The competency index for clinical research professionals: a potential tool for competency-based clinical research academic program evaluation.

Background: Accreditation of graduate academic programs in clinical research requires demonstration of program achievement of Joint Task Force for Clinical Trial Competence-based standards. Evaluation of graduate programs include enrollment, student grades, skills-based outcomes, and completion rates, in addition to other measures. Standardized measures of competence would be useful. Methods: We used the Competency Index for Clinical Research Professionals (CICRP), in a separate-sample pretest-posttest study to measure self-confidence or self-efficacy in clinical research competency comparing cohorts of students entering and completing a master's degree program in clinical research across three semesters (summer 2021 - spring 2022). CICRP is a 20-item Likert scale questionnaire (0 = Not at all confident; 10 = extremely confident). Results: The study sample of 110 students (54 in the entry course, 56 in the exit course) showed overall 80.9% entered the program with only a baccalaureate degree and 55.5% had no prior experience in managing clinical trial research. Cronbach alpha for the instrument showed a high level of content validity (range 0.93-0.98). Median CICRP item rating range at entry was [1, 6] and at exit [7, 10]. Mean CICRP total score (sum of 20 items) at entry was 72.7 (SD 41.9) vs. 167.0 (SD 21.1) at exit (p < 0.001). Mean total score at program entry increased with increasing years of clinical trial management experience but attenuated at program exit. Conclusion: This is the first use of the CICRP for academic program evaluation. The CICRP may be a useful tool for competency-based academic program evaluation, in addition to other measures of program excellence.

Which hematology/oncology patients are high priority for ambulatory clinical pharmacist review? A three-round Delphi survey by the National Comprehensive Cancer Network.

INTRODUCTION: Prioritization and acuity tools have been leveraged to facilitate targeted and efficient clinical pharmacist interventions. However, there is a lack of established pharmacy-specific acuity factors in the ambulatory hematology/oncology setting. Therefore, National Comprehensive Cancer Network's Pharmacy Directors Forum conducted a survey to establish consensus on acuity factors associated with hematology/oncology patients that are high priority for ambulatory clinical pharmacist review. METHODS: A three-round electronic Delphi survey was conducted. During the first round, respondents were asked an open-ended question to suggest acuity factors based on their expert opinion. Respondents were then asked in the second round to agree or disagree with the compiled acuity factors, in which those with ≥75% agreement were included in the third round. The final consensus was defined as a mean score ≥3.33 on a modified 4-point Likert scale (4 = strongly agree, 1 = strongly disagree) during the third round. RESULTS: A total of 124 hematology/oncology clinical pharmacists completed the first round of the Delphi survey (invitation response rate, 36.7%), of which 103 completed the second round (response rate, 83.1%) and 84 the third round (response rate, 67.7%). A final consensus was achieved for 18 acuity factors. Acuity factors were identified in the following themes: antineoplastic regimen characteristics, drug interactions, organ dysfunction, pharmacogenomics, recent discharge, laboratory parameters, and treatment-related toxicities. CONCLUSIONS: This Delphi panel of 124 clinical pharmacists achieved consensus on 18 acuity factors that would identify a hematology/oncology patient as a high priority for ambulatory clinical pharmacist review. The research team envisions incorporating these acuity factors into a pharmacy-specific electronic scoring tool.

Key ePortfolio features and strategies for student success in a competency-based clinical research program.

BACKGROUND: Student ePortfolios provide an interactive space for faculty, student peers, and potential employers to view skillsets and reflective expressions of students. EDUCATIONAL ACTIVITY: The adoption of ePortfolios in an interdisciplinary, competency-based, master's degree program in clinical research at a university in the Midwestern United States is described. Students submitted their ePortfolios as their culminating assessment. A survey was used to collect objective and open-ended responses from 104 students between 2015 and 2019 followed by a voluntary post-survey interview. Two ePortfolio platforms and instructional methods were compared. CRITICAL ANALYSIS OF THE EDUCATIONAL ACTIVITY: A user-friendly platform enhanced student engagement and reduced student and faculty frustration with the ePortfolio requirement. Thirty-seven students and alumni responded to an ePortfolio survey, and five students shared their experiences in a post-survey interview. Students described positive experiences related to their academic program and job search as a result of completing the ePortfolio. However, alumni were not strongly motivated to maintain their ePortfolio post-graduation. ePortfolios provide evidence of student acquisition of core competencies in a professional graduate degree. Facilitating the process of ePortfolio creation with instruction guides, exemplar ePortfolios, and an evaluation rubric support student success. A user-friendly ePortfolio platform with social media linking features will enhance exposure of the student's work to key stakeholders during and after their academic program. If the ePortfolio is to have an impact on a student's professional trajectory after graduation, it should contain meaningful examples of academic work that can be shared publicly and allow updating of ePortfolio content.

Economic Evaluation of a Patient-Directed Music Intervention for ICU Patients Receiving Mechanical Ventilatory Support.

OBJECTIVES: Music intervention has been shown to reduce anxiety and sedative exposure among mechanically ventilated patients. Whether music intervention reduces ICU costs is not known. The aim of this study was to examine ICU costs for patients receiving a patient-directed music intervention compared with patients who received usual ICU care. DESIGN: A cost-effectiveness analysis from the hospital perspective was conducted to determine if patient-directed music intervention was cost-effective in improving patient-reported anxiety. Cost savings were also evaluated. One-way and probabilistic sensitivity analyses determined the influence of input variation on the cost-effectiveness. SETTING: Midwestern ICUs. PATIENTS: Adult ICU patients from a parent clinical trial receiving mechanical ventilatory support. INTERVENTIONS: Patients receiving the experimental patient-directed music intervention received a MP3 player, noise-canceling headphones, and music tailored to individual preferences by a music therapist. MEASUREMENTS AND MAIN RESULTS: The base case cost-effectiveness analysis estimated patient-directed music intervention reduced anxiety by 19 points on the Visual Analogue Scale-Anxiety with a reduction in cost of $2,322/patient compared with usual ICU care, resulting in patient-directed music dominance. The probabilistic cost-effectiveness analysis found that average patient-directed music intervention costs were $2,155 less than usual ICU care and projected that cost saving is achieved in 70% of 1,000 iterations. Based on break-even analyses, cost saving is achieved if the per-patient cost of patient-directed music intervention remains below $2,651, a value eight times the base case of $329. CONCLUSIONS: Patient-directed music intervention is cost-effective for reducing anxiety in mechanically ventilated ICU patients.

Establishing a clinical pharmacology fellowship program for physicians, pharmacists, and pharmacologists: a newly accredited interdisciplinary training program at the Ohio State University.

Studying the effect of drugs on humans, clinical pharmacologists play an essential role in many academic medical and research teams, within the pharmaceutical industry and as members of government regulatory entities. Clinical pharmacology fellowship training programs should be multidisciplinary and adaptable, and should combine didactics, applied learning, independent study, and one-on-one instruction. This article describes a recently developed 2 year clinical pharmacology fellowship program - one of only nine accredited by the American Board of Clinical Pharmacology - that is an integrative, multi faceted, adaptable method for training physicians, pharmacists, and scientists for leadership roles in the pharmaceutical industry, in academia, or with regulatory or accreditation agencies. The purpose of this article is to provide information for academic clinicians and researchers interested in designing a similar program, for professionals in the field of clinical pharmacology who are already affiliated with a fellowship program and may benefit from supplemental information, and for clinical researchers interested in clinical pharmacology who may not be aware that such training opportunities exist. This article provides the details of a recently accredited program, including design, implementation, accreditation, trainee success, and future directions.

Persistence of warfarin therapy for residents in long-term care who have atrial fibrillation.

BACKGROUND: Among long-term care (LTC) residents with atrial fibrillation (AF), the use of warfarin to prevent stroke has been shown to be suboptimal. For those who begin warfarin prophylaxis in LTC, persistence on this therapy has not been reported. OBJECTIVE: This study was conducted to estimate persistence on warfarin among LTC residents with AF. METHODS: A retrospective analysis was conducted by using data from an LTC database. Pharmacy dispensing data were used to track warfarin use in residents with a diagnosis of AF who were newly started on warfarin therapy. The main outcome measure was persistence of warfarin over the first year of therapy. Survival analysis included Kaplan-Meier plots and a multivariate Cox proportional hazards model to test the association of resident characteristics and conditions with warfarin discontinuation. RESULTS: A total of 148 residents new to warfarin therapy met all study inclusion criteria. Median age was 84 years; 69% were female. Median time to therapy discontinuation was 197 days (95% CI, 137-249) across all study residents. By 90 days after the initiation of therapy, 37% (95% CI, 28-47) of study residents had discontinued warfarin; by 1 year, 65% (54%-76%) had discontinued warfarin therapy. The multivariate Cox regression analysis found that the following factors were independently associated with discontinuation of warfarin therapy: age 65 to 74 years (hazard ratio [HR] = 3.01 [95% CI, 1.04-8.73]), female sex (HR = 0.45 [95% CI, 0.24-0.87]), Hispanic race/ethnicity (HR = 2.86 [95% CI, 1.30-6.26]), Midwest region (HR = 2.13 [95% CI, 1.02-4.48]), and Alzheimer disease or dementia (HR = 1.97 [95% CI, 1.05-3.68]). CONCLUSIONS: Although clinical practice guidelines exist for the prevention of stroke in AF patients, persistence on warfarin therapy seems suboptimal in many LTC residents with AF.

Pharmacoeconomic considerations in treating actinic keratosis.

Actinic keratosis is among the most commonly treated skin conditions in the outpatient setting. Its prevalence spans the globe, with greater distribution in fair skinned individuals and the immunocompromised. With high prevalence, increasing incidence and the risk of transformation to a cancerous lesion, prevention and timely treatment present opportunities to rein in costs. The purpose of this article is to review published economic studies relating to the treatment of actinic keratosis, to summarize results discussing the cost drivers of current treatment modalities and to identify parameters most likely to influence the cost effectiveness of treatment. We systematically conducted a published literature search for pharmacoeconomic research of actinic keratosis using title, abstract or full-text searches with the following search terms ([actinic OR solar] AND [keratosis OR keratoses]) AND (economic OR cost OR pharmacoeconomics OR decision). We included published articles referencing actinic keratosis in a standalone study or in a broader study referencing non-melanoma skin cancer and articles evaluating cost-of-illness, cost-of-treatment, cost minimization, cost effectiveness, cost utility, cost-benefit analysis and cost consequence. Our review of the literature found nine studies devoted to pharmacoeconomic considerations of actinic keratosis treatments, with one article investigating both cost-of-illness and cost-of-treatment, two measuring cost-of-illness, two evaluating cost-of-treatment, one focusing on cost minimization, and three focusing on cost effectiveness. The literature compared a broad range of actinic keratosis treatments including topical medications, cryotherapy, photodynamic therapy, excision and a combination of treatment modalities. The direct cost of actinic keratosis management in the US was estimated at $US1.2 billion per year, with indirect costs totalling $US295 million (year 2004 values). The primary drivers of cost were physician office visits and associated procedures. Pharmacoeconomic research defining standards, outcomes and areas of efficiencies in the treatment of actinic keratosis is in its infancy. To move towards more comprehensive analysis, research needs to focus on updating epidemiological data, evolving evidence-based standards, delineating cost drivers in immunocompetent and immunocompromised populations, and on health outcomes.