Simulation-based research for digital health pathologies: A multi-site mixed-methods study.

Background: The advance of digital health technologies has created new forms of potential pathology which are not captured in current clinical guidelines. Through simulation-based research, we have identified the challenges to clinical care that emerge when patients suffer from illnesses stemming from failures in digital health technologies. Methods: Clinical simulation sessions were designed based on patient case reports relating to (a) medical device hardware errors, (b) medical device software errors, (c) complications of consumer technology and (d) technology-facilitated abuse. Clinicians were recruited to participate in simulations at three UK hospitals; audiovisual suites were used to facilitate group observation of simulation experience and focused debrief discussions. Invigilators scored clinicians on performance, clinicians provided individual qualitative and quantitative feedback, and extensive notes were taken throughout. Findings: Paired t-tests of pre and post-simulation feedback demonstrated significant improvements in clinician's diagnostic awareness, technical knowledge and confidence in clinical management following simulation exposure (p < 0.01). Barriers to care included: (a) low suspicion of digital agents, (b) attribution to psychopathology, (c) lack of education in technical mechanisms and (d) little utility of available tests. Suggested interventions for improving future practice included: (a) education initiatives, (b) technical support platforms, (c) digitally oriented assessments in hospital workflows, (d) cross-disciplinary staff and (e) protocols for digital cases. Conclusion: We provide an effective framework for simulation training focused on digital health pathologies and uncover barriers that impede effective care for patients dependent on technology. Our recommendations are relevant to educators, practising clinicians and professionals working in regulation, policy and industry.

Interventions to improve access to primary care for inclusion health groups in England: a scoping review.

BACKGROUND: Everyone in England has the right to primary care without financial charges. Nevertheless, evidence shows that barriers remain for inclusion health populations such as vulnerable migrants, people experiencing homelessness, Gypsy, Roma, and Traveller (GRT) communities, and people who sell sex. There is little evidence for what works to improve access. This study was a scoping review of interventions to improve access to mainstream primary care for inclusion health groups in England. METHODS: In this scoping review, we searched databases (Embase, Medline, APA PsychInfo, the Cochrane Collaboration Library, Web of Science and CINAHL) and grey literature sources, including the National Health Service and National Institute for Clinical Excellence, for articles published in English between Jan 1, 2010, and Dec 31, 2020, with no limit on study design. Data were extracted according to inclusion criteria, including interventions taking place in England and targeting people with insecure immigration status, people who sell sex, people experiencing homelessness, and GRT communities. Results were presented in a narrative synthesis. FINDINGS: 39 studies describing one or more interventions were included: four peer-reviewed articles (one randomised trial, two quality improvement projects, and one mixed-methods study protocol) and 25 grey literature items (38 interventions in total). Interventions mostly targeted people with insecure immigration status (17/38, 45%), and a majority (12/38, 32%) took place in London. The most common types of intervention were training, education, and resources (such as leaflets or websites) for patients or staff (25/38, 66%), and most interventions targeted GP registration processes (28/38, 74%). Interventions commonly involved voluntary and community sector organisations (16/38, 42%). Most interventions were not evaluated to understand their effectiveness (23/38, 61%). Sources with evaluations identified staff training, direct patient advocacy, and involvement of people with lived experience as effective elements. INTERPRETATION: Interventions to improve access to primary care for inclusion health groups in England were heterogeneous, commonly undertaken at community level, and developed to serve local inclusion health groups. Considerations for policymakers and practitioners include groups and geographical areas less commonly included in interventions, the elements of positive practice identified in evaluations, and the need for evaluation of future interventions. FUNDING: National Institute for Health and Care Research (NIHR 202050).

Medical consequences of "contingency accommodation" for people seeking asylum: thematic analysis of a survey from professionals working in contingency accommodation.

BACKGROUND: Concerns about the housing of migrants and asylum seekers have escalated since the COVID-19 pandemic. From the use of quasi-detention facilities and so-called contingency accommodation to outbreaks of diphtheria in processing centres, there is a worrying trend to normalise potentially damaging conditions. The aim of this study was to assess the health risks posed by contingency housing for asylum seekers in the UK. METHODS: In this cross-sectional survey, a 10-point online questionnaire was sent to professional networks working with refugees and asylum seekers within the UK. Responses were collected between March 4, and April 11, 2022, using a mixture of convenience and snowballing sampling approach. The objectives of the survey were (1) to identify and document unmet needs, (2) to offer practical support, and (3) to map out services and organisation. The survey was designed by six medical professionals with experience of working with migrants and validated by three doctors who had experience running out-reach medical clinics for asylum seekers within contingency accommodation. Background details of geographical location and occupation were collected, and a combination of closed and open questions were used to collect information across five domains (medical, legal social, integration, and basic essentials) using a social determinants of health framework. A code book thematic analysis using a deductive/inductive hybrid approach was used to identify health and social needs as well as specific rights being denied. FINDINGS: There were 68 responses from around the UK, of which 30 (44%) were health-care professionals, and 38 (56%) were from the wider voluntary sector. 45 (67%) had visited an accommodation site, and 21 (33%) had worked with those living in contingency accommodation in other respects. Respondents reported observations regarding sites across most parts of the UK. Major themes of access to health-care, access to other services, barriers to access, and safeguarding were identified, with subthemes on access to primary care, maternity, and mental health services (eg, "Vast unmet need in mental health provision, several suicide attempts"); access to basic essential services (eg, "Food was not fit for purpose" "[c]hildren often did not receive breakfast"); education, and legal support; and frequent moving and communication. INTERPRETATION: Through several themes we highlight the substantial impact of structural isolation of asylum seekers through contingency housing, its major effects on wellbeing and the exacerbation of health inequities. We are using these results to work with asylum seekers and local non-governmental organisations to campaign for improved housing conditions. Study limitations include sampling bias, and a lack of voices of those with lived experience. FUNDING: None.

Medical cyber crises and biotechnological syndromes: a multisite clinical simulation study focused on digital health complaints.

BACKGROUND: Biotechnological syndromes refer to the illnesses that arise at the intersection of human physiology and digital technology. Implanted technologies can malfunction (eg, runaway pacemakers, hacked insulin pumps), and consumer technologies can be exploited to impose adverse health effects (eg, technology-facilitated abuse, hacks on epilepsy websites inducing seizures). Through a series of clinical simulation events, our study aimed to (1) evaluate the ability of physicians to respond to biotechnological syndromes, (2) explore gaps in training impeding effective patient care in digital cases, and (3) identify clinical cases due to digital technology arising in the population. METHODS: This was a multisite clinical simulation study. Between Jan 1 and July 1, 2023, four half-day clinical simulation events focused on digital pathologies were delivered across three NHS sites in London and the East Midlands. Participants (n=14) ranged in seniority from clinical medical students through to hospital consultants. Ethics approval was attained from University College London. Participant performance was scored by one researcher, using mark schemes built from the Objective Structured Clinical Examinations (OSCEs) format of UK Medical Schools. Qualitative and quantitative feedback was collected from participants following each of the four scenarios. Participants were asked to identify clinical challenges present in each simulation, discuss cases within their own practice, and evaluate the usefulness of the educational material. FINDINGS: Participants reported a wide range of examples within their own practice (eg, insulin pumps malfunctioning due to Apple watches, cardiac arrests due to faults in ventilators). Participants described barriers to treatment in simulations, including low diagnostic suspicion of technological failures, little education on biotechnological mechanisms, a lack of available expertise, and uncertainty regarding effective therapeutics. In the subjective feedback, participants reported the lowest levels of confidence when managing cases relating to software issues in medical devices, both in terms of confidence in their own ability to deliver care (mean scores: 3·6/10 junior staff, 5·8/10 senior staff) and in their teams (3·8/10 juniors, 6·8/10 seniors). INTERPRETATION: In our digital society, clinical cases related to technology are likely to increase in the population. At present, a lack of clinical awareness, education, training material, and appropriate guidelines are some of the barriers that health-care professionals face when treating these patients. FUNDING: None.

Pregnancy-Related Tuberculous Meningitis and Immune Reconstitution Inflammatory Syndrome: A Case Series and Systematic Review.

Background: Tuberculosis is a leading cause of death among women of reproductive age. However, tuberculous meningitis, the most severe form of extrapulmonary tuberculosis, is rarely discussed in pregnancy despite this being a unique period of immune modulation that may predispose women to active disease. Methods: We identified and described cases of tuberculous meningitis among pregnant or postpartum women screened during meningitis clinical trials in Uganda from 2018 to 2022. We conducted a systematic literature review via PubMed/Medline and Embase for all English-language publications from 1970 to 10 July 2022, to identify additional cases. Results: We identified 8 cases of pregnancy-related tuberculous meningitis in Ugandan women living with human immunodeficiency virus (HIV) and 40 additional cases via systematic literature review (none HIV-positive). Of all combined cases, 50% (24/48) were diagnosed postpartum; 50% (24/48) had initial onset during pregnancy, of which 38% (9/24) had worsening of symptoms or disease relapse following pregnancy cessation. Diagnosis was missed or delayed in 33% (16/48) of cases. For those with known outcomes, maternal mortality was 23% (11/48) and fetal/neonatal mortality was 30% (13/44). Of maternal survivors, 30% (11/37) had residual neurologic deficits. Conclusions: The true incidence of tuberculous meningitis in pregnancy or the postpartum period is unclear but likely underappreciated. To date, nearly all published cases have occurred in HIV-negative or otherwise immunocompetent women. Given the well-described physiological immunosuppression during pregnancy and subsequent reconstitution postpartum, physicians must be aware of tuberculous meningitis and pregnancy-related immune reconstitution inflammatory syndrome, especially in countries with a high burden of tuberculosis and in women living with HIV.

Mechanisms for the prevention of adolescent intimate partner violence: A realist review of interventions in low- and middle-income countries.

Adolescent girls are among those at the greatest risk of experiencing intimate partner violence (IPV). Despite adolescence being widely regarded as a window of opportunity to influence attitudes and behaviours related to gender equality, evidence on what works to prevent IPV at this critical stage is limited outside of high-income, school-based settings. Even less is understood about the mechanisms of change in these interventions. We conducted a realist review of primary prevention interventions for adolescent IPV in low- and middle-income countries (LMICs) to synthesise evidence on how they work, for whom, and under which circumstances. The review took place in four iterative stages: 1) exploratory scoping, 2) developing initial programme theory, 3) systematic database search, screening and extraction, and 4) purposive searching and refinement of programme theory. We identified eleven adolescent IPV prevention interventions in LMICs, most of which demonstrated a positive impact on IPV experience and/or perpetration (n = 10). Most interventions (n = 9) implemented school- or community-based interactive peer-group education to transform attitudes and norms around gender and relationships for behaviour change. The central mechanism of change related to gender transformative content prompting adolescents to critically reflect on their attitudes and relationships, leading to a reconceptualisation of their values and beliefs. This central mechanism was supported by two secondary implementation mechanisms: 1) the design and delivery of interventions: interactive, age-appropriate education delivered in peer-groups provided adolescents a safe space to engage with content and build communication skills, and 2) the target group: social norms interventions targeting the wider community created enabling environments supportive of individual change. This review highlights the immense potential of gender transformative interventions during the critical period of adolescence for IPV prevention. Future interventions should consider the broader drivers of adolescent IPV and ensure intersectionality informed approaches to maximise their potential to capitalise on this window of opportunity.

Charging of overseas visitors in England and universal health coverage: a cross-sectional analysis of NHS trusts.

BACKGROUND: In 2017, new regulations in England introduced upfront charging for non-urgent care within the National Health Service (NHS). Individuals from outside the European Economic Area who have not paid the immigration surcharge are chargeable for NHS care at 150% of cost. METHODS: A freedom of information (FOI) request was sent to 135 acute non-specialist NHS trusts in England to create a database of overseas visitors charges. This was analysed using multiple linear regression to explore the relationship between sex, age, nationality, ethnicity, urgency and the cost of healthcare. RESULTS: Of 135 acute non-specialist trusts in England 64 replied, providing a data set of 13 484 patients. Women were found to be invoiced higher amounts than men (P = 0.002). Patients were more likely to be women (63 versus 37% men), and within this group, almost half of patients were of reproductive age, with 47.9% (3165) aged 16-40 years old. Only seven trusts supplied data on urgency, and within these trusts the urgency of treatment was significantly related to cost, with the most urgent (immediately necessary) treatment costing the most (P < 0.001). CONCLUSION: This research reflects that that migrant women, and particularly undocumented women, are disproportionately impacted by the NHS charging policies in England.

A Journey of Hope: giving research participants a voice to share their experiences and improve community engagement around advanced HIV disease in Uganda.

Over the last decade excellent progress has been made globally in HIV management thanks to antiretroviral therapy (ART) rollout and international guidelines now recommending immediate initiation of ART in all HIV-positive people. Despite this, advanced HIV disease (CD4 less than 200 cells/mL) and opportunistic infections remain a persistent challenge and contribute significantly to HIV-associated mortality, which equates to 23,000 deaths in Uganda in 2018 alone. Our Meningitis Research Team based in Uganda is committed to conducting clinical trials to answer important questions regarding diagnostics and management of HIV-associated opportunistic infections, including tuberculosis and cryptococcal meningitis. However, clinical research is impossible without research participants and results are meaningless unless they are translated into benefits for those affected by the disease. Therefore, we held a series of community engagement events with the aims of giving clinical research participants a voice in sharing their experiences of clinical research and messages of hope around advanced HIV disease with the community, dispelling myths and stigma around HIV, raising awareness about the complications of advanced HIV disease and local ongoing clinical research and recent scientific advances. The purpose of this Open Letter is to describe our community engagement experience in Uganda, which we hope will lay the foundation for further clinical research public engagement activities, giving research participants a greater voice to share their experiences.

Treatment Outcomes in Adult Tuberculous Meningitis: A Systematic Review and Meta-analysis.

BACKGROUND: There is substantial variation in the reported treatment outcomes for adult tuberculous meningitis (TBM). Data on survival and neurological disability by continent and HIV serostatus are scarce. METHODS: We performed a systematic review and meta-analysis to characterize treatment outcomes for adult TBM. Following a systematic literature search (MEDLINE and EMBASE), studies underwent duplicate screening by independent reviewers in 2 stages to assess eligibility for inclusion. Two independent reviewers extracted data from included studies. We employed a random effects model for all meta-analyses. We evaluated heterogeneity by the I 2 statistic. RESULTS: We assessed 2197 records for eligibility; 39 primary research articles met our inclusion criteria, reporting on treatment outcomes for 5752 adults with TBM. The commonest reported outcome measure was 6-month mortality. Pooled 6-month mortality was 24% and showed significant heterogeneity (I 2 > 95%; P < .01). Mortality ranged from 2% to 67% in Asian studies and from 23% to 80% in Sub-Saharan African studies. Mortality was significantly worse in HIV-positive adults at 57% (95% CI, 48%-67%), compared with 16% (95% CI, 10%-24%) in HIV-negative adults (P < .01). Physical disability was reported in 32% (95% CI, 22%-43%) of adult TBM survivors. There was considerable heterogeneity between studies in all meta-analyses, with I 2 statistics consistently >50%. CONCLUSIONS: Mortality in adult TBM is high and varies considerably by continent and HIV status. The highest mortality is among HIV-positive adults in Sub-Saharan Africa. Standardized reporting of treatment outcomes will be essential to improve future data quality and increase potential for data sharing, meta-analyses, and facilitating multicenter tuberculosis research to improve outcomes.

Tuberculosis in HIV-Associated Cryptococcal Meningitis is Associated with an Increased Risk of Death.

Tuberculosis (TB) and cryptococcal meningitis are leading causes of morbidity and mortality in advanced HIV disease. Data are limited on TB co-infection among individuals with cryptococcal meningitis. We performed a retrospective analysis of HIV-infected participants with cryptococcal meningitis from 2010-2017. Baseline demographics were compared between three groups: 'prevalent TB' if TB treated >14 days prior to cryptococcal meningitis diagnosis, 'concurrent TB' if TB treated ± 14 days from diagnosis, or 'No TB at baseline'. We used time-updated proportional-hazards regression models to assess TB diagnosis as a risk for death. Of 870 participants with cryptococcal meningitis, 50 (6%) had prevalent TB, 67 (8%) had concurrent TB, and 753 (86%) had no baseline TB. Among participants without baseline TB, 67 (9%) were diagnosed with incident TB (after >14 days), with a median time to TB incidence of 41 days (IQR, 22-69). The 18-week mortality was 50% (25/50) in prevalent TB, 46% (31/67) in concurrent TB, and 45% (341/753) in the no TB group (p = 0.81). However, TB co-infection was associated with an increased hazard of death (HR = 1.75; 95% CI, 1.33-2.32; p < 0.001) in a time-updated model. TB is commonly diagnosed in cryptococcal meningitis, and the increased mortality associated with co-infection is a public health concern.

Sotos Syndrome Presenting with Neonatal Hyperinsulinaemic Hypoglycaemia, Extensive Thrombosis, and Multisystem Involvement.

Initially described as an uncommon presenting feature of Sotos syndrome (SoS), over the last decades, congenital hyperinsulinaemic hypoglycaemia (CHI) has been increasingly reported in association with this condition. The mechanism responsible for CHI in SoS is unclear. We report the case of a neonate presenting with CHI and extensive venous and arterial thrombosis associated with kidney, heart, liver, skeleton, and brain abnormalities and finally diagnosed with SoS on whole genome sequencing. Our case describes an extended phenotype associated with SoS presenting with CHI (including thrombosis and liver dysfunction) and reinforces the association of transient CHI with SoS. The case also shows that an early neonatal diagnosis of rare genetic conditions is challenging, especially in acutely unwell patients, and that in complex cases with incomplete, atypical, or overlapping phenotypes, broad genomic testing by whole exome or whole genome sequencing may be a useful diagnostic strategy.

Intrauterine fetal death and risk of shoulder dystocia at delivery.

INTRODUCTION: Vaginal delivery is recommended after intrauterine fetal death. However, little is known about the risk of shoulder dystocia in these deliveries. We studied whether intrauterine fetal death increases the risk of shoulder dystocia at delivery. MATERIAL AND METHODS: In this population-based register study using the Medical Birth Registry of Norway, we included all singleton pregnancies with vaginal delivery of offspring in cephalic presentation in Norway during the period 1967-2012 (n = 2 266 118). Risk of shoulder dystocia was estimated as absolute risk (%) and odds ratio with 95% confidence interval. Adjustment was made for offspring birthweight (in grams). We performed sub-analyses within categories of birthweight (<4000 and ≥4000 g) and in pregnancies with maternal diabetes. RESULTS: Shoulder dystocia occurred in 1.1% of pregnancies with intrauterine fetal death and in 0.8% of pregnancies without intrauterine fetal death (p < 0.0001) (crude odds ratio 1.5, 95% confidence interval 1.2-4.9). After adjustment for birthweight, the odds ratio was 5.9 (95% confidence interval 4.7-7.4). In pregnancies with birthweight ≥4000 g, shoulder dystocia occurred in 14.6% of pregnancies with intrauterine fetal death and in 2.8% of pregnancies without intrauterine fetal death (p < 0.001) (crude odds ratio 5.9, 95% confidence interval 4.5-7.9). In pregnancies with birthweight ≥4000 g and concurrent maternal diabetes, shoulder dystocia occurred in 57.1% of pregnancies with intrauterine fetal death and 9.6% of pregnancies without intrauterine fetal death (p < 0.001) (crude odds ratio 12.6, 95% confidence interval 5.9-26.9). CONCLUSIONS: Intrauterine fetal death increased the risk of shoulder dystocia at delivery, and the absolute risk of shoulder dystocia was particularly high if offspring birthweight was high and the mother had diabetes.