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Tuberculosis infection and hypertension: prevalence estimates from the US National Health and Nutrition Examination Survey

Por: Salindri · A. D. · Auld · S. C. · Gujral · U. P. · Urbina · E. M. · Andrews · J. R. · Huaman · M. A. · Magee · M. J.
Objectives

Tuberculosis infection (TBI) is marked by dynamic host–pathogen interactions with persistent low-grade inflammation and is associated with increased risk of cardiovascular diseases (CVD) including acute coronary syndrome, myocardial infarction and stroke. However, few studies assess the relationship between TBI and hypertension, an intermediate of CVD. We sought to determine the association between TBI and hypertension using data representative of the adult US population.

Methods

We performed cross-sectional analyses using data from the 2011–2012 US National Health and Nutrition Examination Survey (NHANES). Eligible participants included adults with valid QuantiFERON-TB Gold In-Tube (QFT-GIT) test results who also had blood pressure measures and no history of TB disease. TBI was defined by a positive QFT-GIT. We defined hypertension by either elevated measured blood pressure levels (ie, systolic ≥130 mm Hg or diastolic ≥80 mm Hg) or known hypertension indications (ie, self-reported previous diagnosis or use of antihypertensive medications). Analyses were performed using robust quasi-Poisson regressions and accounted for the stratified probability sampling design of NHANES.

Results

The overall prevalence of TBI was 5.7% (95% CI 4.7% to 6.7%) and hypertension was present among 48.9% (95% CI 45.2% to 52.7%) of participants. The prevalence of hypertension was higher among those with TBI (58.5%, 95% CI 52.4% to 64.5%) than those without TBI (48.3%, 95% CI 44.5% to 52.1%) (prevalence ratio (PR) 1.2, 95% CI 1.1 to 1.3). However, after adjusting for confounders, the prevalence of hypertension was similar for those with and without TBI (adjusted PR 1.0, 95% CI 1.0 to 1.1). The unadjusted prevalence of hypertension was higher among those with TBI versus no TBI, especially among individuals without CVD risk factors including those with normal body mass index (PR 1.6, 95% CI 1.2 to 2.0), euglycaemia (PR 1.3, 95% CI 1.1 to 1.5) or non-smokers (PR 1.2, 95% CI 1.1 to 1.4).

Conclusions

More than half of adults with TBI in the USA had hypertension. Importantly, we observed a relationship between TBI and hypertension among those without established CVD risk factors.

Summary

The prevalence of hypertension was high (59%) among adults with TBI in the USA. In addition, we found that the prevalence of hypertension was significantly higher among adults with positive QFT without established hypertension risk factors.

Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlle

Por: Friedland · B. A. · Mgodi · N. M. · Palanee-Phillips · T. · Mathur · S. · Plagianos · M. G. · Bruce · I. V. · Lansiaux · M. · Murombedzi · C. · Musara · P. · Dandadzi · A. · Reddy · K. · Ndlovu · N. · Zulu · S. K. · Shale · L. R. · Zieman · B. · Haddad · L. B.
Introduction

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women’s sexual and reproductive health needs. We will gauge the DPP’s acceptability in two cross-over clinical trials.

Methods and analysis

PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16–40 years) and Harare, Zimbabwe (n=30, 16–24 years) will be randomised 1:1 to the order of regimens—DPP or two separate tablets—each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024.

Ethics and dissemination

PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand’s Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences.

Trial registration numbers

NCT04778514, NCT04778527.

What do spouse primary caregivers of patients with glioblastoma want medical providers to know? A qualitative thematic reflexive analysis of letters written by primary caregivers from a secret Facebook support group

Por: Coman · D. L. · Chard · M. P. · Desautels · L. · Lutz · B. J. · Minns · L. A.
Objectives

To analyse the content of letters written by female spouse primary caregivers of patients with glioblastoma multiforme (GBM), a devastating and terminal primary brain cancer, and give voice to their experiences for medical providers of patients with GBM.

Design

A qualitative study using reflexive thematic analysis of letters written by female spouses/life partners and primary caregivers of patients with GBM.

Participants

101 current or former female spouse primary caregivers of patients with GBM wrote letters to share with the medical community between July 2019 and August 2019. Inclusion criteria: (1) the primary caregiver who is a spouse of a patient with glioblastoma, (2) be a member of the secret Facebook group, ‘We are the wives of GBM and this is our story’, and (3) completed informed consent for the contents of their letter to be included for primary and secondary data analysis. Participants who wrote letters but did not complete the informed consent were excluded from the study.

Results

Themes from the letters included the patient experiences: (1) medical details of the disease trajectory, (2) interactions of the patient/caregiver dyads with healthcare and (3) the changing patient condition over time. Themes focused on the caregiver experiences: (1) caregiver challenges, (2) caregiver responses and (3) caregiver coping strategies, and description of tangible needs that would help other caregivers in the future. Caregiver needs were highest during the living with disease progression phase. Caregivers wanted more education and to be valued as members of the care team.

Conclusion

Shared decision-making through family-centred care would be beneficial for primary caregivers of patients with GBM. These findings provide opportunities to guide more timely and tailored interventions to provide support and improve care for patient/caregiver dyads to help mitigate the burden of this progressive disease and improve quality of life for caregivers.

Exploring community behaviours and stakeholder challenges in engaging communities with dengue prevention behaviour in Malaysia: implementation research for a qualitative study with a community-based participatory research design

Por: Samsudin · N. A. · Karim · N. · Othman · H. · Naserrudin · N. A. · Sahani · M. · Hod · R. · Siau · C. S. · Harif · M. N. · Abd. Samad · B. H. · Zaini · Z.-I. I.
Objectives

To use a community-based participatory research (CBPR) design to explore local community behaviours and stakeholders’ challenges in engaging communities in dengue prevention behaviours in Hulu Langat, Selangor, Malaysia.

Design

This CBPR design in implementation comprised in-depth interviews (IDIs) and focus group discussions (FGDs). Themes were identified from the data with inductive and deductive thematic analysis.

Setting

FGDs were conducted in local community areas and IDIs were conducted in the local authority (LA) office and the Hulu Langat district health office.

Participants

All FGD and IDI participants consented to the study, and included health authorities (n=4), LAs (n=7), community leader (n=1), faith leader (n=1), patients diagnosed with dengue (IDIs, n=2) and permanent residents of Hulu Langat who had been exposed to dengue infectious disease (FGDs, n=27).

Results

The main themes were categorised into community behaviour and stakeholder challenges. The community behaviour-related themes were awareness of dengue disease and Aedes mosquitoes, perception of risk and severity, and involvement of authorities. The themes related to stakeholder challenges were resource constraints and capacity issues, jurisdictional constraints and coordination, and educational dissemination and vandalism.

Conclusions

The actions of the authorities shape community and stakeholder behaviours. Effective communication, including clear and aesthetically pleasing messages, motivates individuals to take appropriate actions. It is crucial for the authorities to engage in inclusive communication and consider diverse perspectives, such as those of residents and individuals exposed to dengue infection. Authorities that provide accurate and unbiased information foster transparency and enable informed decision-making by all stakeholders.

Association between expedited review designations and the US or global burden of disease for drugs approved by the US Food and Drug Administration, 2010-2019: a cross-sectional analysis

Por: Jackson · M. J. · Vaughan · G. · Ledley · F. D.
Objectives

Pharmaceutical innovation can contribute to reducing the burden of disease in human populations. This research asks whether products approved by the US Food and Drug Administration (FDA) from 2010 to 2019 and expedited review programmes incentivising development of products for serious disease were aligned with the US or global burden of disease.

Design

Cross-sectional study.

Outcome measures

Association of FDA product approvals (2010–2019), first approved indications, designations for expedited review with the burden of disease (disability-adjusted life years (DALYs)), years of life lost (YLL) and years of life lived with disability (YLD) for 122 WHO Global Health Estimates (GHE) conditions in US and global (ex-US) populations.

Results

The FDA approved 387 drugs in 2010–2019 with lead indications associated with 59/122 GHE conditions. Conditions with at least one new drug had greater US DALYs (p=0.001), US YLL (p1) with US and global YLL.

Conclusions

FDA drug approvals from 2010 to 2019 were more strongly aligned with US than global disease burden. Designations for expedited review were not aligned with either the US or global burdens of disease and may inadvertently disincentivise development of products addressing global disease burdens. These results may inform policies to better align pharmaceutical innovation with the burdens of disease.

Changes in medical student attendance and its impact on student educational outcomes: a systematic review protocol

Por: Nagappan · P. G. · Brown · S. · McManus · A. · Sayers · S. · Absar · S. · Tan · S. R. X. · Kuhn · I. · Lau · E. · Tulinius · C.
Introduction

The COVID-19 pandemic has had a significant impact on medical education, with many institutions shifting to online learning to ensure the safety of students and staff. However, there has been a decline in in-person attendance at medical schools across the UK and worldwide following the relaxation of social distancing rules and the reinstation of in-person teaching. Importantly, this trend has been observed prior to the pandemic. While reflected within the literature, there is currently no systematic review describing these changes. We aim to find out how medical students’ attendance is changing as documented within the literature and its impact on their educational outcomes.

Methods and analysis

This systematic review will follow the guidelines of the Centre of Research and Dissemination, Meta-analyses of Observational Studies in Epidemiology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We will search the major databases of Medline via Ovid, Embase via Ovid, Scopus, Web of Science, British Education Index via EBSCOhost and ERIC via EBSCOhost.

Two reviewers will independently screen each paper and extract data, with a third reviewer for dispute resolution. All studies reporting on medical students from various universities, both graduate and undergraduate and describing changes in attendance and/or students‘ educational outcomes will be included. Risk of bias in individual studies will be assessed using the Newcastle-Ottawa Scale and confidence in cumulative evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative Research approach. A narrative synthesis of the findings from all included studies will be reported.

Ethics and dissemination

Ethical approval is not required for this systematic review of existing publicly available literature. We will subsequently aim to publish the results of this systematic review in a peer-reviewed journal.

Violence against physicians working in public tertiary care hospital of Bangladesh: a facility-based cross-sectional study

Por: Hasan · M. J. · Sarkar · T. Y. · Ahmed · M. · Banik · A. · Islam · S. · Zaman · M. S. · Mahmud · F. · Paul · A. · Sakib · M. N. · Dev · A. · Hossain · M. J. · Fardous · J. · Nishat · N. H. · Rahman · M.
Background

Violence against physicians in the workplace is a prevalent global issue, and Bangladesh is no exception. Such violence significantly disrupts healthcare delivery and the attainment of universal health coverage. This study aimed to comprehensively evaluate the prevalence, nature and associated risk factors of workplace violence (WPV) against physicians in Bangladesh.

Methods

This descriptive cross-sectional study was conducted at a public tertiary care hospital involving 441 physicians with a minimum tenure of 6 months. Data were gathered through a structured self-reported questionnaire, and statistical analyses were performed by using SPSS V.25.

Results

Out of the surveyed physicians, 67.3% (n=297) reported experiencing violence, categorised as 84.5% psychological, 13.5% physical and 2% sexual in nature. Predominant forms of psychological violence included bullying (48.8%) and threats (40.1%). The mean age of exposed physicians was 32.5±4.3 (SD) years. Those working in the emergency unit (45.8%), surgery and allied departments (54.2%), engaging in rotating shift work (70%), morning shifts (59.6%) and postgraduate trainees (68%) were frequently subjected to violence. Factors significantly associated with WPV included placement in surgery and allied departments (p

Conclusion

A higher proportion of physicians at the early to mid-level stages of their careers, especially those in rotating shifts and surgery-related departments, reported incidence of WPV. Urgent intervention from policy-makers and healthcare entities is imperative to implement preventive measures. Strengthening security measures, establishing antiviolence policies and providing comprehensive training programmes are crucial steps towards ensuring a safer work environment for healthcare professionals.

Nephrologists perspectives on communication and decision-making regarding technique survival in peritoneal dialysis: an international qualitative interview study

Por: Yudianto · B. · Jaure · A. · Shen · J. · Cho · Y. · Brown · E. · Dong · J. · Dunning · T. · Mehrotra · R. · Naicker · S. · Pecoits-Filho · R. · Perl · J. · Wang · A. Y.-M. · Wilkie · M. · Guha · C. · Scholes-Robertson · N. · Craig · J. · Johnson · D. · Manera · K.
Objectives

Peritoneal dialysis (PD) allows patients increased autonomy and flexibility; however, both infectious and non-infectious complications may lead to technique failure, which shortens treatment longevity. Maintaining patients on PD remains a major challenge for nephrologists. This study aims to describe nephrologists’ perspectives on technique survival in PD.

Design

Qualitative semistructured interview study. Transcripts were thematically analysed.

Setting and participants

30 nephrologists across 11 countries including Australia, the USA, the UK, Hong Kong, Canada, Singapore, Japan, New Zealand, Thailand, Colombia and Uruguay were interviewed from April 2017 to November 2019.

Results

We identified four themes: defining patient suitability (confidence in capacity for self-management, ensuring clinical stability and expected resilience), building endurance (facilitating access to practical support, improving mental well-being, optimising quality of care and training to reduce risk of complications), establishing rapport through effective communications (managing expectations to enhance trust, individualising care and harnessing a multidisciplinary approach) and confronting fear and acknowledging barriers to haemodialysis (preventing crash landing to haemodialysis, facing concerns of losing independence and positive framing of haemodialysis).

Conclusion

Nephrologists reported that technique survival in PD is influenced by patients’ medical circumstances, psychological motivation and positively influenced by the education and support provided by treating clinicians and families. Strategies to enhance patients’ knowledge on PD and communication with patients about technique survival in PD are needed to build trust, set patient expectations of treatment and improve the process of transition off PD.

Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol

Por: Vahid · F. · Dessenne · C. · Tur · J. A. · Bouzas · C. · Devaux · Y. · Malisoux · L. · Monserrat-Mesquida · M. · Sureda · A. · Desai · M. S. · Turner · J. D. · Lamy · E. · Perez-Jimenez · M. · Ravn-Haren · G. · Andersen · R. · Forberger · S. · Nagrani · R. · Ouzzahra · Y. · Fontefrancesc
Introduction

Despite international efforts, the number of individuals struggling with obesity is still increasing. An important aspect of obesity prevention relates to identifying individuals at risk at early stage, allowing for timely risk stratification and initiation of countermeasures. However, obesity is complex and multifactorial by nature, and one isolated (bio)marker is unlikely to enable an optimal risk stratification and prognosis for the individual; rather, a combined set is required. Such a multicomponent interpretation would integrate biomarkers from various domains, such as classical markers (eg, anthropometrics, blood lipids), multiomics (eg, genetics, proteomics, metabolomics), lifestyle and behavioural attributes (eg, diet, physical activity, sleep patterns), psychological traits (mental health status such as depression) and additional host factors (eg, gut microbiota diversity), also by means of advanced interpretation tools such as machine learning. In this paper, we will present a protocol that will be employed for a scoping review that attempts to summarise and map the state-of-the-art in the area of multicomponent (bio)markers related to obesity, focusing on the usability and effectiveness of such biomarkers.

Methods and analysis

PubMed, Scopus, CINAHL and Embase databases will be searched using predefined key terms to identify peer-reviewed articles published in English until January 2024. Once downloaded into EndNote for deduplication, CADIMA will be employed to review and select abstracts and full-text articles in a two-step procedure, by two independent reviewers. Data extraction will then be carried out by several independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Peer Review of Electronic Search Strategies guidelines will be followed. Combinations employing at least two biomarkers from different domains will be mapped and discussed.

Ethics and dissemination

Ethical approval is not required; data will rely on published articles. Findings will be published open access in an international peer-reviewed journal. This review will allow guiding future directions for research and public health strategies on obesity prevention, paving the way towards multicomponent interventions.

Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol

Por: Ho · C. · Ha · N. T. · Youens · D. · Abhayaratna · W. P. · Bulsara · M. K. · Hughes · J. D. · Mishra · G. · Pearson · S.-A. · Preen · D. B. · Reid · C. M. · Ruiter · R. · Saunders · C. M. · Stricker · B. H. · van Rooij · F. J. A. · Wright · C. · Moorin · R.
Introduction

Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.

Methods and analysis

The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.

Ethics and dissemination

Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.

Trial registration number

NCT05972785.

Sex-specific Impact of the first COVID-19 Lockdown on Age Structure and Case Acuity at Admission in a Patient Population in southwestern Germany: a retrospective comparative Study in Neuroradiology

Por: Reder · S. R. · Herrlich · N. · Grauhan · N. F. · Othman · A. E. · Müller-Eschner · M. · Brockmann · C. · Brockmann · M. A.
Objectives

A hard lockdown was presumed to lead to delayed diagnosis and treatment of serious diseases, resulting in higher acuity at admission. This should be elaborated based on the estimated acuity of the cases, changes in findings during hospitalisation, age structure and biological sex.

Design

Retrospective monocentric cross-sectional study.

Setting

German Neuroradiology Department at a .

Participants

In 2019, n=1158 patients were admitted in contrast to n=884 during the first hard lockdown in 2020 (11th–13th week).

Main outcome measures

Three radiologists evaluated the initial case acuity, classified them into three groups (not acute, subacute and acute), and evaluated if there was a relevant clinical deterioration. The data analysis was conducted using non-parametric methods and multivariate regression analysis.

Results

A 24% decrease in the number of examinations from 2019 to 2020 (p=0.025) was revealed. In women, the case acuity increased by 21% during the lockdown period (p=0.002). A 30% decrease in acute cases in men was observable (in women 5% decrease). Not acute cases decreased in both women and men (47%; 24%), while the subacute cases remained stable in men (0%) and decreased in women (28%). Regression analysis revealed the higher the age, the higher the acuity (p

Conclusion

The lockdown led to a decrease in neuroradiological consultations, with delays in seeking medical care. In women, the number of most severe cases remained stable, whereas the mean case acuity and age increased. This could be due to greater pandemic-related anxiety among women, however, with severe symptoms they were seeking for medical help. In contrast in men, the absolute number of most severe cases decreased, whereas the mean acuity and age remained nearly unaffected. This could be attributable to a reduced willingness to seek for medical consultation.

Examining the impact of COVID-19 on Maori:non-Maori health inequities in Aotearoa, New Zealand: an observational study protocol

Por: Curtis · E. · Jaung · R. · Paine · S.-J. · McLeod · M. · Tamatea · J. · Atkinson · J. · Jiang · Y. · Robson · B. · Reid · P. · Harris · R. B.
Introduction

The COVID-19 pandemic has had both direct and indirect impacts on the health of populations worldwide. While racial/ethnic health inequities in COVID-19 infection are now well known (and ongoing), knowledge about the impact of COVID-19 pandemic management on non-COVID-19-related outcomes for Indigenous peoples is less well understood. This article presents the study protocol for the Health Research Council of New Zealand funded project ‘Mā te Mōhio ka Mārama: Impact of COVID-19 on Māori:non-Māori inequities’. The study aims to explore changes in access to healthcare, quality of healthcare and health outcomes for Māori, the Indigenous peoples of Aotearoa New Zealand (NZ) and non-Māori during the COVID-19 outbreak period across NZ.

Methods and analysis

This observational study is framed within a Kaupapa Māori research positioning that includes Kaupapa Māori epidemiology. National datasets will be used to report on access to healthcare, quality of healthcare and health outcomes between Māori and non-Māori during the COVID-19 pandemic in NZ. Study periods are defined as (a) prepandemic period (2015–2019), (b) first pandemic year without COVID-19 vaccines (2020) and (c) pandemic period with COVID-19 vaccines (2021 onwards). Regional and national differences between Māori and non-Māori will be explored in two phases focused on identified health priority areas for NZ including (1) mortality, cancer, long-term conditions, first 1000 days, mental health and (2) rheumatic fever.

Ethics and dissemination

This study has ethical approval from the Auckland Health Research Ethics Committee (AHREC AH26253). An advisory group will work with the project team to disseminate the findings of this project via project-specific meetings, peer-reviewed publications and a project-specific website. The overall intention of the project is to highlight areas requiring health policy and practice interventions to address Indigenous inequities in health resulting from COVID-19 pandemic management (both historical and in the future).

Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study

Por: Llurba · E. · Crispi · F. · Crovetto · F. · Youssef · L. · Delgado · J. L. · Puig · I. · Mora · J. · Krofta · L. · Mackova · K. · Martinez-Varea · A. · Tubau · A. · Ruiz · A. · Paya · A. · Prat · M. · Chantraine · F. · Comas · C. · Kajdy · A. · Lopez-Tinajero · M. F. · Figueras · F. · Gratac
Introduction

Pre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal–fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35–37 weeks’ gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35–37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes.

Methods and analysis

We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35–37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect).

Ethics and dissemination

The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences.

Trial registration number

NCT04766866.

Sex-related differential item functioning of the Jenkins Sleep Scale: a cross-sectional study among 77 967 employees in the Finnish public sector

Por: Juhola · J. · Arokoski · J. P. A. · Ervasti · J. · Kivimäki · M. · Vahtera · J. · Myllyntausta · S. · Saltychev · M.
Objectives

To investigate if the Jenkins Sleep Scale (JSS) demonstrates sex-related differential item functioning (DIF).

Design

Cross-sectional study.

Setting

Survey data from the Finnish Public Sector study (2015–2017).

Participants

77 967 employees in the Finnish public sector, with a mean age of 51.9 (SD 13.1) years and 82% women.

Outcome measures

Item response theory estimates: difficulty and discrimination parameters of the JSS and differences in these parameters between men and women.

Results

The mean JSS total score was 6.4 (4.8) points. For all four items of the JSS, the difficulty parameter demonstrated a slight shift towards underestimation of the severity of sleep difficulties. The discrimination ability of all four items was moderate to high. For the JSS composite score, overall discrimination ability was moderate (0.98, 95% CI 0.97 to 0.99). Mild uniform DIF (p

Conclusions

The JSS showed overall good psychometric properties among this healthy population of employees in the Finnish public sector. The JSS was able to discriminate people with different severities of sleep disturbances. However, when using the JSS, the respondents might slightly underestimate the severity of these disturbances. While the JSS may produce slightly different results when answered by men and women, these sex-related differences are probably negligible when applied to clinical situations.

Feasibility of quality indicators on prehospital advanced airway management in a physician-staffed emergency medical service: survey-based assessment of the provider point of view

Por: Kottmann · A. · Pasquier · M. · Carron · P.-N. · Maudet · L. · Rouve · J.-D. · Suppan · L. · Caillet-Bois · D. · Riva · T. · Albrecht · R. · Krüger · A. · Sollid · S. J. M.
Objective

We aimed to determine the feasibility of quality indicators (QIs) for prehospital advanced airway management (PAAM) from a provider point of view.

Design

The study is a survey based feasibility assessment following field testing of QIs for PAAM.

Setting

The study was performed in two physician staffed emergency medical services in Switzerland.

Participants

42 of the 44 emergency physicians who completed at least one case report form (CRF) dedicated to the collection of the QIs on PAAM between 1 January 2019 and 31 December 2021 participated in the study.

Intervention

The data required to calculate the 17 QIs was systematically collected through a dedicated electronic CRF.

Primary and secondary outcome measures

Primary outcomes were provider-related feasibility criteria: relevance and acceptance of the QIs, as well as reliability of the data collection. Secondary outcomes were effort to collect specific data and to complete the CRF.

Results

Over the study period, 470 CRFs were completed, with a median of 11 per physician (IQR 4–17; range 1–48). The median time to complete the CRF was 7 min (IQR 3–16) and was considered reasonable by 95% of the physicians. Overall, 75% of the physicians assessed the set of QIs to be relevant, and 74% accepted that the set of QIs assessed the quality of PAAM. The reliability of data collection was rated as good or excellent for each of the 17 QIs, with the lowest rated for the following 3 QIs: duration of preoxygenation, duration of laryngoscopy and occurrence of desaturation during laryngoscopy.

Conclusions

Collection of QIs on PAAM appears feasible. Electronic medical records and technological solutions facilitating automatic collection of vital parameters and timing during the procedure could improve the reliability of data collection for some QIs. Studies in other services are needed to determine the external validity of our results.

Attrition from longitudinal ageing studies and performance across domains of cognitive functioning: an individual participant data meta-analysis

Por: Hernandez · R. · Jin · H. · Lee · P.-J. · Schneider · S. · Junghaenel · D. U. · Stone · A. A. · Meijer · E. · Gao · H. · Maupin · D. · Zelinski · E. M.
Objectives

This paper examined the magnitude of differences in performance across domains of cognitive functioning between participants who attrited from studies and those who did not, using data from longitudinal ageing studies where multiple cognitive tests were administered.

Design

Individual participant data meta-analysis.

Participants

Data are from 10 epidemiological longitudinal studies on ageing (total n=209 518) from several Western countries (UK, USA, Mexico, etc). Each study had multiple waves of data (range of 2–17 waves), with multiple cognitive tests administered at each wave (range of 4–17 tests). Only waves with cognitive tests and information on participant dropout at the immediate next wave for adults aged 50 years or older were used in the meta-analysis.

Measures

For each pair of consecutive study waves, we compared the difference in cognitive scores (Cohen’s d) between participants who dropped out at the next study wave and those who remained. Note that our operationalisation of dropout was inclusive of all causes (eg, mortality). The proportion of participant dropout at each wave was also computed.

Results

The average proportion of dropouts between consecutive study waves was 0.26 (0.18 to 0.34). People who attrited were found to have significantly lower levels of cognitive functioning in all domains (at the wave 2–3 years before attrition) compared with those who did not attrit, with small-to-medium effect sizes (overall d=0.37 (0.30 to 0.43)).

Conclusions

Older adults who attrited from longitudinal ageing studies had lower cognitive functioning (assessed at the timepoint before attrition) across all domains as compared with individuals who remained. Cognitive functioning differences may contribute to selection bias in longitudinal ageing studies, impeding accurate conclusions in developmental research. In addition, examining the functional capabilities of attriters may be valuable for determining whether attriters experience functional limitations requiring healthcare attention.

ATME--Needs, requirements and cross-sectoral patient journeys of patients with out-of-hospital mechanical ventilation and intensive care in outpatient settings: study protocol for an observational study

Por: Knizia · N.-A. · Hirschler · J. · Stegbauer · C. · Schwinger · A. · Büscher · A. · Englert · N. · Peters · L. · Bayarassou · H. A. · Mallmann · L. · Willms · G.
Introduction

An increasing number of tracheotomised and/or ventilated patients with high-cost out-of-hospital intensive care needs and, at the same time, a decreasing number of healthcare professionals inevitably lead to challenges in the care of this patient population. In addition, little is known about this population, their health restrictions, needs, patient journeys, care structures and processes. The project ‘Needs, requirements and cross-sectoral care pathways of out-of-hospital ventilated intensive care patients’ (ATME) aims to analyse these aspects and explore current care structures to inform further development of care in line with patients’ needs and requirements.

Methods and analysis

Qualitative and quantitative methods will be used. In preparation of a semistandardised survey, exploratory interviews will be conducted with tracheotomised and/or ventilated patients with out-of-hospital intensive care needs (TVPOI) (n=15), nursing care providers (n=30), outpatient medical centres, as well as outpatient medical, medical technology and therapeutic care providers (n=35). Three semistandardised survey questionnaires for TVPOI (n=2,000) will be developed and conducted with nursing care facilities (n=250) and outpatient medical centres for mechanical ventilation (n=25). Content analyses will be conducted for qualitative data; survey data will be analysed descriptively. In addition, healthcare claims data will be analysed descriptively to provide information on patient journeys. Three result workshops and one consensus conference will be carried out with representatives of the relevant target groups to analyse the suitability of care structures and to develop recommendations for action to improve TVPOI.

Ethics and dissemination

The ATME study received a positive vote from the Ethics Committee of the Osnabrück University of Applied Sciences and is registered in ‘Deutsches Register Klinischer Studien (DRKS)’ (registration number: DRKS00030891). The study results will be presented at national conferences and in relevant peer-reviewed journals. Additionally, study results will be published by the funding institution (the Innovation Committee of the Federal Joint Committee) on their website.

Study protocol for a cross-sectional online survey investigating patient preferences and experiences of waiting for elective cardiac surgery

Por: Russo · M. · Watson · K. · Richards · K. · Olive · R. R. · Krausova · B. · Kumar · R. · Burridge · J. · Goulding · L. · Chua · K.-C. · Hardy · D. · Vassilios · A. · Kamran · B. · Bhudia · S. · Alia · N. · Habib · K. · Sevdalis · N. · Petrou · M.
Introduction

Being on a waiting list for elective (planned) cardiac surgery can be physically and psychologically challenging for patients. Research suggests that stress associated with waiting for surgery is dependent on different individual and contextual factors. However, most data on patients’ experiences of waiting for surgery and preferences for waiting list management derives from non-cardiac clinical populations. The aim of the current study is to explore patients’ experiences of being on a waiting list for elective cardiac surgery, and their views on how the waiting experience could be improved in the future. This work will inform the patient management strategy during the waiting period for surgery across the four major hospitals in London directly involved in this study, and potentially beyond by transferring learning to other services.

Methods and analysis

This is a mixed-methods study that will collect quantitative and qualitative data using a cross-sectional online survey. Patients who are on waiting lists for elective surgery across four major cardiac surgery departments in London hospitals, and are at least 18 years old, will be invited by their healthcare team via text message or letter to complete the survey. The target sample size of non-randomly selected participants will be 268. Bivariable and multivariable regression models will be used to assess associations between survey items measuring the impact of the cardiac condition on specific life domains (eg, daily activities, social and family relationships, hobbies, sexual life), anxiety and depression symptoms as measured by the Patient Health Questionnaire-4 and survey items evaluating experiences of health services. Data on experience and preferences for improvements to the waiting experience will be analysed with qualitative content analysis using an inductive approach.

Ethics and dissemination

This study was reviewed and granted ethical approval by the East of England—East Cambridge Research Ethics Committee. Findings from this study will be disseminated through peer-reviewed journals, a research website and social media and with an online event engaging patients, members of the public, healthcare professionals and other relevant stakeholders.

Trial registration numb

NCT05996640

NeuroMotion smartphone application for remote General Movements Assessment: a feasibility study in Nepal

Por: Kukka · A. J. · Sundelin · H. E. K. · Basnet · O. · Paudel · P. · Upadhyay Subedi · K. · Svensson · K. · Brown · N. · Litorp · H. · Gurung · R. · Bhattarai · P. · Wrammert · J. · KC · A.
Objectives

To evaluate the feasibility of using the NeuroMotion smartphone application for remote General Movements Assessment for screening infants for cerebral palsy in Kathmandu, Nepal.

Method

Thirty-one term-born infants at risk of cerebral palsy due to birth asphyxia or neonatal seizures were recruited for the follow-up at Paropakar Maternity and Women’s Hospital, 1 October 2021 to 7 January 2022. Parents filmed their children at home using the application at 3 months’ age and the videos were assessed for technical quality using a standardised form and for fidgety movements by Prechtl’s General Movements Assessment. The usability of the application was evaluated through a parental survey.

Results

Twenty families sent in altogether 46 videos out of which 35 had approved technical quality. Sixteen children had at least one video with approved technical quality. Three infants lacked fidgety movements. The level of agreement between assessors was acceptable (Krippendorf alpha 0.781). Parental answers to the usability survey were in general positive.

Interpretation

Engaging parents in screening of cerebral palsy with the help of a smartphone-aided remote General Movements Assessment is possible in the urban area of a South Asian lower middle-income country.

AI assisted reader evaluation in acute CT head interpretation (AI-REACT): protocol for a multireader multicase study

Por: Fu · H. · Novak · A. · Robert · D. · Kumar · S. · Tanamala · S. · Oke · J. · Bhatia · K. · Shah · R. · Romsauerova · A. · Das · T. · Espinosa · A. · Grzeda · M. T. · Narbone · M. · Dharmadhikari · R. · Harrison · M. · Vimalesvaran · K. · Gooch · J. · Woznitza · N. · Salik · N. · Campbell · A.
Introduction

A non-contrast CT head scan (NCCTH) is the most common cross-sectional imaging investigation requested in the emergency department. Advances in computer vision have led to development of several artificial intelligence (AI) tools to detect abnormalities on NCCTH. These tools are intended to provide clinical decision support for clinicians, rather than stand-alone diagnostic devices. However, validation studies mostly compare AI performance against radiologists, and there is relative paucity of evidence on the impact of AI assistance on other healthcare staff who review NCCTH in their daily clinical practice.

Methods and analysis

A retrospective data set of 150 NCCTH will be compiled, to include 60 control cases and 90 cases with intracranial haemorrhage, hypodensities suggestive of infarct, midline shift, mass effect or skull fracture. The intracranial haemorrhage cases will be subclassified into extradural, subdural, subarachnoid, intraparenchymal and intraventricular. 30 readers will be recruited across four National Health Service (NHS) trusts including 10 general radiologists, 15 emergency medicine clinicians and 5 CT radiographers of varying experience. Readers will interpret each scan first without, then with, the assistance of the qER EU 2.0 AI tool, with an intervening 2-week washout period. Using a panel of neuroradiologists as ground truth, the stand-alone performance of qER will be assessed, and its impact on the readers’ performance will be analysed as change in accuracy (area under the curve), median review time per scan and self-reported diagnostic confidence. Subgroup analyses will be performed by reader professional group, reader seniority, pathological finding, and neuroradiologist-rated difficulty.

Ethics and dissemination

The study has been approved by the UK Healthcare Research Authority (IRAS 310995, approved 13 December 2022). The use of anonymised retrospective NCCTH has been authorised by Oxford University Hospitals. The results will be presented at relevant conferences and published in a peer-reviewed journal.

Trial registration number

NCT06018545.

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