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Nevin Manimala Statistics

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review

Int J Health Policy Manag. 2023;12:7648. doi: 10.34172/ijhpm.2023.7648. Epub 2023 Jul 18.

ABSTRACT

BACKGROUND: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.

METHODS: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.

RESULTS: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.

CONCLUSION: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.

PMID:37579359 | DOI:10.34172/ijhpm.2023.7648

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Nevin Manimala Statistics

Factors Associated With In-Hospital Death Among Pneumonia Patients in US Hospitals From 2016~2019

Int J Health Policy Manag. 2023;12:7390. doi: 10.34172/ijhpm.2023.7390. Epub 2023 Jul 24.

ABSTRACT

BACKGROUND: Pneumonia is one of the leading causes of hospital admission in the United States with a global health burden of about 6.8 million hospitalizations and 1.1 million deaths in patients over 65 years old in 2015. This study aimed to identify possible patient and hospital-related risk factors for in-hospital pneumonia death across US hospitals.

METHODS: The National Inpatient Sample (NIS) was used to identify nationwide pneumonia patients (n=374 766, weighted n=1 873 828) from 2016 to 2019. We examined the characteristics of the study sample and their association with in-hospital death. Multivariate survey logistic regression models were used to identify risk factors.

RESULTS: During the study periods, in-hospital death rates continuously decreased (2.45% in 2016 to 2.19% in 2019). Descriptive statistics showed that patient and hospital factors had varied in-hospital death rates. Survey logistic regression results suggested that male, very low income, non-Medicare, government hospitals, rural hospitals, and specific hospital regions were associated with higher in-hospital death rates than their reference groups.

CONCLUSION: Socioeconomic factors, including income and insurance, are associated with pneumonia mortality. Census region, hospital ownership, and rural location are also related to in-hospital mortality. Such findings in underserved, impoverished, and rural areas to identify possible health disparities.

PMID:37579357 | DOI:10.34172/ijhpm.2023.7390

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Nevin Manimala Statistics

Diabetes, Obesity, and Pathologic Upstaging in Renal Cell Carcinoma: Results from a large multi-institutional consortium

J Urol. 2023 Aug 14:101097JU0000000000003650. doi: 10.1097/JU.0000000000003650. Online ahead of print.

ABSTRACT

BACKGROUND: To determine whether clinical risk factors and morphometric features on pre-operative imaging can be utilized to identify those patients with cT1 tumors who are at higher risk of upstaging (pT3a).

METHODS: A retrospective international case control study of consecutive patients treated surgically with radical or partial nephrectomy for non-metastatic RCC (cT1 N0) conducted between January 2010 and December 2018. Multivariable logistic regression models were used to study associations of pre-operative risk factors on pT3a pathological upstaging among all patients, as well as subsets with those with pre-operative tumors <4cm, renal nephrometry scores, tumors <4cm with nephrometry scores, and clear cell histology. We also examined association with pT3a subsets (renal vein, sinus fat, perinephric fat).Resultsand Limitations: Among the 4092 PN and 2056 RN patients, pathologic upstaging occurred in 4.9% and 23.3% patients, respectively. Among each group independent factors associated with pT3a upstaging were increasing preoperative tumor size, increasing age, and the presence of diabetes. Specifically, among PN subjects diabetes (odds ratio, OR =1.65; 95% CI 1.17,2.29), male sex (OR = 1.62; 95% CI 1.14,2.33), and increasing BMI (OR =1.03; 95%CI 1.00,1.05 per one unit BMI) were statistically associated with upstaging. Subset analyses identified hilar tumors as more likely to be upstaged (PN OR = 1.91; 95%CI 1.12,3.16 | RN OR = 2.16; 95% 1.44, 3.25).

CONCLUSIONS: Diabetes and higher BMI were associated with pathologic upstaging, as were preoperative tumor size, increased age, and male sex. Similarly, hilar tumors were frequently upstaged.

PMID:37579345 | DOI:10.1097/JU.0000000000003650

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Nevin Manimala Statistics

Modelling risk factors for intraindividual variability: a mixed-effects beta-binomial model applied to cognitive function in older people in the English Longitudinal Study of Ageing

Am J Epidemiol. 2023 Aug 11:kwad169. doi: 10.1093/aje/kwad169. Online ahead of print.

ABSTRACT

Cognitive functioning in older age profoundly impacts quality of life and health. Whilst most research in cognition in older age has focussed on mean levels, intraindividual variability (IIV) around this may have risk factors and outcomes independent of the mean. Investigating risk factors associated with IIV has typically involved deriving a summary statistic for each person from residual error around a fitted mean. However, this ignores uncertainty in the estimates, prohibits exploring associations with time-varying factors, and is biased by floor/ceiling effects. To address this, we propose a mixed-effects location scale beta-binomial model to estimate average probability and IIV in a word recall test in the English Longitudinal Study of Aging. After adjusting for mean performance, an analysis of 9,873 individuals across 7 (mean: 3.4) waves (2002-2015), found IIV greater: at older ages; with lower education; in females; with more difficulties with activities of daily living; in later cohorts; and when interviewers recorded issues potentially affecting the tests. Our study introduces a novel method to identify groups with greater IIV in bounded discrete outcomes. Our findings have implications for daily functioning and care, with further work needed to identify the impact for future health outcomes.

PMID:37579319 | DOI:10.1093/aje/kwad169

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Nevin Manimala Statistics

“A Much Wider Field in Which to Operate”: Early Black Women Physicians in Public Health

J Hist Med Allied Sci. 2023 Aug 14:jrad048. doi: 10.1093/jhmas/jrad048. Online ahead of print.

ABSTRACT

In a profession shaped by Whiteness and masculinity, the few Black women physicians who earned medical degrees prior to the Second World War found some of their rare professional opportunities in public health. Though their choices were often constrained by racism and sexism, they embraced public health work as a means of carrying out their “mission” in marginalized communities and as a way of practicing medicine with a more expansive definition than treating individual patients or illnesses. Black women physicians shaped public health by creating unique programming to meet the needs of the communities they served, including mobile health clinics and community health weeks. The first Black women physicians who worked in public health in the nineteenth and early twentieth centuries applied the new tool of public health “vital” statistics to Black lives and questioned the limits of their utility when created by White practitioners with racial biases. In the 1930s, some Black women physicians began earning some of the first master’s degrees in public health, just as the field was beginning to professionalize. Throughout the twentieth century, Black women physicians pioneered community health programming and, though born from exclusionary policies that limited where they could practice, experimented with alternative clinical spaces, even as the hospital and laboratory became the primary sites of medicine for White clinicians. By embracing public health, Black women physicians shaped the field and used it as a tool to address racial health disparities in the communities they served, acting on their belief that Black health could be improved, thereby contesting notions of biological inferiority.

PMID:37579294 | DOI:10.1093/jhmas/jrad048

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Nevin Manimala Statistics

Sexual Problems as Late Effects: Awareness and Information Needs Among 1870 Long-term Norwegian Childhood, Adolescent, and Young Adult Cancer Survivors (The NOR-CAYACS Study)

J Adolesc Young Adult Oncol. 2023 Aug 10. doi: 10.1089/jayao.2023.0031. Online ahead of print.

ABSTRACT

Purpose: Treatment-related sexual problems are common, but understudied, among survivors of Childhood, Adolescent, and Young Adult Cancer Survivors (CAYACS). We investigated awareness of, and information needs regarding, sexual problems as late effects in a nation-wide sample of long-term CAYACS. Methods: Five-year survivors were identified by the Cancer Registry of Norway, diagnosed between 1985 and 2009 with any childhood cancer (0-18 years of age, excluding central nervous system tumors), leukemia, colorectal cancer, breast cancer, non-Hodgkin lymphoma, or malignant melanoma (19-39 years of age). Malignant melanoma survivors treated with local surgery only served as an unmatched reference group. Survivors were mailed a survey, including items on awareness and information needs. Descriptive statistics and logistic regression analyses were used for data analyses. Results: Of 5361 CAYACS invited, 2104 responded (39%), of which 1870 were eligible for inclusion. In all, 62% were aware of sexual problems as late effects (46% aware only, 16% experienced it) and 31% reported information needs. Of all groups, childhood cancer survivors reported the lowest level of awareness (43% aware, 7% experienced it) and the highest information needs (38%). In multivariable models, awareness was associated with higher education, shorter time since treatment, more intense treatments, and experiencing hormonal changes and reduced fertility. Information needs were associated with having experienced sexual problems, female gender, higher treatment intensity, chronic fatigue, and increased depressive symptoms. Conclusions: A substantial proportion of long-term CAYACS report being unaware of, and have information needs regarding sexual problems as late effects decades beyond treatment. Addressing such issues during follow-up care is important.

PMID:37579257 | DOI:10.1089/jayao.2023.0031

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Nevin Manimala Statistics

Prevalence and In Vivo Assessment of Virulence in Shiga Toxin-Producing Escherichia coli Clinical Isolates from Greater Cairo Area

Microb Drug Resist. 2023 Aug 10. doi: 10.1089/mdr.2022.0348. Online ahead of print.

ABSTRACT

Background: Shiga toxin-producing Escherichia coli (STEC) has been identified as an important etiologic agent of human disease in Egypt. Aims: To investigate the occurrence and describe the characterization as well as prevalence of STEC in Greater Cairo hospitals as well as molecular characterization of virulence and resistance genes. Methods: Four hundred seventy E. coli clinical isolates were collected from eight hospitals and analyzed by genotypic and phenotypic methods for STEC, followed by histopathological examination and scoring of different organs lesions. Results: The highest proportion of isolates was from urine (151 isolates), whereas the lowest was from splenic drain (3 isolates). In tandem, when serogrouping was performed, 15 serogroups were obtained where the most prevalent was O157 and the least prevalent was O151. All isolates were positive when screened for identity gene gad A, while only typable strains were screened for seven virulence genes stx1 (gene encoding Shiga toxin 1), stx2 (gene encoding Shiga toxin 2), tsh (gene encoding thermostable hemagglutinin), eaeA (gene encoding intimin), invE (gene encoding invasion protein), aggR (gene encoding aggregative adherence transcriptional regulator), and astA (aspartate transaminase) where the prevalence was 48%, 30%, 50%, 57%, 7.5%, 12%, and 58%, respectively. Of 254 typable isolates, 152 were STEC carrying stx1 or stx2 genes or both. Conclusions: Relying on in vivo comparison between different E. coli pathotypes via histopathological examination of different organs, E. coli pathotypes could be divided into mild virulent, moderate virulent, and high virulent strains. Statistical analysis revealed significant correlation between different serogroups and presence of virulence genes.

PMID:37579256 | DOI:10.1089/mdr.2022.0348

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Nevin Manimala Statistics

A randomized clinical trial of intravenous methylprednisolone with two protocols in patients with Graves’ Orbitopathy

J Clin Endocrinol Metab. 2023 Aug 14:dgad476. doi: 10.1210/clinem/dgad476. Online ahead of print.

ABSTRACT

CONTEXT: Intravenous glucocorticoids (IVGC) is an accessible and affordable treatment for Graves’ orbitopathy (GO), 4.5-gram protocol is well studied, but many details of treatment protocols need to be clarified.

OBJECTIVE: To compare the efficacy and safety of weekly and monthly protocol of IVGC in GO.

DESIGN: a prospective, randomized, observer-masked, single-center clinical trial, followed up to week 24.

SETTING: The third affiliated hospital of Southern Medical University.

PATIENTS: 58 GO Patients aged 18-60 years old with active and moderate-to-severe who have not received relevant treatment.

INTERVENTIONS: IVGC of the weekly protocol or monthly protocol, both received a cumulative dose of methylprednisolone 4.5g and had a duration of 12 weeks.

MAIN OUTCOME MEASURES: The overall effective rate, improvement of quality of life (QOL) and signal intensity ratio (SIR).

RESULTS: There was no significant difference in the effective rate between the two groups at week 12 and week 24 (86.21% VS 72.41%, P = 0.195; 86.21% VS 82.61%, P = 0.441), there was no significant difference in the improvement of CAS, exophthalmos, soft tissue involvement, diplopia and QOL. At week 24, the mean SIR and maximum SIR of two groups were lower than those before treatment, and there were no statistically significant difference between two groups. There was no significant difference in the incidence of adverse events between the two groups (31.03% VS 27.59%, P = 0.773).

CONCLUSIONS: The efficacy and safety of the two protocols are comparable, the monthly protocol could be used as an alternative to the weekly protocol.

PMID:37579198 | DOI:10.1210/clinem/dgad476

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Nevin Manimala Statistics

Estimating conflict losses and reporting biases

Proc Natl Acad Sci U S A. 2023 Aug 22;120(34):e2307372120. doi: 10.1073/pnas.2307372120. Epub 2023 Aug 14.

ABSTRACT

Determining the number of casualties and fatalities suffered in militarized conflicts is important for conflict measurement, forecasting, and accountability. However, given the nature of conflict, reliable statistics on casualties are rare. Countries or political actors involved in conflicts have incentives to hide or manipulate these numbers, while third parties might not have access to reliable information. For example, in the ongoing militarized conflict between Russia and Ukraine, estimates of the magnitude of losses vary wildly, sometimes across orders of magnitude. In this paper, we offer an approach for measuring casualties and fatalities given multiple reporting sources and, at the same time, accounting for the biases of those sources. We construct a dataset of 4,609 reports of military and civilian losses by both sides. We then develop a statistical model to better estimate losses for both sides given these reports. Our model accounts for different kinds of reporting biases, structural correlations between loss types, and integrates loss reports at different temporal scales. Our daily and cumulative estimates provide evidence that Russia has lost more personnel than has Ukraine and also likely suffers from a higher fatality to casualty ratio. We find that both sides likely overestimate the personnel losses suffered by their opponent and that Russian sources underestimate their own losses of personnel.

PMID:37579154 | DOI:10.1073/pnas.2307372120

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Nevin Manimala Statistics

Physiological adaptation in flagellar architecture improves Vibrio alginolyticus chemotaxis in complex environments

Proc Natl Acad Sci U S A. 2023 Aug 22;120(34):e2301873120. doi: 10.1073/pnas.2301873120. Epub 2023 Aug 14.

ABSTRACT

Bacteria navigate natural habitats with a wide range of mechanical properties, from the ocean to the digestive tract and soil, by rotating helical flagella like propellers. Species differ in the number, position, and shape of their flagella, but the adaptive value of these flagellar architectures is unclear. Many species traverse multiple types of environments, such as pathogens inside and outside a host. We investigate the hypothesis that flagellar architectures mediate environment-specific benefits in the marine pathogen Vibrio alginolyticus which exhibits physiological adaptation to the mechanical environment. In addition to its single polar flagellum, the bacterium produces lateral flagella in environments that differ mechanically from water. These are known to facilitate surface motility and attachment. We use high-throughput 3D bacterial tracking to quantify chemotactic performance of both flagellar architectures in three archetypes of mechanical environments relevant to the bacterium’s native habitats: water, polymer solutions, and hydrogels. We reveal that lateral flagella impede chemotaxis in water by lowering the swimming speed but improve chemotaxis in both types of complex environments. Statistical trajectory analysis reveals two distinct underlying behavioral mechanisms: In viscous solutions of the polymer PVP K90, lateral flagella increase the swimming speed. In agar hydrogels, lateral flagella improve overall chemotactic performance, despite lowering the swimming speed, by preventing trapping in pores. Our findings show that lateral flagella are multipurpose tools with a wide range of applications beyond surfaces. They implicate flagellar architecture as a mediator of environment-specific benefits and point to a rich space of bacterial navigation behaviors in complex environments.

PMID:37579142 | DOI:10.1073/pnas.2301873120