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Portable devices for diagnosis and monitoring of glaucoma: a scoping review protocol

Por: Garba · F. · Kyari · F. · Nolan · W. · Burton · M. J. · Gordon · I. · Evans · J. R. · Hu · V. H.
Introduction

Glaucoma is the leading cause of irreversible blindness in the world. The need to diagnose glaucoma early in its natural history before extensive sight loss occurs cannot be overemphasised. However, glaucoma is largely asymptomatic in the early stages of the disease making it complex to diagnose clinically and requires the support of technology. The objective of this scoping review is to determine the nature and extent of the evidence for use of portable devices in the diagnosis of glaucoma.

Methods

We will consider studies conducted in all healthcare settings using portable devices for the detection of all type of adult glaucoma. We will also include any systematic reviews or scoping reviews, which relate to this topic. Searches will be conducted in MEDLINE, Embase, CENTRAL on the Cochrane Library and Global Health databases, from their inception to the present. Reference lists from publications identified in the searches will also be reviewed. Two authors will independently screen titles and abstracts, followed by full-text screening to assess studies for inclusion. Any disagreements will be discussed and resolved with a third author. Tables accompanied by narrative descriptions will be employed to discuss results and show how it relates to review questions.

Ethics and dissemination

Ethical approval is not required in this review. Only published and publicly accessible data will be used. We will publish our findings in an open-access, peer-reviewed journal and develop an accessible summary of results and recommendations.

Manchester Intermittent Diet in Gestational Diabetes Acceptability Study (MIDDAS-GDM): a two-arm randomised feasibility protocol trial of an intermittent low-energy diet (ILED) in women with gestational diabetes and obesity in Greater Manchester

Por: Dapre · E. · Issa · B. G. · Harvie · M. · Su · T.-L. · McMillan · B. · Pilkington · A. · Hanna · F. · Vyas · A. · Mackie · S. · Yates · J. · Evans · B. · Mubita · W. · Lombardelli · C.
Introduction

The prevalence of gestational diabetes mellitus (GDM) is rising in the UK and is associated with maternal and neonatal complications. National Institute for Health and Care Excellence guidance advises first-line management with healthy eating and physical activity which is only moderately effective for achieving glycaemic targets. Approximately 30% of women require medication with metformin and/or insulin. There is currently no strong evidence base for any particular dietary regimen to improve outcomes in GDM. Intermittent low-energy diets (ILEDs) are associated with improved glycaemic control and reduced insulin resistance in type 2 diabetes and could be a viable option in the management of GDM. This study aims to test the safety, feasibility and acceptability of an ILED intervention among women with GDM compared with best National Health Service (NHS) care.

Method and analysis

We aim to recruit 48 women with GDM diagnosed between 24 and 30 weeks gestation from antenatal clinics at Wythenshawe and St Mary’s hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000 kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial and adherence to both dietary interventions. Safety outcomes will include birth weight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0 mmol/L). Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals’ experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.

Ethics and dissemination

Ethical approval has been granted by the Cambridge East Research Ethics Committee (22/EE/0119). Findings will be disseminated via publication in peer-reviewed journals, conference presentations and shared with diabetes charitable bodies and organisations in the UK, such as Diabetes UK and the Association of British Clinical Diabetologists.

Trial registration number

NCT05344066.

Feasibility and acceptability of offering breast cancer risk assessment to general population women aged 30-39 years: a mixed-methods study protocol

Por: Hindmarch · S. · Howell · S. J. · Usher-Smith · J. A. · Gorman · L. · Evans · D. G. · French · D. P.
Introduction

Breast cancer incidence starts to increase exponentially when women reach 30–39 years, hence before they are eligible for breast cancer screening. The introduction of breast cancer risk assessment for this age group could lead to those at higher risk receiving benefits of earlier screening and preventive strategies. Currently, risk assessment is limited to women with a family history of breast cancer only. The Breast CANcer Risk Assessment in Younger women (BCAN-RAY) study is evaluating a comprehensive breast cancer risk assessment strategy for women aged 30–39 years incorporating a questionnaire of breast cancer risk factors, low-dose mammography to assess breast density and polygenic risk. This study will assess the feasibility and acceptability of the BCAN-RAY risk assessment strategy.

Methods and analysis

This study involves women undergoing risk assessment as part of the BCAN-RAY case-control study (n=750). They will be aged 30–39 years without a strong family history of breast cancer and invited to participate via general practice. A comparison of uptake rates by socioeconomic status and ethnicity between women who participated in the BCAN-RAY study and women who declined participation will be conducted. All participants will be asked to complete self-report questionnaires to assess key potential harms including increased state anxiety (State Trait Anxiety Inventory), cancer worry (Lerman Cancer Worry Scale) and satisfaction with the decision to participate (Decision Regret Scale), alongside potential benefits such as feeling more informed about breast cancer risk. A subsample of approximately 24 women (12 at average risk and 12 at increased risk) will additionally participate in semistructured interviews to understand the acceptability of the risk assessment strategy and identify any changes needed to it to increase uptake.

Ethics and dissemination

Ethical approval was granted by North West—Greater Manchester West Research Ethics Committee (reference: 22/NW/0268). Study results will be disseminated through peer-reviewed journals, conference presentations and charitable organisations.

Trial registration number

NCT05305963.

The Tuberculosis Sentinel Research Network (TB-SRN) of the International epidemiology Databases to Evaluate AIDS (IeDEA): protocol for a prospective cohort study in Africa, Southeast Asia and Latin America

Por: Enane · L. A. · Duda · S. N. · Chanyachukul · T. · Bolton-Moore · C. · Navuluri · N. · Messou · E. · Mbonze · N. · McDade · L. R. · Figueiredo · M. C. · Ross · J. · Evans · D. · Diero · L. · Akpata · R. · Zotova · N. · Freeman · A. · Pierre · M. F. · Rupasinghe · D. · Ballif · M. · Byakwag
Introduction

Tuberculosis (TB) is a leading infectious cause of death globally. It is the most common opportunistic infection in people living with HIV, and the most common cause of their morbidity and mortality. Following TB treatment, surviving individuals may be at risk for post-TB lung disease. The TB Sentinel Research Network (TB-SRN) provides a platform for coordinated observational TB research within the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium.

Methods and analysis

This prospective, observational cohort study will assess treatment and post-treatment outcomes of pulmonary TB (microbiologically confirmed or clinically diagnosed) among 2600 people aged ≥15 years, with and without HIV coinfection, consecutively enrolled at 16 sites in 11 countries, across 6 of IeDEA’s global regions. Data regarding clinical and sociodemographic factors, mental health, health-related quality of life, pulmonary function, and laboratory and radiographic findings will be collected using standardised questionnaires and data collection tools, beginning from the initiation of TB treatment and through 12 months after the end of treatment. Data will be aggregated for proposed analyses.

Ethics and dissemination

Ethics approval was obtained at all implementing study sites, including the Vanderbilt University Medical Center Human Research Protections Programme. Participants will provide informed consent; for minors, this includes both adolescent assent and the consent of their parent or primary caregiver. Protections for vulnerable groups are included, in alignment with local standards and considerations at sites. Procedures for requesting use and analysis of TB-SRN data are publicly available. Findings from TB-SRN analyses will be shared with national TB programmes to inform TB programming and policy, and disseminated at regional and global conferences and other venues.

Co-designing a nature-based intervention to promote postnatal mental health for mothers and their infants: a complex intervention development study in England

Por: Hall · K. · Evans · J. · Roberts · R. · Brown · R. · Duggan · L. · Williamson · M. · Moran · P. · Turner · K. M. · Barnes · C.
Objectives

There is burgeoning evidence for the potential of nature-based interventions to improve wellbeing. However, the role of nature in enhancing maternal mental health, child development and early relationships remains relatively unexplored. This study aimed to develop a co-designed nature-based intervention to improve postnatal mothers’ and infants’ wellbeing.

Design, setting and participants

Person-based and co-design approaches informed the planning and design of the postnatal nature-based intervention. In stage 1, a multidisciplinary team was formed to agree research questions and appropriate methodology, and a scoping review was conducted. Six qualitative focus groups were then held with 30 mothers and 15 professional stakeholders. In stage 2, intervention guiding principles and a logic model were developed, and a stakeholder consensus meeting was convened to finalise the prototype intervention. The research was conducted in Bristol, UK, across voluntary, educational and community-based healthcare settings.

Results

Stakeholder consultation indicated significant enthusiasm for a postnatal nature-based intervention. A scoping review identified little existing research in this area. Focus group data are reported according to four broad themes: (1) perceived benefits of a group postnatal nature-based intervention, (2) potential drawbacks and barriers to access, (3) supporting attendance and implementation, and (4) ideas for intervention content. The developed intervention was tailored for mothers experiencing, or at risk of, postnatal mental health difficulties. It was identified that the intervention should facilitate engagement with the natural world through the senses, while taking into account a broad range of postnatal-specific practical and psychological needs.

Conclusions

To our knowledge, this is the first reported use of person-based and co-design approaches to develop a postnatal nature-based intervention. The resulting intervention was perceived by target users to address their needs and preferences. Further research is needed to determine the feasibility, clinical and cost-effectiveness of this approach.

Study protocol for a national observational cohort investigating frailty, delirium and multimorbidity in older surgical patients: the third Sprint National Anaesthesia Project (SNAP 3)

Por: Swarbrick · C. · Poulton · T. · Martin · P. · Partridge · J. · Moppett · I. K. · SNAP 3 Project Team · Cortes · Evans · Green · Lourtie · Shah · Taylor · Williams
Introduction

Older surgical patients are more likely to be living with frailty and multimorbidity and experience postoperative complications. The management of these conditions in the perioperative pathway is evolving. In order to support objective decision-making for patients, services and national guidance, accurate, contemporary data are needed to describe the impact and associations between frailty, multimorbidity and healthcare processes with patient and service-level outcomes.

Methods and analysis

The study is comprised of an observational cohort study of approximately 7500 patients; an organisational survey of perioperative services and a clinician survey of the unplanned, medical workload generated from older surgical patients. The cohort will consist of patients who are 60 years and older, undergoing a surgical procedure during a 5-day recruitment period in participating UK hospitals. Participants will be assessed for baseline frailty and multimorbidity; postoperative morbidity including delirium; and quality of life. Data linkage will provide additional details about individuals, their admission and mortality.

The study’s primary outcome is length of stay, other outcome measures include incidence of postoperative morbidity and delirium; readmission, mortality and quality of life. The cohort’s incidence of frailty, multimorbidity and delirium will be estimated using 95% CIs. Their relationships with outcome measures will be examined using unadjusted and adjusted multilevel regression analyses. Choice of covariates in the adjusted models will be prespecified, based on directed acyclic graphs.

A parallel study is planned to take place in Australia in 2022.

Ethics and dissemination

The study has received approval from the Scotland A Research Ethics Committee and Wales Research Ethics Committee 7.

This work hopes to influence the development of services and guidelines. We will publish our findings in peer-reviewed journals and provide summary documents to our participants, sites, healthcare policy-makers and the public.

Trial registration number

ISRCTN67043129.

Epidemiology and clinical manifestations of reported Lyme disease cases: Data from the Canadian Lyme disease enhanced surveillance system

by Kiera Murison, Christy H. Wilson, Katie M. Clow, Salima Gasmi, Todd F. Hatchette, Annie-Claude Bourgeois, Gerald A. Evans, Jules K. Koffi

Lyme disease cases reported in seven Canadian provinces from 2009 to 2019 through the Lyme Disease Enhanced Surveillance System are described herein by demographic, geography, time and season. The proportion of males was greater than females. Bimodal peaks in incidence were observed in children and older adults (≥60 years of age) for all clinical signs except cardiac manifestations, which were more evenly distributed across age groups. Proportions of disease stages varied between provinces: Atlantic provinces reported mainly early Lyme disease, while Ontario reported equal proportions of early and late-stage Lyme disease. Early Lyme disease cases were mainly reported between May through November, whereas late Lyme disease were reported in December through April. Increased awareness over time may have contributed to a decrease in the proportion of cases reporting late disseminated Lyme disease. These analyses help better describe clinical features of reported Lyme disease cases in Canada.

NIMBUS study protocol: a single-centre feasibility study of non-invasive monitoring with bowel ultrasound in paediatric inflammatory bowel disease

Por: Green · Z. · Mayberry · E. · Ashton · J. J. · Beattie · R. M. · Evans · A. · Wahid · A. · Edwards · M. O.
Introduction

Incidence of inflammatory bowel disease (IBD) is increasing in childhood and treatment increasingly targets mucosal healing. Monitoring bowel inflammation requires endoscopy or MRI enterography which are invasive, expensive and have long waiting lists.

We aim to examine the feasibility of a non-invasive monitoring tool—bowel ultrasound (BUS)—in children with IBD and explore correlations with inflammatory markers and disease activity measures. Some BUS criteria have been found to correlate with these markers; however, this has not been validated in children.

We aim to examine the feasibility of BUS for monitoring inflammation in this population; highlighting useful parameters for this purpose. We aim to inform a larger scale randomised controlled trial using BUS.

Methods and analysis

This prospective observational feasibility study will be carried out over 24 months at the Noah’s Ark Children’s Hospital for Wales, Cardiff; with the endpoint recruitment of 50 participants. Children aged 2–18 years with a modified Porto criteria diagnosis of IBD will be included.

Patients without IBD or who have previously undergone IBD-related surgery will be excluded; as will families unable to give informed consent.

Ultrasound scan images and reports will be collected, as well as laboratory results and clinical outcomes.

The primary aim will assess the feasibility of targeted BUS for disease monitoring; including recruitment statistics. The secondary aims will involve data collection and correlation analysis for targeted ultrasound parameters, biomarkers, disease activity scores and prediction of changes in treatment. The statistical methods will include: feasibility metrics, descriptive statistics, cross-tabulation and 2 analysis, correlation analysis, regression analysis.

Ethics and dissemination

Ethical approval is granted by NHS Research Ethics Committee. The sponsor is Cardiff and Vale University Health Board. We will publish the results in a peer-reviewed medical journal.

Trial registration number

NCT05673278.

Family-focused intervention to promote adolescent mental health and well-being in Moldova and North Macedonia (FLOURISH): feasibility study protocol

Por: Shenderovich · Y. · Piolanti · A. · Babii · V. · Calovska-Hertzog · N. · Evans · R. E. · Heinrichs · N. · Burgund Isakov · A. · Lesco · G. · Moore · G. · Mueller · J. · Raleva · M. · Shimbov · B. · Simon · J. · Waller · F. · Wienand · D. · Foran · H. M.
Introduction

Family-Focused Adolescent & Lifelong Health Promotion (FLOURISH) project will adapt, implement and evaluate a programme to support adolescent mental health and well-being through strategies, such as strengthening parenting practices, adolescent-caregiver relationships, adolescent and parent socioemotional skills, and social support.

Methods and analysis

The project will focus on adolescents aged 10–14 years and their caregivers in North Macedonia and Moldova. The countries were selected based on implementation readiness of two organisations and a need for accessible evidence-informed services to help mitigate health risks due to economic, social and political challenges. Parenting for Lifelong Health (PLH) for Parents and Teens is a family-based programme developed for low-resource settings. PLH has been adapted with input from advisory groups. The programme includes additional components to strengthen impacts on adolescents: adolescent mental health tools, based on UNICEF’s Helping Adolescents Thrive, adolescent peer support and participation booster. This pilot is first of three study phases. The pilot will be a feasibility testing of the adapted intervention and the assessment and implementation procedures to determine further refinements. The pilot will examine if the adapted programme is acceptable for adolescents, their families and providers, explore contextual factors relevant to embedding this programme into longer-term scale-up and investigate whether the programme can be delivered with fidelity and participation; whether the participants report changes in adolescent emotional and behavioural problems, well-being and other outcomes; and whether the study tools are feasible and appropriate. Pre-post adolescent and caregiver questionnaires will provide outcome data. Process evaluation will include attendance and fidelity data, and focus groups. We will examine delivery cost and resource requirements.

Ethics and dissemination

The study was approved at the University of Klagenfurt (Austria), Medical Faculty at St. Cyril and Methodius University (North Macedonia) and National Committee of Ethical Expertise for Clinical Trials (Moldova). Through stakeholder engagement and dissemination, FLOURISH will advance scale-up of open-source family interventions.

Trial registration number

Trial registration: ID101095528; project page: https://www.flourish-study.org/about.html; https://www.linkedin.com/company/flourish-study/

Supporting older nurses and midwives in the Australian healthcare workplace—A qualitative descriptive study

Abstract

Aim

To explore support strategies for older nurses and midwives in Australian healthcare workplaces.

Design

A qualitative descriptive study.

Method

Participants were 50 older nurses and midwives and 20 healthcare managers recruited from a broad range of Australian healthcare settings. Data were collected using semi-structured interviews from November 2018 to April 2021. The interviews were recorded, transcribed and thematically analysed.

Results

The limited number of identified sedentary roles and inequitable distribution of workload responsibilities were identified as constraints that impact the provision of workplace support for older nurses and midwives in healthcare settings. Three major themes were identified: Workplace support, Personal support and Doing more. A small number of participants reported support was available at work, but most said there was not. Of the reported strategies some were offered exclusively to a cohort that met an age criterion, while others were open to all staff regardless of age. Personal support strategies were employed outside of the workplace while others used strategies during working hours. Doing more related to suggestions about how organizations could do more to support older nurses and midwives at work.

Conclusion

Support mechanisms like adjustments in workload, employment fraction, practice location, upskilling and wellness programs in workplaces are limited. To facilitate retention and support older nurses and midwives in the workforce, health workplaces should consider implementing support mechanisms that can be tailored to the individual needs of the nurse or midwife over the life course of their career.

Impact

The findings of this study highlight the lack of support for many older nurses and midwives in Australian healthcare workplaces, emphasizing the need for further research into innovative practices on how to better support healthcare staff as they age.

Reporting Method

This study adhered to the COREQ reporting method.

Patient or Public Contribution

No patient or public contribution.

What works for and what hinders deimplementation of low-value care in emergency medicine practice? A scoping review

Por: Gangathimmaiah · V. · Drever · N. · Evans · R. · Moodley · N. · Sen Gupta · T. · Cardona · M. · Carlisle · K.
Objectives

Low-value care can harm patients and healthcare systems. Despite a decade of global endeavours, low value care has persisted. Identification of barriers and enablers is essential for effective deimplementation of low-value care. This scoping review is an evidence summary of barriers, enablers and features of effective interventions for deimplementation of low-value care in emergency medicine practice worldwide.

Design

A mixed-methods scoping review was conducted using the Arksey and O’Malley framework.

Data sources

Medline, CINAHL, Embase, EMCare, Scopus and grey literature were searched from inception to 5 December 2022.

Eligibility criteria

Primary studies which employed qualitative, quantitative or mixed-methods approaches to explore deimplementation of low-value care in an EM setting and reported barriers, enablers or interventions were included. Reviews, protocols, perspectives, comments, opinions, editorials, letters to editors, news articles, books, chapters, policies, guidelines and animal studies were excluded. No language limits were applied.

Data extraction and synthesis

Study selection, data collection and quality assessment were performed by two independent reviewers. Barriers, enablers and interventions were mapped to the domains of the Theoretical Domains Framework. The Mixed Methods Appraisal Tool was used for quality assessment.

Results

The search yielded 167 studies. A majority were quantitative studies (90%, 150/167) that evaluated interventions (86%, 143/167). Limited provider abilities, diagnostic uncertainty, lack of provider insight, time constraints, fear of litigation, and patient expectations were the key barriers. Enablers included leadership commitment, provider engagement, provider training, performance feedback to providers and shared decision-making with patients. Interventions included one or more of the following facets: education, stakeholder engagement, audit and feedback, clinical decision support, nudge, clinical champions and training. Multifaceted interventions were more likely to be effective than single-faceted interventions. Effectiveness of multifaceted interventions was influenced by fidelity of the intervention facets. Use of behavioural change theories such as the Theoretical Domains Framework in the published studies appeared to enhance the effectiveness of interventions to deimplement low-value care.

Conclusion

High-fidelity, multifaceted interventions that incorporated education, stakeholder engagement, audit/feedback and clinical decision support, were administered daily and lasted longer than 1 year were most effective in achieving deimplementation of low-value care in emergency departments. This review contributes the best available evidence to date, but further rigorous, theory-informed, qualitative and mixed-methods studies are needed to supplement the growing body of evidence to effectively deimplement low-value care in emergency medicine practice.

Understanding ‘value’ in the context of community‐based interventions for people affected by dementia: A concept analysis

Abstract

Aim

This study aimed to conduct a concept analysis of value in the context of community-based interventions for people affected by dementia.

Background

Concepts of value play a critical role in shaping the delivery and distribution of community-based health interventions through related concepts. However, the use and meaning of ‘value’ is rarely clarified limiting the term's utility in practice and research. Increasing need for community healthcare and scarce public resources means developing understanding of value in community-based interventions for people affected by dementia is timely, and may support more informed approaches to exploring, explaining and delivering value.

Design

Evolutionary Concept Analysis was used to systematically determine the characteristics of value.

Data Sources

Peer-reviewed and grey literature databases were searched between April and July 2021, with 32 pieces of literature from different disciplines included in the final sample. No limits were set for the years of literature retrieved.

Methods

Literature was thematically analysed for information on the antecedents, attributes and consequences of value.

Results and Discussion

The analysis uncovered a need and/or desire to understand the experience of people affected by or that affect interventions; and to demonstrate, prove/disprove the (best) quality and nature of results of interventions as antecedents of value. Attributes of value were stakeholder/person centred, measurable, time and context dependent and multidimensional. Consequences of the concept included shared decision-making, valuation of interventions and internal/external investment and development of interventions.

Conclusion

Through concept analysis value can now be better understood and applied. The development of a conceptual model to illustrate the constituent elements and relationships of the concept adds transparency to where, why and how concepts of value are enabled that supports future concept development.

Patient and Public Contribution

No patient or public contribution.

Women's information needs, decision-making and experiences of membrane sweeping to promote spontaneous labour

UK policy currently recommends membrane sweeping to avoid prolonged pregnancy and reduce the need for formal induction. Guidance from the National Institute for Health and Care Excellence (NICE, 2008) on induction of labour recommends that at 40- and 41-week antenatal visits, nulliparous women should be offered membrane sweeping prior to formal induction and additional membrane sweeping may be offered if labour does not start spontaneously. Updates to the guideline are expected in July 2020. NICE Quality Standard [QS22] (NICE, 2016) for antenatal care additionally recommends that women having their second or later baby are offered membrane sweeping.
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