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1.
Pharmacy Education ; 22(5):41, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206519

RESUMO

Objective: This project evaluated the effect of patient education and music therapy delivered by telehealth on depression related to COVID19 among rural nursing home residents. Method(s): This was a prospective, pilot intervention involving 56 residents from three rural nursing homes. The study included a convenience sample of residents at three rural nursing homes. The mean age for the three groups ranged from 67-81 years of age. Participants received either patient education or combined patient education and music therapy as depression interventions. The primary outcome was the change in PHQ-9 scores from baseline to the end of an eight-week period. The secondary outcome was resident satisfaction as measured through an evaluation survey. Result(s): Of the 56 participants enrolled, 28 completed the study and were included in data analysis. Low pretreatment PHQ-9 implied minimal depression. Summary statistics show a 1.53 mean PHQ-9 change for those receiving education-only (53.6%) and a -1.16 PHQ-9 for those receiving combined therapy (46.4%) (p = 0.092). Results did not demonstrate positive outcomes on depression. A potential difference was noted among each facility. Two-thirds of participants rated their experiences as good to excellent. Conclusions and Implications: It appears that education played a positive role, yet music therapy delivered as telehealth did not show improvement in depression. Further studies are needed to determine the potential impact of non-pharmacological interventions in rural nursing home residents during the pandemic.

2.
Pharmacy Education ; 22(5):44, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206518

RESUMO

Introduction: As of April 2022, the COVID19 global pandemic has resulted in over six million deaths globally, and over 81 million cases of COVID19 in the United States. Objective(s): The objective of the presentation is to share estimated direct and indirect costs due to COVID19 infection juxtaposed with the costs of COVID19 vaccine administration in the United States. Method(s): A literature review was conducted to identify potential cost savings from being immunized against COVID19. The costs of COVID19 vaccinations, direct costs related to healthcare and types of indirect costs were noted. Result(s): After reviewing over 40 resources, several costs were identified. The cost of COVID19 vaccine series, as defined by the Centers of Medicare and Medicaid Services (CMS), is currently USD40 for single-dose and USD40 per dose in a multiple-dose series. It is estimated that the average hospitalisation stay of an uninsured inpatient was ~USD7000-USD10,000 per day. The average cost of 12 major metropolitan cities in the United States were estimated for primary care facilities, urgent care facilities, and emergency room visits at USD195, USD239, USD1,425, respectively. As of April 2, 2022, 77% of the US have received at least one dose of COVID19 vaccine and 66% are considered to be fully vaccinated against COVID19 primary series. Conclusion(s): According to the data, the cost reduction in healthcare is consequential and cost-effective in vaccinating the population. This analysis contributes to the limited reports of a national cost-benefit analysis.

3.
Pharmacy Education ; 22(5):19-20, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206517

RESUMO

Introduction: Interprofessional education projects with pharmacy and medical students (PS and MS) are rare in Germany (Institut fuer Medizinische und Pharmazeutische Pruefungsfragen, 2019). However, for a future trustful collaboration personal contacts and mutual understanding are vital (Weisenborn et al., 2019). Care by an interprofessional team is beneficial for patients. According to the fifth Action Plan 2021 - 2024 to improve medication safety of the Federal Ministry of Health (2021), interprofessional collaboration is an important key element. Objective(s): The authors developed and implemented an interprofessional education project for PS and MS. The pilot study was conducted to understand the students' perceptions and to evaluate whether students were satisfied with their learning progress and would recommend this project. Method(s): The project, developed by an interprofessional team, consisted of three parts: (1) an interprofessional online seminar, (2) practical training at the Medication Management Center (MMC) and (3) a one-day internship in a general practitioner's (GP's) office. In all three parts, PS and MS performed patient-oriented casework and medication reviews together. The project was evaluated using anonymous pre- and post-questionnaires, containing the German version of the Student Perceptions of Physician-Pharmacist Interprofessional Clinical Education instrument (SPICE-2D) and open-ended questions to further evaluate the students' perceptions (Pudritz et al., 2020). The post-questionnaire asked for feedback as well as a recommendation of this project for other students, using a five-point Likert scale. Furthermore, the students' satisfaction with their learning progress was assessed. Result(s): Due to the SARS-CoV-2 pandemic, only the seminar (part 1) was performed in each term. The other parts of the project were implemented progressively. The third execution in the winter term 2021/22 was eventually able to contain all three parts. Through all executions, 105 students (46 PS, 59 MS) attended the interprofessional seminar, 64 (29 PS, 35 MS) the practical training at the MMC and nine joined the internship in a GP's office. For the seminar, 41 of 53 participants were satisfied with their learning progress and 64 of 67 students would recommend it to others. Regarding the practical training at the MMC, 37 of 46 students were satisfied with their learning progress and 45 of 47 would recommend it to others. Finally, the internship in a GP's office was mostly rated positive. Conclusion(s): Despite the pandemic, the interprofessional education project was successfully implemented. The insights gained from the evaluation will be used to adapt the project and its evaluation, eventually. Moreover, the development of further interprofessional education projects will benefit from the gained understanding. The focus of the evaluation of the main study will shift to the students' perceptions towards patient-oriented casework and medication reviews. In addition to the questionnaires, guided individual interviews will be used.

4.
Pharmacy Education ; 22(5):25-26, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206516

RESUMO

Introduction: Antimicrobial resistance (AMR) is a global threat. The Global South has illustrated gaps and challenges in contextual interventions to tackle AMR due to economic development and existing legislation on antimicrobial use. Community pharmacists are vital healthcare professionals in primary care settings to promote Antibiotic Smart Use (ASU). Objective(s): The aim of this study was to explore their experiences and aspirations around ASU to tailor sustained interventions. Method(s): Virtual online focus group discussions (FGDS) were conducted to explore the views of part- and full-time community pharmacists in Thailand who were systematically recruited to ensure their eligibility to fit with Appreciative Inquiry (AI) theory. Out of a pool of eligible participants, those who had scored above average (> 74%) and above in the attitude questionnaire - the earlier part of the project - were quota sampled and purposively invited to take part. A specific topic guide was developed using the four domains of AI (Discovery, Dream, Design and Destiny), to provide insights into their thought processes and their recommendations for the facilitation of ASU in community pharmacies. Qualitative data were analysed using Nvivo12, using thematic framework analysis with a deductive approach. Result(s): Twenty one community pharmacists participated. Seven themes around ASU emerged in the Discovery Domain of AI. There are pharmacists' practices for non-prescribed antibiotic dispensing, professional experience, work environment, commercialisation and business, commonly used non-prescribed antibiotics, visibility of the National Plan for tackling AMR, and learning points from the COVID19 pandemic. The participants dreamed about the ideals of ASU in the community pharmacy in five themes which are establishing One Health stakeholders- regulating the supply chain, following developed countries as role models, reviewing legislation, and forming witness checks and balances in healthcare professionals. Then the participants designed interventions and strategies on five themes: insurance system, incentive intervention, re-classification of antibiotics, and organisational unity for supporting ASU. The Destiny domain consisted of five themes that would allow sustainable ASU in their settings: the need for ASU literacy, primary care, AMR attitudes and behaviour change strategies, communication of ASU progression and resource management, and trust in pharmacists as a key to building customer loyalty. Conclusion(s): Four domains of Appreciative Inquiry provided community pharmacists with the opportunity to share their experiences and aspire to desired changes to promote ASU in the pharmacy setting and broadly across the country. This framework reflected contextual interventions and strategies with bottom-up brainstorming linked to top-down approaches. The requirement of literacy, along with strategies for changing for public and healthcare providers, could elevate ASU in community pharmacies. Integration of community pharmacy into a part of government primacy care unit and communication of the ASU progression with them might promote engagement with the remaining business aspects.

5.
Pharmacy Education ; 22(5):39, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206515

RESUMO

Introduction: Community pharmacists were amongst the few healthcare professionals readily available for face-to-face consultation after the first COVID19 outbreak in Catalonia, Spain. A collaborative practice programme was created in September 2020 to ease the referral to and communication with Primary Care (PC) of those Community Pharmacy (CP) users who had COVID19-like symptoms. This programme, known as JoDIC, was created by the Epidemiological Surveillance Services (ESS) of Valles and Barcelones-Nord-Maresme Areas, the Catalan Healthcare Service (CatSalut) and Barcelona Pharmacists Association (COFB). After using a paper-based system at the beginning, a safe cloud-based software hosted in Farmaserveis, the Catalan pharmacy services platform, started running in February 2021, to facilitate patients' follow-up. In June 2021, referral for COVID19 vaccination was included to the platform. COVID19 antigenic tests were not available in Spanish CPs until July 2021. Objective(s): To enable an effective and safe referral and communication system from CPs to PC centers of patients needing COVID19-related healthcare interventions, within the JoDIC programme;and to describe the pharmaceutical interventions performed in the JoDIC programme framework. Method(s): COFB, ESS and CatSalut jointly designed JoDIC circuit, which was activated at the CP to detect users with COVID19-like symptoms, users who were a close contact to a COVID19 case or users who were not fully vaccinated. The initial paper-based circuit started in September 2020, involving Valles area only. Complete referral data was gathered from the 5th February 2021 to the 31st December 2020 period of study, when Farmaserveis specific module was launched. On the 23rd June 2021, JoDIC was expanded to the whole Northern Barcelona Metropolitan Area, comprising more than two million inhabitants who are serviced by 649 CP. By filling up a form on Farmaserveis, the patient's data was referred by a community pharmacist to the PC centre to evaluate each case and to provide further care needed. Result(s): 528 community pharmacists working in 372 CP were trained in the protocol. Community pharmacists performed interventions in 1303 CP users (496, paper-based;and 807, registered on Farmaserveis). 111 CP registered pharmaceutical interventions on Farmaserveis (7.4 patients per CP). 63.1% (n = 509) of CP users, received health education by the pharmacist, while 36.9% (n = 298) were referred to their PC centre. 71.6% of the referred patients were due to having COVID19-like symptoms;25.3%, were close contacts to COVID19-positive cases;and 3.1%, to be vaccinated. 68.8% of the referred patients eventually attended their appointments with their family physician. 63.4% of the visited patients needed some kind of diagnostic test. 30.8% tests were COVID19-positive. Conclusion(s): The current pandemic favoured the establishment of new COVID19 detection circuits and communication ways between ESS, CP and PC centers. Our data shows high efficacy to detect COVID19-positive cases (30.8% positivity) and good acceptability amongst referred citizens (68.8% successful referrals). JoDIC programme is a seminal project that will facilitate communication amongst PC and CP professionals in other contexts.

6.
Pharmacy Education ; 22(5):38-39, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206514

RESUMO

Introduction: The COVID19 pandemic has increased the need for timely and reliable health information to optimise citizens' self-protective engagement. Due to preventive measures, such as lock-down and physical distancing, people relied on the internet more than before. There is a large gap in pharmacy educators knowledge about health information-seeking pathways on the internet, especially with the appearance of the COVID19 infodemic. Results of the authors work may help healthcare professionals to better communicate and educate citizens in everyday practice. Objective(s): The aim of this study was to examine the impact of the COVID19 pandemic on searching for and understanding online health information, as well as reliance and confidence in the information gathered from various online sources. Method(s): An online survey was conducted using Google Forms on a sample of anonymous respondents in Serbia. The link for the questionnaire was posted on social media channels and was accessible from April to May 2020, during the epidemic outbreak. The survey included questions on socio-demographic characteristics and behaviour in seeking and evaluating online health information sources. The authors compared the responses collected at a one-time point in regard of period before and during the COVID19 pandemic. Healthcare professionals were excluded from the study. Data were managed using the IBM SPSS Statistics and included methods of descriptive and inferential statistics. Result(s): The age of participants was 37.82 +/-11.11 years in average. Out of 351 respondents, 66.7% were women, 47.9% were university graduates, and 76.6% were employed. At the beginning of the pandemic, the average time for health-related information searching on the internet and social media significantly increased (p < 0.01). The majority of participants found important the profession of the author of health information published on the internet (N = 305, 86.9%) and on social media (N = 272, 77.5%). Prior to COVID19, the respondents valued the most (on a five-point rating scale) the information obtained from physicians (4.33 +/- 0.75) and pharmacists (4.12 +/- 0.79), followed by health officials (3.73 +/- 1.02) and journalists (2.66 +/- 1.02). This trend continued during the pandemic. Understanding of health information published on the internet and/or social media decreased significantly (from 3.82 +/- 1.01 before to 3.67 +/- 1.14 during the pandemic, measured on a five-point rating scale, p < 0.01). This decrease in the understanding of health information was significantly influenced by gender (p < 0.05). The level of education and employment status significantly impacted the understanding of health information before the pandemic (p < 0.05 for both variables), while during the pandemic these factors did not prove to be statistically significant. Conclusion(s): Citizens' interest in health has grown significantly due to the COVID19 pandemic. However, their understanding of health information during this global crisis has decreased. This underlined the importance of clarity of the health information provided online. Physicians and pharmacists are marked as online health information providers with the highest level of confidence at the time of infodemic. They should be more involved in writing and disseminating accurate, precise, clear health information, adjusted to all categories of the population, to improve public health.

7.
Pharmacy Education ; 22(5):10-11, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206513

RESUMO

Introduction: It is widely accepted that the role of a pharmacist is becoming more complex and the scope of practice has broadened over the past decade. With restricted access to hospitals and general practice, the COVID-19 pandemic shone a light on the vital role that pharmacists play in maintaining patient care and disease management. Pharmacists have always been at the forefront delivering safe and effective care across all settings. Recent reforms to the education and training of pharmacists in the United Kingdom, will see that from day one on the register, pharmacists are expected to play an active role in the provision of clinical care and consultations including prescribing medicines. These advances make it more important now to have a better understanding of what moral development through pharmacy education and once in practice. Research has shown that healthcare professionals can make better decisions in the interests of their patients when they have advanced levels of moral decision making. Objective(s): It is hypothesised that as students' progress through pharmacy education they will demonstrate maturation in moral development, and this should continue as they progress through their careers. This research intends to measure and evaluate the pattern of moral reasoning of undergraduate pharmacy students at the University of Hertfordshire (UH) as they progress through formal education and practice. Method(s): A ten-year longitudinal study which employed the Defining Issues Test 2 (DIT2) to quantitatively measure the changes the participants' moral development. The DIT2 was completed by participants of a single cohort of students, who started the Master of Pharmacy (M.Pharm.) programme in 2008 in each year of study at the University of Hertfordshire, once after passing the General Pharmaceutical Council pharmacist registration exam (as Newly Qualified pharmacists) and a final time five years after they qualified (as matured Established Practitioners). Medians and standard deviations were calculated and compared analysed using pairwise comparison with the Wilcoxon signed-rank test. Result(s): The statistically significant changes were in N2 scores between Level 1 (Median = 22.07) and Level 3 (Median = 26.80) (p = 0.025), this is a positive finding which supports the research that shows that moral development can be taught. To further support these results there was an increase in N2 score between Level 1 and Level 4 (p = 0.011). Research has also shown that practice-based experience can give rise to maturation in moral development, this research showed a statistically significant difference between Level 4 (Median = 22.62) and NQ Level (Median = 40.53). Despite this, surprisingly, there was a marked decrease in p and N2 scores at Established Practitioner level. Conclusion(s): Overall, the research showed a general increase in moral development as the participants progressed through the M.Pharm. programme and in the first year after qualifying. However, with the decrease in moral development indices as an Established Practitioner qualitative research to investigate factors that may have caused this then recommend ways to support pharmacists better through education and practice.

8.
Pharmacy Education ; 22(5):46-47, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206512

RESUMO

Introduction: Globally, disparities exist in healthcare quality, accessibility and regulation (Das, & Gertler, 2007). Consequently, few countries have governing bodies overlooking healthcare-professional (HCP) practice (Epstein, & Bing, 2011). Research has suggested that HCP regulation depended on nations' human development index (HDI), gross domestic product (GDP), and safety (Ozturk, & Topcu, 2014). IPC enables partnership working between HCPs to ensure patient-centred care (Gregory, & Austin, 2016). This study thematically analysed pharmacy professional standards' documents of various countries and investigated whether nations' developmental parameters influenced pharmacy regulation. Objectives * To compare global pharmacy professional standards on IPC. * To synthesise a thematic framework to evaluate literature on IPC. * To iInvestigate the relationship between HDI, GDP, global peace index (GPI), and pharmacy regulation. Method(s): A group (N = 8) of countries were studied based on 2018 HDI classification;(N = 4) 'very high' (Australia, Hong Kong, Canada, United Kingdom) and (N = 4) 'low' (Solomon Islands, Haiti, Yemen, South Sudan). Pharmacy professional standards' documents were screened to extract IPC-related themes via a constant comparative method. This facilitated thematic framework synthesis;'pharmacists' attitudes' and 'patient outcomes' were measures of IPC. Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), (N = 17) peer-reviewed journal articles from 2010-2019 studying pharmacists in sample countries were selected. Key terms searched on Medline/PubMed databases were: 'IPC', 'pharmacist' and 'professional standards'. Literature was then reviewed with reference to the thematic framework and development metrics (HDI/GDP/GPI). This study did not require ethics approval. Result(s): Of the countries (N = 8) studied, only HDI-classified 'very high' had professional standards' documents, frequently incorporating IPC. Key themes were: 'shared decision-making', 'continuity-of-care', and 'effective communication'. Seven studies referred to these themes and confirmed IPC benefits: fewer medication-related errors4. The number of IPC standards and HDI-rank for 'very high' countries, except Hong Kong, were positively correlated, suggesting possible economic impact on pharmacy sector progress. Two studies found cultural influences on Hong Kong pharmacists' attitudes as contributory to a hierarchical than IPC-approach to healthcare provision5. HDI and GPI had a strong negative correlation (r = -0.83), potentially explaining low pharmacist density and GDP healthcare expenditure in HDI-classified low. Conclusion(s): Results denote that IPC improved patient safety (Gregory, & Austin, 2016). Global differences existed in pharmacists' attitudes and IPC training. These correlated with growing gaps in HDI and GPI between HDI-classified 'very high' and 'low' countries. Qualitative analysis highlighted the need for elaboration of 'continuity-of-care' and inclusion of 'understanding roles/responsibilities of team members' in the United Kingdom's professional standards set by the General Pharmaceutical Council. Future work could study 2021/inequality-adjusted HDI data, 'high'/'medium' HDI countries to improve validity alongside COVID19 impact on GDP and pharmacy practice.

9.
Pharmacy Education ; 22(5):21-22, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206511

RESUMO

Introduction: During the lockdown enforced from March to June 2020 by authorities due to the COVID19 pandemic in Switzerland, patients included in the Interprofessional Medication Adherence Programme (IMAP) in Lausanne and Bern continued to use electronic monitors (EM), which register daily doses intake. Objective(s): The aim of this study is to use EM data to understand to what extent patients' medication implementation, described as the extent to which the patient takes the daily prescribed regimen, was impacted by the lockdown. The authors hypothesised that medication implementation might be lower during and after the lockdown compared to before. Method(s): Included participants attending the IMAP were diagnosed with diabetic kidney disease (DKD), solid cancer, HIV and miscellaneous long-term diseases. Patients' implementation was defined through a proxy: if all EM of each patient were at least opened once daily, implementation was considered optimal (= 1);and suboptimal (= 0) otherwise. 1) Implementation before (from December 2019 to March 2020), during (March to June 2020) and after (June to September 2020) the lockdown was compared. Subanalyses were also performed according to sub-groups of patients. 2) As comparison, implementation of included patients using at least one EM the year before, in 2019, during the same time frame, defined as winter, spring and summer periods, was analysed. A logistic regression model was used to estimate medication implementation according to the period, using 'before the lockdown' or 'winter' as the reference. The model was fitted using generalized estimating equation. Result(s): 1) In 2020, implementation of the 118 patients did not differ statistically before and during (OR = 0.97, CI: 0.84 - 1.15, p = 0.789), and before and after (OR = 0.91, CI: 0.79 - 1.06, p = 0.217) the lockdown. These findings remain stable even when analysing separately the implementation of patients with HIV (n = 61), DKD (n = 25) or miscellaneous long-term diseases (n = 22). Too few patients with cancer (n = 10) were included in the analysis to interpret their results. 2) In 2019, implementation of the 61/118 (51.7%) patients was statistically significantly lower during summertime compared to winter (OR = 0.73, CI: 0.59 - 0.89, p = 0.002). Conclusion(s): The authors results infirm their hypothesis as the implementation remained steady during and after the lockdown in 2020 in comparison to the period before. Still, adherence in 2020 was different compared to 2019 as the decreased implementation during summertime 2019 was not observed after the lockdown in summer 2020. Because of the COVID-19 pandemic, many patients slowed down their activities, travelled less, and may have been more cautious in managing their treatment due to the fear of developing a complication of their disease in a difficult sanitary context. Moreover, during the pandemic, continuity of care was ensured by medical teleconsultation between patients and their health care providers, mailing medications to patients' home by the pharmacy and leading interviews by phone calls for patients included in IMAP. The IMAP before, during and after the lockdown may have supported the adherence of complex patients across the pandemic in 2020. Interprofessional adherence programmes should support patients during routine-disturbance periods, such as a lockdown in a pandemic context or during summertime.

10.
Pharmacy Education ; 22(5):36, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206510

RESUMO

Introduction: In the last years, the pharmacist has performed a new range of activities, from traditional medicines dispensing to patient-centred services. In many countries, the implementation of pharmaceutical services has showed significant benefits for public health systems. During the COVID19 pandemic, pharmacists had assumed additional responsibilities and adapted their activities. Nevertheless, in Romania the legal framework and definition of pharmaceutical services have been recently established. Objective(s): The aim was to identify recent legislative changes contributing to the implementation of Romanian pharmaceutical services. Moreover, the author has highlighted some new activities performed by pharmacists throughout the COVID19 pandemic. Method(s): Data was collected by searching national authorities' databases (Ministry of Health, the College of Pharmacists from Romania, National Institute of Public Health). Electronic databases (mainly PubMed and Google Scholar) were searched to identify new responsibilities of pharmacists after March 2020. Then, information was extracted, analysed and discussed. Result(s): In November 2020, an official definition of the pharmaceutical services was introduced due to the completion of the Romanian Pharmacy Law no. 266/2008. Another important event for the future of the profession was the approval of the list of pharmaceutical services (Ministry of Health Order No. 2382, November 4, 2021), divided into essential and advanced services. The legal framework could be correlated with a positive change regarding the pharmacy residency training (three year duration) and the number of specialist pharmacists. In 2019, there were reintroduced two specialties, like Pharmaceutical Industry and cosmetology and General Pharmacy, in addition to Clinical Pharmacy and Clinical Laboratory. Consequently, the number of places increased with 32% in 2019 comparing with 2018, respectively 63% in 2020, as a measure of the authorities to increase the health personnel due to the pandemic. During the national state of alert, more than 9% of the pharmacy residents had to fullfil a new professional role and to provide assistance to public health departments concerning COVID-19 public support. Through the order of the head of the department for emergency situations, they were sent to airports, ambulance service, COVID19 call-centres or other administrative departments in the period January 2021-March 2022. In addition to activities carried out usually, such as dispensing, counseling, measuring biological parameters (high blood pressure, blood sugar), community pharmacists were allowed to perform rapid antigen tests for COVID-19 after May 10, 2021. Until the 1st January 2022, there were 137 temporary authorised community pharmacies in Romania. Conclusion(s): The approval of the Romanian official list of pharmaceutical services represented the first step for expanding the role of the pharmacist and his contribution to the healthcare system. As drug professionals, pharmacists are a valuable resource. During the pandemic, pharmacists were in the first line and had an active role in helping patients, proving the ability to adjust and offer new services. Therefore, in the future, regulators should consider integrating pharmacists in medical multidisciplinary teams, with benefits for patient care and health systems.

11.
Pharmacy Education ; 22(5):29, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206509

RESUMO

Introduction: Consultation of minor ailments and direct product request are frequent in community pharmacy in Spain, although every pharmacy offers the service following their own criteria. Standard Operational Procedures (SOP) and referral criteria agreed between community pharmacists (CPs) and general practitioners (GPs) are needed to deliver a safer service. Referral criteria set the limits of action for each healthcare professional (CPs and GPs) when managing patients. Following the positive findings of an impact study, a roll out was required to translate the evidence-based approach into usual practice. Objective(s): The aim was to characterise the referrals between CPs and GPs through a Minor Ailment Service (MAS, service offered in community pharmacy following the SOP). Method(s): A 12-month pragmatic study with hybrid effectiveness-implementation design was planned from October 2020 in Spain. The co-designed MAS service had several components: agreed SOP with GP scientific organisations, protocols for ailments divided into five groups (dermatological, digestive, related to pain, upper respiratory tract related and others) including referral criteria, information technology (IT) based consultation protocol and training before and during the study. Patients were followed up by pharmacists after ten days of the service. All data were collected through an IT system (SEFAC eXPERT) as a by-product of service delivery and implementation. Outcomes for the first fifteen months (up to December 2021) are shown. Result(s): 1246 pharmacists from 24 provinces in Spain were trained having a reach of 14083 consultations. 1858 (13.2%) patients were referred to the GP. 2193 referral criteria were detected, most patients referred had one single referral criteria (n = 965, 80.8%). Referral criteria detected were red flags such as temperature over 38degreeC, dyspnoea, etc. (n = 846, 39.5%);patients' age (n = 398, 18.6%), symptom duration (n = 361, 16.9%);patients' treatments for other health problems different than the minor ailment consulted (n = 263, 12.3%);other patients' health problems (n = 186, 8.7%) and others (n = 85, 4.0%). Minor ailments more frequently referred were joint pain (n = 190, 10.2%), cough (n = 106, 5.7%), dermatitis (n = 104, 5.6%) and heartburn (n = 63, 3.4%). Conclusion(s): High-risk patients (patients with symptoms/condition that do not appear to be minor ailments) can be assessed by CPs and referred to be evaluated and diagnosed by GPs. The use of co-designed management protocols strengthened the identification of red flags in patients suffering minor ailments to be referred when necessary. Joint pain and cough were two of the minor ailments more frequently referred, which could be a result of the study being undertaken during COVID19 pandemic. CPs can perform clinically, referring patients and acting as a triage point through MAS to increase patients' safety.

12.
Pharmacy Education ; 22(5):16-17, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2206508

RESUMO

Objectives: Evaluate the impact of COVID19 on pharmacists' roles and services around the world Methods: A cross-sectional online survey with pharmacists who provided direct patient care during the pandemic. Pharmacists were recruited through social media with assistance from national and international pharmacy organisations. The survey was divided into three sections: 1) demographics, 2) pharmacists' roles and services during the pandemic 3) practice challenges. The data were analysed using SPSS 28, and descriptive statistics were used to report frequencies and percentages. Result(s): A total of 419 pharmacists practicing in 25 countries provided consent to participate. The most common role that pharmacists undertook was responding to drug information requests (90%), followed by allaying patients' fears and anxieties about COVID19 (82.6%), then addressing misinformation about COVID19 treatments and vaccinations (80.4%), and educating the public on strategies to reduce COVID19 transmission (e.g., handwashing) (80.2%). Despite the demands of the pandemic, pharmacists continued to provide clinical services regularly. Managing and/or monitoring patients' chronic diseases was the most frequently provided service (72.6%), followed by treating ambulatory conditions (65.4%), then renewing/extending prescriptions (58%) and prescribing emergency supply refills (52.7%). Interestingly, almost half of the participants reported administering COVID19 vaccines (45.6%). Pharmacists reported being involved in pandemic management through consultations, policy development and participating in taskforces. The most common challenge that pharmacists encountered was increased stress level (84.7%), followed by medication shortages (73.8%), general supply shortages (71.8%), inadequate staffing (69.2%), and concern for the safety of self and others (66.8%). Conclusion(s): Despite the uncertainty, the massive pressure, and the constant need to adapt, pharmacists around the world continued to put the patient first, providing them with highest quality services and making sure that all their needs are met. Pharmacists are definitely the unsung heroes of pandemic and their actions should cement their place as an essential health service.

13.
Journal of Prevention of Alzheimer's Disease ; 9(Supplement 1):S69, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2203901

RESUMO

Background: Despite the tremendous public health need, enrollment in alzheimer's disease (AD) clinical trials has encountered challenges that include lengthy enrollment periods, great expense, and failure to recruit cohorts that represent the diversity of the population at risk. These challenges have been notably acute in trials testing potential disease-modifying drugs in the pre-symptomatic or "preclinical" stage of disease. Enrollment was also thwarted during the COVID-19 pandemic. Advances in the ability to accurately assess AD pathology using plasma biomarkers have provided powerful new tools to address many of these challenges. These biomarkers reduce reliance on in-person, on-site assessments. Tools and mechanisms that reduce the need for in-person assessment are urgently needed to access broader socioeconomic groups and minimize future pandemic-related disruptions. This project leverages two recent advances in the field of AD research. (1) The establishment of online registries to develop "trial ready cohorts", like the alzheimer's Prevention Trials (APT) Webstudy, where participants are recruited and followed through remote assessments, allow for efficient identification of large numbers of individuals and the ability to collect risk information. (2) The ability to quantify plasma biomarkers, specifically concentration ratios of Abeta42/40 and phosphorylated tau species, as early screeners for eligibility in preclinical AD trials, allows researchers to rule out individuals who have low probability of brain amyloid pathology, thereby reducing burden to participants and reducing the number and cost of amyloid PET scans, which are typically required to determine trial eligibility. Objective(s): The AlzMatch study examines the feasibility of blood testing at community-based laboratories that provide suitable plasma to qualified diagnostic laboratories. Validated biomarkers for AD pathology are quantified and used to assess eligibility for preclinical AD trial screening. Method(s): The project will utilize the APT Webstudy, that has consented over 50,000 participants as of September 27, 2022. Participants enrolled in the registry must be over 50 years of age, with no diagnosis of dementia. After consent, the primary measures are engagement of eligible participants and collection of blood samples. Secondary measures include invitation responses, biomarker values obtained, completion of telephone communication of eligibility to screen for a study, and referral to either remote or in person research. Participants will be recruited in two stages;the first stage enrolls 500 participants, and the second stage will enroll up to 5,000. Participants are invited either from an online registry or from a community setting, sign electronic consent, and are given information to schedule their appointment a local Quest Diagnostics- phlebotomy lab. Plasma is aliquoted, frozen according to standardized procedures, and shared with multiple biofluid assay labs. AlzMatch eligibility status will be evaluated using a predictive algorithm that includes C2N Diagnostics- biomarker assay. All participants, irrespective of eligibility status, will be contacted by telephone and informed of their eligibility to be screened for a clinical study. Participants are told whether they are eligible or not eligible to be screened for a research study at a clinical trial site near where they live. Eligible participants that agree to referral will be connected to a local research site for in-person evaluation. Result(s): Initial findings from the first stage of the AlzMatch study will be presented. Conclusion(s): The AlzMatch study will improve our understanding of the feasibility of community-based plasma collection for in-person research. Referral of these pre-screened participants to clinical trial sites may offer a more efficient and decentralized screening approach that reaches a more representative group of participants for currently enrolling preclinical trials like AHEAD 3-45. Samples collected for this project may help refine the optimal c tpoints to identify participants with early AD pathology. The results of this study will also inform design of large-scale prevention trials.

14.
Journal of Prevention of Alzheimer's Disease ; 9(Supplement 1):S153-S154, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2203899

RESUMO

Background: Semorinemab is a humanized anti-tau IgG4 monoclonal antibody that targets the N-terminal domain of tau and is under investigation as a treatment for alzheimer's disease (AD). Mild-to-moderate AD patients treated with semorinemab demonstrated a significant reduction in decline in cognition (ADAS-Cog11) relative to those treated with placebo (Lauriet study, NCT03828747). However, no treatment effects were observed on the co-primary functional endpoint (ADCS-ADL), the secondary endpoints (CDR-SB, MMSE), or on exploratory Tau PET endpoints. Longitudinal plasma and CSF samples were available from a subset of participants for fluid biomarker assessments. Objective(s): To determine the effects of chronic treatment with semorinemab on plasma total Tau, plasma phospho-Tau217, CSF total Tau, CSF phospho-Tau181, phospho-Tau217, and CSF N-terminal Tau in participants with mild-to-moderate AD. Method(s): Lauriet was a multicenter, double blind, placebo controlled study that enrolled 272 participants aged 50-85 years who fulfilled National Institute on Aging-alzheimer's Association criteria for probable AD dementia and had MMSE scores of 16-21 (inclusive) and global CDR scores of 1 or 2. Participants were initially randomized to receive monthly IV doses of either placebo or semorinemab (4500 mg) over 48 weeks, but the blinded dosing period was extended to 60 weeks for a subset of participants who experienced study disruptions attributable to the COVID-19 pandemic. CSF collection was optional;samples were obtained from 48% of participants at baseline and 20% of participants at Weeks 49 or 61. Total Tau, phospho-Tau181, and phospho-Tau217 were measured using qualified ELISAs. N-terminal Tau was measured using a targeted mass spectrometry method. Result(s): In participants treated with semorinemab, plasma total tau and plasma phospho-Tau217 levels increased substantially (>20-fold) compared to baseline, consistent with strong peripheral target engagement. Plasma total Tau plateaued by approximately Week 5, and plasma phospho-Tau217 peaked by Week 24. Levels for both Tau species remained elevated over the course of treatment. CSF samples were available from a subset of participants at baseline and either Week 49 or 61 (n=52) post treatment. These samples were analyzed for semorinemab exposure and four Tau indices: total Tau, pTau181, pTau217, and N-terminal Tau (amino acids 2-24;includes target epitope for semorinemab). Semorinemab pharmacokinetics in CSF and plasma were consistent with previously reported data from healthy volunteers and participants with prodromal-to-mild AD, including a mean CSF/serum ratio of 0.29% (SD 0.13). A reduction in CSF total Tau was observed with semorinemab but not placebo (change from baseline: placebo 1%, semorinemab-12%;p=0.01). Similarly, reductions in CSF pTau181 and pTau217 were observed with semorinemab but not in placebo at both Weeks 49 and 61 (pTau181 change from baseline: placebo-1%, semorinemab-14% p=0.01;pTau217 change from baseline: placebo +19%, semorinemab-27% p=0.01). No significant changes from baseline were observed for N-terminal Tau in either treatment group (change from baseline: placebo +3%, semorinemab +2%). Conclusion(s): In participants with mild-to-moderate AD, treatment with semorinemab resulted in increases in plasma tau levels and reductions in the levels of CSF tau species associated with AD pathology. These data provide further evidence that semorinemab engages and modulates Tau both peripherally and in the central nervous system in a manner consistent with what was previously reported from participants with prodromal-to-mild AD patients (Tauriel study, NCT03289143). The mechanistic interpretation of the observed reductions in CSF tau indices in both the Lauriet and Tauriel studies remains uncertain given that relative reductions in cognitive decline were seen with semorinemab treatment in mild-to-moderate AD (Lauriet) but not prodromal-to-mild AD (Tauriel). SS: Employee of Genentech, Inc., shareholder F. Hoffmann-La Roche, Ltd.

15.
Journal of Prevention of Alzheimer's Disease ; 9(Supplement 1):S235-S236, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2203898

RESUMO

Background: Trials in early alzheimer's disease (eAD) require the quantification of cognitive and functional progression. This is traditionally accomplished with in-clinic standard neuropsychological assessments administered via trained clinical professionals. Digital health technologies (DHT) tools now offer the possibility to collect complementary cognitive and functional information remotely and frequently. Online cognitive testing in lieu of in-person testing at site visits during the COVID-19 pandemic demonstrated the importance and feasibility of remote monitoring of cognition in clinical trials. Compared with traditional in-clinic assessments, remote assessments via DHTs enable the collection of a broader palette of cognitive and functional measures at higher frequency and in patients- home environments. However, these must demonstrate acceptability and participant adherence, as well as validation against standard clinical outcome measures and relevant biomarkers, before their broader use in clinical trials. Objective(s): The objectives were to determine the feasibility, acceptability, and adherence to remote monitoring via the AD Digital Assessment Suite (AD-DAS) in the AD continuum. Method(s): AD-DAS comprises 9 active tasks of cognitive and motor functioning and four survey questionnaires installed on a preconfigured study smartphone, along with a passive monitoring of behavior in daily life measured using sensors in participants- own smartphones. The 9 active tasks measure episodic memory, conceptual fluency and logical memory, executive functioning based on principles of the Trail-Making Test (TMT) and Stroop interference test, visuospatial working memory, attention and visual scanning behavior based on the Symbol Digit Modalities Test (SDMT), dual-task gait, semantic memory, psychomotor speed and language, and simple motor dexterity and reaction time. 4 survey questionnaires queried sleep quality, sociability, mood and orientation in time. Aspects of social cognition and functioning in daily life were measured with an optional smartphone application on participants- own smartphones. This application quantified participants- gait, life space, and sociability as measured by app usage from application logs. Participants included 32 amyloid PET negative healthy controls (HC Abeta-), 61 participants with subjective cognitive decline (SCD) (i.e., 31 SCDn who are Abeta-and 30 SCDp who are Abeta+) and 30 individuals with early alzheimer's disease (eAD Abeta+). They were recruited in two countries (USA and Spain) across 5 sites in 2 languages (English and Spanish) as part of the multicenter cross-sectional Proof-of-Concept (POC) study ( https://www.isrctn.com/ISRCTN17035495 ). Participants aged 65 and above underwent amyloid PET Abeta +/-classification and MRI for measurement of brain atrophy. All completed a battery of standard in-clinic neuropsychological, motor, activities of daily living, and health-related assessments. All 123 participants were instructed to perform a subset of 9 different active smartphone tasks and 4 survey questionnaires daily on the AD-DAS for a period of 28 days remotely without supervision. Participants acceptability and perceived difficulty of the AD-DAS tasks were assessed using an end-of-study visit questionnaire. Result(s): The primary results showed ~98% feasibility (i.e., 120 out of 123 participants successfully completed the study). Among the 120 who completed the study, the median adherence, defined as at least one task completed on a given day, was ~96% (i.e., corresponding to ~27 days) in the 28-day remote monitoring period. More than 85% of respondents rated their experience of using the study smartphone and the AD-DAS as 'good- or 'very good- on a 5-point Likert scale. Over 89% of participants agreed that the task instructions were clear and easy to follow. Participants took part in remote assessments for an average of 10.9 minutes per day, and the majority (~91%) rated their perceived burden as acceptable. No differences were observed in feasibility (percent completed: H : 97%, SCDn: 100%, SCDp: 100%, eAD: 93%), adherence (median (standard deviation) HC: 89% (+/-30%), SCDn: 96% (+/-24%), SCDp: 96% (+/-12%), eAD: 96% (+/-15%)), and acceptability (all groups- median Likert rating 4/5, i.e. 'good-) between groups. Little impact from the COVID19 pandemic was observed. Preliminary validity analyses indicate that age, sex, education, and site impact the cognitive and functional measures collected in the study. Conclusion(s): Primary outcomes of the AD-DAS POC study show excellent feasibility, good acceptability, and good adherence to performing remote cognitive and functional assessments in individuals on the early AD spectrum. This study shows the promise of using remote DHT to measure cognition and function in the real-world, without relying on participant or caregiver recall, and with relatively low burden to the trial participants. The AD-DAS aims to support future clinical trials by identifying target populations, stratifying subgroups of fast progressors, and providing sensitive cognitive measures of disease progression, to ultimately provide clinically meaningful outcomes for observational and interventional trials in preclinical and early AD.

16.
Journal of Prevention of Alzheimer's Disease ; 9(Supplement 1):S61, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2203897

RESUMO

Background: There is an urgent need to identify efficient and effective methods to increase the diversity of participants in alzheimer's disease treatment and prevention trials. Objective(s): To determine whether there are racial/ethnic group differences in response rate to a mailed recruitment letter inviting participation in a multi-modal lifestyle intervention trial to prevent cognitive impairment in older individuals with a high cardiovascular risk factor burden. Method(s): Two clinic systems at one of five sites implementing the U.S. POINTER trial identified potential age and medical history eligible trial participants through an electronic medical record (EMR) query. Participants received a recruitment letter describing the trial and directing them to a web site to begin the eligibility screening process. A major goal of recruitment was to achieve a demographically diverse patient population. To assess the success of a mailed letter campaign as a recruitment tool, we analyzed the response rates to the letter in different race/ethnicity groups, adjusting for age, sex, and neighborhood. Five neighborhoods were defined based on broad geographic regions containing distinct urban and suburban communities within a large metropolitan area. Result(s): Of 81,302 patients who were sent recruitment letters, 76,163 (93.9%) had complete EMR data for analysis. The most common missing variable was race/ethnicity. The racial/ethnic distribution of letter recipients was 45.3% non-Hispanic white (NHW), 25.2% Black/African American (AA), 16.6% Hispanic, and 12.9% other. Overall, 1.6% of letter recipients responded by providing screening information on the study website. The highest response rate was in NHW recipients (2.3%) and the lowest in Hispanic recipients (0.9%). Within ethnic group, the response rate varied by neighborhood. For example, in NHW recipients the response rate ranged from 1.5%-3.1% and in Hispanic recipients it ranged from 0.6%-1.3%. Except for one neighborhood with a lower response rate, the response rate in AA recipients was 1.4% regardless of neighborhood. In logistic regression modeling, age, sex, race/ethnicity, neighborhood, and clinic system were independent predictors of response rate. Of the 1246 responders, 44.5% represented racial/ethnic groups other than NHW. Conclusion(s): Although response rates may vary by ethnic group, mailed invitations to participate in a dementia prevention trial can yield a diverse study population. Oversampling of some groups to achieve desired recruitment targets can compensate for response rate variability among specific racial/ethnic group. Special methods, such as community engagement or bilingual recruitment materials, which have not yet been deployed at our clinical site for the U.S. POINTER study, may be needed to increase recruitment yields in certain groups. All demographic variables included in this analysis were associated with differential response rates, indicating that complex factors in addition to race/ethnicity drive recruitment yields in a particular clinical trial context. Some potentially relevant variables, such as education and household income, were not available in the EMR for inclusion in the analysis. Covid-19 surges throughout the recruitment period may have contributed to the observed variability in response.

17.
Journal of Prevention of Alzheimer's Disease ; 9(Supplement 1):S110-S111, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2203896

RESUMO

Background: Given limited progress in creating treatments for dementia, interest has increased in the possibility of dementia prevention through lifestyle interventions. A large number of factors that have been related to risk and protection from dementia, however, and patients may not be able to choose among confusing claims to develop their own brain health plans, and may have difficulty initiating and maintaining behavior change. We developed the Cogstim shared decision-making model to help patients and clinicians to address these issues. The model organizes brain health activities according to the putative mechanisms through which they affect brain health, lays out evidence-based criteria for activity choices, and integrates both with behavior change techniques. Further, during the COVID-19 pandemic it was difficult to do in-person education or support patients- behavior change efforts, making the development of an online intervention desirable. Objective(s): The purpose of this study was to carry out a test of the Cogstim model for dementia prevention delivered completely online. Persons receiving the model-based intervention were compared to a group receiving an educational intervention without structured goal setting and behavior change techniques. Method(s): Individuals 50 years of age and older were recruited from local organizations for older adults and by word of mouth from other participants. They completed baseline cognitive assessments and a series of self-report inventories evaluating mood, stress, and knowledge of dementia risk and protective factors. The primary outcome measure was score on the alzheimer's Disease Risk Inventory (ADRI) with secondary outcomes designated as self-reports on the Memory Self-Efficacy scale (MSE) and the Dementia Knowledge Scale, Risk subscale (DKAS). Acceptability of the intervention was assessed with a questionnaire based on the Technology Acceptance Model. Participants also completed exit and three-month follow-up interviews. Participants were randomly assigned to 12 weekly videoconference sessions of either (1) the Cogstim (CS) intervention, comprising structured goal setting, weekly review of goals, and problem-solving of behavior change strategies or (2) treatment as usual (TAU), comprising the same educational sessions without structured goal setting and support for behavior change. As part of the study, we tested a brain health tracking tool that asked participants to report daily brain health activities. Participants completed these logs for 7 consecutive days during weeks 1, 6, and 12 of the study. Change over time for outcome measures was assessed with mixed effects models in R, and group differences in report of brain health activities were evaluated using interrupted time series analyses (ITSA) completed in Stata. This study was registered on ClinicalTrials. gov (NCT04822129). Result(s): Eighteen individuals (6 men 12 women, 2 blacks and 16 whites, average age 72.7 years, average years of education 17.9) were enrolled;16 completed the study. Twelve completed all follow-up self-report questionnaires (5 in the TAU and 7 in the CS groups). For the primary outcome measure (ADRI), persons in the CS group showed larger increases than those in the TAU group, and although the difference did not reach statistical significance (t = 1.72, p = 0.11) it represented a large effect size (d > 1.00). Analyses for the two secondary measures (MSE, DKAS) showed no between-group differences (all ps > 0.20). The ITSA models for the composite Cogstim index of brain health activities showed a positive effect over time in both groups, suggesting that persons in both groups increased their brain health activities over time, but no between-group difference existed (linear trend for TAU: t = 2.73, p = 0.01, for CS: t = 3.12, p = 0.004;between group difference: t = 0.25, p = 0.81. On the Technology Acceptance Model (TAM) questionnaire, participants rated the intervention positively for both its usefulness (mean rating 5.38, SD 0.68, on a scale from 0 to 6, with 6 indicating a positiv rating) and ease of use (mean 5.33, SD 0.91). Test of group differences in TAM ratings did not suggest that group membership affected ratings (all ps > 0.10). All 16 completers provided interview data at immediate and three-month follow-up. Interviews showed that the intervention was viewed positively by participants. All 16 participants felt the program was helpful to them in developing better brain health, while 15 indicated they enjoyed the program. All stated they would to the program again. Conclusion(s): This pilot study shows that an online dementia prevention intervention based in the Cogstim model is feasible and acceptable to older persons. The Cogstim daily index may be useful to support self-monitoring persons developing a brain health plan. The Cogstim model provided a useful framework that supported participants- efforts at change, and this pilot study provides preliminary evidence of the intervention's a positive effect on participants- behavior.

18.
Journal of Prevention of Alzheimer's Disease ; 9(Supplement 1):S199-S200, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2203895

RESUMO

Background: Longitudinal studies in cognitively unimpaired individuals with biomarker evidence of alzheimer's pathology suggest that they show a greater rate of decline in performance on tests of memory and executive function, relative to individuals without such evidence. The recent shift towards preventative strategies in early-stage disease requires clinical trials with sensitive outcome measures suitable for detection of therapeutic effect. The ongoing CHARIOT-PRO Substudy aims to estimate the rate of cognitive change in the early alzheimer's pathological continuum, comparing individuals with and without baseline biomarker evidence of amyloid deposition (Abeta+ and Abeta-, respectively) over a 4.5 year follow up. The COVID-19 pandemic necessitated a shift to remote cognitive assessments over several months in 2020-2021. Here we present clinical outcome data through 36 months, comparing Abeta+ and Abeta- participants in both remote and in-person testing conditions. Objective(s): To compare longitudinal cognitive performance in unimpaired Abeta+ and Abeta-individuals, using the Preclinical alzheimer's Cognitive Composite (PACC). To assess whether the PACC's association with amyloid status remained evident under remote (rather than in-person) testing conditions. Method(s): Healthy, cognitively unimpaired individuals (60-85 years), with Clinical Dementia Rating (CDR) scale = 0, underwent amyloid assessment via PET or lumbar puncture;approximately equal numbers of Abeta+ and Abeta-individuals were enrolled. Cognitive outcomes were assessed with the PACC, comprised of the Free and Cued Selective Reminding Task (FCSRT;total + free recall), Logical Memory II (LMII) from the Wechsler Memory Scale, Coding, and the Mini-Mental State Exam. The PACC was calculated as the sum of the z scores for each component calculated relative to the baseline mean and standard deviation for the entire sample. The PACC was obtained in screening and at baseline, and every 6 months thereafter. During the pandemic, remote assessments were conducted by videoteleconference. Verbal stimuli were presented by computer audio or phone. Visual stimuli were displayed via webcam or Power-Point and responses were recorded on forms unsealed at the time of the visit and were captured as screenshots by raters. Change from baseline was analyzed using a mixed effects model for repeated measures (MMRM) with amyloid status (negative, positive), visit, education level (9-12 years, college), APOE 4 status (non-carrier, carrier) and visit-by-amyloid status interaction as factors, and age, hippocampal volume, and baseline value as covariates. Changes from baseline were calculated separately for remote and in-person testing in Abeta+ and Abeta- participants and were summarized with descriptive statistics. Result(s): A total of 258 Abeta+ and 261 Abeta- participants were enrolled in the study. At baseline, Abeta+ participants were older (mean (sd): Abeta+ =72.4y (5.7) vs Abeta- = 70.4y (5.3), p<0.00001), were more likely to be ApoE 4 carriers (Abeta+ = 55.6% vs Abeta- =23.0%, p<0.001), and had lower scores on the PACC (Abeta+ = -0.40 (2.6) vs Abeta- =0.39 (2.7), p=0.001). Due to Covid-19, in-person visits were suspended from March 2020 to May, 2021. During these 14 months, 364 remote PACC assessments for Month 18, 24, 30, and 36 visits were carried out. As participants were at various timepoints in the study, the proportion of remote assessments within each visit window increased from 45 (9.6%) at Month 18 to 154 (44%) at Month 36. Performance on the PACC surpassed baseline at every visit in both groups with maximum mean change at Month 18 of +1.15 (Abeta-) and +0.64 (Abeta+). There was greater improvement for Abeta- than for Abeta+ participants at every visit, with statistically significant differences 18 months (LS mean difference [SE] = 0.39 [0.18], p=0.032), 30 months (0.54 [0.22], p=0.016), and 36 months (0.84 [0.20], p<0.001). Differences between Abeta+ and Abeta- in mean change from baseline were approximately the same magnitude for those that had in-person assessment (+1.03 Abeta- vs. +0.15 Abeta+ at Month 36) vs those that were tested remotely (+1.19 Abeta-vs. +0.37 Abeta+ at Month 36). Across both amyloid groups, mean PACC scores were lower at Month 18 for participants that had remote testing (0.04 Abeta-;-1.04 Abeta+) compared to those that had in-person testing (1.80 Abeta-;0.51 Abeta+) but were comparable between the testing conditions at Months 24, 30, and 36. The difference at Month 18 appeared to arise from lower performance in coding and on the MMSE for remote testing, with minimal difference apparent for the FCSRT and the LMII. Discussion(s): In these cognitively unimpaired individuals, performance on the PACC improved over 36 months, though to a significantly greater extent in Abeta- than Abeta+ participants, consistent with differential practice effects previously reported on the first 2 administrations of the RBANS in this cohort. Though there were differences in performance between remote and in-person testing, the effects of amyloid status were similar in magnitude in both testing conditions. These findings highlight the value of the PACC as a sensitive measure for clinical trials and raises important consideration regarding remote versus in-person cognitive testing.

19.
Journal of Prevention of Alzheimer's Disease ; 9(Supplement 1):S90-S91, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2203894

RESUMO

Background: Tau acetylation at Lys174 may impair tau clearance and is an early pathological change present in patients with alzheimer's disease (AD) and murine models of tauopathy. Salsalate is a nonsteroidal anti-inflammatory (NSAID) which inhibits p300 acetyltransferase and thereby reduces tau acetylation. In a PS19 transgenic mouse model of tauopathy, salsalate treatment lowered p300 activity, decreased acetylation at Lys174, decreased total tau levels, increase tau turnover, reduced memory deficits, and prevented hippocampal atrophy. Given salsalate's potential utility in a preclinical model, we sought to conduct a phase 1b randomized, double-blind, placebO'Controlled of salsalate in patients with mild to moderate alzheimer's disease. Objective(s): The primary objective was to assess the safety and tolerability of salsalate in patients with mild to moderate AD. Secondary objectives were to assess blood and CSF pharmacokinetic (PK) measures of salsalate. Exploratory objectives included assessment of salsalate's pharmacodynamic (PD) impact on cerebrospinal fluid (CSF) biomarkers of AD severity (total tau [t-tau], phosphorylated tau [p-tau181], and amyloid beta [Abeta1-42] measured on the Elecsys platform), CSF neurofilament light chain [NfL], CSF acetylated tau, CSF acetylated histones, measures of AD clinical severity, volumetric brain MRI measures, and brain uptake of 18F-MK6240 positron emission tomography (PET) tracer. Method(s): N=40 patients with biomarker confirmed (via amyloid PET or CSF amyloid and tau) AD and mild to moderate dementia (Mini Mental Status Exam [MMSE] Scores>=14) were enrolled from August 2017 to February 2020 at University of California, San Francisco, and University of California, San Diego. Patients were randomized 1:1 to one year of blinded treatment with either placebo or salsalate 3000 mg daily. CSF, plasma, volumetric imaging, and exploratory clinical measures were collected at baseline, 6 months, and 12 months. The final 21 participants were enrolled in a secondary cohort that included assessment with brain 18F-MK6240 PET imaging at baselined and at 12 months of treatment. Linear mixed effect models determined interactions between treatment assignment (salsalate vs placebo) and time in determining change in exploratory measures. Result(s): Patients randomized to salsalate and placebo were comparable in terms of baseline mean age (66.7 [SD 8.5] years vs 65.8years [10.5] respectively), gender distribution (12 women/8 men, 13 women/7 men), Clinical Dementia Rating Scale (CDR) global score (0.9 [0.4]) vs 0.8 [0.4]), MMSE score (20.8 [5] vs 21.1 [4.5]), CSF total tau (353.9pg/ml [154.6] vs 349.4pg/ml [225.3]), CSF p-tau181 (34.7pg/ml [15.7] vs 34.2pg/ml [24.3]), and CSF NfL (1571.2pg/ml [746.7] vs 1362.5pg/ml [504.8]). However, patients randomized to salsalate tended to have a greater baseline cognitive impairment on the eleven item alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS Cog 11) (45.4 [16.1] vs 38.4 [12.3], p=0.016), and lower baseline CSF Abeta1-42 values (447.7pg/ml [142.0] vs 536.4pg/ml [151.4], p=0.01). The trial experienced a high rate of early discontinuations (45%) in the context of the COVID-19 pandemic;the number of early terminations was higher in patients randomized to salsalate (n=11) compared to the placebo group (n=7;Fisher's exact test p=0.043). The number of patients who experienced adverse events was otherwise similar between cohorts (salsalate n=16, placebo n=15). In intention-to-treat and on treatment analyses, no beneficial effects of salsalate treatment were observed on 52-week changes in CSF biomarkers of AD biology (t-tau, p-tau181, Abeta1-42), NfL, or acetylated tau;or on clinical endpoints. Further analyses of primary, secondary, and exploratory endpoints including tau PET are ongoing and will be presented. Conclusion(s): Salsalate was safe and well tolerated, without evidence of beneficial treatment effects on CSF biomarkers or clinical measures. Further analysis of PK and PD results (including tau PET to evaluate target engagement) a e pending. The trial's high dropout rate and baseline differences in cohorts may have impacted the interpretability of the results.

20.
Journal of Prevention of Alzheimer's Disease ; 9(Supplement 1):S104, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2203893

RESUMO

Background: Hearing and vision impairments are highly prevalent in people with dementia (PwD) and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimise sensory impairment and support sensory function may be a means of improving dementia-related outcomes. The SENSE-cog Trial evaluated whether a home-based multi-part 'sensory support- intervention (SSI) is effective in improving quality of life and other key outcomes in PwD (including hearing and/or vision problems), and their companions. Method(s): This was a pan-European, multi-centre, observer blind, randomised controlled trial (RCT), of PwD with hearing and/or vision impairment and their companions. We evaluated a multi-part complex intervention of hearing and vision rehabilitation tailored to each participant dyad, compared to care as usual (CAU). The intervention included at a minimum: assessment and correction of hearing and/or vision impairments;home-based, therapist-delivered sensory support (i.e., adherence with devices;improving the sensory environment (i.e., lighting), communication training, and signposting to other support agencies. Result(s): Across 7 centres in the UK, Ireland, Greece, France and Cyprus, 291 participants with dementia were randomised from May 2018 to May 2021 to receive either 'care as usual-, or a multi-component sensory intervention (10 visits over 18 weeks). Mitigating strategies to adapt study procedure to the COVID-19 pandemic were implemented. No significant difference in Quality of Life at 36 weeks was found. Average DEMQoL scores at week 36, adjusted for model covariates, were lower (poorer quality-of-life) in the CAU group but, at most, by 0.3 units/ points. A significant difference was observed in Quality of Life at 18 weeks. The average DEMQoL scores at week 18, adjusted for model covariates, were lower in the CAU group by between 2.6 and 2.7 units/ points. There were no Significant differences in care burden, activities of daily living or hearing impairment at 36 weeks, as assessed by the care companion were also not observed. No serious adverse effects were related to the intervention;low grade adverse effects related to the intervention were reported by five participants only. Conclusion(s): Hearing and vision support and rehabilitation in PwD living at home is a potentially important means of improving the lived experience of dementia and may represent a critical step in the diagnostic and post-diagnostic care pathway. However, effects may not be sustained over the longer term. Trial registration: ISRCTN (Trial ID: ISRCTN17056211).

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