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Nevin Manimala Statistics

Is CONUT Score a Prognostic Index in Patients with Diffuse Large Cell Lymphoma?

Turk J Med Sci. 2021 May 7. doi: 10.3906/sag-2101-406. Online ahead of print.

ABSTRACT

BACKGROUND/AIM: The aim of the study was to evaluate the effect of Controlling Nutritional Status (CONUT) score on the prognosis in patients with diffuse large B-cell lymphoma(DLBCL).

MATERIALS AND METHODS: The present study was a retrospective study. The CONUT score was calculated based on serum albumin, total cholesterol and lymphocyte levels. This study included a total of 266 patients, 131(49.2%) were female and 135(50.8%) were male. The median follow-up period was 51 months (range: 1?190).

RESULTS: The median age was 64 years. The cut off CONUT was 1.5. There was a significant difference between patients with high (?2) or low (<2) CONUT scores in terms of overall survival(OS) and progression-free survival(PFS). The 5-year OS and PFS in patients with high CONUT score was 52.1% and 49.7%. The 5-year OS and PFS in patients with low CONUT score was 79.8% and 75.6% (p<0.001). In the multivariate analysis for OS, age ?65 years (HR=1.80, p=0.028), Eastern Cooperative Oncology Group (ECOG) >1 (HR=2.04, p=0.006), stage IIIA?IVB disease (HR=2.75, p=0.001) and the CONUT score (HR=1.15, p = 0.003) were found statistically significant. In the multivariate analysis for PFS, age ?65 years (HR=2.02, p=0.007), stage IIIA?IVB disease (HR=2.42, p=0.002) and the CONUT score (HR=1.19, p=0.001) were found to be significant parameters.

CONCLUSION: High CONUT score reduces OS and PFS in DLBCL. CONUT score is an independent, strong prognostic index in patients with DLBCL.

PMID:33957727 | DOI:10.3906/sag-2101-406

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Nevin Manimala Statistics

Defining Voiding Dysfunction in Women: Bladder Outflow Obstruction versus Detrusor Underactivity

Int Neurourol J. 2021 May 6. doi: 10.5213/inj.2040342.171. Online ahead of print.

ABSTRACT

PURPOSE: We aimed to develop urodynamic criteria for more accurate diagnosis of bladder outlet obstruction (BOO) and detrusor underactivity (DU) in women with lower urinary tract symptoms (LUTS).

METHODS: Initially, in a group of 68 consecutive women with LUTS and increased post-void residual who had undergone urodynamic investigation we examined the level of agreement between operating physician’s diagnosis of BOO or DU and diagnosis according to urodynamic nomograms/indices, including the Blaivas-Groutz (B-G) nomogram, Urethral Resistance Association (URA), Bladder Outlet Obstruction Index (BOOI) and Bladder Contractility Index (BCI). Based on the initial results, we categorized 160 women into four groups using B-G nomogram and URA (Group 1: severe-moderate BOO, Group 2: mild BOO and URA≥20, Group 3: mild BOO and URA<20 and Group 4: non-obstructed) and compared urodynamic parameters. Finally, we redefined women as obstructed (group 1+2) and non-obstructed (group 3+4) for sub-analysis.

RESULTS: The agreement between B-G nomogram and physician’s diagnosis was poor in the mild obstruction zone (kappa=0.308, p=0.01). Adding URA (cutoff value 20), an excellent level of agreement was reached (kappa=0.856, p<0.001). Statistically significant differences were found between the four groups (ANOVA) in maximum flow (Qmax) (p<0.0001), voided volume (VV) (p=0.042), post void residual (PVR) (p=0.032), BOOI (p<0.0001) and BCI (p<0.0001) with a positive linear trend for Qmax and VV and negative linear trend for PVR and BOOI from group 1 to 4. In the subanalysis all parameters were statistically different between obstructed and nonobstructive women except BCI (Qmax: p=0.0001, VV: p=0.0091, PVR: p=0.0005, BOOI: p=0.0001).

CONCLUSIONS: The combination of B-G nomogram with the URA parameter increases the accuracy of diagnosing BOO among women with LUTS. Based on this combination, most women in the mild obstruction zone of the B-G nomogram would be considered underactive rather than obstructed.

PMID:33957716 | DOI:10.5213/inj.2040342.171

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Nevin Manimala Statistics

Evaluation of proprioception in patients who underwent ACL reconstruction: Measurement in functional position

Turk J Med Sci. 2021 May 7. doi: 10.3906/sag-2004-110. Online ahead of print.

ABSTRACT

BACKGROUND/AIM: Anterior cruciate ligament (ACL) injuries cause mechanoreceptor loss in the joint; therefore, proprioceptive deficits are observed after injury. In particular, proprioceptive measurements made in the functional position give more accurate results, and this is an area that requires further studies. This study aimed to evaluate proprioception in patients who had undergone ACL reconstruction (ACLR) in functional positions used in daily life (closed kinetic chain position), according to joint angles where ACL injuries occur more frequently, in comparison with healthy controls.

MATERIALS AND METHODS: Thirty-four participants who underwent ACLR using a hamstring tendon graft (aged 29.18 ± 8.16 years; body mass index (BMI), 26.58 ± 4.02 kg/cm2) and 31 healthy participants (aged 27.35 ± 5.74 years; BMI, 24.76 ± 2.98 kg/cm2) were included. Proprioception was assessed with an active angle repetition test, using an inclinometer in the closed kinetic chain position while standing. Participants were asked to perform single-leg squats until the angle at the knee joint was 30°. After the targeted angle was defined, the participants were asked to find the targeted angle. The difference between the targeted angle and the angle reached by the participants was calculated.

RESULTS: A statistically significant difference in the active joint position sense was found among the ACLR extremity, uninvolved extremity, and control extremity (p < 0.05). The proprioceptive sense between the two extremities in the ACLR group was similar, and the proprioceptive sense was worse than that of the control group.

CONCLUSION: To our knowledge, this is the first study to evaluate closed kinetic chain position in patients who underwent ACLR and showed that proprioceptive sense was still poor in patients with ACLR compared with the control group, even if an average of 24 months have elapsed since surgery.

PMID:33957722 | DOI:10.3906/sag-2004-110

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Nevin Manimala Statistics

Effect of hyperparathyroidism on coagulation: A global assessment by modified rotation thromboelastogram (ROTEM)

Turk J Med Sci. 2021 May 7. doi: 10.3906/sag-2012-247. Online ahead of print.

ABSTRACT

OBJECTIVE: Hyperparathyroidism is an endocrine disorder characterized by hypercalcemia. Because of calcium?s effects on parathyroid glands, bone, intestine and kidney, it has an important place in homeostasis. The results of studies regarding hyperparathyroidism hemostasis are conflicting. Thromboelastography helps to evaluate all steps of hemostatic system. Our aim in this study was to investigate the possible role of hemostatic mechanisms in the development of thrombosis in hyperparathyroid patients with the modified rotation thromboelastogram (ROTEM).

METHODS: Twenty-two patients with primary hyperparathyroidism (PHPT) and 20 healthy controls were involved. This study was conducted in Eskisehir Osmangazi University Faculty of Medicine, Endocrinology and Hematology clinics for 2 years. The complete blood count, fibrinogen, D-dimer levels, prothrombin time, activated prothrombin time and ROTEM parameters [clot formation time (CFT), clotting time (CT), and maximum clot formation (MCF)] were determined by two activated tests, INTEM and EXTEM analyses. A thromboelastographic evaluation was performed in the preoperative and postoperative (three months after surgery) periods.

RESULTS: In INTEM assay, the CT (p= 0.012) and CFT (p= 0.07) values were increased in preoperative PHPT patients compared with the control group. Although there was a decrease in the postoperative CT and CFT values, no statistical difference was found.

CONCLUSION: The prolongation of the CT and CFT values were consistent with a hypocoagulable state in patients with PHPT. Hyperparathyroidism causes a hypocoagulable state that can be successfully assessed by ROTEM. Hemostatic changes, do not seem to have an effect on increased cardiovascular mortality.

PMID:33957726 | DOI:10.3906/sag-2012-247

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Nevin Manimala Statistics

Outcomes of the First Pregnancy After Fertility-Sparing Surgery for Early-Stage Ovarian Cancer

Obstet Gynecol. 2021 May 6. doi: 10.1097/AOG.0000000000004394. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the outcomes of the first pregnancy after fertility-sparing surgery in patients treated for early-stage ovarian cancer.

METHODS: We performed a retrospective study of women aged 18-45 years with a history of stage IA or IC ovarian cancer reported to the California Cancer Registry for the years 2000-2012. These data were linked to the 2000-2012 California Office of Statewide Health Planning and Development birth and discharge data sets to ascertain oncologic characteristics and obstetric outcomes. We included in the case group ovarian cancer patients who conceived at least 3 months after fertility-sparing surgery. The primary outcome was preterm birth, and only the first pregnancy after cancer diagnosis was considered. Secondary outcomes included small-for-gestational-age (SGA) neonates, neonatal morbidity (respiratory support within 72 hours after birth, hypoxic-ischemic encephalopathy, seizures, infection, meconium aspiration syndrome, birth trauma, and intracranial or subgaleal hemorrhage), and severe maternal morbidity as defined by the Centers for Disease Control and Prevention. Propensity scores were used to match women in a 1:2 ratio for the case group and the control group. Wald statistics and logistic regressions were used to evaluate outcomes.

RESULTS: A total of 153 patients who conceived after fertility-sparing surgery were matched to 306 women in a control group. Histologic types included epithelial (55%), germ-cell (37%), and sex-cord stromal (7%). Treatment for ovarian cancer was not associated with preterm birth before 37 weeks of gestation (13.7% vs 11.4%; odds ratio [OR] 1.23, 95% CI 0.69-2.20), SGA neonates (birth weight less than the 10th percentile: 11.8% vs 12.7%; OR 0.91, 95% CI 0.50-1.66), severe maternal morbidity (2.6% vs 1.3%; OR 2.03, 95% CI 0.50-8.25), or neonatal morbidity (both 5.9% OR 1.00, 95% CI 0.44-2.28).

CONCLUSION: Patients who conceived at least 3 months after surgery for early-stage ovarian cancer did not have an increased risk of adverse obstetric outcomes.

PMID:33957660 | DOI:10.1097/AOG.0000000000004394

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Nevin Manimala Statistics

Perspective: Planning and Conducting Statistical Analyses for Human Nutrition Randomized Controlled Trials: Ensuring Data Quality and Integrity

Adv Nutr. 2021 May 6:nmab045. doi: 10.1093/advances/nmab045. Online ahead of print.

ABSTRACT

Appropriate planning, execution, and reporting of statistical methods and results is critical for research transparency, validity, and reproducibility. This paper provides an overview of best practices for developing a statistical analysis plan a priori, conducting statistical analyses, and reporting statistical methods and results for human nutrition randomized controlled trials (RCTs). Readers are referred to the other NURISH (NUtrition inteRventIon reSearcH) publications for detailed information about the preparation and conduct of human nutrition RCTs. Collectively, the NURISH series outlines best practices for conducting human nutrition research.

PMID:33957665 | DOI:10.1093/advances/nmab045

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Nevin Manimala Statistics

Died from or with dementia? The relationship between dementia and cause of death

Dtsch Med Wochenschr. 2021 May;146(10):677-682. doi: 10.1055/a-1380-1436. Epub 2021 May 6.

ABSTRACT

Specifying a singular specific cause of death or an appropriate causal chain in the death certificate can be challenging, especially in cases of elderly, multimorbid deceased persons.The German cause of death statistics suggest that mental illnesses, including dementia, are beneath the most frequent causes of death. But when looking at death certificates in the context of dementia considerable information gaps and a lack of plausibility in the causal chain can be observed quite regularly.In this article we give recommendations for the correct designation of the cause of death and underlying diseases in the death certificate. These recommendations are not only to be seen against an academic background. The correct registration of dementia in the causes of death statistics may be a basis for decision making in health politics and is hence in the interest of optimal patient care.

PMID:33957690 | DOI:10.1055/a-1380-1436

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Nevin Manimala Statistics

BRCA1 Protein Expression Predicts Survival in Glioblastoma Patients from an NRG Oncology RTOG Cohort

Oncology. 2021 May 6:1-9. doi: 10.1159/000516168. Online ahead of print.

ABSTRACT

PURPOSE: Glioblastoma, the most common malignant brain tumor, was associated with a median survival of <1 year in the pre-temozolomide (TMZ) era. Despite advances in molecular and genetic profiling studies identifying several predictive biomarkers, none has been translated into routine clinical use. Our aim was to investigate the prognostic significance of a panel of diverse cellular molecular markers of tumor formation and growth in an annotated glioblastoma tissue microarray (TMA).

METHODS AND MATERIALS: A TMA composed of archived glioblastoma tumors from patients treated with surgery, radiation, and non-TMZ chemother-apy, was provided by RTOG. RAD51, BRCA-1, phosphatase and tensin homolog tumor suppressor gene (PTEN), and miRNA-210 expression levels were assessed using quantitative in situ hybridization and automated quantitative protein analysis. The objectives of this analysis were to determine the association of each biomarker with overall survival (OS), using the Cox proportional hazard model. Event-time distributions were estimated using the Kaplan-Meier method and compared by the log-rank test.

RESULTS: A cohort of 66 patients was included in this study. Among the 4 biomarkers assessed, only BRCA1 expression had a statistically significant correlation with survival. From univariate analysis, patients with low BRCA1 protein expression showed a favorable outcome for OS (p = 0.04; hazard ratio = 0.56) in comparison with high expressors, with a median survival time of 18.9 versus 4.8 months.

CONCLUSIONS: BRCA1 protein expression was an important survival predictor in our cohort of glioblastoma patients. This result may imply that low BRCA1 in the tumor and the consequent low level of DNA repair cause vulnerability of the cancer cells to treatment.

PMID:33957633 | DOI:10.1159/000516168

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Nevin Manimala Statistics

A Bibliometric Analysis of the One Hundred Most Cited Studies in Psychosomatic Research

Psychother Psychosom. 2021 May 6:1-6. doi: 10.1159/000516185. Online ahead of print.

NO ABSTRACT

PMID:33957635 | DOI:10.1159/000516185

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Nevin Manimala Statistics

Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial

Obstet Gynecol. 2021 May 6. doi: 10.1097/AOG.0000000000004409. Online ahead of print.

ABSTRACT

OBJECTIVE: To estimate the efficacy of fractionated carbon dioxide (CO2) laser therapy for vulvar lichen sclerosus.

METHODS: We conducted a prospective, double-blind, randomized, sham-controlled, trial conducted in a clinic specializing in vulvar disorders. The study participants were 40 women with active vulvar lichen sclerosus confirmed with biopsy who were abstaining from topical and systemic treatments for at least 4 weeks before enrollment. Women were randomized in a 1:1 ratio to receive either five sham laser treatments or five fractionated CO2 treatments in a 24-week period. Study participants, treating clinicians, and the evaluating pathologist were blinded. The primary endpoint was the change in the histopathology scale score between pretreatment and posttreatment biopsies. We estimated 20 per group for 80% power to detect a 40% reduction in the histopathology scale score with up to 10% attrition. A secondary endpoint was the change in the validated CSS (Clinical Scoring System for Vulvar Lichen Sclerosus).

RESULTS: From November 2018 to June 2020, 40 women were randomized to participate in the trial, and 37 women (19 fractionated CO2, 18 sham) were included in an intention-to-treat (ITT) analysis. Three women were excluded from the ITT analysis because they did not have posttreatment biopsies and, therefore, a posttreatment histopathology scale score could not be obtained. There was a 0.20 reduction (improvement) in histopathology scale score from baseline in the active treatment group (95% CI -1.1, 0.80, P=.74) and a 0.1 increase from baseline in the sham treatment group (95% CI -0.90, 1.0, P=.91). The change in histopathology scale score between the active and sham arm was not statistically significant (95% CI -1.14, 1.06, P=.76).

CONCLUSION: Fractionated CO2 is not an effective monotherapy treatment for vulvar lichen sclerosus.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03665584.

FUNDING SOURCE: Additional funding for this study was supplied by El.En Group, Florence, Italy, the manufacturer of the laser used in this study. In addition, El.En Group supplied the laser used in the study.

PMID:33957648 | DOI:10.1097/AOG.0000000000004409