Community pharmacists' views and experiences of delivering in-pharmacy medication reviews for people living with severe and persistent mental illness: a qualitative study.

BACKGROUND: People living with severe and persistent mental illness (SPMI) often take multiple medications and are at risk of experiencing medication related problems. Medication review services have the potential to reduce inappropriate use of psychotropic medications and improve adherence. However, there is limited research regarding pharmacists' perspectives when providing such services. AIM: To explore community pharmacists' views and experiences of providing an in-pharmacy medication review (MedsCheck) for people living with SPMI. METHOD: Semi-structured interviews were conducted between November 2021 and May 2022 with community pharmacists participating in the comparator group of the PharMIbridge Randomised Controlled Trial (RCT), which aimed to improve medication adherence and manage physical health concerns for people living with SPMI. Interviews were recorded, transcribed, and analysed using inductive thematic analysis. RESULTS: Fifteen semi-structured interviews were conducted with community pharmacists including pharmacy owners, managers and employee pharmacists. Most pharmacist participants who were interviewed (n = 10) were aged under 39 and more than half (n = 8) had 10 or more years of pharmacy experience. Five key themes were identified: 1) Pharmacists' roles in the management of SPMI in community pharmacy; 2) Mental health education and training; 3) Pharmacy resources; 4) Challenges with interprofessional collaboration and 5) Impact on professional relationships and consumer outcomes. CONCLUSION: Pharmacists are motivated to support people living with SPMI. Mental health training, as well as arrangements regarding pharmacy workflow and appropriate remuneration are needed to enable pharmacists to better support people living with SPMI. Referral pathways should be directly accessible by community pharmacists to assist interprofessional collaboration.

Exploring the implementation of a novel community pharmacist-led support service for people living with severe and persistent mental illness.

BACKGROUND: Community pharmacists are well-placed to promote and provide mental health medication management services. However, literature evaluating the impact of pharmacy services in supporting people living with severe and persistent mental illness (SPMI) is currently limited. An individualised, goal-oriented pharmacist-led support service that focused on improving the physical and mental health of consumers living with SPMI, namely the PharMIbridge intervention, was provided to consumer participants as part of the PharMIbridge Randomised Controlled Trial (RCT). OBJECTIVE(S): To explore the experiences of the participants who delivered and supported the implementation of the PharMIbridge intervention and propose ideas and supports needed for broader implementation and sustainability of pharmacist-led support services for people living with SPMI. METHODS: Interviews and focus group discussions were undertaken with PharMIbridge pharmacists and mentors, respectively. Audio-recordings were de-identified and transcribed verbatim. Data analysis was conducted using an iterative, inductive approach. The key themes identified were furthered divided into subthemes. Subthemes were then mapped to the EPIS (Exploration, Preparation, Implementation and Sustainment) framework. RESULTS: Data were collected from one focus group involving six RCT mentors and 16 semi-structured interviews with community pharmacists. Five overarching themes emerged: "Training needs", "Pharmacist integration within the healthcare system", "Environmental factors", "Attitudes and behaviour" and "Pharmacy operations". Twelve subthemes were mapped to EPIS phases "Preparation", "Implementation" and "Sustainment" and EPIS constructs "Outer" context, "Inner" context and "Bridging" factors. CONCLUSION: Adequate remuneration and supports to encourage healthcare professional collaboration are necessary to establish and sustain functioning, integrated pharmacy mental health services. A shift in pharmacy business and workflow models is necessary to support community pharmacies to implement mental health services. In addition, there is a need to promote psychological support services to ensure that pharmacists are well supported while delivering pharmacy mental health services.

Stakeholder perspectives on electronic prescribing in primary care: A scoping review.

BACKGROUND: Electronic prescribing (e-prescribing) provides a convenient, efficient, paperless mechanism for the legal transfer of prescriptions between service users, prescribers, and dispensers. There have been advances in e-prescribing processes and increased uptake of e-prescribing globally, in recent years. OBJECTIVE: To explore stakeholder perspectives on e-prescribing in primary care settings. METHODS: A scoping review was conducted by systematically searching Medline, EMBASE, Scopus, and International Pharmaceutical Abstracts databases, using the key concepts "primary care", "e-prescribing", and "perspectives". Publications were selected by screening for eligibility against inclusion and exclusion criteria, whereby any publication written in English exploring e-prescribing in primary care settings from the perspective(s) of at least one type of stakeholder was eligible for inclusion. Following a systematic screening process, relevant data were extracted, collated, and synthesized. RESULTS: Two thousand publications were identified and systematically screened, rendering 44 publications (e.g., primary research articles, abstracts) eligible for inclusion in this review. Most publications reported on studies conducted in the USA, the UK, and Europe and explored the views of pharmacists, pharmacy technicians, and pharmacy staff. Barriers to e-prescribing included system design and technical issues, lack of adequate training and communication issues between stakeholders. Enablers for e-prescribing included time savings, convenience, and increased legibility of prescriptions. CONCLUSIONS: This review highlights many benefits of e-prescribing such as time efficiency, convenience, increased legibility, and less mishandling. Despite this, key barriers to e-prescribing within primary care settings were also recognized, including system design, technical issues, and lack of adequate training. As such, forcing functions, prescription tracking technologies, and better training have been identified as potential ways to address these barriers. While some negative experiences were reported, stakeholders were generally satisfied and had positive experiences with e-prescribing.

Are SMART goals fit-for-purpose? Goal planning with mental health service-users in Australian community pharmacies.

Goal planning is an important element in brief health interventions provided in primary healthcare settings, with specific, measurable, achievable, realistic/relevant, and timed (SMART) goals recommended as best practice. This study examined the use of SMART goals by Australian community pharmacists providing a brief goal-oriented wellbeing intervention with service-users experiencing severe and persistent mental illnesses (SPMIs), in particular, which aspects of SMART goal planning were incorporated into the documented goals. Goal data from the PharMIbridge Randomized Controlled Trial (RCT) were used to investigate how community pharmacists operationalized SMART goals, goal quality, and which SMART goal planning format aspects were most utilized. Goals were evaluated using the SMART Goal Evaluation Method (SMART-GEM) tool to determine how closely each documented goal met the SMART criteria. Goals were also categorized into five domains describing their content or purpose. Descriptive analysis was used to describe the SMART-GEM evaluation results, and the Kruskal-Wallis H test was used to compare the evaluation results across the goal domains. All goals (n = 512) co-designed with service-users (n = 156) were classified as poor quality when assessed against the SMART guidelines for goal statements, although most goals contained information regarding a specific behaviour and/or action (71.3% and 86.3%, respectively). Less than 25% of goals identified how goal achievement would be measured, with those related to lifestyle and wellbeing behaviours most likely to include measurement information. Additionally, the majority (93.5%) of goals lacked details regarding monitoring goal progress. Study findings raise questions regarding the applicability of the SMART goal format in brief health interventions provided in primary healthcare settings, particularly for service-users experiencing SPMIs. Further research is recommended to identify which elements of SMART goals are most relevant for brief interventions. Additionally, further investigation is needed regarding the impact of SMART goal training or support tools on goal quality.

Active control of mid-wavelength infrared non-linearity in silicon photonic crystal slab.

Natural materials' inherently weak nonlinear response demands the design of artificial substitutes to avoid optically large samples and complex phase-matching techniques. Silicon photonic crystals are promising artificial materials for this quest. Their nonlinear properties can be modulated optically, paving the way for applications ranging from ultrafast information processing to quantum technologies. A two-dimensional 15-µm-thick silicon photonic structure, comprising a hexagonal array of air holes traversing the slab's thickness, has been designed to support a guided resonance for the light with a wavelength of 4-µm. At the resonance conditions, a transverse mode of the light is strongly confined between the holes in the "veins" of the silicon component. Owing to the confinement, the structure exhibits a ratio of nonlinear to linear absorption coefficients threefold higher than the uniform silicon slab of the same thickness. A customised time-resolved Z-scan method with provisions to accommodate ultrafast pump-probe measurements was used to investigate and quantify the non-linear response. We show that optically pumping free charge carriers into the structure decouples the incoming light from the resonance and reduces the non-linear response. The time-resolved measurements suggest that the decoupling is a relatively long-lived effect on the scale comparable to the non-radiative recombination in the bulk material. Moreover, we demonstrate that the excited free carriers are not the source of the nonlinearity, as this property is determined by the structure design.

Medication-related problems identified by community pharmacists: a descriptive case study of two Australian populations.

BACKGROUND: Medication-related problems (MRPs) contribute significantly to preventable patient harm and global healthcare expenditure. Vulnerable populations, including Indigenous Australians (please note that the use of the term 'Indigenous' in this paper includes all Aboriginal and Torres Strait Islander people and acknowledges their rich traditions and heterogenous cultures.) and people living with severe and persistent mental illness (SPMI), may be at increased risk of MRPs. Pharmacist-led medication reviews can identify MRPs for targeted action. OBJECTIVE: To characterize MRPs identified and recommendations made by community pharmacists during medication reviews conducted with Indigenous Australians and people living with SPMI. METHODS: Participants were recruited through two Australian trials testing the feasibility and/or effectiveness of novel community pharmacist-led interventions, the Indigenous Medication Review Service (IMeRSe) feasibility study (June 2018-July 2019) and Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge) randomized controlled trial (September 2020-December 2021). Trained community pharmacists conducted medication reviews responsive to the cultural and health needs of participants. MRPs, MRP severity and pharmacist recommendations were documented and classified using an established classification system (DOCUMENT). MRP severity was assessed by pharmacists and an independent assessor. Data were analysed descriptively, and paired t-tests were used to compare severity ratings. RESULTS: Pharmacists identified 795 MRPs with 411 participants across both trials (n = 255 IMeRSe, n = 156 PharMIbridge). Non-adherence to medication was the most common (n = 157, 25.1%) and second-most common (n = 25, 14.7%) MRP in IMeRSe and PharMIbridge, respectively. Undertreatment was the second-most common MRP in the sample of Indigenous Australians (n = 139, 22.2%), and reports of toxicity/adverse reactions were most common in people living with SPMI (n = 41, 24.1%). A change in pharmacotherapy was the most frequent recommendation made by pharmacists (40.2% and 55.0% in IMeRSe and PharMIbridge, respectively). Severity ratings varied, with the majority being 'Mild' or 'Moderate' in both groups. Significant differences were found in the severity rating assigned by trial pharmacists and the independent assessor. CONCLUSIONS: Community pharmacists identified a range of MRPs experienced by two at-risk populations, most commonly non-adherence and toxicity or adverse reactions, when conducting medication reviews and proposed diverse strategies to manage these, frequently recommending a change in pharmacotherapy. These findings highlight the opportunity for more targeted approaches to identifying and managing MRPs in primary care and tailored community pharmacist-led interventions may be of value in this space. TRAIL REGISTRATION: Australian and New Zealand Clinical Trial Registry records (IMeRSe ACTRN12618000188235 registered 06/02/2018 & PharMIbridge ACTRN12620000577910 registered 18/05/2020).

Healthcare professionals' knowledge, confidence and attitudes in relation to psychosis care: A systematic review.

BACKGROUND: Psychosis is a mental disorder that, despite its low prevalence, causes high disease and economic burden. Inadequate knowledge, lack of confidence and stigmatising attitudes of healthcare professionals (HCPs) may lead to suboptimal care. AIM: To review the literature exploring HCPs' knowledge, confidence and attitudes in relation to psychosis care. METHOD: A systematic search was undertaken across three databases (MEDLINE, Embase, PsycINFO) using a search strategy encompassing the concepts: 'healthcare professionals', 'knowledge, attitude, and confidence in care' and 'psychotic illnesses and symptoms' to identify relevant records published from 1st January 2002 to 18th March 2022. Results were screened against predetermined inclusion and exclusion criteria by title and abstract, followed by full text. Data were extracted into tables and synthesised narratively. RESULTS: Initially, 7,397 studies were identified. Following two-stage screening, 24 studies were eligible for inclusion. Of these studies, 16 explored attitudes, four explored knowledge and attitudes, one explored knowledge, one explored confidence, one explored attitudes and confidence in care and one explored all three constructs. Most HCPs in the included studies demonstrated stigmatising attitudes towards people with psychosis. Furthermore, certain HCPs, including nurses and general practitioners, demonstrated low levels of knowledge, while psychiatrists, occupational therapists, psychologists and nurses had low levels of confidence in caring for people with psychosis. Conversely, positive attitudes were also observed in some HCPs resulting from having acquaintances with lived experience of psychosis. The need for additional education and training to improve HCPs' knowledge and confidence in relation to caring for people living with psychosis was identified. CONCLUSIONS: Most attitudes identified were negative and stemmed from stigma, while some were positive due to HCPs' compassion and familiarity with psychosis. The level of knowledge and confidence identified were mostly suboptimal, and so further research is required to develop and evaluate tailored interventions to address this gap.

Rare disease variant curation from literature: assessing gaps with creatine transport deficiency in focus.

BACKGROUND: Approximately 4-8% of the world suffers from a rare disease. Rare diseases are often difficult to diagnose, and many do not have approved therapies. Genetic sequencing has the potential to shorten the current diagnostic process, increase mechanistic understanding, and facilitate research on therapeutic approaches but is limited by the difficulty of novel variant pathogenicity interpretation and the communication of known causative variants. It is unknown how many published rare disease variants are currently accessible in the public domain. RESULTS: This study investigated the translation of knowledge of variants reported in published manuscripts to publicly accessible variant databases. Variants, symptoms, biochemical assay results, and protein function from literature on the SLC6A8 gene associated with X-linked Creatine Transporter Deficiency (CTD) were curated and reported as a highly annotated dataset of variants with clinical context and functional details. Variants were harmonized, their availability in existing variant databases was analyzed and pathogenicity assignments were compared with impact algorithm predictions. 24% of the pathogenic variants found in PubMed articles were not captured in any database used in this analysis while only 65% of the published variants received an accurate pathogenicity prediction from at least one impact prediction algorithm. CONCLUSIONS: Despite being published in the literature, pathogenicity data on patient variants may remain inaccessible for genetic diagnosis, therapeutic target identification, mechanistic understanding, or hypothesis generation. Clinical and functional details presented in the literature are important to make pathogenicity assessments. Impact predictions remain imperfect but are improving, especially for single nucleotide exonic variants, however such predictions are less accurate or unavailable for intronic and multi-nucleotide variants. Developing text mining workflows that use natural language processing for identifying diseases, genes and variants, along with impact prediction algorithms and integrating with details on clinical phenotypes and functional assessments might be a promising approach to scale literature mining of variants and assigning correct pathogenicity. The curated variants list created by this effort includes context details to improve any such efforts on variant curation for rare diseases.

Experiences of goal planning in Australian community pharmacy settings for people experiencing mental illness: A qualitative study.

BACKGROUND: Person-centred goal planning is increasingly being incorporated into healthcare interventions. People experiencing severe and persistent mental illnesses (SPMIs) have high levels of co-occurring health conditions, reducing their life expectancy when compared with the general population. As medications are commonly used in the treatment of SPMIs, community pharmacists are well-placed to support the health and wellbeing of this population. OBJECTIVES: To examine pharmacists' and service users' experiences of goal planning as a component of a community pharmacy-based health intervention for people experiencing SPMIs (PharMIbridge intervention). METHODS: This study utilised a qualitative exploratory approach with an interpretive description method. Semistructured interviews were undertaken with community pharmacists (n = 16) and service user participants (n = 26) who had participated in pharmacist support services for people experiencing SPMIs (PharMIbridge intervention). RESULTS: Four themes relating to goal planning were identified. First, goal planning provided purpose and motivation for participation in the intervention. Planning realistic goals was important but often challenging. Both pharmacists and service users highlighted the relational aspects of goal planning and how strong relationships supported positive behaviour change and outcomes. Finally, individualised and flexible approaches were important aspects of the intervention, ensuring goals were meaningful to service users. CONCLUSIONS: The findings from this study identified positive outcomes from the inclusion of goal-planning processes in a community pharmacy-based health intervention. Further research regarding tools, strategies or training that could support future goal-planning interventions in primary healthcare is needed. PATIENT OR PUBLIC CONTRIBUTION: The PharMIbridge randomised controlled trial research team included lived experience members and was overseen by an expert panel that included members with a lived experience of mental illness and representatives from key organisations. The training provided to pharmacists was co-designed and co-delivered by the researchers and lived experience representatives, and pharmacists were supported by lived experience mentors. Service user participants were invited to participate in the interviews through a number of pathways (e.g., at the completion of the intervention, flyers). Those interested were provided with the full study participant information and provided with a $30 gift voucher at the conclusion of the interview.

Refining a taxonomy of goals planned between mental health consumers and community pharmacists.

BACKGROUND: People living with severe and persistent mental illnesses are more likely to experience co-morbid health conditions. Health-related behavior change can be promoted by the use of goal planning within community pharmacy settings. OBJECTIVES: To trial and refine a recently developed taxonomy to categorize goals co-designed between community pharmacists and people living with severe and persistent mental illnesses. This study also compared the data to the previously published taxonomy data to determine if the taxonomy could be applied across a range of mental health conditions. METHODS: The published goal taxonomy was refined using data from a cluster randomized controlled trial (PharMIbridge). Community pharmacists provided an individualized support service using goal planning with people living with severe and persistent mental illnesses. Goals were categorized using the existing taxonomy and inconsistencies were used to modify and refine the taxonomy. Additionally, participant characteristics and categorization of goals were compared with results from the previous study. RESULTS: 512 goals were reported by 158 consumer participants and categorized into five domains that included a diverse range of health behaviors (e.g., relationships, diet). Minor refinements to the taxonomy were made by replacing, adding or removing categories/descriptors. CONCLUSIONS: Significant overlap between the goals of participants and the existing taxonomy was found, supporting the application of the taxonomy across different mental health conditions.

The impact of COVID-19 on clinical research at Australian and New Zealand universities: A qualitative study.

Background: The COVID-19 pandemic resulted in the implementation of social distancing measures, travel restrictions, and infection control measures that introduced a myriad of disruptions in the conduct of clinical research worldwide. As a result, many aspects of clinical research were variably impacted. Aim: To explore the impact of the first 18 months of the COVID-19 pandemic on clinical research across accredited nursing, pharmacy, and medicine program providers in Australian and New Zealand universities. Methods: Representatives from all program providers across Australian and New Zealand universities, with publicly available contact information, were invited to participate in this qualitative study, whereby semi-structured interviews were completed with participants who held senior research or leadership positions within their institution. Interviews were transcribed verbatim and inductively analysed using thematic content analysis. Findings: Interviews were conducted with 16 participants between August and October 2021. Two major themes were identified (Immediate Research Impact and Broader Research Impact) with six subthemes: Prioritisation, Continuation, and Dissemination of Research; Modifications to Research; Funding and Changes to Research Focus; Collaboration; Research Workforce; Context-specific Impacts. Discussion: The impact on clinical research in Australian and New Zealand universities included changes to data collection methods, a perceived decreased quality of research, changes to collaboration, neglect of basic disease research, and loss of the research workforce. Conclusion: This study highlights the impact of the COVID-19 pandemic on clinical research within the Australian and New Zealand university context. Implications of these impacts should be considered to ensure long-term sustainability of research and preparedness for future disruptions.

Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic.

Public health orders were introduced in many countries, including Australia, during the COVID-19 pandemic to reduce the spread of the virus. However, for many people this led to an exacerbation of mental health symptoms, particularly those living with severe or persistent mental illness (SPMI). Additionally, the conduct of clinical research was severely impacted during the pandemic, with many difficulties encountered in the conduct of clinical trials. This paper describes the COVID-related impacts experienced during the implementation of a randomised controlled trial (RCT) testing the effectiveness of a community pharmacist-led support service for people living with SPMI in Australia (the PharMIbridge RCT), and the strategies used to successfully implement the RCT. Australian public health orders led to interstate border closures, stay-at-home orders and work-from-home requirements, resulting in necessary changes to allow for the continuation of the RCT including; changes to trial regions, transferring some training materials online while delaying face-to-face (F2F) training components, delays in pharmacy and consumer recruitment, encouraging telehealth service delivery and extensions to timelines with existing funding. Having a solution-focussed and flexible approach, while still ensuring critical trial protocol elements were adhered to, such as providing opportunities for F2F skills-based training for pharmacists, as well as F2F site visits from researchers and mentors to support trial implementation, resulted in high pharmacy and consumer participant retention through to trial conclusion. Future planning for RCTs should consider possible pandemic-related risks and rapid responses from approval bodies to ensure researchers can be agile and adapt to ensure successful trial completion.

Mental Health First Aid crisis role-plays between pharmacists and simulated patients with lived experience: a thematic analysis of debrief.

PURPOSE: Healthcare professionals, including pharmacists, can recognise and assist people experiencing mental health crises. Despite this, little is known about how pharmacists assist and engage with people presenting with signs and symptoms of mental health crises. This study aimed to (i) examine pharmacists' mental health crisis assessment language during simulated patient role-plays (SPRPs) and (ii) explore participants' experiences of participating in SPRPs of Mental Health First Aid (MHFA) scenarios. METHODS: Fifty-nine MHFA-trained pharmacy staff participated in audio-recorded SPRPs of three crisis scenarios enacted by a mental health consumer educator (MHCE). Post-SPRP, pharmacy staff members (including role-playing and observing participants), engaged in reflective debrief discussions with the facilitator and MHCEs. Debrief discussions were transcribed verbatim and analysed using inductive thematic analysis and suicide assessment language was explored. RESULTS: The majority of role-playing pharmacists asked about suicidal ideation using appropriate, direct language (n = 8). Qualitative analyses of debrief discussions yielded four themes: (i) Relationship with the consumer, (ii) Verbal and non-verbal communication, (iii) Challenges with crisis assessment, which included difficulties associated with initiating conversations about suicide and mania, and (iv) Reflective learning. CONCLUSION: While pharmacists demonstrated the appropriate suicide assessment language post-MHFA training, pharmacists felt uncomfortable initiating conversations around suicide and lacked confidence during crisis assessments. SPRPs provided pharmacists with opportunities to reflect on and practice MHFA skills in a safe learning environment. Future research exploring how MHFA training and SPRPs impact pharmacists' ability to provide MHFA in real-world settings is warranted.

Psychological distress in community-dwelling individuals living with severe and persistent mental illness.

OBJECTIVES: To explore psychological distress levels, using the validated Kessler 6 (K6), as well as the relationship between demographics and K6 scores, and incidence of mental health crises in a cohort of community-dwelling people living with severe and persistent mental illness (SPMI). METHODS: People living with SPMI taking antipsychotic or mood stabiliser medications were recruited from Australian community pharmacies between September 2020 and Februrary 2021 and completed an electronic survey, including the K6 scale. Pharmacists were interviewed and supplied written reports with details of the consultation when participants obtained 'very high' (⩾19/30) K6 scores. Records were reviewed and coded by an independent coder. Multivariate linear regression was used to determine predictors of K6 scores. RESULTS: The median K6 score was 16/30 (IQR = 11,21; range = 6-30). Younger age, unemployment and multimorbid mental health diagnoses were significant predictors of higher K6 scores (p < .01; R2 = .24). Fifty-nine (39.3%) consumers scored ⩾19, of which 25/59 (42.4%) were reported to be exhibiting signs of psychological distress and none were experiencing mental health crises. CONCLUSION: People living with SPMI have high levels of psychological distress as measured by the K6. Further work is needed to understand the prevalence, extent, precipitating factors and impact of psychological distress in people living with SPMI.

Patient-targeted interventions for opioid deprescribing: An overview of systematic reviews.

BACKGROUND: Deprescribing (reduction or cessation) of prescribed opioids can be challenging for both patients and healthcare professionals. OBJECTIVE: To synthesize and evaluate evidence from systematic reviews examining the effectiveness and outcomes of patient-targeted opioid deprescribing interventions for all types of pain. METHODS: Systematic searches were conducted in five databases with results screened against predetermined inclusion/exclusion criteria. Primary outcomes were (i) reduction in opioid dose, reported as change in oral Morphine Equivalent Daily Dose (oMEDD) and (ii) success of opioid deprescribing, reported as the proportion of the sample for which opioid use declined. Secondary outcomes included pain severity, physical function, quality of life and adverse events. The certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. FINDINGS: Twelve reviews were eligible for inclusion. Interventions were heterogeneous in nature and included pharmacological (n = 4), physical (n = 3), procedural (n = 3), psychological or behavioural (n = 3) and mixed (n = 5) interventions. Multidisciplinary care programmes appeared to be the most effective intervention for opioid deprescribing; however, the certainty of evidence was low, with significant variability in opioid reduction across interventions. CONCLUSIONS: Evidence is too uncertain to draw firm conclusions about specific populations who may derive the greatest benefit from opioid deprescribing, warranting further investigation.

Evaluation of a training program to support the implementation of a community pharmacist-led support service for people living with severe and persistent mental illness.

BACKGROUND: With appropriate training, community pharmacists can support people living with severe and persistent mental illness (SPMI) by identifying and managing medication-related issues and physical health concerns. The Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge) randomized controlled trial (RCT) tested the impact of an individualized, pharmacist-led support service for people living with SPMI. OBJECTIVE(S): To evaluate the impact of the PharMIbridge training program on pharmacy participants' knowledge and confidence, as well as stigma and attitudes, in relation to supporting, and providing services to, people living with SPMI; compared to Mental Health First Aid (MHFA) training alone. METHODS: Pharmacy staff (n = 140) from 55 community pharmacies across 4 RCT regions attended face-to-face training. Both intervention group (IG) and comparator group (CG) participants received MHFA training while IG participants received additional PharMIbridge training, involving role-plays and mental health consumer educators (MHCEs). A questionnaire including validated instruments was administered at baseline, after training and after 12 months. Comparative analyses included paired t tests and mixed between/within analysis of variance (ANOVA). RESULTS: Pre and post-training surveys were completed by 136 participants, most of which were pharmacists. Both IG and CG participants had significant reductions in stigma (P < 0.001) post-training. IG participants' confidence and knowledge regarding metabolic monitoring significantly improved compared to CG (P < 0.001). IG participants were significantly more confident and comfortable in providing medication counseling, compared to CG participants (P < 0.05). CONCLUSION: MHFA training reduced participants' stigma toward mental health. However, the purpose-designed PharMIbridge training program provided pharmacists with additional knowledge and skills to confidently support the physical health care needs of people living with SPMI. The inclusion of role-plays and MHCEs allowed pharmacists to self-reflect and practice skills in safe, supportive environments. Future studies should continue to involve MHCEs in pharmacy training and explore whether these improvements are sustainable.

Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review.

BACKGROUND: In response to the COVID-19 pandemic, member countries of the Organisation for Economic Co-operation and Development (OECD) rapidly published guidance regarding the conduct of clinical research. A systematic review was conducted to explore the recommendations issued in relation to the commencement, continuation and termination of clinical research during the early phases of the pandemic. METHODS: Searches consisting of the terms "COVID-19", "clinical research", and "guidance", were conducted in PubMed, Embase, MEDLINE, Trip, Guidelines International Network, and Google in April-May 2021 (up to 4 May 2021). Data were extracted from guidance published from OECD member countries and mapped to inductively-developed categories. RESULTS: 9419 references were systematically screened, resulting in the inclusion of 46 publications from 27 OECD countries. Thirty-three sources made recommendations regarding monitoring, risk-benefit assessments and information technology. There was limited specific recommendations made in relation to personal protective equipment (PPE) in the included guidance. Findings demonstrate that guidance differed by publication date demonstrating the rapidly evolving environment within which research was conducted. Importantly, many organisations opted to endorse existing guidance published by the United States' Food and Drug Administration and the European Medicines Agency rather than develop their own recommendations. CONCLUSIONS: Given the rapidly evolving nature of the pandemic, particularly in the early stages, findings demonstrate the global response in relation to clinical research conduct, thereby providing important insights for future public health emergencies.

Predicting Molecular Subtype and Survival of Rhabdomyosarcoma Patients Using Deep Learning of H&E Images: A Report from the Children's Oncology Group.

PURPOSE: Rhabdomyosarcoma (RMS) is an aggressive soft-tissue sarcoma, which primarily occurs in children and young adults. We previously reported specific genomic alterations in RMS, which strongly correlated with survival; however, predicting these mutations or high-risk disease at diagnosis remains a significant challenge. In this study, we utilized convolutional neural networks (CNN) to learn histologic features associated with driver mutations and outcome using hematoxylin and eosin (H&E) images of RMS. EXPERIMENTAL DESIGN: Digital whole slide H&E images were collected from clinically annotated diagnostic tumor samples from 321 patients with RMS enrolled in Children's Oncology Group (COG) trials (1998-2017). Patches were extracted and fed into deep learning CNNs to learn features associated with mutations and relative event-free survival risk. The performance of the trained models was evaluated against independent test sample data (n = 136) or holdout test data. RESULTS: The trained CNN could accurately classify alveolar RMS, a high-risk subtype associated with PAX3/7-FOXO1 fusion genes, with an ROC of 0.85 on an independent test dataset. CNN models trained on mutationally-annotated samples identified tumors with RAS pathway with a ROC of 0.67, and high-risk mutations in MYOD1 or TP53 with a ROC of 0.97 and 0.63, respectively. Remarkably, CNN models were superior in predicting event-free and overall survival compared with current molecular-clinical risk stratification. CONCLUSIONS: This study demonstrates that high-risk features, including those associated with certain mutations, can be readily identified at diagnosis using deep learning. CNNs are a powerful tool for diagnostic and prognostic prediction of rhabdomyosarcoma, which will be tested in prospective COG clinical trials.

Structural variant analysis of a cancer reference cell line sample using multiple sequencing technologies.

BACKGROUND: The cancer genome is commonly altered with thousands of structural rearrangements including insertions, deletions, translocation, inversions, duplications, and copy number variations. Thus, structural variant (SV) characterization plays a paramount role in cancer target identification, oncology diagnostics, and personalized medicine. As part of the SEQC2 Consortium effort, the present study established and evaluated a consensus SV call set using a breast cancer reference cell line and matched normal control derived from the same donor, which were used in our companion benchmarking studies as reference samples. RESULTS: We systematically investigated somatic SVs in the reference cancer cell line by comparing to a matched normal cell line using multiple NGS platforms including Illumina short-read, 10X Genomics linked reads, PacBio long reads, Oxford Nanopore long reads, and high-throughput chromosome conformation capture (Hi-C). We established a consensus SV call set of a total of 1788 SVs including 717 deletions, 230 duplications, 551 insertions, 133 inversions, 146 translocations, and 11 breakends for the reference cancer cell line. To independently evaluate and cross-validate the accuracy of our consensus SV call set, we used orthogonal methods including PCR-based validation, Affymetrix arrays, Bionano optical mapping, and identification of fusion genes detected from RNA-seq. We evaluated the strengths and weaknesses of each NGS technology for SV determination, and our findings provide an actionable guide to improve cancer genome SV detection sensitivity and accuracy. CONCLUSIONS: A high-confidence consensus SV call set was established for the reference cancer cell line. A large subset of the variants identified was validated by multiple orthogonal methods.

Observed behaviours and suicide assessment language post-Mental Health First Aid training in Australia and the United States: a mixed methods study using discourse analysis.

BACKGROUND: Mental Health First Aid (MHFA) training teaches participants how to respond to mental health crises, including suicide. Little is known about the impact of training on participants' observed MHFA behaviours. This exploratory study aimed to compare MHFA-trained Australian and US student pharmacists' performance and suicide assessment language during simulated patient role-play (SPRP) assessments. METHODS: Student pharmacists (n = 265) completed MHFA training and participated (n = 81) in SPRPs with simulated patients (SP) who were people with lived experience of mental illness. Each SPRP was marked by three raters (student, tutor and SP). One-way ANOVA, chi-squared tests and independent samples t-tests were used to compare scores and pass/fail rates, where appropriate. Transcribed audio-recordings of suicide assessments underwent discourse analysis. A chi-squared test was conducted to investigate the differences in how suicide assessment language was coded across six discursive frames ('confident'/'timid', 'empathetic'/'apathetic', and 'direct'/'indirect'). RESULTS: Three raters assessed 81 SPRPs, resulting in quantitative analysis of 243 rubrics. There were no significant differences between student pharmacists' mean scores and pass/fail rates across countries. Overall, both cohorts across Australia and the US performed better during the mania scenario, with a low failure rate of 13.9 and 19.0%, respectively. Most students in both countries passed their SPRP assessment; however, 27.8% did not assess for suicide or used indirect language during suicide assessment, despite completing MHFA training. Australian student pharmacists demonstrated, more direct language (76.9% versus 67.9%) and empathy (42.3% versus 32.1%) but less confidence (57.7% versus 60.7%) compared to US student pharmacists, during their suicide assessment; however, these differences were not statistically significant. CONCLUSIONS: Findings indicate most MHFA-trained student pharmacists from Australia and the US can provide MHFA during SPRPs, as well as assess for suicide directly, empathetically and confidently. This exploratory study demonstrates the importance of practicing skills post-training and the need for further research exploring participants' hesitance to assess for suicide, despite training completion.