Report of the 2011-2012 AACP Special Advisory Committee on Research and Graduate Education

According to the Bylaws of the American Association of Colleges of Pharmacy (AACP), the Research and Graduate Affairs Committee (RGAC) shall provide assistance to the Association in developing its research, graduate education, and scholarship agenda. This assistance may include facilitating colleges and schools in formulating and advancing legislative and regulatory initiatives, and nurturing collaborative activities with organizations sharing an interest in issues related to the pharmaceutical sciences

Distinct Airway Inflammatory Pathways Associated with Asthma Exacerbations are Modulated by Mepolizumab Therapy in Children

Rationale: Identification of specific airway inflammatory pathways can lead to effective personalized treatment with biologics in asthma and insights to mechanisms of action. Methods: 290 urban children with exacerbation-prone asthma and ≥150/mm3 blood eosinophils were randomized (1:1) to placebo or mepolizumab added to guideline-based care. Nasal lavage samples were collected at randomization and during treatment for RNA-sequencing, and analyzed by cell-deconvolution modular analysis to assess genome-wide expression patterns associated with exacerbation number and effect of treatment. Results: Mepolizumab significantly reduced the frequency of exacerbations compared to placebo. At randomization, there were no differences in expression between treatment groups; multiple modules were subsequently differentially expressed during mepolizumab but not placebo treatment. Furthermore, expression levels of multiple modules were associated with the exacerbation number during the study, with distinct relationships observed in the placebo and/or mepolizumab groups. Notably, higher expression at randomization of an eosinophil-associated module enriched for Type-2 genes including IL4, IL5, and IL13, was associated with increased exacerbations in placebo (β=0.19, p\u3c0.001), but not mepolizumab-treated children (interaction p\u3c0.01). Furthermore, mepolizumab treatment reduced expression of this module (Fold-change=0.62, p\u3c0.001). In contrast, higher expression at randomization of an eosinophil-associated module enriched for eosinophil activation (e.g. CD9) and mucus hypersecretion (e.g. MUC5AC) genes was associated with exacerbation number in both groups throughout the study (β=0.18, p\u3c0.01) and was unaltered by mepolizumab therapy. Conclusions: Multiple distinct airway inflammation patterns were identified associated with exacerbation frequency. These findings identify inflammatory endotypes and indicate likelihood and potential mechanisms of a beneficial clinical response to mepolizumab therapy to prevent exacerbations

Use of fractional exhaled nitric oxide to guide the treatment of asthma an official american thoracic society clinical practice guideline

Background: The fractional exhaled nitric oxide (FENO) test is a point-of-care test that is used in the assessment of asthma.Objective: To provide evidence-based clinical guidance on whether FENO testing is indicated to optimize asthma treatment in patients with asthma in whom treatment is being considered.Methods: An international, multidisciplinary panel of experts was convened to form a consensus document regarding a single question relevant to the use of FENO. The question was selected from three potential questions based on the greatest perceived impact on clinical practice and the unmet need for evidencebased answers related to this question. The panel performed systematic reviews of published randomized controlled trials between 2004 and 2019 and followed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence-to-decision framework to develop recommendations. All panel members evaluated and approved the recommendations.Main Results: After considering the overall low quality of the evidence, the panel made a conditional recommendation for FENO-based care. In patients with asthma in whom treatment is being considered, we suggest that FENO is beneficial and should be used in addition to usual care. This judgment is based on a balance of effects that probably favors the intervention; the moderate costs and availability of resources, which probably favors the intervention; and the perceived acceptability and feasibility of the intervention in daily practice.Conclusions: Clinicians should consider this recommendation to measure FENO in patients with asthma in whom treatment is being considered based on current best available evidence. </p

Geography, generalisability, and susceptibility in clinical trials

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Use of a single, independent IRB: Case study of an NIH funded consortium

In 2014, the Request for Applications from the National Institutes of Health. (NIH) for continued funding of a multi-site clinical and mechanistic research. Network, Inner City Asthma Consortium (ICAC), called for “efficient IRB review. And approval for multi-center studies” and “IRB approval within 30 days from. Submission”. These requirements were precursors to the NIH policy of single. IRB review for multi-site studies. Here we share our challenges, implementation processes, results, and recommendations, using a single, independent IRB

Patient And phaRmacit Telephonic Encounters (PARTE) in an Underserved Rural Population with Asthma: Methods and Rationale

Purpose: Methods used to deliver and test a pharmacy-based asthma care telephonic service for an underserved, rural patient population are described. Summary: In a randomized controlled trial (RCT), the Patient And phaRmacist Telephonic Encounters (PARTE) project is assessing the feasibility, acceptability, and preliminary impact of providing pharmacy-based asthma care service telephonically. The target audience is a low income patient population across a large geographic area served by a federally qualified community health center. Ninety-eight participants have been randomized to either standard care or the intervention group who received consultation and direct feedback from pharmacists via telephone regarding their asthma self-management and medication use. Pharmacists used a counseling framework that incorporates the Indian Health Services 3 Prime Questions and the RIM Technique (Recognition, Identification, and Management) for managing medication use problems. Pharmacists encouraged patients to be active partners in the decision-making process to identify and address the underlying cause of medication use problems. Uniquely, this trial collected process and summative data using qualitative and quantitative approaches. Pharmacists’ training, the fidelity and quality of pharmacists’ service delivery, and short term patient outcomes are being evaluated. This evaluation will improve our ability to address research challenges and intervention barriers, refine staff training, explore patient perspectives, and evaluate measures’ power to provide preliminary patient outcome findings. Conclusion: A mixed method evaluation of a structured pharmacist intervention has the potential to offer insights regarding staff training, service fidelity and short term outcomes using quantitative and qualitative data in an RCT. Results will provide evidence regarding the feasibility and quality of carrying out the study and service delivery from the multiple perspectives of participants, clinicians, and researchers