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Nevin Manimala Statistics

Reappraisal of clinical trauma trials: the critical impact of anthropometric parameters on fracture gap micro-mechanics-observations from a simulation-based study

Sci Rep. 2023 Nov 22;13(1):20450. doi: 10.1038/s41598-023-47910-2.

ABSTRACT

The evidence base of surgical fracture care is extremely sparse with only few sound RCTs available. It is hypothesized that anthropometric factors relevantly influence mechanical conditions in the fracture gap, thereby interfering with the mechanoinduction of fracture healing. Development of a finite element model of a tibia fracture, which is the basis of an in silico population (n = 300) by systematic variation of anthropometric parameters. Simulations of the stance phase and correlation between anthropometric parameters and the mechanical stimulus in the fracture gap. Analysis of the influence of anthropometric parameters on statistical dispersion between in silico trial cohorts with respect to the probability to generate two, with respect to anthropometric parameters statistically different trial cohorts, given the same power assumptions. The mechanical impact in the fracture gap correlates with anthropometric parameters; confirming the hypothesis that anthropometric factors are a relevant entity. On a cohort level simulation of a fracture trial showed that given an adequate power the principle of randomization successfully levels out the impact of anthropometric factors. From a clinical perspective these group sizes are difficult to achieve, especially when considering that the trials takes advantage of a “laboratory approach “, i.e. the fracture type has not been varied, such that in real world trials the cohort size have to be even larger to level out the different configurations of fractures gaps. Anthropometric parameters have a significant impact on the fracture gap mechanics. The cohort sizes necessary to level out this effect are difficult or unrealistic to achieve in RCTs, which is the reason for sparse evidence in orthotrauma. New approaches to clinical trials taking advantage of modelling and simulation techniques need to be developed and explored.

PMID:37993727 | DOI:10.1038/s41598-023-47910-2

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Chasing consistency: On the measurement error in self-reported affect in experiments

Behav Res Methods. 2023 Nov 22. doi: 10.3758/s13428-023-02290-3. Online ahead of print.

ABSTRACT

How feelings change over time is a central topic in emotion research. To study these affective fluctuations, researchers often ask participants to repeatedly indicate how they feel on a self-report rating scale. Despite widespread recognition that this kind of data is subject to measurement error, the extent of this error remains an open question. Complementing many daily-life studies, this study aimed to investigate this question in an experimental setting. In such a setting, multiple trials follow each other at a fast pace, forcing experimenters to use a limited number of questions to measure affect during each trial. A total of 1398 participants completed a probabilistic reward task in which they were unknowingly presented with the same string of outcomes multiple times throughout the study. This allowed us to assess the test-retest consistency of their affective responses to the rating scales under investigation. We then compared these consistencies across different types of rating scales in hopes of finding out whether a given type of scale led to a greater consistency of affective measurements. Overall, we found moderate to good consistency of the affective measurements. Surprisingly, however, we found no differences in consistency across rating scales, which suggests that the specific rating scale that is used does not influence the measurement consistency.

PMID:37993673 | DOI:10.3758/s13428-023-02290-3

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Assessment and evaluation of quality of life in epileptic patients using QOLIE-31 and QOLIE-AD-48 at tertiary care hospital

Int J Neurosci. 2023 Nov 21:1-13. doi: 10.1080/00207454.2023.2272042. Online ahead of print.

ABSTRACT

INTRODUCTION: The World Health Organization (WHO) defines quality of life as a person’s assessment of their place in life in the context of the culture and value systems in which they live, as well as in connection to their objectives, expectations, standards, and worries. Physiological as well as emotional wellness both affect quality of life (QOL).

OBJECTIVE: To assess and evaluate the quality of life in epileptic patients by using Quality of life in epilepsy inventory for adolescent (QOLIE-AD-48) and Quality of life in epilepsy inventory for adults (QOLIE-31) at tertiary care hospital.

METHODS: After receiving approval from the Institution Ethics Committees (IEC) of the ISF College of Pharmacy and Guru Gobind Singh Medical College and Hospital, Faridkot. This observational and questionnaire based study was carried out for a period of six months. Quality of life in epilepsy inventory for adolescent (QOLIE-AD-48) and Quality of life in epilepsy inventory for adults (QOLIE-31) had been used for this research and got approval from Dr. Joyce A. Cramer to use the questionnaire.

RESULTS: Except for the patients who declined to participate in the study, 109 individuals who participated in the observation and questionnaire-based study was enrolled. In this study, it was discovered that adolescents made up the majority of the patients with respect to adults and quality of life was found to be good (p = 0.062). The mean score of quality of life of the patients and standard deviation (SD) was found to be (M = 61.26) and (SD = 21.10). Males (63%, 69 patients) were found higher with respect to females (37%, 40 patients). Linear regression test was found to be significant (p = 0.003) of quality of life score (dependent variable) in relation to age and weight (independent variable) of the patients it. One way ANOVA test was found significant of quality of life score in relation to educational status (p = 0.001), epilepsy from last year (p = 0.001), and drug therapy (p = 0.017).

CONCLUSION: The current study explains the relationship between quality of life and other dependent variables by using different statistical analysis techniques. The quality of life of epileptic patients must be assessed on an individual basis, taking into consideration the patient’s state of physical health and psychological state. This study concludes that the quality of life of epileptic patients was found to be good as per significant results. If any of factors changes then there will also be differ in quality of life score.

PMID:37992399 | DOI:10.1080/00207454.2023.2272042

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Monitoring of Vitiligo Patches Over Six Months to Validate Dermoscopic Findings of Lesional Stability

Dermatol Pract Concept. 2023 Oct 1;13(4). doi: 10.5826/dpc.1304a277.

ABSTRACT

INTRODUCTION: Previously laid down criteria for lesional stability of vitiligo are inconsistent. Longitudinal data on correlation between dermoscopic features of vitiligo and disease activity is limited.

OBJECTIVES: To sequentially determine the dermoscopic features of vitiligo and to assess their association with the dynamic nature of the vitiligo patch.

METHODS: Sixty patients with 200 vitiligo patches fulfilling the inclusion criteria on medical therapy were subjected to sequential clinical and dermoscopic examination for 6 months. Baseline lesional photographs, dermoscopy and tracing of the patch was made and repeated at 6 months. The follow up tracing was superimposed onto the baseline tracing. Based on the increase or decrease in size, their outcomes were grouped as responsive, progressive and quiescent. Paired analysis of dermoscopic features was done between baseline, and their follow up after 6 months.

RESULTS: Well defined border was associated with static nature of the vitiligo patch and ill-defined borders and trichrome pattern depicted its dynamic nature. Statistically significant increase in leukotrichia and satellite lesions amongst progressive patches and a decrease amongst responsive patches was observed. Pigment network changes were statistically significant for both responsive and progressive patches. Satellite lesions and micro-Koebner’s phenomena was suggestive of progressive disease, while perifollicular pigmentation and perilesional hyperpigmentation was suggestive of re-pigmenting disease and proved to be an early marker for response to therapy.

CONCLUSIONS: Repeated dermoscopic evaluation of lesions in a serial manner to assess disease activity helps understand their evolving nature and is a valuable tool in planning appropriate further treatment.

PMID:37992385 | DOI:10.5826/dpc.1304a277

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Cytokine Profiles of Chronic Urticaria Patients and The Effect of Omalizumab Treatment

Dermatol Pract Concept. 2023 Oct 1;13(4). doi: 10.5826/dpc.1304a272.

ABSTRACT

INTRODUCTION: Cytokines are key mediators in immunological and inflammatory conditions, including chronic spontaneous urticaria (CSU).

OBJECTIVES: To investigate Th1, Th2, and Th17 cytokine profiles in CSU and to evaluate the possible effect of omalizumab treatment.

METHODS: Patients who were followed up for CSU, as well as healthy volunteers, were included in the study. To assess urticaria activity, the 7-day-Urticaria Activity Score (UAS-7), the Urticaria Control Test (UCT), and the Chronic Urticaria Quality of Life Questionnaire (CU-QoL) were filled. Serum levels of IL-6, IL-17, IL-31, eotaxin, RANTES, TNF-α, and TSLP were analyzed by ELISA and compared in CSU and control groups. The patients were analyzed in two groups as the omalizumab group and the non-omalizumab group based on their treatment status.

RESULTS: Total IgE, ESR, CRP, RANTES, and TNF-a were significantly different in the overall comparison of the three groups: CSU-receiving omalizumab, CSU-not receiving omalizumab, and control groups (P <0.01, 0.015, <0.01, <0.01 and <0.01 respectively). Total IgE, CRP, RANTES, and TNF-α values were similar in those who received and did not receive omalizumab, yet these biomarkers were significantly higher in both groups than in the control group (P < 0.05). Statistical significance in ESR was observed only between the CSU-receiving omalizumab group and the control group (P = 0.01). Within the CSU patients, there was a slight but significant correlation between UCT and TNF-α (P = 0.008, r = 0.32) and IL-17 (P = 0.06, r = 0.33) levels.

CONCLUSIONS: The investigated cytokine profile in CSU patients may differ from healthy controls, particularly with the higher levels of RANTES and TNF-α, and omalizumab treatment does not seem to affect that profile in CSU patients.

PMID:37992372 | DOI:10.5826/dpc.1304a272

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A Retrospective Review of Chronic Non-Communicable Dermatoses Among Older Adults at a Tertiary Healthcare Facility in Southwestern Nigeria

Dermatol Pract Concept. 2023 Oct 1;13(4). doi: 10.5826/dpc.1304a262.

ABSTRACT

INTRODUCTION: Aging is a ubiquitous human trait that predisposes older persons to chronic diseases. Compared with systemic non-communicable diseases, a significant gap exists in literature on the burden of non-communicable dermatoses (NCDs) amongst older adults particularly in low and middle-income countries.

OBJECTIVES: The aim of this study was to document the epidemiology and clinical pattern of non-communicable skin diseases among older adults at a tertiary healthcare facility in Southwestern Nigeria.

METHODS: We conducted a retrospective review of medical records of ambulant adults aged ≥60 years referred for dermatological care at a teaching hospital in ile-ife, South-Western Nigeria between February 2017 and February 2022. The frequency and pattern of NCDs were recorded for descriptive statistical analysis using SPSS 20 statistics software. The level of statistical significance was set at 0.05.

RESULTS: A total 553 medical records were reviewed with a female: male ratio of 1.3:1 The mean age of the study population was 68.85 ±7.87. Six out of every 10 patients (60.6%) had at least one chronic NCD. The incidence of chronic NCDs declined with increasing age. Chronic eczemas (22.4%), pigmentary dermatoses (9.4%) and skin tumors (8.7%) were the most frequent chronic non-communicable dermatoses recorded. Older males had a significantly higher incidence of chronic eczemas while chronic urticarias and skin tumors demonstrated significant female preponderance.

CONCLUSIONS: There is a high burden of chronic NCDs with significant gender disparities among older adults with skin problems in Nigeria. Pre-emptive planning and resource allocation towards specialist geriatric-dermatology services are needed to address skin-health needs of the growing geriatric population.

PMID:37992368 | DOI:10.5826/dpc.1304a262

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Dermoscopy in the Diagnosis of Mycosis Fungoides: Can it Help?

Dermatol Pract Concept. 2023 Oct 1;13(4). doi: 10.5826/dpc.1304a284.

ABSTRACT

The diagnosis of mycosis fungoides (MF) is challenging since it can mimic a variety of benign skin conditions. Multiple biopsies for histopathologic and immunohistochemical examination are required to diagnose MF. Dermoscopy is an affordable, non-invasive device with expanding indications in dermatology, OBJECTIVES: To investigate the dermoscopic morphology of MF variants and assess the correlation between dermoscopic criteria, histopathologic, and immunohistochemical findings, METHODS: We included 88 patients with several MF variants (classic, hypopigmented, hyperpigmented, poikilodermatous, erythrodermic, and folliculotropic). The diagnosis was histopathologically and immunohistochemically confirmed. Dermoscopic findings were collected, statistically analyzed, and correlated with the results of histopathology and immunohistochemistry, RESULTS: All patients had MF diagnosis in H&E-stained sections. The majority revealed positive staining with CD3, 4, 8 and negative CD7. Orange-red areas of discoloration, short linear, and spermatozoa like blood vessels are the most frequent dermoscopic findings, while an analysis per MF variant was also performed. The frequently observed dermoscopic structures in classic MF were patchy whitish scales, dotted, short linear vessels, and spermatozoa-like vessels, CONCLUSIONS: Dermoscopy reveals a repetitive dermoscopic pattern in MF (non-homogenous pink to erythematous background, patchy areas of orange discoloration, patchy whitish scales, dotted and short linear blood vessels with some variations according to the clinical variant.

PMID:37992354 | DOI:10.5826/dpc.1304a284

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Adult Burn Inpatients Have Increased Burn Severity and Mortality Compared to Children in Retrospective Analysis of National Inpatient Sample 2017

Dermatol Pract Concept. 2023 Oct 1;13(4). doi: 10.5826/dpc.1304a214.

ABSTRACT

INTRODUCTION: Socioeconomic status and comorbidities are associated with increased mortality in patients with external surface burn patients, however differences between pediatric and adult burn populations have not been adequately studied.

OBJECTIVES: Our objectives were to explore the presentation, management, and outcomes of external surface burns across age groups.

METHODS: The 2017 National Inpatient Sample (NIS) was queried for patients with any diagnosis of external body surface burns. Demographics, comorbidities, complications, total charges, length of stay (LOS), number of procedures undergone (NPU), and time from admission to first procedure (TFP) were identified. Univariate and multivariable analyses were used to identify statistical associations with age.

RESULTS: 52,335 inpatients were identified with burns, with the majority male (63.6%) and adults (81.8%). Mean age was 50.5 (standard error [SE] 0.1) and 5.5 (SE 0.1) years for adults and children, respectively. Adults had higher prevalence of hypertensive disease (43.5% versus. 1.4%), diabetes mellitus (24.1% versus 0.3%), and obesity (11.7% versus 1.6%) than children (P < 0.001). Adults versus children had higher odds for mortality (odds ratio [OR] 4.26, 95% confidence interval [CI] 3.08-5.89), sepsis (OR 5.16, 95% CI 4.10-6.48), and pneumonia (OR 4.26, 95% CI 3.30-5.50).

CONCLUSIONS: In this national cohort of inpatients with external surface burns, comorbidities, and odds for mortality and complications varied by age. Pediatric patients more often had lower household incomes; however, adults had significantly higher odds for mortality suggesting that age and comorbidity status are more impactful on burn outcomes than socioeconomic status.

PMID:37992342 | DOI:10.5826/dpc.1304a214

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Burden of AML, 1990-2019: Estimates From the Global Burden of Disease Study

JCO Glob Oncol. 2023 Sep;9:e2300229. doi: 10.1200/GO.23.00229.

ABSTRACT

PURPOSE: AML accounts for 80% of acute leukemia in adults. While progress has been made in treating younger patients in the past 2 decades, there has been limited improvement for older patients until recently. This study examines the global and European Union (EU) 15+ trends in AML between 1990 and 2019.

METHODS: We extracted age-standardized incidence rates (ASIRs), age-standardized death rates (ASMRs), and disability-adjusted life years, stratified by sex from the Global Burden of Disease Study database, and mortality-to-incidence ratio (MIR) were computed. Trends were compared using Joinpoint regression.

RESULTS: The findings show a global increase in AML incidence for both sexes from 1990 to 2019. In the EU15+ countries, most countries exhibited an increase in ASIR for both sexes. Joinpoint revealed that globally for male patients, ASIR steadily increased until 2010, remained stable until 2015 followed by a decline till 2019. Similar trends were observed in female patients. For ASMR, although there was an increase globally and in most EU15+ countries, there was a statistically significant decrease in mortality rates globally and in the majority of EU15+ countries in recent years. MIR improved in both sexes globally. On age stratification, AML burden was highest among older groups (55 years and older), while the lowest rates were observed in younger than 20 years.

CONCLUSION: The findings from our study indicate a global rise in AML incidence and mortality in both sexes and decrease in MIR from 1990 to 2019 suggesting a better survival. However, on Joinpoint analysis, there is no change in MIR in women in the past decade and past 4 years in men indicating plateau in survival trends despite recent advances.

PMID:37992271 | DOI:10.1200/GO.23.00229

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DNA Mutational Profiling in Patients With Colorectal Cancer Treated With Standard of Care Reveals Differences in Outcome and Racial Distribution of Mutations

J Clin Oncol. 2023 Nov 22:JCO2300825. doi: 10.1200/JCO.23.00825. Online ahead of print.

ABSTRACT

PURPOSE: CALGB (Alliance)/SWOG 80405 was a randomized phase III trial that in first-line patients with metastatic colorectal cancer (mCRC) treated with bevacizumab or cetuximab with chemotherapy. We aimed to discover novel mutated genes associated with prognosis and differential response to therapy with the biologics.

METHODS: Primary tumor DNA from 548 patients was sequenced using FoundationOne. The effect of mutated genes and mutations on overall survival (OS) was tested adjusting for microsatellite instability status, BRAF V600E, all RAS mutations, arm, sex, and age.

RESULTS: The median number (lower-upper quartile) of mutated genes was 5 (3-7), 5 (3-6) in microsatellite stable and 12.5 (4.5-32) in microsatellite instability-high tumors. Mutated KRAS and APC were more frequent in Black (53% and 85%) than White (27% and 65%, respectively) patients while BRAF V600E was less frequent in Black (5%) than White (14%) patients. The median OS in patients with BRAF non-V600E (2.2% of patients) was 31.9 months (95% CI, 15.1 to not applicable [NA]) similar to that of BRAF wild-type (WT) patients (31.2 months [95% CI, 29.0 to 33.9]). Mutated LRP1B (10.7% of patients) was associated with improved OS compared with WT LRP1B (hazard ratio, 0.57 [95% CI, 0.40 to 0.80]). RNF43 (5.6% of patients) interacted with treatment arms as, in the cetuximab arm, patients with mutated RNF43 had a median OS of 11.5 (95% CI, 10.8 to NA) months compared with 30.1 (95% CI, 24.9 to 35.3) months in patients with WT RNF43, whereas in the bevacizumab arm, patients with mutated RNF43 had a median OS of 25.0 (95% CI, 14.2 to NA) months compared with 31.3 (95% CI, 29.0 to 34.3) months in patients with WT RNF43.

CONCLUSION: These results can provide new tools to predict patient outcome and improve therapeutic decisions and trial participation in patient minorities. The molecular alterations identified in this study may direct biomarker-driven studies.

PMID:37992266 | DOI:10.1200/JCO.23.00825