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Fertility among women living with HIV in western Ethiopia and its implications for prevention of vertical transmission: a cross-sectional study

Por: Feyissa · T. R. · Harris · M. L. · Forder · P. M. · Loxton · D.
Objective

This study aimed to examine fertility (live births) in the last 3 years and its associated factors among women living with HIV (WLHIV) in western Ethiopia .

Design

Participants were recruited into a cross-sectional survey using systematic sampling.

Settings

Four healthcare facilities in western Ethiopia were included.

Participants

Eligible participants were WLHIV of reproductive age (15–49 years) from western Ethiopia who found out about their HIV-positive status more than 3 years ago (N=866).

Primary outcome measures

The fertility (live births) of HIV-positive women in the last 3 years was surveyed using face-to-face interviews (March–June 2018). Logistic regression analyses were conducted to examine factors influencing fertility in the last 3 years.

Results

A total of 108 (12.5%) HIV-positive women gave birth to 121 live children in the last 3 years. Of these births, 18.2% were reported as mistimed at conception, while 26.4% were reported as unwanted. Of the live births, 8.3% ended in death. Of the 76 (62.8%) children with known HIV status born to HIV-positive women in the last 3 years, 7.9% were HIV-positive. In terms of predictors of fertility, women aged 15–24 years (adjusted OR (AOR) 2.72; 95% CI 1.14 to 6.49) and 25–34 years (AOR 4.34; 95% CI 2.61 to 7.21) had increased odds of fertility compared with women aged 35–49 years. Women using antiretroviral therapy (ART) for less than 5 years were more likely to have given birth in the last 3 years compared with those using ART for 10 years or more (AOR 2.96; 95% CI 1.19 to 7.36), even after controlling for age.

Conclusions

WLHIV in Ethiopia are having children and so it is imperative that safe conception strategies are readily available as well as support to reduce HIV-related risks for children born to these mothers. Strengthening reproductive health services for HIV-positive women in order to achieve their family planning goals is therefore important.

Association between health indicators of maternal adversity and the rate of infant entry to local authority care in England: a longitudinal ecological study

Por: Pearson · R. J. · Jay · M. A. · Wijlaars · L. P. M. M. · De Stavola · B. · Syed · S. · Bedston · S. J. · Gilbert · R.
Objective

Infants enter care at varying rates across local authorities (LAs) in England, but evidence is lacking on what is driving these differences. With this ecological study, we aimed to explore the extent to which adversity indicated within women’s hospitalisation histories, predelivery, explained the rate of infant entry into care.

Methods

We used two longitudinal person-level data sets on hospitalisations and entries to care to create annual measures for 131 English LAs, between 2006/2007 and 2013/2014 (April–March). We combined these measures by LA and financial year, along with other publicly available data on LA characteristics. We used linear mixed-effects models to analyse the relationship between the outcome—LA-specific rate of infant entry into care (per 10 000 infants in the LA population) — and LA-specific percentage of live births with maternal history of adversity-related hospital admissions (ie, substance misuse, mental health problems or violence-related admissions in the 3 years before delivery), adjusted for other predictors of entry into care.

Results

Rate of infant entry into care (mean: 85.16 per 10 000, SD: 41.07) and percentage of live births with maternal history of adversity-related hospital admissions (4.62%, 2.44%) varied greatly by LA. The prevalence of maternal adversity accounted for 24% of the variation in rate of entry (95% CI 14% to 35%). After adjustment, a percentage point increase in prevalence of maternal adversity—both within and between LAs—was associated with an estimated 2.56 (per 10 000) more infants entering care (1.31–3.82).

Conclusions

The prevalence of maternal adversity before birth helped to explain the variation in LA rates of infant entry into care. Preventive interventions are needed to improve maternal well-being before and during pregnancy, and potentially reduce risk of child maltreatment and therefore entries to care. Evidence on who to target and data to evaluate change require linkage between parent–child healthcare data and administrative data from children’s social care.

The GALANT trial: study protocol of a randomised placebo-controlled trial in patients with a 68Ga-DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of lanreotide on tumour size

Por: Boertien · T. M. · Drent · M. L. · Booij · J. · Majoie · C. B. L. M. · Stokkel · M. P. M. · Hoogmoed · J. · Pereira · A. · Biermasz · N. R. · Simsek · S. · Groote Veldman · R. · Tanck · M. W. T. · Fliers · E. · Bisschop · P. H.
Introduction

At present, there is no approved medical treatment option for patients with non-functioning pituitary adenoma. A number of open-label studies suggest that treatment with somatostatin analogues may prevent tumour progression. In vivo somatostatin receptor imaging using 68Ga-DOTATATE PET (PET, positron emission tomography) could help in preselecting patients potentially responsive to treatment. Our aim is to investigate the effect of the somatostatin analogue lanreotide as compared with placebo on tumour size in patients with a 68Ga-DOTATATE PET-positive non-functioning pituitary macroadenoma (NFMA).

Methods and analysis

The GALANT study is a multicentre, randomised, double-blind, placebo-controlled trial in adult patients with a suprasellar extending NFMA. Included patients undergo a 68Ga-DOTATATE PET/CT of the head and tracer uptake is assessed after coregistration with pituitary MRI. Forty-four patients with a 68Ga-DOTATATE PET-positive NFMA are randomised in a 1:1 ratio between lanreotide 120 mg or placebo, both administered as subcutaneous injections every 28 days for 72 weeks. The primary outcome is the change in cranio-caudal tumour diameter on pituitary MRI after treatment. Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events. Final results are expected in the second half of 2021.

Ethics and dissemination

The study protocol has been approved by the Medical Research Ethics Committee of the Academic Medical Centre (AMC) of the Amsterdam University Medical Centres and by the Dutch competent authority. It is an investigator-initiated study with financial support by Ipsen Farmaceutica BV. The AMC, as sponsor, remains owner of all data. Results will be submitted for publication in a peer-reviewed journal.

Trial registration number

NL5136 (Netherlands Trial Register); pre-recruitment.

Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND)

Por: Morriss · R. · Webster · L. · Abdelghani · M. · Auer · D. P. · Barber · S. · Bates · P. · Blamire · A. · Briley · P. M. · Brookes · C. · Iwabuchi · S. · James · M. · Kaylor-Hughes · C. · Lankappa · S. · Liddle · P. · McAllister-Williams · H. · O'Neill-Kerr · A. · Pszczolkowski Parrague
Introduction

The BRIGhTMIND study aims to determine the clinical effectiveness, cost-effectiveness and mechanism of action of connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS) in adults with moderate to severe treatment resistant depression.

Methods and analysis

The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance. A total of 368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring >16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK. The primary outcome is depression response at 16 weeks (50% or greater reduction in HDRS-17 score from baseline). Secondary outcomes include assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life at 8, 16 and 26 weeks postrandomisation. Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.

Ethics and dissemination

Ethical approval was granted by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. The results of the study will be published in relevant peer-reviewed journals, and then through professional and public conferences and media. Further publications will explore patient experience, moderators and mediators of outcome and mechanism of action.

Trial registration number

ISRCTN19674644

Indigenous Australian women's experiences of participation in cervical screening

by Tamara L. Butler, Kate Anderson, John R. Condon, Gail Garvey, Julia M. L. Brotherton, Joan Cunningham, Allison Tong, Suzanne P. Moore, Clare M. Maher, Jacqueline K. Mein, Eloise F. Warren, Lisa J. Whop

Aboriginal and Torres Strait Islander (collectively, Indigenous Australian) women experience a higher burden of cervical cancer than other women. The National Cervical Screening Program (NCSP) is failing to meet the needs of Indigenous Australian women, resulting in many women not regularly participating in cervical screening. However, one third of Indigenous Australian women do participate in cervical screening. The reasons that some women in this population commence and continue to screen remain unheard but could provide insights to support women who currently do not participate. We aimed to describe Indigenous Australian women’s experiences and views of participation in cervical screening by yarning (a culturally-appropriate interview technique) with 50 Indigenous Australian women aged 25–70 years who had completed cervical screening in the past five years, recruited via Primary Health Care Centres (PHCCs) from three jurisdictions. Aboriginal or Torres Strait Islander women researchers conducted the interviews. Thematic analysis identified six themes: screening as a means of staying strong and in control; overcoming fears, shame, and negative experiences of screening; needing to talk openly about screening; the value of trusting relationships with screening providers; logistical barriers; and overcoming privacy concerns for women employed at PHCCs. Despite describing screening as shameful, invasive, and uncomfortable, women perceived it as a way of staying healthy and exerting control over their health. This ultimately supported their participation and a sense of empowerment. Women valued open discussion about screening and strong relationships with health providers. We identified logistical barriers and specific barriers faced by women employed at PHCCs. This study is strengthened by a research approach that centred Indigenous Australian women’s voices. Understanding the experiences of Indigenous Australian women who participate in screening will help screening providers support women to start and continue to screen regularly. Recommendations for practice are provided.

First description of a herpesvirus infection in genus Lepus

by F. A. Abade dos Santos, M. Monteiro, A. Pinto, C. L. Carvalho, M. C. Peleteiro, P. Carvalho, P. Mendonça, T. Carvalho, M. D. Duarte

During the necropsies of Iberian hares obtained in 2018/2019, along with signs of the nodular form of myxomatosis, other unexpected external lesions were also observed. Histopathology revealed nuclear inclusion bodies in stromal cells suggesting the additional presence of a nuclear replicating virus. Transmission electron microscopy further demonstrated the presence of herpesvirus particles in the tissues of affected hares. We confirmed the presence of herpesvirus in 13 MYXV-positive hares by PCR and sequencing analysis. Herpesvirus-DNA was also detected in seven healthy hares, suggesting its asymptomatic circulation. Phylogenetic analysis based on concatenated partial sequences of DNA polymerase gene and glycoprotein B gene enabled greater resolution than analysing the sequences individually. The hare’ virus was classified close to herpesviruses from rodents within the Rhadinovirus genus of the gammaherpesvirus subfamily. We propose to name this new virus Leporid gammaherpesvirus 5 (LeHV-5), according to the International Committee on Taxonomy of Viruses standards. The impact of herpesvirus infection on the reproduction and mortality of the Iberian hare is yet unknown but may aggravate the decline of wild populations caused by the recently emerged natural recombinant myxoma virus.

Recognition of anxiety disorders in children: a cross-sectional vignette-based survey among general practitioners

Por: Aydin · S. · Crone · M. R. · Siebelink · B. M. · Vermeiren · R. R. J. M. · Numans · M. E. · Westenberg · P. M.
Objective

To quantify general practitioners’ (GPs) sensitivity to anxiety disorders (ADs) when confronted with the range of symptoms common to children with ADs. Also, to explore GPs’ conscious preferences and implicit tendencies for referral of children with ADs to mental healthcare.

Design and setting

In a cross-sectional vignette-based survey, all attendees of a Dutch continuing medical education conference for primary care physicians were presented with subtitled audio fragments of five vignettes that we constructed to mimic symptom presentation of children with ADs in general practice. We asked attendees to select per vignette the most plausible diagnoses and most adequate referral option, and for their general referral preferences when they suspect each of the most common mental health problems.

Participants

A sample of 229 GPs, resulting in a total of 1128 vignette evaluations.

Main outcome measure

GPs’ selection rate of ADs in the five vignettes compared with a benchmark provided by mental health professionals (MHPs).

Results

Overall, recognition of ADs was less likely in GPs compared with MHPs (OR=0.26, 95% CI 0.15 to 0.46). GPs varied in their recognition of anxiety, with 44.1% not once selecting anxiety as the probable presenting problem. When asked explicitly, 63.9% of the GPs reported that they would refer a child to mental healthcare when they suspect probable ADs. By contrast, only 12.0% of the GPs who recognised anxiety in the vignettes actually selected that referral option.

Conclusion

A significant fraction of GPs did not notice the depicted symptoms as anxiety. Despite the widespread prevalence of ADs, GPs seem to overlook anxiety already in their early diagnostic opinion. Improving GPs’ familiarity with initial symptom presentation, ADs’ base-rate, relevance and impact yields potential for timely recognition.

Evaluating the Implementation of a Multi‐Component Intervention to Prevent Surgical Site Infection and Promote Evidence‐Based Practice

Abstract

Background

Published clinical practice guidelines on surgical site infection prevention are available; however, adherence to these guidelines remains suboptimal.

Aims

The aim of this study was to evaluate the effectiveness and perceived benefits of intervention and implementation strategies co‐created by researchers and clinicians to prevent surgical site infections.

Methods

This mixed‐method evaluation study involved an audit of nurses’ wound care practices, followed by focus group and individual interviews to understand the perceived benefits of the intervention and implementation strategies. Descriptive statistical analyses were used to compare post‐intervention audit data with baseline results. Deductive and inductive content analyses were undertaken on the qualitative data.

Results

The audit showed improvements in using aseptic technique and wound care documentation practices following intervention implementation. Nurses perceived the change champion as effective in role‐modelling good practice. Education strategies including a poster and using a scenario‐based quiz were viewed as easy to understand and helpful for nurses to apply aseptic technique in practice. The instructions and education conducted to improve documentation were considered important in the success of the Wound Care Template implementation.

Linking Evidence to Action

The integrated knowledge translation approach used in this study ensured the intervention and the implementation strategies employed were appropriate and meaningful for clinicians. Such strategies may be used in other intervention studies. The change champion played an important role in driving change and acted as a vital partner during the co‐creation and the implementation processes. Ongoing education, audit and feedback became integrated in the ward nurses’ routine practice, which has the potential to continuously improve and sustain evidence‐based practice.

Developing a multivariable prediction model for functional outcome after reperfusion therapy for acute ischaemic stroke: study protocol for the Targeting Optimal Thrombolysis Outcomes (TOTO) multicentre cohort study

Por: Holliday · E. · Lillicrap · T. · Kleinig · T. · Choi · P. M. C. · Maguire · J. · Bivard · A. · Lincz · L. F. · Hamilton-Bruce · M. A. · Rao · S. R. · Snel · M. F. · Trim · P. J. · Lin · L. · Parsons · M. W. · Worrall · B. B. · Koblar · S. · Attia · J. · Levi · C.
Introduction

Intravenous thrombolysis (IVT) with recombinant tissue plasminogen activator (rt-PA) is the only approved pharmacological reperfusion therapy for acute ischaemic stroke. Despite population benefit, IVT is not equally effective in all patients, nor is it without significant risk. Uncertain treatment outcome prediction complicates patient treatment selection. This study will develop and validate predictive algorithms for IVT response, using clinical, radiological and blood-based biomarker measures. A secondary objective is to develop predictive algorithms for endovascular thrombectomy (EVT), which has been proven as an effective reperfusion therapy since study inception.

Methods and analysis

The Targeting Optimal Thrombolysis Outcomes Study is a multicenter prospective cohort study of ischaemic stroke patients treated at participating Australian Stroke Centres with IVT and/or EVT. Patients undergo neuroimaging using multimodal CT or MRI at baseline with repeat neuroimaging 24 hours post-treatment. Baseline and follow-up blood samples are provided for research use. The primary outcome is good functional outcome at 90 days poststroke, defined as a modified Rankin Scale (mRS) Score of 0–2. Secondary outcomes are reperfusion, recanalisation, infarct core growth, change in stroke severity, poor functional outcome, excellent functional outcome and ordinal mRS at 90 days. Primary predictive models will be developed and validated in patients treated only with rt-PA. Models will be built using regression methods and include clinical variables, radiological measures from multimodal neuroimaging and blood-based biomarkers measured by mass spectrometry. Predictive accuracy will be quantified using c-statistics and R2. In secondary analyses, models will be developed in patients treated using EVT, with or without prior IVT, reflecting practice changes since original study design.

Ethics and dissemination

Patients, or relatives when patients could not consent, provide written informed consent to participate. This study received approval from the Hunter New England Local Health District Human Research Ethics Committee (reference 14/10/15/4.02). Findings will be disseminated via peer-reviewed publications and conference presentations.

Constructing treatment episodes from concomitant medication logs: a prospective observational study

Por: Kuramoto · L. K. · Sobolev · B. G. · Brasher · P. M. A. · Tang · M. W. · Cragg · J. J.
Objectives

To describe an approach using concomitant medication log records for the construction of treatment episodes. Concomitant medication log records are routinely collected in clinical studies. Unlike prescription and dispensing records, concomitant medication logs collect utilisation data. Logs can provide information about drug safety and drug repurposing.

Design

A prospective multicentre, multicohort observational study.

Setting

Twenty-one clinical sites in the USA, Europe, Israel and Australia.

Participants

415 subjects from the de novo cohort of the Parkinson’s Progression Markers Initiative.

Methods

We construct treatment episodes of concomitant medication use. The proposed approach treats temporal gaps as a stoppage of medication and temporal overlaps as simultaneous use or changes in dose. Log records with no temporal gaps were combined into a single treatment episode.

Results

5723 concomitant medication log records were used to construct 3655 treatment episodes for 65 medications. There were 405 temporal gaps representing a stoppage of medication; 985 temporal overlaps representing simultaneous regimens of the same medication and 2696 temporal overlaps representing a change in dose regimen. The median episode duration was 37 months (IQ interval: 11–73 months).

Conclusions

The proposed approach for constructing treatment episodes offers a method of estimating duration and dose of treatment from concomitant medication log records. The accompanying recommendations guide log data collection to improve their quality for drug safety and drug repurposing.

Observational stepped-wedge analysis of a community health worker-led intervention for diabetes and hypertension in rural Mexico

Por: Worster · D. T. · Franke · M. F. · Bazua · R. · Flores · H. · Garcia · Z. · Krupp · J. · Maza · J. · Palazuelos · L. · Rodriguez · K. · Newman · P. M. · Palazuelos · D.
Objectives

There is emerging interest and data supporting the effectiveness of community health workers (CHWs) in non-communicable diseases (NCDs) in low/middle-income countries (LMICs). This study aimed to determine whether a CHW-led intervention targeting diabetes and hypertension could improve markers of clinical disease control in rural Mexico.

Design and setting

A prospective observational stepped-wedge study was conducted across seven communities in rural Chiapas, Mexico from March 2014 to April 2018.

Participants

149 adults with hypertension and/or diabetes.

Intervention

This study was conducted in the context of the programmatic roll-out of an accompaniment-based CHW-led intervention designed to complement comprehensive primary care for adults with diabetes and/or hypertension. Implementation occurred sequentially at 3-month intervals with point-of-care data collected at baseline and every 3 months thereafter for 12 months following roll-out in all communities.

Outcome measures

Primary outcomes were glycated haemoglobin (HbA1c) and systolic blood pressure (SBP), overall and stratified by baseline disease control. We conducted an individual-level analysis using mixed effects regression, adjusting for time, cohort and clustering at the individual and community levels.

Results

Among patients with diabetes, the CHW-led intervention was associated with a decrease in HbA1c of 0.35%; however, CIs were wide (95% CI –0.90% to 0.20%). In patients with hypertension, there was a 4.7 mm Hg decrease in SBP (95% CI –8.9 to –0.6). In diabetic patients with HbA1c ≥9%, HbA1c decreased by 0.96% (95% CI –1.69% to –0.23%), and in patients with uncontrolled hypertension, SBP decreased by 10.2 mm Hg (95% CI –17.7 to –2.8).

Conclusions

We found that a CHW-led intervention resulted in clinically meaningful improvement in disease markers for patients with diabetes and hypertension, most apparent among patients with hypertension and patients with uncontrolled disease at baseline. These findings suggest that CHWs can play a valuable role in supporting NCD management in LMICs.

Trial registration number

NCT02549495.

Inhibition of Endothelin system during the postnatal nephrogenic period in the rat. Its relationship with hypertension and renal disease in adulthood

by María Florencia Albertoni Borghese, María del Carmen Ortiz, Rocío C. Marinoni, Lucas H. Oronel, Milena Palamidessi, Carolina A. Yarza, Nicolás Di Siervi, Carlos Davio, Mónica P. Majowicz

The aim of this work was to study the effect of a high sodium (HS) diet on blood pressure and renal function in male adult rats that have been treated with a dual Endothelin receptor antagonist (ERA) during their early postnatal period (day 1 to 20 of life). Male Sprague-Dawley rats were divided in four groups: CNS: control rats with normosodic diet; ERANS: ERA-treated rats with normosodic diet; CHS: control rats with high sodium diet; ERAHS: ERA-treated rats with HS diet. Systolic blood pressure (SBP) was recorded before and after the diet and 24-hour metabolic cage studies were performed. AQP2 and α-ENac expressions were measured by western blot and real time PCR in the renal medulla. Vasopressin (AVP) pathway was evaluated by measuring V2 receptor and adenylyl cyclase 6 (AC6) expression and cAMP production in the renal medulla. Pre-pro ET-1mRNA was also evaluated in the renal medulla. Only rats that had been treated with an ERA during their postnatal period increased their SBP after consumption of a HS diet, showing an impaired capacity to excrete sodium and water, i.e. developing salt sensitivity. This salt sensitivity would be mediated by an increase in renomedullary expression and activity of AQP2 and α-ENaC as a consequence of increased AC6 expression and cAMP production and/or a decreased ET-1 production in the renal medulla. The knowledge of the molecular mechanisms underlying the perinatal programming of salt sensitive hypertension will allow the development of reprogramming strategies in order to avoid this pathology.

'Ive always done what I was told by the medical people: a qualitative study of the reasons why older adults attend multifactorial falls risk assessments mapped to the Theoretical Domains Framework

Por: Racine · E. · Soye · A. · Barry · P. · Cronin · F. · Hosford · O. · Moriarty · E. · OConnor · K. A. · Turvey · S. · Timmons · S. · Kearney · P. M. · McHugh · S. M.
Objectives

Multifactorial falls risk assessments reduce the rate of falls in older people and are recommended by international guidelines. Despite their effectiveness, their potential impact is often constrained by barriers to implementation. Attendance is an issue. The aim of this study was to explore why older people attend community-based multifactorial falls risk assessment clinics, and to map these reasons to a theoretical framework.

Design

This is a qualitative study. Semi-structured interviews were conducted and analysed thematically. Each theme and subtheme were then mapped onto the Theoretical Domains Framework (TDF) to identify the determinants of behaviour.

Participants

Older adults (aged 60 and over) who attended community-based multifactorial falls risk assessments.

Results

Sixteen interviews were conducted. Three main themes explained participants’ reasons for attending the multifactorial risk assessment; being that ‘type of person’, being ‘linked in’ with health and community services and having ‘strong social support’. Six other themes were identified, but these themes were not as prominent during interviews. These were knowing what to expect, being physically able, having confidence in and being positive towards health services, imagining the benefits given previous positive experiences, determination to maintain or regain independence, and being ‘crippled’ by the fear of falling. These themes mapped on to nine TDF domains: ‘knowledge’, ‘skills’, ‘social role and identity’, ‘optimism’, ‘beliefs about consequences’, ‘goals’, ‘environmental context and resources’, ‘social influences’ and ‘emotion’. There were five TDF domains that were not relevant to the reasons for attending.

Conclusions

These findings provide theoretically based factors that influence attendance which can be used to inform the development of interventions to improve attendance to falls prevention programmes.

Acute rule-out of non-ST-segment elevation acute coronary syndrome in the (pre)hospital setting by HEART score assessment and a single point-of-care troponin: rationale and design of the ARTICA randomised trial

Por: Aarts · G. W. A. · Camaro · C. · van Geuns · R.-J. · Cramer · E. · van Kimmenade · R. R. J. · Damman · P. · van Grunsven · P. M. · Adang · E. · Giesen · P. · Rutten · M. · Ouwendijk · O. · Gomes · M. E. R. · van Royen · N.
Introduction

Because of the lack of prehospital protocols to rule out a non-ST-segment elevation acute coronary syndrome (NSTE-ACS), patients with chest pain are often transferred to the emergency department (ED) for thorough evaluation. However, in low-risk patients, an ACS is rarely found, resulting in unnecessary healthcare consumption. Using the HEART (History, ECG, Age, Risk factors and Troponin) score, low-risk patients are easily identified. When a point-of-care (POC) troponin measurement is included in the HEART score, an ACS can adequately be ruled out in low-risk patients in the prehospital setting. However, it remains unclear whether a prehospital rule-out strategy using the HEART score and a POC troponin measurement in patients with suspected NSTE-ACS is cost-effective.

Methods and analysis

The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) presentation at the ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value. In total, 866 patients will be included. Follow-up will be performed after 30 days, 6 months and 12 months.

Ethics and dissemination

This trial has been accepted by the Medical Research Ethics Committee region Arnhem-Nijmegen. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses.

Trial registration number

Netherlands Trial Register (NL7148).

Front‐line nurses' perceptions of intra‐hospital handover

Abstract

Aim and objective

To explore nurses' perceptions of factors that help or hinder intra‐hospital handover.

Background

Miscommunication during clinical handover is a leading cause of clinical incidents in hospitals. Intra‐hospital nursing handover between the emergency department and inpatient unit is particularly complex.

Design

A descriptive, qualitative study. This research adheres to the consolidated criteria for reporting qualitative research.

Methods

Forty‐nine nurses participated in group interviews, which were analysed using inductive content analysis.

Results

Three categories emerged: (a) “lacking clear responsibilities for who provides handover”; (b) “strategies to ensure continuity of information”; and (c) “strained relationships during handover.”

Conclusions

Intra‐hospital handover requires clear processes, to promote high‐quality information sharing. Ensuring these processes are broad and acceptable across units may ensure nurses' needs are met. Relational continuity between nurses is an important consideration when improving intra‐hospital handover.

Relevance to clinical practice

Nursing managers are optimally positioned to enhance intra‐hospital handover, by liaising and enforcing standardisation of processes across units. Nurse managers could promote intra‐unit activities that foster front‐line nurses' communication with each other, to encourage problem‐solving and partnerships.

Uptake of best practice recommendations in the management of patients with diabetes and periodontitis: a cross-sectional survey of healthcare professionals in primary care

Por: Bissett · S. M. · Rapley · T. · Preshaw · P. M. · Presseau · J.
Objectives

To investigate the practices of healthcare professionals in relation to best practice recommendations for the multidisciplinary management of people with diabetes and periodontitis, focusing on two clinical behaviours: informing patients about the links between diabetes and periodontitis, and suggesting patients with poorly controlled diabetes go for a dental check-up.

Design

Cross-sectional design utilising online questionnaires to assess self-reported performance and constructs from Social Cognitive Theory (SCT) and Normalisation Process Theory.

Setting

Primary care medical practices (n=37) in North East, North Cumbria and South West of England Clinical Research Networks.

Participants

96 general practitioners (GPs), 48 nurses and 21 healthcare assistants (HCAs).

Results

Participants reported little to no informing patients about the links between diabetes and periodontitis or suggesting that they go for a dental check-up. Regarding future intent, both GPs (7.60±3.38) and nurses (7.94±3.69) scored significantly higher than HCAs (4.29±5.07) for SCT proximal goals (intention) in relation to informing patients about the links (p

Conclusions

Despite evidence-informed best practice recommendations, healthcare professionals currently report low levels of informing patients with diabetes about the links between diabetes and periodontitis and suggesting patients go for a dental check-up. However, healthcare professionals, particularly nurses, value these behaviours and consider them appropriate to their role. While knowledge of the evidence is important, future guidelines should consider different strategies to enable implementation of the delivery of healthcare interventions.

Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study

Por: Volf · C. · Aggestrup · A. S. · Petersen · P. M. · Dam-Hansen · C. · Knorr · U. · Petersen · E. E. · Engstrom · J. · Jakobsen · J. C. · Hansen · T. S. · Madsen · H. O. · Hageman · I. · Martiny · K.
Introduction

Retrospective studies conducted in psychiatric inpatient wards have shown a relation between the intensity of daylight in patient rooms and the length of stay, pointing to an antidepressant effect of ambient lighting conditions. Light therapy has shown a promising antidepressant effect when administered from a light box. The emergence of light-emitting diode (LED) technology has made it possible to build luminaires into rooms and to dynamically mimic the spectral and temporal distribution of daylight. The objective of this study is to investigate the antidepressant efficacy of a newly developed dynamic LED-lighting system installed in an inpatient ward.

Methods and analysis

In all, 150 inpatients with a major depressive episode, as part of either a major depressive disorder or as part of a bipolar disorder, will be included. The design is a two-arm 1:1 randomised study with a dynamic LED-lighting arm and a static LED-lighting arm, both as add-on to usual treatment in an inpatient psychiatric ward. The primary outcome is the baseline adjusted score on the 6-item Hamilton Depression Rating Scale at week 3. The secondary outcomes are the mean score on the Suicidal Ideation Attributes Scale at week 3, the mean score on the 17-item Hamilton Depression Rating Scale at week 3 and the mean score on the World Health Organisation Quality of Life-BREF (WHOQOL-BREF) at week 3. The spectral distribution of daylight and LED-light, with a specific focus on light mediated through the intrinsically photosensitive retinal ganglion cells, will be measured. Use of light luminaires will be logged. Assessors of Hamilton Depression Rating Scale scores and data analysts will be blinded for treatment allocation. The study was initiated in May 2019 and will end in December 2021.

Ethics and dissemination

No ethical issues are expected. Results will be published in peer-reviewed journals, disseminated electronically and in print and presented at symposia.

Trial registration number

NCT03821506; Pre-results.

Prevalence and characteristics of polycystic ovary syndrome in Brazilian women: protocol for a nation-wide case-control study

Por: Spritzer · P. M. · Marchesan · L. B. · Santos · B. R. · Cureau · F. V. · Oppermann · K. · Reis · R. M. d. · Ferriani · R. A. · Weiss · R. · Meirelles · R. · Candido · A. L. · Reis · F. M. · Brazilian PCOS Network · Rocha · Baracat · Maciel · Soares · Filho · Gemelli · Soares Junior
Introduction

Brazil is a large country, with a population of mixed ethnic background and broad variation in dietary and physical activity traits across its five main regions. Because data on Brazilian women with polycystic ovary syndrome (PCOS) are still scarce, a nation-wide collaborative study was designed to determine the prevalence of metabolic and reproductive abnormalities and the presence of anxiety and depression in Brazilian women with PCOS. In addition, the study aims at describing how these characteristics are distributed across PCOS phenotypes and at detecting associations with regional demographic and lifestyle aspects, genetic variants, and epigenetic markers.

Methods and analysis

The Brazilian PCOS study is being conducted in the outpatient clinics of eight university hospitals within the public healthcare network (Unified Health System) across the country. Additional centres will be included following completion of the research ethics approval process. The sample includes women with PCOS according to Rotterdam criteria at inclusion in the study and a control group of healthy women matched by age, socioeconomic status and geographical region. Data will be collected in each centre and incorporated into a unified cloud database. Clinical, demographic, socioeconomic, psychological, metabolic, epigenetic and genotypic variables will be evaluated. The data resulting from this study will be useful to guide specific public strategies for primary and secondary prevention of metabolic and reproductive comorbidities in the PCOS population of Brazil.

Ethics and dissemination

The study protocol was approved by each local Research Ethics Committee. Written informed consent will be obtained from each participant. During data collection, analysis and publication, care will be taken to ensure confidentiality of participant information. Study results will be published in peer-reviewed journals and disseminated at international conferences. This research protocol was registered with the Research Ethics Committee of HCPA, through Plataforma Brasil.

Trial registration number

CAAE 18082413.9.1001.5327

Primary appendicular soft‐tissue sarcoma resection: What tumour parameters affect wound closure planning?

Abstract

Wound closure after wide, local excision of an appendicular soft‐tissue sarcoma (STS) can be challenging. This study evaluates the value of magnetic resonance imaging (MRI)‐based tumour parameters in planning wound closure. A total of 71 patients with a primary limb‐based STS, excluding vascular or osseous involvement, excluding the shoulder or hand and hip or foot were included. Axial MRI images were used to measure the circumferences and cross‐sectional areas of the limb, bone, and tumour. The tumour diameter, length, and depth at the level of maximal tumour dimension were measured to identify the tumour's relative contribution to the planning of optimal wound closure management through primary closure (PC) or reconstructive surgery (RS). Eighteen patients required planned wound RS. Wound complications occurred in 14% overall. Tumours, which were closed by PC, were of significantly greater depth, shorter radial diameter, and shorter tumour circumference relative to those closed by RS. On multivariate analysis, tumour depth was the greatest contributory factor in predicting type of wound closure. A quantitative analysis of MRI‐based tumour parameters demonstrates tumour depth as the most predictive factor in planning for the type of wound closure and may prove beneficial in providing greater insight into planned wound management of sarcoma resection.

Association between carotid intima-media thickness and bone mineral density: a cross-sectional study in Vietnamese men and women aged 50 years and older

Por: Nguyen · L. T. · Pham · V. N. · Chau · P. M. N. · Ho-Pham · L. T. · Nguyen · T. V.
Objectives

The association between osteoporosis and atherosclerosis remains controversial. We sought to define the relationship between carotid intima-media thickness and bone mineral density (BMD) in individuals of Vietnamese background.

Design and setting

Cross-sectional study in Ho Chi Minh City, Vietnam.

Participants

The study involved 1460 individuals (559 men) aged 50 years and older (average age 59 years) who were randomly recruited from the community.

Outcome measures

BMD at the femoral neck and lumbar spine was measured by dual-energy X-ray absorptiometry (Hologic, Waltham, Massachusetts, USA). Carotid intima-media thickness (cIMT) was measured using a Philips Ultrasonography (HD7XE). The presence of atherosclerotic plaque was ascertained for each individual. The association between cIMT and BMD was analysed by a multiple linear regression model.

Results

In unadjusted analysis, cIMT was positively associated with femoral neck BMD in men (p=0.005), but not in women (p=0.242). After adjusting for age, smoking, diabetes and hypertension, the association remained statistically significant in men (partial R2=0.005; p=0.015) but not in women (partial R2=0.008; p=0.369). When the analysis was limited to individuals aged 60 years and older, the association between cIMT and BMD was no longer statistically significant. There was no statistically significant association between cIMT and lumbar spine BMD in either men or women.

Conclusions

In Vietnamese individuals aged 50 years and older, there is a clinically non-significant but statistically significant association between carotid intima-media thickness and BMD in men, not in women.

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