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Nevin Manimala Statistics

Cell-Based Therapy by Autologous Bone Marrow-Derived Mononuclear Cells for bone Augmentation of Plate-Stabilized Proximal Humeral Fractures – A Multicentric, Randomized, Open Phase IIa study

Stem Cells Transl Med. 2023 Nov 23:szad067. doi: 10.1093/stcltm/szad067. Online ahead of print.

ABSTRACT

Proximal humerus fractures are common in an aging population. The standard operative treatment is open reduction internal fixation (ORIF) using an angular stable plate. However, this procedure has complications such as a relatively high rate of secondary dislocation, humeral head necrosis or nonunion caused by delayed bony consolidation. Autologous bone marrow mononuclear cells (BMC) combined with a β-TCP scaffold could support bone healing and is considered clinically safe. This multicentric, randomized, open phase IIa clinical trial (Clinical Trials. Gov Identifier: NCT02803177, Eudra CT No: 2015-001820-51) evaluated whether autologous BMC with β-TCP in addition to ORIF reduces the incidence of secondary dislocations in patients with proximal humerus fracture. Ninty-four patients equally divided between verum group (BMC+β-TCP) and control group (ß-TCP only) were targeted and calculated. At the time of planned interim evaluation, ie, enrolment of 56 patients, no statistical difference in secondary dislocations or complications was demonstrated in either group after an observation period of 12 weeks. Radiographic bone healing and DASH score to determine shoulder function were comparable between both groups. Bone marrow harvest and BMC transplantation did not result in any severe adverse events. Therefore, the study was terminated after the interim analysis, as no other result could be expected. From the study results, it can be concluded that the application of autologous BMC is well tolerated, and bone healing can be achieved. Augmentation of bone defects with β-TCP could be shown to be feasible and might be considered in other clinical situations.

PMID:37995325 | DOI:10.1093/stcltm/szad067

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Nevin Manimala Statistics

Basic health indicators in the NutrIMSS program: a retrospective study

Rev Med Inst Mex Seguro Soc. 2023 Nov 6;61(6):728-735. doi: 10.5281/zenodo.10064287.

ABSTRACT

BACKGROUND: The NutrIMSS program is granted to populations with chronic conditions to improve basic health indicators and its effectiveness in this population is unknown.

OBJECTIVE: To analyze the change in the basic health indicators of patients who attended the NutrIMSS Program, at the UMF No. 2 of the IMSS in Mexico City, during the period 2018 to 2019.

MATERIAL AND METHODS: From 105 files of IMSS beneficiaries, a retrospective cohort study was carried out considering two measurements, before and after the NutrIMSS program. To evaluate the average change over time of health indicators, GEE models (Generalized Estimation Equations) and multiple linear regression models were used. Statistical analysis was used using the statistical program StataCorp 2015.

RESULTS: Patients who attended the Program showed changes between the beginning and end of the period with an average of three months of follow-up. They presented a decrease in the following health indicators: body weight of 1 kg, body mass index: 0.8 kg/m2, glucose of 13 mg/dL, triglycerides of 57 mg/dL and cholesterol of 17 mg/dL (p < 0.005 in all cases). There was no difference in the level of blood pressure.

CONCLUSIONS: The NutrIMSS program influenced the improvement of the health indicators of the population of the program and is an ally to improve the health of the IMSS beneficiary population.

PMID:37995283 | DOI:10.5281/zenodo.10064287

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Nevin Manimala Statistics

Mortality risk from United States coal electricity generation

Science. 2023 Nov 24;382(6673):941-946. doi: 10.1126/science.adf4915. Epub 2023 Nov 23.

ABSTRACT

Policy-makers seeking to limit the impact of coal electricity-generating units (EGUs, also known as power plants) on air quality and climate justify regulations by quantifying the health burden attributable to exposure from these sources. We defined “coal PM2.5” as fine particulate matter associated with coal EGU sulfur dioxide emissions and estimated annual exposure to coal PM2.5 from 480 EGUs in the US. We estimated the number of deaths attributable to coal PM2.5 from 1999 to 2020 using individual-level Medicare death records representing 650 million person-years. Exposure to coal PM2.5 was associated with 2.1 times greater mortality risk than exposure to PM2.5 from all sources. A total of 460,000 deaths were attributable to coal PM2.5, representing 25% of all PM2.5-related Medicare deaths before 2009 and 7% after 2012. Here, we quantify and visualize the contribution of individual EGUs to mortality.

PMID:37995235 | DOI:10.1126/science.adf4915

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Nevin Manimala Statistics

Development of white matter fiber covariance networks supports executive function in youth

Cell Rep. 2023 Nov 22;42(12):113487. doi: 10.1016/j.celrep.2023.113487. Online ahead of print.

ABSTRACT

During adolescence, the brain undergoes extensive changes in white matter structure that support cognition. Data-driven approaches applied to cortical surface properties have led the field to understand brain development as a spatially and temporally coordinated mechanism that follows hierarchically organized gradients of change. Although white matter development also appears asynchronous, previous studies have relied largely on anatomical tract-based atlases, precluding a direct assessment of how white matter structure is spatially and temporally coordinated. Harnessing advances in diffusion modeling and machine learning, we identified 14 data-driven patterns of covarying white matter structure in a large sample of youth. Fiber covariance networks aligned with known major tracts, while also capturing distinct patterns of spatial covariance across distributed white matter locations. Most networks showed age-related increases in fiber network properties, which were also related to developmental changes in executive function. This study delineates data-driven patterns of white matter development that support cognition.

PMID:37995188 | DOI:10.1016/j.celrep.2023.113487

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Nevin Manimala Statistics

Obstructive Sleep Apnea Associated With Increased Failure Rate of Ptosis Repair

Ophthalmic Plast Reconstr Surg. 2023 Nov 23. doi: 10.1097/IOP.0000000000002547. Online ahead of print.

ABSTRACT

PURPOSE: This study investigates how Obstructive sleep apnea (OSA) affects the outcomes of ptosis repair. We hypothesized that patients with OSA have an increased rate of reoperation after ptosis repair.

METHODS: This retrospective cohort study included patients age >18 from the Mayo Clinic who underwent ptosis repair by levator advancement or Müller muscle-conjunctiva resection between 2018 and 2021. Outcomes were measured at 1 to 3 months of follow-up with surgical failure defined as asymmetry or unsatisfactory eyelid height requiring revision surgery within 1 year.

RESULTS: A total of 577 patients met the inclusion criteria. There was a statistically significant difference in surgical failure between patients with OSA and those without (20.5% vs. 13.1%, p = 0.02). Patients with OSA showed a statistically significant difference in risk of revision by a factor of 1.70 (95% CI: 1.06-2.07). Revisions were attributed to unsatisfactory eyelid height in 72.6% of patients and eyelid asymmetry in 21.1%. All patients who had revision surgery had satisfactory outcomes. On logistic regression analysis, when adjusting for age and sex, OSA was significantly associated with ptosis revision (p = 0.007).

CONCLUSIONS: OSA increases risk of surgical failure and need for revision surgery in patients undergoing blepharoptosis repair but is not a sole risk factor.

PMID:37995148 | DOI:10.1097/IOP.0000000000002547

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Nevin Manimala Statistics

Associations between body composition and the risk of fracture according to bone mineral density in postmenopausal women: a population-based database cohort study

Eur J Endocrinol. 2023 Nov 8;189(5):527-536. doi: 10.1093/ejendo/lvad156.

ABSTRACT

OBJECTIVE: We aimed to investigate the associations of body composition and the risk of fracture in postmenopausal women, stratified based on bone mineral density.

METHODS: A population-based cohort study using the database of the National Screening Program for Transitional Ages with women aged 66 years was performed. Bone mineral density was categorized as normal, osteopenia, and osteoporosis. The following body mass index (BMI) categories for general obesity were used: underweight (<18.5), normal (18.5-22.9), overweight (23-24.9), obese (25-29.9), and severely obese (≥30 kg/m2). Waist circumference (WC) used for central obesity assessment was categorized into 5 groups. Newly diagnosed fracture during the follow-up period defined based on ICD-10 codes was the primary outcome.

RESULTS: During 7.7 ± 1.4 years of follow-up, 41 672 (17.9%) participants experienced any fracture, 20 326 (8.7%) experienced vertebral fractures (VFs), and 2883 (1.2%) experienced hip fractures (HFs). The adjusted hazard ratios (aHRs) for any fracture showed a progressive increase with higher BMI and WC categories in individual with osteopenia and osteoporosis. Regarding VF, aHR was highest in severely obese individuals with osteoporosis (aHR [95% CI], 3.45 [2.99-3.97]) and in individuals with WC ≥ 95 cm with osteoporosis (4.79 [4.09-5.60]). The aHR [95% CI] for HF was highest in the underweight group with osteopenia (1.94 [1.16-3.27]) and osteoporosis (2.96 [2.15-4.10]). In central obesity individuals with WC ≥ 95 cm, aHR [95% CI] for HF was 2.80 [1.91-4.91].

CONCLUSIONS: General obesity and central obesity are not protective against any fracture, VF and HF in postmenopausal women with osteopenia or osteoporosis.

PMID:37995142 | DOI:10.1093/ejendo/lvad156

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Nevin Manimala Statistics

The promises and pitfalls of precision: random and systematic error in physical geodesy, c. 1800-1910

Ann Sci. 2023 Nov 23:1-27. doi: 10.1080/00033790.2023.2284335. Online ahead of print.

ABSTRACT

This article discusses the ways in which nineteenth-century geodesists reflected on precision as an epistemic virtue in their measurement practice. Physical geodesy is often understood as a quintessential nineteenth-century precision science, stimulating advances in instrument making and statistics, and generating incredible quantities of data. Throughout most of the nineteenth century, geodesists indeed pursued their most prestigious research problem – the exact determination of the earth’s polar flattening – along those lines. Treating measurement errors as random, they assumed that remaining discordances could be overcome by manufacturing better instruments and extending statistical analysis to a larger amount of data. In the second half of the nineteenth century, however, several German geodesists developed sophisticated methodological critiques of their discipline, in which they diagnosed a too-narrow focus on precision among their peers. On their account, geodesists urgently needed to identify and anticipate the causes of the remaining measurement errors that arose from the earth’s little understood interior constitution. While mostly overlooked in the literature, these critiques paved the way for many empirical successes in late nineteenth- and early twentieth-century geodesy, including the first convergent measurements of the earth’s polar flattening.

PMID:37995136 | DOI:10.1080/00033790.2023.2284335

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Nevin Manimala Statistics

Quality of Digital Health Interventions Across Different Health Care Domains: Secondary Data Analysis Study

JMIR Mhealth Uhealth. 2023 Nov 23;11:e47043. doi: 10.2196/47043.

ABSTRACT

BACKGROUND: There are more than 350,000 digital health interventions (DHIs) in the app stores. To ensure that they are effective and safe to use, they should be assessed for compliance with best practice standards.

OBJECTIVE: The objective of this paper was to examine and compare the compliance of DHIs with best practice standards and adherence to user experience (UX), professional and clinical assurance (PCA), and data privacy (DP).

METHODS: We collected assessment data from 1574 DHIs using the Organisation for the Review of Care and Health Apps Baseline Review (OBR) assessment tool. As part of the assessment, each DHI received a score out of 100 for each of the abovementioned areas (ie, UX, PCA, and DP). These 3 OBR scores are combined to make up the overall ORCHA score (a proxy for quality). Inferential statistics, probability distributions, Kruskal-Wallis, Wilcoxon rank sum test, Cliff delta, and Dunn tests were used to conduct the data analysis.

RESULTS: We found that 57.3% (902/1574) of the DHIs had an Organisation for the Review of Care and Health Apps (ORCHA) score below the threshold of 65. The overall median OBR score (ORCHA score) for all DHIs was 61.5 (IQR 51.0-73.0) out of 100. A total of 46.2% (12/26) of DHI’s health care domains had a median equal to or above the ORCHA threshold score of 65. For the 3 assessment areas (UX, DP, and PCA), DHIs scored the highest for the UX assessment 75.2 (IQR 70.0-79.6), followed by DP 65.1 (IQR 55.0-73.4) and PCA 49.6 (IQR 31.9-76.1). UX scores had the least variance (SD 13.9), while PCA scores had the most (SD 24.8). Respiratory and urology DHIs were consistently highly ranked in the National Institute for Health and Care Excellence Evidence Standards Framework tiers B and C based on their ORCHA score.

CONCLUSIONS: There is a high level of variability in the ORCHA scores of DHIs across different health care domains. This suggests that there is an urgent need to improve compliance with best practices in some health care areas. Possible explanations for the observed differences might include varied market maturity and commercial interests within the different health care domains. More investment to support the development of higher-quality DHIs in areas such as ophthalmology, allergy, women’s health, sexual health, and dental care may be needed.

PMID:37995121 | DOI:10.2196/47043

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Diagnostic Accuracy of Single-Lead Electrocardiograms Using the Kardia Mobile App and the Apple Watch 4: Validation Study

JMIR Cardio. 2023 Nov 23;7:e50701. doi: 10.2196/50701.

ABSTRACT

BACKGROUND: To date, the 12-lead electrocardiogram (ECG) is the gold standard for cardiological diagnosis in clinical settings. With the advancements in technology, a growing number of smartphone apps and gadgets for recording, visualizing, and evaluating physical performance as well as health data is available. Although this new smart technology is innovative and time- and cost-efficient, less is known about its diagnostic accuracy and reliability.

OBJECTIVE: This study aimed to examine the agreement between the mobile single-lead ECG measurements of the Kardia Mobile App and the Apple Watch 4 compared to the 12-lead gold standard ECG in healthy adults under laboratory conditions. Furthermore, it assessed whether the measurement error of the devices increases with an increasing heart rate.

METHODS: This study was designed as a prospective quasi-experimental 1-sample measurement, in which no randomization of the sampling was carried out. In total, ECGs at rest from 81 participants (average age 24.89, SD 8.58 years; n=58, 72% male) were recorded and statistically analyzed. Bland-Altman plots were created to graphically illustrate measurement differences. To analyze the agreement between the single-lead ECGs and the 12-lead ECG, Pearson correlation coefficient (r) and Lin concordance correlation coefficient (CCCLin) were calculated.

RESULTS: The results showed a higher agreement for the Apple Watch (mean deviation QT: 6.85%; QT interval corrected for heart rate using Fridericia formula [QTcF]: 7.43%) than Kardia Mobile (mean deviation QT: 9.53%; QTcF: 9.78%) even if both tend to underestimate QT and QTcF intervals. For Kardia Mobile, the QT and QTcF intervals correlated significantly with the gold standard (rQT=0.857 and rQTcF=0.727; P<.001). CCCLin corresponded to an almost complete heuristic agreement for the QT interval (0.835), whereas the QTcF interval was in the range of strong agreement (0.682). Further, for the Apple Watch, Pearson correlations were highly significant and in the range of a large effect (rQT=0.793 and rQTcF=0.649; P<.001). CCCLin corresponded to a strong heuristic agreement for both the QT (0.779) and QTcF (0.615) intervals. A small negative correlation between the measurement error and increasing heart rate could be found of each the devices and the reference.

CONCLUSIONS: Smart technology seems to be a promising and reliable approach for nonclinical health monitoring. Further research is needed to broaden the evidence regarding its validity and usability in different target groups.

PMID:37995111 | DOI:10.2196/50701

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Nevin Manimala Statistics

Surgery versus radiotherapy for limited-stage small cell esophageal carcinoma: a multicenter, retrospective, cohort study in China (ChiSCEC)

Int J Surg. 2023 Nov 22. doi: 10.1097/JS9.0000000000000912. Online ahead of print.

ABSTRACT

BACKGROUND: There is no standard management for small cell esophageal carcinoma (SCEC). The purpose of this multicenter, retrospective study (ChiSCER) was to investigate the treatment, outcomes, and risk factors impacting on survival endpoints in patients with limited-stage SCEC (LS-SCEC).

MATERIALS AND METHODS: Consecutive patients with LS-SCEC from 14 institutions between 2000 to 2020 in China were enrolled. Survival curves were constructed using the Kaplan-Meier method and compared by log-rank test. Univariate and multivariate Cox regression models and propensity score matching (PSM) analysis were adopted in prognostic analysis. Results were reported as hazard ratio (HR), 95% confidence interval (CI), and P value. Statistical significance was set as P value<0.05 in a two-tailed test.

RESULTS: Among 458 LS-SCEC patients, the median age was 63 (interquartile range [IQR], 57-68) years, 318 (69%) were males. Eighty-four (18%), 167 (36%), and 207 (45%) patients received chemotherapy (CT) alone, CT plus definitive radiotherapy (CT+RT), and CT plus radical surgery (CT+S), respectively. With a median follow-up time of 58.7 (95% CI, 48.9-68.6) months, the median OS and 3-year OS rate for all patients 24.3 (95% CI, 21.6-27) months and 37.3% (95% CI, 32.8%-42.5%), respectively. Multivariate analysis indicated that treatment modes, Karnofsky performance status (KPS), TNM stage, and CT cycle were independent prognostic factors for overall survival (OS) (P<0.05). Compared with CT alone, patients treated with CT+RT (HR, 0.57, 95% CI, 0.41-0.8, P=0.001) or CT+S (HR, 0.59, 95% CI, 0.42-0.82, P=0.002) had an improved OS, with no significant survival differences between CT+S and CT+RT groups after multivariate and PSM analyses (P>0.05). Subgroup analysis indicated that compared with CT+RT, patients with tumor location at lower 1/3 (HR, 0.59, 95% CI, 0.37-0.93, P=0.03) or tumor length>5 cm (HR 0.52, 95% CI, 0.3-0.9, P=0.02) could obtain significant OS benefit from CT+S. Patients with tumor location at middle 1/3 (HR 1.55, 95% CI, 1.03-2.36, P=0.04) or tumor length≤5 cm (HR 1.49, 95% CI, 1.02-2.17, P=0.04) favored CT+RT. Distant metastasis accounted for 73.7% of all treatment failures after multidisciplinary treatments.

CONCLUSION: Surgery and RT were equally effective local therapies for patients with LS-SCEC. The personalized decision of local therapy should be made after comprehensive considerations on tumor location, length, comorbidities, and organ preservation.

PMID:37995095 | DOI:10.1097/JS9.0000000000000912