Category: Nevin Manimala

Osteoporos Int. 2024 Aug 15. doi: 10.1007/s00198-024-07224-z. Online ahead of print.

ABSTRACT

PURPOSE: To identify the optimal statistical approach for predicting the risk of fragility fractures in the presence of competing event of death.

METHODS: We used real-world data from the Dubbo Osteoporosis Epidemiology Study that has monitored 3035 elderly participants for bone health and mortality. Fragility fractures were ascertained radiologically. Mortality was confirmed by the State Registry. We considered four statistical models for predicting fracture risk: (i) conventional Cox’s proportional hazard model, (ii) cause-specific model, (iii) Fine-Gray sub-distribution model, and (iv) multistate model. These models were fitted and validated in the development (60% of the original sample) and validation (40%) subsets, respectively. The model performance was assessed by discrimination and calibration analyses.

RESULTS: During a median follow-up of 11.3 years (IQR: 7.2, 16.2), 628 individuals (34.5%) in the development cohort fractured, and 630 (34.6%) died without a fracture. Neither the discrimination nor the 5-year prediction performance was significantly different among the models, though the conventional model tended to overestimate fracture risk (calibration-in-the-large index = – 0.24; 95% CI: – 0.43, – 0.06). For 10-year risk prediction, the multistate model (calibration-in-the-large index = – 0.05; 95% CI: – 0.20, 0.10) outperformed the cause-specific (- 0.23; – 0.30, – 0.08), Fine-Gray (- 0.31; – 0.46, – 0.16), and conventional model (- 0.54; – 0.70, – 0.39) which significantly overestimated fracture risk.

CONCLUSION: Adjustment for competing risk of death has minimum impact on the short-term prediction of fracture. However, the multistate model yields the most accurate prediction of long-term fracture risk and should be considered for predictive research in the elderly, who are also at high mortality risk. Fracture risk assessment might be compromised by the competing event of death. This study, using real-world data found a multistate model was superior to the current competing risk methods in fracture risk assessment. A multistate model is considered an optimal statistical method for predictive research in the elderly.

PMID:39145778 | DOI:10.1007/s00198-024-07224-z

Glob Health Action. 2024 Dec 31;17(1):2377828. doi: 10.1080/16549716.2024.2377828. Epub 2024 Aug 15.

ABSTRACT

BACKGROUND: Injuries, often preventable, prompted urgent action within the United Nations’ 2030 Agenda for Sustainable Development Goals (SDGs) to improve global health. South Africa (SA) has high rates of injury mortality, but accurate reporting of official national data is hindered by death misclassification.

OBJECTIVE: Two nationally representative surveys for 2009 and 2017 are utilised to assess SA’s progress towards SDG targets for violence and road traffic injuries, alongside changes in suicide and under-5 mortality rates for childhood injuries, and compare these estimates with those of the Global Burden of Disease for SA.

METHODS: The surveys utilised multi-stage, stratified cluster sampling from eight provinces, with mortuaries as primary sampling units. Post-mortem files for non-natural deaths were reviewed, with additional data from the Western Cape. Age-standardised rates, 95% confidence intervals (CIs), and incidence rate ratios (IRRs) were calculated for manner of death rate comparisons and for age groups.

RESULTS: The all-injury age-standardised mortality rate decreased significantly between 2009 and 2017. Homicide and transport remained the leading causes of injury deaths, with a significant 31% decrease in road traffic mortality (IRR = 0.69), from 36.1 to 25.0 per 100 000 population.

CONCLUSIONS: Despite a reduction in SA’s road traffic mortality rate, challenges to achieve targets related to young and novice drivers and male homicide persist. Achieving SA’s injury mortality SDG targets requires comprehensive evaluations of programmes addressing road safety, violence reduction, and mental well-being. In the absence of reliable routine data, survey data allow to accurately assess the country’s SDG progress through commitment to evidence-based policymaking.

PMID:39145429 | DOI:10.1080/16549716.2024.2377828

Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871.

ABSTRACT

PURPOSE: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct.

METHODS: A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop. The prototype was designed to comply with the FAIR principles (findable, accessible, interoperable, reusable), using MOLGENIS software. Metadata collection was piloted by 15 data access partners (DAPs) from across Europe.

RESULTS: A total of 442 metadata variables were defined in six domains: institutions (organizations connected to a data source); data banks (data collections sustained by an organization); data sources (collections of linkable data banks covering a common underlying population); studies; networks (of institutions); and common data models (CDMs). A total of 26 institutions were recorded in the prototype. Each DAP populated the metadata of one data source and its selected data banks. The number of data banks varied by data source; the most common data banks were hospital administrative records and pharmacy dispensation records (10 data sources each). Quantitative metadata were successfully extracted from three data sources conforming to different CDMs and entered into the prototype.

CONCLUSIONS: A metadata list was finalized, a prototype was successfully populated, and a good practice guide was developed. Setting up and maintaining a metadata catalogue on RWDSs will require substantial effort to support discoverability of data sources and reproducibility of studies in Europe.

PMID:39145406 | DOI:10.1002/pds.5871

Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5887. doi: 10.1002/pds.5887.

ABSTRACT

BACKGROUND: The Medicines Intelligence (MedIntel) Data Platform is an anonymised linked data resource designed to generate real-world evidence on prescribed medicine use, effectiveness, safety, costs and cost-effectiveness in Australia.

RESULTS: The platform comprises Medicare-eligible people who are ≥18 years and residing in New South Wales (NSW), Australia, any time during 2005-2020, with linked administrative data on dispensed prescription medicines (Pharmaceutical Benefits Scheme), health service use (Medicare Benefits Schedule), emergency department visits (NSW Emergency Department Data Collection), hospitalisations (NSW Admitted Patient Data Collection) plus death (National Death Index) and cancer registrations (NSW Cancer Registry). Data are currently available to 2022, with approval to update the cohort and data collections annually. The platform includes 7.4 million unique people across all years, covering 36.9% of the Australian adult population; the overall population increased from 4.8 M in 2005 to 6.0 M in 2020. As of 1 January 2019 (the last pre-pandemic year), the cohort had a mean age of 48.7 years (51.1% female), with most people (4.4 M, 74.7%) residing in a major city. In 2019, 4.4 M people (73.3%) were dispensed a medicine, 1.2 M (20.5%) were hospitalised, 5.3 M (89.4%) had a GP or specialist appointment, and 54 003 people died. Anti-infectives were the most prevalent medicines dispensed to the cohort in 2019 (43.1%), followed by nervous system (32.2%) and cardiovascular system medicines (30.2%).

CONCLUSION: The MedIntel Data Platform creates opportunities for national and international research collaborations and enables us to address contemporary clinically- and policy-relevant research questions about quality use of medicines and health outcomes in Australia and globally.

PMID:39145404 | DOI:10.1002/pds.5887

Endocrinol Diabetes Metab. 2024 Sep;7(5):e514. doi: 10.1002/edm2.514.

ABSTRACT

BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve cardiovascular (CV) outcomes in patients with or without Type 2 diabetes and heart failure (HF). However, studies have shown conflicting evidence regarding their efficacy in patients following acute myocardial infarction (MI). We conducted a pilot systematic review and meta-analysis to synthesise the available evidence regarding the effectiveness of SGLT2 inhibitors in MI.

METHODS: A systematic literature search was conducted using PubMed/MEDLINE, the Cochrane Library and Embase databases to identify randomised controlled trials (RCTs) that compared clinical outcomes of SGLT2 inhibitors with placebo following MI. We conducted the statistical analysis using RevMan, version 5.4 and pooled risk ratios (RRs) along the corresponding 95% confidence interval (CI) for all outcomes.

RESULTS: Five RCTs reporting data for 11,211 patients were included in our study. The mean follow-up duration was 43.8 weeks. Our pooled analysis showed that SGLT2 inhibitors significantly reduced the risk of hospitalisations for heart failure (HHF) (RR = 0.76, 95% CI: 0.61-0.88, p = 0.001) in patients with MI. However, the risk of all-cause mortality (RR = 1.05, 95% CI: 0.78-1.41, p = 0.76), CV mortality (RR = 1.04, 95% CI = 0.84-1.29, p = 0.73) and all-cause hospitalisations (RR = 1.06, 95% CI: 0.96-1.17, p = 0.25) remained comparable across the two groups.

CONCLUSION: SGLT2 inhibitors reduce HHF without affecting all-cause mortality, CV mortality and all-cause hospitalisations. However, further evidence is required to reach a definitive conclusion.

PMID:39145401 | DOI:10.1002/edm2.514

Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5855. doi: 10.1002/pds.5855.

ABSTRACT

PURPOSE: Hypertension (HT), dyslipidemia (DL), and diabetes mellitus (DM) are major risk factors for cardiovascular diseases. Despite the wide availability of medications to reduce this risk, poor adherence to medications remains an issue. The aim of this study is to evaluate medication adherence of prevalent users in these disease medications (HT, DL, DM) using claims data. Factors associated with non-adherence were also examined.

METHODS: Of 7538 participants of the Tsuruoka Metabolomics Cohort Study, 3693 (HT: 2702, DL: 2112, DM: 661) were identified as prevalent users of these disease medications. Information on lifestyle was collected through a questionnaire. Adherence was assessed by a proportion of days covered (PDC) and participants with PDC ≥0.8 were defined as adherent. Predictors of non-adherence were determined by performing multivariable logistic regression.

RESULTS: Medication adherence differed by treatment status. Among those without comorbidities, those with HT-only showed the highest adherence (90.2%), followed by those with DM-only (81.2%) and those with DL-only (80.8%). Factors associated with non-adherence in each medication group were skipping breakfast and poor understanding of medications among those with HT medications, females, having comorbidities, having a history of heart disease, and drinking habit among those with DL medications, and good sleep quality and skipping breakfast among those with DM medications.

CONCLUSION: While participants showed high medication adherence, differences were observed across medication groups. The identified predictors of non-adherence could help target those in need of adherence support.

PMID:39145400 | DOI:10.1002/pds.5855

Clin Otolaryngol. 2024 Aug 15. doi: 10.1111/coa.14213. Online ahead of print.

ABSTRACT

PURPOSE: The primary objective of this study was to explore the potential disparity in postoperative fistula occurrence rates between patients who undergo (partial) lateral parotidectomy and those who undergo the extracapsular dissection technique for the management of benign parotid gland tumours.

METHODS: A consecutive series of 363 patients treated with (partial) lateral parotidectomy and extracapsular dissection technique for benign parotid gland tumours at one tertiary centre between 2018 and 2022 were included. To evaluate the impact of the surgical technique and possible other risk factors (tumour location, tumour size, Body Mass Index, age, smoking, diabetes mellitus, arterial hypertension) for the development of fistulas, multivariate logistic regression analyses using backward lection were applied to estimate odds ratios (ORs) and 95%-confidence intervals (CIs).

RESULTS: In 363 patients, 21 patients (5.8%) developed a fistula. Patients who underwent (partial) lateral parotidectomy had three times higher chance of developing a fistula compared to patients who were operated using the extracapsular dissection technique (OR_adjusted = 2.6, 4.1% vs. 12.5%, p = 0.044). In the multivariate analyses, no other risk factors for the development of fistulas were statistically significant in this cohort. The incidence of facial nerve paralysis was not significantly different between the extracapsular dissection and lateral parotidectomy group (5/73 = 6.8% vs. 11/290 = 3.8%, p = 0.333).

CONCLUSION: Fistulas occur more often in patients treated by means of a (partial) lateral parotidectomy approach compared to patients treated using the extracapsular dissection technique. Therefore, surgeons should be vigilant about postoperative fistula risks in lateral parotidectomy and consider preventive measures.

PMID:39145398 | DOI:10.1111/coa.14213

Stroke. 2024 Aug 15. doi: 10.1161/STROKEAHA.123.046118. Online ahead of print.

ABSTRACT

BACKGROUND: Significant age and sex differences have been reported at each stage of the stroke pathway, from risk factors to outcomes. However, there is some uncertainty in previous studies with regard to the role of potential confounders and selection bias. Therefore, using German nationwide administrative data, we aimed to determine the magnitude and direction of trends in age- or sex-specific differences with respect to admission rates, risk factors, and acute treatments of ischemic and hemorrhagic stroke.

METHODS: We obtained and analyzed data from the Research Data Centres of the Federal Statistical Office for the years 2010 to 2020 with regard to all acute stroke hospitalizations, risk factors, treatments, and in-hospital mortality, stratified by sex and stroke subtype. This database provides a complete national-level census of stroke hospitalizations combined with population census counts. All hospitalized patients ≥15 years with an acute stroke (diagnosis code: I60-64) were included in the analysis.

RESULTS: Over the 11-year study period, there were 3 375 157 stroke events; 51.2% (n=1 728 954) occurred in men. There were higher rates of stroke admissions in men compared with women for both ischemic (378.1 versus 346.7/100 000 population) and hemorrhagic subtypes (75.6 versus 65.5/100 000 population) across all age groups. The incidence of ischemic stroke admissions peaked in 2016 among women (354.0/100 000 population) and in 2017 among men (395.8/100 000 population), followed by a consistent decline from 2018 onward. There was a recent decline in hemorrhagic stroke admissions observed for both sexes, reaching its nadir in 2020 (68.9/100 000 for men; 59.5/100 000 for women). Female sex was associated with in-hospital mortality for both ischemic (adjusted odds ratio, 1.11 [1.09-1.12]; P<0.001) and hemorrhagic stroke (adjusted odds ratio, 1.18 [95% CI, 1.16-1.20]; P<0.001).

CONCLUSIONS: Despite improvements in stroke prevention and treatment pathways in the past decade, sex-specific differences remain with regard to hospitalization rates, risk factors, and mortality. Better understanding the mechanisms for these differences may allow us to develop a sex-stratified approach to stroke care.

PMID:39145389 | DOI:10.1161/STROKEAHA.123.046118

Circ Cardiovasc Interv. 2024 Aug 15:e013979. doi: 10.1161/CIRCINTERVENTIONS.123.013979. Online ahead of print.

ABSTRACT

BACKGROUND: The ASTRAL trial (Angioplasty and Stenting for Renal Artery Lesions) recruited 806 patients between 2000 and 2007. Patients with atherosclerotic renal artery stenosis (RAS) and clinician uncertainty about the benefit of revascularization were randomized 1:1 to medical therapy with or without renal artery stenting. The initial results were presented in 2009 at a median 33.6-month follow-up, with no benefit of revascularization on renal or cardiovascular outcomes. Surviving patients remained under follow-up until the end of 2013, and the long-term results are presented in this study.

METHODS: Data were analyzed to assess whether there was a later impact of revascularization on renal function, cardiovascular events, and survival, including a composite outcome of renal and cardiovascular outcomes and death (as in the CORAL trial [Cardiovascular Outcomes in Renal Atherosclerotic Lesions]). Prespecified subgroup analyses included different categories of renal function, rapid deterioration in kidney function, and degree of RAS. Post hoc analyses of patients with severe RAS (bilateral 70% or >70% in a solitary kidney), those with or without proteinuria, and a per-protocol analysis were performed.

RESULTS: The mean age of the entry population was 70.5 years, the mean estimated glomerular filtration rate was 40 mL/min/1.73 m², the mean RAS was 76%, and the mean blood pressure was 150/76 mm Hg; 83% of the revascularization group underwent attempted stenting. The median follow-up was 56.4 months, with 108 patients lost to follow-up. By the end of follow-up, 50% of the evaluable population had died, 18% had suffered a first renal event, and 40% had suffered a first cardiovascular event. No statistical difference was observed for any outcome in the intention-to-treat and per-protocol analyses.

CONCLUSIONS: The long-term follow-up of the ASTRAL trial showed no overall benefit of renal revascularization to renal and cardiovascular outcomes. It has been highlighted that a proportion of the population had lower-risk RAS, and there is likely to be merit in further study in a higher-risk population.

REGISTRATION: URL: https://www.isrctn.com; Unique identifier: ISRCTN59586944.

PMID:39145377 | DOI:10.1161/CIRCINTERVENTIONS.123.013979

J Parasit Dis. 2024 Sep;48(3):450-459. doi: 10.1007/s12639-024-01673-3. Epub 2024 May 24.

ABSTRACT

Tick-borne pathogens pose a significant global threat, causing substantial economic losses to the dairy industry. In India, tropical theileriosis, anaplasmosis, babesiosis, and trypanosomiasis are major hemo-parasitic diseases affecting bovines. A cross-sectional study was conducted to determine the prevalence of hemo-parasites in different farms in India. PCR assays were employed to detect carrier status, using gene targets msp1b, tams1, rap-1, ama1, and ITS1 for A. marginale, T. annulata, B. bovis, B. bigemina, and Trypanosoma species, respectively. Out of the 578 apparently healthy animals screened, 30.45% (95% CI: 26.84-34.32%) were infected with at least one hemo-parasite. Cattle showed an overall positivity of 32.87%, while buffaloes had a prevalence of 15.19%, which was statistically significant (p < 0.001). Interestingly, prevalence was higher in indigenous cattle (47.81%) compared to cross-breeds (25.53%) and exotics (14.62%), with a statistically significant difference (p < 0.001). The prevalence of hemo-parasites varied widely among the farms, ranging from 5.77 to 100%. A. marginale was the most prevalent parasite (23.70% of animals), followed by T. annulata (13.67%), Babesia species (1.90%), and Trypanosoma species (1.56%). Enzootic instability was observed in six of the eight farms, indicating a potential for future outbreaks. Co-infection was detected in 60 out of 176 animals positive for hemo-parasites, with 59 animals co-infected with A. marginale and T. annulata, and only one cross-breed cattle infected with both Anaplasma marginale and Babesia bigemina. The findings highlight the prevalence of hemo-parasites in farms, underscoring the need for whole-herd screening, treatment of infected animals, and improvement in farm management practices to prevent production losses caused by these pathogens.

SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12639-024-01673-3.

PMID:39145369 | PMC:PMC11319688 | DOI:10.1007/s12639-024-01673-3