META-INSTI: metabolic adverse events following integrase strand transfer inhibitor administration in spontaneous adverse event reports.

Background: Metabolic effects of integrase strand transfer inhibitors (INSTIs) have been reported. The FDA Adverse Event Reporting System (FAERS) is a publicly available database that captures spontaneously reported adverse events. The objective of this study was to evaluate the relationship between INSTIs and metabolic adverse events using the FAERS database. Methods: FAERS data were queried from quarter 4 of 2007 through quarter 4 of 2019 and limited to adults. The Standardized MedDRA Query for 'hyperglycaemia/new-onset diabetes mellitus' (H/DM) was used to identify metabolic adverse events of interest. Weight gain was analysed as a separate event. Reporting odds ratios (RORs) and 95% CIs were calculated for the INSTI class and individual agents. Results: Over 10.1 million FAERS reports were identified. Any INSTI was mentioned as a primary and/or secondary suspect agent in 18,400 (0.18%) reports (bictegravir: 1414 [0.01%]; dolutegravir: 7840 [0.08%]; elvitegravir: 4034 [0.04%]; raltegravir: 5551 [0.05%]). RORs (95% CI) for H/DM and weight gain for any INSTI were 1.20 (1.15-1.27) and 2.16 (1.96-2.38). For individual agents, RORs (95% CI) for H/DM and weight gain were as follows: bictegravir, 1.23 (1.10-1.37) and 6.82 (5.50-8.41); dolutegravir, 1.28 (1.19-1.39) and 1.86 (1.58-2.18); elvitegravir, 0.76 (0.56-1.02) and 1.63 (1.37-1.92); and raltegravir, 1.00 (0.90-1.11) and 3.29 (2.77-3.91). H/DM was noted in 159 bictegravir and 712 dolutegravir reports. Conclusion: Overall, H/DM was associated with bictegravir and dolutegravir and weight gain with all INSTIs. Clinicians should know the potential relationship between INSTIs and metabolic effects and institute appropriate monitoring. This paper was previously presented: META-INSTI: Metabolic Adverse Events Following Integrase Strand Transfer Inhibitor Administration in Spontaneous Adverse Event Reports. Platform Presentation. ID Week. Virtual 2020.

Considerations for writing and including demographic variables in education research.

OUR SITUATION: At many points within pharmacy education, we collect demographic information about faculty, staff, students, and trainees. Admissions procedures and surveys, for example, typically categorize participants based on various identities such as race and ethnicity as well as gender and sex. In this article, we interrogate the complex nature of capturing participant identities through demographic variables, using race and ethnicity, gender and sex, sexual orientation and identity, and disability status as specific examples. METHODOLOGICAL LITERATURE REVIEW: Various approaches to defining demographic characteristics can be seen in pharmacy education research. To help readers understand why certain characteristics and categories are commonly utilized, we describe common influences of demographic variables, such as federal laws and professional guidelines. We also review several common demographic variables to illustrate the complexity of this issue. OUR RECOMMENDATIONS AND THEIR APPLICATION(S): Seven recommendations for improving demographic data collection and use are provided. Examples include respecting and honoring lived student experiences, defining demographic data more precisely, and channeling institutional resources toward specific student needs. POTENTIAL IMPACT: Collecting demographic information more accurately and thoughtfully could help pharmacy education improve its educational practice and research. The provided recommendations provided will help researchers and educators measure and utilize demographic variables more effectively.

Last Matter: Introducing infographics to Methodology Matters.

Visual summaries are gaining momentum in the health sciences literature. The Journal is introducing a new article type-Last Matter (LM). These will consist of infographics that quickly summarize and visually describe topics typically addressed in more detail within Methodology Matters reviews. The primary goal is to provide readers with clear guidance related to one or two common issues, pitfalls, or points of confusion when conducting pharmacy education scholarship. In addition to a graphical summary, a key element of each LM is a list of recommended resources for readers interested in more detailed information. The first Last Matter published in this issue summarizes key concepts related to quality in qualitative research. The Journal hopes these infographics may be helpful to for readers to comprehend and share, as well as to influence future contributions to the pharmacy education literature.

Identifying areas of improvement for cultural competence in pharmacy curricula: A multi-school study using the self-assessment of perceived level of cultural competence (SAPLCC) questionnaire.

INTRODUCTION: The implementation of culturally competent healthcare services has been considered a key strategy for the provision of patient-centered care; however, a need remains to address the requirements of teaching cultural competence, including identifying gaps, designing and evaluating curricula, and assessing students' progress toward program objectives. The objective of this study was to explore the applicability of the Self-Assessment of Perceived Level of Cultural Competence (SAPLCC) questionnaire in the identification of improvement areas in cultural competence content in pharmacy curricula. METHODS: This study used previously-collected SAPLCC data from student pharmacists at eight United States pharmacy schools. Total and factor-specific SAPLCC scores were calculated based on the 14 factors published previously and grouped into six domains (knowledge, skills, attitudes, encounters, abilities, and awareness). Differences in overall scores by domain and factors across various student characteristics were examined using analysis of variance. RESULTS: The overall mean total SAPLCC score was classified as moderate. Third-year students had significantly higher SAPLCC mean scores than first-year students, and African American students scored significantly higher than their counterparts. At the factor-level, students scored higher in the Attitudes and Awareness domains and scored lower in the Knowledge, Skills, and Encounters domains. CONCLUSIONS: The application of the SAPLCC in schools participating in this preliminary study allowed for the identification of content areas that may benefit from revision. The SAPLCC may be a useful tool for mapping cultural competence curricular content by each specific domain and identifying areas of potential improvement regarding cultural competence training within pharmacy curricula.

Analysis of pharmacy student communication self-evaluation skills during standardized patient encounters.

INTRODUCTION: The objective of this study was to evaluate pharmacy students' communication self-evaluation skills by comparing student self-evaluations with those completed by course graders and standardized patients (SP). METHODS: As part of a required communications course, third-year pharmacy students completed a medication counseling encounter with a SP during a midpoint encounter and final assessment. Students' communication skills were evaluated by course graders and SPs. Students used the same assessment rubric to also complete self-evaluations immediately after each event and after reviewing a recording of their midpoint encounter. Agreement among student, SP, and course grader ratings on individual items were examined using the kappa statistic. RESULTS: A total of 206 students completed the midpoint encounter, and 208 completed the final assessment. Agreement between students' and SPs' evaluations was high during both the midpoint and final encounters, with >90% agreement on 14 out of 17 items at the midpoint encounter and 16 out of 17 during the final assessment. There were diffiences in scoring for the use of verbal distractors/fillers, with SPs' evaluations showing more favorable scores when differences existed [at midpoint 69 (33.7%) SP vs. 7 (3.4%) student; at final 31 (15%) SP vs. 3 (1.5%) student]. Agreement improved from the midpoint to final assessment (62.9% vs. 83.7%, respectively). CONCLUSIONS: Self-evaluation of communication skills may be an acceptable alternative to faculty or SP evaluations, when appropriate for the purpose of the activity, based on the high agreement observed among communication skills evaluations completed by students, course graders, and SPs.

Meta-research in pharmacy: Time for a look in the mirror.

The volume of the biomedical literature continues to expand at a substantial rate. The research literature surrounding pharmaceutical services is no different. Due in part to events in the recent past, researchers, consumers, funders, and policymakers have raised concerns about the credibility, transparency, and potential waste in the global research enterprise. Meta-research, or research on research, provides a way to examine the efficiency, quality, and potential bias in the overall research ecosystem. The field of meta-research is a relatively new but rapidly growing field that has seen many applications in biomedical research. Applications in pharmacy research, however, are still developing. The goals of this commentary are to introduce pharmacy researchers to the concept of meta-research, discuss several examples of meta-research in pharmacy, and motivate the importance of sustained meta-research efforts in pharmacy.

Using multiple linear regression in pharmacy education scholarship.

OUR SITUATION: There has been an increased interest in regression techniques within pharmacy education to allow researchers to determine variables that may predict a specific outcome (e.g., predicting student scores on the Pharmacy Curriculum Outcomes Assessment). This article has been tailored for individuals who are interested in learning more about multiple linear regression as a data analysis tool and its potential utility in pharmacy education research. METHODOLOGICAL LITERATURE REVIEW: Within this section, the basic steps of regression are outlined, starting with correlational analysis before progressing to simple linear regression and multiple regression. Key terms needed to understand and interpret regressions are also discussed. OUR RECOMMENDATIONS AND THEIR APPLICATIONS: Nine practical recommendations are provided to help researchers better understand and implement regression analyses in their studies. POTENTIAL IMPACT: Regression analyses could be helpful in advancing pharmacy educational scholarship by enabling scholars to better understand variables that may predict specific outcomes such as student achievement or program retention.

Characteristics of studies of pharmacist services registered in ClinicalTrials.gov.

OBJECTIVE: To examine the characteristics of studies of pharmacist services registered in ClinicalTrials.gov. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: ClinicalTrials.gov and MEDLINE databases were searched to identify studies of pharmacist services. Registration information was obtained from the Aggregate Analysis of ClinicalTrials.gov (AACT) database. Studies were excluded if the ClinicalTrials.gov submission date was after December 31, 2018; there were no U.S. study sites; pharmacist services were not mentioned; or pharmacist involvement was limited to medication dispensing, randomization, or measuring study outcomes. OUTCOME MEASURES: Characteristics of registered studies from ClinicalTrials.gov and AACT data, categories of pharmacist services, changes in registration and focus of pharmacist services over time, and relationships between funding source and result availability and between the focus of pharmacist services and types of outcomes and types of pharmacist interventions. RESULTS: Overall 401 studies were identified for initial review, with 151 included for detailed review. Pharmacist services were the only intervention in 68 studies (45.0%), a separate intervention in 14 (9.3%), and part of a combined intervention in 40 (26.5%). In 29 studies (19.2%), pharmacist services were not the focus. Registered studies primarily were interventional, randomized, and open-label; included behavioral or "other" interventions; were conducted in the outpatient setting; and were sponsored by "other" sources. The most common health conditions were hypertension and diabetes. Only 29 of the 104 completed studies (27.9%) posted results. Clinical outcomes were the most common primary (80; 53.0%) and secondary outcomes (66; 58.9%). Medication management (69; 45.7%) and patient education or counseling (88; 58.3%) were the most common types of pharmacist interventions. CONCLUSION: This analysis of ClinicalTrials.gov identified 151 studies of pharmacist services in the United States registered through the end of 2018. Given the breadth of the pharmacy services literature, there is room for improvement in the registration of these types of studies.

Developing a Measure of Students' Potential Involvement in Scholarly Activities.

BACKGROUND: Pharmacy schools must encourage a culture of inquiry so future pharmacists approach practice in a scholarly fashion. OBJECTIVES: To develop an instrument measuring intentions to engage in various scholarly activities. METHODS: Items representing scholarly activities relevant to pharmacists were developed. Exploratory factor analysis (EFA) was used to refine the list and identify underlying factors. Internal consistency was examined using Cronbach's alpha. Results were compared across student characteristics using unpaired t tests and 1-way analysis of variance. Key Findings: The initial list of 54 items was reduced to 31 after review and then administered to 381 pharmacy students (337 complete responses; 88% response rate). EFA suggested 3 factors with 4 items being removed due to low factor loadings. The final Potential Involvement in Scholarly Activities (PISA) instrument contained 27 items in 3 domains: research activities (13 items), professional writing (9 items), and practice evaluation/quality improvement (5 items). Cronbach's alphas were ≥0.85 for the total scale and domains. PISA scores were statistically higher for first-year students and those with previous research experience or post-graduate training interests. CONCLUSIONS: Initial development of the PISA instrument suggested a 3-factor structure with acceptable internal consistency in this sample. Continued work is needed to examine the instrument in more diverse samples.

Updating conceptions of validity and reliability.

Measurement validity is important when conducting research. This is as true for sociobehavioral research as for clinical research. Although the importance of validity is not new, its conceptualization has changed substantially in the past few decades. In the literature, there is a lack of consistency in how validity is presented. This may stem from a lack of awareness of the relatively recent changes in conceptualization of validity, the continued use of a historical framework in some educational texts, and/or the continued use of a historical framework in some training programs. This article presents a brief history of the conceptualization of validity including the progression from a perspective of related concepts of reliability and validity, to multiple types of validity, to a view of validity as a unitary concept supported by different types of evidence. This article closes by raising some important considerations about promoting use of a contemporary validity framework and associated terminology in current research, as well as in the education of future health-sciences researchers.

A Multi-School Validation of a Revised Scale for Assessing Cultural Competence in Pharmacy Students.

Objective. To revise the Self-Assessment of Perceived Level of Cultural Competence (SAPLCC) instrument and validate it within a national sample of pharmacy students. Methods. A cross-sectional study design using a convenience sample of pharmacy schools across the country was used for this study. The target population was Doctor of Pharmacy (PharmD) students enrolled in the participating pharmacy programs. Data were collected using the SAPLCC. Exploratory factor analysis with principal components extraction and varimax rotation was used to identify the factor structure of the SAPLCC instrument. Results. Eight hundred seventy-five students from eight schools of pharmacy completed the survey. Exploratory factor analysis resulted in the selection of 14 factors that explained 76.6% of the total variance and the grouping of 75 of the 86-items in the SAPLCC into six domains: knowledge (16 items), skills (11 items), attitude (15 items), encounters (11 items), abilities (13 items), and awareness (9 items). Using a more diverse, representative sample of pharmacy students resulted in important revisions to the constructs of the SAPLCC and allowed the identification of a new factor: social determinants of health. Conclusion. The 75-item SAPLCC is a reliable instrument covering a full range of domains that can be used to measure pharmacy students' perceived level of cultural competence at baseline and upon completion of the pharmacy program.

Patient preferences for objective quality metrics during community pharmacy selection: A discrete choice experiment.

BACKGROUND: Patients select healthcare providers and facilities based on a complex array of factors. Pharmacy-level quality metrics have been discussed as a way to help direct patients towards high-quality pharmacies. Limited research has been conducted on the potential impact of quality metrics on the pharmacy selection process. OBJECTIVES: This study aimed to measure the relative strength of patient preferences for community pharmacy attributes and to describe associations between patient sociodemographic and health characteristics and pharmacy preferences. METHODS: This study elicited preferences for pharmacy attributes using a discrete choice experiment presenting a scenario in which participants had moved to a new location and needed to select a pharmacy. Six attributes were selected based on published literature, expert opinion, and pilot testing feedback. Attributes were relationship-based (hours of operation, staff friendliness/courtesy, pharmacist communication, pharmacist willingness to establish a personal relationship) or competence-based (overall quality and a drug-drug interaction (DDI) specific quality metric). Participants responded to blocks of 10 random and 2 fixed choice tasks assigned by Sawtooth v9.2. Data were analyzed using conditional logit, and Hierarchical Bayes estimates of individual-level utilities were used to compare preferences across demographic subgroups. RESULTS: Study participants expressed the strongest preferences for competence-based pharmacy attributes, including DDI-specific and overall quality measures (Attribute Importance Values: 40.3% and 31.3%, respectively). Women ascribed higher utility to 5-star DDI and overall quality ratings than men. Rural respondents and those with inadequate health literacy expressed stronger preferences for patient-pharmacist relationships than those in suburban areas and with adequate health literacy, respectively. CONCLUSIONS: Respondents exhibited strong preferences for pharmacies with higher competence-based quality ratings, suggesting that they may perceive medication safety to be a key role of community pharmacists. Future research on patient expectations of and preferences for community pharmacies can inform ways to effectively encourage patient engagement with pharmacists to improve health outcomes.

Evaluating a measure of the research training environment in a sample of pharmacy residents.

INTRODUCTION: While an important predictor of future research involvement, formal assessment of the quality of the research training environment in pharmacy residency training has not been examined. The objective of this study was to evaluate the psychometric properties of a modified version of the shortened form of the revised Research Training Environment Scale (RTES-R-S) in pharmacy residents. METHODS: The original wording of the 18 items from RTES-R-S was modified to reflect pharmacy residency training. Data were collected as part of a larger study involving a random sample of pharmacy residents in the United States during the 2016-2017 residency year. Internal consistency was assessed with Cronbach's α. Confirmatory factor analysis was used to assess the fit of the factor structures examined previously during the original RTES-R-S development. RESULTS: Based on confirmatory factor analysis, the preferred model proposed a single, second-order factor predicting nine factors reflecting Gelso's previously described ingredients of the research training environment. This model had acceptable fit indices and was statistically better than models without second-order factors. Cronbach's α for the global scale was 0.86, with the two subscales >0.7. CONCLUSIONS: Minor rewording of an existing instrument to measure residents' perceptions of the quality of the research training environment demonstrated acceptable internal consistency. The factor structure of the recommended use proposed by the original developers of the RTES-R-S was supported in this sample of pharmacy residents. Continued work with additional samples is needed to generate additional validity evidence supporting the use of this tool in pharmacy residents.

An Exploratory Survey of Incorporation of Gender- and Sex-related Differences in the PharmD Curricula.

INTRODUCTION: Clinical presentation and treatment in many disease states vary due to sex- and gender-differences. Sex-related pharmacokinetic differences are particularly important for pharmacists. The Accreditation Council for Pharmacy Education (ACPE) currently has no standard for the inclusion of gender- and sex-related differences in the didactic PharmD curriculum, but encourages advanced pharmacy practice experiences (APPEs) to include diverse populations related to gender. The purpose of this survey is to explore faculty incorporation of gender and sex differences within the PharmD didactic curriculum in preparation for a nation-wide survey. METHODS: A survey was created to determine how many clinical topics incorporated gender- and sex-related differences and to what extent this information was discussed in the classroom. The survey link was emailed to pharmacotherapeutics and pharmacokinetics faculty at Midwestern University Chicago College of Pharmacy, University of Illinois at Chicago, Roosevelt University, Rosalind Franklin University, and Chicago State University. Chi square analyses were performed to examine relationships across participant responses. RESULTS: A total of 56 faculty members participated in the survey, resulting in a 20% response rate. Of these, 30 (54.5%) faculty indicated that they discussed gender- and sex-related differences in the subject area in which they teach. Approximately 33% of respondents found gender- and sex-related differences very clinically important. Gender- and sex- related differences were taught in a variety of subject areas, including cardiology, diabetes, and chronic obstructive pulmonary disease (COPD). CONCLUSION: With no current standard, faculty members independently choose to include gender- and sex-related differences in their lecture topics and the extent of the discussion. Faculty should be aware of this lack of standardization and that they are independently responsible for including gender- and sex-related differences in their particular topics. Because the surveyed faculty find gender- and sex-related differences clinically important and literature suggests differences in medications depending on gender and sex, further research is planned to provide insight on a national level.

Design, analysis, and conclusions: Telling a consistent causal story.

Pharmacy educators are dedicated to providing the best education to student pharmacists and post-graduate trainees. This involves developing and evaluating new educational approaches or activities, as well as working to understand better other factors that may affect student and program outcomes. Although we may not realize it, the idea of causality, or the presence of a cause-and-effect relationship, is embedded in much of what we do when engaging in pharmacy educational scholarship. Saying that an educational intervention is effective at improving test scores implies that the intervention caused the increase. Perhaps more subtly, a cause-and-effect relationship is implied when identifying poor interviewing skills as a factor that reduces the likelihood that a student will obtain a pharmacy practice residency. The extent to which causal claims can be made depends on appropriate study design and analysis. Similarly, the language used to present these claims is related to study design and analysis. Unfortunately, study designs used when evaluating educational approaches do not always align with the language used to report the results. This review provides a brief overview of current thinking related to causal inference. The role of study design and analysis in causal inference is also discussed along with recommendations for study design and analysis to facilitate making appropriate causal claims. After reading this article, readers should be able to select a study design that best aligns with their particular research question and report their findings in ways that are faithful to the strengths of the study design.

SGLT2 Inhibitors: A Systematic Review of Diabetic Ketoacidosis and Related Risk Factors in the Primary Literature.

STUDY OBJECTIVE: Currently only minimal information is available regarding risk factors for the development of sodium glucose cotransporter-2 inhibitor (SGLT2i)-related diabetic ketoacidosis (DKA). We aim to identify individual patient characteristics associated with cases of SGLT2i-related DKA to better describe potential risk factors. DESIGN: Systematic review of primary literature. PATIENTS: Thirty-four case reports of patients with type 1 and type 2 diabetes mellitus who developed DKA while receiving an SGLT2i. METHODS AND MAIN RESULTS: This systematic review investigated the relationship between SGLT2i and DKA in patients with diabetes. The existing literature was reviewed with a primary outcome to identify patient-specific factors contributing to the incidence of ketoacidosis in patients with diabetes who were treated with a SGLT2i. Numerous databases were searched to identify appropriate primary literature. Search terms included canagliflozin, dapagliflozin, empagliflozin, SGLT2, sodium glucose cotransporter-2 inhibitor, diabetic ketoacidosis, ketoacidosis, metabolic acidosis, and acidosis. Primary literature was analyzed via descriptive statistics. Thirty-four individual case reports were identified via the primary literature search. Two-thirds (25 cases) involved patients with a diagnosis of type 2 diabetes mellitus (T2DM). The average blood glucose on presentation for SGLT2i-induced DKA was 265.6 ± 140.7 mg/dl (14.7 ± 7.8 mmol/L), with common symptoms including nausea, vomiting, and abdominal pain. Common precipitating factors included patients who were diagnosed with T2DM and were subsequently found to have latent autoimmune diabetes of adulthood, patients who had recently undergone major surgery, or patients who had decreased or discontinued insulin. No cases were fatal. CONCLUSION: In this review, episodes of DKA with SGLT2i use were characterized by lower blood glucose levels and were often caused by a precipitating factor. Understanding precipitating factors for SGLT2i-related DKA may help providers better identify patients at risk for development of DKA.