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Duplex ultrasound after endo revascularisation (DUSTER): protocol for a randomised controlled feasibility trial

Por: Gadi · N. · Moore · C. · Hayden · K. · Zhang · J. · Beetar · G. · Rogers · S. · Smith-Ball · C. · Davies · A. · Thapar · A.
Introduction

Endovascular therapy is the main treatment for chronic limb-threatening ischaemia in the UK. Despite a restenosis risk of 50% over 2 years, reintervention rates are low, potentially resulting in preventable amputations. European guidelines recommend ultrasound surveillance to facilitate early treatment of restenosis. This study will investigate the use of duplex ultrasound after endo revascularisation (DUSTER). The aim is to assess the feasibility, acceptability and impact on clinical decision-making of a 1-year integrated ultrasound surveillance programme after lower limb endovascular therapy.

Methods and analysis

DUSTER is a mixed-methods study. Phase I is a three-site, feasibility, open-label, randomised controlled trial. The standard of care, the control arm, is standard clinical surveillance by a vascular specialist at 1, 6 and 12 months. The intervention arm will receive integrated ultrasound (ankle-brachial pressure index, toe pressure and duplex) plus standard clinical surveillance. Primary outcomes are rates of attendance and completion of ultrasound surveillance tests, as well as the percentage of participants undergoing reintervention for restenosis. Secondary outcomes are limb salvage, amputation-free survival, reasons for amputation, complications, serious adverse events and mortality.

Phase II comprises independent semistructured interviews with intervention arm participants. The interviews will explore barriers and facilitators to ultrasound surveillance and the effect of ultrasound surveillance on patients’ lives.

Phase III has two separate focus groups for participants and clinical stakeholders to identify which outcomes matter most in any subsequent large-scale effectiveness trials.

Ethics and dissemination

This research has been approved by a UK (West Midlands, Black Country) Research Ethics Committee (reference 24/WM/0232) and the Health Research Authority (IRAS 349192). Dissemination of results will be by the DUSTER co-investigators in peer-reviewed journals, to the National Institute for Health and Care Research and to a lay audience via the Mid and South Essex NHS Foundations Trust website.

Trial registration number

NCT06702306.

Unravelling non-communicable diseases among pregnant women in a lower-middle-income country and the feto-maternal outcomes: a descriptive cross-sectional study

Por: Matthias · A. T. · Ranaweera · P. · Abeysinghe · H. · Prathapan · R. · Marious · S. · Jayawardena · M. · Herath · R. · Fernandopulle · R. C. · Fernando · A. · Silva · D. · Chamara · S. R. · Prathapan · S.
Objectives

This study aimed to determine the prevalence of non-communicable diseases (NCDs) among pregnant women in Sri Lanka and examine the association between NCDs and maternal and fetal outcomes.

Design

A hospital-based, descriptive cross-sectional study.

Setting

The study was conducted in three tertiary care hospitals in the Western Province and one intermediate obstetrics care facility in the Southern Province of Sri Lanka, encompassing diverse, multiethnic populations, over 3 months.

Participants

Data from 1350 pregnant women were collected from discharged bed head tickets of the postnatal obstetric wards using a standardised checklist.

Primary and secondary outcome measures

The primary outcomes were the prevalence of NCDs. Secondary outcomes included associations between maternal NCDs and adverse fetal outcomes such as preterm births and neonatal complications.

Results

Among the participants, 68.5% (n=926) had one or more NCDs, with anaemia (37.9%), obesity (18.1%), gestational diabetes mellitus (14.9%) and hypertensive disorders (13.6%) being the most prevalent. Women with NCDs were at significantly higher odds of adverse fetal outcomes, including preterm birth (OR=2.3, 95% CI: 1.5 to 3.4), neonatal sepsis (OR=2.5, 95% CI: 1.5 to 4.04) and hypoglycaemia (OR=3.5, 95% CI: 1.2 to 10.0). Maternal complications, including postpartum haemorrhage (3.3%) and placental abruption (0.7%), were also more frequent in this group.

Conclusions

NCDs are highly prevalent among pregnant women in Sri Lanka and are significantly associated with adverse maternal and fetal outcomes. Enhanced screening and management strategies during antenatal care are essential to mitigate risks and improve health outcomes, aligning with global efforts to reduce maternal and neonatal morbidity and mortality.

A Worked Example of Qualitative Descriptive Design: A Step‐by‐Step Guide for Novice and Early Career Researchers

ABSTRACT

Aim

To provide a worked example informed by relevant literature and related studies that novice and early career researchers may use to reflect on, prepare and conduct a thoughtful and rigorous qualitative descriptive study.

Design

Methodological discussion of qualitative descriptive design.

Methods

Seminal work and recent related literature were reviewed to situate the discussion and identify the concepts and steps to conduct a qualitative descriptive study.

Results

Qualitative descriptive design is widely used in nursing and health science research. This design offers flexible use of qualitative methods, which presents a double-edged sword, posing challenges in preparing a well-developed study and achieving methodological rigour. The design often borrows methods from other qualitative traditions, which may need to be clarified for novice and early career researchers, wherein studies may be conducted using a mix and match of methods without giving justice to the heart of qualitative descriptive design. In this paper, we present a step-by-step guide, using a worked example, to demonstrate how to conduct a qualitative descriptive study.

Conclusion

Qualitative descriptive design may be confusing due to its flexibility, which may limit the scope of research and subsequently, the quality and impact of the findings. With the appropriate application of research methods producing high-quality and relevant findings, qualitative descriptive design is a valuable qualitative method in its own right.

Implications for the Profession

Novice and early career researchers may increase the impact of their findings through rigorously conducting their studies. Clarifying steps for thoughtful execution may inform novice and early career researchers, allowing for a rigorous application of the method, which, in turn, may contribute to impactful findings.

Impact

A clear presentation of steps, supported by a worked example and related studies, may support novice and early career researchers in conducting a qualitative descriptive study with methodological rigour.

Reporting Method

Not applicable.

Patient or Public Contribution

No patient or public contribution.

Skills for adolescent WELLbeing (SWELL): protocol for a preventive effectiveness randomised controlled trial for young people at high-familial risk of depression with treatment optimisation for parents with depression at study entry comparing online group

Por: Rice · F. · Powell · V. · Eyre · O. · Bevan Jones · R. · Michelson · D. · Airdrie · J. · Collishaw · S. · Thapar · A. · Grozeva · D. · Munnery · K. · Randell · E. · Brookes-Howell · L. · Garber · J. · Thapar · A. · Moore · G. · Harrison · N. A. · Playle · R. · Bisson · J. · McNamara · R.
Introduction

Young people (YP) whose parents have depression are at elevated risk for developing depression themselves and could benefit from preventive interventions. However, when parents are in a depressive episode, this reduces the effects of psychological interventions for depression in YP. Moreover, parental depression is often managed suboptimally in usual care. There is, therefore, a case for identifying and optimising parental depression treatment to enhance the effectiveness of psychological preventive interventions for depression in YP.

Methods and analysis

This is a randomised controlled trial (Skills for adolescent WELLbeing) to determine the effectiveness of a cognitive behavioural therapy (CBT) intervention compared with usual care in increasing the time to a major depressive episode in YP by 9-month follow-up (primary outcome). The intervention offers a 12-week treatment-optimisation phase for parents depressed at study entry, followed by randomisation of the young person to a small group manualised online CBT programme facilitated by a therapist. YP allocated to the intervention will receive eight weekly sessions plus three monthly continuation sessions. Secondary outcomes include the number of depression-free weeks, mental health symptoms and functioning. Mechanisms of intervention action will be assessed with mediation analysis of quantitative data and thematic analysis of qualitative interviews. Participants (parents/carers with depression and their children aged 13–19 years) will be identified through existing cohorts of adults with depression, from primary care through health boards in Wales and England, UK, schools and advertising including via social media.

Ethics and dissemination

The trial has received ethical approval from Wales NHS Research Ethics Committee (REC) 5, the Health Research Authority and Health and Care Research Wales (IRAS 305331; REC 22/WA/0254). This manuscript is based on V.5.7 of the protocol (17 January 2025). Findings will be disseminated in peer-reviewed journals and conferences. Reports and social media messages will be used to disseminate findings to the wider public.

Trial registration number

ISRCTN13924193 (date registered: 15 March 2023).

Psychometric properties of early childhood development assessment tools in low- and middle-income countries: a systematic review

Por: Bliznashka · L. · Hentschel · E. · Ali · N. B. · Hunt · X. · Neville · S. E. · Olney · D. · Pitchik · H. O. · Roy · A. · Seiden · J. · Solis-Cordero · K. · Thapa · A. · Jeong · J.
Objective

Valid and reliable measurement of early childhood development (ECD) is critical for monitoring and evaluating ECD-related policies and programmes. Although ECD tools developed in high-income countries may be applicable to low- and middle-income countries (LMICs), directly applying them in LMICs can be problematic without psychometric evidence for new cultures and contexts. Our objective was to systematically appraise available evidence on the psychometric properties of tools used to measure ECD in LMIC.

Design

A systematic review following the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines.

Data sources

MEDLINE, Embase, PubMed, PsycInfo, SciELO and BVS were searched from inception to February 2025.

Eligibility criteria

We included studies that examined the reliability, validity, and measurement invariance of tools assessing ECD in children 0–6 years of age living in LMICs.

Data extraction and synthesis

Each study was independently screened by two researchers and data extracted by one randomly assigned researcher. Risk of bias was assessed using a checklist developed by the study team assessing bias due to training/administration, selective reporting and missing data. Results were synthesised narratively by country, location, age group at assessment and developmental domain.

Results

A total of 160 articles covering 117 tools met inclusion criteria. Most reported psychometric properties were internal consistency reliability (n=117, 64%), concurrent validity (n=81, 45%), convergent validity (n=74, 41%), test–retest reliability (n=73, 40%) and structural validity (n=72, 40%). Measurement invariance was least commonly reported (n=16, 9%). Most articles came from Brazil, China, India and South Africa. Most psychometric evidence was from urban (n=92, 51%) or urban–rural (n=41, 23%) contexts. Study samples focused on children aged 6–17.9 or 48–59.9 months. The most assessed developmental domains were language (n=111, 61%), motor (n=104, 57%) and cognitive (n=82, 45%). Bias due to missing data was most common.

Conclusions

Psychometric evidence is fragmented, limited and heterogeneous. More rigorous psychometric analyses, especially on measurement invariance, are needed to establish the quality and accuracy of ECD tools for use in LMICs.

PROSPERO registration number

CRD42022372305.

Domestic violence perpetration, victimisation and self-poisoning in Sri Lanka: a protocol for a hospital-based case-control study

Por: Hewa Kankanamge · D. V. · Rubbo · B. · Morgan · K. · Cramer · H. · Collard · S. · Ekanayaka · R. · Latheef · A. · Athapaththu · A. · Siddeek · M. · Wickramasuriya · I. · Knipe · D. W. · Rajapakse · T.
Introduction

Domestic violence is a key risk factor for suicidal behaviour. While there is some evidence on the association between suicide and victimisation, there is a notable paucity of evidence pertaining to the perpetration of domestic violence and its association with suicidal behaviour. The aim of this study is to investigate the association between domestic violence (victimisation and perpetration) and self-poisoning in Sri Lanka.

Methods and analysis

This is a hospital-based case-control study. Cases (n=260) will be individuals admitted to the toxicology ward of the Teaching Hospital Peradeniya, Sri Lanka, for medical management of self-poisoning. We will recruit controls (n=520) from other patients with unrelated conditions or accompanying visitors presenting to the outpatient department of Teaching Hospital Peradeniya. We will use unconditional logistic regression models to investigate the association between domestic violence and self-poisoning.

Ethics and dissemination

We obtained ethics approval from the Ethical Review Committee of the Faculty of Medicine, University of Peradeniya, Sri Lanka. The research assistants will be trained in administering the questionnaire and ensuring participant safety. Results will be disseminated in peer-reviewed articles, local media and at national and international conferences.

Evidence‐Based Teaching Strategies for Assessing Pressure Injuries in Older Nursing Home Residents With Darker Skin Tones

ABSTRACT

Aim

To describe the development and implementation of evidence-based teaching strategies for assessing and classifying pressure injuries in older nursing home individuals ≥ 60 years old with darker skin tones.

Design

Pressure injury assessment learning interventions based on pre- and post-test assessments.

Methods

The learning interventions were developed by experts in pressure injury education and were based on empirical evidence, international clinical practice guidelines, and underpinned by social constructivism theory and the integrated interactive teaching model. The teaching strategy was developed to educate research assistants in the assessment of pressure injuries in darker skin tone individuals. The content included requisite knowledge and skills for pressure injury assessment and classification in darker skinned individuals. Using evidence-based teaching strategies, the content was delivered through face-to-face lectures, small group discussions, and practical application sessions delivered using classroom and practical-based activities. Photographic images were used to assess their knowledge and skills in classifying pressure injuries. Four Bachelor of Nursing-qualified registered nurses in Sri Lanka were recruited as research assistants using the new education resource. Using scores from 1 to 20 points, mastery of the theory and practice components was assessed.

Results

The mean pre-test score was 9 ± 1.6 (95% confidence interval 6.4–11.6), demonstrating that assessment and classification of pressure injury knowledge were lacking. The mean post-test score was 16 ± 0.8 (95% confidence interval 14.7–17.3) indicating an improvement in the participants' ability to assess and staging pressure injuries.

Conclusion

Early pressure injury detection among older individuals with darker skin tones is challenging. This evidence-based teaching approach can be used to educate clinical nurses and research assistants in assessing pressure injuries in individuals with darker skin tones.

Clinical Relevance

This study contributes to the body of knowledge by improving the early detection and accurate classification of pressure injuries in older nursing home residents with darker skin tones, addressing a significant gap in current nursing practice.

Prevalence and incidence of pressure injuries among nursing home residents with darker skin tones: A prospective cohort study

Abstract

Aim

To measure the prevalence and incidence of nursing home-acquired pressure injuries in older adults residing in Sri Lankan nursing homes.

Background

Pressure injury prevalence and incidence are indicators of safety and quality of care. A significant portion of the global population has a skin color dominated by the presence of melanin. Yet, the number of nursing home residents with darker skin tones who develop pressure injuries in nursing homes is relatively unknown.

Design

Prospective multisite cohort study conducted in nine nursing homes in Sri Lanka. The sample comprised 210 residents aged ≥60 years old.

Methods

Semi structured observations and chart audits were used to gather data from July to October 2023. Head-to-toe visual skin assessment to check for nursing home- acquired pressure injuries, Braden pressure injury risk scale and Fitzpatrick skin tone assessments were conducted on all recruited residents at baseline. All recruited residents were followed-up weekly for 12 weeks until detection of a new pressure injury, death, discharge, or transfer.

Results

Pressure injury point prevalence at baseline was 8.1% (17/210). Cumulative incidence was 17.1% (36/210). Incidence density was 15.8 per 1000 resident weeks. Most nursing home-acquired pressure injuries were located on the ankle at baseline (29.4%; 5/17) and in the follow-up period (27.8%; 10/36). Stage I pressure injuries were most common: 58.8% (10/17) and 44.4% (16/36) at baseline and during follow-up respectively.

Conclusions

About one in six nursing home residents developed a new pressure injury over the 12-week follow-up period. Despite staff and resource constraints, there remains a need to focus on the prevention of pressure injuries in Sri Lankan nursing homes.

Clinical Relevance

Studies on the burden of pressure injuries among darker skin tone nursing home residents are lacking and the current evidence available are predominantly from Western countries. The findings of this study highlight the need of targeted preventive measures for nursing home residents with darker skin tones.

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