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Nevin Manimala Statistics

Sleep Disorders and Quality of Life in Patients With Cancer: Prospective Observational Study of the Rafael Institute

JMIR Form Res. 2022 Nov 24;6(11):e37371. doi: 10.2196/37371.

ABSTRACT

BACKGROUND: Sleep disorders are a common occurrence in the general population. Yet today, it is clearly agreed that sleep disorders represent both a cancer risk factor and a biological consequence of the of the activation of the immuno-inflammatory system induced by cancer itself.

OBJECTIVE: The aim of this study was to assess the impact of sleep disorders on quality of life and identify the type of disorder and its causes in order to offer an adapted and personalized care plan.

METHODS: In a survey completed during the COVID-19 lockdown, 2000 hours of interviews were collected by remote consultations. During these calls, we administered a sleep questionnaire. This questionnaire was inspired by the STOP-BANG questionnaire and enquired about 6 items. The demographic details of each patient (eg, age and sex), the nature of the pathology, their past treatments, the ongoing cancer treatment, the mood, whether or not the patient is anxious or depressed, and the use of sleeping drug pills were analyzed. A univariate analysis was performed according to the presence or absence of fatigue. Chi-square test was applied to assess possible differences of variables’ link to sleep disturbance between patients complaining of fatigue and those without fatigue. The same test was then used to analyze patients on hormone therapy and those with no hormone therapy for 2 types of cancer-breast cancer and prostate cancer.

RESULTS: A total of 905 patients were prospectively included in this study. The average age was 66.7 (5 SD) years, and 606 (67%) patients were women; 142 patients declared being overweight. Breast cancer was the most frequently reported cancer. Nocturnal awakening was reported by 70% (n=633), fatigue by 50% (n=452), difficulty falling asleep by 38% (n=343), snoring reported by an independent observer in 38% (n=343), and apnea reported by an independent observer in 9% (n=81) of the patients. The univariate analysis showed that the feeling of tiredness was significantly greater in patients reporting difficulty falling asleep (P≥.99), pain (P<.001), and frequent awakening (P<.001), as well as in patients who were not receiving cancer treatment (P<.001). The univariate analysis showed that patients who were receiving breast cancer treatment and were under hormone therapy reported difficulty falling asleep (P=.04) and pain (P=.05). In a univariate analysis of patients treated for prostate cancer, being overweight was the only factor reported that had a statistically significant value.

CONCLUSIONS: Our preliminary data support and are consistent with data in the literature regarding the importance of sleep disorders in oncology. This justifies the usefulness of a diagnosis and early treatment of sleep disorders in patients with cancer. The Rafael Institute sleep observatory will enable patients to be identified and treated.

PMID:36422866 | DOI:10.2196/37371

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Nevin Manimala Statistics

Developmental and Momentary Dynamics in the Onset and Maintenance of Nonsuicidal Self-Injurious Behavior and Borderline Personality Disorder

Curr Psychiatry Rep. 2022 Nov 24. doi: 10.1007/s11920-022-01396-3. Online ahead of print.

ABSTRACT

PURPOSE OF REVIEW: Traditional conceptualizations of both nonsuicidal self-injury (NSSI) and borderline personality disorder (BPD) typically rely on static and unidirectional, linear associations between key biopsychosocial vulnerabilities. Instead, we argue that utilizing a complex dynamic systems view of NSSI and BPD will advance the field, as such conceptual models allow for analysis of bottom-up effects for key vulnerabilities on disorder and behavior emergence, as well as top-down effects of the emergent disorder on underlying vulnerabilities.

RECENT FINDINGS: Following the presentation of a novel framework highlighting momentary and developmental dynamics, we explore several advances in the field that exhibit key dynamic qualities or inform dynamic conceptualizations of NSSI and BPD. At the momentary dynamic level, several advances are being made with multimethod and repeated assessment approaches, as well as advanced bidirectional and complex modeling procedures. Additional progress is being made at the developmental dynamic level, although several questions have arisen regarding the problem of onset and subsequent trajectory, particularly with issues such as pain perception and the interplay between interpersonal, emotional, and behavioral symptoms before and after treatment. Self-injury and BPD both exhibit substantial momentary and developmental dynamics in underlying vulnerabilities, including potential variance in momentary dynamics as a function of psychopathological developmental stage (e.g., onset versus maintenance versus recovery). Recent work has highlighted the necessity of utilizing multimodal research to encapsulate a holistic view of the interplay of several vulnerability factors, the developmental importance of assessment timing, and the need to examine the dynamic interplay between affect, behavior, and interpersonal experiences in BPD and/or NSSI. Research also indicated substantial variation in key vulnerability factors at both between- and within-person levels, highlighting the utility of harnessing statistical models that allow for the simultaneous incorporation of numerous variables at both levels and across several time points. As such, by using a complex dynamic systems conceptualization, we can begin to better understand integrated connections between key vulnerabilities, how they collectively interact in the short term, and how changes in the dynamic interplay between vulnerabilities may arise over the long term and with successful treatment.

PMID:36422833 | DOI:10.1007/s11920-022-01396-3

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Nevin Manimala Statistics

Levothyroxine Bioequivalence Study and Its Narrow Therapeutic Index: Comparative Bioavailability Results Between Two Formulations Available in Latin America

Adv Ther. 2022 Nov 24. doi: 10.1007/s12325-022-02352-6. Online ahead of print.

ABSTRACT

INTRODUCTION: The history of levothyroxine has been linked to advances in the treatment of thyroid disease and to date it is the standard therapy for the treatment of hypothyroidism. Bioequivalence studies are the most widely used method to demonstrate interchangeability, although controversy persists regarding the best design for this molecule declared as a narrow therapeutic index product in many countries. This study aimed to evaluate the pharmacokinetic profile of two formulations of levothyroxine to determine bioequivalence between them.

METHODS: This two-period, randomized, crossover, blind study was conducted in 80 healthy volunteers, of both sexes, using a single levothyroxine dose of 600 μg with a washout period of 42 days. Blood sampling was performed at – 30 min, – 15 min, and 0 h pre-dose and 30 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, and 48 h post-dose.

RESULTS: A total of 78 subjects successfully completed both periods. There were no serious adverse events during the study and both formulations were well tolerated. Baseline correction of serum levothyroxine concentrations was performed before statistical analysis. The mean maximum plasma concentration of the test product (Levotiroxina MK®) was 57.49 ng/mL while for the reference product it reached 59.32 ng/mL. Importantly, both test and reference formulations reached maximum concentrations in plasma at about the same time. The areas under the pharmacokinetic curves with the test product showed AUC0-t of 1407.1 ng h/mL and the reference product 1394.3 ng h/mL. The bioequivalence statistical analysis showed that the 90% confidence interval (CI90%) of the ratio of test over reference formulation was within the bioequivalence margins of 90-111%. For Cmax, the test/reference ratio was 96.2% with CI90% of 91.6-100.9%, and for AUC0-t the test/reference ratio was 99.9 with CI90% of 93.3-107.0%.

CONCLUSIONS: Both formulations have the same pharmacokinetic profile and are bioequivalent in the narrow therapeutic index required by some health authorities.

PMID:36422808 | DOI:10.1007/s12325-022-02352-6

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Nevin Manimala Statistics

Social Needs and Acculturation as Predictors of Emotional Problems and Perceived Stress Among Latinx Mothers with Low Income

J Immigr Minor Health. 2022 Nov 24. doi: 10.1007/s10903-022-01430-9. Online ahead of print.

ABSTRACT

Associations between household social needs, acculturation, and emotional health remain understudied, particularly among Latinx mothers. We analyzed baseline survey data from 455 Latinx mothers in a previous study. Using multinomial regression, we examined whether emotional problems and perceived stress were associated with household social needs and acculturation. Almost half the sample reported four or more household social needs. Social needs cumulatively and independently predicted increased odds of frequent emotional problems or perceived stress. Lower acculturation predicted lower odds of frequent emotional problems. There is increased risk for emotional problems and stress in low-income Latinx mothers who experience high social need. Integrated social service and mental health care models may be one way to improve health outcomes. More research is needed to understand how clinical settings can leverage unique cultural protective factors to address the social and emotional health needs of Latinx mothers.

PMID:36422792 | DOI:10.1007/s10903-022-01430-9

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Nevin Manimala Statistics

Does the mesh type influence the outcomes and costs of robotic inguinal hernia repair?

J Robot Surg. 2022 Nov 23. doi: 10.1007/s11701-022-01494-7. Online ahead of print.

ABSTRACT

The aim of this study was to compare the clinical outcomes and hospital costs associated with two different meshes in robotic transabdominal preperitoneal inguinal hernia repair (IHR). Patients who underwent IHR were assigned to either the polyester self-gripping (PSG) or the polypropylene (PP) group depending on the mesh used. A propensity score matching analysis was performed to obtain balanced populations. Postoperative variables included complications such as surgical site events and recurrences. Hospital costs included all possible expenses generated by the surgery during the hospitalization period. From a database of IHR performed between February 2012 and July 2022, 131 PSG patients were matched to 131 PP repairs. Median operative time was shorter in the PSG group [55 (40-78) vs. 80 (60-116) minutes, p < 0.001]. No intraoperative complications were recorded. Patients who received the PSG mesh experience reduced immediate postoperative pain compared to the PP group. Average follow-up time was 35.2 months in the PSG group vs. 12.5 months in the PP group (p < 0.001). Median Comprehensive Complication Index was comparable in both groups (p = 0.489), with no surgical site infections logged. No cases of chronic pain were noted. Only two recurrences were recorded in the cohort, both of them in the PSG repairs. Hospital costs were USD $232 higher in the PP group but did not statistically differ (p = 0.523). There were no differences between the polyester self-gripping and the polypropylene mesh in terms of postoperative complications, clinical outcomes and hospital costs. Surgeons may opt for either meshes depending on their preferences and familiarity with each of the products.

PMID:36422791 | DOI:10.1007/s11701-022-01494-7

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Nevin Manimala Statistics

Does location of the households’ matters? Identifying the households’ willingness to pay and preference heterogeneity in advancement of vulnerable ecosystem services: An approach of choice experiment

Environ Sci Pollut Res Int. 2022 Nov 23. doi: 10.1007/s11356-022-24299-5. Online ahead of print.

ABSTRACT

The present research underlines the need to expand far outside bundling or hierarchical providing strategy that often focuses on a specific habitat or ecosystem and creates a location-based strategy that considers how dependency in other parts of the region with ecosystem functions and processes leads to complements and resources’ trade-offs. Thus, for assessment of spatial heterogeneity based on willingness to pay (WTP) for upgrading environmental attributes across Heihe River Basin (HRB), a choice experiment survey was carried out in the entire river basin. The HRB is one of the big inland river in the Northwestern region of China and is selected on basis of its geomorphological and geographical significance. A sum of 1679 individuals were interviewed through choice experiment technique from whole river basin consisting of five main cities and 33 adjoining rural areas. The Random Parameter logit model, Krinsky-Robb technique as well as delta method were applied for the evaluation of spatial heterogeneity and estimation of individual specific WTP, respectively. Spatial heterogeneity is verified among sampled individuals’ preferences about upgradation of environmental attributes, such as, observed preferences of individuals’ and their varying corresponding WTP amounts for per unit’s upgradation in agriculture product quality, greenhouse gases reduction, farmland landscape, and biodiversity, which reflects heterogeneous tastes and preferences of the selected individuals. In addition, the assessed outcomes for identifying the impacts of distance decay through random parameter logit model depicted the vital role of distance influence on respondents’ WTP for restoring the degraded environmental attributes, such that among 3 ad hoc distance bands, WTP of those sampled individuals who are in proximity of ≤ 10 km to HRB is more than the rest of the individuals, i.e., individuals living in the range of ≤ 20 km and > 20 km. For instance, WTP for agriculture product quality is 119.147 CNY/year in ≤ 10 km and is higher than the remainders.

PMID:36422782 | DOI:10.1007/s11356-022-24299-5

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Nevin Manimala Statistics

Telemedicine approach for patient follow-up after total knee and reverse total shoulder arthroplasty: a pilot study

Int J Comput Assist Radiol Surg. 2022 Nov 23. doi: 10.1007/s11548-022-02784-z. Online ahead of print.

ABSTRACT

PURPOSE: The study aimed to demonstrate the reduction in postoperative follow-up visit time for patients receiving total knee arthroplasty (TKA) or reverse total shoulder arthroplasty (RTSA) by implementing a novel asynchronous telemedicine system compared to face-to-face visits. The range of motion interobserver agreement and patient satisfaction were evaluated in the telemedicine group.

METHODS: A randomized controlled trial was conducted with a total of 28 patients with a mean age of 71 years (range 13.3). Patients were distributed into two study groups, TKA (n = 14) and RTSA (n = 14), and each group was randomly allocated into a face-to-face or virtual follow-up visit group. For the virtual group, software was designed including patient-specific model items (X-ray, range of motion and functional scores) for each arthroplasty. Functional assessment was conducted using the International Knee Documentation Committee (IKDC) score for TKA and American Shoulder and Elbow score (ASES) and Simple Shoulder Test (SST) for RTSA. The range of motion interobserver concordance was conducted in the virtual follow-up groups via an intraclass correlation coefficient. Finally, a satisfaction survey was performed in the virtual follow-up groups. Mann-Whitney U test was used for statistical analysis.

RESULTS: Mean time differences between face-to-face and virtual follow-ups were 502.5 s (95% CI 387.8-617.1; p < 0.002) in the RTSA group and 710 s (95% CI 597.91-822; p < 0. 002) in the TKA group. The range of motion interobserver concordance in the virtual group was 0.974 for TKA and 0.804 for RTSA. Finally, virtual follow-up satisfaction using the telematic method was 8.9 out of 10.

CONCLUSION: The results of this study showed that a virtual follow-up using asynchronous telemedicine systems could reduce visit times, allow a correct articular range of motion evaluation and maintain satisfaction perception for patients. Asynchronous telemedicine could be an efficient method to conduct postoperative follow-up after knee and shoulder arthroplasty.

PMID:36422767 | DOI:10.1007/s11548-022-02784-z

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MRI remains highly accurate in the diagnosis of appendicitis in pregnancy when read by radiologists of mixed specialty training and experience

Emerg Radiol. 2022 Nov 23. doi: 10.1007/s10140-022-02102-9. Online ahead of print.

ABSTRACT

PURPOSE: To audit the accuracy of magnetic resonance imaging (MRI) abdominal studies performed in the diagnosis of appendicitis in pregnant patients when read by radiologists of mixed experience.

METHODS: MRI reports from 45 pregnant women presenting to our emergency department for the investigation of appendicitis between 2009 and 2020 were retrospectively reviewed. Where available, these reports were correlated with surgical and pathology reports as well as follow-up clinical information. Following a review of literature, accuracy targets were set. Statistical analyses including sensitivity, specificity, positive, and negative predictive values were calculated.

RESULTS: A total of 18 radiology consultants read 45 MRI abdominal studies in the assessment of appendicitis during pregnancy with 62% (n = 28) of these read by specialist radiologists and the remainder by general radiologists. This yielded an accuracy in diagnosis of 99.8%, sensitivity of 80% (95% CI: 49-94.3%), and specificity of 100% (95% CI: 90-100%). The calculated negative predictive value was 94.6% (95% CI: 82.3-98.5%), and positive predictive value was 100% (95% CI: 90-100%). The appendix was not identified in 19 patients (42%). A statistically significant relationship between the presence of right iliac fossa stranding of the fat OR free fluid was associated with appendicitis (p = 0.01). Alternate diagnoses were identified in 8% (n = 4) of cases.

CONCLUSION: MRI is a highly accurate imaging modality for the assessment of appendicitis in pregnancy. Even with variable reader MRI experience, MRI demonstrates an accuracy of 99.8% and a positive predictive value for acute appendicitis of 100%. Double reading and the possible inclusion of DWI may help further improve accuracy and minimise false-negative rates.

PMID:36422751 | DOI:10.1007/s10140-022-02102-9

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Nevin Manimala Statistics

The HIF1α polymorphism rs2301104 is associated with obesity and obesity-related cytokines in Han Chinese population

Acta Diabetol. 2022 Nov 23. doi: 10.1007/s00592-022-02008-5. Online ahead of print.

ABSTRACT

AIMS: To evaluate the association between genetic polymorphisms of HIF1α and obesity and obesity-related cytokines in the Han Chinese population.

METHODS: The study consisted of 160 subjects with obesity and 166 age- and gender-matched healthy controls. We genotyped three tag single nucleotide polymorphisms (SNPs) of HIF1α by using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS)-based genotyping technology. Plasma cytokine concentrations were determined on the Luminex platform. The genetic associations were analysed statistically.

RESULTS: Obese subjects had significant obesity-related metabolic abnormalities, including hyperglycaemia, insulin resistance, and abnormalities in blood lipids, liver enzymes, and uric acid levels. SNP analysis of HIF1α revealed that the allele and genotype frequencies of rs2301104 were significantly associated with obesity. Our results suggest that the minor allele C of rs2301104 might be a protective mutation of obesity, and CC/CG genotypes of rs2301104 could be protective genotype of obesity. We also found that subjects with CC/CG genotypes of rs2301104 had significantly lower levels of IL-6, TNF-α, IL-1β, IL-8, and IL-10 than subjects with GG genotypes.

CONCLUSIONS: This is the first study to report an association between HIF1α polymorphisms and obesity and obesity-related cytokines in a Han Chinese population. These results require replication in larger populations but suggest that HIF1α may play an important role in obesity development.

PMID:36422747 | DOI:10.1007/s00592-022-02008-5

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The comparison between contrast-enhanced ultrasound and contrast-enhanced magnetic resonance imaging in diagnosing bladder urothelial carcinoma

Int Urol Nephrol. 2022 Nov 24. doi: 10.1007/s11255-022-03410-2. Online ahead of print.

ABSTRACT

PURPOSE: The surgical treatment of bladder urothelial carcinoma depends on whether the tumor has invaded the bladder muscular layer. Normal ultrasound and contrast-enhanced magnetic resonance imaging (contrast-enhanced MRI) are widely used in patients bear bladder tumors; the latter is also widely used in estimating the muscularis invasion of bladder cancer (BC). However, contrast-enhanced ultrasound (CEUS) is rarely used in this aspect. As the gold standard in diagnosing muscularis invasion remains being pathological examination, this study was set to find out whether there are differences between CEUS and contrast-enhanced MRI in diagnosing bladder malignant tumors and in diagnosing the muscularis invasion of the bladder urothelial carcinoma under the guide of the pathological results.

METHODS: 160 patients from Yongchuan Hospital of Chongqing Medical University and The Second Affiliated Hospital of Chongqing Medical University were recruited from July 1st, 2021, to June 30th, 2022. Patients are arranged to undergo CEUS, contrast-enhanced MRI and then take a surgery. After surgery, we compare the results of CEUS, MRI and the pathological results, using software to run the statistical examinations.

RESULTS: The accuracies of CEUS and contrast-enhanced MRI in diagnosing malignant bladder tumors were 85.90 and 84.62%, and they had no differences (P > 0.05). While the accuracies of CEUS and contrast-enhanced MRI in diagnosing the muscularis invasion were 84.62 and 76.92%, in which CEUS had a better sensitivity (P < 0.05).

CONCLUSIONS: We found that CEUS and contrast-enhanced MRI had no differences in diagnosing the different pathological types (benign or malignant) of BC, but CEUS holds a better sensitivity in diagnosing muscularis invasions of bladder urothelial carcinoma than the contrast-enhanced MRI.

PMID:36422743 | DOI:10.1007/s11255-022-03410-2