Opportunities to Improve Informed Consent with AHRQ Training Modules.

BACKGROUND: Informed consent is a process of communication between clinician and patient that results in the patient's decision about whether to undergo a specific intervention. However, patients often do not understand the risks, benefits, and alternatives, even after signing a consent form. METHODS: Mixed-methods pilot test of two Agency for Healthcare Research and Quality (AHRQ) informed consent training modules implemented in four hospitals. Methods included staff and patient surveys, interviews, site visits, and pre- and posttests of the modules. RESULTS: A low proportion of clinicians reported using teach-back (40.0%) or high-quality decision aids (55.0%). Patients reported limited use of best practices, including being asked to teach-back (58.4%), having other options described (54.9%), viewing decision aids (37.4%), and finding the form very easy to understand (66.8%). Content of the training modules aligned well with identified deficiencies. Barriers to completing the modules included staff turnover, competing demands, and lack of accountability. Facilitators included committed champions with available time, motivation, and release time for staff to take modules. Knowledge increased for leaders (p <0.05) and staff (p <0.001) who completed the training modules. Hospitals reported the effects of piloting the modules included fostering dialogue and identifying opportunities for improvements, identifying and rectifying policy ambiguity and noncompliance, reinforcing the use of interpreter services, and using modules' strategies and tools to improve informed consent. CONCLUSION: Many opportunities exist for hospitals to improve their informed consent practices. AHRQ's two training modules, have face validity, addressed demonstrated deficiencies in hospitals' informed consent policies and processes, and stimulated improvement activity in motivated hospitals.

Development and validation of a logic model for comprehensive medication management services.

OBJECTIVES: To develop and validate a theoretical logic model for comprehensive medication management (CMM) services. METHODS: The components of a logic model were constructed after a literature review and interviews with 4 CMM professionals. To validate the logic model, a panel of 17 CMM experts participated in three online Delphi method rounds to achieve consensus on the model. The consensus between the experts on each component of the logic model was evaluated using the Content Validity Index and Inter-rater Agreement in each of the rounds. KEY FINDINGS: A logic model for CMM services containing 51 items was constructed and validated. Both the items of each component of the model and the linkage between the main components were agreed upon among the experts. CONCLUSIONS: A logic model for CMM services was developed and validated. It is an innovative tool that, if used as a theoretical framework for the implementation of CMM, can ensure greater reproducibility of CMM services in different scenarios of practice and levels of care.

Application of the Consolidated Framework for Implementation Research to community pharmacy: A framework for implementation research on pharmacy services.

BACKGROUND: Community pharmacies are an increasingly important health care setting with opportunities for improving quality and safety, yet little is understood about determinants of implementation in this setting. OBJECTIVE: This paper presents an implementation framework for pharmacy based on the Consolidated Framework for Implementation Research (CFIR). METHODS: This study employed a critical review of 45 articles on professional services provided in community pharmacies, including medication therapy management (MTM), immunizations, and rapid HIV testing. RESULTS: The relevant domains and associated constructs for pharmacy services were as follows. Intervention Characteristics ultimately depend on the specific service; of particular note for pharmacy are relative advantage and complexity. The former because implementation of services can pose a cost-benefit challenge where dispensing is the primary role and the latter because of the greater challenge implementing multi-faceted services like MTM compared to a discrete service like immunizations. "In terms of Outer Setting, pharmacies are affected by patient needs and acceptance, and external policies and incentives such as reimbursement and regulations. For Inner Setting, structural characteristics like pharmacy type, size and staff were important as was pharmacists' perception of their role and available resources to provide the service. Key Characteristics of Individuals include training, preparedness, and self-efficacy of the pharmacist for providing a new service. Few studies revealed relevant Process constructs, but if they did it was primarily related to engaging (e.g., champions). CONCLUSIONS: As pharmacists' roles in health care are continuing to expand, a framework to inform implementation research in community pharmacy (and other) settings is crucially needed.

Assessing Four Quality Indicators for Multiple Sclerosis Management Through Patient-Reported Data.

BACKGROUND: Although hundreds of quality indicators (QIs) have been developed for various chronic conditions, QIs specific to multiple sclerosis (MS) care have only recently been developed. We sought to examine the extent to which the self-reported care of individuals with MS meets four recently developed MS QIs related to treatment of depression, spasticity, and fatigue and timely initiation of disease-modifying agents (DMAs) for relapsing MS. METHODS: Using the Sonya Slifka Study data, we examined the proportion of the MS population meeting four QIs (based on patient-reported data) in a sample of individuals with MS in 2007-2009. For the three diagnoses, meeting the QI was defined as receiving appropriate medication or seeing a provider for treatment of the diagnosis; for timely initiation, it was defined as receiving a DMA within 3 months of a relapsing MS diagnosis. We also examined differences in characteristics between respondents who met the QI versus those who did not. RESULTS: Approximately two-thirds of people with MS in this sample, per the predefined criteria, met the QIs for treatment of depression, management of spasticity, and DMA initiation within 3 months of a relapsing diagnosis, and approximately one-fifth met the QI for management of fatigue. There were some significant differences in characteristics between respondents who met the QIs and those who did not. CONCLUSIONS: This study examined a subset of MS QIs based on patient-reported data. Additional data sources are needed to fully assess compliance with MS QIs.

Case Report of Methylone, Oxymorphone and Ethanol in a Fatality Case with Tissue Distribution.

It is reasonable to expect the presence of multiple drugs to present a complicated picture of toxicity. We report a fatal case involving a young man who purchased illicit drugs and knowingly consumed them. After consuming these drugs and going to sleep in his friend's car, he was found unresponsive the next morning with no signs of physical violence. Drugs found in the peripheral blood at autopsy were oxymorphone, methylone and ethanol at concentrations of 0.106, 0.50 and 130 mg/dL, respectively. The levels of oxymorphone and methylone in peripheral blood were comparable to those observed in other reported fatalities. Cocaine and benzoylecgonine were detected in the urine but not in the blood. Measureable concentrations were also observed for oxymorphone and methylone in urine, liver, kidney and bile. The physical findings at autopsy included pulmonary edema. This is the only reported fatal case involving this combination of drugs encountered in our laboratory.

A review of instruments to measure interprofessional team-based primary care.

Interprofessional team-based care is increasingly regarded as an important feature of delivery systems redesigned to provide more efficient and higher quality care, including primary care. Measurement of the functioning of such teams might enable improvement of team effectiveness and could facilitate research on team-based primary care. Our aims were to develop a conceptual framework of high-functioning primary care teams to identify and review instruments that measure the constructs identified in the framework, and to create a searchable, web-based atlas of such instruments (available at: http://primarycaremeasures.ahrq.gov/team-based-care/ ). Our conceptual framework was developed from existing frameworks, the teamwork literature, and expert input. The framework is based on an Input-Mediator-Output model and includes 12 constructs to which we mapped both instruments as a whole, and individual instrument items. Instruments were also reviewed for relevance to measuring team-based care, and characterized. Instruments were identified from peer-reviewed and grey literature, measure databases, and expert input. From nearly 200 instruments initially identified, we found 48 to be relevant to measuring team-based primary care. The majority of instruments were surveys (n = 44), and the remainder (n = 4) were observational checklists. Most instruments had been developed/tested in healthcare settings (n = 30) and addressed multiple constructs, most commonly communication (n = 42), heedful interrelating (n = 42), respectful interactions (n = 40), and shared explicit goals (n = 37). The majority of instruments had some reliability testing (n = 39) and over half included validity testing (n = 29). Currently available instruments offer promise to researchers and practitioners to assess teams' performance, but additional work is needed to adapt these instruments for primary care settings.

High-intensity sweetener consumption and gut microbiome content and predicted gene function in a cross-sectional study of adults in the United States.

PURPOSE: To evaluate gut microbiome in relation to recent high-intensity sweetener consumption in healthy adults. METHODS: Thirty-one adults completed a four-day food record and provided a fecal sample on the fifth day. Bacterial community in the samples was analyzed using multitag pyrosequencing. Across consumers and nonconsumers of aspartame and acesulfame-K, bacterial abundance was compared using nonparametric statistics, and bacterial diversity was compared using UniFrac analysis. Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) was used to predict mean relative abundance of gene function. RESULTS: There were seven aspartame consumers and seven acesulfame-K consumers. Three individuals overlapped groups, consuming both sweeteners. There were no differences in median bacterial abundance (class or order) across consumers and nonconsumers of either sweetener. Overall bacterial diversity was different across nonconsumers and consumers of aspartame (P < .01) and acesulfame-K (P = .03). Mean predicted gene abundance did not differ across consumers and nonconsumers of aspartame or acesulfame-K. CONCLUSIONS: Bacterial abundance profiles and predicted gene function were not associated with recent dietary high-intensity sweetener consumption. However, bacterial diversity differed across consumers and nonconsumers. Given the increasing consumption of sweeteners and the role that the microbiome may have in chronic disease outcomes, work in further studies is warranted.

Business Models, Vaccination Services, and Public Health Relationships of Retail Clinics: A Qualitative Study.

Despite the rapid growth of retail clinics (RCs), literature is limited in terms of how these facilities offer preventive services, particularly vaccination services. The purpose of this study was to obtain an in-depth understanding of the RC business model pertaining to vaccine offerings, profitability, and decision making. From March to June 2009, we conducted 15 interviews with key individuals from three types of organizations: 12 representatives of RC corporations, 2 representatives of retail hosts (i.e., stores in which the RCs are located), and 1 representative of an industry association. We analyzed interview transcripts qualitatively. Our results indicate that consumer demand and profitability were the main drivers in offering vaccinations. RCs in this sample primarily offered vaccinations to adults and adolescents, and they were not well integrated with local public health and immunization registries. Our findings demonstrate the potential for stronger linkages with public health in these settings. The findings also may help inform future research to increase patient access to vaccination services at RCs.

Exemplification of HAART and HIV/AIDS: A News Experiment.

Recent data show that the number of deaths from HIV has declined but the disease continues to spread. An emerging line of research suggests that the apparent increase may be due to complacency, whereby faith in medicine encourages risk-taking behavior. This study examines the hypothesis that certain approaches in the news media could disproportionately influence perceptions of treatment success even when paired with statistics. College students and gay men, recruited in the community, were exposed to a fictional news story in which the ratio of four cases of people taking antiretroviral (ARV) medications was varied in two conditions. The story was either consistent with or inconsistent with the success-rate data presented by an alleged medical expert in the story. Participants' perceptions of ARV success were estimated following exposure to the story. As expected, the personal news stories influenced estimation of ARV success more than the presence of statistical success rate data. Consistent with previous exemplification research, the size of the effect suggests that the stories influenced judgments of the true success rate by roughly 10 to 20%. The effect was moderated by sexual orientation, but not by gender. Exemplification as a journalistic tendency may be one factor that contributes to unrealistic faith in medical advancements. These data suggest that future research should explore in detail the extent and context of HIV/AIDS reporting using exemplification theory with considerations for how reporting might be modified to have less of an effect on increased sexual risk-taking.

Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information.

OBJECTIVE: To develop a reliable and valid instrument to assess the understandability and actionability of print and audiovisual materials. METHODS: We compiled items from existing instruments/guides that the expert panel assessed for face/content validity. We completed four rounds of reliability testing, and produced evidence of construct validity with consumers and readability assessments. RESULTS: The experts deemed the PEMAT items face/content valid. Four rounds of reliability testing and refinement were conducted using raters untrained on the PEMAT. Agreement improved across rounds. The final PEMAT showed moderate agreement per Kappa (Average K=0.57) and strong agreement per Gwet's AC1 (Average=0.74). Internal consistency was strong (α=0.71; Average Item-Total Correlation=0.62). For construct validation with consumers (n=47), we found significant differences between actionable and poorly-actionable materials in comprehension scores (76% vs. 63%, p<0.05) and ratings (8.9 vs. 7.7, p<0.05). For understandability, there was a significant difference for only one of two topics on consumer numeric scores. For actionability, there were significant positive correlations between PEMAT scores and consumer-testing results, but no relationship for understandability. There were, however, strong, negative correlations between grade-level and both consumer-testing results and PEMAT scores. CONCLUSIONS: The PEMAT demonstrated strong internal consistency, reliability, and evidence of construct validity. PRACTICE IMPLICATIONS: The PEMAT can help professionals judge the quality of materials (available at: http://www.ahrq.gov/pemat).

The Lewis S. Feuer Papers at Brandeis University.

The Lewis S. Feuer papers at Brandeis University include correspondence, manuscripts, Feuer's collection of radical literature, and other personal and professional materials. The process by which these materials came to Brandeis and were organized into an archival collection reveals connections and lacunae inherent in the material record and illuminates the principles involved in "archiving a life."

Factors affecting adoption and implementation of AHRQ health literacy tools in pharmacies.

BACKGROUND: Pharmacies are key sources of medication information for patients, yet few effectively serve patients with low health literacy. The Agency for Healthcare Research and Quality (AHRQ) supported the development of four health literacy tools for pharmacists to address this problem, and to help assess and improve pharmacies' health literacy practices. OBJECTIVES: This study aimed to understand the facilitators and barriers to the adoption and implementation of AHRQ's health literacy tools, particularly a tool to assess a pharmacy's health literacy practices. METHODS: We conducted a comparative, multiple-case study of eight pharmacies, guided by an adaptation of Rogers's Diffusion of Innovations model. Data were collected and triangulated through interviews, site visit observations, and the review of documents, and analyzed on the factors affecting pharmacies' adoption decisions and implementation of the tools. RESULTS: Factors important to pharmacies' decision to adopt the health literacy tools included awareness of health literacy; a culture of innovation; a change champion; the relative advantage and compatibility of the tools; and an invitation to utilize and receive support to use the tools. The barriers included a lack of leadership support, limited staff time, and a perception of the tools as complex with limited value. For implementation, the primary facilitators were buy-in from leadership, qualified staff, college-affiliated change champions, the adaptability and organization of the tool, and support. Barriers to implementation were limited leadership buy-in, prioritization of other activities, lack of qualified staff, and tool complexity. CONCLUSIONS: If pharmacists are provided tools that could ultimately improve their health literacy practices and patient-centered services; and the tools have a clear relative advantage, are simple as well adaptable, and the pharmacists are supported in their efforts - either by colleagues or by collaborating with colleges of pharmacy-then there could be important progress toward achieving the goals of the National Action Plan for Health Literacy.

Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems.

OBJECTIVE: Medication errors in hospitals are common, expensive, and sometimes harmful to patients. This study's objective was to derive a nationally representative estimate of medication error reduction in hospitals attributable to electronic prescribing through computerized provider order entry (CPOE) systems. MATERIALS AND METHODS: We conducted a systematic literature review and applied random-effects meta-analytic techniques to derive a summary estimate of the effect of CPOE on medication errors. This pooled estimate was combined with data from the 2006 American Society of Health-System Pharmacists Annual Survey, the 2007 American Hospital Association Annual Survey, and the latter's 2008 Electronic Health Record Adoption Database supplement to estimate the percentage and absolute reduction in medication errors attributable to CPOE. RESULTS: Processing a prescription drug order through a CPOE system decreases the likelihood of error on that order by 48% (95% CI 41% to 55%). Given this effect size, and the degree of CPOE adoption and use in hospitals in 2008, we estimate a 12.5% reduction in medication errors, or ∼17.4 million medication errors averted in the USA in 1 year. DISCUSSION: Our findings suggest that CPOE can substantially reduce the frequency of medication errors in inpatient acute-care settings; however, it is unclear whether this translates into reduced harm for patients. CONCLUSIONS: Despite CPOE systems' effectiveness at preventing medication errors, adoption and use in US hospitals remain modest. Current policies to increase CPOE adoption and use will likely prevent millions of additional medication errors each year. Further research is needed to better characterize links to patient harm.

Preventing and resolving drug therapy problems by understanding patients' medication experiences.

OBJECTIVES: To provide tools for pharmacists to uncover patients' medication experiences and to discuss strategies that medication therapy management (MTM) pharmacists use to prevent and resolve drug therapy problems rooted in patients' medication experiences. DESIGN: Qualitative study. SETTING: Health care delivery system in the Minneapolis/Saint Paul, MN, area from January to October 2010. PARTICIPANTS: 10 MTM pharmacists. INTERVENTION: Thematic analysis of data from a focus group of MTM pharmacists and an MTM pharmacist's practice diary. RESULTS: Patients' medication experiences were revealed as a foundational aspect of MTM pharmacists' daily practices because they had to take these experiences into consideration to be effective practitioners. According to MTM pharmacists, patients express attitudes toward drug therapy in many different ways, thereby affecting how each patient takes his/her medications. Patients' medication experiences often were at the root of drug therapy problems (DTPs). From MTM pharmacists' examples, we identified DTPs at the root of patients' medication experiences and several strategies used by pharmacists to address patients' needs and concerns regarding medications. MTM pharmacists approached patients in a nonjudgmental way so that patients would feel comfortable sharing their perspectives and goals. After understanding patients' motivations and the basis of their attitudes and decision making, pharmacists could negotiate the process of behavioral change, if needed. CONCLUSION: If pharmacists understand patients' medication experiences, they may be able to address and resolve DTPs to ultimately improve therapeutic outcomes and reduce adverse events.

Understanding the landscape of MTM programs for Medicare. Part D: Results from a study for the Centers for Medicare & Medicaid services.

OBJECTIVES: To describe the features of medication therapy management (MTM) programs, including eligibility criteria, enrollment, services, and reimbursement, and to describe the criteria used to evaluate MTM programs and assess the evidence of relevance to Medicare. DESIGN: Descriptive, exploratory, nonexperimental study. SETTING: United States between July 2007 and June 2008. PARTICIPANTS: 60 key informants from 46 different organizations and case studies with 28 representatives from four MTM programs. INTERVENTION: Literature review, key informant interviews, and evaluation of case studies. MAIN OUTCOME MEASURES: MTM program features and evidence of effectiveness. RESULTS: MTM programs used a variety of practice models. Medicare MTM programs used different eligibility criteria than MTM programs sponsored by Medicaid or other payers. MTM programs that required patients to opt-in had less success in enrolling participants than those using opt-out. Most MTM programs conducted annual medication reviews. Most non-Medicare MTM programs provided face-to-face interventions, whereas Medicare MTM programs relied more on telephone or mail; no research tested the effectiveness of different modes. Almost all MTM programs used pharmacists to provide services. Little research on Medicare MTM programs was available. Costs were commonly measured in the MTM literature, although results were inconsistent. A few studies demonstrated significant improvements in intermediate outcomes (e.g., low-density lipoprotein cholesterol), while less studies demonstrated an impact on serious sequelae (e.g., emergency department visits). CONCLUSION: Medicare MTM programs were still evolving when this study was conducted, and we found limited evidence to determine which beneficiaries would benefit most from MTM, which features achieved the desired outcomes, and which outcomes should be measured to compare MTM program performance.

The medication experience: preliminary evidence of its value for patient education and counseling on chronic medications.

OBJECTIVE: To describe medication therapy management (MTM) pharmacists' encounters with patients' medication experiences, to examine the utility of the medication experience in practice, and to explore the value of the medication experience in patient education and counseling on medications. METHODS: A focus group of 10 MTM pharmacists, and 1 pharmacist's 9-month practice diary were analyzed to reveal patients' medication experiences and the utility and value of the medication experience in practice. RESULTS: MTM pharmacists commonly encountered patients' medication experiences in their practices. The medication experience was often at the root of drug therapy problems (DTPs) the practitioners identified. The pharmacists identified several examples of drug therapy problems with an associated medication experience at the root. The medication experience was a meaningful construct to guide patient education and counseling on new chronic medications to ultimately prevent DTPs, and valuable for tailoring patient education and counseling on medications to resolve DTPs. CONCLUSION: Our study provides preliminary evidence of the value of the medication experience for patient education and counseling on chronic medications in practice. PRACTICE IMPLICATIONS: The medication experience is a valuable tool for practitioners to understand patients' needs, identify and resolve DTPs, and tailor patient education and counseling for chronic medications.

Specific functions for ERK/MAPK signaling during PNS development.

We have established functions of the stimulus-dependent MAPKs, ERK1/2 and ERK5, in DRG, motor neuron, and Schwann cell development. Surprisingly, many aspects of early DRG and motor neuron development were found to be ERK1/2 independent, and Erk5 deletion had no obvious effect on embryonic PNS. In contrast, Erk1/2 deletion in developing neural crest resulted in peripheral nerves that were devoid of Schwann cell progenitors, and deletion of Erk1/2 in Schwann cell precursors caused disrupted differentiation and marked hypomyelination of axons. The Schwann cell phenotypes are similar to those reported in neuregulin-1 and ErbB mutant mice, and neuregulin effects could not be elicited in glial precursors lacking Erk1/2. ERK/MAPK regulation of myelination was specific to Schwann cells, as deletion in oligodendrocyte precursors did not impair myelin formation, but reduced precursor proliferation. Our data suggest a tight linkage between developmental functions of ERK/MAPK signaling and biological actions of specific RTK-activating factors.