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Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol

Por: Smorenburg · S. P. M. · Lely · R. J. · Jacobs · M. J. · Hoksbergen · A. W. J.
Introduction

Type II endoleaks (T2ELs) following endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) can lead to aneurysm growth, compromising the stent graft seal and risking rupture. Preventing these endoleaks during EVAR involves filling the AAA sac around the stent graft to exclude the aneurysm and block any arteries causing the endoleak. This study investigates the feasibility and safety of using AneuFix, a biocompatible injectable polymer developed by TripleMed (Geleen, the Netherlands), for aneurysmal sac filling during EVAR in high-risk T2EL patients.

Methods and analysis

A feasibility, single-arm, single-centre clinical trial will initially include five patients with infrarenal AAA, eligible for EVAR, and at high risk for T2EL based on the number of patent lumbar arteries and the cross-sectional area of the aortic lumen at the level of the inferior mesenteric artery. Postevaluation by the Data Safety and Monitoring Board, the study cohort will extend to 25 patients. During EVAR and after stent graft deployment, the aneurysm sac is filled with AneuFix polymer using a filling sheath positioned parallel to the contralateral limb with the tip inside the aneurysm sac. Primary outcome is technical success (successful AAA sac filling). The secondary outcomes include clinical success at 6 and 12 months (occurrence of T2ELs and AAA growth assessed with CT angiography), intraoperative and perioperative complications, all endoleaks, adverse events, re-interventions, aneurysm rupture and patient survival.

Ethics and dissemination

This trial was approved by the Dutch Authorities (Central Committee on Research Involving Human Subjects, IGJ), Amsterdam University Medical Centre Ethical Commission, and adheres to the Declaration of Helsinki and European Medical Device Regulation. Results will be shared at (inter)national conferences and in peer-reviewed journals.

Trial registration number

NCT04307992.

Safety and efficacy of PCSK9 inhibitor (evolocumab) in patients with non-ST segment elevation acute coronary syndrome and non-culprit artery critical lesions: a randomised controlled trial protocol (SPECIAL study)

Por: Wang · Y.-W. · Xu · J. · Ma · L. · Hu · H. · Chen · H.-W. · Hua · J.-S. · Kong · X.-Y. · Li · D. · Li · L.-W. · Pan · J.-Y. · Wu · J.
Introduction

Patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) and concomitant multivessel coronary artery disease (CAD) are considered patients with extremely high-risk atherosclerotic cardiovascular disease (ASCVD), and current guidelines specify a lower low-density lipoprotein cholesterol (LDL-C) target for this population. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to effectively reduce LDL-C levels on a statin background. Additionally, several studies have confirmed the role of PCSK9 inhibitors in plaque regression and reducing residual cardiovascular risk in patients with ACS. However, those studies included coronary lesions with a degree of stenosis

Methods and analysis

In this single-centre clinical randomised controlled trial, 122 patients with NSTE-ACS and concomitant multivessel CAD (non-culprit artery stenosis between 50% and 75%) will be randomly assigned to either the evolocumab treatment group or the standard treatment group after completing culprit vessel revascularisation. The evolocumab treatment group will receive evolocumab in addition to statin therapy, while the standard treatment group will receive standard statin therapy. At baseline and week 50, patients in the evolocumab treatment group will undergo coronary angiography and OCT imaging to visualise pre-existing non-lesional vessels. The primary end point is the absolute change in average minimum fibrous cap thickness (FCT) from baseline to week 50. Secondary end points include changes in plaque lipid arc, lipid length, macrophage grading, lipid levels and major adverse cardiovascular events during the 1-year follow-up period.

Ethics and dissemination

Ethics: this study will adhere to the principles outlined in the Helsinki Declaration and other applicable ethical guidelines. This study protocol has received approval from the Medical Research Ethics Committee of the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital), with approval number 2022-ky214. Dissemination: we plan to disseminate the findings of this study through various channels. This includes publication in peer-reviewed academic journals, presentation at relevant academic conferences and communication to the public, policymakers and healthcare professionals. We will also share updates on the research progress through social media and other online platforms to facilitate the exchange and application of scientific knowledge. Efforts will be made to ensure widespread dissemination of the research results and to have a positive impact on society.

Trial registration number

ChiCTR2200066675.

Does clinical experience influence the effects of team simulation training in stroke thrombolysis? A prospective cohort study

Por: Ajmi · S. C. · Kurz · M. · Lindner · T. W. · Dalen · I. · Ersdal · H. L.
Objectives

After introducing a team simulation training programme at our hospital, we saw a reduction in door-to-needle times (DNT) for stroke thrombolysis but persisting variability prompting further investigation. Our objective is to examine this gap through assessing: (1) whether there is an association between DNT and the clinical experience of neurology registrars and (2) whether experience influences the benefits from attending simulation.

Design

Prospective cohort study.

Setting and participants

Patients treated with intravenous thrombolysis between January 2016 and 2020 at a Norwegian stroke centre.

Primary and secondary outcome measures

Using DNT and prior intravenous thrombolysis administrations (case-based definition of clinical experience) as continuous variables, a mixed effects linear regression model was performed to examine the association between clinical experience, DNT and simulation attendance. For dichotomised analyses, neurology registrars with 15 or more prior treatments were defined as experienced.

Results

A total of 532 patients treated by 36 neurology registrars from January 2016 to 2020 were included. There was a linear association between clinical experience and DNT (test for non-linearity p=0.479). Each prior intravenous thrombolysis administration was associated with a significant 1.1% decrease in DNT in the adjusted analysis (DNT –1.1%; 95% CI, –2.2% to –0.0%; p=0.048). The interaction between effects of clinical experience and simulation on DNT was not statistically significant (p=0.150). In the dichotomised analysis, experienced registrars had similar gains from attending simulation sessions (mean DNT from 18.5 min to 13.5 min) compared with less experienced registrars (mean DNT from 22.4 min to 17.4 min).

Conclusions

Less experienced registrars had longer DNT in stroke thrombolysis. Attending team simulation training was associated with similar improvements for experienced and inexperienced neurology registrars. We suggest a focus on high-quality onboarding programmes to close the experience-related quality gap. Our findings suggest that both inexperienced and experienced neurology registrars might benefit from team simulation training for stroke thrombolysis.

Protocol for a longitudinal study examining the trajectory of COVID-19, post-COVID, multidimensional disadvantage and health-related quality of life in India: the IndiQol Project

Por: Sinha · K. · Gutacker · N. · Gu · Y. · Haagsma · J. · Kumar · K. · Aghdaee · M.
Introduction

The COVID-19 pandemic has raised concerns about the persistence of symptoms after infection, commonly referred to as ‘post-COVID’ or ‘long-COVID’. While countries in high-resource countries have highlighted the increased risk of disadvantaged communities, there is limited understanding of how COVID-19 and post-COVID conditions affect marginalised populations in low-income and middle-income countries. We study the longitudinal patterns of COVID-19, post-COVID symptoms and their impact on the health-related quality of life through the IndiQol Project.

Methods and analysis

The IndiQol Project conducts household surveys across India to collect data on the incidence of COVID-19 and multidimensional well-being using a longitudinal design. We select a representative sample across six states surveyed over four waves. A two-stage sampling design was used to randomly select primary sampling units in rural and urban areas of each State. Using power analysis, we select an initial sample of 3000 household and survey all adult household members in each wave. The survey data will be analysed using limited dependent variable models and matching techniques to provide insights into the impact of COVID-19 pandemic and post-COVID on health and well-being of individuals in India.

Ethics and dissemination

Ethics approval for the IndiQol Project was obtained from the Macquarie University Human Research Ethics Committee in Sydney, Australia and Institutional Review Board of Morsel in India. The project results will be published in peer-reviewed journals. Data collected from the IndiQol project will be deposited with the EuroQol group and will be available to use by eligible researchers on approval of request.

Effects of pre-existing type 1 diabetes mellitus on survival outcome following out-of-hospital cardiac arrest: a registry-based observational study in Sweden

Por: Eken · B. · Rawshani · A. · Rawshani · A. · Mandalenakis · Z. · Thunstrom · E. · Louca · A. · Petursson · P. · Angeras · O. · Nadhir · S. · Dworeck · C. · Ramunddal · T.
Background

It has been estimated that 80% of cases of out-of-hospital cardiac arrest (OHCA) are due to cardiac causes. It is well-documented that diabetes is a risk factor for conditions associated with sudden cardiac arrest. Type 1 diabetes (T1D) displays a threefold to fivefold increased risk of cardiovascular disease and death compared with the general population.

Objective

This study aims to assess the characteristics and survival outcomes of individuals with and without T1D who experienced an OHCA. Design: A registry-based nationwide observational study with two cohorts, patients with T1D and patients without T1D. Setting: All emergency medical services and hospitals in Sweden were included in the study.

Participants

Using the Swedish Cardiopulmonary Resuscitation Registry, we enrolled 54 568 cases of OHCA where cardiopulmonary resuscitation was attempted between 2010 and 2020. Among them, 448 patients with T1D were identified using International Classification of Diseases-code: E10.

Methods

Survival analysis was performed using Kaplan-Meier and logistic regression. Multiple regression was adjusted for age, sex, cause of arrest, prevalence of T1D and time to cardiopulmonary resuscitation.

Main outcome measures

The outcomes were discharge status (alive vs dead), 30 days survival and neurological outcome at discharge.

Results

There were no significant differences in patients discharged alive with T1D 37.3% versus, 46% among cases without T1D. There was also no difference in neurological outcome. Kaplan-Meier curves yielded no significant difference in long-term survival. Multiple regression showed no significant association with survival after accounting for covariates, OR 0.99 (95% CI 0.96 to 1.02), p value=0.7. Baseline characteristics indicate that patients with T1D were 5 years younger at OHCA occurrence and had proportionally fewer cases of heart disease as the cause of arrest (57.6% vs 62.7%).

Conclusion

We conclude, with the current sample size, that there is no statistically significant difference in long-term or short-term survival between patients with and without T1D following OHCA.

Time to resolution of symptoms and recovery after mild traumatic brain injury: protocol for a systematic review and meta-analysis

Por: Ngai · A. · Hibberd · O. · Hassan · H. · Whitehouse · D. P. · Richter · S. · Newcombe · V.
Introduction

Mild traumatic brain injury (mTBI) is a leading cause of morbidity and mortality, with approximately 1 out of 200 people each year sustaining an mTBI in Europe. There is a growing awareness that recovery may take months or years. However, the exact time frame of recovery remains ill-defined in the literature. This systematic review aims to record the range of outcome measures used for mTBI and understand the time to recovery for different outcomes.

Methods and analysis

This protocol complies with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guideline. A prespecified literature search for articles in the English language will be conducted from database inception to the date of searches using MEDLINE and EMBASE. A trial search was conducted on 5 October 2023 with refinement of the search criteria following this. For each study, screening of the title, abstract and full text, as well as data extraction, will be done by two reviewers, with an adjudicating third reviewer if required. The risk of bias will be assessed using the Cochrane risk of bias tool for clinical trials and the Newcastle Ottawa score for cohort studies. The primary outcome is the time to resolution of symptoms in mTBI patients who have a full recovery, using any validated outcome measure. Results will be categorised by symptom groups, including but not limited to post-concussive symptoms, mental health, functional recovery and health-related quality of life. For mTBI patients who do not recover, this review will also explore the time to the plateau of symptoms and the sequelae of these symptoms. Where possible, meta-analysis will be undertaken, with a narrative review undertaken when this is not possible. Subgroup analyses of patients aged over 64 years, and patients with repetitive head injury, are planned.

Ethical review and dissemination

Ethical review is not required, as no original data will be collected. Results will be disseminated through peer-reviewed publications and academic conferences.

PROSPERO registration number

CRD42023462797.

Defining the gaps in transitional care to adulthood for patients in paediatric surgical specialties: a scoping review protocol

Por: Lu · D. · Wang · Z. · Clar · M. · Shen · J.
Introduction

Transitioning patients from their paediatric centres to adulthood is an important subject for many of these patients living with different chronic pathologies. There are few studies that assess its effectiveness in paediatric surgical pathologies. The overall objective of this scoping review is to assess the extent of the literature describing transitional programmes dedicated to young patients living with surgical conditions. The primary question will look to assess what transitional programmes are available for young patients living with surgical conditions either operated or not.

Methods and analysis

The proposed scoping review will follow guidelines described by the Joanna Briggs Institute manual described by Peters et al in 2020. This protocol will employ the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols checklist. The concept that will be included in this review is the exposure of these patients to a transition of care pathway or care programmes. Patients between the ages of 16 and 30 with a surgical condition will be included. There will be no comparator. No specific outcomes will be assessed, however, the outcomes that will be found from the transition programmes will be reviewed. A knowledge synthesis librarian will search MEDLINE All (Ovid), Embase (Ovid), Web of Science Core Collection (Clarivate) and CINAHL Complete (EBSCOhost). The literature search will be limited to 2000 onwards publications. No language or age group limitation will be applied. The reference list of all included sources of evidence will be screened for additional studies. Screening of search results and data extraction from included studies will be completed in Covidence by two independent reviewers. We will also use the PAGER (Patterns, Advances, Gaps, Evidence for practice and Research recommendations) framework to report and summarise the results.

Ethics and dissemination

This review does not require ethics approval. Our dissemination strategy includes peer review publication, conference presentation, co-constructed guidelines with stakeholders and policymakers.

Trial registration

This review is registered on OSF

Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study)

Por: Wang · P. · Sun · W. · Gong · J. · Han · X. · Xu · C. · Chen · Y. · Yang · Y. · Luan · H. · Li · S. · Li · R. · Wen · B. · Lv · S. · Wei · C.
Introduction

The efficacy of multitarget neuroprotective drug DL-3-n-butylphthalide (NBP) in improving cognitive function has been confirmed in patients with vascular cognitive impairment without dementia. However, its efficacy in patients with symptomatic predementia phase of Alzheimer’s disease remains uncertain. This study aims to evaluate the efficacy and safety of NBP in improving cognitive function in patients with mild cognitive impairment (MCI) through a clinical randomised controlled trail.

Methods and analysis

This study is a 12-month, randomised, double-blind, placebo-controlled, multicentric trial, involving 270 patients with MCI. Subjects are randomly assigned to receive either NBP soft capsule (200 mg, three times per day) or placebo with an allocation ratio of 1:1. The efficacy and safety of NBP are assessed by comparing the results of neuropsychological, neuroimaging and laboratory tests between the two groups. The primary endpoint is the change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale after 12 months. All patients will be monitored for adverse events.

Ethics and dissemination

This study involving human participants has been reviewed and approved by Ethics Committee of Xuan Wu Hospital (No.2017058). The participants provide their written informed consent to participate in this study. Results will be published in peer-reviewed medical journals and disseminated to healthcare professionals at local and international conferences.

Protocol version

V 3.0, 3 September 2022.

Trial registration number

ChiCTR1800018362.

Cost-effectiveness analysis of rezvilutamide versus bicalutamide in the treatment of metastatic hormone-sensitive prostate cancer

Por: Ding · H. · Li · S. · Xu · X. · Xu · W. · He · C. · Xin · W. · Zhan · Z. · Fang · L.
Objectives

The economic implications of combining rezvilutamide with androgen deprivation therapy (ADT) remain uncertain, despite the observed survival advantages compared with bicalutamide plus ADT. Therefore, this study evaluates the cost-effectiveness of rezvilutamide plus ADT as the first-line treatment of metastatic hormone-sensitive prostate cancer (mHSPC) from the perspective of the Chinese healthcare system.

Design

A partitioned survival model was developed to assess the cost-effectiveness of rezvilutamide combined with ADT. Clinical data were obtained from the CHART trial. Costs and utility values were obtained from local estimate and published literature. Only direct medical costs were included in the model.

Interventions

Rezvilutamide was administered at 240 mg daily or bicalutamide at 50 mg daily until progression.

Outcome measures

The main outputs of the model included costs and quality-adjusted life years (QALYs), which were used to determine the incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analysis (PSA) were used to explore model uncertainties.

Results

The rezvilutamide group showed an expected gain of 2.28 QALYs and an incremental cost of US$60 758.82 compared with the bicalutamide group. The ICER for rezvilutamide group versus bicalutamide group was US$26 656.94 per QALY. The variables with the greatest impact on the model results were the utility for progression-free survival state and the price of rezvilutamide. PSA revealed that rezvilutamide group had 100% probability of being cost-effective at a willingness-to-pay threshold of US$35707.5 per QALY.

Conclusion

Rezvilutamide in combination with ADT is more cost-effective compared with bicalutamide plus ADT as the first-line treatment of mHSPC from the perspective of the Chinese healthcare system.

Indicators of technostress, their association with burnout and the moderating role of support offers among nurses in German hospitals: a cross-sectional study

Por: Wirth · T. · Kräft · J. · Marquardt · B. · Harth · V. · Mache · S.
Objectives

To examine the level of indicators of technostress among nurses with and without a leadership position, the relationship between indicators of technostress and burnout and the moderating role of support offered by employers. The availability of support offers and further needs of nurses were also explored.

Design

Cross-sectional online survey.

Setting

Acute care hospitals in Germany.

Participants

303 nurses (73.3% female) who have worked at the hospital for at least 1 year and a minimum of 10 hours per week.

Primary and secondary outcome measures

Indicators of technostress (complexity, overload, usefulness, lack of technical support and unreliability) served as predictors in multiple linear regression analyses to examine their association with the primary outcome burnout. Support of employers was included as a moderator variable. Validated subscales from the Digital Stressors Scale and Copenhagen Burnout Inventory as well as open-ended questions were applied.

Results

There were no differences in the level of indicators of technostress found between nurses with and without a leadership position. Techno-overload (β=0.259, p=0.004) and techno-complexity (β=0.161, p=0.043) were significantly associated with burnout. Support by the employer moderated the relationship between lack of technical support and burnout significantly (R² change=0.026, F(1,292)=7.41, p=0.007). Support offers such as training, IT service and contact persons on the ward helped nurses to be more confident in the use of information and communication technologies. However, they expressed further needs with regard to these and new offers.

Conclusions

There was an association between two indicators of technostress and burnout. Therefore, particular attention should be paid to supporting nurses in terms of techno-overload and techno-complexity. Furthermore, there is still a need for customised support and further offers from employers in the use of digital technologies.

Asian Neonatal Network Collaboration (AsianNeo): a study protocol for international collaborative comparisons of health services and outcomes to improve quality of care for sick newborn infants in Asia - survey, cohort and quality improvement studies

Por: Isayama · T. · Miyake · F. · Rohsiswatmo · R. · Dewi · R. · Ozawa · Y. · Tomotaki · S. · Morisaki · N. · Chee · S. C. · Neoh · S. H. · Imperial · M. L. S. · Velasco · B. A. E. · Chang · Y. S. · Cho · S. J. · Youn · Y. · Quek · B. H. · Poon · W. B. · Amin · Z. · Jayaratne · K. · Kumara · S.
Introduction

Reducing neonatal deaths in premature infants in low- and middle-income countries is key to reducing global neonatal mortality. International neonatal networks, along with patient registries of premature infants, have contributed to improving the quality of neonatal care; however, the involvement of low-to-middle-income countries was limited. This project aims to form an international collaboration among neonatal networks in Asia (AsianNeo), including low-, middle- and high-income countries (or regions). Specifically, it aims to determine outcomes in sick newborn infants, especially very low birth weight (VLBW) infants or very preterm infants, with a view to improving the quality of care for such infants.

Methods and analysis

Currently, AsianNeo comprises nine neonatal networks from Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Sri Lanka, Taiwan and Thailand. AsianNeo will undertake the following four studies: (1) institutional questionnaire surveys investigating neonatal intensive care unit resources and the clinical management of sick newborn infants, with a focus on VLBW infants (nine countries/regions); (2) a retrospective cohort study to describe and compare the outcomes of VLBW infants among Asian countries and regions (four countries/regions); (3) a prospective cohort study to develop the AsianNeo registry of VLBW infants (six countries/regions); and (4) implementation and evaluation of educational and quality improvement projects in AsianNeo countries and regions (nine countries/regions).

Ethics and dissemination

The study protocol was approved by the Research Ethics Board of the National Center for Child Health and Development, Tokyo, Japan (reference number 2020–244, 2022–156). The study findings will be disseminated through educational programmes, quality improvement activities, conference presentations and medical journal publications.

EPIC-CP pilot trial study protocol: a multicentre, randomised controlled trial investigating the feasibility and acceptability of social prescribing for Australian children with cerebral palsy

Por: Ostojic · K. · Karem · I. · Paget · S. · Berg · A. · Burnett · H. · Scott · T. · Martin · T. · Dee-Price · B.-J. · McIntyre · S. · Smithers-Sheedy · H. · Mimmo · L. · Masi · A. · Scarcella · M. · Azmatullah · S. · Calderan · J. · Mohamed · M. · Olaso · A. · van Hoek · M. · van Hoek · D. · Wo
Introduction

The social determinants of health contribute to poorer health outcomes for children with cerebral palsy (CP) and are barriers to families accessing health services. At an individual level, social determinants of health are experienced as unmet social needs, for example, unsafe housing conditions. There is emerging evidence that clinical pathways for the systematic identification and referral to services for unmet social needs can support families to address these needs. These clinical pathways have not been implemented for children with CP. The objectives are to investigate the feasibility and acceptability of two co-designed social needs clinical pathways for parents/caregivers of children with CP—social prescribing (ie, Community Linker plus resource pack) compared with resource pack only.

Methods and analysis

This pilot randomised controlled trial will run at the three tertiary paediatric rehabilitation services in New South Wales, Australia. A total of 120 participants will be recruited, with randomisation stratified by study site. A survey tool will be used to identify families experiencing unmet social needs. Parents/caregivers who report one or more unmet social need/s and consent will be eligible. The active control group will receive a resource pack containing information on community services to support unmet social needs. The social prescribing intervention group will receive one-on-one Community Linker support, in addition to the resource pack. The survey tool, intervention, logic model, and resource pack were co-designed with patient families and their healthcare workers. Feasibility of the research design and the clinical pathways will be evaluated using the number/proportion of parents/caregivers who complete the survey tool, consent, engage with the intervention, and complete research measures. Acceptability will be evaluated using questionnaires and qualitative interviews.

Ethics and dissemination

Human research ethics approval was granted by the Sydney Children’s Hospitals Network Human Research Ethics Committee (2022/ETH01688). Participants and stakeholders will receive updates and findings via regular communication channels including meetings, presentations, and publications.

Trial registration number

Australia New Zealand Clinical Trials Registry: 12622001459718.

Views and opinions of patients with glaucoma and age-related macular degeneration on vision home-monitoring: a UK-based focus group study

Por: Dave · S. · Rathore · M. · Campbell · P. · Edgar · D. F. · Crabb · D. P. · Callaghan · T. · Jones · P. R.
Objective

To investigate the views, hopes and concerns of patients living with glaucoma and age-related macular degeneration (AMD) regarding vision home-monitoring.

Design

Qualitative study using focus groups and questionnaires. Participants were given three disease-relevant home-monitoring tests to try. The tests consisted of three visual field tests for the glaucoma groups (Melbourne Rapid Fields, Eyecatcher, Visual Fields Fast) and three acuity and/or contrast-sensitivity tests for AMD groups (Alleye, PopCSF, SpotChecks). Focus group data were thematically analysed.

Setting

University meeting rooms in London, UK.

Participants

Eight people with glaucoma (five women, median age 74) and seven people with AMD (four women, median age 77) volunteered through two UK-based charities. Participants were excluded if they did not self-report a diagnosis of glaucoma or AMD or if they lived further than a 1-hour travel distance from the university (to ensure minimal travel burden on participants).

Results

Six themes emerged from focus groups, the two most frequently referenced being: ‘concerns about home-monitoring’ and ‘patient and practitioner access to results’. Overall, participants believed home-monitoring could provide patients with a greater sense of control, but also expressed concerns, including: the possibility of home-monitoring replacing face-to-face appointments; the burden placed on clinicians by the need to process additional data; struggles to keep up with requisite technologies; and potential anxiety from seeing worrying results. Most devices were scored highly for usability, though several practical improvements were suggested.

Conclusion

Patients with mild-to-moderate glaucoma/AMD expect vision home-monitoring to be beneficial, but have significant concerns about its potential implementation.

Evaluating a model of best practice in primary care led post-diagnostic dementia care: feasibility and acceptability findings from the PriDem study

Por: Griffiths · S. · Spencer · E. · Flanagan · K. · O'Keeffe · A. · Hunter · R. · Wiegand · M. · D'Andrea · F. · Benjamin · L. · Poole · M. · Hagan · A. J. · Brar · M. · Wilcock · J. · Walters · K. R. · Robinson · L. · Rait · G. · on behalf of the PriDem Study Team · Burns · Evans · King · K
Objectives

To evaluate the feasibility and acceptability of a primary care-based intervention for improving post-diagnostic dementia care and support (PriDem), and implementation study procedures.

Design

A non-randomised, mixed methods, feasibility study.

Setting

Seven general practices from four primary care networks (PCNs) in the Northeast and Southeast of England.

Participants

We aimed to recruit 80 people with dementia (PWD) and 66 carers

Intervention

Clinical Dementia Leads delivered a 12-month intervention in participating PCNs, to develop care systems, build staff capacity and capability, and deliver tailored care and support to PWD and carers.

Outcomes

Recruitment and retention rates were measured. A mixed methods process evaluation evaluated feasibility and acceptability of the intervention and study procedures. Using electronic care records, researchers extracted service use data and undertook a dementia care plan audit, preintervention and postintervention, assessing feasibility of measuring the primary implementation outcome: adoption of personalised care planning by participating general practices. Participants completed quality of life, and service use measures at baseline, 4 and 9 months.

Results

60 PWD (75% of recruitment target) and 51 carers (77% of recruitment target) were recruited from seven general practices across four PCNs. Retention rate at 9 months was 70.0% of PWD and 76.5% of carers. The recruitment approach showed potential for including under-represented groups within dementia. Despite implementation challenges, the intervention was feasible and acceptable, and showed early signs of sustainability. Study procedures were feasible and accessible, although researcher capacity was crucial. Participants needed time and support to engage with the study. Care plan audit procedures were feasible and acceptable.

Conclusions

The PriDem model is an acceptable and feasible intervention. A definitive study is warranted to fully inform dementia care policy and personalised dementia care planning guidance. Successful strategies to support inclusion of PWD and their carers in future research were developed.

Trial registration number

ISRCTN11677384.

Burden of non-communicable diseases among women of reproductive age in Kenya: a cross-sectional study

Por: Okyere · J. · Ayebeng · C. · Dickson · K. S.
Objective

To examine the burden of non-communicable diseases (NCDs) among women of reproductive age in Kenya, highlighting the prevalence and risk factors.

Design

Cross-sectional design based on the 2022 Kenya Demographic and Health Survey.

Setting

Kenya.

Primary outcomes

Predict the burden of hypertension, diabetes, heart disease, lung disease, arthritis, depression, anxiety, breast and cervical cancer.

Results

Overall, 15.9% of Kenyan women aged 15–49 years were living with at least one NCD. The most prevalent NCD among this cohort was hypertension (8.7%) followed by arthritis (2.9%) and depression (2.8%). Our findings revealed that increasing age, increasing wealth, being married or formerly married, being overweight or obese, consuming alcohol and some occupations were risk factors of NCDs among women of reproductive age in Kenya.

Conclusion

We conclude that hypertension is the most prevalent NCD among women of reproductive age in Kenya. The findings underscore the multifaceted nature of NCD risk factors in Kenya, emphasising the importance of targeted interventions that consider age, economic status, education, marital status, occupation and lifestyle factors.

Uncovering the state of knowledge about healthcare gentrification: a scoping review protocol

Por: Espinoza Suarez · N. R. · Loignon · C. · Dupere · S. · Dufour · I. · Shareck · M. · Apparicio · P. · Ouellet · J. · Pineault · J. · Amagnamoua · S. · Laferriere · M.-C. · Wilson · I.
Introduction

Healthcare gentrification is the process in which the distribution of healthcare resources within a neighbourhood affects residents' access to healthcare services. To understand the complexity of healthcare access and to consider the socio-structural dimensions affecting equity in access to care, we aim to explore how healthcare gentrification has been described in the scientific literature and to document the reported relations between gentrification and healthcare access.

Methods and analysis

We will conduct a scoping review from data published from inception to September 2024 based on the methodology developed by Arksey and O'Malley (2005) and improved by Levac et al (2010). We will search the following databases: MEDLINE (OVID), Embase (embase.com), CINAHL Plus with Full Text (EBSCO), Web of Science and Geobase (Engineering Village). The review will be conducted from February 2024 to September 2024. The search strategy will be elaborated in conjunction with a professional librarian. Screening of titles and abstracts and full-text screening will be done in duplicates. A third reviewer will arbitrate discrepancies during the screening process. We will present our results narratively.

Ethics and dissemination

This scoping review does not require ethical approval since it will be collected from publicly available documents. The results of this scoping review will also be presented as a scientific article, scientific conferences, research webinars also in social media, workshops and conferences organised by healthcare organisations or academic institutions or on any appropriate platform.

Fetal alcohol spectrum disorder resources for health professionals: a scoping review

Por: Stubbs · T. · Cannon · L. · Carter · E. · Naanai · H. · Okurame · J. C. · Martiniuk · A. L. C. · Davies · J. · Thomas · S. · Bedford · M. · Elliott · E. J. · Rice · L. J.
Objectives

This scoping review aimed to identify and critically appraise resources for health professionals to identify, diagnose, refer, and support individuals with fetal alcohol spectrum disorder (FASD)—including the extent to which the resources are appropriate for use in communities with First Nations Peoples.

Method

Seven peer-reviewed databases (April 2022) and 14 grey literature websites (August 2022) were searched. The reference lists of all sources that underwent full-text review were handsearched, and FASD experts were consulted for additional sources. Resources were assessed using the Appraisal of Guidelines for REsearch and Evaluation II instrument and an adapted version of the National Health and Medical Research Council FORM Framework and iCAHE Guideline Quality Checklist.

Results

A total of 41 resources underwent data extraction and critical appraisal, as screening and/or diagnosis guidelines were excluded because they are covered in other reviews. Most were recently published or updated (n=24), developed in the USA (n=15, 36.6%) or Australia (n=12, 29.3%) and assisted with FASD patient referral or support (n=40). Most management guidelines scored 76%–100% on overall quality assessment (n=5/9) and were recommended for use in the Australian context with modifications (n=7/9). Most of the guides (n=15/22) and factsheets (n=7/10) received a ‘good’ overall score. Few (n=3/41) resources were explicitly designed for or with input from First Nations Australians.

Conclusion

High-quality resources are available to support health professionals providing referrals and support to individuals with FASD, including language guides. Resources should be codesigned with people living with FASD to capture and integrate their knowledge and preferences.

Exploring the literature on racism and health practitioner regulation: a scoping review protocol

Por: Chiu · P. · Louie-Poon · S. · Leslie · K. · Kung · J. Y.
Introduction

Racism in healthcare leads to significant harm to healthcare professionals and the clients, families and communities they serve. Increasingly, health practitioner regulators—responsible for protecting the public and ensuring practitioner competence—are recognising the importance of reforming policies and practices to contribute to antiracist regulatory approaches. Examples of this work include developing specific standards of practice related to antiracism and antidiscrimination, supporting education and training, re-evaluating discriminatory licensure policies for internationally educated professionals and reforming internal governance structures to address unconscious bias. An understanding of the current state of literature can help identify knowledge gaps and inform the development of research agendas that can build the evidence base required to improve health practitioner regulators’ approaches to addressing racism.

The objective of this scoping review is to explore the nature, extent and range of literature focused on racism and health practitioner regulation and identify gaps in the literature.

Methods and analysis

The review will be conducted in accordance with the Joanna Briggs Institute guidelines for scoping reviews. Database searches will include OVID MEDLINE, EMBASE, CINAHL, Scopus and Web of Science Core Collection. The review will include papers that discuss how health practitioner regulation can contribute to and perpetuate interpersonal and institutional racism, and how regulatory policies and practices can help address racism. We will also search for grey literature using the websites of leading regulatory organisations. Data will be analysed using descriptive statistics and conventional content analysis. Findings will be presented using evidence tables and a narrative summary. Reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews.

Ethics and dissemination

Ethics approval is not applicable to this review protocol. Findings will be disseminated through presentations, meetings with health practitioner regulators and a publication in a peer-reviewed journal.

Demographic, socioeconomic and health determinants of depressive symptoms in adults 50 years and older from Mexico: a secondary data longitudinal analysis from the Mexican Health and Aging Study

AbstractBackground

Depression in ageing adults is a public health problem. Worldwide studies have identified social and health risk factors for depressive symptoms. However, little is known about their longitudinal determinants in Mexico.

Objectives and setting

To find the prevalence of depressive symptoms and their longitudinal individual and contextual risk factors in Mexican adults aged 50 and older.

Design

Secondary data of 6460 persons aged 50 years and older from the Mexican Health and Aging Study were analysed using a ‘between-within’ panel data analysis approach.

Results

The prevalence of depressive symptoms increased from 35% in 2003 to 38% in 2015. The significantly longitudinal factors associated with these symptoms were getting older (OR 1.02, 95% CI 1.01 to 1.03), being a woman (OR 2.39, 95% CI 2.16 to 2.64), less time spent in formal education (0 years and less than 6 years OR 1.52, 95% CI 1.32 to 1.75 and OR 1.33, 95% CI 1.19 to 1.50, respectively), lower net worth (OR 1.13, 95% CI 1.08 to 1.17), being recently unemployed (OR 1.25, 95% CI 1.10 to 1.25), increased (OR 1.17, 95% CI 1.10 to 1.25) or increasing number (OR 1.23, 95% CI 1.15 to 1.31) of chronic conditions, poor (OR 4.68, 95% CI 4.26 to 5.15) or worsened (OR 1.71, 95% CI 1.61 to 1.81) self-rated health and having impairments on instrumental activities of daily living (IADLs) (OR 2.94 95% CI 2.35 to 3.67) or a new IADL impairment (OR 1.67, 95% CI 1.48 to 1.89), as well as having impairments on ADLs (OR 1.51, 95% CI 1.23 to 1.86) or a new ADL impairment (OR 1.34, 95% CI 1.21 to 1.48).

Conclusions

The prevalence of depressive symptoms in Mexican adults aged 50 and older is high. Our findings show that they are longitudinally associated with the individual’s demographic, socioeconomic, health and disability characteristics. Efforts in public policy should focus on preventing chronic conditions and disability, as well as fighting inequalities to reduce the prevalence of depressive symptoms.

Defining indicators for disease burden, health outcomes, policies and barriers and facilitators to health services for migrant populations in the Middle East and North African region: a protocol for a suite of systematic reviews

Por: Seedat · F. · Evangelidou · S. · Abdellatifi · M. · Bouaddi · O. · Cuxart-Graell · A. · Edries · H. · Elafef · E. · Maatoug · T. · Ouahchi · A. · Mathilde Pampiri · L. · Deal · A. · Arias · S. · Abdelkhalek · A. · Arisha · A. H. · Assarag · B. · Bani · I. A. · Chaoui · A. · Chemao-Elfihr
Introduction

The Middle East and North African (MENA) region is characterised by high and complex migration flows, yet little is known about the health of migrant populations, their levels of underimmunisation and access to healthcare provision. Data are needed to support regional elimination and control targets for key diseases and the design and delivery of programmes to improve health outcomes in these groups. This protocol describes a suite of seven systematic reviews that aim to identify, appraise and synthesise the available evidence on the burden and health outcomes, policies and access (barriers and facilitators) related to these mobile populations in the region.

Methods

Seven systematic reviews will cover three questions to explore the: (1) burden and health outcomes, (2) policies and (3) healthcare barriers and facilitators for the following seven disease areas in migrants in the MENA region: tuberculosis, HIV and hepatitis B and C, malaria and neglected tropical diseases, diabetes, mental health, maternal and neonatal health, and vaccine-preventable diseases. We will search electronic databases for studies in any language (year 2000–2023), reference-check relevant publications and cross-check included studies with experts. We will search for grey literature by hand searching key databases and websites (including regional organisations and MoH websites) for country-specific guidelines and talking to our network of experts for local and regional reports and key datasets. We will assess the studies and policies for their quality using appropriate tools. We will meta-analyse the data by disease outcome if they are of sufficient volume and similarity. Where meta-analysis is not possible and where data are on policy or access, we will narratively synthesise the evidence using summary tables, figures and text.

Dissemination

We anticipate disseminating the findings through peer-reviewed publications, conferences and other formats relevant to all stakeholders. We are following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and protocols will be registered on International Prospective Register of Systematic Reviews.

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