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Questions remain regarding the effect of baseline host and exposure factors on vaccine efficacy (VE) across pathogens and vaccine platforms. We report placebo-controlled data from four Phase 3 COVID-19 trials during the early period of the pandemic. This was a cross-protocol analysis of four randomized, placebo-controlled efficacy trials (Moderna/mRNA1273, AstraZeneca/AZD1222, Janssen/Ad26.COV2.S, and Novavax/NVX-CoV2373) using a harmonized design. Trials were conducted in the United States and international sites in adults ≥ 18 years of age. VE was assessed for symptomatic and severe COVID-19. We analyzed 114,480 participants from both placebo and vaccine arms, enrolled July 2020 to February 2021, with follow up through July 2021. VE against symptomatic COVID-19 showed little heterogeneity across baseline socio-demographic, clinical or exposure characteristics, in either univariate or multivariate analysis, regardless of vaccine platform. Similarly, VE against severe COVID-19 in the single trial (Janssen) with sufficient endpoints for analysis showed little evidence of heterogeneity. COVID-19 VE is not influenced by baseline host or exposure characteristics across efficacy trials of different vaccine platforms and countries when well matched to circulating virus strains. This supports use of these vaccines, regardless of platform type, as effective tools in the near term for reducing symptomatic and severe COVID-19, particularly for older individuals and those with common co-morbidities during major variant shifts. Clinical trial registration numbers: NCT04470427, NCT04516746, NCT04505722, and NCT04611802., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brett Leav reports a relationship with Moderna Inc that includes: employment. Jacqueline Miller reports a relationship with Moderna Inc that includes: employment. Kathryn Shoemaker reports a relationship with AstraZeneca R&D Gaithersburg that includes: employment and equity or stocks. An Vandenbosch reports a relationship with Janssen Pharmaceuticals Inc that includes: employment. Jerald Sadoff reports a relationship with Janssen Pharmaceuticals Inc that includes: employment. Wayne Woo reports a relationship with Novavax Inc that includes: employment. Iksung Cho reports a relationship with Novavax Inc that includes: employment. Lisa M. Dunkle reports a relationship with Novavax Inc that includes: employment. Peter Gilbert reports a relationship with Janssen Pharmaceuticals Inc that includes: consulting or advisory. Hana M. El Sahly reports a relationship with Gilead Sciences Inc that includes: funding grants. Hana M. El Sahly reports a relationship with Janssen Global Services LLC that includes: funding grants. Hana M. El Sahly reports a relationship with Merck & Co Inc that includes: funding grants. Hana M. El Sahly reports a relationship with Sanofi Pasteur Inc that includes: funding grants. Kathleen M. Neuzil reports a relationship with Pfizer Inc that includes: funding grants. Ann R. Falsey reports a relationship with Biofire Diagnostics Inc that includes: funding grants. Ann R. Falsey reports a relationship with Janssen Biotech Inc that includes: funding grants. Ann R. Falsey reports a relationship with Merck & Co Inc that includes: funding grants. Ann R. Falsey reports a relationship with Pfizer Inc that includes: funding grants. Ann R. Falsey reports a relationship with Novavax Inc that includes: consulting or advisory., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: Medication adherence is widely recognized as an essential component of chronic disease management, yet only 50% of patients take their medication as prescribed. Newer technologies have the potential to improve medication adherence. Objective: To conduct a pilot study estimating the impact of a pharmacy-dispensed electronic reminder cap (SMARxT cap), which also records cap openings, on medication adherence and blood pressure (BP). Methods: After a 30-day run-in period, 28 individuals were randomized to receive a SMARxT or placebo cap on each BP medication. The primary outcome was adherence measured via (1) the medication possession ratio, (2) number of cap openings, and (3) self-report. The secondary outcome was the average of 2 BP readings at 6 months. Mean changes from baseline to 6 months were compared between the 2 groups. Results: The medication possession ratio increased 2.7% in the SMARxT cap group and decreased 1.1% in the control group ( P = .13), and cap openings increased 11.9% in the SMARxT cap group and 9.9% in the control group ( P = .83). Self-reported adherence increased 1.1 points in the SMARxT cap group and 0.8 points in the control group ( P = .64). Systolic BP decreased 8.2 mm Hg in the SMARxT cap group and 2.8 mm Hg in the placebo cap group ( P = .35), and diastolic BP decreased to 6.2 mm Hg in the SMARxT cap group and was unchanged in the placebo cap group ( P = .06). Conclusions: Use of SMARxT cap showed nonsignificant improvement in medication adherence and BP lowering. This technology has potential to characterize and improve medication-taking behavior., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Downey and Mr Klink have ownership interest in the electronic cap that was part of this study, and they are employed by Concordance Health Solutions. The other authors have no conflicts of interest to disclose., (© The Author(s) 2021.)

Despite the importance of pharmacy practice-based research in generating knowledge that results in better outcomes for patients, health systems and society alike, common challenges to PPBR persist. Herein, we authors describe PPBR challenges our research teams have encountered, and our experiences using technology-driven solutions to overcome such challenges. Notably, limited financial resources reduce the time available for clinicians and researchers to participate in study activities; therefore, resource allocation must be optimized. We authors have also encountered primary data collection challenges due to unique data needs and data access/ownership issues. Moreover, we have experienced a wide geographic dispersion of study practices and collaborating researchers; a lack of trained, on-site research personnel; and the identification and enrollment of participants meeting study eligibility criteria. To address these PPBR challenges, we authors have begun to turn to technology-driven solutions, as described here.

Objective: To (1) characterize community pharmacists' and community pharmacy residents' decision making and unmet information needs when conducting comprehensive medication reviews (CMRs) as part of medication therapy management and (2) explore any differences between community pharmacists and community pharmacy residents in CMR decision making and unmet information needs., Design: Thirty-to 60-minute semistructured interviews framed using a clinical decision-making model (CDMM) were conducted with community pharmacists and residents., Setting and Participants: Participants were recruited from practice-based research networks and researchers' professional networks. Eligible participants had completed or supported the completion of at least 2 CMRs in the last 30 days., Outcome Measures: Two researchers independently coded transcripts using a combination of inductive and deductive methods to identify themes pertaining to community pharmacists' and residents' decision making and unmet information needs in the provision of CMRs. Discrepancies among researchers' initial coding decisions were resolved through discussion., Results: Sixteen participants (8 pharmacists and 8 residents) were interviewed. Themes were mapped to 5 CDMM steps. Participants primarily used subjective information during "case familiarization"; objective information was secondary. Information used for "generating initial hypotheses" varied by medication therapy problem (MTP) type. During "case assessment," if information was not readily available, participants sought information from patients. Thus, patients' levels of self-management and health literacy influenced participants' ability to identify and resolve MTPs, as described under "identifying final hypotheses." Finally, participants described "decision-making barriers," including communication with prescribers to resolve MTPs. Although pharmacist and resident participants varied in the types of MTPs identified, both groups cited the use and need of similar information., Conclusion: Community pharmacists and residents often rely primarily on patient-provided information for decision making during CMRs because of unmet information needs, specifically, objective information. Moreover, confidence in MTP identification and resolution is reduced by communication challenges with prescribers and limitations in patients' ability to convey accurate and necessary information., (Copyright © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: Medication therapy management (MTM) is a service, most commonly provided by pharmacists, intended to identify and resolve medication therapy problems (MTPs) to enhance patient care. MTM is typically documented by the community pharmacist in an MTM vendor's web-based platform. These platforms often include integrated alerts to assist the pharmacist with assessing MTPs. In order to maximize the usability and usefulness of alerts to the end users (e.g., community pharmacists), MTM alert design should follow principles from human factors science. Therefore, the objectives of this study were to 1) evaluate the extent to which alerts for community pharmacist-delivered MTM align with established human factors principles, and 2) identify areas of opportunity and recommendations to improve MTM alert design., Methods: Five categories of MTM alerts submitted by community pharmacists were evaluated: 1) indication, 2) effectiveness; 3) safety; 4) adherence; and 5) cost-containment. This heuristic evaluation was guided by the Instrument for Evaluating Human-Factors Principles in Medication-Related Decision Support Alerts (I-MeDeSA) which we adapted and contained 32 heuristics. For each MTM alert, four analysts' individual ratings were summed and a mean score on the modified I-MeDeSA computed. For each heuristic, we also computed the percent of analyst ratings indicating alignment with the heuristic. We did this for all alerts evaluated to produce an "overall" summary of analysts' ratings for a given heuristic, and we also computed this separately for each alert category. Our results focus on heuristics where ≤50% of analysts' ratings indicated the alerts aligned with the heuristic., Results: I-MeDeSA scores across the five alert categories were similar. Heuristics pertaining to visibility and color were generally met. Opportunities for improvement across all MTM alert categories pertained to the principles of alert prioritization; text-based information; alarm philosophy; and corrective actions., Conclusions: MTM alerts have several opportunities for improvement related to human factors principles, resulting in MTM alert design recommendations. Enhancements to MTM alert design may increase the effectiveness of MTM delivery by community pharmacists and result in improved patient outcomes.

Background: Preventable emergency department (ED) use may be targeted with interventions for improving the medication use process, as medication misadventures and non-adherence frequently cause preventable ED utilization. One intervention that could prevent ED visits is Medication Therapy Management (MTM)., Objective: To evaluate the effectiveness of a telephonic medication therapy management (MTM) service on reducing emergency department utilization within a Medicare insured home health population., Methods: This was a secondary analysis of data from a cluster-randomized controlled trial examining re-hospitalizations among Medicare insured patients within forty randomly selected, geographically diverse, home-health centers. The intervention consisted of an initial telephonic medication reconciliation with a pharmacy technician, a telephonic pharmacist-provided medication review, and follow-up pharmacist phone calls. The primary outcome of this analysis was 60-day all-cause emergency department utilization. Patients' baseline risk of ED utilization was calculated, and patients were stratified into quartiles based on their risk of ED utilization. Adjusted odd ratios of ED utilization were calculated., Results: Data from 656 patients (intervention n=297, usual care n=359) were available for this study. Overall, the MTM intervention was not associated with 60-day ED use, as 24.4% of intervention patients and 25.1% of usual care patients utilized the ED (Adjusted Odds Ratio=1.11; 95% CI: 0.79-1.57). However, there was lower ED utilization among patients in the lowest risk-quartile (Adjusted Odds Ratio=2.52; 95% CI: 1.15-5.49; p= 0.02)., Conclusion: This pharmacist-delivered telephonic medication therapy management program did not decrease ED utilization overall in a Medicare insured home health population, but may further reduce the risk of ED utilization among patients who are at lower risk of utilization., Competing Interests: All authors meet the criteria for authorship and the authors will sign a statement attesting authorship, disclosing all potential conflicts of interest, and releasing the copyright should the manuscript be accepted for publication.

Study Objective: To identify predictors of medication-related problems (MRPs) among Medicaid patients participating in a telephonic medication therapy management (MTM) program., Design: Retrospective analysis of data from patients enrolled in a previously published study., Data Sources: Two Medicaid administrative claims file databases (for health care utilization and prescription dispensing information) and one pharmacy organization file for MTM program information., Patients: Seven hundred twelve adult Medicaid patients who participated in a statewide pharmacist-provided telephone-based MTM program and who received an initial medication therapy review., Measurements and Main Results: The primary dependent variable was the number of MRPs detected during the initial medication therapy review. Secondary dependent variables were the detection of one or more MRPs related to indication, effectiveness, safety, and adherence. Predictor variables were selected a priori that, from the literature and our own practice experiences, were hypothesized as being potentially associated with MRPs: demographics, comorbidities, medication use, and health care utilization. Bivariate analyses were performed, and multivariable models were constructed. All predictor variables with significant associations (defined a priori as p<0.1) with the median number of MRPs detected were then entered into a three-block multiple linear regression model. The overall model was significant (p<0.001, R(2)  = 0.064). Significant predictors of any MRPs (p<0.05) were total number of medications, obesity, dyslipidemia, and one or more emergency department visits in the past 3 months. For indication-related MRPs, the model was significant (p<0.001, R(2)  = 0.049), and predictors included female sex, obesity, dyslipidemia, and total number of medications (p<0.05). For effectiveness-related MRPs, the model was significant (p<0.001, R(2)  = 0.054), and predictors included bone disease and dyslipidemia (p<0.05). For safety-related MRPs, the model was significant (p<0.001, R(2)  = 0.046), and dyslipidemia was a predictor (p<0.05). No significant predictors of adherence-related MRPs were identified., Conclusion: This analysis supports the relative importance of number of medications as a predictor of MRPs in the Medicaid population and identifies other predictors. However, given the models' low R(2) values, these findings indicate that other unknown factors are clearly important and that criteria commonly used for determining MTM eligibility may be inadequate in identifying appropriate patients for MTM in a Medicaid population., (© 2014 Pharmacotherapy Publications, Inc.)

Background: Patients with chronic heart failure (HF) have cognitive deficits in memory, psychomotor speed, and executive function and poor health-related quality of life (HRQL), but the association between cognitive deficits and HRQL is unknown., Objectives: The objectives of this study were to (1) evaluate the relationship between HF severity, age, comorbidities, and cognitive deficits and HRQL among patients with chronic HF and (2) examine whether cognitive deficits mediated the relationship between HF severity and HRQL., Design and Sample: This study was part of a larger explanatory study; 249 patients with HF completed face-to-face interviews., Methods: Measures of HF severity, comorbidity (multiple comorbid conditions, hypertension, and depressive symptoms), cognitive function (domains of language, working memory, memory, psychomotor speed, and executive function), and HRQL were obtained. Clinical variables were abstracted from patients' records. Statistical analyses were conducted using descriptive statistics, Pearson correlation coefficients, and multiple linear regression analyses., Results: Overall, the HRQL of patients was moderately poor. Heart failure severity, age, depressive symptoms, and total recall memory explained 55% of the variance in HRQL, but the contribution of memory was minimal (1%). Patients with more severe HF, younger age, and more depressive symptoms had poorer HRQL. Other cognitive function variables, multiple comorbidity, and hypertension were not significant explanatory variables for HRQL. Cognitive deficits did not mediate the relationship between HF severity and HRQL., Conclusions: Novel interventions targeted at improving HRQL continue to be urgently needed, particularly among younger patients and patients with depressive symptoms. Measures of HRQL are not sufficient as outcomes when investigating cognitive deficits in HF. Investigators need to include outcome measures of patients' actual abilities to perform daily activities and HF self-care.

Background: Patients with heart failure (HF) have been found to have cognitive deficits, but it remains unclear whether these deficits are associated with HF or with aging or comorbid conditions common in HF., Objectives: : The purpose of this study was (a) to determine the types, the frequency, and the severity of cognitive deficits among patients with chronic HF compared with age- and education-matched healthy participants and participants with major medical conditions other than HF, and (b) to evaluate the relationships between HF severity, age, and comorbidities and cognitive deficits., Methods: A sample of 414 participants completed the study (249 HF patients, 63 healthy and 102 medical participants). The HF patients completed measures of HF severity, comorbidity (multiple comorbidity, depressive symptoms), and neuropsychological functioning. Blood pressure and oxygen saturation were assessed at interview; clinical variables were abstracted from records. Participants in the comparison groups completed the same measures as the HF patients except those specific to HF., Results: Compared with the healthy and medical participants, HF patients had poorer memory, psychomotor speed, and executive function. Significantly more HF patients (24%) had deficits in three or more domains. Higher (worse) HF severity was associated with more cognitive deficits; HF severity interacted with age to explain deficits in executive function. Surprisingly, men with HF had poorer memory, psychomotor speed, and visuospatial recall ability than women. Multiple comorbidity, hypertension, depressive symptoms, and medications were not associated with cognitive deficits in this sample., Discussion: HF results in losses in memory, psychomotor speed, and executive function in almost one fourth of patients. Patients with more severe HF are at risk for cognitive deficits. Older patients with more severe HF may have more problems in executive function, and men with HF may be at increased risk for cognitive deficits. Studies are urgently needed to identify the mechanisms for the cognitive deficits in HF and to test innovative interventions to prevent cognitive loss and decline.

Analyses were done to evaluate among- and within-brand variation in the composition of five types of commercial salads. Samples from five companies were collected at three different times and analyzed for fat, protein, fiber, ash, and moisture. Carbohydrate and caloric content were calculated. Wide variations in composition were evident both among brands and within brands, which indicated a need for ingredient specifications, ingredient listing, and application of basic control procedures in the operations examined.