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Introduction Clinical pharmacy services often involve multifaceted pharmacist-led interventions. However, current pharmacy practice models vary across different countries. Despite the documented benefits of clinical pharmacy services, the characteristics of pharmacist-led interventions in different countries have not yet been adequately explored and described. Therefore, this protocol outlines the methodology for a proposed scoping review aiming to investigate various types of multifaceted pharmacist-led interventions and the outcomes used to evaluate their effectiveness within secondary care settings. Additionally, the scoping review will map the current evidence surrounding the characteristics of interventions and outcomes reported across various countries of socioeconomic status.Methods and analysis The scoping review will be conducted according to the JBI Methodology for Scoping Reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Extension for Scoping Reviews. We will systematically search the following electronic databases: MEDLINE (Ovid), CINAHL (EbscoHost), Embase (embase.com), Scopus (scopus.com), Cochrane Library (cochranelibrary.com) and APA PsycInfo (Ovid). Additionally, the reference lists of identified reviews and included full texts will be searched for relevant papers. Grey literature sources, such as International Pharmaceutical Abstracts and the International Pharmaceutical Federation (FIP) website, will be searched. We will include primary studies published in the English language from January 2013 to December 2023, involving secondary care multifaceted pharmacist-led interventions. Two independent reviewers will screen studies against eligibility criteria and use a piloted data extraction form to extract relevant information. We will extract relevant data, complete a tabular summary from each included publication and analyse it.Ethics and dissemination Ethical approval is not required as we will be using data from publicly available literature sources. Findings will be disseminated in publications and presentations with relevant stakeholders. We aim to map available evidence across the breadth of studies that have reported multifaceted pharmacist-led interventions and their outcomes.

Introduction Severe and persistent mental illness (SPMI) can significantly impact a person’s social, personal and professional life. Previous studies have demonstrated pharmacists’ roles in mental healthcare; however, limited studies to date have focused on pharmacists’ roles in providing healthcare services, specifically, to people living with SPMI. The aim of this systematic review is to explore the pharmacists’ roles in providing support to people living with SPMI.Methods and analysis A systematic search will be conducted in Medline, Embase (Ovid), PsycINFO, CINAHL, Web of Science, Scopus, Cochrane Library, International Pharmaceutical Abstracts and ProQuest Dissertations and Theses to identify potentially relevant primary research for inclusion. This will be guided by the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist for systematic reviews. All primary research publications regardless of study design exploring or reporting on pharmacists’ involvement in supporting people living with SPMI will be considered for inclusion. A tabular summary will be completed using data extracted from each included publication. Data synthesis and quality assessment methods will be chosen based on included study designs.Ethics and dissemination The results will be published in a peer-reviewed journal and used to inform the development of a pharmacist-specific training package to support people living with SPMI.PROSPERO registration number CRD42020170711.

Introduction There is a significant life expectancy gap attributable to physical comorbidities for people living with severe and persistent mental illness (SPMI) compared with the general population. Medications are a major treatment for SPMI management and physical illnesses, hence pharmacists are well positioned to support mental healthcare and comorbidities. The randomised controlled trial (RCT) aim is to evaluate effectiveness of an individualised, pharmacist led, support service for people experiencing SPMI focusing on medication adherence and physical comorbidity management, compared with standard care (a medication-management service; MedsCheck).Methods and analysis PharMIbridge is a cluster RCT, whereby community pharmacies in four Australian regions will be randomised (1:1 ratio), to either Intervention Group (IG) or Comparator Group (CG). All IG and CG pharmacy staff will receive Blended-Mental Health First Aid training. Additionally, IG pharmacists will receive further training on medication adherence, goal setting, motivational interviewing, managing physical health concerns and complex issues relating to psychotropic medication. CG pharmacists will not receive additional training, and will provide standard care (MedsCheck). The primary outcome will be change in participants medication adherence for psychotropic medication over 6-months. Using mixed-effects logistic regression model and a cluster size of 48 pharmacies, a total of 190 participants will need to be recruited to each arm to find a statistically significant difference in medication adherence. Secondary outcomes will be changes in factors associated with cardiometabolic risk and quality of life, emphasising physical and psychological well-being; medication-related problems; adherence to other prescribed medication; pharmacists knowledge, confidence and ability to support people experiencing SPMI; and effects on healthcare utilisation. A within RCT-based economic evaluation comparing the intervention with standard care will be undertaken.Ethics and dissemination The protocol and pharmacist training programme received Griffith University Human Research Ethics Committee approval (HREC/2019/473 and HREC/2019/493 respectively). Results will be published in peer-reviewed journals and available at the Sixth Community Pharmacy Agreement website (http://6cpa.com.au/about-6cpa/).Trial registration number ANZCTR12620000577910.

Objective Hypertrophic cardiomyopathy (HCM), including obstructive HCM (oHCM), is the most common inherited cardiomyopathy causing lifestyle-limiting symptoms. Data are lacking about patients’ perspectives on the daily impact of their symptoms. This qualitative interview study was conducted to better understand patients’ experiences with oHCM.Methods In October 2019, telephone interviews were conducted with 20 US adults with oHCM identified by the Hypertrophic Cardiomyopathy Association. Using a semi-structured interview guide, key symptoms, impacts of oHCM and oHCM treatment goals were discussed.Results Median age was 54 years (range 29–78), 55% were women, 85% were white and 15% were Hispanic or Latino. Median time since diagnosis was 3 years. Symptoms included shortness of breath, dizziness/light-headedness, heart palpitations/fluttering (all 95%), fatigue (90%) and chest pain/pressure (80%). All participants reported limitations in physical functioning/activities; most reported additional impacts (emotional stress (80%), fear of dying (55%)). Shortness of breath and fatigue were among their most bothersome symptoms; an effective oHCM treatment would need to improve ≥1 of these symptoms (allowing increased physical/social activity).Conclusions Patients with oHCM experience a high symptom burden and psychosocial impacts, affecting health status. Improved shortness of breath, fatigue and physical functioning are highly valued by patients and represent important treatment goals.

Background A digital decision support system in healthcare is a digital health intervention that assists healthcare professionals in decision-making by providing treatment recommendations and enhancing diagnostic accuracy and quality of care. This will be the first study in Pakistan to assess the system’s usability, acceptability and effectiveness in improving healthcare outcomes while also evaluating the perceived quality of care. This comprehensive assessment will inform policy development in areas such as the scale-up of digital health interventions, data privacy and technology interoperability. Measures of effectiveness will include changes in clinical outcomes through a patient exit feedback survey. This study aims to evaluate the role of digital decision support systems in healthcare decision-making, which may be integrated into Pakistan’s tele-primary healthcare system.Methods The study will employ a multimethod approach. The data collection tools are adapted from the WHO’s digital health intervention monitoring and evaluation framework and include a technology assessment, healthcare provider surveys, patient exit interviews and focus group discussions with healthcare providers. Purposive sampling will be used for qualitative interviews with providers (doctors) and patients. Government stakeholders, private sectors, multilateral, academia and policymakers will be engaged through a consultative meeting. We will also conduct a literature review, as well as a comprehensive analysis of existing studies, documents and data relevant to digital decision support systems and digital health interventions implemented globally, and assess the performance, challenges and opportunities.Ethics and dissemination The study has been approved by the Ethics Review Committee at The Aga Khan University (2023-8514-26533). The dissemination of study findings through scientific publications and seminars will enable programme managers and policymakers to design tools to improve the quality of care provided through telemedicine platforms. This will contribute to efficient decision-making, access and quality of care for primary healthcare in low-income and middle-income countries. This study will also inform policy regarding the scale-up of decision support systems in primary care settings, data privacy and technology interoperability.

Objective This study aims to measure the prevalence of mental health disorders in low-resource settings through telepsychiatry and evaluate data from Pakistan’s Sehat Kahani nurse-assisted online clinics serving low-income communities. This will help to understand the magnitude and nature of the demand for contextual therapies to promote mental health. The paper will discuss the challenges faced in these settings, such as limited access to mental health facilities, stigma and opportunities telemedicine brings.Design An observational cross-sectional study of telepsychiatry consultations using Patient Health Questionnaire-9 and Generalised Anxiety Disorder-7 to screen for depression and anxiety was conducted between October and December 2022.Setting This research was conducted at Dadar Mansehra e-health clinics of Sehat Kahani with telepsychiatry services in Pakistan.Participants The study included 2660 participants who visited Sehat Kahani e-health clinics between October and December 2022 and voluntarily completed the questionnaire for data collection.Results The study was comprised of 2660 participants with a mean age of 34.3 years. The study findings show that the majority of participants were females (98.4%), 16.9% of participants had moderate depression, and 20.8% had severe depression. Furthermore, the participants who were widowed/divorced were more likely to have depression than those who were single (OR=3.3, 95% CI (2.0 to 5.2)).Conclusions Based on the findings, most study participants were female, and their mental health was negatively impacted. Women in Pakistan are disproportionately affected by the rising rates of depression and anxiety, and telepsychiatry therapies effectively respond to this growing need. Potentially, it is a game-changer for dealing with mental health problems. Telepsychiatry can help policymakers and mental health professionals to develop effective low-income mental health initiatives.

Introduction Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus. Being a common reason for hospitalisation, it affects 13–17% of all hospitalised children younger than 2 years. Only supportive therapy, including suctioning nasal secretions, water–electrolyte balance maintenance and oxygen supplementation when needed, is recommended. However, non-evidence-based diagnostic and therapeutic approaches, including the use of inhaled bronchodilators, nebulised epinephrine, and nebulised and systemic steroids, are common. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty. We aim to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.Methods and analysis This will be a randomised, double-blinded, parallel-group, controlled trial. Children younger than 2 years who are hospitalised due to bronchiolitis will be recruited from at least three paediatric departments in Poland. Bronchiolitis is defined as an apparent viral respiratory tract infection associated with airway obstruction that is manifested by at least one of following symptoms: tachypnoea, increased respiratory effort, crackles and/or wheezing. A total of 140 children will be randomised (1:1) to receive either hypertonic saline nebulisation (5 mL, three times a day) or normal saline at the same dose. The primary outcome measure will be the duration of hospitalisation.Ethics and dissemination The Bioethics Committee of the Lower Silesia Medical Chamber in Wroclaw approved the study protocol (4/PNDR/2023). Caregivers will receive oral and written information about the study and written informed consent will be obtained by the study physicians. The findings of the study will be submitted to a peer-reviewed journal, and abstracts will be submitted to relevant national and international conferences.Trial registration number ClinicalTrials.gov Registry (NCT06069336).

Introduction Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.Methods and analysis AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.Ethics and dissemination Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.Trial registration number NCT05134454.

Objectives This study aims to identify and critically examine the components of health complexity, and explore the factors that allow it to exist, among urban Indigenous peoples in Canada.Design Qualitative exploration with relational conversations.Setting Calgary, Alberta, Canada.Participants A total of nine urban Indigenous patients were recruited from a multidisciplinary primary healthcare clinic that serves First Nations, Métis and Inuit peoples. Recruitment and data collection took place between September and November 2021.Results Thematic analysis revealed three main themes, namely: sources of health complexity, psychological responses to adversity, and resilience, strengths, and protective factors. Key sources of health complexity arose from material resource disparities and adverse interpersonal interactions within the healthcare environment, which manifest into psychological distress while strengths and resilience emerged as protective factors.Conclusion The healthcare system remains inapt to address complexity among urban Indigenous peoples in Canada. Healthcare violence experienced by Indigenous peoples only further perpetuates health complexity. Future clinical tools to collect information about health complexity among urban Indigenous patients should include questions about the factors defined in this study.

Introduction A prescribing cascade occurs when a drug is prescribed to manage the often unrecognised side effect of another drug; these cascades are of particular concern for older adults who are at heightened risk for drug-related harm. It is unknown whether, and to what extent, gender bias influences physician decision-making in the context of prescribing cascades. The aim of this transnational study is to explore the potential impact of physician implicit gender biases on prescribing decisions that may lead to the initiation of prescribing cascades in older men and women in two countries, namely: Canada and Italy.Methods and analysis Male and female primary care physicians at each site will be randomised 1:1 to a case vignette that features either a male or female older patient who presents with concerns consistent with the side effect of a medication they are taking. During individual interviews, while masked to the true purpose of the study, participants will read the vignette and use the think-aloud method to describe their ongoing thought processes as they consider the patient’s concerns and determine a course of action. Interviews will be recorded, transcribed verbatim and thematic analysis will be conducted to highlight differences in decisions in the interviews/transcripts, using a common analytical framework across the sites.Ethics and dissemination This study has received ethics approval at each study site. Verbal informed consent will be received from participants prior to data collection and all data will be deidentified and stored on password-protected servers. Results of this study will be disseminated through peer-reviewed journal articles and presented at relevant national and international conferences.

Introduction Existing literature demonstrates that medical students and residents experience complex emotions and substantial grief after patient deaths. Over time, this can lead to burnout and depression and adversely impact patient care. In response, medical schools and training programmes worldwide have developed and implemented interventions to help medical trainees to better cope with patient deaths. This manuscript provides a scoping review protocol that aims to systematically identify and document the published research reporting on the implementation or delivery of interventions to support medical students and residents/fellows in dealing with patient death.Methods and analysis A scoping review will be conducted following the Arksey-O’Malley five-stage scoping review method and the Scoping Review Methods Manual by the Joanna Briggs Institute. English language interventional studies published through 21 February 2023, will be identified in the following databases: MEDLINE, Scopus, Embase, Psych Info, Cochrane Database of Systematic Reviews, CINAHL and ERIC. Two reviewers will screen titles and abstracts and then independently screen full-text articles for inclusion. Two reviewers will assess the methodological quality of included studies using the Medical Education Research Study Quality Instrument. After extraction, data will be narratively synthesised. Experts in the field will be consulted to ensure the feasibility and relevance of the findings.Ethics and dissemination Ethical approval is not required as all data will be collected from published literature. The study will be disseminated through publication in peer-reviewed journals and presentation at local and international conferences.

Objective We investigated some aspects of menstrual health and hygiene among young female students at Birzeit University in the West Bank of the occupied Palestinian territory.Design Cross-sectional study in a large central university.Participants Out of a total of 8473 eligible female students, a calculated sample size of 400 students aged between 16 and 27 years was obtained.SettingLarge central university, West Bank, occupied Palestinian territory (oPt).Measures An anonymous structured international research instrument consisting of 39 questions based on the Menstrual Health Questionnaire, in addition to few questions relevant to the context, was administered.Results 30.5% of participants were not informed about menstruation before menarche, and 65.3% reported that they were not ready when they got their first period. The highest reported source of information regarding menstruation was family (74.1%), followed by school (69.3%). About 66% of respondents reported that they need more information on various topics of menstruation. The most common type of menstrual hygiene products used were single-use pads (86%), followed by toilet paper (13%), nappies (10%) and reusable cloths (6%). Of the total 400 students, 14.5% reported that menstrual hygiene products are expensive, and 15.3% reported that they always/sometimes had to use menstrual products that they do not like because they are cheaper. Most (71.9%) of the respondents reported that they used menstrual products for longer time than recommended due to inadequate washing facilities at the university campus.Conclusions The findings provide useful evidence on the lack and the need for menstrual-related information for female university students, inadequate infrastructure to help them manage their menstruation with dignity and pointed to some menstrual poverty in accessing menstrual products. A national intervention programme is needed to increase awareness regarding menstrual health and hygiene among women in local communities and female teachers in schools and universities to enable them to disseminate information to and meet the practical needs of girls at home, at school and at the university.

Objectives When seeking to prevent type 2 diabetes, a balance must be struck between individual approaches (focusing on people’s behaviour ‘choices’) and population approaches (focusing on the environment in which those choices are made) to address the socioeconomic complexity of diabetes development. We sought to explore how this balance is negotiated in the accounts of policy-makers developing and enacting diabetes prevention policy.Methods Twelve semistructured interviews were undertaken with nine UK policy-makers between 2018–2021. We explored their perspectives on disease prevention strategies and what influenced policy decision-making. Interviews were transcribed and analysed thematically using NVIVO. We used Shiffman’s political priority framework to theorise why some diabetes prevention policy approaches gather political support while others do not.Results The distribution of power and funding among relevant actors, and the way they exerted their power determined the dominant approach in diabetes prevention policy. As a result of this distribution, policy-makers framed their accounts of diabetes prevention policies in terms of individual behaviour change, monitoring personal quantitative markers but with limited ability to effect population-level approaches. Such an approach aligns with the current prevailing neoliberal political context, which focuses on individual lifestyle choices to prevent disease rather than on infrastructure measures to improve the environments and contexts within which those choices are made.Conclusion Within new local and national policy structures, there is an opportunity for collaborative working among the National Health Service, local governments and public health teams to balance the focus on disease prevention, addressing upstream drivers of ill health as well as targeting individuals with the highest risk of diabetes.

Objective To test whether providing relevant clinical trial registry information to peer reviewers evaluating trial manuscripts decreases discrepancies between registered and published trial outcomes.Design Stepped wedge, cluster-randomised trial, with clusters comprised of eligible manuscripts submitted to each participating journal between 1 November 2018 and 31 October 2019.Setting Thirteen medical journals.Participants Manuscripts were eligible for inclusion if they were submitted to a participating journal during the study period, presented results from the primary analysis of a clinical trial, and were peer reviewed.Interventions During the control phase, there were no changes to pre-existing peer review practices. After journals crossed over into the intervention phase, peer reviewers received a data sheet describing whether trials were registered, the initial registration and enrolment dates, and the registered primary outcome(s) when enrolment began.Main outcome measure The presence of a clearly defined, prospectively registered primary outcome consistent with the primary outcome in the published trial manuscript, as determined by two independent outcome assessors.Results We included 419 manuscripts (243 control and 176 intervention). Participating journals published 43% of control-phase manuscripts and 39% of intervention-phase manuscripts (model-estimated percentage difference between intervention and control trials = −10%, 95% CI −25% to 4%). Among the 173 accepted trials, published primary outcomes were consistent with clearly defined, prospectively registered primary outcomes in 40 of 105 (38%) control-phase trials and 27 of 68 (40%) intervention-phase trials. A linear mixed model did not show evidence of a statistically significant primary outcome effect from the intervention (estimated difference between intervention and control=−6% (90% CI −27% to 15%); one-sided p value=0.68).Conclusions These results do not support use of the tested intervention as implemented here to increase agreement between prospectively registered and published trial outcomes. Other approaches are needed to improve the quality of outcome reporting of clinical trials.Trial registration number ISRCTN41225307.

Objectives Despite WHO guidelines recommending household contact investigation, and studies showing the impact of active screening, most tuberculosis (TB) programmes in resource-limited settings only carry out passive contact investigation. The cost of such strategies is often cited as barriers to their implementation. However, little data are available for the additional costs required to implement this strategy. We aimed to estimate the cost and cost-effectiveness of active contact investigation as compared with passive contact investigation in urban Pakistan.Methods We estimated the cost-effectiveness of ‘enhanced’ (passive with follow-up) and ‘active’ (household visit) contact investigations compared with standard ‘passive’ contact investigation from providers and the programme’s perspective using a simple decision tree. Costs were collected in Pakistan from a TB clinic performing passive contact investigation and from studies of active contact tracing interventions conducted. The effectiveness was based on the number of patients with TB identified among household contacts screened.Results The addition of enhanced contact investigation to the existing passive mode detected 3.8 times more cases of TB per index patient compared with passive contact investigation alone. The incremental cost was US$30 per index patient, which yielded an incremental cost of US$120 per incremental patient identified with TB. The active contact investigation was 1.5 times more effective than enhanced contact investigation with an incremental cost of US$238 per incremental patient with TB identified.Conclusion Our results show that enhanced and active approaches to contact investigation effectively identify additional patients with TB among household contacts at a relatively modest cost. These strategies can be added to the passive contact investigation in a high burden setting to find the people with TB who are missed and meet the End TB strategy goals.

Introduction Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy.Methods and analysis Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter. Scope: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients. Population: patients (≥18 years) with polypharmacy (≥5 prescriptions). Sample size: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved. Intervention: complex intervention eMMa. Follow-up: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa. Outcomes: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse. Statistical analysis: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints.Ethics and dissemination Trial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences.Trial registration NCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336).

Introduction The COVID-19 pandemic compelled health systems to protect patients and medical personnel during transit in hospitals by minimising transfers, prompting the use of telehealth systems. In the field of neurology, telemedicine has been used in emergency settings for acute stroke management between spoke and hub hospital networks, where good outcomes have been achieved. However, data on the use of telemedicine in non-stroke acute neurological conditions accessing the emergency department (ED) are currently missing.Methods and analyses This is an interventional, open-label trial on the use of teleconsultation in the ED for neurological diseases other than stroke. The study aims to develop a remote consultancy system (TeleNeurological Evaluation and Support, TeleNS) for patients with acute neurological symptoms referred to hospital facilities without a 24-hour availability of a neurologist consultant (spoke hospitals). The study population will include 100 ED patients referred to two spoke hospitals in 6 months, who will be asked to perform teleconsultation instead of inperson visits. As a control group, retrospectively available data from patients admitted to the ED of spoke hospitals during the same time period over the last 2 years will be evaluated. The primary objective is to assess whether a TeleNS for the ED guarantees a faster but qualitatively non-inferior diagnostic/therapeutic work-up if compared with inperson examination, assuring the availability of all the necessary examinations and treatments with consistent time-saving.Ethics and dissemination The trial was designed following the national guidelines on clinical investigation on telemedicine provided by the Italian Ministry of Health and according to the Standard Protocol Items for Randomized Trials statement guidelines. This research protocol was approved by Comitato Etico Area Vasta Emilia Nord in September 2020 (number/identification: 942/2020/DISP/AOUMO SIRER ID 805) and was written without patient involvement. Patients’ associations will be involved in the dissemination of study design and results. The results of the study will be presented during scientific symposia or published in scientific journals.Trial registration number NCT04611295.

Objective To evaluate the consistency of causal statements in observational studies published in The BMJ.Design Review of observational studies published in a general medical journal.Data source Cohort and other longitudinal studies describing an exposure-outcome relationship published in The BMJ in 2018. We also had access to the submitted papers and reviewer reports.Main outcome measures Proportion of published research papers with ‘inconsistent’ use of causal language. Papers where language was consistently causal or non-causal were classified as ‘consistently causal’ or ‘consistently not causal’, respectively. For the ‘inconsistent’ papers, we then compared the published and submitted version.Results Of 151 published research papers, 60 described eligible studies. Of these 60, we classified the causal language used as ‘consistently causal’ (48%), ‘inconsistent’ (20%) and ‘consistently not causal’(32%). Eleven out of 12 (92%) of the ‘inconsistent’ papers were already inconsistent on submission. The inconsistencies found in both submitted and published versions were mainly due to mismatches between objectives and conclusions. One section might be carefully phrased in terms of association while the other presented causal language. When identifying only an association, some authors jumped to recommending acting on the findings as if motivated by the evidence presented.Conclusion Further guidance is necessary for authors on what constitutes a causal statement and how to justify or discuss assumptions involved. Based on screening these papers, we provide a list of expressions beyond the obvious ‘cause’ word which may inspire a useful more comprehensive compendium on causal language.

Introduction Goal planning is widely recognised as an integral part of mental health service delivery and an important element in supporting recovery. Goal planning identifies priorities for treatment through discussion and negotiation between service users and health practitioners. Goal planning enhances motivation, directs effort, and focuses the development of strategies and treatment options to improve recovery outcomes and promote service users’ ownership of the recovery process. While goal planning is a common practice in mental health settings, evidence regarding its impact on treatment outcomes is lacking. This paper outlines a protocol for a systematic review that aims to explore the types of goals planned, experiences of service users and practitioners, and the effectiveness of goal planning as a mental health intervention.Methods and analysis A systematic search will be conducted during March 2021 by searching Medline, CINAHL, Embase, Scopus and PsycINFO electronic databases to answer the following questions: (1) What types of goals are being developed within mental healthcare?; (2) What is the evidence for the effectiveness of goal planning on health and well-being for mental health service users?; (3) What are the experiences of mental health service users and their treating healthcare practitioners in relation to goal planning?; and (4) What are the barriers and facilitators to effective goal planning in mental health settings? Two independent researchers will screen the articles, selecting literature that meets criteria. All literature, regardless of study design that involves adult participants, with a mental illness and reporting on goal planning will be considered for inclusion. Data will be extracted from all eligible articles regardless of study design and summarised in a table. Appropriate quality assessment and data synthesis methods will be determined based on included study designs.Ethics and dissemination No ethics approval is required. The results will be disseminated through peer-reviewed publications and conference presentations.PROSPERO registration number CRD42020220595.

Objectives Medical school serves as a critical developmental period for future physicians, during which students begin to form a professional identity. Just as personal appearance, particularly clothing, is an important external expression of one’s personal identity, ‘uniforms’ in healthcare, including white coats and scrubs, symbolise status and a group identity. There are, however, limited studies on the impact of physician attire on medical students’ formation of professional identity. Accordingly, through qualitative analysis of written narratives, we sought to analyse medical students’ experiences of wearing professional physician attire, namely scrubs, and how the uniform impacted their confidence level, performance and behaviours, as well as their identity as future physicians.Design Qualitative analysis of medical student’s written narratives.Setting Khalifa University College of Medicine and Health Sciences (KU CMHS) is a new medical school in the United Arab Emirates, with an inaugural class of 30 students admitted in August 2019. It is the only medical school in the city of Abu Dhabi, and the only school in the country that follows a postgraduate medical curriculum.Participants All first year medical students at KU CMHS were purposively sampled.Methods Students completed a voluntary online anonymous questionnaire. We employed a social identity approach to data analysis. Thematic content analysis was conducted on their narratives to identify themes.Results We identified three major themes, namely (1) emotions, (2) logistics and (3) interpersonal relationships.Conclusions Medical students form early perceptions regarding physician attire and its impact on their professional identity. Engaging in conversations regarding professional attire with educators or mentors could provide an important opportunity for students to discuss and explore professional identity early in training.

Objectives To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency.Design Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain).Participants 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm.Interventions The IM arm received 1 mg VB12 on alternate days in weeks 1–2, 1 mg/week in weeks 3–8 and 1 mg/month in weeks 9–52. The oral arm received 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52.Main outcomes Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction.Results The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were −0.7% (133 out of 135 vs 129 out of 130; 95% CI: −3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: −1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were −6.3% (103 out of 112 vs 115 out of 117; 95% CI: −11.9 to −0.1; p=0.025) and −6.8% (103 out of 140 vs 115 out of 143; 95% CI: −16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>−10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route.Conclusions Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.Trial registration numbers NCT 01476007; EUDRACT (2010-024129-20).

Objective To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.Design Randomised controlled trial (RCT).Setting BMJ Open’s quality improvement programme.Participants 24 manuscripts describing RCTs.Interventions We used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.Outcomes The primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.Results Manuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.Conclusions We demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.Trial registration number NCT03751878.

Purpose With the population-based, prospective Biology, Affect, Stress, Imaging and Cognition (BASIC) cohort, we aim to investigate the biopsychosocial aetiological processes involved in perinatal depression (PND) and to pinpoint its predictors in order to improve early detection.Participants From September 2009 to November 2018, the BASIC study at Uppsala University Hospital, Sweden, has enrolled 5492 women, in 6478 pregnancies, of which 46.3% first-time pregnancies and with an average age of 31.5 years. After inclusion around gestational week 16–18, participants are followed-up with data collection points around gestational week 32, at childbirth, as well as three times postpartum: after 6 weeks, 6 months and 1 year. At the last follow-up, 70.8% still remain in the cohort.Findings to date In addition to internet-based surveys with self-report instruments, participants contribute with biological samples, for example, blood samples (maternal and from umbilical cord), biopsies (umbilical cord and placenta) and microbiota samples. A nested case–control subsample also takes part in cognitive and emotional tests, heart rate variability tests and bioimpedance tests. Subprojects have identified various correlates of PND of psychological and obstetric origin in addition to factors of the hypothalamic–pituitary–adrenal axis and immune system.Future plans In parallel with the completion of data collection (final follow-up November 2019), BASIC study data are currently analysed in multiple subprojects. Since 2012, we are conducting an ongoing follow-up study on the participants and their children up to 6 years of age (U-BIRTH). Researchers interested in collaboration may contact Professor Alkistis Skalkidou (corresponding author) with their request to be considered by the BASIC study steering committee.

Introduction Osteoarthritis is one of the most common types of musculoskeletal diagnoses also among working-age populations, and often leads to long-term sickness absence (SA) spells or even disability pension (DP).The aim was to identify future trajectories of days of SA and/or DP among people with a new SA spell due to osteoarthritis that became ≥21 long, and to investigate sociodemographic and morbidity characteristics of individuals in identified trajectories.Methods This is a prospective population-based cohort study using data from several Swedish registers. We studied future SA/DP among all 4894 individuals aged 16–64 years who, during the first 6 months of 2010, had an incident SA spell due to osteoarthritis (ICD-10 codes M15-19) ≥21 days. Using group-based trajectory modelling, we identified trajectories of mean SA/DP net days/month and 95% CIs for the 13 months from the 21st day of the index SA spell. Sociodemographic and morbidity characteristics were compared by χ2 tests and multinomial logistic regression.Results We identified five trajectories of SA/DP days: ‘fast decrease’ (36% of the cohort), ‘medium fast decrease’ (29%), ‘slow decrease’ (15%), ‘fluctuating’ (12%) and ‘late decrease’ (8%). Individuals in the two trajectories who still had SA/DP days at end of follow-up (late decrease and fluctuating) were more likely to be older, born outside the EU and have indicators of more severe morbidity than those in the other trajectories.Conclusion Five trajectories of future SA/DP days were identified; 80% of the cohort belonged to trajectories with no SA/DP by the end of follow-up. Identifying trajectories of future SA/DP provides new insights regarding the developments of SA/DP over time among people on SA due to osteoarthritis; not only days in the initial SA spell but also in new spells during follow-up need to be included for a better understanding.

Objectives Adding, omitting or changing prespecified outcomes can result in bias because it increases the potential for unacknowledged or post hoc revisions of the planned analyses. Journals have adopted initiatives such as requiring the prospective registration of trials and the submission of study protocols to promote the transparency of reporting in clinical trials. The main objective of this feasibility study was to document the frequency and types of outcome discrepancy between prespecified outcomes in the protocol and reported outcomes in trials submitted to The BMJ.Methods A review of all 3156 articles submitted to The BMJ between 1 September 2013 and 30 June 2014. Trial registry entries, protocols and trial reports of randomised controlled trials published by The BMJ and a random sample of those rejected were reviewed. Editorial, peer reviewer comments and author responses were also examined to ascertain any reasons for discrepancies.Results In the study period, The BMJ received 311 trial manuscripts, 21 of which were subsequently published by the journal. In trials published by The BMJ, 27% (89/333) of the prespecified outcomes in the protocol were not reported in the submitted paper and 11% (31/275) of reported outcomes were not prespecified. In the sample of 21 trials rejected by The BMJ, 19% (63/335) of prespecified outcomes went unreported and 14% (45/317) of reported outcomes were not prespecified. None of the reasons provided by published authors were suggestive of outcome reporting bias as the reasons were unrelated to the results.Conclusions Mandating the prospective registration of a trial and requesting that a protocol be uploaded when submitting a trial article to a journal has the potential to promote transparency and safeguard the evidence base against outcome reporting biases as a result of outcome discrepancies. Further guidance is needed with regard to documenting reasons for outcome discrepancies.

Introduction: Children with medical complexity (CMC) have chronic, intensive care needs managed by many healthcare practitioners. Medical advances have enabled CMC to survive well into adulthood. However, the availability of supports as CMC transition into the adult care system remain suboptimal, contributing to poor care coordination, and discontinuity. Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care (PITCare) aims to assess whether intensive patient and caregiver-oriented transition support beyond age 18 will improve continuity of care for CMC compared with usual care., Methods and Analysis: This is a pragmatic superiority randomised controlled trial in a parallel group, two-arm design with an embedded qualitative component. CMC turning 17.5 years old will be recruited (n=154), along with their primary caregiver. Participants randomised to the intervention arm will be provided with access to a multidisciplinary transition team who will support patients and caregivers in care planning, integration with an adult primary care provider (PCP), adult subspecialty facilitation and facilitation of resource supports for 2 years. Outcomes will be measured at baseline, 12 and 24 months. The primary outcome measure is successful transfer completion, defined as continuous care in the 2 years after age 18 years old. Secondary outcomes include satisfaction with transitional care, self-management, care coordination, healthcare service use, caregiver fatigue, family distress, utility and cost-effectiveness. Qualitative interviews will be conducted to explore the experiences of patients, caregivers, the transition team, and healthcare providers with the PITCare intervention., Ethics and Dissemination: Institutional approval was obtained from the Hospital for Sick Children Research Ethics Board. Our findings and resources will be shared with child health policymakers and transitions advocacy groups provincially, nationally, and internationally., Trial Registration Number: ClinicalTrials.gov, US National Library of Medicine, National Institutes of Health, #NCT06093386., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To identify patient-safety-related unintended consequences of healthcare technologies experienced by their primary users: patients, carers and healthcare providers (HCPs)., Design: Qualitative study based on data collected in online focus groups. Transcripts were analysed inductively after each focus group using reflexive thematic analysis, focusing on identifying unintended consequences of healthcare technologies with implications for patient safety. Patient safety was broadly conceptualised to include a more subjective concept of 'feeling safe' as well as risks of actual harm., Setting: Patient/public and HCP participants from the UK with experience in healthcare technologies were recruited using a mixture of purposive, convenience and snowball sampling., Participants: 40 participants (29 patients/public, 11 HCPs) took part in 5 focus groups between November 2021 and February 2022., Results: We identified five main themes of unintended consequences with implications for patient safety: inequity of access, increased end-user burden, loss of the human element of healthcare, over-reliance on technology and unclear responsibilities. Both groups of participants identified unintended consequences directly affecting patients; HCPs also described those affecting themselves. Some unintended consequences are described in previous literature, including alert fatigue, the 'illusion of communication', reduced opportunities for face-to-face interactions and increased end-user burden. Others are potentially novel, including patients' psychological dependence on technologies, 'gaming' of data entry and incorrect interpretation of health data., Conclusions: Drawing on the perspectives of patients/public as well as HCPs, we identified five areas of patient-safety-related unintended consequences associated with healthcare technologies. These should be considered when developing tools to identify and mitigate the patient-safety-related unintended consequences of healthcare technologies., Competing Interests: Competing interests: ALN and BDF are theme leads of the NIHR North West London Patient Safety Research Collaboration (PSRC). BDF is also director of this PSRC. SA is a research assistant in this PSRC. JL and JN, the PPI partners in this study, received honoraria as per the NIHR INVOLVE guidelines. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Suspected preterm labour (SPL) is an obstetric complication that occurs in 9% of all pregnancies and is the leading cause of antenatal hospital admissions. More than half of women with SPL deliver a premature baby which is a known risk factor for developing cardiovascular and metabolic disorders in childhood and later in adult life. On the other hand, the other half of these women will deliver at term, labelled as 'false preterm labour'. Although this has been thought to be a benign condition, accumulating evidence reported in recent years showed long-term effects for the foetus, neonate and infant even when birth occurs at term. However, the impact of SPL on cardiovascular and metabolic programming has not been studied yet. The aim of this prospective cohort study is to evaluate the impact of SPL on cardiac remodelling and function and on cardiovascular and metabolic profiles independently of gestational age at birth., Methods and Analysis: Prospective cohort study of subjects exposed and not exposed to an episode of SPL. Women with singleton pregnancies who are admitted at a tertiary hospital due to SPL and matched controls will be recruited. Evaluation of cardiovascular remodelling by foetal echocardiography will be performed during admission. Cord blood will be collected at birth in order to analyse different metabolomic footprints and several cardiovascular and metabolic risk biomarkers. Moreover, children will undergo an echocardiography 6 months after birth. The relationship between SPL and cardiovascular and metabolic programming will be modelled considering different covariates such as socioeconomic factors, perinatal characteristics, lifestyle, diet and exercise., Ethics and Dissemination: Ethical approval was granted in April 2020 from CEIC Aragón (CEICA) (C.P.-C.I. PI20/136). Study outcomes will be disseminated at international conferences and published in peer-reviewed scientific journals., Trial Registration Number: NCT05670665., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Financial protection (FP) is a central function of health systems to enhance access to essential care and improve health equity. We aim to characterise evidence on the distribution of FP in high-income countries as well as how equity of FP is conceptualised and measured in these settings. Findings from this review can advance methodological and conceptual knowledge about equity in FP, guide the evaluation of health systems and inform policy on eliminating inequitable barriers to care to achieve universal health coverage., Methods and Analysis: We will undertake a scoping review following guidance from Colquhoun et al and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We will search four academic databases covering health sciences and economic literature as well as four grey literature sources for relevant publications. Screening for eligibility will be performed independently by two reviewers after calibration of screening criteria. Data will be charted using a standardised form and summarised by thematic analysis., Ethics and Dissemination: Institutional research ethics review was not required; however, research ethics will be considered iteratively throughout the research process. Research findings will be disseminated to scientific and policy meetings, summarised for lay audiences and submitted for publication in a peer-reviewed journal., Competing Interests: Competing interests: Xie, Ali, Allin, Proaño and Sander have no competing interests. Law consulted for Health Canada and CADTH, and acted as an expert witness for the Federation of Post-secondary Educators and the Durham Police Association., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Objectives: Violence against women (VAW) is widespread and can have serious physical and mental health consequences, including post-traumatic stress disorder (PTSD) and sleep disorders. Victim-survivors often face barriers in accessing specialised care, highlighting the need for a multidisciplinary response, especially in healthcare settings. The Maison des Femmes (MdF) model provides holistic support to women experiencing VAW, including medical, psychological, social and legal support. The aim of this study is to examine whether the MdF's comprehensive intervention programme offers advantages over standard care in improving mental health indicators, such as PTSD., Method and Analysis: Our pragmatic quasi-experimental study uses a non-randomised controlled cluster design. The intervention group comprises women enrolled in MdFs in five French cities, while the comparison group includes women receiving usual care in sociomedical structures located geographically close to MdF centres. Our study aims to recruit 360 women (180 per group), aged 18 years or older, who have experienced intimate partner violence or sexual violence and who seek care at the study centres. The primary analysis will compare the change in PTSD Checklist for DSM-5 (PCL-5) scores over 6 months in the two groups using multivariable linear regression with propensity score adjustment. Secondary outcomes include sleep disorders, quality of life, symptoms of anxiety and depression, self-esteem, sense of safety and well-being, initiation of legal and socioprofessional proceedings, and healthcare utilisation., Ethics and Dissemination: The study was approved by the 'Comité de protection des personnes Ile de France III' (CPP Committee for the Protection of Persons Ile de France III; institutional review board on 20 December 2023; Ref no. (Numéro SI): 23.04197.000491).The results of the study will be communicated via academic publications; easily understandable briefs for a broader public; and proactive involvement with medical institutions, journalists and advocacy groups., Trial Registration Number: NCT06226818. Version Number 1- february2024., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Human papillomavirus (HPV) infection is the most prevalent sexually transmitted infection worldwide. HPV vaccination is an important tool to prevent and control HPV infection and its complications. Despite carrying the severe burden of disease, HPV vaccine coverage in Africa remains low. The aim of the current review is to evaluate the factors associated with HPV vaccination acceptance among adolescent men and women, young men and women, parents/caregivers, men who have sex with men, healthcare workers and programme managers in Africa., Methods and Analysis: We will include peer-reviewed quantitative studies. We will search PubMed, Scopus, PsycInfo, Web of Science and Cochrane Central Register of Controlled Trials, with no language restriction, to identify eligible studies. Two review authors will independently screen the titles and abstracts of the search output in Covidence to select potentially eligible studies. The same two reviewers will independently screen the full-text of all identified potentially eligible articles to identify studies meeting inclusion criteria. Two review authors will independently extract data from eligible studies using a predefined data extraction form. Two review authors will independently assess the risk of bias in each included study, using the Effective Public Health Practice Project 'Quality Assessment Tool for Quantitative Studies'. We will assess the quality of evidence using the method for Grading of Recommendations Assessment, Development and Evaluation., Ethics and Dissemination: Ethical approval is not required for this study because we will use already published data. The results of this review will be disseminated through peer-reviewed publication and conference presentation., Prospero Registration Number: CRD42023475810., Competing Interests: Competing interests: CSW serves on the Editorial Advisory Board of BMJ Open., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: In the evolving healthcare landscape of the United Arab Emirates (UAE), establishing cost-effectiveness thresholds (CETs) is pivotal to informing decision-makers about the value of health technologies., Objective: This study aimed to establish CETs for the UAE that harmonise with international standards while reflecting the nation's unique healthcare needs and economic context., Setting: United Arab Emirates., Methods: A multitiered methodology was employed, involving a literature review, a panel of national experts and workshops with key stakeholders, including healthcare providers, government health departments and healthcare payers. The panel and workshops were integral in assessing global CET practices and their applicability to the UAE providing a preliminary framework for CET in the UAE. Structured voting sessions were then conducted allowing voting on crucial aspects of CET to determine the baseline threshold, multipliers for severity, rarity and health gain, and methodologies for quantifying disease severity., Results: CETs were linked to the economic status of the UAE, with a baseline threshold of 0.75 times the gross domestic product per capita for one quality-adjusted life year gained. A multiplier system was introduced to reflect societal views on disease severity, disease rarity and the relative health benefit of health technologies. Based on the voting results, disease rarity was deemed the most crucial factor, receiving a maximum multiplier of 3X, while severity and health gain were assigned a maximum of 2X. The multiplier values for both disease severity and relative health gain would be determined on a continuous scale. The proportional or relative shortfall method would be used to assess disease severity., Conclusions: The proposed CET framework for the UAE will be dependent on local generation of cost-effectiveness evidence. Periodic review of CETs based on initial experiences ensures the responsiveness of policymakers to the changing healthcare and economic environment., Competing Interests: Competing interests: Syreon Middle East was a contractual partner of Bayer. AF, ZK and SAb are shareholders in Syreon Middle East. NK is an employee in Syreon Middle East. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: ISMiHealth is a clinical decision support system, integrated as a software tool in the electronic health record system of primary care, that aims to improve the screening performance on infectious diseases and female genital mutilation (FGM) in migrants. The aim of this study is to assess the health impact of the tool and to perform a process evaluation of its feasibility and acceptability when implemented in primary care in Catalonia (Spain)., Methods and Analysis: This study is a cluster randomised control trial where 35 primary care centres in Catalonia, Spain will be allocated into one of the two groups: intervention and control. The health professionals in the intervention centres will receive prompts, through the ISMiHealth software, with screening recommendations for infectious diseases and FGM targeting the migrant population based on an individualised risk assessment. Health professionals of the control centres will follow the current routine practice.A difference in differences analysis of the diagnostic rates for all aggregated infections and each individual condition between the intervention and control centres will be performed. Mixed-effects logistic regression models will be carried out to identify associations between the screening coverage and predictor factors. In addition, a process evaluation will be carried out using mixed methodology., Ethics and Dissemination: The study protocol has been approved by the institutional review boards at Hospital Clínic (16 June 2022, HCB/2022/0363), Clinical Research Ethics Committee of the Primary Care Research Institute IDIAPJGol (22 June 2022, 22/113-P) and the Almería Research Ethics Committee (27 July 2022, EMC/apg). The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards.Findings will be disseminated in peer-reviewed journals and communications to congresses., Trial Registration Number: NCT05868005., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Medical adhesives provide securement of medical devices, facilitate skin protection and allow non-invasive monitoring. Application and removal of medical adhesives can result in pain, dermatitis, trauma or other skin lesions. Understanding patients' experiences when subjected to medical adhesives will contribute to the improvement of clinical routines and the development and improvement of new adhesive technologies. A qualitative systematic review was conducted to identify patients' experiences with the application of medical adhesives to the skin., Design: Qualitative systematic review., Data Sources: CINAHL, EMBASE, MEDLINE and PsycINFO were systematically searched for records published between January 2012 and March 2024. Reference lists of systematic reviews and included articles were reviewed., Eligibility Criteria: Studies published in Danish, Dutch, English, German, Norwegian and Swedish that collected qualitative data on the experience of patients with the application of medical adhesives to the skin were considered. There were no restrictions regarding age, gender or setting., Data Extraction and Synthesis: Study selection, data extraction and quality appraisal were independently conducted by two reviewers. The methodological quality of the studies under consideration was assessed using the Joanna Briggs Institute Critical Appraisal Tool for Qualitative Research. The extracted data were synthesised using meta-aggregation., Results: Nine studies describing patients' experiences were included. The included studies only reflected experiences with wound dressings. Meta-aggregation of the extracted findings resulted in seven categories that were further synthesised into two synthesised findings: 'strategies to alleviate pain during dressing changes' and 'dressing construction and characteristics'. The synthesised findings illustrate that patients experience pain during dressing change and removal and employ various strategies to alleviate this pain., Conclusions: Patients experience pain and discomfort when dressings are changed or removed. Future research should focus on enhancing both routines and technologies, with a particular emphasis on advancing skin-friendly adhesives to reduce unwanted side effects., Prospero Registration Number: CRD42023457711., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study aimed to determine the prevalence of the negative D antigen phenotype, adherence to routine antenatal anti-D immunoglobulin prophylaxis (RAADP) administration and D antigen sensitisation among pregnant women in the UAE., Design: Data was collected from pregnant women enrolled in the Mutaba'ah Study. The Mutaba'ah Study is an ongoing prospective mother and child cohort study in the UAE. Data were extracted from the medical records and baseline questionnaire administered to the participants between May 2017 and January 2021., Setting: The study was conducted in Al Ain city of the UAE., Participants: A total of 5080 pregnant women residing in Al Ain participated in the study., Outcome Measures: The study estimated the prevalence of negative D antigen phenotype and the provision of RAADP in this population., Results: Of the 5080 pregnant women analysed, 4651 (91.6%) had D antigen positive status, while 429 (8.4%) were D-negative. D antigen sensitisation was low at 0.5%, and there was a high uptake of RAADP in the population at 88.8%., Conclusions: The adherence to RAADP is consistent with published data from other healthcare settings. Knowledge of the prevalence of D antigen negative mothers is crucial to the financial and resource consideration for implementing antenatal foetal cell-free DNA screening to determine foetal D antigen status., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Traumatic brain injury (TBI) brings about inevitable and significant changes for family members. Mental health effects for family members are well documented but there are significant gaps in support options across services. Here, we describe our protocol for a study that seeks to investigate the potential for a narrative, creative approach, the 'Life Threads' approach, as a low intensity, accessible means of support that can be applied across service contexts., Methods: We will recruit 20 family members of someone who sustained a TBI from services in an area of the UK with a diverse demographic. Family members will be provided with the 'Life Threads' approach materials and guided in their use. The study is planned to run from March 2023 to July 2024., Analysis: Collection of data on potential usefulness, feasibility and acceptability will be through focus groups and individual interviews. Transcripts will be analysed using reflexive thematic analysis, conducted within a relativist, constructivist orientation., Ethics and Dissemination: Ethical approvals have been sought and gained (Nottingham 1 Research Ethics Committee, 23/EM/0185, 4 September 2023), and the study has been registered with ISRCTN. As a research team, we are guided by our own personal, professional and research experiences of TBI which we will consider reflexively throughout the research process. Results will be disseminated in collaboration with our patient and public involvement group through open peer-reviewed journal publication and scientific conference, with lay summaries shared via recruitment sites., Trial Registration Number: ISRCTN17392794., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objective: Hypertrophic cardiomyopathy (HCM), including obstructive HCM (oHCM), is the most common inherited cardiomyopathy causing lifestyle-limiting symptoms. Data are lacking about patients' perspectives on the daily impact of their symptoms. This qualitative interview study was conducted to better understand patients' experiences with oHCM., Methods: In October 2019, telephone interviews were conducted with 20 US adults with oHCM identified by the Hypertrophic Cardiomyopathy Association. Using a semi-structured interview guide, key symptoms, impacts of oHCM and oHCM treatment goals were discussed., Results: Median age was 54 years (range 29-78), 55% were women, 85% were white and 15% were Hispanic or Latino. Median time since diagnosis was 3 years. Symptoms included shortness of breath, dizziness/light-headedness, heart palpitations/fluttering (all 95%), fatigue (90%) and chest pain/pressure (80%). All participants reported limitations in physical functioning/activities; most reported additional impacts (emotional stress (80%), fear of dying (55%)). Shortness of breath and fatigue were among their most bothersome symptoms; an effective oHCM treatment would need to improve ≥1 of these symptoms (allowing increased physical/social activity)., Conclusions: Patients with oHCM experience a high symptom burden and psychosocial impacts, affecting health status. Improved shortness of breath, fatigue and physical functioning are highly valued by patients and represent important treatment goals., Competing Interests: Competing interests: SSh has received a grant from the American Heart Association (grant ID 855105). CE, KK and SF are employees of RTI Health Solutions. LS has no conflicts of interest to declare. MB, SBH and DJ are employees of Cytokinetics, Incorporated, and hold stock in Cytokinetics, Incorporated. SSa has received consultant/adviser fees from Bristol Myers Squibb and research grants from Bristol Myers Squibb, Cytokinetics, Novartis and Actelion Pharmaceuticals., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Cancer is a leading cause of death in unhoused adults. We sought to examine the association between housing status, stage at diagnosis and all-cause survival following cancer diagnosis at a public hospital., Design: Retrospective cohort study examining new cancer diagnoses between 1 July 2011 and 30 June 2021., Setting: A public hospital in San Francisco., Exposure: Housing status (housed, formerly unhoused, unhoused) was ascertained via a county-wide integrated dataset that tracks both observed and reported homelessness., Methods: We reported univariate analyses to investigate differences in demographic and clinical characteristics by housing group. We then constructed Kaplan-Meier curves stratified by housing group to examine unadjusted all-cause mortality. Finally, we used multivariable Cox proportional hazards models to compare the hazard rate of mortality for each housing status group, adjusting for demographic and clinical factors., Results: Our cohort included 5123 patients with new cancer diagnoses, with 4062 (79%) in housed patients, 623 (12%) in formerly unhoused patients and 438 (9%) in unhoused patients. Unhoused and formerly unhoused patients were more commonly diagnosed with stage 4 disease (28% and 27% of the time, respectively, vs 22% of housed patients). After adjusting for demographic and clinical characteristics, unhoused patients with stage 0-3 disease had a 50% increased hazard of death (adjusted HR (aHR) 1.5, 95% CI 1.1 to 1.9; p<0.004) as did formerly unhoused patients (aHR 1.5, 95% CI 1.2 to 1.9; p=0.001) compared with housed individuals 3 months after diagnosis., Conclusions: Unhoused and formerly unhoused patients diagnosed with non-metastatic cancer had substantially increased hazards of death compared with housed patients cared for in a public hospital setting. Current or former lack of housing could contribute to poor outcomes following cancer diagnoses via multiple mechanisms., Competing Interests: Competing interests: Outside of the published work, HD is a National Clinician Scholar with salary support from the VA and receives person fees from Moon Surgical. HKK's salary is supported by a grant from the Benioff Homelessness and Housing Initiative, University of California, San Francisco, California, and he works as an advisor for Amae Health. MK is on the Board of Housing California, National Homelessness Law Center and Steinberg Institute (K24 2K24AG046372 and BHHI)., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Compared with the operating room, tracheal intubations in the intensive care unit (ICU) are associated with worsened glottic view, decreased first-time success rate and increase in the technical difficulty of intubation and incidence of complications. Videolaryngoscopes (VLs) have been proposed to improve airway management, and while recent studies have confirmed that VLs improve intubation conditions in this patient population, there remains a lack of clarity regarding the selection between a standard Macintosh blade or a hyperangulated one, to determine which yields the best outcomes. The purpose of this study was to compare successful intubation on the first attempt with the Macintosh VL versus the hyperangulated VL during tracheal intubation in ICU patients. We hypothesise that tracheal intubation using the hyperangulated VL will improve the frequency of successful intubation on the first attempt., Methods and Analysis: The INtubation VIdeolaryngoscopy BLADE-ICU trial is a prospective, multicentre, open-label, interventional, randomised, controlled superiority study conducted in 29 ICUs in Spain. Patients will be randomly assigned in a 1:1 ratio to undergo intubation using a Macintosh VL (control group) or a hyperangulated VL (experimental group) for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcomes include the time to intubation, attempts for successful intubation, laryngoscopic vision assessed with the modified Cormack-Lehane scale, the need for adjuvant airway devices for intubation, difficulty assessed by the anaesthesiologist and complications during tracheal intubation. Enrolment began on 1 May 2024 and is expected to be completed in 2025., Ethics and Dissemination: The study protocol was approved on 29 February 2024, by the Ethics Committee of Galicia (CEImG, code No. 2024-031).The results will be submitted for publication in a peer-reviewed journal., Trial Registration Number: NCT06322719., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)