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Nevin Manimala Statistics

The effect of a combined treatment of foot soak and lavender oil inhalation therapy on the severity of insomnia of patients with cancer: Randomized interventional study

Explore (NY). 2022 Sep 29:S1550-8307(22)00164-1. doi: 10.1016/j.explore.2022.09.003. Online ahead of print.

ABSTRACT

OBJECTIVES: This three-arm randomized intervention study was carried out with the aim to evaluate the effects of a combined foot soak and lavender oil inhalation therapy on the severity of insomnia of patients with cancer.

METHOD: This research was carried out in oncology and palliative services. Forty-five patients were randomly assigned to three groups. Throughout a 14-day period, 20 min of foot soak treatment was applied to the patients in the F group, patients in the L group were applied lavender oil inhalation therapy for 5 min and a combined treatment of foot soak and lavender oil inhalation therapy were applied to the patients in the FL group. Insomnia severity of the patients in all groups were evaluated twice using the Insomnia Severity Index at the baseline and on the fifteenth day.

RESULTS: The severity of the insomnia of the patients in all groups was found to be moderate. The severity of the insomnia in the second evaluation was found to be statistically significantly lower in the L and FL groups (p<0.05) compared to the baseline evaluation within the group, however no significant difference was found in the F group (p>0.05). The effect size of a combined treatment of foot soak and lavender oil inhalation therapy on the severity of insomnia of patients in the FL group was higher and moderate (d = 0.684) compared to merely foot soak and merely lavender oil inhalation therapy.

CONCLUSION: A combined treatment of foot soak and lavender oil inhalation therapy shall mitigate the severity of a moderate level of insomnia of patients with cancer.

PMID:36270928 | DOI:10.1016/j.explore.2022.09.003

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Validity of low-cost measures for global surveillance of physical activity in pre-school children: The SUNRISE validation study

J Sci Med Sport. 2022 Oct 10:S1440-2440(22)00437-6. doi: 10.1016/j.jsams.2022.10.003. Online ahead of print.

ABSTRACT

OBJECTIVES: To validate parent-reported child habitual total physical activity against accelerometry and three existing step-count thresholds for classifying 3 h/day of total physical activity in pre-schoolers from 13 culturally and geographically diverse countries.

DESIGN: Cross-sectional validation study.

METHODS: We used data involving 3- and 4-year-olds from 13 middle- and high-income countries who participated in the SUNRISE study. We used Spearman’s rank-order correlation, Bland-Altman plots, and Kappa statistics to validate parent-reported child habitual total physical activity against activPAL™-measured total physical activity over 3 days. Additionally, we used Receiver Operating Characteristic Area Under the Curve analysis to validate existing step-count thresholds (Gabel, Vale, and De Craemer) using step-counts derived from activPAL™.

RESULTS: Of the 352 pre-schoolers, 49.1 % were girls. There was a very weak but significant positive correlation and slight agreement between parent-reported total physical activity and accelerometer-measured total physical activity (r: 0.140; p = 0.009; Kappa: 0.030). Parents overestimated their child’s total physical activity compared to accelerometry (mean bias: 69 min/day; standard deviation: 126; 95 % limits of agreement: -179, 316). Of the three step-count thresholds tested, the De Craemer threshold of 11,500 steps/day provided excellent classification of meeting the total physical activity guideline as measured by accelerometry (area under the ROC curve: 0.945; 95 % confidence interval: 0.928, 0.961; sensitivity: 100.0 %; specificity: 88.9 %).

CONCLUSIONS: Parent reports may have limited validity for assessing pre-schoolers’ level of total physical activity. Step-counting is a promising alternative – low-cost global surveillance initiatives could potentially use pedometers for assessing compliance with the physical activity guideline in early childhood.

PMID:36270900 | DOI:10.1016/j.jsams.2022.10.003

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Nevin Manimala Statistics

Prostate-specific Antigen Density Cutoff of 0.15 ng/ml/cc to Propose Prostate Biopsies to Patients with Negative Magnetic Resonance Imaging: Efficient Threshold or Legacy of the Past?

Eur Urol Focus. 2022 Oct 18:S2405-4569(22)00230-9. doi: 10.1016/j.euf.2022.10.002. Online ahead of print.

ABSTRACT

BACKGROUND: A prostate-specific antigen density (PSAd) cutoff of 0.15 ng/ml/cc is a commonly recommended threshold to identify patients with negative prostate magnetic resonance imaging (MRI) who should proceed to a prostate biopsy. We were unable to find any study that explicitly examined the properties of this threshold compared with others.

OBJECTIVE: To investigate whether the 0.15 cutoff is justified for selecting patients at risk of harboring high-grade cancer (Gleason score ≥3 + 4) despite negative MRI.

DESIGN, SETTING, AND PARTICIPANTS: A cohort of 8974 prostate biopsies provided by the Prostate Biopsy Collaborative Group (PBCG) was included in the study.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Locally weighted scatterplot smoothing was used to investigate whether there was a change in the risk of high-grade cancer around this value. We examined whether the use of this cutoff in patients with negative MRI corresponds to a reasonable threshold probability for a biopsy (defined as a 10% risk of high-grade disease). To do so, we applied the negative likelihood ratio of MRI, calculated from eight studies on prostate MRI, to the risk curve derived from the PBCG.

RESULTS AND LIMITATIONS: There was no discontinuity in the risk of high-grade prostate cancer at a PSAd cutoff of 0.15. This cutoff corresponded to a probability of high-grade disease ranging from 2.6% to 10%, depending on MRI accuracy. Using 10% as threshold probability, the corresponding PSAd cutoff varied between 0.15 and 0.38, with the threshold increasing for greater MRI accuracy. Possible limitations include difference between studies on MRI and the use of ultrasound to measure prostate volume.

CONCLUSIONS: The 0.15 cutoff to recommend prostate biopsies in patients with negative MRI is justified only under an extreme scenario of poor MRI properties. We recommend a value of at least ≥0.20. Our results suggest the need for future studies to look at how to best identify patients who need prostate biopsies despite negative MRI, likely by using individualized risk prediction.

PATIENT SUMMARY: In this study, we investigated whether the commonly used prostate-specific antigen density cutoff of 0.15 is justified to identify patients with negative magnetic resonance imaging (MRI) who should proceed to a prostate biopsy. We found that this cutoff is appropriate only in case of very poor MRI quality, and a higher cutoff (≥0.20) should be used for the average MRI.

PMID:36270887 | DOI:10.1016/j.euf.2022.10.002

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Treatment effect analysis of curettage for jaw cysts based on volumetric assessment and image registration

J Craniomaxillofac Surg. 2022 Oct 1:S1010-5182(22)00132-9. doi: 10.1016/j.jcms.2022.09.005. Online ahead of print.

ABSTRACT

The study was conducted to develop a visual and intuitive quantitative evaluation method for maxillary cystic lesions after curettage. Mimics 16.0 and Geomagic Studio 2013 were used to form a precise reconstruction of the cystic lesion morphology of 60 cases; the average reduction rates and 95% confidence interval were calculated. Computed tomography (CT) registration was performed before and after surgery to observe morphology features of the bone regeneration of the cystic area. The average reduction rates (RR) of the cysts after curettage were (43.56 ± 16.79)%, (54.33 ± 17.15)% and (68.53 ± 15.99)% at 3 months, 6 months and 12 months after surgery, respectively. The average monthly reduction rates (MRR) were (12.07 ± 4.35)%, (8.16 ± 2.84)% and (5.35 ± 1.52)% at 3 months, 6 months and 12 months after surgery, respectively. Correlation analysis by comparing with each group showed that the effect of sex and age in the 3-month group and the initial size in the 12-month group on RR and MRR were statistically significant. Within the limitations of the study it seems that the chosen approach for quantitative evaluation of the therapeutic effect of curettage for jaw cystic lesions might facilitate visual and quantitative follow-up of cyst curettage and timely detection of recurrence.

PMID:36270886 | DOI:10.1016/j.jcms.2022.09.005

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Role of VEGF I/D variant in suspectibility to odontogenic cyst formation

Nucleosides Nucleotides Nucleic Acids. 2022 Oct 21:1-9. doi: 10.1080/15257770.2022.2136693. Online ahead of print.

ABSTRACT

Odontogenic cysts, are located in the jawbones, filled with fluid surrounded by epithelial lining and fibrous connective tissue. Vascular endothelial growth factor (VEGF) can induce physiological and pathological angiogenesis and is an endothelial cell-specific mitogen. The aim of the present study was to investigate whether any possible association between the VEGF insertion/deletion (I/D) variant and odontogenic cyst in Turkish population. Clinical information and venous blood samples were collected from 62 odontogenic cyst patients and 98 healthy controls. DNA was isolated from peripheral blood leukocytes. Genotyping of the VEGF I/D variant was done by the polymerase chain reaction (PCR) method. There was a statistically differece in terms of VEGF I/D allele frequencies between patients and controls. VEGF I/D variant I allele frequency was more prevalant in patients compared to controls (p = 0.006411, OR: 2.08, 95%Cl: 1.322-3.272). A statistically significant association was observed when the patients were compared with the controls according to D/D + I/D versus I/I genotype (p = 0.0508, OR: 1.925, 95%Cl: 0.872-4.246). The genotype distribution of VEGF I/D was not statistically different between patients and controls (p > 0.05). For the first time, our results provided evidence supporting the odontogenic cyst formation associated with the I/D variant at the promoter region of the VEGF gene in a group of Turkish population. Although it was seen in our study that the I/D variant in the promoter region of the VEGF gene supports odontogenic cyst formation, large-scale studies are needed to elucidate the effect of this variant on odontogenic cysts.

PMID:36270022 | DOI:10.1080/15257770.2022.2136693

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Efficacy of a Novel LAM Femoral Cutaneous Block Technique for Acute Donor Site Pain

J Burn Care Res. 2022 Oct 21:irac159. doi: 10.1093/jbcr/irac159. Online ahead of print.

ABSTRACT

Patients with severe burn injuries often require split thickness skin grafting to expedite wound healing with the thigh being a common donor site. Uncontrolled pain is associated with increased opioid consumption, longer lengths of stay, and delay in functional recovery. Peripheral nerve blocks are increasing in popularity although supportive literature is limited, and techniques vary. The purpose of this case series is to assess the safety, feasibility, and clinical efficacy of a recently demonstrated novel continuous LAM (lateral, anterior, medial) femoral cutaneous block technique in a larger cohort. The study was a dual IRB approved, observational case series from a single verified burn center. The electronic health record was retrospectively reviewed for patients admitted between June 2018 to May 2021 who had the continuous LAM block performed for donor site pain by the acute pain service team. Demographics were reported with descriptive statistics and morphine milligram equivalents (MME) were analyzed via Friedman analysis of variance. Forty-seven patients had a total of 53 blocks placed, where 2 patients received the LAM block on two separate occasions and 4 patients had bilateral LAM blocks placed. Most were African American males, but mechanism of injury varied. Over half had a neurologic (17 %) or psychiatric history (34 %) outside of substance use. Almost three-quarters had a history of substance use with 17 % being opioids, and a quarter had a history of polysubstance use. Median day from admission to LAM was 7 (2.5, 11.5) with a median duration of 4 (3, 5) days. Temperature and pressure sensation were reduced at the donor site. Quadricep strength remained intact, and median day until first ambulation after LAM placement was 2 (1, 3) days. Pain was adequately controlled, and there were no significant adverse events associated with the block. There was a significant reduction in MME after block placement (p < 0.001). Continuous peripheral nerve blocks offer an advantageous means of analgesia, while reducing potential adverse events associated with opioids or multimodal regimens. The novel LAM technique reduced sensation and pain without inhibiting early ambulation, and patients were able to fully participate in their rehabilitation.

PMID:36270008 | DOI:10.1093/jbcr/irac159

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Even-Denominator Fractional Quantum Hall State at Filling Factor ν=3/4

Phys Rev Lett. 2022 Oct 7;129(15):156801. doi: 10.1103/PhysRevLett.129.156801.

ABSTRACT

Fractional quantum Hall states (FQHSs) exemplify exotic phases of low-disorder two-dimensional (2D) electron systems when electron-electron interaction dominates over the thermal and kinetic energies. Particularly intriguing among the FQHSs are those observed at even-denominator Landau level filling factors, as their quasiparticles are generally believed to obey non-Abelian statistics and be of potential use in topological quantum computing. Such states, however, are very rare and fragile, and are typically observed in the excited Landau level of 2D electron systems with the lowest amount of disorder. Here we report the observation of a new and unexpected even-denominator FQHS at filling factor ν=3/4 in a GaAs 2D hole system with an exceptionally high quality (mobility). Our magnetotransport measurements reveal a strong minimum in the longitudinal resistance at ν=3/4, accompanied by a developing Hall plateau centered at (h/e^{2})/(3/4). This even-denominator FQHS is very unusual as it is observed in the lowest Landau level and in a 2D hole system. While its origin is unclear, it is likely a non-Abelian state, emerging from the residual interaction between composite fermions.

PMID:36269975 | DOI:10.1103/PhysRevLett.129.156801

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Sequencing of Androgen-Deprivation Therapy of Short Duration With Radiotherapy for Nonmetastatic Prostate Cancer (SANDSTORM): A Pooled Analysis of 12 Randomized Trials

J Clin Oncol. 2022 Oct 21:JCO2200970. doi: 10.1200/JCO.22.00970. Online ahead of print.

ABSTRACT

PURPOSE: The sequencing of androgen-deprivation therapy (ADT) with radiotherapy (RT) may affect outcomes for prostate cancer in an RT-field size-dependent manner. Herein, we investigate the impact of ADT sequencing for men receiving ADT with prostate-only RT (PORT) or whole-pelvis RT (WPRT).

MATERIALS AND METHODS: Individual patient data from 12 randomized trials that included patients receiving neoadjuvant/concurrent or concurrent/adjuvant short-term ADT (4-6 months) with RT for localized disease were obtained from the Meta-Analysis of Randomized trials in Cancer of the Prostate consortium. Inverse probability of treatment weighting (IPTW) was performed with propensity scores derived from age, initial prostate-specific antigen, Gleason score, T stage, RT dose, and mid-trial enrollment year. Metastasis-free survival (primary end point) and overall survival (OS) were assessed by IPTW-adjusted Cox regression models, analyzed independently for men receiving PORT versus WPRT. IPTW-adjusted Fine and Gray competing risk models were built to evaluate distant metastasis (DM) and prostate cancer-specific mortality.

RESULTS: Overall, 7,409 patients were included (6,325 neoadjuvant/concurrent and 1,084 concurrent/adjuvant) with a median follow-up of 10.2 years (interquartile range, 7.2-14.9 years). A significant interaction between ADT sequencing and RT field size was observed for all end points (P interaction < .02 for all) except OS. With PORT (n = 4,355), compared with neoadjuvant/concurrent ADT, concurrent/adjuvant ADT was associated with improved metastasis-free survival (10-year benefit 8.0%, hazard ratio [HR], 0.65; 95% CI, 0.54 to 0.79; P < .0001), DM (subdistribution HR, 0.52; 95% CI, 0.33 to 0.82; P = .0046), prostate cancer-specific mortality (subdistribution HR, 0.30; 95% CI, 0.16 to 0.54; P < .0001), and OS (HR, 0.69; 95% CI, 0.57 to 0.83; P = .0001). However, in patients receiving WPRT (n = 3,049), no significant difference in any end point was observed in regard to ADT sequencing except for worse DM (HR, 1.57; 95% CI, 1.20 to 2.05; P = .0009) with concurrent/adjuvant ADT.

CONCLUSION: ADT sequencing exhibits a significant impact on clinical outcomes with a significant interaction with field size. Concurrent/adjuvant ADT should be the standard of care where short-term ADT is indicated in combination with PORT.

PMID:36269935 | DOI:10.1200/JCO.22.00970

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Nevin Manimala Statistics

Distributed Estimation of Support Vector Machines for Matrix Data

IEEE Trans Neural Netw Learn Syst. 2022 Oct 21;PP. doi: 10.1109/TNNLS.2022.3212390. Online ahead of print.

ABSTRACT

Discrimination problems are of significant interest in the machine learning literature. There has been growing interest in extending traditional vector-based machine learning techniques to their matrix forms. In this article, we investigate the statistical properties of the nuclear-norm-based regularized linear support vector machines (SVMs), in particular establishing the convergence rate of the estimator in the high-dimensional setting. Furthermore, within the distributed estimation paradigm, we propose a communication-efficient estimator that can achieve the same convergence rate. We illustrate the performances of the estimators via some simulation examples and an empirical data analysis.

PMID:36269928 | DOI:10.1109/TNNLS.2022.3212390

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Positron Emission Tomography-Adapted Therapy in Bulky Stage I/II Classic Hodgkin Lymphoma: CALGB 50801 (Alliance)

J Clin Oncol. 2022 Oct 21:JCO2200947. doi: 10.1200/JCO.22.00947. Online ahead of print.

ABSTRACT

PURPOSE: Patients with bulky stage I/II classic Hodgkin lymphoma (cHL) are typically treated with chemotherapy followed by radiation. Late effects associated with radiotherapy include increased risk of second cancer and cardiovascular disease. We tested a positron emission tomography (PET)-adapted approach in patients with bulky, early-stage cHL, omitting radiotherapy in patients with interim PET-negative (PET-) disease and intensifying treatment in patients with PET-positive (PET+) disease.

METHODS: Eligible patients with bulky disease (mass > 10 cm or 1/3 the maximum intrathoracic diameter on chest x-ray) received two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by interim fluorodeoxyglucose PET (PET2). Patients with PET2-, defined as 1-3 on the 5-point scale, received four additional cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine. Patients with PET2+ received four cycles of escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone followed by 30.6 Gy involved-field radiation.

RESULTS: Of 94 evaluable patients, 53% were female with median age 30 years (range, 18-58 years). Eight-five (90%) had stage II disease, including 48 (51%) with stage IIB/IIBE. Seventy-eight (78%) were PET2- and 21 (22%) were PET2+. The predominant toxicity was neutropenia, with 9% of patients developing febrile neutropenia and one developing sepsis. The primary end point of 3-year progression-free survival (PFS) was 93.1% in PET2- and 89.7% in PET2+ patients. Three-year overall survival was 98.6% and 94.4%, respectively. The estimated hazard ratio comparing PFS of patients with PET2+ and patients with PET2- was 1.03 (85% upper bound 2.38) and was significantly less than the null hypothesis of 4.1 (one-sided P = .04).

CONCLUSION: Our study of PET-adapted therapy in bulky stage I/II cHL met its primary goal and was associated with an excellent 3-year PFS rate of 92.3% in all patients, with the majority being spared radiotherapy and exposure to intensified chemotherapy.

PMID:36269899 | DOI:10.1200/JCO.22.00947