Treatments, medical expenses and complications of hospital outpatient healthcare associated with stroke in patients with diabetes in China: a retrospective analysis of the Beijing Municipal Medical Insurance Database

Objectives
Diabetes is closely associated with risk of stroke and its adverse sequelae. Approximately 20%–33% of patients with stroke have diabetes. In China, however, it is unclear how stroke affects healthcare utilisation, medications and complications among people with diabetes. This study aimed to analyse the clinical characteristics, treatment options, medical expenses and complications of hospital outpatient healthcare associated with stroke in patients with diabetes in China.

Design
A retrospective, multicentre, observational study.

Setting
Beijing Municipal Medical Insurance Database, with data from 2016 to 2018.

Participants
The study included patients with diabetes whose data included 2016–2018 outpatient medication records and who had Beijing medical insurance. Patients who did not have continuous prescription records for more than 2 months were excluded from the analysis. In total, 2 853 036 people with diabetes were included, and patients who had and did not have a stroke were compared.

Results
In our study, 19.75%–22.30% of patients with diabetes suffered from stroke between 2016 and 2018. The average annual medical cost for a patient diagnosed with diabetes is ¥9606.65, and the cost increases to ¥13 428.39 when diabetes was combined with stroke; thus, stroke increases the medical cost for patients with diabetes by 39.78% (p

Leggi
Ottobre 2024

Real-world safety profile of zanubrutinib: a disproportionality analysis based on the FAERS database

Objective
Zanubrutinib is a second-generation Bruton’s tyrosine kinase inhibitor that has been approved for the treatment of several B cell malignancies. The aim of this study was to evaluate adverse events (AEs) associated with zanubrutinib based on the real-world data.

Design
A disproportionality analysis was performed to identify the potential zanubrutinib-related AEs.

Setting
The Food and Drug Administration AE Reporting System database from the fourth quarter of 2019 to the third quarter of 2023.

Main outcome measures
The results of the disproportionality analyses were presented as reported ORs (RORs). When the lower limit of the 95% CI for the ROR is greater than 1 and the number of AE reports is≥3, it indicates that the preferred term (PT) may be a positive AE signal.

Results
A total of 846 AE reports with zanubrutinib as the primary suspect drug were obtained, with 2826 AEs. A total of 74 positive PT signals were detected across 18 system organ classes (SOCs). The most significant signal for SOC was ‘blood and lymphatic system disorders’ (ROR=2.8, 95% CI 2.3 to 3.3), while the most significant signal for PT was ‘haemorrhage subcutaneous’ (ROR=190.8, 95% CI 128.0 to 284.5). 13 unexpected off-label AEs were also observed, such as abnormal hair texture, skin discolouration, hypernatraemia, pericardial effusion and hypersomnia. The median time to onset of AEs associated with zanubrutinib was 51 days (IQR 13–192 days) and was consistent with the early failure model. In comparison with zanubrutinib monotherapy, the combination of zanubrutinib and rituximab therapy was linked to a higher risk of specific AEs, including myelosuppression, pneumonia, leucopenia, thrombocytopenia, abdominal pain, anaemia, pancytopenia and respiratory failure. Furthermore, the combination of zanubrutinib and chemotherapy increased the risk of several severe AEs, such as cardiac arrest, elevated blood lactate dehydrogenase levels and pancytopenia.

Conclusions
The results of the analysis provided valuable insights into the safety profile of zanubrutinib-treated patients, which was helpful for clinical monitoring and identifying potential AEs related to zanubrutinib.

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Ottobre 2024

Akrivia Health Database–deep patient characterisation using a secondary mental healthcare dataset in England and Wales: cohort profile

Purpose
The Akrivia Health cohort was created to extract data from electronic health records in secondary mental health and dementia care services in England and Wales. The data are anonymised, structured and harmonised from the source electronic health records across a range of information technology systems, enabling for unified, privacy-preserving access for research purposes.

Participants
The cohort contains data from electronic health records for over 4.6 million patients in England and Wales, as of January 2024. The data are refreshed with regularity, and the dataset expands whenever a new healthcare provider joins the Akrivia network. 13% of the database are patients under 18 years old (n=590 160), 56% are adults 18–65 years old (n=2 631 690) and 31% are older people (n=1 422 609). About 11.5% are deceased (n=538 371).

Findings to date
Structured data include patient demographics and service pathways. Akrivia Health also uses a bespoke natural language processing model to further extract the research-relevant information from free-text progress notes, including diagnoses, medications and clinical symptoms. This allows for an in-depth longitudinal description of patient journeys.

Future plans
The anonymised data can be accessed in collaboration with Akrivia Health, following the National Health Service guidelines and without requiring a separate ethics application. There is no planned end date for data collection.

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Ottobre 2024

Prevalence and management of ectopic and molar pregnancies in 17 countries in Africa and Latin America and the Caribbean: a secondary analysis of the WHO multi-country cross-sectional survey on abortion

Introduction
There are limited global data on ectopic pregnancy (EP) and molar pregnancy (MP), making it important to understand their epidemiology and management across different regions. Our study aimed to describe their prevalence for both conditions, severity of their complications and management among women in selected health facilities across 17 countries in Africa and Latin America and the Caribbean (LAC).

Methods
This is a secondary analysis of the WHO multi-country survey on abortion. Data were collected from 280 healthcare facilities across 11 countries in Africa and 6 in LAC. Sociodemographic information, signs and symptoms, management and clinical outcomes were extracted from medical records. Facility-level data on post-abortion care (PAC) capabilities were also collected, and facilities were classified accordingly. 2 or Fisher’s exact tests were used to compare categorical data.

Results
The total number of women with EP and MP across both regions was 9.9% (2 415/24 424) where EP accounted for 7.8% (1 904/24 424) and MP for 2.1% (511/24 424). EP presented a higher severity of complications than MP. At admission, 49.8% of EP had signs of peritoneal irritation. The most common surgical management for EP was laparotomy (87.2%) and for MP, uterine evacuation (89.8%). Facilities with higher scores in infrastructure and capability to provide PAC more frequently provided minimal invasive management using methotrexate/other medical treatment (34.9%) and laparoscopy (5.1%).

Conclusion
In Africa and LAC, EP and MP cause significant maternal morbidity and mortality. The disparity in the provision of good quality care highlights the need to strengthen the implementation of evidence-based recommendations in the clinical and surgical management of EP and MP.

Leggi
Ottobre 2024

[Review] Designing for medication adherence in inflammatory bowel disease: multi-disciplinary approaches for self-administrable biotherapeutics

Biotherapeutics are among the therapeutics that have revolutionized standard inflammatory bowel disease (IBD) treatment, which was previously limited to mesalamine, 5-aminosalicylic acid, corticosteroids, and classical immunosuppressants. Self-administrable biotherapeutics for IBD would enable home-based treatment and reduce the burden on medical infrastructure. Self-administration is made possible through subcutaneous injectable, oral, and rectal dosage forms. Nevertheless, the full benefits of self-administration cannot be realized without first addressing the issue of medication adherence, which remains woefully inadequate for IBD biotherapies.

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Ottobre 2024

ECO-MIND: enhancing pro-environmental behaviours and mental health through nature contact for urban youth – a research protocol for a multi-country study using geographic ecological momentary assessment and mental models

Introduction
Urban youth are experiencing increasing mental health problems due to diverse personal, social and environmental concerns. Youths’ detachment from natural environments, including green and blue spaces, may intensify such issues further. Contact with nature can benefit mental health and promote pro-environmental behaviour (PEB). Yet, only a few studies assess these relationships among the youth usually ignoring effects of living in diverse urban contexts, and everyday nature experiences. ECO-MIND will investigate whether urban youth’s dynamic greenspace exposure and their mental models about nature connectedness explain the associations between greenspace exposure, mental health and PEB in multiple urban contexts.

Methods and analysis
We will collect data from university students from the Global South (ie, Dhaka, Kampala) and Global North cities (ie, Utrecht). Participants aged 18–24 will be recruited through stratified random sampling. We will use geographic ecological momentary assessment to assess respondents’ everyday experiences and exposure to greenspaces. Our definition of greenspace exposure will be based on the availability, accessibility and visibility of greenspaces extracted from satellite and street view images. We will administer a baseline questionnaire to participants about mental health, nature connectedness and PEB characteristics. Further, we will ask participants to build mental models to show their perception of nature connectedness. Finally, we will fit partial least square structural equation models and multi-level models to our longitudinal geographic momentary assessment data.

Ethics and dissemination
The study was approved by the Ethical Review Board of the Utrecht University (Geo S-23221). Informed consent must be given freely, without coercion and based on a clear understanding of the participation in the study. Findings will be disseminated in peer-reviewed journals and at conferences. Furthermore, we will implement public engagement activities (eg, panel discussion) to share results among local stakeholders and policymakers and cocreate policy briefs.

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Ottobre 2024

Effect of telemonitoring on the rate of dropout during home non-invasive ventilation: a retrospective study using a home care provider database

Objectives
Telemonitoring (TM) of home non-invasive ventilation (NIV) has been shown to facilitate home/outpatient therapy set-up. However, the impact of long-term TM on therapy dropouts, compliance and leak control has not yet been clearly determined. This study evaluated whether the NIV dropout rate was reduced by TM combined with remote patient support compared with a non-telemonitoring (NTM) pathway.

Design
Retrospective cohort study.

Setting
Data were obtained from all agencies of a single home care provider in France.

Participants
Adults with chronic respiratory failure (n=659) who started nocturnal NIV between January 2017 and December 2019 and had ≥8 days of NIV therapy (51% male; mean age 68.5±13.8 years; 35.5% on long-term oxygen therapy) were included. The TM group included 275 patients who spent ≥80% of the follow-up using TM, and the NTM group included 384 patients who had 0 to ≤10 days of telemonitoring during follow-up.

Primary and secondary outcome measures
The primary outcome was the rate of NIV dropouts at 1 year (ie, treatment discontinuation, excluding deaths). Secondary outcomes included therapy compliance and leaks.

Results
82 patients died during follow-up. Significantly fewer patients in the TM vs NTM group had dropped out of NIV therapy at 1 year (13% vs 34%; p

Leggi
Ottobre 2024