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Feasibility of a theory-based intervention towards benzodiazepine deprescribing in Belgian nursing homes: protocol of the END-IT NH cluster-randomised controlled trial
Introduction
Despite several calls to deprescribe benzodiazepine receptor agonists (BZRA) in older adults, their use among nursing home residents (NHRs) remains high. Therefore, we developed an intervention targeting general practitioners’ and healthcare professionals’ behaviours regarding BZRA deprescribing in nursing homes (NHs): The END-IT NH (bENzodiazepines Deprescribing InTerventions Nursing homes) 6-component intervention. Before moving on to a large-scale effectiveness and cost-effectiveness evaluation, this feasibility study aims at: (1) assessing the feasibility of the intervention implementation in NHs, (2) assessing the feasibility of conducting a larger-scale evaluation, in terms of recruitment and data collection and (3) conducting an exploratory cost-effectiveness evaluation.
Methods and analysis
We will conduct a cluster-randomised controlled trial in a sample of 6 NHs, with 10–15 NHRs included per NHs. Four NHs will be randomised into the intervention group, and two NHs will deliver usual care (control group). Data collection will occur at baseline, 3, and 6 months (study end). We will collect information to explore implementation fidelity, mechanisms of impact and contextual factors at patient-level, NH-level and healthcare professional-level, using both quantitative and qualitative measures. The feasibility of the study conduction will be assessed by measuring recruitment and attrition rates and completeness of data collection. An exploratory cost-effectiveness evaluation will be conducted based on quality of life and healthcare use and cost data.
Ethics and dissemination
This study protocol received approval from the ethical committee of CHU UCL Namur on the 20 June 2023. All data are confidential and will be anonymised prior to analysis. De-identified data will be shared on a data depository with a 2-year embargo. The results of the study will be disseminated through a scientific paper and will be communicated to local stakeholders and policymakers through a local symposium.
Trial registration number
NCT05929443.
Impact of financial incentives introduced during the COVID-19 pandemic on nursing staff: a mixed-method protocol
Introduction
The COVID-19 pandemic has had a major impact on nursing staff, resulting in alarming turnover rates. As part of the Quebec (Canada) government’s response to the pandemic, nurses have been offered exceptional financial incentives. Considering the cost of these measures, the current article presents the research protocol of a study aiming to explore the impact of financial incentives on full-time equivalent, and retention rates among the nursing staff in two healthcare settings in Quebec.
Methods and analysis
A sequential mixed design (QUANT- >QUAL) will be used. The quantitative phase will involve a quantitative descriptive analysis and the qualitative phase will consist of a qualitative descriptive study. Administrative data (working hours, employment status and retention rate) will be analysed over a 4.5-year follow-up (from 1 January 2019 to 30 June 2023) to explore the impact of the financial incentives. Focus groups will explore nurses’ views on financial incentives. The results will inform the development of future interventions to mitigate attrition problems among nurses and ultimately improve access to and the continuity of public health services.
Ethics and dissemination
The study has been approved by ethics committees of the participating healthcare settings (Comité d’éthique de la recherche sectorial en santé des populations et première ligne du CIUSSS de la Capitale-Nationale; Comité d’éthique de la recherche du CISSS de Chaudière-Appalaches). The results will be disseminated mainly in scientific publications and at academic conferences in addition to presentations tailored to various non-academic audiences.
Assessment of bleeding events in patients receiving DOACs with or without statins to treat venous thromboembolism: insights from the RIETE registry
Objective
To evaluate the impact of coadministering statins with direct oral anticoagulants (DOACs) on the risk of major bleeding events in patients with venous thromboembolism (VTE).
Design
Observational cohort analysis based on a multicentre international registry.
Setting
Data were extracted from the Registro Informatizado de Enfermedad TromboEmbolica Registry, which involves 205 centres across 27 countries.
Participants
A total of 73 659 patients diagnosed with VTE were classified based on their anticoagulant therapy (DOACs) versus low-molecular-weight heparin (LMWH) or vitamin K antagonists (VKAs) and concurrent use of statins.
Methods
Multivariable Cox proportional hazards models adjusted for confounding variables to assess the risk of major bleeding events stratified by the type of anticoagulant use and statin use.
Results
From October 2013 to February 2023, 73 659 patients were recruited: 2573 were statin users on DOACs, 14 090 were statin users on LMWH or VKA therapy, 10 088 were non-statin users on DOACs and 46 908 were non-statin users on LMWH or VKA therapy. Statin users were 10 years older and more likely to have hypertension, diabetes, renal failure or prior artery disease. During anticoagulation (median, 187 days), 1917 patients (2.6%) suffered major bleeding. Rates of major bleeding per 100 patient-years were 2.33 (95% CI 1.72 to 3.09), 3.75 (95% CI 3.43 to 4.10), 1.39 (95% CI 1.13 to 1.69) and 3.10 (95% CI 2.93 to 3.27), respectively. On multivariable analysis, patients treated with DOACs had a significantly lower risk of major bleeding compared with those on LMWH or VKA therapy (adjusted HR 0.59; 95% CI 0.48 to 0.74). The adjusted HR in statin users versus non-users was 1.03 (95% CI 0.92 to 1.14), while in statin users on DOACs versus the rest of patients, it was 1.18 (95% CI 0.79 to 1.76).
Conclusions
In patients with VTE receiving statins, long-term anticoagulation with DOACs was associated with a reduced risk of major bleeding, regardless of the statin use. These findings support the safety profile of DOACs over VKAs or LMWH in the management of VTE in patients requiring statins.
Piloting a patient navigation programme for individuals living with dementia, their care partners and members of the care team: protocol for a mixed-methods evaluation
Introduction
Internationally, the number of individuals living with dementia continues to rise. Individuals living with dementia, their care partners and their care team face many barriers and challenges to accessing dementia care resources and supports. One solution to address the multifaceted care needs of this population is patient navigation (PN).
Methods and analysis
This protocol describes the implementation and evaluation plan for a pilot PN programme in New Brunswick (NB) Canada for individuals living with dementia, their care partners and care providers. This project will include two components: (1) an in-person PN programme called Navigating Dementia NB/ Naviguer la démence NB and (2) two virtual peer-to-peer navigational support groups. The PN programme will be codesigned with stakeholders including researchers, patient partners, clinicians and health system managers. Patient navigators will be housed at six primary care sites across the province and the services will be offered in English and French. We will conduct a mixed-methods evaluation to explore the characteristics and experiences of participants who enrol in the PN programme and the navigational support groups, as well as the facilitators and barriers to implementation. Data collection will include navigation charts, Facebook analytics, as well as postintervention surveys, semistructured interviews and focus groups. All participants will provide written informed consent to take part in the intervention and have their data collected for research and evaluation purposes. Demographic data will be analysed using frequency and central tendency measures, while qualitative data from interviews and focus groups will undergo thematic analysis. Content analysis will be used to analyse posts published to the Facebook groups. The evaluation will assess the programme’s effectiveness in the short and medium terms, evaluating its ability to achieve the intended outcomes.
Ethics and dissemination
This study has been approved by the research ethics boards at the University of New Brunswick, Université de Moncton, Horizon Health Network and Vitalité Health Network. Knowledge translation activities (eg, presentations at local, national and international conferences; publications for open-access journals; reports and lay summaries) will be undertaken to share the findings from this pilot project with diverse stakeholders, such as decision-makers, health system managers, clinicians and the general public.
Elsewhere in The AGA Journals (Preview Section)
Comparative Efficacy of Advanced Therapies for Management of Moderate-to-Severe Ulcerative Colitis: 2024 American Gastroenterological Association Evidence Synthesis
We performed an updated systematic review and network meta-analysis to inform the 2024 American Gastroenterological Association (AGA) Clinical Guidelines on the management of moderate-to-severe ulcerative colitis (UC).
Alla guida dopo aver bevuto, il 5% degli italiani rischia
Dati Iss, il 66% senza cintura nei sedili posteriori, il 20% non usa il seggiolino per i bambini
Metabolic and bariatric surgery for obstructive sleep apnoea syndrome: bibliometric analysis and visualisation from 1999 to 2023
Objectives
Metabolic and bariatric surgery (MBS) for obstructive sleep apnoea syndrome (OSAS) has garnered significant research interest. The main aim of this study was to analyse the unique characteristics of publications centred around MBS for OSAS. We aimed to provide valuable insights into the present status of the field and offer predictions regarding future trends.
Design
Bibliometric analysis through science mapping and performance analysis methods.
Data sources
Scientific articles.
Data extraction and synthesis
A comprehensive search was conducted in the Web of Science database to retrieve publications on MBS for OSAS within the time frame of 1999–2023. The search was performed using keywords such as “Obstructive Sleep Apnea syndrome”, “OSAS”, “metabolic surgery” and “bariatric surgery” to identify relevant papers. To analyse the bibliometric characteristics of these publications, VOSviewer and R software were used. This analysis encompassed various aspects, including the number of publications, contributions by different countries and institutions, the most cited author, journal publications, citation frequency and the identification of keywords related to popular scientific fields.
Results
1264 papers on MBS for OSAS were identified and are currently in a stage of rapid growth. The relevant study involved 1230 institutions from 53 different countries, with the USA topping the field with 465 publications contributed. Assistance Publique Hopitaux Paris proved to be the most productive institution, with De Vries N posting the highest number of papers (n=24). The most prolific journal was Obesity Surgery, with 241 publications. Keywords “Bariatric surgery”, “Obstructive sleep apnea”, “Obesity”, “Weight loss” and “Morbid obesity” have the highest frequency of occurrence.
Conclusions
The relationship between obesity and OSAS, various metabolic surgical techniques, and the mechanism of MBS for OSAS will continue to be related areas of frontiers. Furthermore, while there has been a gradual increase in basic research, the mechanisms involved and the long-term efficacy of bariatric MBS for OSAS still require further investigation. It is anticipated that these research areas may emerge as potential hot topics in the future.
In Memoriam: Ikuo Hirano, MD
On Monday morning, July 22nd, 2024, Dr Ikuo Hirano passed away after a heroic battle with pancreatic cancer. A brilliant physician and researcher, Dr Hirano was an American Gastroenterological Association (AGA) and physician leader in so many ways. A graduate of Yale University and the University of Pennsylvania School of Medicine, Ikuo completed his residency and gastroenterology fellowship at Beth Israel Hospital, Harvard Medical School, in Boston. He began his career at the West Roxbury VA, where he quickly achieved success, winning the prestigious teaching award at Brigham and Women’s Hospital.
AGA Clinical Practice Update on Advances in Per-Oral Endoscopic Myotomy (POEM) and Remaining Questions—What We Have Learned in the Past Decade: Expert Review
This American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) aims to review the available evidence and provide expert advice regarding advances in per-oral endoscopic myotomy (POEM).
Screening, diagnosis, treatment and outcomes of developmental dysplasia of the hip in Brazilian population: a scoping review protocol
Introduction
Developmental dysplasia of the hip (DDH) includes a spectrum of clinical and imaging findings at birth or early infancy. The circumstances in which this condition is detected and managed may be heterogeneous in Brazil owing to its large territory and regional socio-economic differences. Mapping DDH perspectives in a country is fundamental for designing guidelines and strategies for public policy. This scoping review aims to map the available literature related to screening, diagnosis, treatment and outcomes of DDH in the Brazilian population to provide an overview of this condition and to describe regional variations in presentation and management across the country.
Methods and analysis
This study will follow the methods outlined in the Joanna Briggs Institute Reviewers manual for conducting a scoping review. Relevant publications will be first searched in PubMed/MEDLINE, Scientific Electronic Library Online, Web of Science, Scopus, “Biblioteca virtual em saúde” and “Biblioteca Digital Brasileira de Teses e Dissertacões” using search terms developed from a brief preliminary search of those databases. There were no language or date range limitations for study inclusion. Databases will be searched from their inception until February 2024. Titles and abstracts will be analysed by two or more independent reviewers to assess them against the inclusion criteria for the review. The search results and study inclusion process will be reported in full in the final version of the scoping review and presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping review (PRISMA-ScR) flowchart. The resulting data will be recorded and organised to present the key information contained in all examined articles.
Ethics and dissemination
This review will include existing available studies and does not require a specific ethical review or approval. The final study will be submitted for presentation at conferences that focus on Brazilian healthcare and publication in peer-reviewed journals. This scoping review protocol was registered in the Open Science Framework. DOI registration (https://doi.org/10.17605/OSF.IO/V3AYH).
Effects of a sedentary behaviour intervention in emergency dispatch centre phone operators: a study protocol for the SECODIS randomised controlled cross-over trial
Introduction
Sedentary behaviour is a public health problem. We mainly have sedentary behaviour at work, transforming them into occupational risk. To our knowledge, there is no intervention study on the reduction of occupational sedentary behaviour in a real work situation and its impact on health and biomarkers of stress. The main objective is to study changes in sedentary behaviour following a behavioural intervention (sit-and-stand desk and cycle ergometer).
Methods and analysis
This is a randomised controlled trial in cross-over design conducted in a single centre. The study will be proposed to emergency medical dispatchers of Clermont-Ferrand. Each volunteer will be followed during three cycles of 1 week (3 weeks in total). Each 1-week cycle is made up of 12 hours of work (three conditions: a control and two interventions), 12 hours of successive rest and 6 days of follow-up. For each condition, the measurements will be identical: questionnaire, measure of heart rate variability, electrodermal activity and level of physical activity, saliva and blood sampling. The primary outcome is sedentary behaviour at work (ie, number of minutes per day standing/active). Data will be analysed with both intention-to-treat and per protocol analysis. A p
Long-term probabilistic forecasts of activity mitigation in English hospitals: a national elicitation exercise providing an outside view based on judgements of experts in support of the New Hospital Programme
Objectives
The planning process for a new hospital relies on assumptions about future levels of demand. Typically, such assumptions are characterised by point estimates, the flaw-of-averages, base-rate neglect and overoptimism from an inside view. To counteract these limitations, we elicited an outside view of probabilistic forecasts based on judgements of experts about the extent to which various types of hospital activity might be mitigated over 20 years, in support of the New Hospital Programme (NHP) in the English National Health Service.
Design
A prospective online elicitation exercise, over two rounds, to forecast the reduction (0% no reduction to 100% total reduction) in 77 types of hospital activity across England via five types of activity mitigation: outpatient attendance avoidance (n=8); inpatient admission avoidance (n=31); A&E attendance avoidance (n=12); outpatient delivery mode (n=4); inpatient length of stay reduction (n=22) and eight types of activity groups.
Primary outcomes are the aggregated forecasts representing the percentage reduction (0%–100%) in hospital activity across England based on ‘surprisingly low’ (10th percentile—P10) to ‘surprisingly high’ (90th percentile—P90) forecasts from 17 experts.
Results
We had 657 forecasts from 17 experts. The most pessimistic forecast was for inpatient avoidance of frail elderly admissions (mean 5.71%, P10=0.43%, P90=16.40%). The most optimistic forecast was for inpatient admission avoidance for vascular surgery (mean 48.27%, P10=19.82%, P90=78.57%). The overall (n=77) aggregate means ranged from a low of 5.71% to a high of 48.27% with an average width of 50.08%. Experts highlighted mainly four types of mitigation mechanisms—prevention, displacement, quality improvement and de-adoption.
Conclusion
A national elicitation exercise has provided long-term aggregate forecasts across England that make explicit the wide variation and uncertainty associated with future mitigation activities from an outside perspective. These aggregate forecasts may now be incorporated into the NHP, providing a more robust foundation for planning.
Long-Term Outcomes After Septal Reduction Therapies in Obstructive Hypertrophic Cardiomyopathy: Insights From the SHARE Registry
Circulation, Ahead of Print. BACKGROUND:Septal reduction therapy (SRT) provides substantial symptomatic improvement in patients with obstructive hypertrophic cardiomyopathy (HCM). However, long-term disease course after SRT and predictors of adverse outcomes have not been systematically examined.METHODS:Data from 13 high clinical volume HCM centers from the international SHARE (Sarcomeric Human Cardiomyopathy Registry) were analyzed. Patients were followed from the time of SRT until last follow-up or occurrence of heart failure (HF) composite outcome (cardiac transplantation, implantation of a left ventricular assist device, left ventricular ejection fraction
Prospective cohort for early detection of liver cancer (Pearl): a study protocol
Introduction
Hepatocellular carcinoma (HCC) is the fastest-rising and fourth most common cause of cancer death worldwide. Liver cirrhosis is the largest underlying risk factor for HCC. Therefore, patients with cirrhosis should have regular ultrasound and biochemical screening to pick up early HCC. Early HCC can be cured; more advanced HCCs have limited treatment options and poor prognosis. Current screening methods are suboptimal with poor sensitivity in picking up early disease. In this study, the investigators aim to recruit people with liver cirrhosis into a Prospective cohort for early detection of liver cancer—the Pearl cohort. The investigators believe that by using state-of-the-art tests we can improve the detection of early HCC.
Methods and analysis
This is a UK-based prospective, longitudinal, diagnostic, prognostic, multicentre, non-CTIMP study. Aiming to recruit 3000 patients with liver cirrhosis without a HCC diagnosis, the Pearl cohort will be followed actively for 3 years from recruitment and then passively via registry data for ten years thereafter. Blood and urine samples will be taken and information from routine care will be gathered. These will be used to assess novel diagnostic approaches for the detection early HCC and to develop models to identify those most at risk for developing HCC.
Participants will be linked to national UK health registries to ensure long-term capture of HCC incidence and other relevant endpoints. Approximately 75 patients are predicted to develop de novo HCC within the 3-year follow up period. After this period, the study teams will obtain data on participants for at least 10 years after the last contact. This cohort will help develop an understanding of the incidence of HCC in a UK population stratified by underlying cirrhosis aetiology.
Ethics and dissemination
Ethical approval has been granted by REC and the trial is registered on ClinicalTrials.gov. The results will be published in peer-reviewed journals and presented at relevant meetings.
Trial registration number
NCT05541601.