Distribution (OEND) program was implemented to increase naloxone access for the prevention of opioid overdose mortality in veterans at the U.S. Department of Veterans Affairs (VA). However, implementation was not uniform leading to varying levels of intervention exposure potentially impacting naloxone prescribing. We examined the impact of implementation strength (proportion of providers exposed to academic detailing) at each station on naloxone prescribing from September 2014 to December 2017. STUDY DESIGN AND SETTING: Retrospective cohort design with fixed effects models at the VA. DATA COLLECTION/EXTRACTION METHODS: We used VA Corporate Data Warehouse for data on pharmacy dispensing, station-, provider- and patient-level characteristics. OEND-specific academic detailing activities came from data recorded by academic detailers using Salesforce.com. PRINCIPAL FINDINGS: VA stations wherein 100 percent of providers exposed to an OEND-related academic detailing educational outreach visit experienced an increased incident rate of naloxone prescribing that was 5.52 times the incident rate of stations where no providers were exposed; alternatively, this is equivalent to an average monthly increase of 2.60 naloxone prescriptions per 1000 population at risk for opioid overdose. CONCLUSIONS: Our findings highlight the importance of academic detailing's implementation strength on naloxone prescribing. Decision makers must carefully consider the implementation process to achieve the greatest effectiveness from the intervention.

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.

Automating Electronic Clinical Data Capture for Quality Improvement and Research: The CERTAIN Validation Project of Real World Evidence.

BACKGROUND: The availability of high fidelity electronic health record (EHR) data is a hallmark of the learning health care system. Washington State's Surgical Care Outcomes and Assessment Program (SCOAP) is a network of hospitals participating in quality improvement (QI) registries wherein data are manually abstracted from EHRs. To create the Comparative Effectiveness Research and Translation Network (CERTAIN), we semi-automated SCOAP data abstraction using a centralized federated data model, created a central data repository (CDR), and assessed whether these data could be used as real world evidence for QI and research. OBJECTIVES: Describe the validation processes and complexities involved and lessons learned. METHODS: Investigators installed a commercial CDR to retrieve and store data from disparate EHRs. Manual and automated abstraction systems were conducted in parallel (10/2012-7/2013) and validated in three phases using the EHR as the gold standard: 1) ingestion, 2) standardization, and 3) concordance of automated versus manually abstracted cases. Information retrieval statistics were calculated. RESULTS: Four unaffiliated health systems provided data. Between 6 and 15 percent of data elements were abstracted: 51 to 86 percent from structured data; the remainder using natural language processing (NLP). In phase 1, data ingestion from 12 out of 20 feeds reached 95 percent accuracy. In phase 2, 55 percent of structured data elements performed with 96 to 100 percent accuracy; NLP with 89 to 91 percent accuracy. In phase 3, concordance ranged from 69 to 89 percent. Information retrieval statistics were consistently above 90 percent. CONCLUSIONS: Semi-automated data abstraction may be useful, although raw data collected as a byproduct of health care delivery is not immediately available for use as real world evidence. New approaches to gathering and analyzing extant data are required.

Empowering genomic medicine by establishing critical sequencing result data flows: the eMERGE example.

The eMERGE Network is establishing methods for electronic transmittal of patient genetic test results from laboratories to healthcare providers across organizational boundaries. We surveyed the capabilities and needs of different network participants, established a common transfer format, and implemented transfer mechanisms based on this format. The interfaces we created are examples of the connectivity that must be instantiated before electronic genetic and genomic clinical decision support can be effectively built at the point of care. This work serves as a case example for both standards bodies and other organizations working to build the infrastructure required to provide better electronic clinical decision support for clinicians.

The impact of e-prescribing on prescriber and staff time in ambulatory care clinics: a time motion study.

Electronic prescribing has improved the quality and safety of care. One barrier preventing widespread adoption is the potential detrimental impact on workflow. We used time-motion techniques to compare prescribing times at three ambulatory care sites that used paper-based prescribing, desktop, or laptop e-prescribing. An observer timed all prescriber (n = 27) and staff (n = 42) tasks performed during a 4-hour period. At the sites with optional e-prescribing >75% of prescription-related events were performed electronically. Prescribers at e-prescribing sites spent less time writing, but time-savings were offset by increased computer tasks. After adjusting for site, prescriber and prescription type, e-prescribing tasks took marginally longer than hand written prescriptions (12.0 seconds; -1.6, 25.6 CI). Nursing staff at the e-prescribing sites spent longer on computer tasks (5.4 minutes/hour; 0.0, 10.7 CI). E-prescribing was not associated with an increase in combined computer and writing time for prescribers. If carefully implemented, e-prescribing will not greatly disrupt workflow.