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Prospective meta-analysis protocol on randomised trials of renin-angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension

Por: Gnanenthiran · S. R. · Borghi · C. · Burger · D. · Charchar · F. · Poulter · N. R. · Schlaich · M. P. · Steckelings · U. M. · Stergiou · G. · Tomaszewski · M. · Unger · T. · Wainford · R. D. · Williams · B. · Rodgers · A. · Schutte · A. E.
Introduction

Whether ACE inhibitors (ACEi) or angiotensin II receptor blocker (ARB) therapy should be continued, initiated or ceased in patients with COVID-19 is uncertain. Given the widespread use of ACEi/ARBs worldwide, guidance on the use of these drugs is urgently needed. This prospective meta-analysis aims to pool data from randomised controlled trials (RCTs) to assess the safety and efficacy of ACEi/ARB therapy in adults infected with SARS-CoV-2.

Methods and analysis

RCTs will be eligible if they compare patients with COVID-19 randomised to ACEi/ARB continuation or commencement versuss no ACEi/ARB therapy; study duration ≥14 days; recruitment completed between March 2020 and May 2021. The primary outcome will be all-cause mortality at ≤30 days. Secondary outcomes will include mechanical ventilation, admission to intensive care or cardiovascular events at short-term follow-up (≤30 days) and all-cause mortality at longer-term follow-up (>1 month). Prespecified subgroup analyses will assess the effect of sex; age; comorbidities; smoking status; ethnicity; country of origin on all-cause mortality. A search of ClinicalTrials.gov has been performed, which will be followed by a formal search of trial registers, preprint servers, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials to identify RCTs that meet inclusion criteria. To date, a search of ClinicalTrials.gov identified 21 potentially eligible trials for this meta-analysis. We will request trial investigators/sponsors to contribute standardised grouped tabular outcome data.

Ethics and dissemination

Ethics approval and informed consent will be the responsibility of the individual RCTs. Dissemination of results will occur by peer-reviewed publication. The results of our analysis can inform public health policy and clinical decision making regarding ACEi/ARB use in patients with COVID-19 on a global scale.

Prescribing patterns for medical treatment of suspected prostatic obstruction: a longitudinal register-based study of the Scottish Health and Social Care Open Data

Por: Andreis · F. · Bryant · R. · Giorgi · E. · Williamson · A. E. · Ward · A.
Background

The diagnosis of lower urinary tract symptoms related to suspected bladder outflow obstruction from benign prostate hyperplasia/enlargement in men is increasing. This is leading to high demand on healthcare services; however, there is limited knowledge of differences in pharmacotherapy prescribing for this condition based on geography.

Objective

To investigate potential variation in drug prescribing for suspected bladder outflow obstruction in Scotland, based on analysis of publicly available data, to identify trends and inform future prescribing.

Study design

A longitudinal register-based data study of prescribing and patient data publicly available from Scottish registries. All information is available as monthly aggregates at the level of single general practices.

Setting and participants

903 (97%) general practices in Scotland, over a 50-month period (October 2015 to November 2019).

Outcome measurements and statistical analysis

We analysed numbers of daily doses of drugs for suspected bladder outflow obstruction prescribed per month using a Bayesian Poisson regression analysis, incorporating random effects to account for spatial and temporal elements.

Results

Prescriptions for suspected bladder outflow obstruction medications increased during the observation period (overall average rate of change 1.24±0.28, ranging from 0.893 in Orkney to 1.95 in Lanarkshire). While some determinants of health inequality regarding prescribing practices across health boards are consistent with those known from the literature, other inequalities remain unexplained after accounting for practice-specific and patient-specific characteristics such as deprivation and rurality.

Conclusions

Inequalities in prescribing for suspected bladder outflow obstruction medications exist in Scotland, partially ascribable to accepted sociodemographic and geographic factors.

Rates and risk factors for suicidal ideation, suicide attempts and suicide deaths in persons with HIV: a protocol for a systematic review and meta-analysis

Por: Wisnousky · H. · Lazzara · N. · Ciarletta · M. · Pelton · M. · Chinchilli · V. M. · Ssentongo · A. E. · Ssentongo · P.
Introduction

The prevalence of HIV/AIDS is high and is associated with psychiatric morbidity and suicide risk. The objective of this study will be to assess the rates of suicidal ideation, suicide attempts and suicide deaths in people living with HIV/AIDS (PLWHA).

Methods and analysis

We present a study protocol for a systematic review and meta-analysis of studies reporting the suicidality outcomes (suicidal ideation, suicide attempts and suicide deaths) in PLWHA. PubMed (MEDLINE), Scopus, EMBASE, Cochrane Library, OVID (HEALTH STAR), OVID (MEDLINE), Joanna Briggs Institute EBP Database, Web of Science and PsychINFO databases will be searched from their inception until 1 January 2020. The primary outcome of interest will be the incidence of suicidality in PLWHA. In addition, we will delineate risk factors associated with suicidality in PLWHA. Citations, full-text articles and abstracts will be screened by four reviewers independently. Disagreements will be resolved through discussion. The study methodological quality (or bias) will be appraised using an appropriate tool. Random-effects meta-analysis will be conducted if we find that the studies are very heterogenous. For the suicidality outcome, probability of suicide risk will be reported. Relative risk ratios (with 95% CIs) will be reported for the effects of the risk factors. Potential publication bias will be assessed by conducting Egger’s test and creating funnel plots. We will conduct additional analyses to explore the potential sources of heterogeneity (eg, age, sex and geographical location).

Ethics and dissemination

No ethics clearance is required as no primary data will be collected. The results of this systematic review and meta-analysis will be presented at scientific conferences and published in a peer-reviewed journal. The results may inform clinical management of PLWHA and may guide future population-specific interventions.

We will search PubMed (MEDLINE), Scopus, EMBASE, Cochrane Library, OVID (HEALTH STAR), OVID (MEDLINE), Joanna Briggs Institute EBP Database, Web of Science and PsychINFO from their inception until 1 January 2020.

PROSPERO registration number

CRD42020161501.

How many people will need palliative care in Scotland by 2040? A mixed-method study of projected palliative care need and recommendations for service delivery

Por: Finucane · A. M. · Bone · A. E. · Etkind · S. · Carr · D. · Meade · R. · Munoz-Arroyo · R. · Moine · S. · Iyayi-Igbinovia · A. · Evans · C. J. · Higginson · I. J. · Murray · S. A.
Objective

To estimate future palliative care need and complexity of need in Scotland, and to identify priorities for future service delivery.

Design

We estimated the prevalence of palliative care need by analysing the proportion of deaths from defined chronic progressive illnesses. We described linear projections up to 2040 using national death registry data and official mortality forecasts. An expert consultation and subsequent online consensus survey generated recommendations on meeting future palliative care need.

Setting

Scotland, population of 5.4 million.

Participants

All decedents in Scotland over 11 years (2007 to 2017). The consultation had 34 participants; 24 completed the consensus survey.

Primary and secondary outcomes

Estimates of past and future palliative care need in Scotland from 2007 up to 2040. Multimorbidity was operationalised as two or more registered causes of death from different disease groups (cancer, organ failure, dementia, other). Consultation and survey data were analysed descriptively.

Results

We project that by 2040, the number of people requiring palliative care will increase by at least 14%; and by 20% if we factor in multimorbidity. The number of people dying from multiple diseases associated with different disease groups is projected to increase from 27% of all deaths in 2017 to 43% by 2040. To address increased need and complexity, experts prioritised sustained investment in a national digital platform, roll-out of integrated electronic health and social care records; and approaches that remain person-centred.

Conclusions

By 2040 more people in Scotland are projected to die with palliative care needs, and the complexity of need will increase markedly. Service delivery models must adapt to serve growing demand and complexity associated with dying from multiple diseases from different disease groups. We need sustained investment in secure, accessible, integrated and person-centred health and social care digital systems, to improve care coordination and optimise palliative care for people across care settings.

College suicide prevention programmes are most effective when they incorporate students sense of coherence and connectedness in their design

Por: Ghassemi · A. E.

Commentary on: Blasco MJ, Vilagut G, Alayo I, et al. First-onset and persistence of suicidal ideation in university students: a one-year follow-up study. J Affect Disord 2019;256:192–204.

Implications for practice and research

  • Planning strategies for both detection and interventions among students with suicidal ideation to decrease severe suicidal thoughts and behaviours.

  • Creating universal strategies for promoting a sense of membership and connectedness will prevent suicide among first-year college students.

  • Context

    Based on the current evidence suicidal thoughts and behaviour (STB) among university students has shown steady incline. Suicide is the second worldwide cause of death for those between ages 15 and 29.1 Suicidal behaviour (ideation, plan, attempt) has been linked to and stressors such as moving away from established social network, social isolation, issues of sexual identity, and academic and social challenges.2 Considering the significance of the problem, a number...

    Zika virus infection in pregnancy: a protocol for the joint analysis of the prospective cohort studies of the ZIKAlliance, ZikaPLAN and ZIKAction consortia

    Por: Ades · A. E. · Brickley · E. B. · Alexander · N. · Brown · D. · Jaenisch · T. · Miranda-Filho · D. d. B. · Pohl · M. · Rosenberger · K. D. · Soriano-Arandes · A. · Thorne · C. · Ximenes · R. A. d. A. · de Araujo · T. V. B. · Avelino-Silva · V. I. · Bethencourt Castillo · S. E. · Bo
    Introduction

    Zika virus (ZIKV) infection in pregnancy has been associated with microcephaly and severe neurological damage to the fetus. Our aim is to document the risks of adverse pregnancy and birth outcomes and the prevalence of laboratory markers of congenital infection in deliveries to women experiencing ZIKV infection during pregnancy, using data from European Commission-funded prospective cohort studies in 20 centres in 11 countries across Latin America and the Caribbean.

    Methods and analysis

    We will carry out a centre-by-centre analysis of the risks of adverse pregnancy and birth outcomes, comparing women with confirmed and suspected ZIKV infection in pregnancy to those with no evidence of infection in pregnancy. We will document the proportion of deliveries in which laboratory markers of congenital infection were present. Finally, we will investigate the associations of trimester of maternal infection in pregnancy, presence or absence of maternal symptoms of acute ZIKV infection and previous flavivirus infections with adverse outcomes and with markers of congenital infection. Centre-specific estimates will be pooled using a two-stage approach.

    Ethics and dissemination

    Ethical approval was obtained at each centre. Findings will be presented at international conferences and published in peer-reviewed open access journals and discussed with local public health officials and representatives of the national Ministries of Health, Pan American Health Organization and WHO involved with ZIKV prevention and control activities.

    Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial

    Por: Holland · A. E. · Corte · T. · Chambers · D. C. · Palmer · A. J. · Ekström · M. P. · Glaspole · I. · Goh · N. S. L. · Hepworth · G. · Khor · Y. H. · Hoffman · M. · Vlahos · R. · Sköld · M. · Dowman · L. · Troy · L. K. · Prasad · J. D. · Walsh · J. · McDonald · C. F.
    Introduction

    Interstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation.

    Methods and analysis

    A randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King’s Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken.

    Ethics and dissemination

    Ethical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences.

    Trial registration number

    ClinicalTrials.gov Registry (NCT03737409).

    Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study

    Por: Sherif · A. E. · McFadyen · R. · Boyd · J. · Ventre · C. · Glenwright · M. · Walker · K. · Zheng · X. · White · A. · McFadyen · L. · Connon · E. · Damaskos · D. · Steven · M. · Wackett · A. · Thomson · E. · Cameron · D. C. · MacLeod · J. · Baxter · S. · Semple · S. · Morris · D. · Clark-Stew
    Introduction

    Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared with the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP.

    Methods and analysis

    This is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus and quality of life. Recruitment was from 30 November 2017 to 31 May 2020; last follow-up measurements is due on 31 May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, Gastrointestinal Quality of Life Index); montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis.

    Ethics and dissemination

    This study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access.

    Trial registration numbers

    ClinicalTrials.gov Registry (NCT03342716) and ISRCTN50581876; Pre-results.

    Systematic review of international Delphi surveys for core outcome set development: representation of international patients

    Por: Lee · A. · Davies · A. · Young · A. E.
    Objectives

    A core outcome set (COS) describes a minimum set of outcomes to be reported by all clinical trials of one healthcare condition. Delphi surveys are frequently used to achieve consensus on core outcomes. International input is important to achieve global COS uptake. We aimed to investigate participant representation in international Delphi surveys, with reference to the inclusion of patients and participants from low and middle income countries as stakeholders (LMICs).

    Design

    Systematic review.

    Data sources

    EMBASE, Medline, Web of Science, COMET database and hand-searching.

    Eligibility criteria

    Protocols and studies describing Delphi surveys used to develop an international COS for trial reporting, published between 1 January 2017 and 6 June 2019.

    Data extraction and synthesis

    Delphi participants were grouped as patients or healthcare professionals (HCPs). Participants were considered international if their country of origin was different to that of the first or senior author. Data extraction included participant numbers, country of origin, country income group and whether Delphi surveys were translated. We analysed the impact these factors had on outcome prioritisation.

    Results

    Of 90 included studies, 69% (n=62) were completed and 31% (n=28) were protocols. Studies recruited more HCPs than patients (median 60 (IQR 30–113) vs 30 (IQR 14–66) participants, respectively). A higher percentage of HCPs was international compared with patients (57% (IQR 37–78) vs 20% (IQR 0–68)). Only 31% (n=28) studies recruited participants from LMICs. Regarding recruitment from LMICs, patients were under-represented (16% studies; n=8) compared with HCPs (22%; n=28). Few (7%; n=6) studies translated Delphi surveys. Only 3% studies (n=3) analysed Delphi responses by geographical location; all found differences in outcome prioritisation.

    Conclusions

    There is a disproportionately lower inclusion of international patients, compared with HCPs, in COS-development Delphi surveys, particularly within LMICs. Future international Delphi surveys should consider exploring for geographical and income-based differences in outcome prioritisation.

    PROSPERO registration number

    CRD42019138519.

    Prevalence of general and abdominal obesity in 2015-2016 and 8-year longitudinal weight and waist circumference changes in adults and elderly: the Tromso Study

    Por: Lovsletten · O. · Jacobsen · B. K. · Grimsgaard · S. · Njolstad · I. · Wilsgaard · T. · Lochen · M.-L. · Eggen · A. E. · Hopstock · L. A.
    Objectives

    To describe the prevalence of general (body mass index (BMI) ≥30 kg/m2) and abdominal (waist circumference women >88 cm, men >102 cm) obesity in Tromsø 7 (2015–2016), and the secular change from Tromsø 6 (2007–2008). Furthermore, to study longitudinal changes in body weight and waist circumference from Tromsø 6 to Tromsø 7.

    Setting

    A population study in Tromsø, Norway.

    Participants

    The cross-sectional analyses included 20 855 participants in Tromsø 7 (aged ≥40 years) and 12 868 in Tromsø 6 (aged ≥30 years). The longitudinal analyses included 8592 participants with repeated measurements, aged 35–79 in Tromsø 6.

    Outcome measures

    Mean age-specific and sex-specific BMI, waist circumference, prevalence of general and abdominal overweight and obesity, as well as longitudinal changes in body weight and waist circumference according to sex and birth cohort.

    Results

    Over 8 years, the age-adjusted prevalence of general obesity increased (p

    Conclusions

    Repeated cross-sectional analyses showed that the prevalence of general obesity increased, whereas the increase in abdominal obesity was less marked. Longitudinal analyses showed increases in both body weight and waist circumference. The youngest age groups have the largest increase.

    Study protocol for a multicentre implementation trial of monotherapy anticoagulation to expedite home treatment of patients diagnosed with venous thromboembolism in the emergency department

    Por: Kline · J. · Adler · D. · Alanis · N. · Bledsoe · J. · Courtney · D. · D'Etienne · J. · B Diercks · D. · Garrett · J. · Jones · A. E. · MacKenzie · D. · Madsen · T. · Matuskowitz · A. · Mumma · B. · Nordenholz · K. · Pagenhardt · J. · Runyon · M. · Stubblefield · W. · Willoughby · C.
    Introduction

    In the USA, many emergency departments (EDs) have established protocols to treat patients with newly diagnosed deep vein thrombosis (DVT) as outpatients. Similar treatment of patients with pulmonary embolism (PE) has been proposed, but no large-scale study has been published to evaluate a comprehensive, integrated protocol that employs monotherapy anticoagulation to treat patients diagnosed with DVT and PE in the ED.

    Methods and analysis

    This protocol describes the implementation of the Monotherapy Anticoagulation To expedite Home treatment of Venous ThromboEmbolism (MATH-VTE) study at 33 hospitals in the USA. The study was designed and executed to meet the requirements for the Standards for Reporting Implementation Studies guideline. The study was funded by investigator-initiated awards from industry, with Indiana University as the sponsor. The study principal investigator and study associates travelled to each site to provide on-site training. The protocol identically screens patients with both DVT or PE to determine low risk of death using either the modified Hestia criteria or physician judgement plus a negative result from the simplified PE severity index. Patients must be discharged from the ED within 24 hours of triage and treated with either apixaban or rivaroxaban. Overall effectiveness is based upon the primary efficacy and safety outcomes of recurrent VTE and bleeding requiring hospitalisation respectively. Target enrolment of 1300 patients was estimated with efficacy success defined as the upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0%. Thirty-three hospitals in 17 states were initiated in 2016–2017.

    Ethics and dissemination

    All sites had Institutional Review Board approval. We anticipate completion of enrolment in June 2020; study data will be available after peer-reviewed publication. MATH-VTE will provide information from a large multicentre sample of US patients about the efficacy and safety of home treatment of VTE with monotherapy anticoagulation.

    HPV vaccination and Native Americans: protocol for a systematic review of factors associated with HPV vaccine uptake among American Indians and Alaska Natives in the USA

    Por: Gopalani · S. V. · Sedani · A. E. · Janitz · A. E. · Clifton · S. C. · Stoner · J. · Peck · J. · Comiford · A. · Salvatore · A. L. · Campbell · J.
    Introduction

    The nine-valent human papillomavirus (HPV) vaccine could prevent an estimated 92% of the cancers attributable to HPV types targeted by the vaccine. However, uptake of the HPV vaccine among American Indian and Alaska Native (AI/AN) adolescents has been low. AI/ANs also bear a disproportionate burden of cervical and other HPV-associated cancers. Increasing HPV vaccination rates is a national priority, but reviews and national surveys on HPV vaccination factors are lacking for the AI/AN population. The objective of this systematic review is to assess factors associated with HPV vaccination among AI/ANs in the USA.

    Methods and analysis

    A systematic review is proposed to synthesise the current literature on HPV vaccination factors in AI/ANs from 1 July 2006 until 30 September 2019. As applicable, controlled vocabulary terms, keywords and special features (eg, limits, explode and focus) will be incorporated into database searches. To maximise the identification of relevant studies, citation indexes and databases that index dissertations, preprints and grey literature are included. Studies will be screened and selected independently in two stages. In stage 1, titles and abstracts will be screened. In stage 2, full-text articles will be screened and selected. A data extraction form and quality assessment tool will be piloted, revised and implemented. If available, measures of frequency and association will be presented. A narrative synthesis of the included studies will also be undertaken and reported.

    Ethics and dissemination

    As our review will use publicly available data and publications, an Institutional Review Board review will not be required. We will disseminate the findings from this review through peer-reviewed publication(s) and conference presentation(s).

    Potential amendments

    In the event of amendments to the protocol, we will provide the date, rationale, and description of the change for each amendment.

    PROSPERO registration number

    CRD42020156865.

    Comparative CT with stress manoeuvres for diagnosing distal isolated tibiofibular syndesmotic injury in acute ankle sprain: a protocol for an accuracy- test prospective study

    Por: Rodrigues · J. C. · Santos · A. L. G. · Prado · M. P. · Alloza · J. F. M. · Masagao · R. A. · Rosemberg · L. A. · Barros · D. d. C. S. · Castro · A. d. A. e. · Demange · M. K. · Lenza · M. · Ferretti · M.
    Introduction

    Although several imaging options are available for diagnosing syndesmotic injury, a fundamental question that guides treatment remains unanswered. Syndesmotic instability is still challenging to diagnose correctly, and syndesmotic disruption and true syndesmotic instability should be differentiated. Currently, imaging tests quickly diagnose severe syndesmotic instability but have difficulty in diagnosing mild and moderate cases. This study aims to investigate which strategy among an existing CT index test and two new add-on CT index tests with stress manoeuvres more accurately diagnoses syndesmotic instability. The secondary objective is to investigate the participants’ disability outcomes by applying the Foot and Ankle Ability Measure questionnaire.

    Methods and analyses

    This study of a diagnostic accuracy test will consecutively select individuals older than 18 years with a clinical diagnosis of a suspected acute syndesmotic injury. Three strategies of the CT index test (one in the neutral position and two with stress) will examine the accuracy using MRI as the reference standard. The external rotation and dorsiflexion of the ankle will guide the stress manoeuvres. A comparison of measurements between the injured syndesmosis and the uninjured contralateral side of the same individual will investigate the syndesmotic instability, by evaluating the rotational and translational relationships between the fibula and tibia. Sensitivity, specificity, area under the receiver operating characteristic curve and likelihood analyses will compare the diagnostic accuracies of the strategies.

    Ethics and dissemination

    The Internal Review Board and the Einstein Ethics Committee approved this study (registered number 62100016.5.0000.0071). All participants will receive an oral description of the study’s aim, and the choice to participate will be free and voluntary. Participants will be enrolled after they sign the written informed consent form, including the terms of confidentiality. The results will be presented at national and international conferences and published in peer-reviewed journals and social media.

    Trial registration number

    ClinicalTrials.gov Registry (NCT04095598; preresults).

    Do sex differences in the prevalence of ECG abnormalities vary across ethnic groups living in the Netherlands? A cross-sectional analysis of the population-based HELIUS study

    Por: Bolijn · R. · ter Haar · C. C. · Harskamp · R. E. · Tan · H. L. · Kors · J. A. · Postema · P. G. · Snijder · M. B. · Peters · R. J. G. · Kunst · A. E. · van Valkengoed · I. G. M.
    Objectives

    Major ECG abnormalities have been associated with increased risk of cardiovascular disease (CVD) burden in asymptomatic populations. However, sex differences in occurrence of major ECG abnormalities have been poorly studied, particularly across ethnic groups. The objectives were to investigate (1) sex differences in the prevalence of major and, as a secondary outcome, minor ECG abnormalities, (2) whether patterns of sex differences varied across ethnic groups, by age and (3) to what extent conventional cardiovascular risk factors contributed to observed sex differences.

    Design

    Cross-sectional analysis of population-based study.

    Setting

    Multi-ethnic, population-based Healthy Life in an Urban Setting cohort, Amsterdam, the Netherlands.

    Participants

    8089 men and 11 369 women of Dutch, South-Asian Surinamese, African Surinamese, Ghanaian, Turkish and Moroccan origin aged 18–70 years without CVD.

    Outcome measures

    Age-adjusted and multivariable logistic regression analyses were performed to study sex differences in prevalence of major and, as secondary outcome, minor ECG abnormalities in the overall population, across ethnic groups and by age-groups (18–35, 36–50 and >50 years).

    Results

    Major and minor ECG abnormalities were less prevalent in women than men (4.6% vs 6.6% and 23.8% vs 39.8%, respectively). After adjustment for conventional risk factors, sex differences in major abnormalities were smaller in ethnic minority groups (OR ranged from 0.61 in Moroccans to 1.32 in South-Asian Surinamese) than in the Dutch (OR 0.49; 95% CI 0.36 to 0.65). Only in South-Asian Surinamese, women did not have a lower odds than men (OR 1.32; 95% CI 0.96 to 1.84). The pattern of smaller sex differences in ethnic minority groups was more pronounced in older than in younger age-groups.

    Conclusions

    The prevalence of major ECG abnormalities was lower in women than men. However, sex differences were less apparent in ethnic minority groups. Conventional risk factors did not contribute substantially to observed sex differences.

    Newborn signal functions in Bangladesh: identification through expert consultation and assessment of readiness among public health facilities--study protocol using Delphi technique

    Por: Rahman · A. E. · Banik · G. · Mhajabin · S. · Tahsina · T. · Islam · M. J. · Uddin Ahmed · F. · Islam · M. U. · Mannan · M. A. · Dey · S. K. · Sharmin · S. · Mehran · F. · Khan · M. · Ahmed · A. · Al Sabir · A. · Sultana · S. · Ahsan · Z. · Rubayet · S. · George · J. · Karim · A. · Shahidull
    Introduction

    There is a set of globally accepted and nationally adapted signal functions for categorising health facilities for maternal services. Newborn resuscitation is the only newborn intervention which is included in the WHO recommended list of emergency obstetric care signal functions. This is not enough to comprehensively assess the readiness of a health facility for providing newborn services. In order to address the major causes of newborn death, the Government of Bangladesh has prioritised a set of newborn interventions for national scale-up, the majority of which are facility-based. Effective delivery of these interventions depends on a core set of functions (skills and services). However, there is no standardised and approved set of newborn signal functions (NSFs) based on which the service availability and readiness of a health facility can be assessed for providing newborn services. Thus, this study will be the first of its kind to identify such NSFs. These NSFs can categorise health facilities and assist policymakers and health managers to appropriately plan and adequately monitor the progress and performance of health facilities delivering newborn healthcare.

    Methods and analysis

    We will adopt the Delphi technique of consensus building for identification of NSFs and 1–2 indicator for each function while employing expert consultation from relevant experts in Bangladesh. Based on the identified NSFs and signal function indicators, the existing health facility assessment (HFA) tools will be updated, and an HFA survey will be conducted to assess service availability and readiness of public health facilities in relation to the new NSFs. Descriptive statistics (proportion) with a 95% CI will be used to report the level of service availability and readiness of public facilities regarding NSFs.

    Ethics and dissemination

    Ethical approval was obtained from Research Review and Ethical Review Committee of icddr, b (PR-17089). Results will be disseminated through meetings, seminars, conference presentations and international peer-review journal articles.

    ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder

    Por: Whittingham · K. · McGlade · A. · Kulasinghe · K. · Mitchell · A. E. · Heussler · H. · Boyd · R. N.
    Introduction

    Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with impacts on behaviour, cognition, communication, social interaction and family mental health. This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.

    Methods and analysis

    We aim to recruit 66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT. Families will be randomly assigned to care-as-usual or ENACT. ENACT is a very early intervention, leveraging parent–child interactions to improve early social reciprocity, while supporting parental mental health and the parent–child relationship through Acceptance and Commitment Therapy. Intervention content is delivered online (approximately 8 hours) and supported by more than 7 consultations with a clinician. Parents will perform the social reciprocity intervention with their child (30 min per day). Assessments at four time points (baseline, 3 months, 6 months, and 12 months corrected age) will assess parent–infant interaction, parental mental health, infant development and early ASD markers. Analysis will be by intention to treat using general linear models for RCTs.

    Ethics and dissemination

    This protocol has been approved by the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/50131) and the University of Queensland Human Research Ethics Committee (2019000558). If efficacy is demonstrated, the intervention has the potential for wide and accessible dissemination.

    Trial registration number

    Australian New Zealand Clinical Trials Registry (ACTRN12618002046280).

    Efficacy of deep learning methods for predicting under-five mortality in 34 low-income and middle-income countries

    Por: Adegbosin · A. E. · Stantic · B. · Sun · J.
    Objectives

    To explore the efficacy of machine learning (ML) techniques in predicting under-five mortality (U5M) in low-income and middle-income countries (LMICs) and to identify significant predictors of U5M.

    Design

    This is a cross-sectional, proof-of-concept study.

    Settings and participants

    We analysed data from the Demographic and Health Survey. The data were drawn from 34 LMICs, comprising a total of n=1 520 018 children drawn from 956 995 unique households.

    Primary and secondary outcome measures

    The primary outcome measure was U5M; secondary outcome was comparing the efficacy of deep learning algorithms: deep neural network (DNN); convolution neural network (CNN); hybrid CNN-DNN with logistic regression (LR) for the prediction of child’s survival.

    Results

    We found that duration of breast feeding, number of antenatal visits, household wealth index, postnatal care and the level of maternal education are some of the most important predictors of U5M. We found that deep learning techniques are superior to LR for the classification of child survival: LR sensitivity=0.47, specificity=0.53; DNN sensitivity=0.69, specificity=0.83; CNN sensitivity=0.68, specificity=0.83; CNN-DNN sensitivity=0.71, specificity=0.83.

    Conclusion

    Our findings provide an understanding of determinants of U5M in LMICs. It also demonstrates that deep learning models are more efficacious than traditional analytical approach.

    How do healthcare professionals perceive physical activity prescription for community-dwelling people with COPD in Australia? A qualitative study

    Por: Lahham · A. · Burge · A. T. · McDonald · C. F. · Holland · A. E.
    Objectives

    Clinical practice guidelines recommend that people with chronic obstructive pulmonary disease (COPD) should be encouraged to increase their physical activity levels. However, it is not clear how these guidelines are applied in clinical practice. This study aimed to understand the perspectives of respiratory healthcare professionals on the provision of physical activity advice to people with COPD. These perspectives may shed light on the translation of physical activity recommendations into clinical practice.

    Design

    A qualitative study using thematic analysis.

    Setting

    Healthcare professionals who provided care for people with COPD at two major tertiary referral hospitals in Victoria, Australia.

    Participants

    30 respiratory healthcare professionals including 12 physicians, 10 physical therapists, 4 nurses and 4 exercise physiologists.

    Interventions

    Semistructured voice-recorded interviews were conducted, transcribed verbatim and analysed by two independent researchers using an inductive thematic analysis approach.

    Results

    Healthcare professionals acknowledged the importance of physical activity for people with COPD. They were conscious of low physical activity levels among such patients; however, few specifically addressed this in consultations. Physicians described limitations including time constraints, treatment prioritisation and perceived lack of expertise; they often preferred that physical therapists provide more comprehensive assessment and advice regarding physical activity. Healthcare professionals perceived that there were few evidence-based strategies to enhance physical activity. Physical activity was poorly differentiated from the prescription of structured exercise training. Although healthcare professionals were aware of physical activity guidelines, few were able to recall specific recommendations for people with COPD.

    Conclusion

    Practical strategies to enhance physical activity prescription may be required to encourage physical activity promotion in COPD care.

    Family members' prioritisation of care in residential aged care facilities: A case for individualised care

    Abstract

    Objectives

    To investigate family members' prioritisation of care in residential aged care facilities (RACFs).

    Introduction and background

    Family members are often involved in the care of their older relatives even after these relatives transit to a RACF. Understanding family members' priorities regarding care (i.e., what is most important to them) can provide valuable insights into how to better meet residents' needs.

    Design

    A multisite mixed‐methods study comprising qualitative methods and Q methodology. The qualitative component of the study was guided by the COREQ checklist.

    Methods

    Participants comprised 27 family members of residents living in one of five participating Australian RACFs. Participants rank‐ordered 34 cards, each representing an aspect of care, on a predefined grid from “Least important” (−4) to “Most important” (+4). Participants also engaged in a think‐aloud task, demographic questionnaire, post‐sorting interview and semi‐structured interview. Q data were analysed using inverted factor techniques to identify factors that each represent a portion of shared meaning. Factors were interpreted as viewpoints using data from the think‐aloud task and interviews. These data were further analysed using inductive content analysis to reveal influences on prioritisation decision‐making.

    Results

    Three distinct viewpoints were identified through Q methodology: prioritisation of residents' physical needs, maintaining residents' independence, and human connection. Inductive content analysis revealed four influences on prioritisation decision‐making: residents' capabilities and support requirements, unmet needs, family bridging the gaps, and family knowledge of residents.

    Conclusions

    The study indicated that to meet residents' needs and family members' priorities, individualised approaches to care are warranted. It also demonstrated the vital role family members play in residents' care when needs are not fully met.

    Relevance to Clinical Practice

    Strategies to improve individualised care in clinical practice include flexibility of routines, supporting family members' involvement in care, workforce training focused on family–staff communication, and safer staffing ratios.

    Autologous platelet‐rich plasma injection enhances healing of chronic venous leg ulcer: A prospective randomised study

    Abstract

    Our aim was to compare the efficacy and safety of platelet‐rich plasma (PRP) application versus PRP injection for chronic venous leg ulcer (VLU) healing compared with compression therapy as a control. From July 2018 to December 2019, 90 chronic VLU patients were randomly assigned to PRP dressings (n = 30), local PRP injections (n = 30), and compression therapy alone (n = 30). Standard compression accompanied both PRP groups. The main endpoints were ulcer healing and area reduction within 3, 6, and 12 months. Complications and ulcer recurrence were also recorded. The study included 72 (80.0%) males and 18 (20.0%) females aged 22 to 66 years, having VLUs for 1 to 11 years. PRP injection promoted healing (24/30, 80%) more than PRP application (20/30, 66.7%) and compression (14/30, 46.7%), P = .007. Healing time was significantly shorter after PRP injection compared with the other two groups. A greater area reduction was observed after PRP injection compared with compression at all follow‐up visits, P = .013, .002, and < .001, and compared with PRP application only at 3 months post‐treatment, P = .016. Recurrence and complications were comparable among the groups. PRP injection enhances the healing of chronic venous ulcers more than each of PRP application and compression therapy. All had comparable recurrence and safety.

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