Identifying Shared Values for School-Affiliated Student Organizations

Objective. To identify shared values for student organizations

Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial

Background: Strategies to improve the care of elderly, multimorbid patients frequently focus on implementing evidence-based knowledge by structured assessments and standardization of care. In Germany, disease management programs (DMPs), for example, are run by general practitioners (GPs) for this purpose. While the importance of such measures is undeniable, there is a risk of ignoring other dimensions of care which are essential, especially for elderly patients: their spiritual needs and personal resources, loneliness and social integration, and self-care (i.e., the ability of patients to do something on their own except taking medications to increase their well-being). The aim of this study is to explore whether combining DMPs with interventions to address these dimensions is feasible and has any impact on relevant outcomes in elderly patients with polypharmacy. Methods: An explorative, cluster-randomized controlled trial with general practices as the unit of randomization will be conducted and accompanied by a process evaluation. Patients aged 70 years or older with at least three chronic conditions receiving at least three medications participating in at least one DMP will be included. The control group will receive DMP as usual. In the intervention group, GPs will conduct a spiritual needs assessment during the routinely planned DMP appointments and explore whether the patient has a need for more social contact or self-care. To enable GPs to react to such needs, several aids will be provided by the study: a) training of GPs in spiritual needs assessment and training of medical assistants in patient counseling regarding self-care and social activity; b) access to a summary of regional social offers for seniors; and c) information leaflets on nonpharmacological interventions (e.g., home remedies) to be applied by patients themselves to reduce frequent symptoms in old age. The primary outcome is health-related self-efficacy (using the Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES-6G)). Secondary outcomes are general self-efficacy (using the General Self-Efficacy Scale (GSES)), physical and mental health (using the Short-Form Health Survey (SF-12)), patient activation (using the Patient Activation Measure (PAM)), medication adherence (using the Medication Adherence Report Scale (MARS)), beliefs in medicine (using the Beliefs About Medicines Questionnaire (BMQ)), satisfaction with GP care (using selected items of the European Project on Patient Evaluation of General Practice (EUROPEP)), social contacts (using the 6-item Lubben Social Network Scale (LSNS-6)), and loneliness (using the 11-item De-Jong-Gierveld Loneliness Scale (DJGS-11)). Interviews will be conducted to assess the mechanisms, feasibility, and acceptability of the interventions. Discussion: If the interventions prove to be effective and feasible, large-scale implementation should be sought and evaluated by a confirmatory design. Trial registration: German Clinical Trials Register (DRKS), DRKS00015696 . Registered on 22 January 2019

Liver injury and fibrosis induced by dietary challenge in the ossabaw miniature Swine

BACKGROUND: Ossabaw miniature swine when fed a diet high in fructose, saturated fat and cholesterol (NASH diet) develop metabolic syndrome and nonalcoholic steatohepatitis (NASH) characterized by liver injury and fibrosis. This study was conducted to further characterize the development of NASH in this large animal model. METHODS: Ossabaw swine were fed standard chow (control group; n = 6) or NASH diet (n = 6) for 24 weeks. Blood and liver tissue were collected and liver histology were characterized at 0, 8, 16 and 24 weeks of dietary intervention. Hepatic apoptosis and lipid levels were assessed at week 24. RESULTS: The NASH diet group developed metabolic syndrome and progressive histologic features of NASH including: (a) hepatocyte ballooning at 8 weeks which progressed to extensive ballooning (>90% hepatocytes), (b) hepatic fibrosis at week 16, which progressed to moderate fibrosis, and (c) Kupffer cell accumulation with vacuolization at 8 weeks which progressed through week 24. The NASH diet group showed increased hepatocyte apoptosis that correlated with hepatic total and free cholesterol and free fatty acids, but not esterified cholesterol or triglycerides. CONCLUSIONS: This report further characterizes the progression of diet-induced NASH in the Ossabaw swine model. In Ossabaw swine fed the NASH diet: (a) hepatocyte injury and fibrosis can occur without macrovesicular steatosis or excess triglyceride accumulation; (b) hepatocyte ballooning generally precedes the development of fibrosis; (c) there is increased hepatocyte apoptosis, and it is correlated more significantly with hepatic free cholesterol than hepatic free fatty acids and had no correlation with hepatic triglycerides

A Comparison of Clofarabine-based (GCLAC) and Cladribine-based (CLAG) Salvage Chemotherapy for Relapsed/Refractory AML

Background: Salvage chemotherapy regimens for patients with relapsed/refractory acute myeloid leukemia (AML) are associated with complete response rates of 30 ­‐ 60%. Determining the superiority of one treatment over another is difficult due to the lack of comparative data. Clofarabine and cladribine based regimens appear to be superior to combinations of mitoxantrone, etoposide, and cytarabine (MEC). However, there are no data comparing treatments with these purine analogs to each other. Therefore, we conducted a retrospective study of GCLAC (clofarabine 25 mg/m2 IV days 1-­5, cytarabine 2 gm/m2 IV days 1­‐5, and G­‐CSF) and CLAG (cladribine 5 mg/m2 IV days 1­‐5, cytarabine 2 gm/m2 IV days 1­‐5, and G­‐CSF). Methods: We identified 41 consecutive patients with pathologically diagnosed relapsed or refractory AML who received either GCLAC or CLAG between 2011 and 2014. The primary outcome was the complete response rate (CRi or CR) as defined by the International Working Group. Secondary outcomes included the percentage of patients who underwent allogenic stem cell transplant, relapse free survival (RFS), and overall survival (OS). Fisher’s exact and Wilcoxon Rank Sum tests were used to compare patient characteristics and response rates. The Kaplan Meier method and Log Rank tests were used to evaluate RFS and OS. Results: We found no significant differences in the baseline characteristics of patients treated with GCLAC (n=22) or CLAG (n=19) including age, race, gender, organ function, or cytogenetic risk group (table 1). There were also no significant differences in the percentage of relapsed patients (36% vs. 21%), the average duration of the previous remission (28.6 vs. 19.4 months) or in their previous therapy. An anthracycline-­‐based “7+3” regimen was given to 82% of the GCLAC patients and to 90% of the CLAG patients. The outcomes with these two regimens were also not significantly different. Patients treated with GCLAC had a 64% CR/CRi rate compared with 47% for CLAG patients (p=0.36). 45% GCLAC patients underwent allogeneic stem cell transplant compared with 26% of CLAG patients (p=0.32). The median RFS on GCLAC and CLAG respectively was 1.59 years [0.41, non-­estimable (NE)] and 1.03 years [0.49, 1.03], (p=0.75). The median OS was 1.03 years [0.52, NE] and 0.70 years [0.28, 1.11], (p=0.08). Given the similarities of these regimens, we combined the data sets to compare the OS for patients with refractory AML to relapsed AML. The OS for patients with refractory AML was not significantly worse than patients with relapsed AML (0.94 years [0.36, 1.3] vs. 1.11 years [0.46, not evaluable]; p=0.49). Conclusion: We find no significant differences in outcomes using GCLAC or CLAG for relapsed/refractory AML patients. The trends in outcome that favored GCLAC are likely explained by trends in patient populations (e.g. longer first remission for GCLAC patients). Since our results are similar to the published reports describing these regimens, we feel the choice of regimen can be based on other considerations such as cost. We do find the efficacy of both regimens in refractory AML to be encouraging. However, we recognize that overall survival of one year is not acceptable and that most relapsed/refractory patients should be entered into clinical trials.Doctor of Pharmac

Impact of Oncology Pharmacists on the Knowledge, Attitude, and Practices of Clinicians to Enhance Patient Engagement of Self-Administered Oral Oncolytics

Oncology clinical pharmacists are uniquely positioned to make interventions to impact the knowledge, attitudes, and practices of clinicians as well as patient activation and engagement. To accomplish this goal, pharmacists can target health system-related, provider-related, and patient-related factors to enhance patient-centered care and drive behavioral health changes. Interventions that pharmacists must tackle include educating team members and patients on the medication acquisition process, communicating urgency of treatment, optimizing workflows, facilitating guideline recommendations, preventing, and managing treatment toxicities, and promoting patient self-advocacy through education and shared decision-making. As crucial members of the healthcare team, oncology pharmacists can simplify highly complex treatment regimens to facilitate and optimize patients’ ownership of their care. This narrative review will focus on the example of venetoclax treatment in acute myeloid leukemia to demonstrate the impact that pharmacists provide that leads to behavioral change of patients and clinicians

Outpatient initiation of venetoclax in patients with acute myeloid leukemia

INTRODUCTION: Venetoclax is a treatment option in patients with acute myeloid leukemia (AML) in both the front-line and relapsed/refractory settings. Initiation of therapy has been previously restricted to the inpatient setting at some institutions due to a risk of tumor lysis syndrome (TLS) and limitations in medication access efficiency given the high cost of therapy. METHODS: We assessed the safety of initiating venetoclax in the outpatient setting through a single-arm, retrospective study of adult AML patients between April 1, 2019 and June 30, 2020. RESULTS: Eighty-two patients started venetoclax during this time, with 47 (57%) patients initiated in the outpatient setting. Fifty-five percent of patients received venetoclax as first-line treatment for AML (n = 45) and 45% of patients received venetoclax for relapsed/refractory AML (n = 37). Successful initiation, defined as no hospitalizations secondary to TLS within seven days of therapy initiation, occurred in 98% of patients. The rate of TLS was 2.1% (n = 1) following venetoclax initiation. TLS symptoms were managed during hospitalization, requiring only one day of missed AML therapy. Median turnaround time for medication access was three days. Hospitalizations within seven days occurred in 17% of patients (n = 8), with the majority due to febrile neutropenia. CONCLUSIONS: The results of our study provide further evidence for the safety and feasibility of initiating venetoclax in the outpatient setting with a pharmacist-led interdisciplinary protocol