Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial.

BACKGROUND: Afamitresgene autoleucel (afami-cel) showed acceptable safety and promising efficacy in a phase 1 trial (NCT03132922). The aim of this study was to further evaluate the efficacy of afami-cel for the treatment of patients with HLA-A*02 and MAGE-A4-expressing advanced synovial sarcoma or myxoid round cell liposarcoma. METHODS: SPEARHEAD-1 was an open-label, non-randomised, phase 2 trial done across 23 sites in Canada, the USA, and Europe. The trial included three cohorts, of which the main investigational cohort (cohort 1) is reported here. Cohort 1 included patients with HLA-A*02, aged 16-75 years, with metastatic or unresectable synovial sarcoma or myxoid round cell liposarcoma (confirmed by cytogenetics) expressing MAGE-A4, and who had received at least one previous line of anthracycline-containing or ifosfamide-containing chemotherapy. Patients received a single intravenous dose of afami-cel (transduced dose range 1·0 × 109-10·0 × 109 T cells) after lymphodepletion. The primary endpoint was overall response rate in cohort 1, assessed by a masked independent review committee using Response Evaluation Criteria in Solid Tumours (version 1.1) in the modified intention-to-treat population (all patients who received afami-cel). Adverse events, including those of special interest (cytokine release syndrome, prolonged cytopenia, and neurotoxicity), were monitored and are reported for the modified intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04044768; recruitment is closed and follow-up is ongoing for cohorts 1 and 2, and recruitment is open for cohort 3. FINDINGS: Between Dec 17, 2019, and July 27, 2021, 52 patients with cytogenetically confirmed synovial sarcoma (n=44) and myxoid round cell liposarcoma (n=8) were enrolled and received afami-cel in cohort 1. Patients were heavily pre-treated (median three [IQR two to four] previous lines of systemic therapy). Median follow-up time was 32·6 months (IQR 29·4-36·1). Overall response rate was 37% (19 of 52; 95% CI 24-51) overall, 39% (17 of 44; 24-55) for patients with synovial sarcoma, and 25% (two of eight; 3-65) for patients with myxoid round cell liposarcoma. Cytokine release syndrome occurred in 37 (71%) of 52 of patients (one grade 3 event). Cytopenias were the most common grade 3 or worse adverse events (lymphopenia in 50 [96%], neutropenia 44 [85%], leukopenia 42 [81%] of 52 patients). No treatment-related deaths occurred. INTERPRETATION: Afami-cel treatment resulted in durable responses in heavily pre-treated patients with HLA-A*02 and MAGE-A4-expressing synovial sarcoma. This study shows that T-cell receptor therapy can be used to effectively target solid tumours and provides rationale to expand this approach to other solid malignancies. FUNDING: Adaptimmune.

Perception of burden of oral and inhaled corticosteroid adverse effects on asthma-specific quality of life.

BACKGROUND: A multistakeholder core outcome set created for asthma trials showed that asthma-specific quality of life (QoL) was a critically meaningful outcome. However, the definition and measurement methods were undetermined. The adverse effects (AEs) of corticosteroids may be a vital clinical trial outcome. Nevertheless, the AE burden from the patient perspective has not yet been elucidated in an asthma population. OBJECTIVE: To characterize patient burden of AEs in oral (OCS) and inhaled corticosteroids (ICS) and how this relates to QoL within an asthma population. METHODS: We used a convergent parallel mixed-methods design with quantitative surveys of known ICS and OCS AEs that were distributed through the Allergy & Asthma Network database, social channels, and the Asthma UK newsletter. Participants rated the AEs that were (1) most burdensome and (2) most desired to be eliminated. Qualitative interviews and focus groups were performed to better understand patient views on barriers reported in the quantitative data, and to identify patient-important barriers that were not a part of the quantitative survey. RESULTS: The 3 most burdensome AEs for OCS were bone mineral density, infectious complications, and weight gain, whereas weight gain was the most desired to be eliminated. The 3 most burdensome AEs for ICS were pneumonia, hoarse voice, and oral thrush, with concordant results for the most desired to be eliminated. In the focus groups, OCS AEs were concordant with quantitative findings. Focus groups identified unmeasured psychosocial effects, such as embarrassment. CONCLUSION: The most burdensome AEs may not be those that would cause patients to stop therapy. Furthermore, qualitative focus groups suggest a psychosocial burden associated with ICS, which needs further investigation.

ARIA pharmacy 2018 "Allergic rhinitis care pathways for community pharmacy": AIRWAYS ICPs initiative (European Innovation Partnership on Active and Healthy Ageing, DG CONNECT and DG Santé) POLLAR (Impact of Air POLLution on Asthma and Rhinitis) GARD Demonstration project.

Pharmacists are trusted health care professionals. Many patients use over-the-counter (OTC) medications and are seen by pharmacists who are the initial point of contact for allergic rhinitis management in most countries. The role of pharmacists in integrated care pathways (ICPs) for allergic diseases is important. This paper builds on existing studies and provides tools intended to help pharmacists provide optimal advice/interventions/strategies to patients with rhinitis. The Allergic Rhinitis and its Impact on Asthma (ARIA)-pharmacy ICP includes a diagnostic questionnaire specifically focusing attention on key symptoms and markers of the disease, a systematic Diagnosis Guide (including differential diagnoses), and a simple flowchart with proposed treatment for rhinitis and asthma multimorbidity. Key prompts for referral within the ICP are included. The use of technology is critical to enhance the management of allergic rhinitis. However, the ARIA-pharmacy ICP should be adapted to local healthcare environments/situations as regional (national) differences exist in pharmacy care.

Antimicrobial stewardship education in US colleges and schools of pharmacy.

Background: Pharmacists are key members of antimicrobial stewardship (AS) teams. It is unknown if and how US colleges and schools of pharmacy incorporate AS into their Doctor of Pharmacy (PharmD) curricula. Methods: This study was a cross-sectional, multicentre, electronic survey distributed to infectious diseases faculty or department chairs of 137 accredited and candidate-status PharmD programmes. Results: One hundred and sixteen programmes participated, representing an 84.7% response rate. AS education was integrated into the required didactic, elective didactic and experiential education components of the curricula in 79 (68.1%), 43 (37.1%) and 97 (83.6%) PharmD programmes, respectively. The most common AS topics in required and elective didactic curricula were AS definitions, principles and purpose (98.7% and 86.0%) and the pharmacist's role in AS (93.7% and 83.7%). In the required and elective didactic curricula, lecture (93.7% and 86.0%) and case-based instruction (57.0% and 83.7%) were the most common instructional methods. For experiential education, the pharmacist's role in AS (96.9%), de-escalation of antimicrobials (96.9%) and antimicrobial dose optimization (95.9%) were the most common AS topics. PharmD programmes employing a faculty member who specializes in AS were more likely to offer AS experiential education than programmes without AS faculty (88.1% versus 71.9%, P = 0.049). Conclusions: Integration of AS education in US PharmD curricula is variable and there are considerable differences in the AS activities and topics delivered. PharmD programmes should attempt to expose students to AS education to prepare future pharmacists for AS practice. Efforts should be made to incorporate interprofessional collaboration into AS education.

Evaluation of a field-deployable reverse transcription-insulated isothermal PCR for rapid and sensitive on-site detection of Zika virus.

BACKGROUND: The recent emergence of Zika virus (ZIKV) in Brazil and its precipitous expansion throughout the Americas has highlighted the urgent need for a rapid and reliable on-site diagnostic assay suitable for viral detection. Such point-of-need (PON), low-cost diagnostics are essential for ZIKV control in vulnerable areas with limited resources. METHODS: We developed and evaluated a ZIKV-specific field-deployable RT-iiPCR reagent set targeting the E gene for rapid detection of ZIKV in ZIKV-spiked human and mosquito specimens, and compared its performance to the Center for Disease Control and Prevention (CDC) and Pan American Health Organization (PAHO) RT-qPCR assays targeting the E and NS2B genes, respectively. RESULTS: These assays demonstrated exclusive specificity for ZIKV (African and Asian lineages), had limits of detection ranging from 10 to 100 in vitro transcribed RNA copies/µl and detection endpoints at 10 plaque forming units/ml of infectious tissue culture fluid. Analysis of human whole blood, plasma, serum, semen, urine, and mosquito pool samples spiked with ZIKV showed an agreement of 90% (k = 0.80), 92% (k = 0.82), 95% (k = 0.86), 92% (k = 0.81), 90% (k = 0.79), and 100% (k = 1), respectively, between the RT-iiPCR assay and composite results from the reference RT-qPCR assays. Overall, the concurrence between the ZIKV RT-iiPCR and the reference RT-qPCR assays was 92% (k = 0.83). CONCLUSIONS: The ZIKV RT-iiPCR has a performance comparable to the reference CDC and PAHO RT-qPCR assays but provides much faster results (~1.5 h) with a field-deployable system that can be utilized as a PON diagnostic with the potential to significantly improve the quality of the health care system in vulnerable areas.

T-cell suppression by red blood cells is dependent on intact cells and is a consequence of blood bank processing.

BACKGROUND: Red blood cells (RBCs) suppress T-cell responsiveness through a mechanism requiring cell-cell contact. Questions remain as to whether this effect is an allogeneic response, related to cell death, or dependent on particular components of the RBCs. STUDY DESIGN AND METHODS: Peripheral T cells were isolated from healthy donors and exposed to stored allogeneic RBCs or autologous RBCs after processing. RBCs were lysed by hypotonic solvent to produce cellular ghosts. Tritiated thymidine proliferation assays were utilized. Cultures were saturated with interleukin (IL)-2 to determine whether impaired IL-2 synthesis played a role. RESULTS: T-cell proliferation was suppressed by both autologous and allogeneic RBCs. RBC membrane integrity does enhance T-cell suppression. T-cell death is not responsible for the suppressive changes. IL-2 synthesis is suppressed in RBC-exposed T cells but addition of exogenous IL-2 does not rescue proliferative capabilities. Proliferation of T cells was inhibited with RBC exposure but mitigated with the addition of fresh RBCs. CONCLUSIONS: T-cell suppression is enhanced by intact RBCs but this effect is unrelated solely to alloantigens. Neither apoptosis nor necrosis of T cells contributes to this phenomenon. IL-2 synthesis is suppressed after RBC exposure as a consequence of T-cell inhibition, but is not the primary cause of suppression. Fresh RBCs do not mediate T-cell suppression, indicating that changes in the RBC and development of the storage lesion may occur during initial blood bank processing.

A prospective examination of asthma symptom monitoring: provider, caregiver and pediatric patient influences on peak flow meter use.

OBJECTIVE: This study examined whether provider, caregiver and child communication predicted peak flow meter (PFM) use one month later. METHODS: Five practices, 35 providers and 296 children with persistent asthma and their caregivers comprised the study sample. Audio-recorded provider-caregiver-child communication during the baseline medical visit captured discussion of the PFM; and child and caregiver baseline interviews after the medical visit collected factors associated with PFM use. Child- and caregiver-reported PFM availability and use, and observed child use of PFM were collected one-month later in the family's home. RESULTS: During the medical visit, provider communication about PFM use was infrequent (10% maximum) and child- or caregiver-initiated communication was nearly absent (0%-2%). Despite this, children demonstrated good use of the PFM one month later. Children were significantly more likely to perform at least six PFM steps correctly one month later when there was more communication about PFM during the medical visit. Few other factors predicted availability and use. CONCLUSIONS: Few providers discussed use of a PFM; observed performance was predicted by having talked about it with the child's provider. Provider communication should be targeted in future interventions to improve asthma management skills.

Discussions between medical providers and children/caregivers about the benefits of asthma-control medications.

OBJECTIVES: To describe the content of discussions between general pediatric providers and children and their caregivers about the benefits of asthma-control medication; describe the extent to which these discussions occur; and examine factors that are associated with medication benefit discussions. DESIGN: Cross-sectional secondary analysis of audiotaped medical visits. SETTING: Five primary care pediatric clinics in North Carolina. PARTICIPANTS: 35 pediatric providers and 248 children with persistent asthma and their caregivers. MAIN OUTCOME MEASURES: Presence of discussion about benefits associated with asthma-control medications. RESULTS: Providers discussed benefits associated with asthma-control medications during 56% of medical visits. Benefits were more likely to be discussed when the child was younger and when medication adherence was discussed during the visit. When providers discussed benefits of asthma-control medications, they were most likely to ask questions and make statements regarding symptom control/prevention. CONCLUSION: General pediatric medical providers often do not discuss the benefits of asthma-control medications. Pharmacists could fill this information gap by counseling both children and their caregivers about benefits that a child with asthma can expect as a result of treatment.

Identifying MAGE-A4-positive tumors for TCR T cell therapies in HLA-A∗02-eligible patients.

T cell receptor (TCR) T cell therapies target tumor antigens in a human leukocyte antigen (HLA)-restricted manner. Biomarker-defined therapies require validation of assays suitable for determination of patient eligibility. For clinical trials evaluating TCR T cell therapies targeting melanoma-associated antigen A4 (MAGE-A4), screening in studies NCT02636855 and NCT04044768 assesses patient eligibility based on: (1) high-resolution HLA typing and (2) tumor MAGE-A4 testing via an immunohistochemical assay in HLA-eligible patients. The HLA/MAGE-A4 assays validation, biomarker data, and their relationship to covariates (demographics, cancer type, histopathology, tissue location) are reported here. HLA-A∗02 eligibility was 44.8% (2,959/6,606) in patients from 43 sites across North America and Europe. While HLA-A∗02:01 was the most frequent HLA-A∗02 allele, others (A∗02:02, A∗02:03, A∗02:06) considerably increased HLA eligibility in Hispanic, Black, and Asian populations. Overall, MAGE-A4 prevalence based on clinical trial enrollment was 26% (447/1,750) across 10 solid tumor types, and was highest in synovial sarcoma (70%) and lowest in gastric cancer (9%). The covariates were generally not associated with MAGE-A4 expression, except for patient age in ovarian cancer and histology in non-small cell lung cancer. This report shows the eligibility rate from biomarker screening for TCR T cell therapies and provides epidemiological data for future clinical development of MAGE-A4-targeted therapies.

Immunologic profiles of red blood cells using in vitro models of transfusion.

BACKGROUND: Transfusion of packed red blood cells (RBCs) produces a myriad of immunologic derangements, from suppressive to stimulatory. Proliferation of human T cells is suppressed in vitro after exposure to processed red blood cells (PRBCs). We hypothesized that this effect would be mitigated by using fresh RBCs. We also hypothesized that this suppressive effect was a generalized effect on lymphocyte proliferation and would be observed in both CD4+ and CD8+ T-cell subpopulations as well as B cells. MATERIALS AND METHODS: We isolated human T cells from donor peripheral blood mononuclear cells and exposed them to either blood bank PRBCs or fresh RBCs from volunteer donors and stimulated them with anti-CD3/anti-CD28. Human B cells were stimulated with lipopolysaccharide and exposed to PRBCs or fresh RBCs. We measured proliferation of B cells by thymidine incorporation assays. We also treated RBCs with citrate-phosphate-dextrose (CPD) at different time points before culture them with stimulated T cells to determine the role of this common RBC storage solution in lymphocyte proliferation. RESULTS: In vitro proliferation of CD4+ and CD8+ T cells was suppressed by blood bank RBCs. This suppression is eliminated when fresh RBCs were used. The B cells showed inhibition of proliferation when exposed to similar conditions, which appeared to be consistent over serial dilutions. Fresh RBCs exposed to CPD did not appear suppressive in the first 6 h after exposure. CONCLUSIONS: T-cell and B-cell proliferation inhibition by blood banked RBCs suggests a generalized effect of RBCs on cellular proliferation. The lack of suppression by fresh RBCs further suggests that something involved in blood banking alters RBC properties such that they attain a suppressive phenotype. One such blood banking component, CPD, does not appear to affect this suppressive phenotype within the first 6 h.

Journal Club: Voice recognition dictation: analysis of report volume and use of the send-to-editor function.

OBJECTIVE: The purpose of this study was to evaluate use of the send-to-editor function of a radiology voice recognition dictation system and compare study volumes of radiologists who self-edit with those of radiologists who send reports to the editor. Use of voice recognition shortcuts was also evaluated. MATERIALS AND METHODS: Voice recognition dictation systems were installed in a six-hospital system, including an 800-bed tertiary care center and five community hospitals, in 2002. This became the only means of radiologist dictation in July 2005. Report volumes, use of the send-to-editor function, and use of shortcuts were tracked from October 2005 through October 2008. A subspecialty private radiology group, ranging from 37 radiologists in July 2005 to 50 radiologists in October 2008, interpreted the imaging studies. Radiologists had no financial incentives to self-edit. RESULTS: The percentage of radiologists using the send-to-editor function remained relatively constant at 46%, resulting in 21% of total reports sent to the editor. Radiologists who used the send-to-editor function dictated approximately 41% more reports than those who self-edited. The volume of reports generated by general radiologists reading large volumes of computed radiography cases and sending to the editor was greater than that of radiologists who self-edited (p < 0.05). There was no significant difference between radiologists who self-edited and those who sent to the editor with respect to number of shortcuts used. CONCLUSION: Radiologists reading large volumes of computed radiography cases and using the send-to-editor function generated significantly more reports than radiologists who did not, suggesting that the send-to-editor function may be useful for improving productivity among radiologists reading large volumes of computed radiography cases.

The relationship between patient-provider communication and quality of life for children with asthma and their caregivers.

OBJECTIVE: This study examined whether patient-provider communication is associated with asthma-related quality of life (QOL) and asthma outcomes among children with asthma and their caregivers. METHODS: Children ages 8-16 years with asthma and their caregivers (n = 296) were recruited at five pediatric practices in North Carolina. Children and caregivers reported demographic and clinical characteristics immediately after an audio-taped medical visit with their health care provider. During a home visit that took place 1 month after the medical visit, children and caregivers reported asthma-related QOL, and caregivers reported child asthma outcomes, including asthma symptom days and missed school days. Generalized estimating equations were used to determine whether patient-provider communication during the medical visit was associated with child and caregiver QOL and child asthma outcomes 1 month later. RESULTS: On average, providers asked caregivers 4.5 questions and asked children 3 questions per visit, whereas caregivers and children asked less than 1 question per visit. Providers asked children more asthma-related questions, caregivers reported better QOL and fewer asthma symptom days 1 month later. Children and caregivers with higher asthma-management self-efficacy at the office visit reported better QOL 1 month later. CONCLUSIONS: Mirroring national guideline recommendations, our results suggest that providers should ask children about their asthma during medical visits. Future longitudinal studies should conduct mediation analyses to determine whether asking children asthma-related questions during medical visits increases children's asthma management self-efficacy and ultimately improve outcomes, such as QOL, health care utilization, symptom days and missed school days.

Real-world use and perceptions of shared decision-making for allergy and asthma care in a US population.

Background: Shared decision-making (SDM), the process of engaging patients in their healthcare decisions, is an integral component of personalized medicine. The use of SDM in real-world allergy and asthma care in the United States (US) is unknown. Cross-sectional surveys of allergists and patients in a US population were conducted to assess the use and perceptions of SDM and SDM tools in real-world allergy and asthma care. Methods: Allergists (N = 101) who were members of the American College of Allergy Asthma & Immunology (ACAAI) and who were also Dynata (a marketing research firm) research partners or in the Allergy & Asthma Network customer database completed an online survey from February-March 2022. Adult patients (N = 110) with asthma, allergy, and/or eczema in the United States who were participants of online research panels hosted by Dynata completed on online survey from February 1-7, 2022. Results: Based on their own definition, 98% of the allergists reported familiarity with SDM, and 79% reported using it frequently. Allergists reported using SDM with an average of 44% of their patients. The most commonly used tool was the Immunotherapy SDM toolkit (40%); 43% had not used any SDM tool. Among allergists not using SDM or using it infrequently (n = 19), 42% considered it too time-consuming and 37% believed their patients have low health literacy. Of the surveyed patients, 25% reported their provider used SDM "frequently" or "occasionally" when being treated for allergies, asthma, or eczema, and 22% reported using SDM tools with their provider at some point. The most commonly used tool was the Asthma and Allergy Symptom Test (60%). Among patients whose allergists used SDM infrequently or never (n = 56), 70% reported they would be likely to ask their allergist to use SDM more often. Conclusion: Survey responses revealed a disconnect between allergists and patients regarding SDM use. Barriers to SDM are consistent with those across the healthcare industry. Patients clearly expressed their desire for SDM.

Patterns of care in the management of high-risk COPD in the US (2011-2019): an observational study for the CONQUEST quality improvement program.

Background: In this study, we compare management of patients with high-risk chronic obstructive pulmonary disease (COPD) in the United States to national and international guidelines and quality standards, including the COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST). Methods: Patients were identified from the DARTNet Practice Performance Registry and categorized into three high-risk cohorts in each year from 2011 to 2019: newly diagnosed (≤12 months after diagnosis), already diagnosed, and patients with potential undiagnosed COPD. Patients were considered high-risk if they had a history of exacerbations or likely exacerbations (respiratory consult with prescribed medication). Descriptive statistics for 2019 are reported, along with annual trends. Findings: In 2019, 10% (n = 16,610/167,197) of patients met high-risk criteria. Evidence of spirometry for diagnosis was low; in 2019, 81% (n = 1228/1523) of patients newly diagnosed at high-risk had no record of spirometry/peak expiratory flow in the 12 months pre- or post-diagnosis and 43% (n = 651/1523) had no record of COPD symptom review. Among those newly and already diagnosed at high-risk, 52% (n = 4830/9350) had no evidence of COPD medication. Interpretation: Findings suggest inconsistent adherence to evidence-based guidelines, and opportunities to improve identification, documentation of services, assessment, therapeutic intervention, and follow-up of patients with COPD. Funding: This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd (OPRI) for its contribution.

Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial.

Affinity-optimized T cell receptors can enhance the potency of adoptive T cell therapy. Afamitresgene autoleucel (afami-cel) is a human leukocyte antigen-restricted autologous T cell therapy targeting melanoma-associated antigen A4 (MAGE-A4), a cancer/testis antigen expressed at varying levels in multiple solid tumors. We conducted a multicenter, dose-escalation, phase 1 trial in patients with relapsed/refractory metastatic solid tumors expressing MAGE-A4, including synovial sarcoma (SS), ovarian cancer and head and neck cancer ( NCT03132922 ). The primary endpoint was safety, and the secondary efficacy endpoints included overall response rate (ORR) and duration of response. All patients (N = 38, nine tumor types) experienced Grade ≥3 hematologic toxicities; 55% of patients (90% Grade ≤2) experienced cytokine release syndrome. ORR (all partial response) was 24% (9/38), 7/16 (44%) for SS and 2/22 (9%) for all other cancers. Median duration of response was 25.6 weeks (95% confidence interval (CI): 12.286, not reached) and 28.1 weeks (95% CI: 12.286, not reached) overall and for SS, respectively. Exploratory analyses showed that afami-cel infiltrates tumors, has an interferon-γ-driven mechanism of action and triggers adaptive immune responses. In addition, afami-cel has an acceptable benefit-risk profile, with early and durable responses, especially in patients with metastatic SS. Although the small trial size limits conclusions that can be drawn, the results warrant further testing in larger studies.

Communication during pediatric asthma visits and child asthma medication device technique 1 month later.

OBJECTIVE: This study investigated how provider demonstration of and assessment of child use of asthma medication devices and certain aspects of provider-patient communication during medical visits is associated with device technique 1 month later. METHODS: Two hundred and ninety-six children aged 8-16 years with persistent asthma and their caregivers were recruited at five North Carolina pediatric practices. All of the medical visits were audio-tape recorded. Children were interviewed 1 month later and their device technique was observed and rated. RESULTS: If the provider asked the child to demonstrate metered dose inhaler technique during the medical visit, then the child was significantly more likely to perform a greater percentage of inhaler steps correctly 1 month later. Children with higher asthma management self-efficacy scores were significantly more likely to perform a greater percentage of diskus steps correctly. Additionally, children were significantly more likely to perform a greater percentage of diskus steps correctly if the provider discussed a written action plan during the visit. Children were significantly more likely to perform a greater percentage of turbuhaler steps correctly if they asked more medication questions. CONCLUSIONS: Providers should ask children to demonstrate their inhaler technique during medical visits so that they can educate children about proper technique and improve child asthma management self-efficacy. Providers should encourage children to ask questions about asthma medication devices during visits and they should discuss asthma action plans with families.

Impact of a transfusion-related acute lung injury reduction strategy on apheresis platelet collections.

BACKGROUND: Most blood centers in the US have implemented transfusion-related acute lung injury (TRALI) mitigation strategies for apheresis platelet (AP) donations based on theoretical impact of donor loss. The aim of this study is to determine the actual impact of a TRALI mitigation strategy in a US blood center. STUDY DESIGN AND METHODS: Daily collection events and resulting products were retrospectively obtained before and after implementation of a TRALI reduction strategy (HLA antibody testing female AP donors four or more pregnancies) for comparison. The retention rate of reassigned donors was determined by reviewing whole blood (WB) and/or apheresis red blood cell (AR) donations post reassignment. Data were obtained to compare donor frequency and split rate from reassigned (historical data) and new AP donors. RESULTS: Mean daily collections (27.7 vs. 30.0) and total products (12,211 vs. 12,957) were significantly higher after implementation, but the number of products/collection event was lower (1.49 vs. 1.40). Mean collections/donor/year (4.0 vs. 1.8) and split rate (36% vs. 27%) were historically higher for reassigned (n = 45) versus new AP donors (n = 1,090). Seventy-three of 112 donors (65%) testing positive for HLA antibodies returned for WB or AR donations, 31 of 45 (69%) active AP donors returned. CONCLUSIONS: Donor loss may not be adequate to estimate impact on AP inventory, as donation characteristics may differ between new donors and those reassigned. We show successful implementation of a TRALI mitigation strategy by increasing collection goals and AP donor recruitment efforts beyond donor loss. Retaining the majority of reassigned donors is feasible.

The Role of the Pharmacist in Optimizing Outcomes With Roflumilast, a PDE4 Inhibitor for the Treatment of COPD.

PURPOSE: The pharmacology of roflumilast, recent dosing revisions, and the integral roles of pharmacists in effective chronic obstructive pulmonary disease (COPD) management are reviewed here. SUMMARY: COPD is characterized by progressive airflow limitation and intermittent acute exacerbations of symptoms, which contribute to disease progression, worsening of comorbidities, and reduced health-related quality of life. Patients with COPD may use a variety of pharmacotherapies (in combination with nonpharmacological modalities) to prevent exacerbations, reduce the impact of symptoms, and reduce or prevent COPD progression. Given the complex and multifaceted nature of disease management, pharmacists are uniquely positioned to collaborate with other clinicians to improve treatment adherence and efficacy via a number of diverse avenues in patients with COPD. Central to this endeavor is patient education and counseling regarding their treatment regimen. CONCLUSION: Recent findings from a phase 3 clinical trial demonstrate improved tolerability and reduced treatment discontinuation resulting from the use of an uptitration regimen in patients with severe COPD who initiate therapy with roflumilast. Pharmacists have a central role in effective COPD management, especially with respect to patient education about treatments.

Knowledge and Attitudes Concerning Herpes Zoster among People with COPD: An Interventional Survey Study.

Herpes zoster (HZ) is common in older adults with conditions such as chronic obstructive pulmonary disease (COPD). Effective prevention is available through vaccination, but HZ vaccine uptake remains incomplete. Using an online survey of people with self-reported COPD, ShiPPS assessed HZ risk awareness, HZ vaccine use and barriers, and the impact of an HZ educational video on vaccine intent. USA members of the COPD Foundation's Patient-Powered Research Network aged >50 years were surveyed in fall 2020. The responses were analyzed using descriptive and comparative statistics. Of the 735 respondents (59.6% female, mean age 68.5 years), 192 (26.1%) reported previous HZ, of whom 49 (25.5%) reported increased COPD symptoms during HZ episodes. Most participants (94.0%) knew of HZ vaccines, but only 33.1% reported receiving the Advisory Committee on Immunization Practices-preferred recombinant HZ vaccination. The recall of receiving HZ vaccine recommendations differed by the site attended: 68.8% primary care, 26.6% pulmonology offices. Most (74.7%) were unaware that COPD increases HZ risk. Among unvaccinated participants, interest in getting the HZ vaccine increased from 32.0% to 73.5% after watching the video. These results highlight the need for people with COPD to receive further HZ education, such as the five-minute video, and HZ vaccine recommendations from healthcare professionals.