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Abstract Background Rather than being perceived as merely ‘part of the problem’, the perspectives and experiences of young people play a pivotal role in devising effective solutions for mental health challenges. Two distinct methodologies that aid in this endeavour are ‘patient and public involvement’ (PPI) and ‘responsible research and innovation’ (RRI). However, there is a tendency to conflate PPI and RRI practices, leading to ambiguity in their application. Moreover, the extent and nature of young people’s involvement in mental health-related projects (namely: research, intervention, product development) employing these methodologies, and the subsequent implications thereof, remain unclear. Consequently, the proposed scoping review aims to identify and analyse literature pertaining to PPI and RRI approaches in mental health projects that engage young people in collaboration. Methods The selected databases will be MEDLINE, PsycINFO, PsycArticles, Scopus, Web of Science, IBBS, CINAHL (EBSCO) and ASSIA. Comprehensive searches will span from the inception of each database. A pilot test will be conducted to assess the screening criteria and data extraction form, with two authors independently reviewing titles and abstracts. Full-text articles meeting the inclusion criteria will undergo narrative syntheses, with results presented in tabular format. Feedback on the findings from a youth perspective will be sought from young people within our broader research network, namely Sprouting Minds. The review will adhere to the guidelines outlined by the Joanna Briggs Institute (JBI) and follow the PRISMA-ScR procedures. Inclusion criteria will comprise English-language, primary research peer-reviewed articles focused on Patient and Public Involvement (PPI) or Responsible Research and Innovation (RRI), examining mental health-related research processes, interventions, and products developed in collaboration with young people. Studies employing quantitative, qualitative, and mixed-methods approaches will be considered, while non-journal publications will be excluded. Discussion The intended scoping review aims to map the literature concerning mental health-related projects that engage with young people through PPI or RRI approaches. The outcomes hold promise for enriching the participatory research domain, particularly in studies centred on young people and their mental well-being. Furthermore, by delineating potential overlaps and distinctions between PPI and RRI, the findings stand to aid mental health researchers and practitioners in making informed decisions about the most suitable approach for their projects when partnering with young individuals. Systematic review registration Open Science Framework (registration: DOI https://doi.org/10.17605/OSF.IO/N4EDB ).

Abstract Transesophageal echocardiography (TEE) has been the preferred imaging modality to help guide left atrial appendage closure. Newer technologies such as the Nuvision 4D Intracardiac echocardiography (ICE) catheter allow for real-time 3D imaging of cardiac anatomy. There are no direct comparison studies for procedural imaging between TEE and 4D ICE. To evaluate the performance and safety of left atrial appendage (LAA) closure procedures with the Watchman FLX and Amulet, guided by the Nuvision 4D ICE Catheter. This retrospective observational analysis was conducted on institutional LAAO National Cardiovascular Data Registry from January 2022 to March 2023. Patients had undergone LAA closure procedures with the Watchman FLX or Amulet device guided by TEE or a 4D ICE Catheter. The primary outcome evaluated was successful LAAO device placement. A total of 121 patients underwent LAAO device placement with 46 (38.0%) patients guided by 4D ICE during LAAO implantation. The 4D ICE group had a shorter procedural time compared with TEE guidance. Post procedural 45-day TEE post implant was also comparable for both groups with no patients in either group having incomplete closure of the left atrial appendage and peri-device leak > 5 mm. No device related complications (device related access, stroke, or pericardial effusion) occurred in either group at follow-up. There was no significant difference in device implant success or post procedural outcomes at 45 days in either the TEE or 4D ICE group. However, there was a noticeable improvement in procedural time with the 4D ICE catheter.

key Clinical Message Constrictive Pericarditis is a rare fibrotic conversion of the pericardium that results in non‐specific clinical symptoms such as hepatomegaly, ascites, pleural effusions, and lower extremity edema. A multi‐modal diagnostic approach with cardiac imaging tools, cardiac hemodynamic measurements, and tissue biopsy can be used to diagnose Constrictive Pericarditis. Abstract Constrictive Pericarditis is a rare complication resulting in the fibrotic conversion of the pericardium secondary to idiopathic, infective, post‐surgical, or post‐radiation etiologies. The rigid and restrictive nature of the pericardium can result in non‐specific symptoms of volume overload that can mimic liver cirrhosis or congestive heart failure. We present the case of a 73‐year‐old female with constrictive pericarditis who presented with vague symptoms of abdominal pain, abdominal bloating, and bilateral lower extremity edema. This case report highlights the clinical manifestation, invasive, and non‐invasive diagnostic work‐up, and management of constrictive pericarditis.

Introduction Heterogeneity in reported outcomes of infants with oesophageal atresia (OA) with or without tracheo-oesophageal fistula (TOF) prevents effective data pooling. Core outcome sets (COS) have been developed for many conditions to standardise outcome reporting, facilitate meta-analysis and improve the relevance of research for patients and families. Our aim is to develop an internationally-agreed, comprehensive COS for OA-TOF, relevant from birth through to transition and adulthood.Methods and analysis A long list of outcomes will be generated using (1) a systematic review of existing studies on OA-TOF and (2) qualitative research with children (patients), adults (patients) and families involving focus groups, semistructured interviews and self-reported outcome activity packs. A two-phase Delphi survey will then be completed by four key stakeholder groups: (1) patients (paediatric and adult); (2) families; (3) healthcare professionals; and (4) researchers. Phase I will include stakeholders individually rating the importance and relevance of each long-listed outcome using a 9-point Likert scale, with the option to suggest additional outcomes not already included. During phase II, stakeholders will review summarised results from phase I relative to their own initial score and then will be asked to rescore the outcome based on this information. Responses from phase II will be summarised using descriptive statistics and a predefined definition of consensus for inclusion or exclusion of outcomes. Following the Delphi process, stakeholder experts will be invited to review data at a consensus meeting and agree on a COS for OA-TOF.Ethics and dissemination Ethical approval was sought through the Health Research Authority via the Integrated Research Application System, registration no. 297026. However, approval was deemed not to be required, so study sponsorship and oversight were provided by Alder Hey Children’s NHS Foundation Trust. The study has been prospectively registered with the COMET Initiative. The study will be published in an open access forum.

Abstract This work aims to investigate how smoking exerts effect on the development of inflammatory bowel disease (IBD). A prospective cohort study and a Mendelian randomization study are first conducted to evaluate the association between smoking behaviors, smoking-related DNA methylation and the risks of Crohn’s disease (CD) and ulcerative colitis (UC). We then perform both genome-wide methylation analysis and co-localization analysis to validate the observed associations. Compared to never smoking, current and previous smoking habits are associated with increased CD (P = 7.09 × 10−10) and UC (P

Background & Aims: There is great current interest in the potential application of DNA methylation alterations in peripheral blood leukocytes (PBLs) as biomarkers of susceptibility, progression, and treatment response in inflammatory bowel disease (IBD). However, the intra-individual stability of PBL methylation in IBD has not been characterized. Here, we studied the long-term stability of all probes located on the Illumina HumanMethylation EPIC BeadChip array. Methods: We followed a cohort of 46 adult patients with IBD (36 Crohn’s disease [CD], 10 ulcerative colitis [UC]; median age, 44 years; interquartile range [IQR] 27–56 years; 50% female) that received standard care follow-up at the Amsterdam University Medical Centers. Paired PBL samples were collected at 2 time points with a median of 7 years (range, 2–9 years) in between. Differential methylation and intra-class correlation (ICC) analyses were used to identify time-associated differences and temporally stable CpGs, respectively. Results: Around 60% of all EPIC array loci presented poor intra-individual stability (ICC

Boards of pharmacy have the authority to discipline licensees whose actions fall short of practice standards. Disciplinary action may include license suspension, revocation, practice restrictions, fines and reprimands. Once discipline is levied against a board of pharmacy licensee, it is usually part of the licensee’s permanent record. At least four states have created a pathway for individuals to seek expungement of previous disciplinary actions levied by a board of pharmacy. These states have variations on what violations may be expunged and when. Given the evolving approach to the regulation of pharmacists, more states may want to consider expungement pathways in the years ahead.

Introduction: Healthcare-associated infections (HAI) after viral illnesses are important sources of morbidity and mortality. This has not been extensively studied in hospitalized COVID-19 patients. Methods: This study included all COVID-19-positive adult patients (≥18 years) hospitalized between 01 March and 05 August 2020 at the current institution. The Centers for Disease Control and Prevention definition of HAI in the acute care setting was used. The outcomes that were studied were rates and types of infections and in-hospital mortality. Several multivariable logistic regression models were constructed to examine characteristics associated with development of HAI. Results: Fifty-nine (3.7%) of 1565 patients developed 140 separate HAIs from 73 different organisms: 23 were Gram-positive, 39 were Gram-negative and 11 were fungal. Patients who developed HAI did not have higher odds of death (OR 0.85, 95% CI 0.40–1.81, p = 0.69). HAIs were associated with the use of tocilizumab (OR 5.04, 95% CI 2.4–10.6, p

OBJECTIVES/GOALS: The COVID-19 pandemic impacted health systems and exposed disparities in access to health care among underserved populations. We examined how the pandemic shaped social, mental, and physical health among Native American and Latino communities in rural and underserved areas. METHODS/STUDY POPULATION: Using Theory of Planned Behavior, Social Cognitive Theory, and Social Contextual Factor frameworks, we developed interview guides to examine perceptions of the COVID-19 pandemic on social, mental, and physical health among community members. Stakeholders of the Confederated Salish and Kootenai Tribes of the Flathead Reservation in Montana and the Hispanic/Latinx population in Yakima Valley in Washington were selected through purposeful community-engagement. A total of six focus group discussions and 30 key informant interviews were administered in both communities. A codebook was developed and deductive coding was applied to informant responses, followed by an inductive, constant comparison approach. The codebook was further refined and inter-rater agreement was completed by three analysts. RESULTS/ANTICIPATED RESULTS: Four themes were highlighted as areas impacted by the COVID-19 pandemic (mental and physical health, family dynamics, and social disruptions) with few differences among geographic areas or between focus group (n=39) and key informant (n=28) participants. Perceived impacts on mental health included increased stress, anxiety, and depression, while pandemic-related lifestyle or family changes impacted physical health. Participants reported changes to family routines and dynamics due to staying home, social distancing, and more frequent interactions inside or limited interactions outside the household respectively. Social distruptions reported included impacts on finances, employment, and household staples, though participants highlighted how many community members stepped up to help those in need. DISCUSSION/SIGNIFICANCE: The COVID-19 pandemic had similar impacts on two geographically distinct underserved communities in Montana and Washington. Understanding the community’s experience with the COVID-19 pandemic is critical to identify strategies to support families, community needs, and mental and physical health in underserved communities.

OBJECTIVES/GOALS: Despite efforts to improve COVID-19 health outcomes through testing and vaccination, SARS-CoV-2 has exacerbated health disparities in underserved populations. Through this study we examined socio-contextual factors impacting decisions to test for COVID-19 among Native Americans in the Flathead Reservation and Hispanics in the Yakima Valley. METHODS/STUDY POPULATION: A series of 28 key informant interviews and 6 focus groups (N=39 focus group participants) were completed with community and tribal leaders using an interview guide informed by the Theory of Planned Behavior, Social Cognitive Theory, and the Social Contextual Factor Frameworks. The interview guide was designed to examine the socio-contextual factors impacting decisions to test for COVID-19 among Native Americans and Hispanics in the Northwest. A codebook was developed to apply deductive coding to informant responses, followed by an inductive, constant comparison approach. Three analysts met to refine the codebook and conduct inter-rater agreement. RESULTS/ANTICIPATED RESULTS: Five themes (social, cultural, health, religious and political factors) were identified that impacted testing for COVID-19. For social factors, participants discussed the influence of families and friends and unfair employment practices influencing decisions to test. Cultural factors included deep rooted distrust for the government and historical trauma. Health factors participants reported included the importance of testing to save lives, distrust for medical system, and health communications around COVID-19 affecting decisions to test. There was some interaction between religious and political factors. While participants mentioned beliefs in putting things in God’s hands, some decisions to test seemed to be affected by their political views. DISCUSSION/SIGNIFICANCE: Several socio-cultural factors influence decisions to test for COVID-19. Understanding the community’s perception of COVID-19 testing is critical for successful implementation of preventive strategies.

Pharmacy has traditionally been a highly regulated profession. In a recent study, the state with the largest pharmacy regulatory word count had 6.7 times as many words as the state with the lowest word count. Given the wide variation in state pharmacy regulations, this paper seeks to spark discussion on how we can assess public safety outcomes in states based on the overall volume of pharmacy regulation with a focus on: 1) fitness to practice; 2) controlled substance outcomes; and 3) compounding safety. In examining these categories, existing data sources are limited and suboptimal, though formal disciplinary actions against pharmacy licensees are very infrequent. Thus, it seems preferable for states to have a regulatory framework that allows boards of pharmacy to deal with the rare public safety issues that occur, while not holding back the vast majority of pharmacists from practicing to the top of their education and training.

Herpes labialis, commonly known as cold sores, is an infection of the mouth and surrounding area. Antiviral therapy can be used to block viral replication, which shortens the duration of symptoms, facilitates resolution of lesions, and lessens the risk of spreading the virus. Increasing access to antivirals targeted against herpes labialis by allowing assessment and prescribing by a pharmacist may decrease time to treatment for HSV-1, and improve patient satisfaction. Experience from Canada, Australia, New Zealand and the United States demonstrate that pharmacist management of cold sores has a safe track record and may be considered by other jurisdictions. Commentary

Nearly all states require that each licensed pharmacy designate a pharmacist-in-charge (PIC). By law, the PIC typically has responsibility for all professional practice laws and facility standards laws and can be held accountable for such. However, the extent to which the PIC has actual authority over many facility standards varies by organization. This can seemingly put a target on the back of the PIC for decisions they wield little authority over. Idaho recently removed the legal references to the PIC, signaling that facilities are responsible for facility standards and insulating pharmacists from discipline for matters that are outside their control. Letter

Objective: Explore the intersection of the Pharmacists’ Patient Care Process (PPCP) and state laws in order to identify laws that may impede the delivery of optimal patient care. Summary: A review of the PPCP identified six areas in which state laws can limit full pharmacist engagement: 1) ordering and interpreting laboratory tests; 2) participating in a collaborative practice agreement; 3) independently prescribing certain medications; 4) independently adapting medications; 5) administering medications; and 6) effective delegation. A framework is put forth to organize how these scope of practice matters are interrelated. Conclusion: For pharmacists to fully engage in the PPCP, state laws must enable full participation. By unleashing pharmacists to fully engage in the process, patient care delivery and outcomes can be improved, and total health care costs can be reduced. Article Type: Commentary

Purpose. To describe the potential role for pharmacy technicians in administering immunizations – limited for this discussion to specifically inserting the needle into the patient’s arm and pressing down on the plunger – at the discretion of a supervising pharmacist as a way to enhance patient care and workflow efficiency. Summary. Pharmacy technicians currently play an important role in facilitating pharmacy-based immunization programs. Technicians routinely perform non-clinical tasks related to pharmacy-based immunizations, though nearly all states prohibit technicians from administering vaccines. Several studies demonstrate that untrained laypersons can safely administer intranasal or intradermal vaccines, and laypersons routinely administer medications through intramuscular or subcutaneous routes (e.g., patients with diabetes or rheumatic conditions). It stands to reason that a trained pharmacy technician could perform comparably on these techniques that laypersons have mastered. One state has adopted rules to allow pharmacy technicians to administer immunizations if the technician has completed specific training on administration techniques and on basic life support. This task is performed at the discretion of the supervising pharmacist, and the pharmacist would still be responsible for clinical aspects of immunizing such as prescribing the right vaccine to the right patient. Additional considerations factoring into the decision as to whether or not to involve pharmacy technicians in immunization administration are also summarized. Conclusion. If safety can be reasonably assured through training and supervision, it may be appropriate to delegate vaccine administration to appropriately trained pharmacy technicians. Such delegation may enhance workflow efficiency, which may confer added value for patient care and potentially improve access to community pharmacy-based immunizations. Type: Commentary

The Mantoux Tuberculin Skin Test (TST) is the standard method for detecting latent tuberculosis and has been provided by pharmacists since at least 2006. In the largest published study of pharmacy-based TST involving 578 patients, the most common reason for obtaining the test were employment or school requirements.Pharmacists have demonstrated high rates of follow-up for the reading of the test, reported to be 92.8% to 94.4%. The biggest barrier to pharmacy-based TST is that a prescription is required for the two tuberculosis (TB) purified protein derivative products available on the market in the United States. States have adopted three strategies to enable pharmacy-based TST prescribing: 1) collaborative practice agreements; 2) statewide protocols; and 3) independent prescribing. These three approaches are reviewed, with a focus on the New Mexico statewide protocol and the recent statutory authority in Idaho that grants pharmacists independent prescriptive authority for TST. States may consider pursuing more autonomous models of TST prescribing given the safety and track record of this service at pharmacies. Type: Commentary

Objective: To determine any differences in career paths and career attributes of pharmacists who have completed a PGY1 community pharmacy residency program (CPRP) as compared to those that have not completed a PGY1 CPRP. Methods: A web-based survey evaluating various aspects of community pharmacists' careers was distributed to 274 CPRP graduates in addition to a random sample of 7,376 community pharmacists. The survey contained 32 questions evaluating various career attributes. Questions that assessed level of agreement were on a 6-point Likert-type Scale (1=strongly disagree; 6=strongly agree). Results: A total of 353 participants completed the survey, with 224 indicating that they had not completed a CPRP. Pharmacists who completed a CPRP responded that they spend significantly more time on patient care services, teaching, and research, and spend less time dispensing medications compared to those that have not completed a CPRP. Compared to those that did not complete a CPRP, CPRP graduates were less likely to agree that current level of workload negatively impacts job performance, motivation to work, job satisfaction, mental/emotional health, and physical health. Conclusion: Pharmacists completing a CPRP noted significant differences in their current employment and job responsibilities. Additional expansion and education regarding the importance of CPRPs should be considered. Type: Original Research

Background Chronic obstructive pulmonary disease affects nearly 400 million worldwide – over a million in the United Kingdom – and is the third leading cause of death. However, there is limited understanding of what prompts a diagnosis, how long this takes from symptom onset and the different approaches to clinical management by primary care professionals. Objectives Map out the clinical management and National Health Service contacts from symptom presentation to chronic obstructive pulmonary disease diagnosis and first acute exacerbation of chronic obstructive pulmonary disease in three time periods; construct risk prediction for first acute exacerbation of chronic obstructive pulmonary disease. Design Retrospective cohort study and cross-sectional survey. Setting Primary care. Participants Patients with incident chronic obstructive pulmonary disease aged > 35 years in England. Interventions None. Main outcome measures First acute exacerbation of chronic obstructive pulmonary disease. Data sources Clinical Practice Research Datalink Aurum; new online survey. Results Forty thousand five hundred and seventy-seven patients were diagnosed between April 2006 and March 2007 (cohort 1), 48,249 between April 2016 and March 2017 (cohort 2) and 4752 between March and August 2020 (cohort 3). The mean (standard deviation) age was 68.3 years (12.0); 47.3% were female. Around three-quarters were diagnosed in primary care, with a slight fall in cohort 3. Compliance with National Institute for Health and Care Excellence diagnostic guidelines was slightly higher in cohorts 2 and 3 for all patients; 35.8% (10.0% in the year before diagnosis) had all four elements met for all cohorts combined. Multilevel modelling showed considerable between-practice variation in spirometry. The survey on the charity website had 156 responses by chronic obstructive pulmonary disease patients. Many respondents had not heard of the condition, hoped the symptoms would go away and identified various healthcare-related barriers to earlier diagnosis. Clinical Practice Research Datalink analysis showed notable changes in post-diagnosis prescribing from cohort 1 to 2, such as increases in long-acting muscarinic antagonist (21.7–46.3%). Triple therapy rose from 2.9% in cohort 2 to 11.1% in cohort 3. Documented pulmonary rehabilitation rose from just 0.8% in cohort 1 to 13.7% in cohort 2 and 20.9% in cohort 3. For all patients combined, the median time to first acute exacerbation of chronic obstructive pulmonary disease in patients who had one was 1.4 years in cohorts 1 and 2. Acute exacerbation of chronic obstructive pulmonary disease prediction models identified some consistent predictors, such as age, deprivation, severity, comorbidities, post-diagnosis spirometry and annual review. Models without post-diagnosis general practitioner actions had a c-statistic of around 0.70; the highest c-statistic was 0.81, for cohort 2 with post-diagnosis general practitioner actions and 6-month follow-up. All models had good calibration. The three most important predictors in terms of their population attributable risks were being a current smoker and offered smoking cessation advice (32.8%), disease severity (30.6%) and deprivation (15.4%). The highest population attributable risks for variables with adjusted hazard ratios