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Abstract Background Chronic pain often clusters in families, where parents and their offspring both experience chronic pain conditions. Young children of parents with irritable bowel syndrome (IBS) represent an at-risk group for the development of abdominal pain, disability, and excess health care visits in later childhood. Parental solicitous responses to children’s expressions of discomfort and maternal modeling of their own illness behavior contribute to a greater focus on somatic sensations, leading to illness behaviors in children. This randomized controlled trial will test the effectiveness of an early preventive web-based psychosocial intervention (REACH)[TM] vs. an educational web-based safety comparison condition delivered to parents with IBS to alter parental responses and lead to improved child health and decreased health care costs. Methods Parents with IBS who have children ages 4–7 years are recruited via community-based approaches (e.g., social media advertisements, school electronic distribution, research networks) and health care providers. The target sample is 460 parents randomized to REACH, a web-based social learning and cognitive behavior therapy (SLCBT) intervention or an educational web-based safety comparison condition (EC). Participants will be assessed at baseline, 6-week (immediate post-intervention), 6-month, 12-month, and 18-month follow-up periods (months post-completion of intervention). The primary outcome is change in parental solicitous/protective behaviors. Secondary outcomes include parent risk and protective factors, child health and symptom outcomes, and health care utilization and cost savings. Discussion This study adapts a validated, parent-delivered intervention to treat chronic pain in children to a web-based application designed to prevent the development of chronic pain in very young, high-risk children. If successful, this strategy can both prevent adverse sequelae of this condition from developing as well as be widely accessible. Furthermore, the availability of a prevention model for parent training could result in significant short- and long-term health benefits across a broad spectrum of conditions. Trial registration ClinicalTrials.gov NCT05730491. Registered on February 15, 2023.

Abstract Background Participants in research trials often disclose severe depression symptoms, including thoughts of self-harm and suicidal ideation, in validated self-administered questionnaires such as the Patient Health Questionnaire (PHQ-9). However, there is no standard protocol for responding to such disclosure, and the opportunity to support people at risk is potentially missed. We developed and evaluated a risk assessment protocol for the IBD-BOOST randomised controlled trial (ISRCTN71618461 09/09/2019). Methods Participants completed the PHQ-9 at baseline and 6-month and 12-month follow-ups. The trial database automatically alerted the research team to risk assess participants. Trial researchers, trained in the protocol, contacted participants by telephone, completed the risk assessment, and signposted participants to appropriate professional services. Results Seven hundred eighty participants were randomised in the trial; 41 required risk assessment. One participant declined assessment, so 40 risk assessments were completed. Twenty-four participants were assessed as low-risk and 16 participants as medium-risk, with 12 declaring previous suicide attempts. None were rated as high-risk. Trial participants expressed appreciation for being contacted, and all except two wished to receive information about professional support services. Trial risk assessors reported positive experiences of conducting the risk assessment with suggestions for improvement, which resulted in minor modifications to the protocol. Discussion Our evaluation demonstrated that it was viable for a research trial team to successfully conduct a risk-assessment protocol for trial participants reporting thoughts of self-harm, with training and support from senior colleagues. Resources are required for training and delivery, but it is not unduly onerous. Trial participants appeared to find completing the assessment acceptable.

Background: Myocardial infarction (MI), presented as ST-segment elevation MI (STEMI) and non-ST-segment elevation MI (NSTEMI), is influenced by atherosclerosis risk factors. Aim: The aim of this study was to assess the patterns of presentation of patients with acute MI in Kosovo. Methods: This was a cross-sectional study conducted at the University Clinical Center of Kosovo, which included all patients hospitalized with acute MI over a period of 7 years. Results: Among the 7353 patients admitted with acute MI (age 63 ± 12 years, 29% female), 59.4% had STEMI and 40.6% had NSTEMI. The patients with NSTEMI patients less (48.3% vs. 54%, p < 0.001), but more of them had diabetes (37.8% vs. 33.6%, p < 0.001), hypertension (69.6% vs. 63%, p < 0.001), frequently had a family history of coronary artery disease (CAD) (40% vs. 38%, p = 0.009), and had more females compared to the patients with STEMI (32% vs. 27%, p < 0.001). The patients with NSTEMI underwent less primary percutaneous interventions compared with the patients with STEMI (43.6% vs. 55.2%, p < 0.001). Smoking [1.277 (1.117–1.459), p ˂ 0.001] and high triglycerides [0.791 (0.714–0.878), p = 0.02] were independent predictors of STEMI. Conclusions: In Kosovo, patients with STEMI are more common than those with NSTEMI, and they were mostly males and more likely to have diabetes, hypertension, and a family history of CAD compared to those with NSTEMI. Smoking and high triglycerides proved to be the strongest predictors of acute STEMI in Kosovo, thus highlighting the urgent need for optimum atherosclerosis risk control and education strategies.

Background and Aim: Bats are a reservoir for the pathogenic bacteria Klebsiella pneumoniae and can spread it through feces that fall in nests/caves, carried, and dropped while they fly near human settlements, and from their saliva. The emergence and spread of multidrug resistance (MDR) strains of K. pneumoniae indicate that resistant to antibiotics, especially extended-spectrum beta-lactamase (ESBL), is considered an important global health threat. The aim of this study was to determine the presence of the gene encoding extended beta-lactamase in K. pneumoniae isolated from fresh bat feces collected from the Tanjung Ringgit bat cave, East Lombok. Materials and Methods: In this study, 150 fresh fecal samples were analyzed using standard microbiological techniques for the presence of K. pneumoniae. K. pneumoniae-positive isolates were subjected to antibiotic sensitivity testing, followed by molecular detection using polymerase chain reaction. Results: This study showed that 14 (9.3%) of 150 samples were positive for K. pneumoniae. Ten of the 14 samples (71.4%) were MDR isolates and 6 (42.9%) had the blaSHV gene identified. Conclusion: The presence of K. pneumoniae isolated from fresh bat feces, which is MDR and has the blaSHV gene encoding ESBL indicates that bats can be a reservoir for the transmission of MDR and ESBL bacteria has an impact on public health in the study area.

BACKGROUND: Cluster of differentiation (CD)36 and adenosine triphosphate-binding cassette transporter A1 (ABCA1) are 2 macrophages-expressed receptors that promote cholesterol uptake and efflux, in which their imbalance might be associated with the foam cell formation risk. Type 2 diabetes mellitus (T2DM) has been correlated with the increase of this plaque formation. Therefore, it is necessary to determine whether expression of CD36 and ABCA1 in macrophages are correlated with coronary artery disease (CAD) risk markers in T2DM cases. METHODS: Peripheral blood mononuclear cells (PBMC) were isolated from 13 diabetic patients and 11 healthy donors. Then, the PBMC-derived macrophages were cultured with supplement of oxidized low-density lipoprotein (ox-LDL) or lipopolysaccharide (LPS). Expression of CD36 and ABCA1 was measured using flowcytometry, meanwhile the supernatant concentration of interleukin (IL)-1b and IL-10 was measured by multiplex immunoassay. RESULTS: T2DM subjects more likely to have low proportion of CD36-ABCA+ macrophages compared to healthy donors (p=0.041) and it had negative correlation with glucose homeostasis and insulin resistance markers, including fasting blood glucose (FBG, r=-0.408, p=0.048), glycated hemoglobin (HbA1c, r=-0.380, p=0.049), triglyceride glucose index (r=-0,518, p=0.009), and high-sensitivity C-reactive protein (hs-CRP, r=-0.556, p=0.005). Moreover, it also had a negative correlation with atherogenic markers such as triglyceride (r=-0.417, p=0.043), triglyceride/HDL, and LDL/HDL, but had positive correlation with HDL (r=0.540, p=0.007). Most of T2DM subjects had high IL-1β/IL-10 ratio after ox-LDL and LPS stimulation (p=0.02 and p=0.05, respectively). CONCLUSION: Reduced proportion of CD36-ABCA1+ macrophages followed with high IL-1β/IL-10 can be a marker of CAD in T2DM. KEYWORDS: type 2 diabetes mellitus, coronary artery disease, macrophages, ABCA1, CD36

Objetivo: apresentar as evidências científicas sobre as orientações para a coleta de sangue de cordão umbilical para realização de exame laboratorial de recém-nascidos, publicados no período de 2011 a 2021. Metodologia: revisão integrativa da literatura com utilização do Prefered Reporting Itens for Systematic Reviews and Meta-Analyses. Bases de dados utilizadas: Biblioteca Virtual de Saúde, LILACS, MEDLINE, PUBMED, CINAHL, UpToDate e Cochrane Library. Resultados: analisados 12 estudos, sendo 1 artigo de revisão, revelando positividade em coletar amostras no sangue de cordão umbilical; e 1 estudo de caso, com descrição dos benefícios dessa coleta. Os outros 10 trabalhos foram estudos prospectivos, caso-controle. Em 7 estudos foi comparada a qualidade dos exames laboratoriais obtidos em sangue de cordão umbilical e diretamente nos recém-nascidos, na avaliação de sepses, com resultados positivos; e nos outros 3, observaram desfechos favoráveis na redução das transfusões de sangue quando coletadas no cordão umbilical ao se comparar a coleta direta, com melhores índices hematológicos. Conclusões: Os achados apoiam a viabilidade e precisão do sangue umbilical para coleta de exames laboratoriais admissionais. Isso reduz a perda na flebotomia e permite coletar maior volume sanguíneo. Há aumento da sensibilidade para hemocultura quando as equipes coletadoras são treinadas para esse fim.

The KOSovan Acute Coronary Syndrome (KOS-ACS) Registry is established as a prospective, continuous, nationwide, web-based registry that is operated online. The KOS-ACS registry is designed with the following objectives: (1) to obtain data on the demographic, clinical, and laboratory characteristics of ACS patients treated in Kosovo; (2) to create a national database with information on health care in ACS patients treated in Kosovo; (3) to identify the national features of associations between ACS characteristics and clinical outcomes, including mortality, complications, the length of hospital stay, and the quality of clinical care; and (4) to propose a practical guide for improving the quality and efficiency of ACS treatment in Kosovo. The Kosovo Society of Cardiology and University of Prishtina will be responsible for the development of the KOS-ACS registry and centralized data analysis at the national level. The KOS-ACS Registry will enroll all patients admitted, at any of the registered clinical centers, with the diagnosis of ACS and who will be clinically managed at any of the Kosovo hospitals. Data on patient demographics, clinical characteristics, previous and hospital drug treatment, and reperfusion therapy will be collected. The type of ACS (unstable angina, NSTEMI, or STEMI) will also be clearly defined. The time from first medical contact to balloon inflation (FMC-to-balloon) and door-to-ballon time will be registered. In-hospital death and complications will be registered. Data on the post-hospital primary outcome (MACE: cardiac death, all-cause mortality, hospitalization, stroke, need for coronary revascularization) of patients, at 30 days and 1 year, will be included in the registry.

Abstract Background Improving the health and well-being of young people is a public health priority. Schools present an ideal setting to implement strategies to improve young people’s health and well-being. A key strategy involves conducting surveys to assess student health needs, inform interventions, and monitor health over time. Conducting research in schools is, however, challenging. Schools can find it difficult to participate and adhere to research processes, even when they are keen to be involved in research, because of competing priorities (e.g., attendance and educational achievement), as well as time and resource constraints. There is a lack of literature on the perspectives of school staff and other key stakeholders working in young people’s health on how best to work with schools to conduct health research, and in particular, health surveys. Methods Participants (n = 26) included members of staff from 11 secondary schools (covering students aged 11–16 years), 5 local authority professionals, and 10 wider key stakeholders in young people's health and well-being (e.g., a school governor, a national government member), based in South West England. Participants took part in semi-structured interviews that were conducted either over the phone or via an online platform. Data were analysed using the Framework Method. Results Three main themes were identified: Recruitment and Retention, Practicalities of Data Collection in Schools, and Collaboration from Design to Dissemination. It is important to acknowledge the role of local authorities and academy trusts in the English education system, and work closely with these when conducting school-based health surveys. School staff prefer to be contacted about research via email and in the summer term, following exams. Researchers should contact a member of staff involved in student health/well-being, as well as senior leadership, during recruitment. Data collection during the start and end of the school year is undesirable. Research should be collaborative with school staff and young people, consistent with school priorities and values, and flexible and tailored to school timetables and resources. Conclusions Overall the findings demonstrate that survey-based research methods should be school-led and tailored to each school.

Pulmonary alveolar microlithiasis (PAM) is a rare genetic disorder that causes calcium phosphate microliths to form in the alveoli. Symptoms usually appear in a person’s third or fourth decade of life. A definitive diagnosis does not always demand a lung biopsy but can be achieved in families with more than one member with PAM and compatible chest imaging. We present the case of a 47-year-old woman referred to us for shortness of breath. Chest imaging revealed bilateral diffuse ground-glass opacities, interlobar fissure calcification, and subpleural linear calcifications, leading to a diagnosis of PAM. Although there is no specific treatment for this condition, early diagnosis can help prevent it from progressing rapidly by avoiding exposure to risk factors.

Abstract Background Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to SARS-CoV-2 infection by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination. Methods PROTECT-V is a platform trial testing pre-exposure prophylactic interventions against SARS-CoV-2 infection in vulnerable patient populations (organ transplant recipients; individuals with oncological/haematological diagnoses, immune deficiency or autoimmune diseases requiring immunosuppression or on dialysis). Multiple agents can be evaluated across multiple vulnerable populations sharing placebo groups, with the option of adding additional treatments at later time points as these become available. The primary endpoint is symptomatic SARS-CoV-2 infection, and each agent will be independently evaluated in real time when the required number of events occurs. Presently, three agents are approved in the platform: intranasal niclosamide, nasal and inhaled ciclesonide and intravenous sotrovimab. Discussion Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to COVID-19 disease by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination. Trial registration ClinicalTrials.gov NCT04870333. EudraCT 2020-004144-28

Abstract Background Antimicrobial resistance is a leading global public health threat, with inappropriate use of antimicrobials in healthcare contributing to its development. Given this urgent need, we developed a complex ePrescribing-based Anti-Microbial Stewardship intervention (ePAMS+). Methods ePAMS+ includes educational and organisational behavioural elements, plus guideline-based clinical decision support to aid optimal antimicrobial use in hospital inpatients. ePAMS+ particularly focuses on prompt initiation of antimicrobials, followed by early review once test results are available to facilitate informed decision-making on stopping or switching where appropriate. A mixed-methods feasibility trial of ePAMS+ will take place in two NHS acute hospital care organisations. Qualitative staff interviews and observation of practice will respectively gather staff views on the technical component of ePAMS+ and information on their use of ePAMS+ in routine work. Focus groups will elicit staff and patient views on ePAMS+; one-to-one interviews will discuss antimicrobial stewardship with staff and will record patient experiences of receiving antibiotics and their thoughts on inappropriate prescribing. Qualitative data will be analysed thematically. Fidelity Index development will enable enactment of ePAMS+ to be measured objectively in a subsequent trial assessing the effectiveness of ePAMS+. Quantitative data collection will determine the feasibility of extracting data and deriving key summaries of antimicrobial prescribing; we will quantify variability in the primary outcome, number of antibiotic defined daily doses, to inform the future larger-scale trial design. Discussion This trial is essential to determine the feasibility of implementing the ePAMS+ intervention and measuring relevant outcomes, prior to evaluating its clinical and cost-effectiveness in a full scale hybrid cluster-randomised stepped-wedge clinical trial. Findings will be shared with study sites and with qualitative research participants and will be published in peer-reviewed journals and presented at academic conferences. Trial registration The qualitative and Fidelity Index research were approved by the Health and Research Authority and the North of Scotland Research Ethics Service (ref: 19/NS/0174). The feasibility trial and quantitative analysis (protocol v1.0, 15 December 2021) were approved by the London South East Research Ethics Committee (ref: 22/LO/0204) and registered with ISRCTN ( ISRCTN 13429325 ) on 24 March 2022

Colonic volvulus is one of the most common causes of bowel obstruction. It could occur in different parts of the colon. The sigmoid is the most common part, but it rarely occurs in the transverse colon because of the colon’s anatomical features. So, simultaneous sigmoid and transverse colon volvulus is a rare phenomenon that could endanger patients’ lives due to its rarity, ischemia, necrosis of the colon wall, and the lack of a definite algorithm to approach this disease. So, it is essential to consider this disease as one of the most important differential diagnoses in patients with abdominal pain and distention. In this article, a 45-year-old male presented to the surgical ward with severe prolonged abdominal pain, diagnosed with simultaneous sigmoid and transverse colon volvulus during laparotomy.

Plain English Summary All major problems, including complex global problems such as air pollution and pandemics, require reliable data sharing between disciplines in order to respond effectively. Such problems require evidence-informed collaborative methods, multidisciplinary research and interventions in which the people who are affected are involved in every stage. However, there is currently no standardised way to share information about initiatives and problem-solving across and between fields such as health, environment, basic science, manufacturing, education, media and international development. A multi-disciplinary international team of over 100 citizens, experts and data-users has been involved in co-creating STARDIT to help everyone in the world share, find and understand information about collective human actions, which are referred to as ‘initiatives’. STARDIT is an open access data-sharing system to standardise the way that information about initiatives is reported, including information about which tasks were done by different people. Reports can be updated at all stages, from planning to evaluation, and can report impacts in many languages, using Wikidata. STARDIT is free to use, and data can be submitted by anyone. Report authors can be verified to improve trust and transparency, and data checked for quality. STARDIT can help create high-quality standardised information on initiatives trying to solve complex multidisciplinary global problems. Among its main benefits, STARDIT offers those carrying out research and interventions access to standardised information which enables well-founded comparisons of the effectiveness of different methods. This article outlines progress to date; current usage; information about submitting reports; planned next steps and how anyone can become involved.

Mature ovarian cystic teratoma, also known as the dermoid cyst, is one of the most common benign ovarian neoplasms that can occur in different age groups and could appear in various sizes. Diagnosing this problem as soon as possible is essential due to complications that can coincide, such as torsion, rupture, internal hemorrhage and malignant transformation. In this article, we reported a 66-year-old female patient with a single huge mature ovarian cyst teratoma who presented to the surgical ward with abdominal pain and swelling but did not see any doctor during that period and disregarded her problems for 4 years.

Abstract Background Positive Choices is a whole-school social marketing intervention to promote sexual health among secondary school students. Intervention comprises school health promotion council involving staff and students coordinating delivery; student survey to inform local tailoring; teacher-delivered classroom curriculum; student-run campaigns; parent information; and review of sexual/reproductive health services to inform improvements. This trial builds on an optimisation/pilot RCT study which met progression criteria, plus findings from another pilot RCT of the Project Respect school-based intervention to prevent dating and relationship violence which concluded such work should be integrated within Positive Choices. Young people carry a disproportionate burden of adverse sexual health; most do not report competence at first sex. Relationships and sex education in schools can contribute to promoting sexual health but effects are small, inconsistent and not sustained. Such work needs to be supplemented by ‘whole-school’ (e.g. student campaigns, sexual health services) and ‘social marketing’ (harnessing commercial marketing to social ends) approaches for which there is good review-level evidence but not from the UK. Methods We will conduct a cluster RCT across 50 schools (minimum 6440, maximum 8500 students) allocated 1:1 to intervention/control assessing outcomes at 33 months. Our primary outcome is non-competent first sex. Secondary outcomes are non-competent last sex, age at sexual debut, non-use of contraception at first and last sex among those reporting heterosexual intercourse, number of sexual partners, dating and relationship violence, sexually transmitted infections, and pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys. We will recruit 50 school and undertake baseline surveys by March 2022; implement the intervention over the 2022–2024 school years and conduct the economic and process evaluations by July 2024; undertake follow-up surveys by December 2024; complete analyses, all patient and policy involvement and draft the study report by March 2025; and engage in knowledge exchange from December 2024. Discussion This trial is one of a growing number focused on whole-school approaches to public health in schools. The key scientific output will be evidence about the effectiveness, costs and potential scalability and transferability of Positive Choices. Trial registration ISRCTN No: ISRCTN16723909 . Trial registration summary: Date:. Funded by: National Institute for Health Research Public Health Research Programme (NIHR131487). Sponsor: LSHTM. Public/scientific contact: Chris Bonell. Public title: Positive Choices trial. Scientific title: Phase-III RCT of Positive Choices: a whole-school social marketing intervention to promote sexual health and reduce health inequalities. Countries of recruitment: UK. Intervention: Positive Choices. Inclusion criteria: Students in year 8 (age 12–13 years) at baseline deemed competent by schools to participate in secondary schools excluding pupil referral units, schools for those with special educational needs and disabilities, and schools with ‘inadequate’ Ofsted inspections. Study type: interventional study with superiority phase III cluster RCT design. Enrollment: 1/9/21-31/3/22. Sample size: 50 schools and 6440–8500 students. Recruitment status: pending. Primary outcome: binary measure of non-competent first sex. Secondary outcomes: non-competent last sex; age at sexual debut; non-use of contraception at first and last sex; number of sexual partners; dating and relationship violence (DRV) victimisation; sexually transmitted infections; pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys using adapted versions of the RIPPLE measures. Ethics review: LSHTM research ethics committee (reference 26411). Completion data: 1/3/25. Sharing statement: Data will be made available after the main trial analyses have been completed on reasonable request from researchers with ethics approval and a clear protocol. Amendments to the protocol will be communicated to the investigators, sponsor, funder, research ethics committee, trial registration and the journal publishing the protocol. Amendments affecting participants’ experience of the intervention or important amendments affecting the overall design and conduct of the trial will be communicated to participants.

Abstract Background Positive Choices is a whole-school social-marketing intervention to promote sexual health among secondary school students. Intervention comprises the following: school health promotion council involving staff and students coordinating delivery, student survey to inform local tailoring, teacher-delivered classroom curriculum, student-run campaigns, parent information and review of sexual/reproductive health services to inform improvements. This trial builds on an optimisation/pilot-RCT study which met progression criteria, plus findings from another pilot RCT of the Project Respect school-based intervention to prevent dating and relationship violence which concluded such work should be integrated within Positive Choices. Young people carry a disproportionate burden of adverse sexual health; most do not report competence at first sex. Relationships and sex education in schools can contribute to promoting sexual health but effects are small, inconsistent and not sustained. Such work needs to be supplemented by ‘whole-school’ (e.g. student campaigns, sexual health services) and ‘social marketing’ (harnessing commercial marketing to social ends) approaches for which there is good review-level evidence but not from the UK. Methods We will conduct a cluster RCT across 50 schools (minimum 6440, maximum 8500 students) allocated 1:1 to intervention/control assessing outcomes at 33 months. Our primary outcome is non-competent first sex. Secondary outcomes are non-competent last sex, age at sexual debut, non-use of contraception at first and last sex among those reporting heterosexual intercourse, number of sexual partners, dating and relationship violence, sexually transmitted infections and pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys. We will recruit 50 school and undertake baseline surveys by March 2022, implement the intervention over the 2022–2024 school years and conduct the economic and process evaluations by July 2024; undertake follow-up surveys by December 2024; complete analyses, all patient and policy involvement and draft the study report by March 2025 and engage in knowledge exchange from December 2024. Discussion This trial is one of a growing number focused on whole-school approaches to public health in schools. The key scientific output will be evidence about the effectiveness, costs and potential scalability and transferability of Positive Choices. Trial registration ISRCTN No: ISRCTN16723909 . Registered on 3 September 2021.

Abstract Background Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support. Primary research question In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0–10 scale) compared with care as usual? Methods A pragmatic two-arm, parallel group randomised controlled trial (RCT), of a 12-session facilitator-supported online cognitive behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain and faecal urgency/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation. We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12 months post randomisation will be compared between the study groups. Discussion The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients’ quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals. Trial registration ISRCTN71618461 . Registered on 9 September 2019.

Abstract Background Dizziness is a common complaint that often persists and leads to disability and distress. Several cognitive and behavioural responses may contribute to the neurobiological adaptations that maintain persistent vestibular symptoms. This paper will present the protocol of a two-arm parallel group feasibility randomised controlled trial designed to determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of an integrated cognitive behavioural therapy and vestibular rehabilitation (CBT-VR) treatment for people with persistent dizziness. Methods Forty adult patients will be recruited from a tertiary vestibular clinic with persistent movement–triggered dizziness for 3 months or longer who have moderate–high levels of dizziness handicap. Participants will be 1:1 randomised, using a minimisation procedure, to six sessions of either CBT-VR (intervention arm) or VR only (control arm). Measures will be collected at baseline and 4 months post randomisation. The primary feasibility outcomes include descriptive data on numbers meeting eligibility criteria, rates of recruitment, numbers retained post randomisation, treatment adherence and an acceptability questionnaire. Treatment effects on self-report outcomes will be estimated to determine that 95% confidence intervals for the effects are consistent with anticipated effects and minimum clinically important differences, and to provide information needed for the power calculation of an efficacy trial. A nested qualitative study will be conducted post-intervention (intervention group only) to explore the acceptability of the intervention and identify any areas in need of improvement. Discussion If a trial of CBT-VR is feasible, acceptability data will be used to enhance the intervention if needed and refine the multicentre RCT protocol. Future studies will need to consider the training required for other physiotherapists to deliver the intervention. Trial registration ClinicalTrials.gov, ISRCTN 10420559

Abstract Background Chronic pain is a poorly managed symptom of inflammatory bowel disease (IBD). Cognitive behavioural therapy (CBT) has an evidence base in functional gastrointestinal conditions and chronic pain. This study aimed to test the feasibility and acceptability of a 9-week online facilitator-supported CBT intervention, tailored for people with chronic IBD-related pain. Design A single-arm pre-post design with nested qualitative interviews was used. Twenty individuals with IBD and chronic pain were recruited through an online IBD charity and had consented to research in a previous survey or responded to an online charity advert. Individuals who indicated a pain-interference score of ≥ 4/10 (Brief Pain Inventory) and met inclusion criteria were invited to take part. Outcomes included recruitment and retention rates, pain interference and severity, quality of life (QoL) and psychosocial measures. Results Of 145 individuals contacted, 55 (37.9%) responded. Two individuals were recruited from the study advertisement. Twenty out of 57 (35.1%) met screening and eligibility criteria. Eighty-five percent of the sample engaged with intervention sessions and 55% completed at least 5/9 sessions. Eighty percent of recruited participants completed the post-intervention questionnaire at week 9. The mean score for overall acceptability was 43.4 (0–70). Qualitative feedback demonstrated the value of thought monitoring and facilitator support. Scores improved for QoL and pain self-efficacy and reduced for depression, anxiety, pain catastrophising and avoidance resting behaviour. Conclusions Online CBT for chronic IBD-related pain appears feasible and acceptable. The study suggests positive effects for improving QoL and reducing psychological distress; however, online and face-to-face recruitment methods are recommended and establishing efficacy through larger randomised controlled trials is required.

Abstract Background Mental health disorders in the context of long-term conditions in children and young people are currently overlooked and undertreated. Evidence-based psychological treatments for common childhood mental health disorders (anxiety, depression and disruptive behaviour disorders) have not been systematically evaluated in young people with epilepsy despite their high prevalence in this population. The aim of this multi-site randomised controlled trial is to determine the clinical and cost-effectiveness of adding a modular psychological intervention to usual care for the mental health disorders in comparison to assessment-enhanced usual care alone. Methods In total, 334 participants aged 3–18 years attending epilepsy services will be screened for mental health disorders with the Strengths and Difficulties Questionnaire (SDQ) and the diagnostic Development and Wellbeing Assessment (DAWBA). Those identified as having a mental health disorder and consenting to the trial will be randomised to either receive up to 22 sessions of the modular psychological intervention (MATCH-ADTC) delivered over the telephone over 6 months by non-mental health professionals in addition to usual care or to assessment-enhanced usual care alone. Outcomes will be measured at baseline, 6 months and 12 months post-randomisation. It is hypothesised that MATCH-ADTC plus usual care will be superior to assessment-enhanced usual care in improving emotional and behavioural symptoms. The primary outcome is the SDQ reported by parents at 6 months. Secondary outcomes include parent-reported mental health measures such as the Revised Children’s Anxiety and Depression Scale, quality of life measures such as the Paediatric Quality of Life Inventory and physical health measures such as the Hague Seizure Severity Scale. Outcome assessors will be blinded to group assignment. Qualitative process evaluations and a health economic evaluation will also be completed. Discussion This trial aims to determine whether a systematic and integrated approach to the identification and treatment of mental health disorders in children and young people with epilepsy is clinically and cost-effective. The findings will contribute to policies and practice with regard to addressing mental health needs in children and young people with other long-term conditions. Trial registration ISRCTN ISRCTN57823197 . Registered on 25 February 2019.

Abstract Background Whole-school interventions represent promising approaches to promoting adolescent sexual health, but they have not been rigorously trialled in the UK and it is unclear if such interventions are feasible for delivery in English secondary schools. The importance of involving intended beneficiaries, implementers and other key stakeholders in the co-production of such complex interventions prior to costly implementation and evaluation studies is widely recognised. However, practical accounts of such processes remain scarce. We report on co-production with specialist providers, students, school staff, and other practice and policy professionals of two new whole-school sexual heath interventions for implementation in English secondary schools. Methods Formative qualitative inquiry involving 75 students aged 13–15 and 23 school staff. A group of young people trained to advise on public health research were consulted on three occasions. Twenty-three practitioners and policy-makers shared their views at a stakeholder event. Detailed written summaries of workshops and events were prepared and key themes identified to inform the design of each intervention. Results Data confirmed acceptability of addressing unintended teenage pregnancy, sexual health and dating and relationships violence via multi-component whole-school interventions and of curriculum delivery by teachers (providing appropriate teacher selection). The need to enable flexibility for the timetabling of lessons and mode of parent communication; ensure content reflected the reality of young people’s lives; and develop prescriptive teaching materials and robust school engagement strategies to reflect shrinking capacity for schools to implement public-health interventions were also highlighted and informed intervention refinements. Our research further points to some of the challenges and tensions involved in co-production where stakeholder capacity may be limited or their input may conflict with the logic of interventions or what is practicable within the constraints of a trial. Conclusions Multi-component, whole-school approaches to addressing sexual health that involve teacher delivered curriculum may be feasible for implementation in English secondary schools. They must be adaptable to individual school settings; involve careful teacher selection; limit additional burden on staff; and accurately reflect the realities of young people’s lives. Co-production can reduce research waste and may be particularly useful for developing complex interventions, like whole-school sexual health interventions, that must be adaptable to varying institutional contexts and address needs that change rapidly. When co-producing, potential limitations in relation to the representativeness of participants, the ‘depth’ of engagement necessary as well as the burden on participants and how they will be recompensed must be carefully considered. Having well-defined, transparent procedures for incorporating stakeholder input from the outset are also essential. Formal feasibility testing of both co-produced interventions in English secondary schools via cluster RCT is warranted. Trial registration Project Respect: ISRCTN12524938 . Positive Choices: ISRCTN65324176

Abstract Idiopathic normal pressure hydrocephalus (iNPH) is a neurological disorder that occurs in about 1% of individuals over age 60 and is characterized by enlarged cerebral ventricles, gait difficulty, incontinence, and cognitive decline. The cause and pathophysiology of iNPH are largely unknown. We performed whole exome sequencing of DNA obtained from 53 unrelated iNPH patients. Two recurrent heterozygous loss of function deletions in CWH43 were observed in 15% of iNPH patients and were significantly enriched 6.6‐fold and 2.7‐fold, respectively, when compared to the general population. Cwh43 modifies the lipid anchor of glycosylphosphatidylinositol‐anchored proteins. Mice heterozygous for CWH43 deletion appeared grossly normal but displayed hydrocephalus, gait and balance abnormalities, decreased numbers of ependymal cilia, and decreased localization of glycosylphosphatidylinositol‐anchored proteins to the apical surfaces of choroid plexus and ependymal cells. Our findings provide novel mechanistic insights into the origins of iNPH and demonstrate that it represents a distinct disease entity.

Abstract Incomplete obliteration of urachus during the fetal period can lead to urachal abnormalities. One of these abnormalities is the urachal sinus that can be asymptomatic, or it can be symptomatic by becoming infected or being malignant, and it can mimic other diseases' symptoms. Although it is rare in adults, it should be considered a significant differential diagnosis in patients with abdominal pain or umbilical discharge. This article presents a young patient with urachal sinus mimicking umbilical pilonidal sinus symptoms.

Abstract Background Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an ‘integrated GP care’ approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit. Methods A feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to ‘integrated GP care plus treatment as usual’ or ‘treatment as usual’. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level. Results Two thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small. Conclusions It was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients’/GPs’ utilisation of audio/visual and training resources before proceeding to a full trial evaluation. Trial registration NCT02444520 (ClinicalTrials.gov).

Abstract Background Improving children and young people’s provision for mental health is a current health priority in England. Secondary school teachers have worse mental health outcomes than the general working population, which the Wellbeing in Secondary Education (WISE) cluster randomised controlled trial aimed to improve. The WISE intervention comprised a Mental Health First Aid (MHFA) training package delivered to at least 16% of staff, a short mental health awareness session to all teachers and development of a staff peer support service. Twenty-five schools were randomised to intervention or control arms. This paper reports findings regarding the extent of uptake and fidelity of the intervention. Methods Mixed methods data collection comprised researcher observations of training delivery, training participant evaluation forms, trainer and peer supporter interviews, peer supporter feedback meetings, logs of support provided, and teacher questionnaires. Quantitative data were summarised descriptively, while thematic analysis was applied to the qualitative data. Results In the 12 schools assigned to the intervention arm, 113 (8.6%) staff completed the 2-day standard MHFA training course, and a further 146 (11.1%) staff completed the 1-day MHFA for schools and colleges training. In seven (58.3%) schools, the required 8% of staff completed the MHFA training packages. A 1-h mental health awareness-raising session was attended by 666 (54.5%) staff. Delivery of the MHFA training package was achieved with high levels of fidelity and quality across schools. All schools set up the peer support service following training, with a majority adhering to most of the operational guidelines developed from the pilot study at the outset. Teachers reported limited use of the peer support service during follow-up. At the 1-year follow-up, only three (25.0%) schools indicated they had re-advertised the service and there was evidence of a reduction in support from senior leadership. Conclusion The MHFA training package was delivered with reasonably high fidelity, and a staff peer support service was established with general, but not complete, adherence to guidelines. In some schools, insufficient staff received MHFA training and levels of delivery of the peer support service compromised intervention dose and reach. Trial registration ISRCTN 95909211 . Registered on 15 January 2016

Abstract Background The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment approaches in a trial of behavioral weight loss programs to (1) describe the yields from each approach and (2) compare the demographics, weight control histories, and study involvement of samples recruited by each approach. Methods Data for this observational study include source of recruitment, demographic information, weight loss experiences (e.g., lifetime weight loss, current weight loss behaviors), and completion of the 6-month assessment visit. Results Men comprised 14.2% of participants who responded to non-targeted recruitment efforts, while targeted efforts yielded 50.4% men. Similarly, people of color comprised 12.8% of those who responded to non-targeted approaches, whereas targeted recruitment methods yielded 47.2% people of color. Men recruited through targeted methods were younger (p = 0.01) than men recruited through non-targeted means but were otherwise similar. Women of color recruited through targeted methods reported use of fewer weight loss strategies relative to women of color recruited through non-targeted means (p = 0.006) but were otherwise similar. There were no differences by recruitment method on retention to the study. Conclusions Using targeted recruitment methods increased the ethnic and gender diversity of the recruited sample without reducing study retention. This targeting also increased the enrollment of women with less weight loss experience who may not have otherwise sought out a weight loss program. Developing and implementing a targeted recruitment plan should be considered early in the clinical trial development process. Trial registration Clinicaltrials.gov, NCT02368002 . Registered on 20 February 2015.

Background: Menstrual personal hygiene is an effort to maintain personal hygiene and reproductive organs during menstruation. If the personal hygiene of menstruation is poor, it may be at risk of infection of the reproductive tract and can cause vaginal discharge. The results of the preliminary study showed that 8 out of 10 adolescents knew little about menstrual hygiene. Purpose: To produce animated video content motion graphics of adolescent girls about personal hygiene during menstruation. Method: This study using uses the PProcess media development model. The expert review was conducted by media experts and materials experts. The pre-test media will conduct on girls adolescents aged 13-18. Results: The expert review results showed that the animation video media motion graphic about menstrual personal menstrual hygiene belonged to an excellent category (81-100%), and the materials in the animated videos motion graphic about menstrual personal hygiene belonged to a good category (61-80%). The results of a small-scale experiment conducted on 13-18-year-old girls showed an increase in knowledge before and after watching animated videos about menstruation and personal hygiene. All interviewees believed that animated videos were very educational and useful for young women. Conclusion: This study shows a change in the increase in knowledge of adolescent girls after seeing an animated video motion graphic about menstrual personal hygiene.

We present a case of ptosis secondary to metastatic lobular carcinoma of the breast which was initially diagnosed as involutional ptosis. A 67-year-old woman previously diagnosed with lobular carcinoma of the breast presented to our clinic with mild restriction of lateral gaze and persistent droopiness of her right eyelid (associated with decreased levator function) despite recent repair of a suspected involutional ptosis. Orbital magnetic resonance imaging revealed a mass in the right orbit which was biopsied and diagnosed as lobular carcinoma of the breast. Poor levator function is rarely present in involutional ptosis. Especially in conjunction with abnormal extraocular motility, other etiologies of acquired ptosis must be considered. This case highlights the importance of patient history and ocular examination in identifying the underlying etiology of ptosis. A review of the literature to evaluate the incidence of signs and symptoms associated with metastatic breast cancer to the orbit is included.

Background: Both opioid use and COVID-19 affect respiratory and pulmonary health, potentially putting individuals with opioid use disorders (OUD) at risk for complications from COVID-19. We examine the relationship between OUD and subsequent hospitalization, length of stay, risk for invasive ventilator dependence (IVD), and COVID-19 mortality. Methods: Multivariable logistic and exponential regression models using electronic health records data from the Cerner COVID-19 De-Identified Data Cohort from January through June 2020. Findings: Out of 52,312 patients with COVID-19, 1.9% (n=1,013) had an OUD. COVID-19 patients with an OUD had higher odds of hospitalization (aOR=3.44, 95% CI=2.81–4.21), maximum length of stay (eβ^=1.16, 95% CI=1.09–1.22), and odds of IVD (aOR=1.26, 95% CI=1.06–1.49) than patients without an OUD, but did not differ with respect to COVID-19 mortality. However, OUD patients under age 45 exhibited greater COVID-19 mortality (aOR=3.23, 95% CI=1.59–6.56) compared to patients under age 45 without an OUD. OUD patients using opioid agonist treatment (OAT) exhibited higher odds of hospitalization (aOR=5.14, 95% CI=2.75–10.60) and higher maximum length of stay (eβ^=1.22, 95% CI=1.01–1.48) than patients without OUDs; however, risk for IVD and COVID-19 mortality did not differ. OUD patients using naltrexone had higher odds of hospitalization (aOR=32.19, 95% CI=4.29–4,119.83), higher maximum length of stay (eβ^=1.59, 95% CI=1.06–2.38), and higher odds of IVD (aOR=3.15, 95% CI=1.04–9.51) than patients without OUDs, but mortality did not differ. OUD patients who did not use treatment medication had higher odds of hospitalization (aOR=4.05, 95% CI=3.32–4.98), higher maximum length of stay (eβ^=1.14, 95% CI=1.08–1.21), and higher odds of IVD (aOR=1.25, 95% CI=1.04–1.50) and COVID-19 mortality (aOR=1.31, 95% CI=1.07–1.61) than patients without OUDs. Interpretation: This study suggests people with OUD and COVID-19 often require higher levels of care, and OUD patients who are younger or not using medication treatment for OUDs are particularly vulnerable to death due to COVID-19.

Abstract Background More people are living longer lives leading to a growth in the population of older adults, many of whom have comorbidities and low levels of physical function. Physical activity in later life can prevent or delay age-related disability. Identifying a cost-effective means of increasing physical activity in older adults therefore remains an important public health priority. Physical Activity Facilitation (PAF) is an intervention shown to increase physical activity in adults with depression. The PAF model was modified for a population of older adults at risk of disability. This study aimed to assess the feasibility of undertaking a definitive RCT of the PAF intervention in the target population. Methods A pilot randomised controlled trial (RCT) was delivered through primary care. Patients at risk of disability and who were not meeting recommended levels of physical activity were recruited through postal invitation and direct approach in the practice waiting room. Those meeting eligibility criteria were enrolled and randomised at a 2:1 ratio to the PAF intervention and control. Behaviour change techniques were used by facilitators with participants over the telephone and face-to-face for 6 months. Outcome measures including physical function, physical activity, depression, social support, and quality of life were collected at baseline and at 6 months. Results A high proportion of patients responded to the initial invitation (68%), yet many were ineligible due to high levels of self-reported physical activity and baseline physical function. Fifty-one participants were recruited to the trial, with an average age of 74 years (range 65–89), and there were high rates of adherence and retention to the study (94% follow-up at 6 months). The majority of outcome data collected from participants was complete; however, the validated scale used to measure self-reported physical activity was associated with high levels of missing data. Conclusions The findings of this pilot RCT suggest that it is feasible to deliver a definitive RCT of the PAF intervention in this population. Further work is required to improve the efficiency of recruitment and to minimise missing data from self-reported physical activity measures. Trial registration Current controlled trials ISRCTN80470273. Registered 25 October 2013.

Background: Suicide is a major issue for global public health. Suicidality describes a broad spectrum of thoughts and behaviours, some of which are common in the general population. Although suicide results from a complex interaction of multiple social and psychological factors, predisposition to suicidality is at least partly genetic. Methods: Ordinal genome-wide association study of suicidality in the UK Biobank cohort comparing: ‘no suicidality’ controls (N = 83,557); ‘thoughts that life was not worth living’ (N = 21,063); ‘ever contemplated self-harm’ (N = 13,038); ‘act of deliberate self-harm in the past’ (N = 2498); and ‘previous suicide attempt’ (N = 2666). Outcomes: We identified three novel genome-wide significant loci for suicidality (on chromosomes nine, 11 and 13) and moderate-to-strong genetic correlations between suicidality and a range of psychiatric disorders, most notably depression (rg 0·81). Interpretation: These findings provide new information about genetic variants relating to increased risk of suicidal thoughts and behaviours. Future work should assess the extent to which polygenic risk scores for suicidality, in combination with non-genetic risk factors, may be useful for stratified approaches to suicide prevention at a population level. Fund: UKRI Innovation-HDR-UK Fellowship (MR/S003061/1). MRC Mental Health Data Pathfinder Award (MC_PC_17217). MRC Doctoral Training Programme Studentship at the University of Glasgow (MR/K501335/1). MRC Doctoral Training Programme Studentship at the Universities of Glasgow and Edinburgh. UKRI Innovation Fellowship (MR/R024774/1).

Abstract Background Dating and relationship violence (DRV)—intimate partner violence during adolescence—encompasses physical, sexual and emotional abuse. DRV is associated with a range of adverse health outcomes including injuries, sexually transmitted infections, adolescent pregnancy and mental health issues. Experiencing DRV also predicts both victimisation and perpetration of partner violence in adulthood. Prevention targeting early adolescence is important because this is when dating behaviours begin, behavioural norms become established and DRV starts to manifest. Despite high rates of DRV victimisation in England, from 22 to 48% among girls and 12 to 27% among boys ages 14–17 who report intimate relationships, no RCTs of DRV prevention programmes have taken place in the UK. Informed by two school-based interventions that have shown promising results in RCTs in the USA—Safe Dates and Shifting Boundaries—Project Respect aims to optimise and pilot a DRV prevention programme for secondary schools in England. Methods Design: optimisation and pilot cluster RCT. Trial will include a process evaluation and assess the feasibility of conducting a phase III RCT with embedded economic evaluation. Cognitive interviewing will inform survey development. Participants: optimisation involves four schools and pilot RCT involves six (four intervention, two control). All are secondary schools in England. Baseline surveys conducted with students in years 8 and 9 (ages 12–14). Follow-up surveys conducted with the same cohort, 16 months post-baseline. Optimisation sessions to inform intervention and research methods will involve consultations with stakeholders, including young people. Intervention: school staff training, including guidance on reviewing school policies and addressing ‘hotspots’ for DRV and gender-based harassment; information for parents; informing students of a help-seeking app; and a classroom curriculum for students in years 9 and 10, including a student-led campaign. Primary outcome: the primary outcome of the pilot RCT will be whether progression to a phase III RCT is justified. Testing within the pilot will also determine which of two existing scales is optimal for assessing DRV victimisation and perpetration in a phase III RCT. Discussion This will be the first RCT of an intervention to prevent DRV in the UK. If findings indicate feasibility and acceptability, we will undertake planning for a phase III RCT of effectiveness. Trial registration ISRCTN, ISRCTN 65324176. Registered 8 June 2017.

Abstract Background Previous studies have shown that, in a variety of health care settings, patients often do not understand what health care professionals tell them about their diagnoses and care plans; this is particularly true among male patients. Emergency department (ED) settings present unique challenges to communication with patients due to the rapid pace of activity, substantial changes in personnel over the course of the day and the week, and the need for fast decision-making processes. The aim of our study was to investigate the extent to which patients in an Israeli ED comprehended their plan of care and whether there were gender differences in this regard. Methods We conducted a questionnaire-based prospective study, in which patients admitted to the ED at Rabin Medical Center were evaluated during the years 2014–2016. The primary outcome was patients’ comprehension of their plan of care, stratified by gender of patients. Plan of care included information related to diagnosis, treatment and discharge instructions. The secondary outcome was patients’ satisfaction with the instruction process. Results One hundred seventy seven ED patients met study criteria and were asked to participate in the study; 85% of them agreed to do so. Overall, 150 ED patients aged 18–80 were recruited [75 men (50%) and 75 women (50%)]. 80% of the respondents reported a satisfactory understanding of their plan of care. Overall, no gender-related differences were found. Differences between men and women concerning satisfaction with the instructions provided by nurses were found among non-Hebrew speakers, but not among Hebrew speakers. Conclusion Contrary to most earlier studies, patients at our ED demonstrated a high degree of self-reported adequate comprehension concerning their plan of care, and overall no gender-related differences were found. These finding may be due in part to improved training of the medical staff to better communicate with the patients and to answer their questions. In addition, patients may feel more comfortable than in the past about asking the medical staff questions regarding their plan of care and diagnosis. The main implication of this study is that physician education programs should continue to emphasize patient-physician communications skills and improving methods for providing patients with information.

Background: Circadian rhythms are fundamental to health and are particularly important for mental wellbeing. Disrupted rhythms of rest and activity are recognised as risk factors for major depressive disorder and bipolar disorder. Methods: We conducted a genome-wide association study (GWAS) of low relative amplitude (RA), an objective measure of rest-activity cycles derived from the accelerometer data of 71,500 UK Biobank participants. Polygenic risk scores (PRS) for low RA were used to investigate potential associations with psychiatric phenotypes. Outcomes: Two independent genetic loci were associated with low RA, within genomic regions for Neurofascin (NFASC) and Solute Carrier Family 25 Member 17 (SLC25A17). A secondary GWAS of RA as a continuous measure identified a locus within Meis Homeobox 1 (MEIS1). There were no significant genetic correlations between low RA and any of the psychiatric phenotypes assessed. However, PRS for low RA was significantly associated with mood instability across multiple PRS thresholds (at PRS threshold 0·05: OR = 1·02, 95% CI = 1·01–1·02, p = 9·6 × 10−5), and with major depressive disorder (at PRS threshold 0·1: OR = 1·03, 95% CI = 1·01–1·05, p = 0·025) and neuroticism (at PRS threshold 0·5: Beta = 0·02, 95% CI = 0·007–0·04, p = 0·021). Interpretation: Overall, our findings contribute new knowledge on the complex genetic architecture of circadian rhythmicity and suggest a putative biological link between disrupted circadian function and mood disorder phenotypes, particularly mood instability, but also major depressive disorder and neuroticism. Funding: Medical Research Council (MR/K501335/1). Keywords: Circadian rhythmicity, Mood instability, Relative amplitude, Gwas, Polygenic risk score

Abstract Background Secondary school teachers have low levels of wellbeing and high levels of depression compared with the general population. Teachers are in a key position to support students, but poor mental health may be a barrier to doing so effectively. The Wellbeing in Secondary Education (WISE) project is a cluster randomised controlled trial (RCT) of an intervention to improve the mental health support and training available to secondary school teachers through delivery of the training package Mental Health First Aid and a staff peer support service. We will conduct a process evaluation as part of the WISE trial to support the interpretation of trial outcomes and refine intervention theory. The domains assessed will be: the extent to which the hypothesised mechanisms of change are activated; system level influences on these mechanisms; programme differentiation and usual practice; intervention implementation, including any adaptations; intervention acceptability; and intervention sustainability. Methods Research questions will be addressed via quantitative and qualitative methods. All study schools (n = 25) will provide process evaluation data, with more detailed focus group, interview and observation data being collected from a subsample of case study schools (4 intervention and 4 control). Mechanisms of change, as outlined in a logic model, will be measured via teacher and student surveys and focus groups. School context will be explored via audits of school practice that relate to mental health and wellbeing, combined with stakeholder interviews and focus groups. Implementation of the training and peer support service will be assessed via training observations, training participant evaluation forms, focus groups with participants, interviews with trainers and peer support service users, and peer supporter logs recording help provided. Acceptability and sustainability will be examined via interviews with funders, head teachers, trainers and peer support services users, and focus groups with training participants. Discussion The process evaluation embedded within the WISE cluster RCT will illuminate how and why the intervention was effective, ineffective or conferred iatrogenic effects. It will contribute to the refinement of the theory underpinning the intervention, and will help to inform any future implementation. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN95909211 registered on 24 March 2016.

Abstract Background Since the introduction of the Teenage Pregnancy Strategy (TPS), England’s under-18 conception rate has fallen by 55%, but a continued focus on prevention is needed to maintain and accelerate progress. The teenage birth rate remains higher in the UK than comparable Western European countries. Previous trials indicate that school-based social marketing interventions are a promising approach to addressing teenage pregnancy and improving sexual health. Such interventions are yet to be trialled in the UK. This study aims to optimise and establish the feasibility and acceptability of one such intervention: Positive Choices. Methods Design: Optimisation, feasibility testing and pilot cluster randomised trial. Interventions: The Positive Choices intervention comprises a student needs survey, a student/staff led School Health Promotion Council (SHPC), a classroom curriculum for year nine students covering social and emotional skills and sex education, student-led social marketing activities, parent information and a review of school sexual health services. Systematic optimisation of Positive Choices will be carried out with the National Children’s Bureau Sex Education Forum (NCB SEF), one state secondary school in England and other youth and policy stakeholders. Feasibility testing will involve the same state secondary school and will assess progression criteria to advance to the pilot cluster RCT. Pilot cluster RCT with integral process evaluation will involve six different state secondary schools (four interventions and two controls) and will assess the feasibility and utility of progressing to a full effectiveness trial. The following outcome measures will be trialled as part of the pilot:1.Self-reported pregnancy and unintended pregnancy (initiation of pregnancy for boys) and sexually transmitted infections,2.Age of sexual debut, number of sexual partners, use of contraception at first and last sex and non-volitional sex3.Educational attainment The feasibility of linking administrative data on births and termination to self-report survey data to measure our primary outcome (unintended teenage pregnancy) will also be tested. Discussion This will be the first UK-based pilot trial of a school-wide social marketing intervention to reduce unintended teenage pregnancy and improve sexual health. If this study indicates feasibility and acceptability of the optimised Positive Choices intervention in English secondary schools, plans will be initiated for a phase III trial and economic evaluation of the intervention. Trial registration ISRCTN registry (ISCTN12524938. Registered 03/07/2017).

Abstract Diseases of infection, of neurodegeneration (such as Alzheimer’s and Parkinson’s diseases), and of malignancy (cancers) have complex and varied causative factors. Modern drug discovery has the power to identify potential modulators for multiple targets from millions of compounds. Computational approaches allow the determination of the association of each compound with its target before chemical synthesis and biological testing is done. These approaches depend on the prior identification of clinically and biologically validated targets. This Perspective will focus on the molecular and computational approaches that underpin drug design by medicinal chemists to promote understanding and collaboration with clinical scientists.

Healthy, intelligent, attractive, and good moral children is the desire of every parent. There are many children undergo growth delays that can be caused by a lack of parents caring in stimulating growth, early detection or early intervention. The method used in this study was exploratory qualitative research design presented in descriptive analytic. Data analysis technique used were data collection and categorization of data reduction, draw conclusions verification and presentation of data. The results showed that stimulation of the parents to their children was 51.1% or 23 respondents. Early detection of children development irregularities with the greatest frequency was the respondents who did early detection with the result of 55.6 % as 25 respondents. Early intervention against deviations growth of children with the greatest frequency was the respondents who did not intervene early in children under five against irregularities with results of 71.1% or 32 respondents

Introduction: Approximately 40% of Irish people have a long term health condition (LTHC),and as our population ages, LTHC’s are becoming a greater challenge for the Irish Healthcare Service Executive, (HSE) each year. Self-management programmes for people with conditions have been shown to improve participants health behaviours, health outcomes and reduce healthcare utilization. The HSE framework for self-management support (2016) recommended adopting generic chronic disease self-management programmes (CDSMP) based on the Stanford model to help tackle the burden of chronic disease on both the individual and the health service. Objective: The purpose of the study was to evaluate the effectiveness of the Stanford CDSMP on adults in County Donegal with LTHCs. The parameters evaluated were health statusand behaviours, self-efficacy and healthcare utilization. Methods: Adults in County Donegal with LTHCs (n=39) attended a six week generic Stanford CDSMP. A mixed quantitative and qualitative research design was used, with matched pre and post-testing to allow comparison between participant’s health markers before and after participation in the programme. Validated measurement tools and wilcoxon signed ranks and paired t-tests were used to examine and analyse health status and behaviours, quality of life, self-eficacy and healthcare utilization. Results: 39 participants with LTHC’s were included in the study, the average age was 57 years and the majority (77%) was female. In line with previous studies in the area, this study showed improvements in many aspects of participant’s health markers six months following completion of the programme. There were improvements in participant’s self efficacy, evidenced by increased confidence to manage their condition (p=0.005) and to perform other self-management tasks in addition to taking medication (p=0.06).The impact of participant’s LTHC on their mood and feelings of hopelessness lessened (p=0.03), with improved concentration levels (p=0.01), and reduced levels of restlessness (p=0.006). Socially, there were improvements in ability to work(p=0.04), socialise (p= 0.01), partake in hobbies/ recreational activities (p= 0.03) and carry out household chores (p=0.01). Adherence to medication protocol improved (p=0.0001) and there was a statistically significant reduction in the number of overnight hospital occurrences(p=0.03). Although there was a reduction in the number of GP and A&E visits, this reduction was not statistically significant (p=0.192). Conclusion: The findings of this current study are in line with previous research, and provide encouraging evidence that the CDSMP helps tackle the burden of chronic disease on individuals and the health service in County Donegal. This provides the background for further research in rural Ireland, particularly in view of the fact that the HIQA report (2015) has recommended that the HSE prioritise investment in self-management-programmes for patients with LTHC’s. Recommendations for further research include follow-up beyond six months, the inclusion of greater numbers and more men in the programme, the use of simpler, shorter questionnaires, and increased engagement with HSE clinicians prior to the programme.

Abstract Background This study aimed to characterise the factors relating to participation in a postal follow-up study in Aboriginal and non-Aboriginal individuals, given the need to quantify potential biases from loss to follow-up and the lack of evidence regarding postal surveys among Aboriginal people. Methods The first 100,000 participants from the Sax Institute’s 45 and Up Study, a large scale cohort study, were posted a follow-up questionnaire gathering general demographic, health and risk factor data, emphasising Social, Economic and Environmental Factors (“The SEEF Study”). For each variable of interest, percentages of those invited who went on to participate in follow-up were tabulated separately for Aboriginal and non-Aboriginal participants and age- and sex-adjusted participation rate ratios (aPRR) were calculated. Results Of the 692 Aboriginal and 97,178 non-Aboriginal invitees to the study, 314 Aboriginal (45 %) and 59,175 non-Aboriginal (61 %) individuals responded. While Aboriginal people were less likely to respond than non-Aboriginal people (aPRR 0.72, 95 % CI 0.66–0.78), factors related to response were similar. Follow-up study participants were more likely than non-participants to have university versus no educational qualifications (1.6, 1.3–2.0 [Aboriginal]; 1.5, 1.5–1.5 [non-Aboriginal]) and an annual income of ≥70,000 versus

Abstract Background Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants’ views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Methods Digitally recorded interviews were conducted with 55 participants aged 17–19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Results Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with ‘opt-in’ consent through which participants are ‘asked’ if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent. Conclusions Findings from this study question the validity of ‘informed consent’ as a cornerstone of good governance, and the extent to which potential research participants understand different types of consent and what they are consenting, or not consenting, to. Pragmatic, imaginative and flexible approaches are needed if research using data linkage is to successfully realise its potential for public good without undermining public trust in the research process.

O planejamento familiar é o direito que toda pessoa tem de optar em ter ou não ter filhos, por meio de uma assistência especializada e com informação. Estas informações são ofertadas por intermédio da atenção básica durante o programa de planejamento familiar. Englobar os adolescentes no planejamento familiar é uma tarefa de grande importância, sendo que neste período os jovens estão despertando em si a sexualidade. Por meio de estudos já realizados observa-se que há um despreparo da equipe de enfermagem para abordar esses usuários. Para tanto, este estudo propõe refletir sobre a importância das práticas educativas criativas em saúde a fim de contribuir para uma maior participação dos jovens e adolescentes nas atividades do planejamento familiar, utilizando como recurso metodológico a revisão de literatura, constituída principalmente por artigos científicos. Para o levantamento dos artigos na literatura, realizou-se uma busca na Biblioteca Virtual em Saúde (BVS), em diversos bancos de dados. Acredita-se que a abordagem de novas pedagogias de ensino baseadas na arte e criatividade poderá atrair os jovens e adolescentes ao programa. Disponibilizar informações lúdicas durante o planejamento familiar é uma das melhores formas de adesão a um programa de prevenção e promoção.

An amendment to this paper has been published and can be accessed via the original article.

Background: Endomyocardial biopsy is considered as the gold standard in patients with suspected myocarditis. We aimed to evaluate the impact of bioptic findings on prediction of successful return to work. Methods: In 1153 patients (48.9 ± 12.4 years, 66.2% male), who were hospitalized due to symptoms of left heart failure between 2005 and 2012, an endomyocardial biopsy was performed. Routine clinical and laboratory data, sociodemographic parameters, and noninvasive and invasive cardiac variables including endomyocardial biopsy were registered. Data were linked with return to work data from the German statutory pension insurance program and analyzed by Cox regression. Results: A total of 220 patients had a complete data set of hospital and insurance information. Three quarters of patients were virus-positive (54.2% parvovirus B19, other or mixed infection 16.7%). Mean invasive left ventricular ejection fraction was 47.1% ± 18.6% (left ventricular ejection fraction

Este estudo tem por objetivo descrever a finalidade da auditoria de enfermagem e sua importância para a melhoria da qualidade da assistência à saúde. O método utilizado foi a revisão integrativa da literatura. A amostra constituiu-se de 10 artigos, 12 livros e 01 resolução do Conselho Federal de Enfermagem. A pesquisa bibliográfica foi realizada em Belo Horizonte, no período de agosto de 2015. A análise dos artigos e redação dos resultados ocorreu no período de setembro de 2015. Nossos resultados originaram as seguintes categorias temáticas: Auditoria: alguns apontamentos, Gestão da qualidade: uma competência do Enfermeiro Auditor e, A relevância da comunicação nos processos de auditoria. Concluímos que a auditoria de enfermagem avalia a assistência de enfermagem pela análise dos prontuários, acompanhamento do cliente e verificação da compatibilidade entre o procedimento realizado e os itens que compõem a conta hospitalar cobrada, garantindo um pagamento justo mediante a cobrança adequada. Palavras-chave: Auditoria de enfermagem. Enfermagem. Indicadores de qualidade.

The present review summarizes many of the major research trends investigated in the past five years regarding pediatric functional abdominal pain, and also summarizes the primary related findings from the authors’ research program. Specific areas discussed based on work within the authors’ group include familial illness patterns, genetics, traits, and mechanisms or processes related to abdominal pain. Topics covered from research published in the past five years include prevalence and cost, longitudinal follow-up, overlap with other disorders, etiology and mechanisms behind functional abdominal pain and treatment studies. It is hoped that findings from this work in abdominal pain will be interpreted as a framework for understanding the processes by which other pain phenomena and, more broadly, reactions to any physical state, can be developed and maintained in children. The present article concludes with recommendations for clinical practice and research.

Background: Magelang Regency is one of the endemic area of malaria in central Java. The working area of Health centre of Kajoran I, Banjaretno, has the highest incidence of malaria annually (Dinkes Magelang, 2010). Malaria is is transmitted through the bite of female Anopheles infected by Plasmodium sp. Its most effective prevention is vector eradication. This study was aimed at finding out the behavioral risk for the incidence of malaria. Design and Methods: In this observasional study using case control design include 40 cases and 40 controls using the simple random sampling. Chi square test followed by double-logistic regression was applied for the data analysis with p=5%. Results: Bivariate analysis on the 6 factors resulted in p0.05. multivariate analysis showed that the habit factor of going out in the evening, installing wire gauze on the ventilation, hanging used clothes, mowing lawn, the existence of closed waste basket, washing the curtain resulted in the p=0.010 (OR = 10; 95% CI = 3.4-39.2), p=0.001 (OR = 4.1; 95% CI = 3.5-15.8), p=0.018 (OR = 3.3; 95% CI = 1.9 -16.2), p=0.044 (OR = 6.5; 95% CI = 2.1-30.9), p=0.380 (OR = 0.43; 95% CI = 0.1-1.2), p=0.002 (OR = 2.4; 95% CI =3.4 -5.6) respectively. Conclusion: The habit of going out in the evening has been shown to be most important behavioral factor associated with the malaria incidence (Sains Medika, 3(2):168-184).

AbstrakStatus gizi anak balita salah satunya dipengaruhi oleh faktor kondisi sosial ekonomi, antara lain pendidikan ibu, pekerjaan ibu, jumlah anak, pengetahuan dan pola asuh ibu serta kondisi ekonomi orang tua secara keseluruhan. Penelitian ini dilakukan untuk mengetahui apakah ada hubungan kondisi sosial ekonomi keluarga terhadap status gizi anak balita. Penelitian ini adalah survei analitik menggunakan desain cross sectional study dengan jumlah sampel 227 orang yang terdiri dari anak balita dan ibu balita di Wilayah Kerja Puskesmas Nanggalo Padang. Data dikumpulkan melalui kuesioner yang telah diisi oleh ibu balita yang kemudian di analisis secara bivariat dan multivariat. Berdasarkan analisis bivariat didapatkan pendidikan ibu (p=0,022), pekerjaan ibu (p=0,000), pendapatan keluarga (p=0,012), jumlah anak (p=0,008) dan pola asuh ibu (p=0,000). Sementara dari analisis multivariat didapatkan pendidikan ibu (p=0,004; OR=2,594; CI95%=1,356-4,963), pekerjaan ibu (p=0,000; OR=74,769; CI95%=24,141-231,577), pendapatan keluarga (p=0,013; OR=3,058; CI95%=1,246-7,4) dan pola asuh ibu (p=0,000; OR=15,862; CI95%=5,973-42,128). Analisis bivariat menunjukan bahwa terdapat hubungan antara pendidikan ibu, pekerjaan ibu, pendapatan keluarga, jumlah anak dan pola asuh ibu dengan status gizi anak balita. Berdasarkan hasil analisis multivariat faktor pekerjaan ibu merupakan faktor yang paling berhubungan dengan status gizi anak balita.Kata kunci: status gizi, anak balita, faktor sosial ekonomiAbstractNutritional status of children under five years has affected by a political and socio-economic condition factors, among others, maternal education, maternal occupation, number of children, maternal knowledge and parenting also parents' economic conditions as a whole. This research is conduct to determine whether there is a relationship between the socio-economic conditions of families on the nutritional status of children under five.This research is a analytic survey using a cross sectional study design with the number of samples are 227 people consisting of children under five and the mothers in the working areas Puskesmas Nanggalo Padang. Data were collected through questionnaires which is completed by mothers whose later been analyzed in bivariate and multivariateBased on bivariate analysis we can get the maternal education (p = 0.022), maternal occupation (p = 0.000), household income (p = 0.012), number of children (p = 0.008) and maternal parenting (p = 0.000). While the multivariate analysis obtained from the maternal education (p = 0.004; OR = 2.594; CI95% = 1.356 to 4.963), maternal occupation (p = 0.000; OR = 74.769; CI95% = 24.141 to 231.577), household income (p = 0.013; OR = 3.058; CI95% = 1.246 to 7.4) and maternal parenting (p = 0.000; OR = 15.862; CI95% = 5.973 to 42.128).Bivariate analysis showed that there is a relationship between maternal education, maternal occupation, family income, number of children and parenting mothers with a nutritional status of children under five. Based on the results of the multivariate analysis, maternal occupation is the most associated factor with nutritional status of children under five.Keywords: Nutritional Status, Children Under Five, Socio-economic Factor

Amamentação exclusiva até os seis meses de idade é fato importante para a saúde e para a relação mãe e filho. Quando essa amamentação é prejudicada, o desmame precoce pode ocorrer. O objetivo da pesquisa foi investigar o perfil das doadoras do Banco de Leite Humano do Hospital Universitário de Maringá, Estado do Paraná. Foramentrevistadas 48 nutrizes doadoras de leite humano durante os meses de outubro e novembro de 2004. O estudo foi observacional transversal e os dados foram coletados utilizando-se um questionário estruturado. Observou-se que 41,7% das nutrizes tinham entre 20 e 29 anos, 33,3% ensino médio completo e 66,6% receberam informações sobre amamentação. A falta de informação, contudo, sobre mama ingurgitada (20,8%), estimulação para produção de leite (29,1%) e outras funções do leite materno, além da alimentação (31,3%), foram relevantes. Apenas metade das nutrizes não tinha oferecido qualquer outro alimento para o bebê antes dos seis meses de vida. Dados apontam paraimportância de orientação das nutrizes de forma direcionada, ainda durante a gestação.Exclusive maternal breast feeding until six months of age is an important practice for health and mother and son’s relationship. However, when that exclusive maternal breast feeding is harmed, precocious weans may occur. This work aims at investigating the Human Milk Bank donors’ profile at Hospital Universitário de Maringá,State of Paraná. Forty-eight nursing mothers were interviewed during two months: October and November, 2004. A transversal and observational study was carried out and the data were collected by means of individual interviews conducted by structured questionnaire. 41.7% of the women were aged between 20 and 29, 33.3% had concluded secondary school and 66.6% had received information on breast-feeding. The lack of information on engorged breast (20.8%), on stimulation for milk production (29.1%) and other maternal milk functions, besides feeding (31.3%), was also relevant. Only half of the breastfeeding women had not offered the baby any other food, except maternal milk. Data pointed out to the importance of these women’s direct orientation regarding breast feeding during gestation.

Amamentação exclusiva até os seis meses de idade é fato importante para a saúde e para a relação mãe e filho. Quando essa amamentação é prejudicada, o desmame precoce pode ocorrer. O objetivo da pesquisa foi investigar o perfil das doadoras do Banco de Leite Humano do Hospital Universitário de Maringá, Estado do Paraná. Foram entrevistadas 48 nutrizes doadoras de leite humano durante os meses de outubro e novembro de 2004. O estudo foi observacional transversal e os dados foram coletados utilizando-se um questionário estruturado. Observou-se que 41,7% das nutrizes tinham entre 20 e 29 anos, 33,3% ensino médio completo e 66,6% receberam informações sobre amamentação. A falta de informação, contudo, sobre mama ingurgitada (20,8%), estimulação para produção de leite (29,1%) e outras funções do leite materno, além da alimentação (31,3%), foram relevantes. Apenas metade das nutrizes não tinha oferecido qualquer outro alimento para o bebê antes dos seis meses de vida. Dados apontam para importância de orientação das nutrizes de forma direcionada, ainda durante a gestação