Search Results for: Follow-up ottimale dopo embolia polmonare acuta

Objectives
In response to a critical shortage of skilled workforce, Ethiopia has scaled up its health professional education (HPE) by increasing the number of training institutions and student enrolment capacity. However, strong evidence that shows how the HPE scale-up affected clinical placements is lacking. This study investigated the challenges and effects of the rapid HPE scale-up in clinical placements, and the adjustments made in response to the challenges.

Design
A qualitative study using focus group discussions and constructivist grounded theory was conducted in July–August 2022.

Setting
The teaching hospitals of six medical schools in Ethiopia.

Participants
53 purposefully selected participants (25 clinician-teachers and 28 intern students).

Measures
Adequacy of skilled clinicians, student preparedness and learning environment were input measures. Quality of supervision, assessment, feedback and practice exposure are process measures. Clinical competence was an outcome measure.

Results
We identified six themes: (1) class size and student motivation, (2) availability of skilled and motivated clinician-teachers, (3) learning environment and practice management, (4) clinical supervision and assessment, (5) extent of exposure, and (6) clinical competence. The HPE upscaling caused student overcrowding, resource shortages and unconducive learning environments. Concerns were reported on clinical supervision, assessment, feedback, role modelling and programme management. Clinician-teachers and students had low levels of motivation. Competitions for practice diminished learning collaboration. In response to the challenges, adjustments were made to strengthen clinical rotations, engage teaching methods and hire more clinician-teachers.

Conclusion
The rapid HPE scale-up affected clinical placements, reducing student authentic practice and skill development. There is a need to optimise student enrolment, train clinicians as teachers and improve clinical learning resources. Interprofessional education can optimise student practice. Placement coordination facilitates supervision. Student practice should be expanded to primary healthcare settings.

Introduction
Evidence links night shift work to circadian rhythm disruption, causing hormonal and metabolic alterations, as well as increased risk for cardiovascular disease (CVD). This study investigates whether night shift work affects blood glucose variability and dysregulation, potentially driven by circadian misalignment. It also examines whether such disruptions elevate inflammatory markers involved in atherosclerosis and contribute to the exacerbation of CVD risk markers.

Methods and analysis
The study includes 60 participants: rotating night shift workers (day, evening, and night shifts) and day workers (controls) at a pharmaceutical plant. We will assess the effects of night shift work on metabolic and cardiovascular health over three phases: an initial 6-week observational period (phase I), baseline registration of CVD risk factors (phase II), and follow-up assessment of CVD risk factors at 2 years (phase III). Phase I registrations include working hours derived from payroll data, sleep metrics by OURA ring (actigraphy, plethysmography and temperature), continuous assessments of blood glucose using continuous glucose monitor, self-reported food diary and measurements of circadian rhythm markers (monocyte mRNA expression). In phases II and III, blood CVD risk factors such as markers of inflammation, lipids, glycosylated haemoglobin, D-dimer, clinical examination of blood pressure, resting heart rate, arterial stiffness by the means of carotid to femoral pulse wave velocity, carotid intima–media thickness and maximal oxygen uptake (VO2max) are measured. To this end, a comprehensive set of methods will be used in a prospective manner to provide new knowledge on shift work-induced glucose regulation and CVD risk factors.

Ethics and dissemination
All participants provided written informed consent prior to participating in the study, which will adhere to the principles outlined in the Declaration of Helsinki. Ethical approval has been granted by the Norwegian Regional Committee for Medical Research Ethics South-East B (reference # 745702). Dissemination plans include academic and public publications, as well as collaborations with national and regional policy-makers.

Introduction
Delirium is a common and serious condition that frequently affects patients in the intensive care unit (ICU). It is characterised by an acute disturbance in cognition, attention and awareness that develops over a short period of time and tends to fluctuate in severity. Patients with ICU delirium (ICUD) may experience confusion, disorientation, difficulty focusing and perceptual disturbances such as hallucinations or delusions. The prevalence of ICUD is high, with estimates suggesting that it can affect up to 70% of ICU patients. The development of ICUD is associated with several adverse outcomes, including prolonged ICU and hospital stays, increased healthcare costs, higher mortality rates and an increased risk of long-term cognitive impairment, including dementia. It is unclear which components should be included in a complex intervention to prevent and manage ICUD. Furthermore, we need to understand how the different components have been implemented and their impact on clinical practice.

Methods and analysis
The review will be reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis Protocols (PRISMA-P) and the enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) reporting recommendations. We will perform systematic searches to identify relevant interventions and implementation strategies for the prevention or management of ICUD. We will assess primary research, service evaluations and audits for the use of the Standards for QUality Improvement Reporting Excellence (SQUIRE) as a checklist for quality improvement in healthcare. We will extract both qualitative and quantitative data and assess study quality using the Critical Appraisal Skills Programme (CASP) tool. Our findings will be synthesised using a best-fit framework synthesis mapped against the Theoretical Domains Framework (TDF). Our Patient and Public Involvement (PPI) group will contribute to the development of review processes such as the research question and methodology and will help to evaluate which outcomes are most important.

Ethics and dissemination
No ethical approval is required for this study. The results of this systematic review of implementation strategies will be disseminated through peer-reviewed publications and conferences. They will also form part of an evidence map and logic model for factors that can improve the implementation of strategies for prevention, identification and management of ICUD.

PROSPERO registration number
CRD42024537313.

Introduction
There are a substantial number of patients developing heart failure after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS), even though AS has been successfully treated. The purpose of this randomised controlled trial was to determine whether the addition of an angiotensin receptor–neprilysin inhibitor (ARNI), sacubitril/valsartan, is superior to conventional medications in lowering N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients undergoing TAVI for AS.

Methods and analysis
The study design is a prospective, single-centre, open-label, randomised, parallel-group, two-arm study, in which participants will be randomised in a 1:1 ratio to receive either conventional medications plus ARNI or conventional medications only. In the ARNI group, if a patient was on an ACE inhibitor or angiotensin II receptor blocker before TAVI, it will be switched to ARNI 100 mg/day (50 mg two times per day) on the first postoperative day. If not, candesartan 4 mg/day will be started 1–2 days before TAVI, and switched to ARNI 100 mg/day on the first postoperative day. As the patient has tolerability to ARNI, dosage will be increased stepwise to 400 mg/day 2–4 weeks apart. ARNI will be continued until at least 6-month follow-up. In the control group, the patient will receive conventional medications. The primary endpoint is the serum NT-proBNP value at 6-month follow-up after TAVI. Each group includes 42 patients (84 total patients).

Ethics and dissemination
Ethical approval for this study has been obtained from the Chiba University Hospital Certified Clinical Research Review Board (CRB3180015). The study is ongoing. Findings from this study will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number
This trial has been registered on the Japan Registry of Clinical Trials: jRCT1031220344.

Introduction
Cervical cancer, a major global health concern, is primarily caused by human papillomavirus (HPV) infection. Although cervical intraepithelial neoplasia grade 2 (CIN2), a precancerous lesion, exhibits high spontaneous regression rates (50%–60%), particularly in younger women, current clinical management lacks accurate risk stratification. This study examines HPV integration status as a prognostic biomarker in women aged 18–45 diagnosed with CIN2, with the objective of developing a predictive tool for personalised therapeutic strategies and minimising overtreatment in this high-regression population.

Method and analysis
This multicentre cohort study will be implemented across 20 tertiary Grade A hospitals in China, encompassing eastern, western, central and northern regions. It will recruit 240 CIN2 patients, collecting sociodemographic, lifestyle and medical history data via questionnaires. Clinical examinations will be performed at baseline and follow-up. Disease regression ((to cervical intraepithelial neoplasia grade 1 [CIN1] or lower)) and non-regression (persistent CIN2 or progression) will be evaluated. Prognostic factors will be analysed using Cox proportional hazards models, adjusting for confounders such as age, weight and socioeconomic status.

Ethics and dissemination
The cohort study protocol and informed consent procedures adhere to the Declaration of Helsinki and pertinent Chinese clinical research regulations. Ethical approval has been obtained from the Clinical Research Review Committee of the Fujian Maternal and Child Health Hospital (2022KYLLR01018) and from the participating hospitals. Written informed consent is secured from all participants prior to enrolment, with detailed information provided regarding study objectives, procedures, potential risks and benefits and participants’ rights. Results will be published in peer-reviewed scientific journals, presented at academic meetings and conferences and released to the public through press releases.

Trial registration number
ClinicalTrials.gov (NCT05282095); Pre-results.

Objectives
To document adaptations that were made to the implementation of the two-way texting (2wT) randomised controlled trial (RCT) for voluntary medical male circumcision (VMMC) in South Africa and to provide a nuanced discussion on the differences between adaptations and fidelity in this context.

Design
We conducted a qualitative study using the Framework for Reporting Adaptations and Modifications in Evidence-based Implementation Strategies (FRAME-IS) to examine 2wT adaptations. We reported adaptations to the 2wT intervention using two steps. First, we categorised adaptations in a shared study-specific Google Docs that documented participant engagement with the 2wT system, tracked daily RCT implementation notes, reported software bugs and noted reminder emails about adaptations for the research team. Second, we conducted a qualitative assessment of the influence of adaptations on project outcomes via 10 periodic reflection meetings with VMMC implementers. Reflection documentation included notes from field observations, meeting minutes and informal partner check-ins to complete adaptation documentation. Using the FRAME-IS as a codebook, adaptations were categorised.

Setting
The RCT was conducted in rural and urban VMMC clinics in the North West and Gauteng districts of South Africa.

Participants
Implementation scientists and VMMC implementers who implemented the 2wT pragmatic randomised controlled trial (pRCT) were participants for the adaptation study.

Primary and secondary outcome measures
The primary outcome measure was the adaptations that were made during the implementation of the 2wT pRCT. The secondary outcome measures were fidelity and rigour of implementing adaptations to the 2wT pRCT.

Results
Between June 2021 and February 2022, 13 adaptations were identified in three phases during the implementation of the 2wT pRCT. The first phase of adaptations aimed to augment study recruitment, including conducting weekend VMMC recruitment camps, using mobile outreach services in the rural site, adding two urban sites to increase recruitment, using weekly WhatsApp calls for updates with all implementing teams, using virtual meetings to implement the 2wT strategy remotely during COVID-19 restrictions and allocating one clinician to work outside of normal working hours. The second phase of adaptations further enhanced enrolments, including adding two local language translations in the usability survey for 2wT men and contributing a portion towards the salary of the implementing staff by the research partner. The third phase included the exclusion of two rural clinics as recruitment sites due to inconsistent mobile phone networks, adding another layer of data quality checks to ensure data quality, training non-clinical counsellors to help with enrolling clients, retraining of staff in the rural site with high staff turnover and using both primary and alternative phone numbers for enrolment to reduce loss to follow-up.

Conclusions
This study made adaptations to the 2wT pRCT without compromising the fidelity of the study. The 2wT pRCT balances rigour (fidelity) and relevance (adaptation). Adaptations should not be confined by rigour but should also not go unchallenged or unverified. We conclude that fidelity can be maintained with adaptations that are implemented to close the gap between research in the laboratory and practice.

Trial registration number
The trial from which this study was conducted, ‘Expanding and Scaling Two-way Texting to Reduce Unnecessary Follow-Up and Improve Adverse Event Identification Among Voluntary Medical Male Circumcision (VMMC) Participants in the Republic of South Africa’, was registered at ClinicalTrials.gov (ID: NCT04327271) on 31 March 2020.

Introduction
Interstitial lung disease (ILD) patients may develop a progressive phenotype usually characterised by progressive pulmonary fibrosis. While this condition is life-limiting, wide variations in its clinical course have made it difficult to predict the rate of disease progression, onset of acute exacerbations and mortality. New approaches are needed to predict the clinical course of ILD, to enable treatment planning, evaluation and clinical trial design. Advances in digital health technologies have facilitated the ability to collect ‘real-time’ data to monitor diseases. These data, including physiological measures, activity indices and patient-reported outcomes, may be useful as components of new outcome predictors. The objective of this study is to first deploy comprehensive data collection enabling deep profiling of patients with ILD and to use these data to develop better predictors of outcome. Finally, these predictions will be evaluated based on real observed outcomes for individual patients.

Methods and analysis
This study is a prospective cohort study with 50 participants. Inclusion criteria: Age 18 years or older with a diagnosis of ILD and the ability to provide written informed consent. Exclusion criteria: Age under 18 years or unwilling to wear a smartwatch for the duration of the study. Participants will be provided with a smartwatch to passively collect biometric data. These data will be combined with clinical history and course, in addition to a set of patient-reported outcome measures. Participants will be followed for 3 years to assess the rate of disease progression, occurrence of acute exacerbations and mortality. Initial data will be used to develop clinical prediction models. These models will be further evaluated for accuracy using regular follow-up data.

Ethics and dissemination
This study was approved by the St. Vincent’s University Hospital Research Ethics Committee, Dublin, Ireland (reference no: RS23-023). Results will be presented at medical conferences and disseminated via peer-reviewed journals.

Introduction
Maternal undernutrition and infections during pregnancy may influence birth and long-term child development outcomes. Characterising the micronutrient, metabolomic and microbiome profiles of pregnant women and infants may elucidate the underlying biology of adverse birth outcomes and early child development in the first 1000 days.

Methods and analysis
The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study was a 2×2 factorial, randomised clinical effectiveness study conducted in Amhara, Ethiopia from August 2020 to June 2022. We cluster-randomised pregnant women (n=2399) to receive either a nutrition intervention (iron-folic acid (IFA), iodised salt and balanced energy-protein supplementation for women with mid-upper arm circumference

Objective
To assess patient satisfaction (PS) with services and its associated factors across selected primary care facilities in Kono district, Sierra Leone.

Design
Facility-based cross-sectional study.

Setting
Five primary healthcare facilities (Wellbody, Sewafe, Kombayendeh, Gandorhun and Kayima) located in Kono district, Sierra Leone. All five are Community Health Centres (CHCs), with two CHCs benefiting from a comprehensive package of support (5S model) from the non-governmental organisation, Partners In Health (PIH). This support, dubbed as 5S health systems strengthening (HSS) model, will be elaborated in this article. The other three CHCs were not beneficiaries of the 5S model.

Participants
The study population comprised all patients and caregivers who attended outpatient services at the selected health facilities. We included adult outpatients over 18 years old and adult caregivers accompanying their children while waiting in the various outpatient departments. This study considered a sample size of 290 and the data were collected from 3rd March to 31st March 2021.

Outcomes
PS was measured using an 11-item Likert scale questionnaire. The outcome was categorised as good or poor satisfaction level using the median value. Descriptive statistics were applied to assess satisfaction level and multivariable binary logistic regression analysis was applied to identify factors associated with the outcome variable.

Results
Out of the 290 respondents included for analysis, the overall PS level was 63.8% (95% CI 58.1% to 69.0%). Around 69.2% (95% CI 62.1% to 75.4%) of respondents from PIH intervention sites and 53.9% (95% CI 44.1% to 63.4%) from the non-PIH intervention sites had a good satisfaction level. The multivariable binary logistic regression analysis indicated that PIH intervention site status (adjusted OR (AOR)=2.47, 95% CI 1.28 to 4.78), educational status of respondents (AOR=0.53, 95% CI 0.28 to 0.98), distance to health facility (AOR=0.40, 95% CI 0.18 to 0.87) and waiting time to receive care (AOR=0.41, 95% CI 0.22 to 0.76) were the significant factors associated with PS.

Conclusion
The overall PS was relatively high andPIH-supported health facilities show better PS than non-PIH health facilities. In addition, patients’ educational status, distance to health facility and waiting time were negatively associated with PS level. The findings suggest that PIH’s model of health systems strengthening with targeted investment on the 5S model can be scaled up and the Ministry of Health could consider implementing this approach for improving the quality of services provided at the primary healthcare facilities.

Stroke, Ahead of Print. BACKGROUND:ANNEXA-I (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of FXA Inhibitors) was a randomized trial that demonstrated that andexanet compared with usual care in patients with intracranial hemorrhage associated with FXa (factor Xa) inhibitor treatment reduces the risk of hematoma expansion and increases the risk of arterial thromboembolic events.METHODS:In a secondary analysis of the ANNEXA-I trial, we compared the effects of andexanet with usual care on change in anti-FXa activity and endogenous thrombin potential (ETP) using Wilcoxon rank-sum test. We examined the associations between 1-hour reduction in anti-FXa and 1-hour increase in ETP and hematoma expansion at 12 hours (≥12.5 mL or percentage volume change ≥35%) using logistic regression, both unadjusted and adjusted for time from symptom onset to baseline scan, baseline diastolic blood pressure, hematoma volume, baseline biomarker level and time from baseline scan to treatment, and association with arterial thromboembolic events (ischemic stroke, myocardial infarction, and systemic embolism) during 30 days of follow-up using Cox regression, both unadjusted and adjusted for age, baseline biomarker level, prior MI, and eligibility for treatment with high-dose andexanet.RESULTS:ANNEXA-I enrolled 530 patients. Among 438 patients with baseline anti-FXa results, andexanet compared with usual care reduced anti-FXa activity at 1 hour (median, 8.6 versus 97.5 ng/mL; median reduction from baseline, 98.3 versus 10.9 ng/mL;P

Introduction
Liver cirrhosis and its severe complication, oesophageal variceal bleeding (EVB), pose significant health risks. Standard treatment for EVB combines non-selective beta-blockers (NSBB) with endoscopic variceal ligation (EVL). Carvedilol, an NSBB with additional benefits, is preferred for compensated cirrhosis. However, no randomised controlled trial (RCT) has compared carvedilol with propranolol, a conventional NSBB, in combination with EVL for secondary prophylaxis. This study aims to compare the effectiveness and safety of these treatments in preventing variceal rebleeding or death in patients with cirrhosis and EVB.

Methods and analysis
This multicentre, RCT is scheduled to begin in December 2024, with recruitment and follow-up continuing until December 2026. Eligible participants are patients with liver cirrhosis and EVB. Participants are randomly assigned in a 1:1 ratio to receive EVL combined with either carvedilol or propranolol. The primary endpoint is the incidence of variceal rebleeding or all-cause death. Secondary endpoints include all-cause death, liver-related death, each of the complications of portal hypertension (overt ascites, overt hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome, portal vein thrombosis), hepatocellular carcinoma, changes in liver function (assessed by Child-Pugh and Model for End-Stage Liver Disease scores), changes in liver stiffness, changes in spleen stiffness, and adverse events. Subgroup and sensitivity analyses will be conducted to evaluate the consistency and robustness of the treatment effects. A total sample size of 524 patients (262 per group) is required to detect a significant difference between the treatment arms.

Ethics and dissemination
The study protocol has been approved by the ethics committee of the First Hospital of China Medical University (No. 2024-656-2). The study will follow the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this trial will be disseminated through peer-reviewed publications, conference presentations and healthcare professionals to guide future clinical practice.

Trial registration number
Chinese Clinical Trial Registry (Registration number: ChiCTR2400089692).

Introduction
Early and lifelong treatment is essential in patients with familial hypercholesterolaemia (FH) due to genetically elevated low-density lipoprotein cholesterol (LDL-C) from the first years of life. In women with FH, lipid-lowering treatment is interrupted during childbearing years due to contraindication of the medication during conception, pregnancy and breastfeeding. However, little is known about the impact of breastfeeding on lipid profile and other risk markers for atherosclerotic cardiovascular disease (ASCVD) in women with FH compared with women without hypercholesterolaemia, and to what extent statins transfer into breast milk.
We aim to investigate (1) the association between breastfeeding and serum lipid profile in women with and without FH; (2) the association between breastfeeding and other ASCVD risk markers in women with and without FH and (3) the concentration of statins in breast milk of women with FH.

Methods and analysis
FH-FEMINA is a prospective study aiming to include 50 women with FH in Norway, the Netherlands and the Czech Republic. Additionally, 20 women without hypercholesterolaemia will be enrolled as a control group in Norway. Women will be included at the first study visit in gestational week 36, and follow-up visits will be scheduled at 2–4 weeks, and at 3, 6, 9 and 12 months postpartum. Information on lifestyle factors, treatment history and current and previous pregnancies will be collected. At each visit, a non-fasting blood sample, breast milk sample and information on diet, body mass index and blood pressure will be collected. Additional blood samples will be collected from the women with FH at 2, 4, 5, 7, 8, 10 and 11 months postpartum for as long as they are breastfeeding. At (re-)initiation of statin treatment, breast milk samples from women with FH will be collected for drug concentration measurements.

Ethics and dissemination
Ethical approval will be obtained prior to study start in all three countries. Participants will be informed about the study and receive ample time to ask questions before the informed consent form is signed. The findings from this study will be disseminated to healthcare professionals, researchers and patients via peer-reviewed scientific article(s), conferences, patient organisations and social media.

Trial registration number
NCT05367310.

Introduction
The management of immunoglobulin A (IgA) nephropathy remains a topic of debate. Hydroxychloroquine and mycophenolate mofetil (MMF) are two immunosuppressive agents that have recently garnered increased attention among patients with IgA nephropathy in China. Several studies have shown the comparable efficacy between MMF and enteric-coated mycophenolate sodium (EC-MPS), with lower adverse event rates for EC-MPS. The present study aims to evaluate the efficacy and safety of EC-MPS combined with hydroxychloroquine as an immunosuppressive regimen for patients with high-risk progressive IgA nephropathy, despite receiving routine supportive treatment.

Methods and analysis
This study is a multicentre, prospective, randomised controlled, open-label, blinded endpoint trial. 96 patients diagnosed with IgA nephropathy and persistent proteinuria from 12 general hospitals in Shanxi Province of China will be recruited and randomly assigned to receive either EC-MPS plus hydroxychloroquine or hydroxychloroquine alone in a 1:1 ratio. We will compare the efficacy and safety of hydroxychloroquine combined with or without oral EC-MPS (720–1080 mg/day for 6 months, and tapered to 360–540 mg/day for another 6 months) on a background of supportive care. All enrolled patients will receive standard basic treatment to achieve optimum blood pressure and the maximum tolerated dose of ACE inhibitors or angiotensin receptor blockers. The primary outcome is the change in 24-hour urine protein at 6 months relative to baseline. Participants will be subject to regular follow-up for a duration of 12 months.

Ethics and dissemination
This study has received ethical approval from the Ethics Committee of Shanxi Medical University Second Hospital (No. 2024YX-481). A duly signed and dated informed consent form must be obtained from each participant or his/her legal guardian prior to any operational procedures related to the trial. The result of this study will be presented and published at international conferences and in scientific journals.

Trial registration number
ChiCTR2400093530.

Objective
The objective is to examine the correlation of anti-phosphatidylethanolamine (aPE) antibodies with premature birth. Premature birth is an important risk factor for infant mortality and subsequent development of mental, metabolic and cardiovascular diseases. However, the risk factors associated with preterm birth are not well understood. aPE antibodies are an anti-phospholipid autoantibody that is thought to be a factor in pathological pregnancy. However, aPE antibodies have not been included in the classification criteria for antiphospholipid syndrome. Therefore, we aimed to check the clinical significance of aPE antibodies in association with premature birth.

Design
We conducted a retrospective analysis of 442 pregnant women who had experienced at least one unexplained miscarriage and were tested for aPE antibodies and compared their clinical characteristics, coagulation indicators, immune biomarkers and pregnancy outcomes. Logistic regression analysis was employed to identify factors associated with premature birth.

Setting
Ruian City, Wenzhou, Zhejiang Province, China.

Participants
A total of 442 patients with ultrasound-confirmed intrauterine pregnancy from the Third Affiliated Hospital of Wenzhou Medical University between May 2018 and December 2022 were retrospectively selected and included in the study. The inclusion criteria were as follows: having been tested for aPE and having experienced at least one unexplained miscarriage. The exclusion criteria were as follows: (a) incomplete clinical records, (b) being positive for typical antiphospholipid antibodies (aPL, aβ2-GP1 and LA), (c) hormone or metabolic disorder, (d) lost to follow-up, (e) known clinical autoimmune diseases, (f) severe reproductive system infection or malformation, (g) fetal loss: pregnancy loss before 24 weeks and (h) multiple pregnancy. In this study, preterm birth was defined as birth before 37 weeks.

Primary and secondary outcome measures
We enrolled 442 patients in our study: 60 pregnancies with premature birth and 382 pregnancies with term birth.

Results
Our findings revealed that among the 442 participants, 13.6% had a premature birth (

Introduction
Existing interventions for people with Parkinson’s disease (PwP) often fall short in addressing gait disturbances and falls, impacting their quality of life. The CUE1 non-invasive medical device, along with its updated version, CUE1+, offers vibrotactile stimulation with cueing. The device shows promise in alleviating motor symptoms and reducing falls based on early user testing and a 9-week pilot study. This study aims to assess the usability, safety, tolerability and effectiveness of CUE1+ in improving Parkinson’s symptoms compared with a sham device over a 12-week period.

Methods and analysis
This multicentre, phase II double-blind randomised controlled trial will recruit 50 PwP from Barts Health and Homerton NHS Hospitals, enrolling them at Queen Mary University of London. Participants, diagnosed with idiopathic Parkinson’s, aged 18+ and providing written consent, will be randomly assigned to either the experimental group (CUE1+ device) or control group (sham device). The primary outcome is the device usability over 12 weeks. Measures include the recruitment, compliance and dropout rates, and safety/tolerability which will be collected through a participant clinical diary at baseline (week 0) and follow-up (week 13). Effectiveness will be evaluated at the same time points using movement tests (MDS-UPDRS Part III, Functional Gait Assessment, Timed Up and Go in isolation and with dual tasking and two keyboard-based typing tests—Bradykinesia Akinesia Incoordination and Digital Finger Tapping), with video recordings. Participants will wear a Parkinson’s KinetiGraph wristband to monitor symptoms at home continuously for 12 weeks and collect real-world data. Patient-reported outcomes will be collected at baseline and follow-up and include MDS-UPDRS Part I, II and IV, Activity-specific Balance Scale, Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Fatigue Symptom Scale and Parkinson’s Disease Questionnaire-39.

Ethics and dissemination
The study has received ethical approval from London-Dulwich Research Ethics Committee (reference: 23/PR/1526). Findings will be submitted for peer-reviewed publications.

Trial registration number
NCT06174948.

Objectives
This review summarises the impact of hip fractures on health outcomes including subsequent falls, hospitalisation, length of hospital stay (LOS), functional status, quality of life and mortality in older adults with cognitive impairment or dementia. It also explores the risk of institutionalisation following a hip fracture in this population.

Design
A scoping review following the Arksey and O’Malley framework guided by the Joanna Briggs Institute methodology and adheres to Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews guidelines.

Data sources
A comprehensive search strategy was developed to search MEDLINE, EMBASE, CINAHL and grey literature, with additional references identified through citation searching and Web of Science.

Eligibility criteria
Studies were included if they examined older adults with cognitive impairment or dementia who experienced a hip fracture and reported outcomes related to hospitalisation, functional status, quality of life, mortality or institutionalisation.

Data extraction and synthesis
Study selection and data extraction were conducted independently by two reviewers using Covidence software. A narrative synthesis approach was employed to summarise findings and identify key themes, patterns and gaps in the literature.

Results
We identified 30 studies reporting health outcomes following hip fracture. Overall, the studies indicated that individuals with cognitive impairment or dementia have higher hospitalisation rates, poorer walking ability and functional outcomes, as well as reduced quality of life posthip fracture. The LOS for individuals with dementia following hip fracture was inconsistent across studies, with some reporting shorter LOS and others indicating longer LOS. Individuals with dementia consistently exhibit higher mortality rates at 30 days, 90 days and 1-year postfracture compared with those without dementia. We found 21 studies that evaluated the risk of institutionalisation following a hip fracture. Older adults with dementia were significantly more likely to be institutionalised posthip fracture, with nearly five times the risk of failing to return home compared with those without dementia. This increased risk persists up to 1-year postfracture and is particularly pronounced in those with severe cognitive impairment, with higher rates of nursing home placement observed among individuals with hip fractures.

Conclusion
Older adults with cognitive impairment or dementia experience significantly worse outcomes following hip fractures, including higher mortality, poorer functional outcomes, reduced quality of life and a higher risk of institutionalisation postfracture. Future research should focus on developing effective strategies for fracture prevention, including optimising osteoporosis treatment in this high-risk population, and developing targeted interventions to improve the impact of fractures on functional outcomes and reduce institutionalisation rates in this vulnerable population.