Implementation of standard setting for high-stakes objective structured clinical examinations.

BACKGROUND AND PURPOSE: To describe one institution's approach to transformation of high-stakes objective structure clinical examinations (OSCEs) from norm-referenced to criterion-referenced standards setting and to evaluate the impact of these changes on OSCE performance and pass rates. EDUCATIONAL ACTIVITY AND SETTING: The OSCE writing team at the college selected a modified Angoff method appropriate for high-stakes assessments to replace the two standard deviation method previously used. Each member of the OSCE writing team independently reviewed the analytical checklist and calculated a passing score for active stations on OSCEs. Then the group met to determine a final pass score for each station. The team also determined critical cut points for each station, when indicated. After administration of the OSCEs, scores, pass rates, and need for remediation were compared to the previous norm-referenced method. Descriptive statistics were used to summarize the data. FINDINGS: OSCE scores remained relatively unchanged when switched to a criterion-referenced method, but the number of remediators increased up to 2.6 fold. In the first year, the average score increased from 86.8% to 91.7% while the remediation rate increased from 2.8% to 7.4%. In the third year, the average increased from 90.9% to 92% while the remediation rate increased from 6% to 15.6%. Likewise, the fourth-year average increased from 84.9% to 87.5% while the remediation rate increased from 4.4% to 9%. SUMMARY: Transition to a modified Angoff method did not impact average OSCE score but did increase the number of remediations.

Design and Evaluation of an APPE Readiness Dashboard Tool.

OBJECTIVE: To describe the design and evaluation of a dashboard tool to assess the readiness for advanced pharmacy practice experiences (APPEs). METHODS: The investigators developed a dashboard tool for the appraisal of APPE readiness consisting of indicators of pharmacy student knowledge, skills, and noncognitive attributes. For the 2018-2019 and 2019-2020 rotation years, a panel of stakeholders used the dashboard to evaluate APPE readiness. Students deemed not ready (5 or more dashboard indicators) had a remediation experience before the APPEs. The investigators monitored the students who were deemed ready but at risk for substandard performance (3 or 4 indicators or completion of remediation experience) and tracked the incidence of substandard performance for all APPE students. The outcomes were presented using descriptive statistics. Performance of the tool between years was compared using the χ2 test. RESULTS: For 2 APPE rotation cycles, the investigators evaluated readiness in 499 students. A total of 3 students were deemed not ready, and 78 students were considered at risk for substandard performance. The tool predicted 52.1% of students who experienced a substandard performance. It had a negative predictive value of 93.6% and a positive predictive value of 38.5% for substandard performance. The predictive value was similar across the risk categories of knowledge, skills, and noncognitive attributes. CONCLUSION: A dashboard tool facilitating holistic evaluation of APPE readiness was helpful in identifying students who were not ready for APPEs or at risk for substandard performance. The next steps include refinement of the tool through the evaluation of characteristics of students who experienced substandard performance and were not identified by the tool.

Curricular changes in times of crisis: Lessons learned.

BACKGROUND AND PURPOSE: During the early months of the COVID-19 pandemic, experiential education became challenging as sites began to cancel scheduled rotations, and the University of Florida College of Pharmacy had to cancel the first advanced pharmacy practice experience (APPE) block. This was allowable given the excess number of experiential hours built into the curriculum. EDUCATIONAL ACTIVITY AND SETTING: To meet total program credit hour requirements, a six-credit virtual course was created to mimic an experiential rotation. This course was designed to bridge didactic learning with experiential learning. The course included presentation of patient cases, topic discussions, pharmaceutical calculations, self-care cases, disease state management cases, and career development. FINDINGS: Students provided feedback via a survey containing 23 Likert type questions and four open-ended questions. Most students agreed or strongly agreed that participation in self-care scenarios, small group discussions (calculations and topic discussion), and disease state management cases (preceptor dialogue and verbal defense activities) were valuable learning experiences. The verbal defense portion of the disease management case and the self-care scenarios were the most highly rated learning activities. Peer review activities in the career development assignments were seen as the least beneficial component of the course. SUMMARY: This course allowed students an opportunity to further prepare for APPEs in a unique learning environment. The college was able to identify students requiring additional support during APPEs and provide earlier intervention. Additionally, data supported exploring incorporation of new learning activities into the current curriculum.

A Monitoring and Early Intervention Program for At-Risk Students on Advanced Pharmacy Practice Experiences.

Objective. To describe a monitoring and early intervention process for students at risk of substandard performance on advanced pharmacy practice experiences (APPEs).Methods. Using a dashboard of key indicators, students with potential deficits in knowledge, skills, or noncognitive attributes were identified as at risk of substandard performance on APPEs and placed on a list of students to be monitored during the APPE year. Employing a traffic light-based approach, at-risk students were initially designated with a monitoring status of red. If no issues were identified, students were de-escalated to yellow status and, subsequently, to green status. Monitored students who had issues or received a substandard evaluation on APPEs had a deficit-specific action plan implemented.Results. For the 2018-2019 and 2019-2020 academic years, 87 of 499 students entering APPEs were monitored. Of those 87 students, 77 (88.5%) completed experiences successfully on the first attempt, but 66 (75.9%) did require extended higher-level (red or yellow) monitoring. Over these two years, 54 (62.1%) of the 87 students deemed at risk did not have a substandard performance on APPEs, with 26 in the 2018-2019 year and 28 in the 2019-2020 year.Conclusion. A student monitoring and early intervention process may be beneficial in assisting at-risk students to successfully complete APPEs.

Romosozumab: A Novel Agent in the Treatment for Postmenopausal Osteoporosis.

Objective: To review the safety and efficacy of romosozumab (Evenity) in the treatment of osteoporosis in women. Data Sources: An English-language search of PubMed and Medline (1966 to August 2020) was conducted using the keywords romosozumab, sclerostin inhibitor, AMG785, and osteoporosis. Manufacturer prescribing information, abstracts, fda.gov, and ClinicalTrials.gov data were incorporated for additional materials. In addition, a review of bibliographies of retrieved articles was performed to identify additional references. Study Selection/Data Extraction: Articles selected included those that described clinical studies of pharmacokinetics, efficacy, or safety of romosozumab. Data Synthesis: Romosozumab is a human monoclonal antibody that inhibits the action of sclerostin and is the first agent in its class to reach Phase III trials. Significant increases in bone mineral density and decreases in vertebral and hip fractures are demonstrated in Phase III trials. Favorable results led to its marketing approval in several countries. Major adverse cardiac events were observed in one clinical trial. Other adverse effects include arthralgia, headache, and injection site reactions. Place in Therapy: Romosozumab is the first agent to inhibit bone resorption and stimulate bone formation. Romosozumab should be reserved for postmenopausal women at highest risk for fracture and should be followed by an anti-resportive agent to maintain or further increase bone mineral density. This injectable agent should not be considered for women with a history of or at high risk of cardiovascular disease.

Impact of supplemental individual verbal defense on confidence, engagement, and performance in a team-based learning therapeutics course.

BACKGROUND AND PURPOSE: Team-based learning (TBL) has been successfully applied to multiple healthcare education disciplines. A primary tenet of TBL is the development of solutions leveraging the collective knowledge of a team rather than the individual competency of any one student. In an effort to enhance individual student accountability, an individual verbal defense (IVD) format was implemented in a multi-campus TBL-based pharmacotherapeutics course. The study sought to investigate the use of TBL-IVD embedded within a traditional TBL format on student engagement, teaching style preferences, and exam performance compared to a TBL-only format. EDUCATIONAL ACTIVITY AND SETTING: In this cross-sectional study, second-year pharmacy students enrolled in a pharmacotherapeutics course during fall 2019 completed an 11-item survey. The survey was designed to assess TBL-IVD on student engagement and teaching style preference. Free-response qualitative feedback was solicited to assess positive-negative themes related to the activity. Aggregate exam performance for community-acquired pneumonia (CAP) related content was compared to historical exam data to assess the impact on student performance. FINDINGS: The majority of students (72%, n = 54) preferred the TBL-IVD compared to a TBL-only format. Students reported higher engagement with TBL-IVD (84%, n = 63). Correct exam responses for CAP related content were higher in the TBL-IVD group (67% vs. 55%, P < .001). Positive themes included an increased opportunity to defend recommendations verbally and increased interaction with an on-campus faculty member. SUMMARY: The study demonstrates the addition of IVD can enhance student perceptions, confidence, and performance within a large, multi-campus, TBL-based pharmacotherapeutics course.

Development and Validation of a Situational Judgement Test to Assess Professionalism.

Objective. The purpose of this study was to develop, pilot, and validate a situational judgement test (SJT) to assess professionalism in Doctor of Pharmacy (PharmD) students. Methods. Test specifications were developed and faculty members were educated on best practices in item writing for SJTs. The faculty members then developed 75 pilot scenarios. From those, two versions of the SJT, each containing 25 scenarios, were created. The pilot population for the SJT was student pharmacists in their third professional year, just prior to starting their advanced pharmacy practice experiences. The students completed the two versions of the test on different days, approximately 48 hours apart, with 50 minutes allowed to complete each. Subsequently, students completed a questionnaire regarding the SJT at the conclusion of the second test. Results. Version 1 of the SJT was completed by 228 students, and version 2 was completed by 225 students. Mean scores were 390 (SD=20, range 318-429) and 342 (SD=21, range 263-387) on test versions 1 and 2, respectively. The reliability of the tests was appropriate (test version 1, α=0.77; test version 2, α=0.79). Students felt that the content of the tests was realistic with respect to pharmacy practice (90.1%), and that the tests gave them an opportunity to reflect on how to approach challenging situations (82.6%). Conclusion. We developed a reliable SJT to assess professionalism in PharmD students. Future research should focus on creating a personalized learning plan for students who do not meet minimum performance standards on this SJT.

The Use of Aerosolized Ribavirin in Respiratory Syncytial Virus Lower Respiratory Tract Infections in Adult Immunocompromised Patients: A Systematic Review.

Introduction: Respiratory syncytial virus (RSV)-associated lower respiratory tract infection (LRTI) is a concern in immunocompromised patients. Aerosolized ribavirin (RBV AER) is used for treatment of RSV LRTI; however, adverse events and rising drug costs remain a challenge for patient management. The purpose of this systematic review is to summarize the efficacy and adverse event profile of RBV AER for the treatment of hospitalized RSV LRTI in immunocompromised adult patients. Methods: A Medline/PubMed, Embase, Google Scholar, Clinicaltrials.gov, and Cochrane Library database search was conducted from 1966 to January 2019 for the use of RBV AER. Search strategy: [(ribavirin OR ICN1229) AND ("administration, oral" OR "oral" OR "administration, inhalation" OR "inhalation)] AND ("respiratory tract infection" OR "pneumonia"). Studies were reviewed if adult patients were hospitalized, immunocompromised, had RSV LRTI, received RBV AER, and included the outcome of mortality and/or adverse reactions. Methodological quality was assessed using the Cochrane Collaboration GRADE approach. Results: A total of 1787 records were identified and 15 articles met inclusion criteria: hematopoietic stem cell transplant (HSCT)/bone marrow transplant (n = 8), other malignancy/neutropenic (n = 2), solid organ transplant (n = 5). All of the trials are observational with a low quality rating; therefore, a meta-analysis was not performed. The 30-day mortality in studies that contain >10 patients with HSCT, malignancy, and transplant range from 0 to 15.4%, 6.3%, and 0 to 27%, respectively. Improved mortality was cited in 4 studies when RBV AER started before mechanical ventilation or within 2 weeks of symptom onset. Only 3 studies had comparative mortality data with RBV AER and RBV PO. Adverse reactions were reported in 5 studies and included psychiatric manifestations (anxiety, depression, feeling of isolation; n = 14), wheezing/bronchospasm (n = 6), snowflakes/hail blowing in face (n = 6), and precipitation in ventilator tubing (n = 5). Conclusion: There is a lack of high quality, comparative trials on the use of RBV AER for the treatment of RSV LRTI in adult hospitalized immunocompromised patients. There may be a mortality benefit when RBV AER is initiated early after diagnosis or prior to mechanical ventilation, but requires further study. Patient isolation and psychological effects must be weighed against the benefit of therapy.

Implementation of a Ponseti Clubfoot Program Decreases Major Surgery: A Quality Improvement Initiative.

Clubfoot describes a congenital condition. If untreated, clubfoot can cause long-term functional issues. The Ponseti method is the gold-standard treatment; it emphasizes casting over surgery. We identified a high rate of major recurrence in patients with isolated clubfoot at our institution. We implemented a quality improvement intervention to address the recurrences. METHODS: We established a clubfoot program that aimed to (1) develop a standardized treatment pathway; (2) improve care team education; (3) improve coordination of care with families; and (4) improve documentation. The purpose of this study was to outline our quality improvement intervention and evaluate its success. Data were retrospectively collected from isolated clubfeet before (2003-2007, phase I) and after (2012-2014, phase II) implementation of the clubfoot program. We compared the differences in treatment and major recurrence between the 2 phases using generalized logistic or linear mixed models. Modified Poisson regression models were used to evaluate the association between provider nonadherence and recurrence. RESULTS: The pre- (phase I) and post- (phase II) implementation groups included 91 patients (131 feet) and 68 patients (101 feet), respectively. The incidence of major recurrence (odds ratio: 59.5, 95% confidence interval: 7.8-454.4, P < 0.0001) was lower during phase II compared to phase I. Nonadherence with the care pathway was associated with an increased risk of recurrence (risk ratio: 4.1, 95% confidence interval: 1.2-14.3, P = 0.0274). CONCLUSIONS: The implementation of a clubfoot program was associated with a decrease in major clubfoot surgery and improved adherence to established guidelines for clubfoot management.

Fassier-Duval Rods are Associated With Superior Probability of Survival Compared With Static Implants in a Cohort of Children With Osteogenesis Imperfecta Deformities.

BACKGROUND: The survival of Fassier-Duval (FD) telescoping rods as compared with static implants in children affected by osteogenesis imperfecta is not well characterized. The purpose of this study was to compare risk of lower extremity implant failure in FD rods versus static implants. METHODS: Data were retrospectively collected from patients with osteogenesis imperfecta who underwent surgical treatment using either FD rods or static implants (Rush rods, flexible nails, or Steinmann pins) between 1995 and 2015. The timing of implant failure was the primary outcome variable of interest. Comparisons were limited to limbs with no previous history of implants. Cox-proportional hazards regression analyses were used to compare the hazard of implant failure across implants. Negative binomial regression analyses were used to compare the incidence of surgical procedures in the 2 implant groups. RESULTS: The final cohort consisted of 64 limbs (n=21 patients). The static implant group (n=38) consisted of 24 Rush rods (63%), 14 flexible nails (37%), and 2 Steinmann pins (5%). The hazard of implant failure in the static implant group was 13.2 times [95% confidence interval (CI), 2.5-69.6; P=0.0024] the hazard of implant failure in the FD rod group. The hazard of implant failure among females was 4.8 (95% CI, 1.4-16.7; P=0.0125) times the hazard of implant failure among males. The total surgery rate in the static implant group was 7.8 (95% CI, 1.8-33.0; P=0.0056) times the total surgery rate in the FD group. CONCLUSIONS: Among surgically naive limbs, FD rods were associated with significantly improved probability of survival compared with static implants. LEVEL OF EVIDENCE: Level II-retrospective study.

The Role of Sodium-Glucose Co-Transporter 2 Inhibitors in the Treatment of Type 2 Diabetes.

PURPOSE: Diabetes is a chronic metabolic disorder characterized by hyperglycemia that results from insulin resistance, diminished or absent insulin secretion, or both. Approximately one-half of patients with diabetes fail to achieve acceptable glycemic control. Consequently, morbidity and mortality associated with diabetes is high, resulting from complications such as cardiovascular disease and nephropathy. The sodium-glucose co-transporter 2 (SGLT2) inhibitors are a new class of medications for the treatment of type 2 diabetes. This article provides an overview of efficacy and safety data for the SGLT2 inhibitors and outlines their role in the management of diabetes. METHODS: Relevant articles were identified through searches of PubMed and International Pharmaceutical Abstracts by using the key terms canagliflozin, dapagliflozin, empagliflozin, and sodium-glucose co-transporter 2 inhibitor. A review of bibliographies of retrieved articles was also performed to identify additional references. All identified trials published in English and that involved the efficacy and safety of SGLT2 inhibitors in the treatment of type 2 diabetes were reviewed. FINDINGS: The SGLT2 inhibitors improve glucose control by increasing urinary glucose excretion. Effectiveness is decreased in the presence of renal dysfunction. These agents are efficacious as monotherapy and add-on therapy for patients with type 2 diabetes uncontrolled on metformin, sulfonylureas, insulin, and other antihyperglycemic combinations. The SGLT2 inhibitors lower glycosylated hemoglobin by 0.5% to 1% and fasting plasma glucose by ~15 to 35 mg/dL, depending on the agent and the dosage used, and are also associated with modest reductions in weight (-1.5 to -3.5 kg) and systolic blood pressure (-3 to -5 mm Hg). Genital mycotic infections and increased urination, owing to the mechanism of action, are the most common adverse effects. In general, the class is well tolerated, and the risk of hypoglycemia is low. IMPLICATIONS: With their unique mechanism of action and good safety and tolerability profiles, the SGLT2 inhibitors are an important addition to existing treatments for type 2 diabetes. Because of the lack of data with this class of drugs when current treatment guidelines for diabetes were published, the SGLT2 inhibitors are recommended as second- or third-line therapies for diabetes. Forthcoming data on the long-term efficacy and safety profile of these agents should help to solidify the role of SGLT2 inhibitors in the management of diabetes.

Bupivacaine liposomal versus bupivacaine: comparative review.

Bupivacaine liposomal injection was recently approved by the US Food and Drug Administration (FDA) as a local anesthetic for use in management of postsurgical pain in adults. When compared to placebo, bupivacaine liposomal decreases postoperative pain and opioid use. This review examines the efficacy of bupivacaine liposomal when compared to conventional bupivacaine ± epinephrine using published and unpublished data provided to the FDA by the manufacturer.

Perceptions of tenure and tenure reform in academic pharmacy.

OBJECTIVES: To determine the academic pharmacy community's perceptions of and recommendations for tenure and tenure reform. METHODS: A survey instrument was administered via either a live interview or an online survey instrument to selected members of the US academic pharmacy community. RESULTS: The majority of respondents felt that tenure in academic pharmacy was doing what it was intended to do, which is to provide academic freedom and allow for innovation (59.6%). Respondents raised concern over the need for faculty mentoring before and after achieving tenure, whether tenure adequately recognized service, and that tenure was not the best standard for recognition and achievement. The majority (63%) agreed that tenure reform was needed in academic pharmacy, with the most prevalent recommendation being to implement post-tenure reviews. Some disparities in opinions of tenure reform were seen in the subgroup analyses of clinical science vs basic science faculty members, public vs private institutions, and administrators vs nonadministrators. CONCLUSIONS: The majority of respondents want to see tenure reformed in academic pharmacy.

Preparation of faculty members and students to be citizen leaders and pharmacy advocates.

To identify characteristics and quality indicators of best practices for leadership and advocacy development in pharmacy education, a national task force on leadership development in pharmacy invited colleges and schools to complete a phone survey to characterize the courses, processes, and noteworthy practices for leadership and advocacy development at their institution. The literature was consulted to corroborate survey findings and identify additional best practices. Recommendations were derived from the survey results and literature review, as well as from the experience and expertise of task force members. Fifty-four institutions provided information about lecture-based and experiential curricular and noncurricular components of leadership and advocacy development. Successful programs have a supportive institutional culture, faculty and alumni role models, administrative and/or financial support, and a cocurricular thread of activities. Leadership and advocacy development for student pharmacists is increasingly important. The recommendations and suggestions provided can facilitate leadership and advocacy development at other colleges and schools of pharmacy.

Estradiol valerate/dienogest: a novel oral contraceptive.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of the new oral contraceptive estradiol valerate/dienogest. DATA SOURCES: Searches of PubMed (1966-July 2011) and International Pharmaceutical Abstracts (1970-July 2011) were conducted using the key words estradiol valerate, dienogest, Natazia, and Qlaira. Bibliographies of retrieved articles were reviewed to identify additional references. STUDY SELECTION AND DATA EXTRACTION: All identified studies published in English and involving efficacy and safety of estradiol valerate/dienogest as an oral contraceptive were reviewed. DATA SYNTHESIS: Estradiol valerate/dienogest is a 4-phasic oral contraceptive approved for the prevention of pregnancy. The 4-phasic design allows for acceptable cycle control with this hormonal combination. In efficacy trials of estradiol valerate/dienogest in women aged 18-35 years, the Pearl Index ranged from 0.40 to 1.64, a range comparable to that of other combination oral contraceptives. The safety profile was also similar to that of other oral contraceptives, with headache, metrorrhagia, breast tenderness, nausea or vomiting, acne, and weight gain reported as the most common adverse effects. Menstrual bleeding patterns and cycle control with estradiol valerate/dienogest were comparable to those of a monophasic oral contraceptive containing ethinyl estradiol/levonorgestrel. Estradiol valerate/dienogest differs from other oral contraceptives in that it necessitates more stringent dosing guidelines for maximum contraceptive efficacy. New starts should be on the first day of menses only, and a back-up method of contraception is required for the first 9 days, as compared to 7 days with other oral contraceptives. Back-up contraception is usually required for any pill taken more than 12 hours later than scheduled. CONCLUSIONS: Estradiol valerate/dienogest is an effective oral contraceptive. Because it has more stringent start times and requires a longer duration of backup contraception and stricter adherence, estradiol valerate/dienogest should be reserved for patients who are intolerant of other combination oral contraceptives.