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Prospective accuracy study on an artificial intelligence-based ultrasound system for gestational age estimation among pregnant women in Ghana, Kenya and South Africa: protocol

Por: Swarray Deen · A. · McDougall · A. R. A. · Chemway · R. · Craik · R. · Jayaratnam · S. · Joseph · N. · Mahar · R. · Koye · D. · Nguyen · L. · Simpson · J. · Gwako · G. · Hadebe · R. L. · Nartey · E. T. · Minckas · N. · Gülmezoglu · A. M. · Vogel · J. P. · Osman · A. · PEARLS Collaborat
Background

Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the ‘Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening’ (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.

Methods and analysis

This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11+0 to 13+6 weeks’ gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14+0 and 27+6 weeks’ gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11+0 to 13+6 weeks’).

Ethics and dissemination

This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024–28489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.

Evaluating cannabis-nicotine substitution and demand during nicotine cessation treatment in young adults: protocol for a prospective, remote 12-week nicotine cessation trial in the USA

Por: Dowd · A. N. · Baker · N. L. · Koffarnus · M. N. · Raiff · B. R. · Tomko · R. L. · Gray · K. M. · McClure · E. A.
Introduction

The co-use of nicotine/tobacco products and cannabis among young adults is prevalent, yet little is known regarding the treatment impact of co-use and the underlying relationship between substances. No prospective treatment studies to date have evaluated the impact of cannabis use on nicotine cessation specifically among young adults, with an emphasis on dual-use substance patterns predicting outcomes. The overall goal of this protocol is to characterise the relationship between nicotine and cannabis and evaluate how patterns of co-use are associated with nicotine cessation outcomes through a behavioural economics framework to examine how cannabis co-use may be associated with nicotine cessation. This study protocol describes an ongoing, prospective nicotine cessation trial being conducted among young adults who co-use nicotine (vaping and/or cigarettes) and cannabis products to: (1) evaluate the association between behavioural economically derived measures of substance substitutability on end of treatment (EOT) nicotine abstinence, (2) examine whether changes in nicotine use are associated with changes in cannabis demand and use and (3) assess reciprocal prospective relationships between patterns of nicotine and cannabis use during treatment.

Methods and analysis

This is a fully remote, prospective, 12-week nicotine cessation trial among young adults (ages 18–25; target N=350) across the USA who co-use nicotine and cannabis. Eligible participants vape nicotine and/or smoke cigarettes regularly (20+ days in the past 30) and use cannabis on 10+ out of the past 30 days. Participants receive comprehensive nicotine cessation treatment, which includes digital contingency management to reinforce nicotine abstinence, brief counselling and SMS-text based cessation support whereas cannabis use is monitored but not treated. Biochemical verification (through oral fluid samples) and self-reports (mobile daily diaries) of substance use are collected longitudinally. Study enrolment began in May 2024 and is expected to conclude in September 2027.

Aim 1 (primary outcome) analyses will evaluate whether baseline behavioural economic indices of nicotine–cannabis substitutability predict EOT nicotine abstinence using logistic regression models. Aim 2 (exploratory outcome) analyses will use generalised linear mixed-effects models to examine within-person associations between changes in nicotine use (abstinence, reduction in use, nicotine withdrawal) and cannabis demand and use over time, and whether these associations are moderated by time-varying substitutability. Cross-lagged panel models will be used for Aim 3 (exploratory outcome) to assess reciprocal prospective relationships between nicotine and cannabis use during treatment.

Ethics and dissemination

This study has received Institutional Review Board approval from the Medical University of South Carolina (reference ID: Pro00131124). All participants provide informed consent prior to study procedures. Findings will be disseminated through peer-reviewed publications, conference presentations and data sharing in accordance with National Institutes of Health and institutional guidelines. The manuscript reports protocol components according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.

Trial registration number

NCT06239350.

Protocol for assessment of pain biomarkers in orthopaedic patients undergoing total knee arthroplasty in a tertiary care hospital and neuroimmunopharmacology laboratory in South Australia: a cross-sectional matched-subject observational study

Por: Aalders · M. B. · van Marle · L. · Evans · S. G. · Lin · D.-Y. · Wilson · C. · Verjans · J. W. · Doornberg · J. N. · Hutchinson · M. R. · Jaarsma · R. L.
Introduction

Knee osteoarthritis is a leading cause of pain and disability and frequently results in total knee arthroplasty (TKA). Decisions about surgery and postoperative management rely largely on subjective pain scales and patient-reported outcome measures (PROMs), and 10–15% of patients remain dissatisfied after TKA despite technically successful surgery. Evidence suggests that pain is partly reflected in peripheral immune signalling, yet this neuroimmune interface has not been studied in patients with joint pain due to knee osteoarthritis. This study will explore whether peripheral immune responses (interleukin-1 beta, IL-1β) are associated with pain and may serve as objective pain biomarkers in patients with painful knee osteoarthritis compared with pain-free controls and how these markers relate to pain and psychological (anxiety, depression and pain catastrophising) PROMs. This will be the first study to correlate pain markers (peripheral immune responses) with subjective pain levels in orthopaedic patients with symptomatic knee osteoarthritis.

Methods and analysis

This is a protocol for a prospective cross-sectional matched-subject observational study. We will include 20 adults undergoing unilateral primary TKA for painful advanced knee osteoarthritis, their contralateral pain-free knees as internal controls and 20 age and sex matched healthy controls without joint pain or functional limitation. All participants will undergo standardised clinical assessment and complete pain and psychological PROMs. In patients with TKA, venous blood will be collected pre-operatively. During TKA surgery, synovial fluid will be aspirated from the painful operated knee and the contralateral pain-free knee. Healthy controls will provide a single venous blood sample at a hospital visit. Peripheral blood mononuclear cells and synovial fluid mononuclear cells will be stimulated ex vivo with toll-like receptor 2 and 4 agonists to quantify IL-1β release. In parallel, hyperspectral imaging will characterise unstimulated immune cell phenotypes. Multivariable statistical and machine-learning approaches will relate biomarker profiles to pain and psychological PROMs.

Ethics and dissemination

The study has been approved by the Southern Adelaide Local Health Network (SALHN) HREC (references: 2024/HRE00253, SSA 2024/SSA00641). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences.

Trial number registration

ACTRN12626000084381.

Towards the development of a framework for monitoring and evaluating the multidimensional sustainability of healthcare organisations: a scoping review protocol

Por: Pain · G. C. F. · Chaves · R. L. P. · Zhao · W. · Haren · M. T. · Gartner · J.-B. · Bergeron · F. · Cote · A.
Introduction

The literature on sustainability performance frameworks for healthcare organisations varies in its applicability to different types of organisations and settings, functions and activities, and definitions and dimensions of sustainability. This fragmentation creates implementation barriers which may be overcome by consolidating existing evidence in a format that can be linked directly to organisations’ business models. This protocol proposes a scoping review to assess the extent of the literature on frameworks for monitoring and evaluating the multidimensional sustainability performance of healthcare organisations and to assemble a consolidated framework in an operationally relevant format to support progress towards sustainable healthcare organisations.

Methods and analysis

The search strategy will be applied across Semantic Scholar, Google Scholar, Web of Science, MEDLINE, Embase, Academic Search Premier, CINAHL and Business Source Premier databases. Search results from 2009, coinciding with the publication of the WHO’s ‘Healthy Hospitals, Healthy Planet, Healthy People’ report, will be considered. The scoping review will include studies reporting on multidimensional sustainability monitoring or evaluation frameworks applied or developed for use at the level of healthcare delivery organisations. Studies relating to operational units within organisations or to healthcare systems will be excluded. The review’s context will be restricted to operational sustainability and will not consider the literature on sustainable design planning and construction of new facilities. No specific exclusion criteria will be applied to the types of healthcare delivery organisations nor participants implicated in the frameworks. Title and abstract screening against the inclusion and exclusion criteria, followed by full-text assessment of remaining articles, will be performed by two reviewers. Data from included studies will be extracted using a custom-designed extraction tool, analysed using topic or thematic analysis to consolidate themes and presented within the triple-layered business model canvas.

Ethics and dissemination

Only publicly available sources will be used; research ethics approval is not required. Findings will be submitted to a peer-reviewed journal and presented at scientific meetings.

Seroprevalence of COVID-19 among healthcare workers in Hong Kong during the first 2 years of the COVID-19 pandemic (2020-2021): a longitudinal cohort study

Por: Lim · W. W. · Mak · L. · Ho · F. · Ng · T. W. Y. · Yau · E. M. · Ko · R. L. W. · Chen · D. · Xiao · J. · Seto · W. H. · Cheng · S. M. S. · Perera · R. A. P. M. · Ip · D. K. M. · Peiris · M. · Cowling · B. J.
Background

In the first 2 years of the COVID-19 pandemic, Hong Kong adopted strict public health and social measures to stop community transmission of SARS-CoV-2. These include border screening and control, isolation of cases and quarantine of their contacts and universal masking. During this period, attack rates in Hong Kong were among the lowest globally.

Objectives

To estimate the seroprevalence of COVID-19 among healthcare workers (HCWs) in Hong Kong in 2020 and 2021.

Methods

We reviewed contact tracing data from the Hong Kong Department of Health to identify COVID-19 cases reported among HCWs. Between June 2020 and December 2021, we conducted a longitudinal cohort study to estimate the seroprevalence of COVID-19 among HCWs working in hospitals and clinics in Hong Kong during the first 2 years of the COVID-19 pandemic.

Results

Overall seropositivity of COVID-19 by plaque reduction neutralisation test during the first (May–October 2020) and second round (November 2020–April 2021) of the study was 0% (95% CI 0.00% to 0.49%) and 0.52% (95% CI 0.14% to 1.33%). After COVID-19 vaccines were offered to HCWs in February 2021, seroprevalence by surrogate virus neutralisation assay among cohort participants who provided biannual blood samples rose to 68.7% (95% CI 65.9%, 71.3%) and 80.2% (95% CI 76.8%, 83.2%) in round 3 (May–October 2021) and the first 2 months of round 4 (November–December 2021).

Conclusions

Seroprevalence in Hong Kong HCWs in our study was low despite considerable exposure to confirmed COVID-19 cases in some study participants. However, the low rate of community transmission may have also contributed to the observed low seroprevalence among HCWs in our cohort.

Pre-diagnostic route reported by patients with sarcoma from the Netherlands, the UK, Australia and New Zealand: early detection challenges for general practitioners - an international observational cohort study

Por: Holthuis · E. I. · Soomers · V. L. M. N. · Rafiq · M. · Jones · R. L. · Hayes · A. · Van De Wal · D. · Drabbe · C. · Been · L. B. · Bonenkamp · H. · van der Hage · J. H. · Lee · A. T. J. · Verhoef · C. · van Houdt · W. J. · Young · R. J. · Bae · S. · Andelkovic · V. · Hong · A. M. · Conn
Objective

To investigate how patients with sarcoma present prior to diagnosis—through a general practitioner (GP) or another healthcare professional (HCP)—and describe presenting symptoms.

Design

International observational cohort study.

Setting

Data were obtained from the longitudinal ‘QUality of life and Experiences of Sarcoma Trajectories’ (QUEST) cohort study, conducted across the Netherlands, the United Kingdom (UK), Australia and New Zealand.

Results

Among 572 patients, 487 (85.1%) started their diagnostic trajectory at the GP (subcohort 1) and 85 (14.9%) with another HCP (subcohort 2)—mainly medical specialists treating unrelated conditions (36/85; 42.4%). Soft tissue sarcoma patients most often reported swelling, whereas bone sarcoma patients reported unexplained pain. Notably, 31/85 (36.5%) of subcohort 2 were asymptomatic. Reasons for delaying GP visits included assuming symptoms were minor and expecting them to resolve. Patients sought care when, among others, symptoms persisted and worsened.

Conclusions

Most patients first consulted a GP, underlining the role of primary care in sarcoma diagnosis internationally. Due to rarity and nonspecific symptoms, faster diagnosis remains challenging, requiring improvements in both primary and specialist care.

Trial registration number

NCT03441906; Results.

Engagement with behaviour change in people with mild cognitive impairment and mild frailty: a qualitative study

Por: Rookes · T. A. · Frost · R. · Barrado-Martin · Y. · Catchpole · J. · Armstrong · M. · Gardner · B. · Gould · R. L. · Cooper · C. · Hammond · C. · Marston · L. · Walters · K. R.
Background

Many older people experience Mild Cognitive Impairment (MCI), which may compromise the effectiveness of health promotion programmes.

Objectives

We explored engagement with behaviour change among participants scoring 18-25 on the Montreal Cognitive Assessment receiving HomeHealth, a health promotion intervention supporting older adults with mild frailty to maintain independence in England ().

Methods

Of the 46 semistructured process evaluation interviews, 29 participants scored in the MCI range, purposively selected for demographic characteristics and degrees of cognitive impairment and the seven support workers.

Results

Thematic analysis resulted in three themes: Navigating the impact of MCI; Addressing memory as a goal in the intervention; and Adapting Behaviour Change Interventions for MCI. Participants had varied opinions about whether their memory was problematic and whether anything could be done to help. Many reported not discussing memory concerns with support workers. Barriers to engagement in behaviour change included limited social support and not acknowledging memory problems. Facilitators included setting goals which increased or were linked to existing health behaviours, using reminders/prompts and actively involving family members.

Conclusions

Implementing these facilitators into existing and new health promotion interventions delivered to older adults, with suspected but unacknowledged MCI, could overcome the current barriers people with MCI face when trying to engage and benefit from interventions.

Trial registration number

ISRCTN54268283

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