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.

The Impact of Integrated Case Management on Health Services Use and Spending Among Nonelderly Adult Medicaid Enrollees.

BACKGROUND: Medicaid plans, whose patients often have complex medical, social, and behavioral needs, seek tools to effectively manage enrollees and improve access to quality care while containing costs. OBJECTIVES: The aim of this study is to examine the effects of an integrated case management (ICM) program operated by a Medicaid managed care plan on health service use and spending for nonelderly, nonpregnant adults. RESEARCH DESIGN: We estimate the relationship between intensity of ICM program involvement and changes in utilization and spending for patients who participated in ICM. We examine whether effects differ between high-risk and lower-risk individuals and between the early and late stages of the program, given that the latter relied on more targeted and patient-centered approaches. Specifically, we estimate linear regressions modeling changes in utilization and spending outcomes as a function of number of program contacts, conditional on number of days over which contacts occurred, as well as individual-level covariates and case manager fixed effects. RESULTS: In the late ICM program period, we observe significant decreases in outpatient utilization associated with program involvement intensity among high-risk ICM participants. We also observe decreases in spending associated with program involvement intensity among the lower-risk group in the late period, although there is no significant impact on spending among high-risk enrollees. CONCLUSIONS: ICM can be a successful strategy for impacting health services use and spending. Our findings suggest that careful program targeting, well-structured client engagement, and direct one-on-one contact are vitally important for achieving program objectives.

The Choice of Analytical Strategies in Inverse-Probability-of-Treatment-Weighted Analysis: A Simulation Study.

We sought to explore the impact of intention to treat and complex treatment use assumptions made during weight construction on the validity and precision of estimates derived from inverse-probability-of-treatment-weighted analysis. We simulated data assuming a nonexperimental design that attempted to quantify the effect of statin on lowering low-density lipoprotein cholesterol. We created 324 scenarios by varying parameter values (effect size, sample size, adherence level, probability of treatment initiation, associations between low-density lipoprotein cholesterol and treatment initiation and continuation). Four analytical approaches were used: 1) assuming intention to treat; 2) assuming complex mechanisms of treatment use; 3) assuming a simple mechanism of treatment use; and 4) assuming invariant confounders. With a continuous outcome, estimates assuming intention to treat were biased toward the null when there were nonnull treatment effect and nonadherence after treatment initiation. For each 1% decrease in the proportion of patients staying on treatment after initiation, the bias in estimated average treatment effect increased by 1%. Inverse-probability-of-treatment-weighted analyses that took into account the complex mechanisms of treatment use generated approximately unbiased estimates. Studies estimating the actual effect of a time-varying treatment need to consider the complex mechanisms of treatment use during weight construction.

Risk of fracture and the concomitant use of bisphosphonates with osteoporosis-inducing medications.

OBJECTIVE: To review the literature on the concomitant use of bisphosphonates and medications that can influence bone metabolism and potentially attenuate bisphosphonate antifracture efficacy. DATA SOURCES: MEDLINE and CINAHL were searched for articles published in English through December 2014 using the following terms: bisphosphonates, bone density conservation agents, acid-suppressive therapy, levothyroxine, thiazolidinediones (TZDs), selective serotonin reuptake inhibitors (SSRIs), bone fractures. STUDY SELECTION AND DATA EXTRACTION: Studies were included if they reported results of concomitant use of any listed medications with bisphosphonates and risk of fractures and focused on women. Articles that focused generally on the use of one of the listed medications and fractures without explicitly examining the potential antifracture efficacy or attenuation of bisphosphonates were excluded. DATA SYNTHESIS: A total of 6 relevant studies were identified. Four epidemiological studies reported a statistically significant dose-dependent increase in the risk of fractures when bisphosphonates and acid-suppressive drugs were used together. One post hoc analysis of clinical trial data suggested no attenuation of the antifracture effects of bisphosphonates when used concomitantly with acid-suppressive therapy. One study involving bisphosphonates and SSRIs noted a statistically significant association between fracture risk and SSRI use. No study examining TZDs or levothyroxine with bisphosphonates was identified. CONCLUSIONS: Existing research suggests potential attenuation of bisphosphonate antifracture efficacy among patients taking acid-suppressive medications. Based on their pharmacological actions, TZDs, SSRIs, and levothyroxine have similar implications. The paucity of evidence in the literature associating the attenuation of bisphosphonate antifracture efficacy when combined with other medications suggests that further investigation is needed.

Medication risk factors associated with healthcare-associated Clostridium difficile infection: a multilevel model case-control study among 64 US academic medical centres.

OBJECTIVES: The main objective of this study was to determine patient- and hospital-level medication risk factors associated with Clostridium difficile infection (CDI) occurrence among patients clustered within hospitals using a multilevel model. METHODS: Patients with healthcare-associated (HA)-CDI were identified from among 64 academic medical centres in 2009. A frequency match was conducted; for each case, up to two controls were selected, matched on similar pre-infection length of stay and clinical service line. Patient- and hospital-level medication use, including antibacterial and gastric acid-suppressant agents, was assessed using a two-level logistic regression model. RESULTS: A total of 5967 CDI cases and 8167 controls were included in the analysis. The odds of acquiring HA-CDI increased with the following medications [OR (95% CI)]: anti-methicillin-resistant Staphylococcus aureus agents [1.38 (1.22-1.56)]; third- or fourth-generation cephalosporins [1.75 (1.62-1.89)]; carbapenems [1.60 (1.44-1.79)]; ß-lactam/ß-lactamase inhibitor combinations [1.49 (1.36-1.64)]; vancomycin [1.73 (1.57-1.89)]; and proton pump inhibitors [1.43 (1.30-1.57)]. The odds of acquiring HA-CDI decreased with the following medications: clindamycin [0.74 (0.63-0.87)]; and macrolides [0.88 (0.77-0.99)]. Controlling for patient-level covariates, no hospital-level medication covariates that we analysed had statistically significant effects on HA-CDI. The odds of acquiring HA-CDI increased with the hospital proportion of patients aged ≥ 65 years [1.01 (1.00-1.02)]. CONCLUSIONS: We found several medications that were associated with the risk of patients developing HA-CDI, including ß-lactam/ß-lactamase inhibitor combinations, third- or fourth-generation cephalosporins, carbapenems, vancomycin, proton pump inhibitors and anti-methicillin-resistant S. aureus agents. There were no medication effects significant at the hospital level.

Potentially inappropriate medication use is associated with clinical outcomes in critically ill elderly patients with neurological injury.

BACKGROUND: Limited data suggest that potentially inappropriate medications (PIMs) impact outcomes in critically ill elderly patients. No data are available on the association between PIM use as well as drug burden index (DBI), which is a measure of PIM use, and clinical outcomes in neurocritical care elderly patients. This study evaluates whether PIM use and a higher DBI are associated with poor clinical outcomes in neurocritical care elderly patients. METHODS: PIMs were retrospectively identified in critically ill elderly patients admitted to the neuroscience intensive care unit (NSICU) from March to July 2011. DBI was calculated based on PIM doses. Relationships with clinical outcomes were evaluated. RESULTS: PIMs were prescribed to a majority (81.3 %) of the 112 patients. Opioids were most commonly associated with a decrease in Richmond Agitation Sedation Scale (RASS) scores (56 % of PIM doses). Time to recovery was significantly longer in patients with a higher PIM burden (≤2 PIMs: 8 h, >2 PIMs: 29 h; p = 0.02). There was a significantly longer NSICU and hospital length of stay (9 vs 2; 15 vs 5 days; p < 0.0001) as well as a lower Glasgow Coma Scale score upon discharge (14 vs 15, p = 0.02) in patients with a higher DBI after 72 h of hospitalization. There was no difference in mortality. CONCLUSIONS: PIM use and higher DBI scores were associated with poor clinical outcomes and longer lengths of stay. Further studies are needed to determine the impact of PIMs and DBI on mortality in neurocritical care elderly patients.

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.

Methodological Challenges in Studies of Personal and Professional Identity Formation.

Demographic information about the identities of faculty, staff, students, and trainees is frequently collected in pharmacy education. A wide range of identities and characteristics can influence the choices and experiences of students as they progress through curricula and develop their professional goals. Understanding personal and professional identity formation within dynamic and complex environments is critical to promoting the success of pharmacy education and practice. Emerging research efforts highlight the importance of considering identity development from varying perspectives, and offer new methods for collecting and analyzing data. The objective of this commentary is to reflect on the methodological challenges of identity formation research in pharmacy education and offer recommendations for those interested in this work.

Assessment of communication and physical exam skills: A comparison of students, faculty and standardized patients.

PURPOSE/OBJECTIVES: The objective of this retrospective study was twofold: it aimed to investigate dental students' communication and physical exam self-assessment skills by comparing students' self-evaluations with those completed by faculty and standardized patients (SPs). Second, it aimed to compare faculty and SPs assessment of students' communication skills. METHODS: At the end of their first year of training, students (n = 127), participated in one SP encounter about an initial dental consultation. Students completed self-assessment before receiving feedback from faculty (n = 19) and SPs (n = 19). The data source included evaluation forms submitted by students, faculty and SPs. The Wilcoxon signed rank test was used to compare the overall scores between groups. Agreement between evaluations items were analyzed with McNemar's test (p < 0.05). RESULTS: Overall, there were no statistically significant differences in how students and faculty graded for either communication (p = 0.6724) or physical exam (p = 0.1921) skills. However, both students and faculty provided less favorable marks than SPs for communication skills with a statistically significant difference in the overall grading between both students and SPs (p = 0.0146) and between faculty and SPs (p = 0.0045). CONCLUSIONS: While there was disagreement between students and faculty versus SPs, they weren't meaningful differences in scores and the dissimilarities mainly consisted of ratings of explanation skills. We suggest that, when applicable, dental student's self-evaluations may represent an alternative to faculty assessments of communication and physical exam skills. Nonetheless, we recommend that SPs be included in the assessment of communication skills to provide students with comprehensive feedback that more realistically represents the natural patient-provider relationship.

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.

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.

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.

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.