Categories
Nevin Manimala Statistics

Record linkage based patient intersection cardinality for rare disease studies using Mainzelliste and secure multi-party computation

J Transl Med. 2022 Oct 8;20(1):458. doi: 10.1186/s12967-022-03671-6.

ABSTRACT

BACKGROUND: The low number of patients suffering from any given rare diseases poses a difficult problem for medical research: With the exception of some specialized biobanks and disease registries, potential study participants’ information are disjoint and distributed over many medical institutions. Whenever some of those facilities are in close proximity, a significant overlap of patients can reasonably be expected, further complicating statistical study feasibility assessments and data gathering. Due to the sensitive nature of medical records and identifying data, data transfer and joint computations are often forbidden by law or associated with prohibitive amounts of effort. To alleviate this problem and to support rare disease research, we developed the Mainzelliste Secure EpiLinker (MainSEL) record linkage framework, a secure Multi-Party Computation based application using trusted-third-party-less cryptographic protocols to perform privacy-preserving record linkage with high security guarantees. In this work, we extend MainSEL to allow the record linkage based calculation of the number of common patients between institutions. This allows privacy-preserving statistical feasibility estimations for further analyses and data consolidation. Additionally, we created easy to deploy software packages using microservice containerization and continuous deployment/continuous integration. We performed tests with medical researchers using MainSEL in real-world medical IT environments, using synthetic patient data.

RESULTS: We show that MainSEL achieves practical runtimes, performing 10 000 comparisons in approximately 5 minutes. Our approach proved to be feasible in a wide range of network settings and use cases. The “lessons learned” from the real-world testing show the need to explicitly support and document the usage and deployment for both analysis pipeline integration and researcher driven ad-hoc analysis use cases, thus clarifying the wide applicability of our software. MainSEL is freely available under: https://github.com/medicalinformatics/MainSEL CONCLUSIONS: MainSEL performs well in real-world settings and is a useful tool not only for rare disease research, but medical research in general. It achieves practical runtimes, improved security guarantees compared to existing solutions, and is simple to deploy in strict clinical IT environments. Based on the “lessons learned” from the real-word testing, we hope to enable a wide range of medical researchers to meet their needs and requirements using modern privacy-preserving technologies.

PMID:36209221 | DOI:10.1186/s12967-022-03671-6

Categories
Nevin Manimala Statistics

Feasibility and effectiveness of self-monitoring of blood glucose among insulin-dependent patients with type 2 diabetes: open randomized control trial in three rural districts in Rwanda

BMC Endocr Disord. 2022 Oct 8;22(1):244. doi: 10.1186/s12902-022-01162-9.

ABSTRACT

BACKGROUND: The prevalence of type 2 diabetes in sub Saharan Africa (SSA) has been on the rise. Effective control of blood glucose is key towards reducing the risk of diabetes complications. Findings mainly from high-income countries have demonstrated the effectiveness of self-monitoring of blood-glucose (SMBG) in controlling blood glucose levels. However, there are limited studies describing the implementation of SMBG in rural SSA. This study explores the feasibility and effectiveness of implementing SMBG among patients diagnosed with insulin-dependent type 2 diabetes in rural Rwanda.

METHODS: Participants were randomized into intervention (n = 42) and control (n = 38) groups. The intervention group received a glucose-meter, blood test-strips, log-book, waste management box and training on SMBG in addition to usual care. The control group continued with their usual care consisting of, routine monthly medical consultation and health education. The primary outcomes were adherence to the implementation of SMBG (testing schedule and recording data in the log-book) and change in hemoglobin A1c. Descriptive statistics and a paired t-test were used to analyze the primary outcomes.

RESULTS: In both the intervention and control arms, majority of the participants were female (59.5% vs 52.6%) and married (71.4% vs 73.7%). Most had at most a primary level education (83.3% vs. 89.4%) and were farmers (54.8% vs. 50.0%). Among those in the intervention group, 63.4% showed good adherence to implementing SMBG based on the number of tests recorded in the glucose meter. Only 20.3% demonstrated accurate recording of the glucose level tests in log-books. The mean difference of the HbA1C from baseline to six months post-intervention was significantly better among the intervention group -0.94% (95% CI -1.46, -0.41) compared to the control group 0.73% (95% CI -0.09, 1.54) p < 0.001.

CONCLUSION: Our study showed that among patients with insulin-dependent type 2 diabetes residing in rural Rwanda, SMBG was feasible and demonstrated positive outcomes in improving blood glucose control. However, there is need for strategies to enhance accuracy in recording blood glucose test results in the log-book.

TRIAL REGISTRATION: The trial was registered retrospectively on the Pan African Clinical Trial Registry, on 17th May 2019. The registration number is PACTR201905538846394.

PMID:36209209 | DOI:10.1186/s12902-022-01162-9

Categories
Nevin Manimala Statistics

Anatomical observation, classification, fracture and finite element analysis of the posterior process of the Asian adult talus

J Orthop Surg Res. 2022 Oct 8;17(1):444. doi: 10.1186/s13018-022-03345-5.

ABSTRACT

BACKGROUND: Fractures of the posterior process of the talus are rarely seen and frequently overlooked. In our study, anatomical observation and classification of the posterior process of the talus were carried out, and related imaging and finite element methods were combined. The study aimed to observe and provide anatomical data related to posterior process of talus in Asian adults and explore the potential relationships between the different types with fracture of posterior process of talus.

METHODS: Combined with the anatomical morphology and imaging data, the posterior process of talus was divided into four types, and the incidence and fracture situation were statistically analyzed. The finite element models of four different types of talus processes were established and verified, and the stress and strain were simulated and analyzed.

RESULTS: The total incidence of the posterior process of the talus was 97.47%. The proportions of the four types were neck-like 10.13%, flat 36.29%, pointy 12.66% and round blunt 38.39%. The overall incidence of bone cracks of the posterior process of the talus was 4.98%; the most common type was neck-like type. Compared with the value on the other types, the maximum von Mises stress increased by 67.66%, 83.90% and 111.18% on the neck-like posterior process of talus respectively.

CONCLUSIONS: It is speculated that different types of the posterior process of the talus may be related to the probability of fracture, and it may be better to consider different treatment strategies for different types of fractures.

PMID:36209168 | DOI:10.1186/s13018-022-03345-5

Categories
Nevin Manimala Statistics

Early insights of the COVID-19 pandemic in the Veterans’ Affairs spinal cord injury and disorders population

Spinal Cord Ser Cases. 2022 Oct 8;8(1):83. doi: 10.1038/s41394-022-00548-0.

ABSTRACT

STUDY DESIGN: Retrospective cohort.

OBJECTIVES: The primary outcome of the study was to identify patient characteristics associated with a positive COVID-19 test. The secondary outcome was to identify patient characteristics associated with mortality from COVID-19.

SETTING: Veterans Health Administration (VHA) National Spinal Cord Injury and Disorders (SCI) Registry, created by the National Spinal Cord Injury and Disorders SCI Program Office in March 2020.

METHODS: Data was analyzed in the form of descriptive statistics and then subsequent regression analysis was performed.

RESULTS: A total of 4,562 persons with SCI were tested for COVID-19 between March and July 2020, and 290 were positive. The study found that African Americans had increased odds of testing positive for COVID-19 (OR 1.53 (1.18-2.00), p < 0.01). Increased age correlated with increased odds of mortality after testing positive for COVID-19 (1.046 (1.003-1.090)). Non-smokers had lower odds of mortality following positive COVID-19 test (0.15 (0.04-0.52)). No association was found between neurologic level of injury (NLI) and positive COVID-19 test or increased mortality. Increased Body Mass Index (BMI) did correlate with positive COVID-19 test but not increased mortality. The case fatality rate for persons with SCI and a positive test for COVID-19 was 12%.

CONCLUSIONS: It is important to define the risk factors for patients with SCI to elucidate and mitigate individual and population risks. These risk factors also can play a role in determining the allocation of critical healthcare resources.

PMID:36209160 | DOI:10.1038/s41394-022-00548-0

Categories
Nevin Manimala Statistics

Workload and quality of nursing care: the mediating role of implicit rationing of nursing care, job satisfaction and emotional exhaustion by using structural equations modeling approach

BMC Nurs. 2022 Oct 8;21(1):273. doi: 10.1186/s12912-022-01055-1.

ABSTRACT

BACKGROUND: Nursing workload and its effects on the quality of nursing care is a major concern for nurse managers. Factors which mediate the relationship between workload and the quality of nursing care have not been extensively studied. This study aimed to investigate the mediating role of implicit rationing of nursing care, job satisfaction and emotional exhaustion in the relationship between workload and quality of nursing care.

METHODS: In this cross-sectional study, 311 nurses from four different hospitals in center of Iran were selected by convenience sampling method. Six self-reported questionnaires were completed by the nurses. The data were analyzed by SPSS version 16. Structural equation modeling was used to determine the relationships between the components using Stata 14 software.

RESULTS: Except direct and mutual relationship between workload and quality of nursing care (P ≥ 0.05), the relationship between other variables was statistically significant (P < 0.05). The hypothesized model fitted the empirical data and confirmed the mediating role of implicit rationing of nursing care, job satisfaction and emotional exhaustion in the relationship between workload and the quality of nursing care (TLI, CFI > 0.9 and RMSEA < 0.08 and χ2/df < 3).

CONCLUSION: Workload affects the quality of the provided nursing care by affecting implicit rationing of nursing care, job satisfaction and emotional exhaustion. Nurse managers need to acknowledge the importance of quality of nursing care and its related factors. Regular supervision of these factors and provision of best related strategies, will ultimately lead to improve the quality of nursing care.

PMID:36209155 | DOI:10.1186/s12912-022-01055-1

Categories
Nevin Manimala Statistics

Epidemiological and etiological characteristics of mild hand, foot and mouth disease in children under 7 years old, Nanjing, China, 2010-2019

Arch Public Health. 2022 Oct 8;80(1):220. doi: 10.1186/s13690-022-00974-4.

ABSTRACT

BACKGROUND: Mild hand, foot and mouth disease (HFMD) cases make up a relatively high proportion of HFMD while have often been overlooked. This study aimed to investigate the epidemiological and etiological characteristics of mild HFMD in Nanjing.

METHODS: Data on mild HFMD cases, during 2010-2019 in Nanjing, were collected from the China Information System for Disease Control and Prevention. This study mainly focused on mild cases aged < 7 years. Descriptive analysis was used to summarize epidemiological and etiological characteristics of mild cases. Flexible spatial scan statistic was used to detect spatial clusters of mild cases.

RESULTS: A total of 175,339 mild cases aged < 7 years were reported, accounting for 94.4% of all mild cases. There was a higher average annual incidence of mild HFMD in children aged < 7 years (4,428 cases/100,000) compared with children aged ≥ 7 years (14 cases/100,000, P < 0.001), and especially children aged 1-year-old (7,908 cases/100,000). Mild cases showed semi-annual peaks of activity, including a major peak (April to July) and a minor peak (September to November). The average annual incidence was higher in males (5,040 cases/100,000) than females (3,755 cases/100,000). Based on the cumulative reported cases, the most likely cluster was detected, including Yuhuatai District, Jiangning District, Jiangbei new Area, and Pukou District. The annual distribution of enterovirus serotypes showed a significant difference. During 2010-2016, Enterovirus 71 (EV71), Coxsackievirus A16 (Cox A16), and other non-EV71/Cox A16 EVs, accounted for 29.1%, 34.6%, 36.3% of all the enterovirus test positive cases, respectively. Moreover, during 2017-2019, Cox A6, Cox A16, EV71, and other non-EV71/Cox A16/Cox A6 EVs, accounted for 47.3%, 32.5%, 10.7%, 9.5%, respectively.

CONCLUSIONS: Children under 7 years old are at higher risk of mild HFMD. Regions with high risk are mainly concentrated in the areas surrounding central urban areas. Cox A16 and Cox A6 became the dominant serotypes and they alternated or were co-epidemic. Our findings could provide valuable information for improving the regional surveillance, prevention and control strategies of HFMD.

PMID:36209145 | DOI:10.1186/s13690-022-00974-4

Categories
Nevin Manimala Statistics

Sex steroid hormones and risk of breast cancer: a two-sample Mendelian randomization study

Breast Cancer Res. 2022 Oct 8;24(1):66. doi: 10.1186/s13058-022-01553-9.

ABSTRACT

BACKGROUND: Breast cancer (BC) has the highest cancer incidence and mortality in women worldwide. Observational epidemiological studies suggest a positive association between testosterone, estradiol, dehydroepiandrosterone sulphate (DHEAS) and other sex steroid hormones with postmenopausal BC. We used a two-sample Mendelian randomization analysis to investigate this association.

METHODS: Genetic instruments for nine sex steroid hormones and sex hormone-binding globulin (SHBG) were obtained from genome-wide association studies (GWAS) of UK Biobank (total testosterone (TT) N: 230,454, bioavailable testosterone (BT) N: 188,507 and SHBG N: 189,473), The United Kingdom Household Longitudinal Study (DHEAS N: 9722), the LIFE-Adult and LIFE-Heart cohorts (estradiol N: 2607, androstenedione N: 711, aldosterone N: 685, progesterone N: 1259 and 17-hydroxyprogesterone N: 711) and the CORtisol NETwork (CORNET) consortium (cortisol N: 25,314). Outcome GWAS summary statistics were obtained from the Breast Cancer Association Consortium (BCAC) for overall BC risk (N: 122,977 cases and 105,974 controls) and subtype-specific analyses.

RESULTS: We found that a standard deviation (SD) increase in TT, BT and estradiol increased the risk of overall BC (OR 1.14, 95% CI 1.09-1.21, OR 1.19, 95% CI 1.07-1.33 and OR 1.03, 95% CI 1.01-1.06, respectively) and ER + BC (OR 1.19, 95% CI 1.12-1.27, OR 1.25, 95% CI 1.11-1.40 and OR 1.06, 95% CI 1.03-1.09, respectively). An SD increase in DHEAS also increased ER + BC risk (OR 1.09, 95% CI 1.03-1.16). Subtype-specific analyses showed similar associations with ER+ expressing subtypes: luminal A-like BC, luminal B-like BC and luminal B/HER2-negative-like BC.

CONCLUSIONS: TT, BT, DHEAS and estradiol increase the risk of ER+ type BCs similar to observational studies. Understanding the role of sex steroid hormones in BC risk, particularly subtype-specific risks, highlights the potential importance of attempts to modify and/or monitor hormone levels in order to prevent BC.

PMID:36209141 | DOI:10.1186/s13058-022-01553-9

Categories
Nevin Manimala Statistics

Spatial structure of city population growth

Nat Commun. 2022 Oct 8;13(1):5931. doi: 10.1038/s41467-022-33527-y.

ABSTRACT

We show here that population growth, resolved at the county level, is spatially heterogeneous both among and within the U.S. metropolitan statistical areas. Our analysis of data for over 3,100 U.S. counties reveals that annual population flows, resulting from domestic migration during the 2015-2019 period, are much larger than natural demographic growth, and are primarily responsible for this heterogeneous growth. More precisely, we show that intra-city flows are generally along a negative population density gradient, while inter-city flows are concentrated in high-density core areas. Intra-city flows are anisotropic and generally directed towards external counties of cities, driving asymmetrical urban sprawl. Such domestic migration dynamics are also responsible for tempering local population shocks by redistributing inflows within a given city. This spill-over effect leads to a smoother population dynamics at the county level, in contrast to that observed at the city level. Understanding the spatial structure of domestic migration flows is a key ingredient for analyzing their drivers and consequences, thus representing a crucial knowledge for urban policy makers and planners.

PMID:36209135 | DOI:10.1038/s41467-022-33527-y

Categories
Nevin Manimala Statistics

A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network

Trials. 2022 Oct 8;23(1):865. doi: 10.1186/s13063-022-06791-y.

ABSTRACT

BACKGROUND: In the ongoing COVID-19 pandemic, advanced age is a risk factor for a severe clinical course of SARS-CoV-2 infection. Thus, older people may benefit in particular from booster doses with potent vaccines and research should focus on optimal vaccination schedules. In addition to each individual’s medical history, immunosenescence warrants further research in this population. This study investigates vaccine-induced immune response over 1 year.

METHODS/DESIGN: EU-COVAT-1-AGED is a randomised controlled, adaptive, multicentre phase II protocol evaluating different booster strategies in individuals aged ≥75 years (n=600) already vaccinated against SARS-CoV-2. The initial protocol foresaw a 3rd vaccination (1st booster) as study intervention. The present modified Part B of this trial foresees testing of mRNA-1273 (Spikevax®) vs. BNT162b2 (Comirnaty®) as 4th vaccination dose (2nd booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants. The primary endpoint of the trial is to assess the rate of 2-fold antibody titre increase 14 days after vaccination measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wild-type virus. Secondary endpoints include the changes in neutralising antibody titres (Virus Neutralisation Assay) against wild-type as well as against Variants of Concern (VOC) at 14 days and up to 12 months. T cell response measured by qPCR will be performed in subgroups at 14 days as exploratory endpoint. Biobanking samples are being collected for neutralising antibody titres against potential future VOC. Furthermore, potential correlates between humoral immune response, T cell response and neutralising capacity will be assessed. The primary endpoint analysis will be triggered as soon as for all patients the primary endpoint (14 days after the 4th vaccination dose) has been observed.

DISCUSSION: The EU-COVAT-1-AGED trial Part B compares immunogenicity and safety of mRNA-1273 (Spikevax®) and BNT162b2 (Comirnaty®) as 4th SARS-CoV-2 vaccine dose in adults ≥75 years of age. The findings of this trial have the potential to optimise the COVID-19 vaccination strategy for this at-risk population.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05160766 . Registered on 16 December 2021.

PROTOCOL VERSION: V06_0: 27 July 2022.

PMID:36209129 | DOI:10.1186/s13063-022-06791-y

Categories
Nevin Manimala Statistics

Effectiveness of an eHealth intervention to improve subjective well-being and self-efficacy in cardiovascular disaease patients: A pilot non-randomized controlled trial

Nurs Open. 2022 Oct 8. doi: 10.1002/nop2.1400. Online ahead of print.

ABSTRACT

AIM: To evaluate the effectiveness of a multicomponent, eHealth-based self-efficacy intervention to promote subjective well-being and self-efficacy in patients with cardiovascular disease, exploring sex differences.

DESIGN: A pilot study of a two-arm non-randomized controlled trial.

METHODS: Forty-two cardiovascular patients (31% women) participated in the study. The experimental group received a personalized psychoeducational session and a 14-days eHealth intervention. Subjective well-being (positive and negative affect) and self-efficacy (chronic and cardiac) were assessed at baseline, post-psychoeducational session, post-eHealth intervention and at two follow-ups.

RESULTS: The levels of the experimental group in positive affect, at post-eHealth and follow-up 1, and self-efficacy, at post-eHealth, and both follow-ups, were statistically significantly higher compared to the control group (all ps < .05). When considering sex, the intervention was effective only for men. The results highlight the potential of eHealth interventions for cardiac patients and underline the importance of considering a gender perspective in their treatment.

PMID:36208471 | DOI:10.1002/nop2.1400