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Abstract Background The joint evidence of the cost and the effectiveness of family-based therapies is modest. Objective To study the cost-effectiveness of family therapy (FT) versus treatment-as-usual (TAU) for young people seen after self-harm combining data from an 18-month trial and hospital records up to 60-month from randomisation. Methods We estimate the cost-effectiveness of FT compared to TAU over 5 years using a quasi-Markov state model based on self-harm hospitalisations where probabilities of belonging in a state are directly estimated from hospital data. The primary outcome is quality-adjusted life years (QALY). Cost perspective is NHS and PSS and includes treatment costs, health care use, and hospital attendances whether it is for self-harm or not. Incremental cost-effectiveness ratios are calculated and deterministic and probabilistic sensitivity analyses are conducted. Results Both trial arms show a significant decrease in hospitalisations over the 60-month follow-up. In the base case scenario, FT participants incur higher costs (mean +£1,693) and negative incremental QALYs (-0.01) than TAU patients. The associated ICER at 5 years is dominated and the incremental health benefit at the £30,000 per QALY threshold is -0.067. Probabilistic Sensitivity Analysis finds the probability that FT is cost-effective is around 3 − 2% up to a maximum willingness to pay of £50,000 per QALY. This suggest that the extension of the data to 60 months show no difference in effectiveness between treatments. Conclusion Whilst extended trial follow-up from routinely collected statistics is useful to improve the modelling of longer-term cost-effectiveness, FT is not cost-effective relative to TAU and dominated in a cost-utility analysis.

Abstract Background NHS Health Check (NHSHC) is a national cardiovascular disease (CVD) risk identification and management programme. However, evidence suggests a limited understanding of the most used metric to communicate CVD risk with patients (10-year percentage risk). This study used novel application of video-stimulated recall interviews to understand patient perceptions and understanding of CVD risk following an NHSHC that used one of two different CVD risk calculators. Methods Qualitative, semi-structured video-stimulated recall interviews were conducted with patients (n = 40) who had attended an NHSHC using either the QRISK2 10-year risk calculator (n = 19) or JBS3 lifetime CVD risk calculator (n = 21). Interviews were transcribed and analysed using reflexive thematic analysis. Results Analysis resulted in the development of four themes: variability in understanding, relief about personal risk, perceived changeability of CVD risk, and positive impact of visual displays. The first three themes were evident across the two patient groups, regardless of risk calculator; the latter related to JBS3 only. Patients felt relieved about their CVD risk, yet there were differences in understanding between calculators. Heart age within JBS3 prompted more accessible risk appraisal, yet mixed understanding was evident for both calculators. Event-free survival age also resulted in misunderstanding. QRISK2 patients tended to question the ability for CVD risk to change, while risk manipulation through JBS3 facilitated this understanding. Displaying information visually also appeared to enhance understanding. Conclusions Effective communication of CVD risk within NHSHC remains challenging, and lifetime risk metrics still lead to mixed levels of understanding in patients. However, visual presentation of information, alongside risk manipulation during NHSHCs can help to increase understanding and prompt risk-reducing lifestyle changes. Trial registration ISRCTN10443908. Registered 7th February 2017.

Abstract Background Evidence suggests resources and services benefit from being developed in collaboration with the young people they aim to support. Despite this, patient and public involvement and engagement (PPIE) with young people is often tokenistic, limited in engagement and not developmentally tailored to young people. Our paper aims to build knowledge and practice for meaningfully engaging with young people in research design, analysis and as research participants. Methods We report the participatory processes from the INSCHOOL project, examining long-term health conditions and schooling among 11–18 year olds. Young people were consulted at the inception of the project through a hospital-based youth forum. This began a partnership where young people co-designed study documents, informed the recruitment process, developed creative approaches to data collection, participated in pilot interviews, co-analysed the qualitative data and co-presented results. Results PPIE advisors, participants and researchers all benefitted from consistent involvement of young people throughout the project. Long-term engagement allowed advisors and researchers to build rapport and facilitated openness in sharing perspectives. PPIE advisors valued being able to shape the initial aims and language of the research questions, and contribute to every subsequent stage of the project. Advisors co-designed flexible data collection methods for the qualitative project that provided participants with choices in how they took part (interviews, focus groups, written tasks). Further choice was offered through co-designed preparation activities where participants completed one of four creative activities prior to the interview. Participants were therefore able to have control over how they participated and how they described their school experiences. Through participatory analysis meetings advisors used their first-hand experiences to inform the creation of themes and the language used to describe these themes. PPIE in every stage of the process helped researchers to keep the results grounded in young people’s experience and challenge their assumptions as adults. Conclusions Young people have much to offer and the INSCHOOL project has shown that researchers can meaningfully involve young people in all aspects of research. Consistent PPIE resulted in a project where the voices of young people were prioritised throughout and power imbalances were reduced, leading to meaningful participant-centred data.

Abstract Background Parkinson’s disease (PD) is a neurodegenerative condition that is characterized by a progressive decline of neural pathways, and its pathology is associated with alpha-synuclein abnormalities. Currently, infertility affects about 10% of individuals of fertile age within the USA. Interestingly, an increased length of fertility is associated with a decreased incidence of PD. Our study utilized QIAGEN’s Ingenuity Pathway Analysis (IPA) to identify and analyze molecular pathways that affect the underlying connection between alpha-synuclein (SNCA)-associated Parkinson’s disease (PD) and infertility condition (IC). Furthermore, we explored nicotine’s potential as a therapeutic in preventing the exacerbation of IC in terms of SNCA. Results Although the connection between SNCA-related PD and IC is not well explored, the Qiagen Knowledge Base (QKB) showed an overlap of 12 distinct molecules between SNCA and IC. These molecular pathways were established by adding SNCA and IC to “Pathway Explorer” and establishing connections to distinct molecules including transcription regulators, cytokines, and other enzymes/proteins. The Molecule-Activity-Predictor (MAP) tool predicted that SNCA activation would lead to an exacerbation of PD and IC with the potential involvement of dihydrotestosterone (DHT) and caspases. Specifically, it was found that SNCA decreased MAPK8 expression, which led to a downstream upregulation of IC. Activation of nicotine within this overarching molecular network resulted in a downregulation in both PD pathology and IC. Conclusions Together, these findings reveal a possible connection between infertility condition and genes regularly associated with alpha-synuclein-related Parkinson’s disease while identifying nicotine as a potential therapeutic application. Graphical Abstract

Abstract Background The last decade has seen a significant increase in media attention, industrial growth, and patient interest in stem cell-based interventions. This led to a rise in direct-to-consumer businesses offering stem cell “therapies” for multiple indications with little evidence of safety and efficacy. In parallel, the use of stem cell secretomes as a substitute for stem cell transplantation has become an increasing trend in regenerative medicine with multiple clinical trials currently assessing their efficacy and safety profile. As a result, multiple businesses and private clinics have now started to exploit this situation and are offering secretome-based interventions despite the lack of supporting data. This poses significant risks for the patients and could lead to a credibility crisis in the field. Methods Internet searches were used to locate clinics marketing and selling interventions based on stem cell secretomes, exosomes, or extracellular vesicles. Data were extracted from websites with a particular focus on the global distribution of the businesses, the cellular source of the secretome, the indication spectrum, and the pricing of the provided services. Lastly, the types of evidence used on the websites of the businesses to market their services were extracted. Results Overall, 114 companies market secretome-based therapies in 28 countries. The vast majority of the interventions are based on allogenic stem cells from undisclosed cellular sources and skin care is the most marketed indication. The price range is USD99–20,000 depending on the indication. Conclusions The direct-to-consumer industry for secretome-based therapies appears to be primed for growth in the absence of appropriate regulatory frameworks and guidelines. We conclude that such business activity requires tight regulations and monitoring by the respective national regulatory bodies to prevent patients from being conned and more importantly from being put at risk.

Objective The objective of this research was to examine how different measurements of poverty (household-level and neighborhood-level) were associated with asthma care utilisation outcomes in a community health centre setting among Latino, non-Latino black and non-Latino white children.Design, setting and participants We used 2012–2017 electronic health record data of an open cohort of children aged 200% FPL (55%). Overall, neighbourhood poverty (

Abstract Background As part of a multifaceted approach to patient and public involvement and engagement (PPIE), alongside traditional methods, a closed Facebook group was established to facilitate PPIE feedback on various aspects of a project that used video‐recording to examine risk communication in NHS Health Checks between June 2017 and July 2019. Objective To explore the process and impact of conducting PPIE through a closed Facebook group and to identify the associated benefits and challenges. Methods Supported by reflections and information from project meetings used to document how this engagement informed the project, we describe the creation and maintenance of the Facebook Group and how feedback from the group members was obtained. Facebook data were used to investigate levels and types of engagement in the closed Facebook group. We reflect on the challenges of using this method of engaging the public in health research. Results A total of 289 people joined the ‘Risk Communication of Cardiovascular disease in NHS Health Checks’ PPIE closed Facebook group. They provided feedback, which was used to inform aspects of the study, including participant‐facing documents, recruitment, camera position and how the methodology being used (video‐recorded Health Checks and follow‐up interviews) would be received by the public. Discussion Using a closed Facebook group to facilitate PPIE offered a flexible approach for both researchers and participants, enabled a more inclusive method to PPIE (compared with traditional methods) and allowed rapid feedback. Challenges included maintaining the group, which was more labour intensive than anticipated and managing members' expectations. Suggestions for best practice include clear communication about the purpose of the group, assigning a group co‐ordinator to be the main point of contact for the group, and a research team who can dedicate the time necessary to maintain the group. Conclusion The use of a closed Facebook group can facilitate effective PPIE. Its flexibility can be beneficial for researchers, patients and public who wish to engage in the research process. Dedicated time for sustained group engagement is important. Patient or Public Contribution Patient representatives were engaged with the development of the research described in this paper and a patient representative reviewed the manuscript.

Abstract Background Natural disasters and public health crises can disrupt communities’ capacities to implement important public health programs. A nationwide implementation of an evidence-based HIV prevention program, Focus on Youth in The Caribbean (FOYC) and Caribbean Informed Parents and Children Together (CImPACT), in The Bahamas was disrupted by Hurricane Dorian and the COVID-19 pandemic, especially in its more remote, Family Islands. We explored the teacher- and school-level factors that affected implementation of the program in these islands during those disruptions. Methods Data were collected from 47 Grade 6 teachers and 984 students in 34 government elementary schools during the 2020–2021 school year. Teachers completed a pre-implementation questionnaire to record their characteristics and perceptions that might affect their implementation fidelity and an annual program training workshop. School coordinators and high-performing teachers acting as mentors received additional training to provide teachers with monitoring, feedback, and additional support. Teachers submitted data on their completion of the 9 sessions and 35 core activities of FOYC + CImPACT. The fidelity outcomes were the number of sessions and core activities taught by teachers. Results On average, teachers taught 60% of sessions and 53% of core activities. Teachers with “very good” school coordinators (34% of teachers) taught more activities than those with “satisfactory” (43%) or no (34%) school coordinator (27.5 vs. 16.8 vs. 14.8, F = 12.86, P < 0.001). Teachers who had attended online training or both online and in-person training taught more sessions (6.1 vs. 6.2 vs. 3.6, F = 4.76, P < 0.01) and more core activities (21.1 vs. 20.8 vs. 12.6, F = 3.35, P < 0.05) than those who received no training. Teachers’ implementation was associated with improved student outcomes (preventive reproductive health skills, self-efficacy, and intention). Conclusions The Hurricane Dorian and the COVID-19 pandemic greatly disrupted education in The Bahamas Family Islands and affected implementation of FOYC + CImPACT. However, we identified several strategies that supported teachers’ implementation following these events. Teacher training and implementation monitoring increased implementation fidelity despite external challenges, and students achieved the desired learning outcomes. These strategies can better support teachers’ implementation of school-based interventions during future crises.

_Background_: Indicators of quality in physiotherapy clinical placements offer opportunity to assess current practise. The Consolidated Framework for Implementation Research (CFIR) provides a framework to identify barriers and enablers to guide tailored strategies for improvement. _Aims_: The aims of this study were to explore adherence to indicators of quality in a single physiotherapy department at a metropolitan teaching hospital, and to conceptualise the barriers and enablers to achieving quality in clinical placements in this context using the CFIR. _Methods_: A mixed-methods sequential explanatory study design was undertaken at a metropolitan hospital in Queensland, Australia. Stakeholder’s perceptions of enablers and barriers to meeting quality indicators in relation to current practise were assessed using a standardised survey (n=28), followed by focus groups and semi-structured interviews (n=19). _Results_: Three main themes were identified: (i) training in clinical education skills is essential but currently focuses on assessment, (ii) the clinical educator (CE) role is perceived as having low value, and (iii) opportunities identified to develop existing supports for CEs. _Conclusion_: Findings from this study have informed strategies implemented at the facility under study, which focus on increasing the perceived value of the CE role, engaging CEs in training as educators, and collaboration with university coordinators.

Summary: Background: HIV can infect multiple cells in the liver including hepatocytes, Kupffer cells and infiltrating T cells, but whether HIV can persist in the liver in people with HIV (PWH) on suppressive antiretroviral therapy (ART) remains unknown. Methods: In a prospective longitudinal cohort of PWH and hepatitis B virus (HBV) co-infection living in Bangkok, Thailand, we collected blood and liver biopsies from 18 participants prior to and following ART and quantified HIV and HBV persistence using quantitative (q)PCR and RNA/DNAscope. Antiretroviral (ARV) drug levels were quantified using mass spectroscopy. Findings: In liver biopsies taken prior to ART, HIV DNA and HIV RNA were detected by qPCR in 53% (9/17) and 47% (8/17) of participants respectively. Following a median ART duration of 3.4 years, HIV DNA was detected in liver in 61% (11/18) of participants by either qPCR, DNAscope or both, but only at very low and non-quantifiable levels. Using immunohistochemistry, HIV DNA was observed in both hepatocytes and liver infiltrating CD4+ T cells on ART. HIV RNA was not detected in liver biopsies collected on ART, by either qPCR or RNAscope. All ARVs were clearly detected in liver tissue. Interpretation: Persistence of HIV DNA in liver in PWH on ART represents an additional reservoir that warrants further investigation. Funding: National Health and Medical Research Council of Australia (Project Grant APP1101836, 1149990, and 1135851); This project has been funded in part with federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. 75N91019D00024.

Abstract Background Physician associates (PA) form part of the policy-driven response to increased primary care demand and a general practitioner (GP) recruitment and retention crisis. However, they are novel to the primary care workforce and have limitations, for example, they cannot prescribe. The novel 1 year Staffordshire PA Internship (SPAI) scheme, introduced in 2017, was established to support the integration of PAs into primary care. PA interns concurrently worked in primary and secondary care posts, with protected weekly primary care focussed education sessions. This evaluation established the acceptability of PA interns within primary care. Methods All ten PAs from the first two SPAI cohorts, the nine host practices (supervising GPs and practice managers) and host practice patients were invited to participate in the evaluation. A conceptual framework for implementing interventions in primary care informed data collection and analysis. Data were gathered at three time points over the internship from practices, through discussions with the supervising GP and/or practice manager, and from the PAs via discussion groups. To enrich discussion data, PA and practices were sent brief surveys requesting information on PA/practice characteristics and PA primary care roles. Patient acceptability data were collected by the host practices. Participation at every stage was optional. Results By evaluation end, eight PAs had completed the internship. Seven PAs and six practices provided data at every time point. Five practices provided patient acceptability data. Overall PA interns were acceptable to practices and patients, however ambiguity about the PA role and how best to communicate and operationalise PA roles was revealed. An expectation-preparedness gap resulted in PAs needing high levels of supervision early within the internship. SPAI facilitated closure of the expectation-preparedness gap and its funding arrangements made the high supervision requirements more acceptable to practices. Conclusions The test-of-concept SPAI successfully integrated new PAs into primary care. However, the identified challenges risk undermining PAs roles in primary care before they have attained their full potential. Nationally, workforce leaders should develop approaches to support new PAs into primary care, including commitments to longer-term, sustainable, cohesive and appropriately funded schemes, including structured and standardised education and supervision.

Syphilis has the potential to result in serious irreversible morbidity and mortality during pregnancy and has been increasing in incidence across the United States. While syphilis is a common disease and a known but rare cause of membranous nephropathy, it can complicate the clinical picture and obscure accurate diagnosis of women presenting with proteinuria during pregnancy. We report a case of proteinuria with syphilis in the second trimester of pregnancy as an educational review.

Abstract As populations age across the world, osteoporosis and osteoporosis-related fractures are becoming the most prevalent degenerative bone diseases. More than 75 million patients suffer from osteoporosis in the USA, the EU and Japan. Furthermore, it is anticipated that the number of patients affected by osteoporosis will increase by a third by 2050. Although conventional therapies including bisphosphonates, calcitonin and oestrogen-like drugs can be used to treat degenerative diseases of the bone, they are often associated with serious side effects including the development of oesophageal cancer, ocular inflammation, severe musculoskeletal pain and osteonecrosis of the jaw. The use of autologous mesenchymal stromal cells/mesenchymal stem cells (MSCs) is a possible alternative therapeutic approach to tackle osteoporosis while overcoming the limitations of traditional treatment options. However, osteoporosis can cause a decrease in the numbers of MSCs, induce their senescence and lower their osteogenic differentiation potential. Three-dimensional (3D) cell culture is an emerging technology that allows a more physiological expansion and differentiation of stem cells compared to cultivation on conventional flat systems. This review will discuss current understanding of the effects of different 3D cell culture systems on proliferation, viability and osteogenic differentiation, as well as on the immunomodulatory and anti-inflammatory potential of MSCs.

Abstract Background The aim of the study was to explore practitioner-patient interactions and patient responses when using QRISK®2 or JBS3 cardiovascular disease (CVD) risk calculators. Data were from video-recorded NHS Health Check (NHSHC) consultations captured as part of the UK RIsk COmmunication (RICO) study; a qualitative study of video-recorded NHSHC consultations from 12 general practices in the West Midlands, UK. Participants were those eligible for NHSHC based on national criteria (40–74 years old, no existing diagnoses for cardiovascular-related conditions, not on statins), and practitioners, who delivered the NHSHC. Method NHSHCs were video-recorded. One hundred twenty-eight consultations were transcribed and analysed using deductive thematic analysis and coded using a template based around Protection Motivation Theory. Results Key themes used to frame the analysis were Cognitive Appraisal (Threat Appraisal, and Coping Appraisal), and Coping Modes (Adaptive, and Maladaptive). Analysis showed little evidence of CVD risk communication, particularly in consultations using QRISK®2. Practitioners often missed opportunities to check patient understanding and encourage risk- reducing behaviour, regardless of the risk calculator used resulting in practitioner verbal dominance. JBS3 appeared to better promote opportunities to initiate risk-factor discussion, and Heart Age and visual representation of risk were more easily understood and impactful than 10-year percentage risk. However, a lack of effective CVD risk discussion in both risk calculator groups increased the likelihood of a maladaptive coping response. Conclusions The analysis demonstrates the importance of effective, shared practitioner-patient discussion to enable adaptive coping responses to CVD risk information, and highlights a need for effective and evidence-based practitioner training. Trial registration ISRCTN ISRCTN10443908 . Registered 7th February 2017.

Abstract Background Osteoarthritis is a leading cause of pain and disability worldwide. Despite research supporting best practice, evidence-based guidelines are often not followed. Little is known about the implementation of non-surgical models of care in routine primary care practice. From a knowledge mobilisation perspective, the aim of this study was to understand the uptake of a clinical innovation for osteoarthritis and explore the journey from a clinical trial to implementation. Methods This study used two methods: secondary analysis of focus groups undertaken with general practice staff from the Managing OSteoArthritis in ConsultationS research trial, which investigated the effectiveness of an enhanced osteoarthritis consultation, and interviews with stakeholders from an implementation project which started post-trial following demand from general practices. Data from three focus groups with 21 multi-disciplinary clinical professionals (5–8 participants per group), and 13 interviews with clinical and non-clinical stakeholders, were thematically analysed utilising the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, in a theoretically informative approach. Public contributors were involved in topic guide design and interpretation of results. Results In operationalising implementation of an innovation for osteoarthritis following a trial, the importance of a whole practice approach, including the opportunity for reflection and planning, were identified. The end of a clinical trial provided opportune timing for facilitating implementation planning. In the context of osteoarthritis in primary care, facilitation by an inter-disciplinary knowledge brokering service, nested within an academic institution, was instrumental in supporting ongoing implementation by providing facilitation, infrastructure and resource to support the workload burden. ‘Instinctive facilitation’ may involve individuals who do not adopt formal brokering roles or fully recognise their role in mobilising knowledge for implementation. Public contributors and lay communities were not only recipients of healthcare innovations but also potential powerful facilitators of implementation. Conclusion This theoretically informed knowledge mobilisation study into the uptake of a clinical innovation for osteoarthritis in primary care has enabled further characterisation of the facilitation and recipient constructs of i-PARIHS by describing optimum timing for facilitation and roles and characteristics of facilitators.

Introduction Despite national efforts to establish patient-centered medical homes (PCMH), 57.3% of children with special health care needs are receiving care that does not meet medical home criteria. Project DOCC, a national curriculum designed by parents of children with disabilities or chronic disease, has shown documented strengths in medical resident learner education of children with special health care needs from the parent perspectives for over a decade. Because of the importance of PCMH and the need to provide compassionate care, our team adapted the curriculum to incorporate team-based learning in the rural setting. Materials and Methods Reading materials were distributed to learners prior to an in-person workshop at which time, learners reviewed a video and discussed PCMH materials to identify elements of the PCMH. Learners then engaged with parent mentors across three breakout sessions. A final group reflection was completed to review and discuss efforts providers would take to establish and maintain the PCMH in their own practice. Baseline and post-workshop PCMH perceptions and parent mentor reflections were collected and compared using t-test comparisons. Results Learner knowledge, perceptions, and comfort significantly increased after the workshop. Parent mentor comments also highlighted an increased understanding for the provider. Discussion: The adapted PCMH curriculum significantly impacted learner outcomes using a feasible approach that fit nicely within health professional curricula and limited resources of the rural setting. Parents enjoyed the opportunity to serve as mentors and valued the instruction format.

Ectopic pregnancies implanted in the cervix account for less than one percent of all extra-uterine pregnancies. Due to the rare incidence of cervical ectopic pregnancies, there are no established guidelines for medical versus surgical management. We report a case of a cervical ectopic pregnancy with a fetal heartbeat successfully treated with single-dose methotrexate therapy.

Background: NHS Health Check (NHSHC) is a national programme to identify and manage cardiovascular disease (CVD) risk. Practitioners delivering the programme should be competent in discussing CVD risk, but there is evidence of limited understanding of the recommended 10-year percentage CVD risk scores. Lifetime CVD risk calculators might improve understanding and communication of risk. Aim: To explore practitioner understanding, perceptions, and experiences of CVD risk communication in NHSHCs when using two different CVD risk calculators. Design & setting: Qualitative video-stimulated recall (VSR) study with NHSHC practitioners in the West Midlands. Method: VSR interviews were conducted with practitioners who delivered NHSHCs using either the QRISK2 10-year risk calculator (n = 7) or JBS3 lifetime CVD risk calculator (n = 8). Data were analysed using reflexive thematic analysis. Results: In total, nine healthcare assistants (HCAs) and six general practice nurses (GPNs) were interviewed. There was limited understanding and confidence of 10-year risk, which was used to guide clinical decisions through determining low-, medium-, or high-risk thresholds, rather than as a risk communication tool. Potential benefits of some JBS3 functions were evident, particularly heart age, risk manipulation, and visual presentation of risk. Conclusion: There is a gap between the expectation and reality of practitioners’ understanding, competencies, and training in CVD risk communication for NHSHCs. Practitioners would welcome heart age and risk manipulation functions of JBS3 to promote patient understanding of CVD risk, but there is a more fundamental need for practitioner training in CVD risk communication.

Background: Daily oral emtricitabine (FTC, F)/tenofovir disoproxil fumarate (TDF) combination is approved for HIV pre-exposure prophylaxis (PrEP) in men and women. Tenofovir alafenamide fumarate (TAF) is a newer, more potent prodrug of tenofovir (TFV), and in combination with FTC, has recently been approved for prevention of HIV through rectal transmission. Methods: This Phase I, prospective, interventional, randomized study was conducted in three clinical sites: PROFAMILIA, Santo Domingo, Dominican Republic; University of Pittsburgh and Eastern Virginia Medical School. We assessed the multi-compartmental pharmacokinetics (primary outcome) and safety (secondary outcome) among HIV uninfected women randomized to F/TDF (200mg/300mg) or F/TAF (200mg/25mg; F/TAF25) (n=24) in a single dose phase (SDP) and F/TDF, F/TAF (200mg/10mg; F/TAF10), or F/TAF25 (n=75) in a multiple dose (14 daily doses) phase (MDP). We described PK parameters in plasma, peripheral blood mononuclear cells (PBMCs), and cervicovaginal (CV) and rectal fluids and tissues. ClinicalTrials.gov #NCT02904369, completed. Findings: Recruitment for the study began on 5 October 2016. The first participant was enrolled on 6 October 2016 and the last participant completed the study 21 November 2017. Plasma: TFV concentrations area under curve (AUC) were ~20 fold lower following F/TAF versus F/TDF. TFV-diphosphate (TFV-DP) AUC concentrations in PBMCs were 7-fold higher with F/TAF25 versus F/TDF. Median TFV-DP concentrations in vaginal tissue (4hours post last dose) were approximately 6-fold higher with F/TAF25 versus F/TDF. TFV and TFV-DP were lower with F/TAF versus F/TDF in rectal tissue. Concentrations of FTC and FTC-triphosphate (FTC-TP) were similar across matrices and treatment arms. Gastrointestinal adverse events (AEs) occurred more frequently in F/TDF users (44.0%) than in either F/TAF group (11.5 and 12.0%). Interpretation: F/TAF was safe and well-tolerated. TFV-DP concentrations were higher in PBMCs and similar or higher (4h post dose) in female genital tract tissues for F/TAF versus F/TDF. High FTC and FTC-TP concentrations in all compartments support the potential of F/TAF as a new PrEP combination for women.

Abstract Background Reduction in sensorimotor function of the upper limb is a common and persistent impairment after stroke, and less than half of stroke survivors recover even basic function of the upper limb after a year. Previous work in stroke has shown that repetitive sensory stimulation (RSS) of the upper limb may benefit motor function. As yet, there have been no investigations of RSS in the early-acute period despite this being the time window during which the neuroplastic processes underpinning sensorimotor recovery are likely to occur. Methods A single-blinded, stratified, randomised controlled feasibility study was undertaken at two NHS acute trusts to determine the recruitment rate, intervention adherence, and safety and acceptability of an RSS intervention in the early period after stroke. Participants were recruited within 2 weeks of index stroke. Stratified on arm function, they were randomised to receive either 45 min of daily RSS and usual care or usual care alone (UC) for 2 weeks. Changes from baseline on the primary outcome of the Action Research Arm Test (ARAT) to measurements taken by a blinded assessor were examined after completion of the intervention (2 weeks) and at 3 months from randomisation. Results Forty patients were recruited and randomised (RSS n = 23; UC n = 17) with a recruitment rate of 9.5% (40/417) of patients admitted with a stroke of which 52 (12.5%) were potentially eligible, with 10 declining to participate for various reasons. Participants found the RSS intervention acceptable and adherence was good. The intervention was safe and there were no serious adverse events. Conclusions This study indicates that recruitment to a trial of RSS in the acute period after stroke is feasible. The intervention was well tolerated and appeared to provide additional benefit to usual care. In addition to a definitive trial of efficacy, further work is warranted to examine the effects of varying doses of RSS upon arm function and the mechanism by which RSS induces sensorimotor recovery in the acute period after stroke. Trial registration ISRCTN, registry no: ISRCTN17422343; IRAS Project ID: 215137. Registered on October 2016

Abstract Background NHS Health Check is a national cardiovascular disease (CVD) risk assessment programme for 40–74 year olds in England, in which practitioners should assess and communicate CVD risk, supported by appropriate risk-management advice and goal-setting. This requires effective communication, to equip patients with knowledge and intention to act. Currently, the QRISK®2 10-year CVD risk score is most common way in which CVD risk is estimated. Newer tools, such as JBS3, allow manipulation of risk factors and can demonstrate the impact of positive actions. However, the use, and relative value, of these tools within CVD risk communication is unknown. We will explore practitioner and patient CVD risk perceptions when using QRISK®2 or JBS3, the associated advice or treatment offered by the practitioner, and patients’ responses. Methods RIsk COmmunication in NHS Health Check (RICO) is a qualitative study with quantitative process evaluation. Twelve general practices in the West Midlands of England will be randomised to one of two groups: usual practice, in which practitioners use QRISK®2 to assess and communicate CVD risk; intervention, in which practitioners use JBS3. Twenty Health Checks per practice will be video-recorded (n = 240, 120 per group), with patients stratified by age, gender and ethnicity. Post-Health Check, video-stimulated recall (VSR) interviews will be conducted with 48 patients (n = 24 per group) and all practitioners (n = 12–18), using video excerpts to enhance participant recall/reflection. Patient medical record reviews will detect health-protective actions in the first 12-weeks following a Health Check (e.g., lifestyle referrals, statin prescription). Risk communication, patient response and intentions for health-protective behaviours in each group will be explored through thematic analysis of video-recorded Health Checks (using Protection Motivation Theory as a framework) and VSR interviews. Process evaluation will include between-group comparisons of quantitatively coded Health Check content and post-Health Check patient outcomes. Finally, 10 patients with the most positive intentions or behaviours will be selected for case study analysis (using all data sources). Discussion This study will produce novel insights about the utility of QRISK®2 and JBS3 to promote patient and practitioner understanding and perception of CVD risk and associated implications for patient intentions with respect to health-protective behaviours (and underlying mechanisms). Recommendations for practice will be developed. Trial registration ISRCTN ISRCTN10443908. Registered 7th February 2017.

Abstract Background National leaders recommend documenting social determinants of health and actions taken to address social determinants of health in electronic health records, and a growing body of evidence suggests the health benefits of doing so. However, little evidence exists to guide implementation of social determinants of health documentation/action. Methods This paper describes a 5-year, mixed-methods, stepped-wedge trial with realist evaluation, designed to test the impact of providing 30 community health centers with step-by-step guidance on implementing electronic health record-based social determinants of health documentation. This guidance will entail 6 months of tailored support from an interdisciplinary team, including training and technical assistance. We will report on tailored support provided at each of five implementation steps; impact of tailored implementation support; a method for tracking such tailoring; and context-specific pathways through which these tailored strategies effect change. We will track the competencies and resources needed to support the study clinics’ implementation efforts. Discussion Results will inform how to tailor implementation strategies to meet local needs in real-world practice settings. Secondary analyses will assess impacts of social determinants of health documentation and referral-making on diabetes outcomes. By learning whether and how scalable, tailored implementation strategies help community health centers adopt social determinants of health documentation and action, this study will yield timely guidance to primary care providers. We are not aware of previous studies exploring implementation strategies that support adoption of social determinants of action using electronic health and interventions, despite the pressing need for such guidance. Trial registration clinicaltrials.gov, NCT03607617, registration date: 7/31/2018—retrospectively registered

Abstract Background Following institutionalization of a relative with Alzheimer disease and related dementias (ADRD), family carers continue to provide care. They must learn to negotiate with staff and navigate the system all of which can affect their mental health. A web-based intervention, My Tools 4 Care-In Care (MT4C-In Care) was developed by the research team to aid carers through the transitions experienced when their relative/friend with ADRD resides in a long-term care (LTC) facility. The purpose of this study was to evaluate MT4C-In Care for feasibility, acceptability, ease of use, and satisfaction, along with its potential to help decrease carer’s feelings of grief and improve their hope, general self-efficacy, and health-related quality of life. Methods The study was a mixed-methods single-arm repeated measures feasibility study. Participants accessed MT4C-In Care over a 2-month period. Data were collected at baseline and 1 and 2 months. Using a checklist, participants evaluated MT4C-In Care for ease of use, feasibility, acceptability, and satisfaction. Measures were also used to assess the effectiveness of the MT4C-In Care in improving hope (Herth Hope Index), general self-efficacy (GSES), loss and grief (NDRGEI), and health-related quality of life (SF12v2) of participants. Qualitative data were collected at 2 months and informed quantitative findings. Results The majority of the 37 participants were female (65%; 24/37), married (73%; 27/37), and had a mean age of 63.24 years (SD = 11.68). Participants reported that MT4C-In Care was easy to use, feasible, and acceptable. Repeated measures ANOVA identified a statistically significant increase over time in participants hope scores (p = 0.03) and a significant decrease in grief (

Objective: Emergency medicine program directors (PD) value the standardized letter of evaluation (SLOE) as the most important aspect of a residency application when making both invitation and ranking decisions. This study aims to determine whether the presence of any lower-third in either SLOE global assessment (GA) question impacted the ability of an applicant to match into EM. We hypothesized that any lower-third ranking would be associated with increased odds of not matching into EM. Methods: We conducted a retrospective cohort study evaluating allopathic applicants from medical schools in the United States (US allopathic applicants) to a single EM residency program during the 2018/2019 match cycles. GA SLOE rankings from all applications were tabulated and compared to the applicant’s National Resident Matching Program (NRMP) match outcome. Comparative analyses were conducted between SLOE groupings and odds ratios (OR) were calculated. Results: A total of 2,017 SLOEs from 781 US allopathic applicants were analyzed during the study period. Of the total, 277 (35%) applicants in our sample had any lower-third GA ranking, which significantly decreased an applicant’s odds of matching in EM by 79% (OR 0.21, 95% CI, 0.12-0.34). Having more than one lower-third GA ranking did not further statistically decrease the odds of a successful EM match (OR 0.60, 95% CI 0.31-1.17). As a secondary finding of the study, results demonstrate that those applicants having no lower-third GA rankings had a nearly 5 times increased odds of an EM match (OR 4.84, 95% CI, 2.91-8.03). Conclusion: Having any lower-third GA ranking significantly reduced an applicant’s chances of matching into an EM program. Faculty advisors should be aware of the increased risk of not matching for any applicant with any lower-third GA ranking and advise students appropriately, while maintaining the integrity of the SLOE and not divulging the confidential information contained within.

The objective of this case series is the evaluation of the efficacy and visual outcomes after displacement of subretinal hemorrhage using intravitreal injection of recombinant tissue plasminogen activator, expansile gas, and in some cases an anti-vascular endothelial growth factor agent. A case series of 28 eyes of 28 patients (16 men and 12 women with age range 67–95 years) suffering from subretinal hemorrhage (duration range 1–15 days) caused by age-related macular degeneration or retinal macroaneurysm is presented. All the patients were treated with intravitreal injection of recombinant tissue plasminogen activator and gas and some of them received an anti-vascular endothelial growth factor agent between January 2013 and December 2016. The outcomes assessed were visual acuity (preoperatively 1 week, and 1 month postoperatively) with respect to duration and dimension of hemorrhage, displacement of hemorrhage, and possible complications of the procedure. Successful displacement of hemorrhage was achieved in 25 patients (89.3%), 18 of 28 patients had significant improvement in visual acuity 1 week after the treatment, and 22 of 28 patients had significant improvement in visual acuity 1 month after the treatment. The mean improvement of all patients with anatomical displacement of the hemorrhage in visual acuity was 0.7 ± 0.5 (LogMAR) in 1 month. Two patients developed vitreous hemorrhage after the procedure and one retinal detachment. Visual outcome a month after therapy displayed week correlation with duration, diameter, and thickness of hemorrhage. The results lead to the conclusion that intravitreal treatment of recombinant tissue plasminogen activator and expansible gas with or without injection of anti-vascular endothelial growth factor agent is effective in improving visual acuity and displacing submacular hemorrhage secondary to age-related macular degeneration and retinal macroaneurysm. The best functional outcomes can be expected in patients regardless of the size and duration of the hemorrhage.

Background: The Systemic Therapy for At Risk Teens (START) trial is a randomised controlled trial of multisystemic therapy (MST) compared with management as usual (MAU). The present study reports on long-term follow-up of the trial (to 60 months). Objectives: The primary objective was to compare MST and MAU for the proportion of young people in each group with criminal convictions up to 60 months post baseline. Secondary outcomes included group comparisons of psychological and behavioural factors. An economic analysis was carried out to determine the cost-effectiveness of MST compared with MAU. Two qualitative studies were conducted to better understand the subjective experiences of the participants. Design: Primary outcomes (collected up to 60 months) were collected using a centralised police database. Secondary outcomes were evaluated using self-report questionnaires completed by both young people and parents or carers at the 24-, 36- and 48-month follow-ups. Research assistants were blind to treatment allocation. Setting: Participants were recruited from participating MST sites in nine areas of England. Secondary outcomes were typically collected within the family home. Participants: A total of 684 families were recruited into the START trial and allocated randomly to a treatment group. Of these, 487 remained in the second phase of the trial. Young people were aged, on average, 13.8 years at baseline, with 63% male and 37% female. Interventions: MST is a manualised programme for young people exhibiting antisocial behaviour and their families that uses principles from cognitive–behavioural and family therapy to provide an individualised approach. MAU content was not prespecified, but consisted of the standard care offered to young people who met eligibility for the trial. Main outcome measures: Young people’s offending was evaluated using the Police National Computer. Secondary measures included validated self-report measures completed by both the young person and their parent or carer. The economic evaluation took a broad perspective and outcomes were assessed in terms of quality-adjusted life-years and offending. Results: No significant differences were found in the proportion of offending between the groups (hazard ratio 1.03, 95% confidence interval 0.84 to 1.26; p = 0.78). No differences were found between the groups on secondary outcome measures, with a few exceptions that did not hold up consistently across the follow-up period. The economic analysis did not find evidence to support the cost-effectiveness of MST compared with MAU. Outcomes from the qualitative studies suggest that families mostly felt positive about MST, and that MST was associated with greater maturity in young men. Limitations: Some intended evaluations were not possible to deliver. Selective attrition may have influenced the nature of the sample size. It is also unclear how representative the MAU services were of reality. Future research: Recommendations are made for the evaluation of MST in populations with more severe behavioural problems, as well as for identifying and testing new moderators. Conclusions: The results of the second phase of the START trial do not support the long-term superiority of MST to MAU, but elements of the intervention may be adapted successfully. Trial registration: Current Controlled Trials ISRCTN77132214 and London South-East REC registration number 09/H1102/55. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 23. See the NIHR Journals Library website for further project information.

Background: Self-harm in adolescents is common and repetition frequent. Evidence for effective interventions to reduce self-harm is limited. Long term follow-up of existing studies is rare. Methods: Extended follow up, from 18 to at least 36-months, of the SHIFT trial: a pragmatic, multi-centre, individually-randomised, controlled trial involving young people (11–17) who had self-harmed at least twice and presented to Child & Adolescent Mental Health Services (CAMHS). SHIFT evaluated manualised family therapy (FT) versus treatment as usual (TAU) in reducing repetition of self-harm leading to hospital attendance 18 months post-randomisation.We obtained ONS mortality data, adult mental health data, and further details of hospital attendance from routine Hospital Episode Statistics (HES) data plus researcher follow-up. We assessed longer-term differences in outcome using multivariable Cox Proportional Hazards regression analysis, and assessed all-cause mortality and morbidity relating to hospital attendances for reasons other than self-harm. Study registration: ISRCTN 59793150 Outcomes: The original sample of 832 were randomised between April 2010 and December 2013. Extended follow-up continued until February 2017 for a median 55·4 months (range 0–82·5 months), providing post 18-month data for 804 (96·6%) participants, of whom 785 (94·4%) had a minimum of 36-months follow-up.There was no evidence of a between-group difference in the primary outcome during the extended follow-up period (Hazard Ratio (HR) 1·03; 95% CI: 0·83, 1·28; p-value=0·78), consistent with our findings in the original trial with 18 months follow-up (HR 1·14, 95% CI 0·87, 1·49; p-value 0·33). There was a reduced rate of self-harm in older participants aged 15–17 (HR 0·7, 95% CI 0·56, 0·88), as compared with those aged 11–14; and significantly increased rates of self-harm in participants whose index episode combined self-injury and poisoning (HR 1·8, 95% CI 1·2, 2·7). Two deaths were reported during the extended follow up period. Interpretation: For adolescents referred to CAMHS after self-harm, having self-harmed at least once before, trial FT confers no benefits over TAU in reducing subsequent hospitalisation for self-harm over 18 months or 36 months. Funding: NIHR HTA Reference: 07/33/01 Keywords: Self-harm, Family therapy, Long term follow up, RCT

Hepatitis C (HCV) is a common form of liver disease encountered in pregnancy. The purpose of this study is to evaluate if hepatitis C is associated with elevated maternal serum bile acids and abnormal fetal cardiac function measured by the left ventricular Tei index in the absence of intrahepatic cholestasis of pregnancy. This is a prospective cohort study on pregnant women with hepatitis C seen through Marshall University’s high-risk obstetrics clinic from 2013 to 2014. Women with hepatitis C had a laboratory evaluation and an ultrasound on the fetus to calculate the left ventricular Tei index. Demographic information and delivery outcomes were recorded. There were 77 participants with hepatitis C recruited and consented for this study. Sixty-one participants had complete laboratory and delivery information available for analysis. Twenty-one participants had a viral load that was not detectable and 40 participants had a detectable viral load. The mean viral load overall was 1943771 IU/mL (SD 4257143). There was no difference in Tei index between detectable and non-detectable viral load, 0.41 and 0.38 respectively (p = 0.41). There was no statistical difference in bile acid level between detectable and undetectable viral load, 12 and 8 µmol/L respectively (p = 0.05). Hepatic liver disease manifested by elevated hepatitis C viral load or elevated bile acids did not affect the left ventricular Tei index.

Abstract Background The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting programmes as a first-line intervention for conduct disorders (CD) in children aged 5–11 years. As these are not effective in 25–33% of cases, NICE has requested research into second-line interventions. Child and Adolescent Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD. A feasibility trial is needed to determine whether a confirmatory trial of manualised PCP (mPCP) versus Treatment as Usual (TaU) for CD is practicable or needs refinement. The aim of this paper is to publish the abridged protocol of this feasibility trial. Methods and design TIGA-CUB (Trial on improving Inter-Generational Attachment for Children Undergoing Behaviour problems) is a two-arm, pragmatic, parallel-group, multicentre, individually randomised (1:1) controlled feasibility trial (target n = 60) with blinded outcome assessment (at 4 and 8 months), which aims to develop an optimum practicable protocol for a confirmatory, pragmatic, randomised controlled trial (RCT) (primary outcome: child’s behaviour; secondary outcomes: parental reflective functioning and mental health, child and parent quality of life), comparing mPCP and TaU as second-line treatments for children aged 5–11 years with treatment-resistant CD and inter-generational attachment difficulties, and for their primary carers. Child-primary carer dyads will be recruited following a referral to, or re-referral within, National Health Service (NHS) Child and Adolescent Mental Health Services (CAMHS) after an unsuccessful first-line parenting intervention. PCP will be delivered by qualified CAPTs working in routine NHS clinical practice, using a trial-specific PCP manual (a brief version of established PCP clinical practice). Outcomes are: (1) feasibility of recruitment methods, (2) uptake and follow-up rates, (3) therapeutic delivery, treatment retention and attendance, intervention adherence rates, (4) follow-up data collection, and (5) statistical, health economics, process evaluation, and qualitative outcomes. Discussion TIGA-CUB will provide important information on the feasibility and potential challenges of undertaking a confirmatory RCT to evaluate the effectiveness and cost-effectiveness of mPCP. Trial registration Current Controlled Trials, ID: ISRCTN86725795 . Registered on 31 May 2016.

Abstract Background People with decompensated cirrhosis require complex medical care and are often prescribed an intricate and frequently changing medication and lifestyle regimen. However, many patients mismanage their medications or have poor comprehension of their disease and self-management tasks. This can lead to harm, hospitalization, and death. Methods/design A patient-oriented education and medication management intervention has been developed for implementation at a tertiary hospital hepatology outpatient center in Queensland, Australia. Consenting patients with decompensated cirrhosis will be randomly allocated to education intervention or usual care treatment arms when they attend routine follow-up appointments. In the usual care arm, participants will be reviewed by their hepatologist according to the current model of care in the hepatology clinic. In the intervention arm, participants will be reviewed by a clinical pharmacist to receive the education and medication management intervention at baseline in addition to review by their hepatologist. Intervention participants will also receive three further educational contacts from the clinical pharmacist within the following 6-month period, in addition to routine hepatologist review that is scheduled within this time frame. All participants will be surveyed at baseline and follow-up (approximately 6 months post-enrollment). Validated questionnaire tools will be used to determine participant adherence, medication beliefs, illness perceptions, and quality of life. Patients’ knowledge of dietary and lifestyle modifications, their current medications, and other clinical data will be obtained from the survey, patient interview, and medical records. Patient outcome data will be collected at 52 weeks. Discussion The intervention described within this protocol is ready to adapt and implement in hepatology ambulatory care centers globally. Investigation of potentially modifiable variables that may impact medication management, in addition to the effect of a clinical pharmacist-driven education and medication management intervention on modifying these variables, will provide valuable information for future management of these patients. Trial registration Australian and New Zealand Clinical Trial Registry identifier: ACTRN12616000780459 . Registered on 15 June 2016.

The detrimental effects of cigarette use during pregnancy are well documented. Studies have shown that cigarette smoking while pregnant is associated with multiple adverse outcomes including: pre-term birth, placental abruption, placenta previa, fetal growth restriction, stillbirth, increased rate of birth defects, and increased risk of sudden infant death syndrome. Cotinine is the primary metabolite of nicotine and allows for measurement of active as well as passive exposure. Cotinine freely cross the placental barrier and maternal concentrations are closely correlated with newborn plasma levels. The aim of this study was to compare maternally reported rates of tobacco use to fetal umbilical cord blood cotinine levels at the time of delivery. A cross-sectional study was conducted on 172 patients. Patients were asked a single yes or no question in regards to their cigarette use during pregnancy. Cord blood was collected at the time of delivery and analyzed for serum concentrations of cotinine. Cotinine levels greater than 3.0 ng/mL were considered consistent with the use of tobacco or tobacco cessation products. Maternal self-reporting of tobacco use indicates a reported tobacco use rate of 27.3% and an actual use rate of 30.2%. The reported tobacco non-use rate was 72.7% and the actual non-use rate was 66.3%. The prevalence of tobacco use during pregnancy in our study was 30.2%, while the overall rate in the United States is reported to be 12.3%. Our findings indicate that self-reported smoking prevalence and verified umbilical cord blood cotinine levels at the time of delivery have excellent correlation (kappa=0.76). Compared to the national average our study group also had nearly double the rate of tobacco use. Due to the deleterious effects of cigarette use during pregnancy continued efforts to educate patients regarding cigarette cessation is of utmost importance as cessation of tobacco products will improve and promote maternal and fetal well-being.

Background: Social media has been utilised in a variety of healthcare settings. While its potential for extending healthcare services is recognised by the NHS, potential pitfalls exist. The place, benefits and practical problems of using Facebook in general practice are unclear. Aim: To understand the utilisation of Facebook by general practices, whether Facebook provides novel insights when compared to other centrally-hosted feedback platforms, and the prevalence of unofficial Facebook pages. Design & setting: Eighty-three general practices in North Staffordshire Method: Publicly available information and feedback relating to general practices on official and unofficial Facebook sites was examined and compared to other, centrally-hosted feedback platforms (NHS Choices and Patient Satisfaction ratings). Thematic and descriptive analyses were undertaken to understand the nature of the content. Results: Thirty-one practices had publicly-accessible, practice-owned, official Facebook sites which, overall, had received over 7000 likes. Two had integrated booking systems, 14 allowed reviews and all had accurate practice information. Most remaining practices (41/52) were found to have an unofficial Facebook page. Conclusion: General practice use of open Facebook pages is variable, but most commonly used to provide generic practice information and for gaining patient feedback. Patient engagement with pages suggests demand for this technology. Risks associated with unmoderated unofficial pages can be mitigated by practices having official pages hosted by the practice with appropriate protocols in place for managing them. Practices need to be supported to better understand meaningful uses of this technology and the potential risks of unofficial practice Facebook pages.

William Neil Cottrell,1 Charles P Denaro,2,3 Lynne Emmerton1,41School of Pharmacy, University of Queensland, Brisbane, Qld, Australia; 2Department of Internal Medicine and Aged Care, The Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia; 3School of Medicine, University of Queensland, Brisbane, Qld, Australia; 4Curtin Health Innovation Research Institute, School of Pharmacy, Curtin University, Perth, WA, AustraliaPurpose: Beliefs about medicines impact on adherence, but eliciting core beliefs about medicines in individual patients is difficult. One method that has the potential to elicit individual core beliefs is the "repertory grid technique." This study utilized the repertory grid technique to elicit individuals' beliefs about their heart failure treatment and to investigate whether generated constructs were different between adherent and nonadherent patients.Methods: Ninety-two patients with heart failure were interviewed using a structured questionnaire that applied the repertory grid technique. Patients were asked to compare and contrast their medicines and self-care activities for their heart failure. This lead to the generation of individual constructs (perceptions towards medicines), and from these, beliefs were elicited about their heart failure treatment, resulting in the generation of a repertory grid. Adherence was measured using the Medication Adherence Report Scale (MARS). Patients with a MARS score ≥ 23 were categorized as "adherent" and those with a score ≤ 22 as "nonadherent." The generated grids were analyzed descriptively and constructs from all grids themed and the frequency of these constructs compared between adherent and nonadherent patients.Results: Individual grids provided insight into the different beliefs that patients held about their heart failure treatment. The themed constructs "related to water," "affect the heart," "related to weight," and "benefit to the heart" occurred more frequently in adherent patients compared with nonadherent patients.Conclusion: The repertory grid technique elicited beliefs of individual participants about the treatment of their heart failure. Constructs from self-reported adherent patients were more likely to reflect that their medicines and self-care activities were related to water and weight, and affect and benefit to the heart. Providing clinicians with better insight into individuals' beliefs about their treatment may facilitate the development of tailored interventions to improve adherence.Keywords: adherence, heart failure, repertory grid, beliefs, treatment

Background: Treatment of vomiting in acute gastroenteritis can increase the rate of successful oral rehydration therapy (ORT) and lower the need for intravenous fluid administration. The aim of this study was to investigate the role of ondansetron in decreasing vomiting and duration of hospitalization in 6 month to 14 year old children.Methods: In 2010, a double blind randomized controlled trial was carried out based on 100 children between six months and 14 years old with acute gastroenteritis and vomiting. Each child satisfied the inclusion criteria and agreed to participate in the study after receiving a complete explanation about the study. Participants were randomly divided into two groups to either receive intravenous ondansetron (single dose of 0.15mg/kg) or an intravenous placebo (5% dextrose water). The duration of hospitalization and number of vomiting episodes were compared between the two groups 4 hours after treatment. Data were analyzed using SPSS16 software.Results: Duration of hospitalization was 38.30±18.62 hours in those receiving ondansetron and 45.10±25.79 hours in the control group. There was no statistically significant difference between the two groups (P=0.352). The number of vomiting episodes was 0.06±0.23 in the ondansetron group and 0.58±0.90 in the control group. This difference is statistically significant (P=0.000). No adverse effects were seen in either group relating to the drug.Conclusions: This study demonstrated that intravenous ondansetron can effectively reduce the frequency of vomiting associated with acute gastroenteritis. We recommend administration of ondansetron for management of children with acute gastroenteritis but further studies with a larger sample size would be beneficial.

Introduction: Medical students in Iran are required to undertake a Basic Sciences Comprehensive Exam (BSCE) at the end of their BS course in order to progress to the next stage of medical education. BSCE results are widely used to evaluate medical education programs among different medical universities. The aim of this study is to explore the correlation between BSCE results and students’ mean BS course scores.Methods: A cross-sectional study, using secondary data analysis, was carried out in 2007 in Hormozgan University of Medical Sciences (HUMS) in Iran. Data from the 20th BSCE (held in 1998) to the 36th BSCE (held in 2006) was collected. All medical students who took these exams and for whom the mean results of the BS course and the BSCE were available were eligible for inclusion in the study. For each medical student, data were obtained regarding age at the time of participation in BSCE, together with sex, entrance year, zone as categorised by the national quota system, mean BS course scores, BSCE result, duration of BS course (number of semesters) and number of failed semesters. Students whose data was not complete were excluded from the study. Data was analysed by using SPSS 15 (SPSS Inc., Chicago, Illinois, USA) software.Results: 372 students undertook the BSCE during the research study period. Complete data was available for 365 medical students (98.1%). Among the participants, 224 (61.4%) were female and 141 (38.6%) were male. The mean age at the time of sitting the BSCE was 22.01±1.22. Mean BSCE scores were higher among students who had not previously failed a semester and who also finished the BS course within five semesters. Students with higher BS course scores had higher BSCE scores (P=0.000).Conclusions: Students’ BS course scores were found to correlate to BSCE results. Hence it may be prudent to identify medical students with low BS course scores, in order to provide additional educational support to improve their medical knowledge and thereby enhance their performance on the BSCE.

Background: This study was concerned with developing the evidence base for public involvement in research in health and social care. There now is significant support for public involvement within the National Institute for Health Research, and researchers applying for National Institute for Health Research grants are expected to involve the public. Despite this policy commitment, evidence for the benefits of public involvement in research remains limited. This study addressed this need through a realist evaluation. Aim and objectives: The aim was to identify the contextual factors and mechanisms that are regularly associated with effective public involvement in research. The objectives included identifying a sample of eight research projects and their desired outcomes of public involvement, tracking the impact of public involvement in these case studies, and comparing the associated contextual factors and mechanisms. Design: The research design was based on the application of realist theory of evaluation, which argues that social programmes are driven by an underlying vision of change – a ‘programme theory’ of how the intervention is supposed to work. The role of the evaluator is to compare theory and practice. Impact can be understood by identifying regularities of context, mechanism and outcome. Thus the key question for the evaluator is ‘What works for whom in what circumstances . . . and why?’ (Pawson R. The Science of Evaluation. London: Sage; 2013). We therefore planned a realist evaluation based on qualitative case studies of public involvement in research. Setting and participants: Eight diverse case studies of research projects in health and social care took place over the calendar year 2012 with 88 interviews from 42 participants across the eight studies: researchers, research managers, third-sector partners and research partners (members of the public involved in research). Results: Case study data supported the importance of some aspects of our theory of public involvement in research and led us to amend other elements. Public involvement was associated with improvements in research design and delivery, particularly recruitment strategies and materials, and data collection tools. This study identified the previously unrecognised importance of principal investigator leadership as a key contextual factor leading to the impact of public involvement; alternatively, public involvement might still be effective without principal investigator leadership where there is a wider culture of involvement. In terms of the mechanisms of involvement, allocating staff time to facilitate involvement appeared more important than formal budgeting. Another important new finding was that many research proposals significantly undercosted public involvement. Nurturing good interpersonal relationships was crucial to effective involvement. Payment for research partner time and formal training appeared more significant for some types of public involvement than others. Feedback to research partners on the value of their contribution was important in maintaining motivation and confidence. Conclusions: A revised theory of public involvement in research was developed and tested, which identifies key regularities of context, mechanism and outcome in how public involvement in research works. Implications for future research include the need to further explore how leadership on public involvement might be facilitated, methodological work on assessing impact and the development of economic analysis of involvement. Funding details: The National Institute for Health Research Health Service and Delivery programme.

Abstract Introduction Research suggests that well-being impacts residents' ability to learn and provide patient care. The purpose of this study was to investigate the descriptive statistics, factors and the internal reliability of the Resident Well-being (RWB) scale. Analyses were also conducted to investigate the construct validity of the responses to the RWB. Methods The resource includes an investigation of the descriptive statistics, factors and the internal reliability of residents' responses to the RWB scale. This resource also includes an investigation of the construct validity of the RWB by exploring potential relationships between residents' well-being and two theoretically related constructs: the quantity of sleep and rotation demands. The development of the RWB and an investigation of the internal reliability and validity of the responses help contribute to how educators can assess residents' well-being and inform residency program implementation. This project also serves as the beginning of a long-term project to efficiently measure the well-being of residents and other learners in the health care professions. Results The RWB responses were internally reliable (Cronbach's alpha = .89) and one factor (i.e., well-being) was distinguished. There was a statistically significant relationship between the frequency residents slept and well-being. There was also a statistically significant effect of rotations' time intensiveness on residents' well-being; however, effect sizes suggest the amount of sleep and rotation intensiveness explains only a small to a moderate amount of variance of resident well-being. Discussion The RWB is a tool that program directors may utilize to monitor residents' well-being. Future research is required to investigate how other triggers, such as program quality and life-stressors, may impact residents' well-being. Future research may also investigate how the RWB may be applied to other health professionals, as learners across the disciplines struggle to negotiate a balance between their personal lives, learning, and patient care.

Abstract Introduction Teaching is an important skill that is addressed in the Accreditation Council for Graduate Medical Education (ACGME) competency framework. Research has demonstrated that residents can spend as much as 25% of their time teaching, and receive as much as 40% of their training from peers. It is important, then, to prepare residents to become informed teachers, who will partner with other educators to ensure the future and quality of medical education. ACGME characterizes teaching as a practice-based learning and improvement competency that is defined as facilitating the learning of students and other healthcare professionals. Methods The purpose of this resource is to provide the materials used for an online course: Residents as Teachers. Medical educators may use or tailor this online course to address residents' teaching skills. An investigation was conducted to explore the course's potential to help further residents' knowledge of teaching and learning issues. Each resident received a pre-/postcourse survey evaluating the residents' knowledge of educational theory, assessment of student learning, and educational research. The residents also self-reported their level of interest and motivation about teaching. Data was analyzed by a two-way, repeated-measures analysis of variance using survey (pretest vs. posttest) and resident group (surgical vs. medical) as variables in the model along with their interaction. Results Residents self-reported spending a higher percentage of their time teaching in a clinical setting versus a classroom setting. There was no significant difference between surgical and medical resident groups. Time spent teaching in a clinical setting was 17.8% and 14% for surgical and medical residents, respectively, while time spent teaching in the classroom was 5.48% and 4.57%. After taking the online teaching course, knowledge of educational theory, assessment, and research was significantly (p < .01) enhanced with no difference between resident groups. Although residents self-reported significantly (p < .05) greater interest and motivation about teaching after completing the online course, the low effect size of 0.26 would indicate practical limitations of this course in altering attitudes toward teaching. Discussion Overall, the study suggests that medical residents will improve their understanding of educational theory, assessment, and research with online instruction. While the course enhanced residents' interest, it may be limited and additional learning experiences may be required to further enhance residents' attitudes about teaching. This study supports the efficacy of online instruction to improve residents' knowledge and interest toward teaching and offers a practiced-based approach to meeting teaching competencies set forth by the ACGME.

Abstract Background Joint pain, specifically chronic knee pain (CKP), is a frequent cause of chronic pain and limitation of function and mobility among older adults. Multiple evidence-based guidelines recommend exercise as a first-line treatment for all patients with CKP or knee osteoarthritis (KOA), yet healthcare practitioners' attitudes and beliefs may limit their implementation. This systematic review aims to identify the attitudes, beliefs and behaviours of General Practitioners (GPs) regarding the use of exercise for CKP/KOA. Methods We searched four electronic databases between inception and January 2008, using subject headings to identify studies examining the attitudes, beliefs or behaviours of GPs regarding the use of exercise for the treatment of CKP/KOA in adults aged over 45 years in primary care. Studies referring to patellofemoral pain syndrome or CKP secondary to other causes or that occurring in a prosthetic joint were excluded. Once inclusion and exclusion criteria were applied, study data were extracted and summarised. Study quality was independently reviewed using two assessment tools. Results From 2135 potentially relevant articles, 20 were suitable for inclusion. A variety of study methodologies and approaches to measuring attitudes beliefs and behaviours were used among the studies. Quality assessment revealed good reporting of study objective, type, outcome factors and, generally, the sampling frame. However, criticisms included use of small sample sizes, low response rates and under-reporting of non-responder factors. Although 99% of GPs agreed that exercise should be used for CKP/KOA and reported ever providing advice or referring to a physiotherapist, up to 29% believed that rest was the optimum management approach. The frequency of actual provision of exercise advice or physiotherapy referral was lower. Estimates of provision of exercise advice and physiotherapy referral were generally higher for vignette-based studies (exercise advice 9%-89%; physiotherapy referral 44%-77%) than reviews of actual practice (exercise advice 5%-52%; physiotherapy referral 13-63%). Advice to exercise and exercise prescription were not clearly differentiated. Conclusions Attitudes and beliefs of GPs towards exercise for CKP/KOA vary widely and exercise appears to be underused in the management of CKP/KOA. Limitations of the evidence base include the paucity of studies directly examining attitudes of GPs, poor methodological quality, limited generalisability of results and ambiguity concerning GPs' expected roles. Further investigation is required of the roles of GPs in using exercise as first-line management of CKP/KOA.