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Nevin Manimala Statistics

MRI signal and morphological alterations of the suprapatellar fat pad in asymptomatic subjects: are these normal variants?

Skeletal Radiol. 2022 Apr 15. doi: 10.1007/s00256-022-04055-z. Online ahead of print.

ABSTRACT

OBJECTIVE: To study the prevalence of suprapatellar fat pad (SPFP) MR alterations in asymptomatic subjects, in relation to a wide range of clinical/imaging parameters, including muscle performance tests and physical activity data.

MATERIALS AND METHODS: We prospectively included 110 asymptomatic subjects as part of a cohort study. Inclusion criteria were no knee pain in the last year. Exclusion criteria were any medical/surgical history of a knee disorder. Subjects underwent knee and low-dose posture radiographs [EOS®], 3 T MRI, clinical examination including muscle performance tests, and physical activity monitoring. The presence/absence of SPFP alterations (hyperintensity and mass effect) were assessed through consensus reading on fluid-sensitive sequences. Differences between groups of knees with SPFP alterations and controls were tested for a total of 55 categorical/continuous clinical/imaging parameters, including SPFP relative-T2-signal, trochlear/patellar/lower-limb morphologic measurements. Wilcoxon-rank-sum and chi-square tests were used to compare groups of patients. The histological correlation was obtained in a cadaveric specimen.

RESULTS: SPFP alterations were common in asymptomatic subjects: hyperintensity 57% (63/110) and mass effect 37% (41/110), with 27% (30/110) showing both. Among the 55 imaging, clinical, or activity parameters tested, only increased patellar tilt angle (p = 0.02) and TT-TG distance (p = 0.03) were statistically different between groups of SPFP alterations and controls. The histological correlation showed more abundant connective tissue in SPFP compared to the prefemoral fat pad.

CONCLUSIONS: SPFP hyperintensity and mass effect are common MRI findings in asymptomatic knees, and they are not related to most imaging, clinical, and activity parameters. Care should be taken not to overcall them pathological findings as they most likely represent normal variants.

PMID:35426502 | DOI:10.1007/s00256-022-04055-z

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Nevin Manimala Statistics

Mediolateral/lateral episiotomy with operative vaginal delivery and the risk reduction of obstetric anal sphincter injury (OASI): A systematic review and meta-analysis

Int Urogynecol J. 2022 Apr 15. doi: 10.1007/s00192-022-05145-1. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: OASI complicates approximately 6% of vaginal deliveries. This risk is increased with operative vaginal deliveries (OVDs), particularly forceps. However, there is conflicting evidence supporting the use of mediolateral/lateral episiotomy (MLE/LE) with OVD. The aim of this study was to assess whether MLE/LE affects the incidence of OASI in OVD.

METHODS: Electronic searches were performed in OVID Medline, Embase and the Cochrane Library. Randomised and non-randomised observational studies investigating the risk of OASI in OVD with/without MLE/LE were eligible for inclusion. Pooled odds ratios (OR) were calculated using Revman 5.3. Risk of bias of was assessed using the Cochrane RoB2 and ROBINS-I tool. The quality of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE).

RESULTS: A total of 703,977 patients from 31 studies were pooled for meta-analysis. MLE/LE significantly reduced the rate of OASI in OVD (OR 0.60 [95% CI 0.42-0.84]). On sub-group analysis, MLE/LE significantly reduced the rate in nulliparous ventouse (OR 0.51 [95% CI 0.42-0.84]) and forceps deliveries (OR 0.32 [95% CI 0.29-0.61]). In multiparous women, although the incidence of OASI was lower when a ventouse or forceps delivery was performed with an MLE/LE, this was not statistically significant. Heterogeneity remained significant across all studies (I2 > 50). The quality of all evidence was downgraded to “very low” because of the critical risk of bias across many studies.

CONCLUSIONS: MLE/LE may reduce the incidence of OASI in OVDs, particularly in nulliparous ventouse or forceps deliveries. This information will be useful in aiding clinical decision-making and counselling in the antenatal period and during labour.

PMID:35426490 | DOI:10.1007/s00192-022-05145-1

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Factors contributing to neonatal readmissions to a level 4 hospital within 28 days after birth

J Paediatr Child Health. 2022 Apr 15. doi: 10.1111/jpc.15970. Online ahead of print.

ABSTRACT

AIM: To identify maternal and neonatal factors associated with neonatal readmissions.

METHODS: A case controlled, cross-sectional, retrospective review of neonatal readmissions within 28 days from birth to a level 4 hospital in Western Sydney was conducted from January to December 2018. Maternal and neonatal factors for readmission were assessed. A control group of 122 neonates were randomly selected. Comparative statistics and logistic regression analysis were used to analyse the data.

RESULTS: Of the 3914 neonatal discharges following birth, there were 129 neonatal readmissions (3.3%). Following regression analysis, gestational age (odds ratio 0.82, 95% confidence interval 0.7-0.97, P = 0.02) and intrapartum intravenous (IV) fluids (odds ratio 2.78, 95% confidence interval 1.66-4.67, P < 0.001) were associated with readmission. The majority of readmissions were feeding-related (72.9%). Of these readmissions, 29.8% had feeding concerns noted by nursing or midwifery staff during the initial hospital stay. During the initial hospital stay following birth, neonatal feeding issues were significantly associated with primiparous mothers (P = 0.005). Mothers who did not receive IV fluids during labour were also more likely to experience feeding issues (P = 0.015).

CONCLUSION: Our findings indicate that hospital discharge prior to established feeding patterns may be associated with an increased incidence of neonatal readmission. The factors associated with neonatal readmission are earlier gestational age and intrapartum IV fluid administration. These findings suggest that more comprehensive feeding assessment prior to discharge, flexibility of discharge timing and increased community support may reduce neonatal readmission.

PMID:35426474 | DOI:10.1111/jpc.15970

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Nevin Manimala Statistics

Hyperpolarized 13 C MRI Reveals Large Changes in Pyruvate Metabolism During Digestion in Snakes

Magn Reson Med. 2022 Apr 15. doi: 10.1002/mrm.29239. Online ahead of print.

ABSTRACT

PURPOSE: Hyperpolarized 13 C MRI is a powerful technique to study dynamic metabolic processes in vivo; but it has predominantly been used in mammals, mostly humans, pigs, and rodents.

METHODS: In the present study, we use this technique to characterize the metabolic fate of hyperpolarized [1-13 C]pyruvate in Burmese pythons (Python bivittatus), a large species of constricting snake that exhibits a four- to tenfold rise in metabolism and large growth of the visceral organs within 24-48 h of ingestion of their large meals.

RESULTS: We demonstrate a fivefold elevation of the whole-body lactate-to-pyruvate ratio in digesting snakes, pointing to a large rise in lactate production from pyruvate. Consistent with the well-known metabolic stimulation of digestion, measurements of mitochondrial respiration in hepatocytes in vitro indicate a marked postprandial upregulation of mitochondrial respiration. We observed that a low SNR of the hyperpolarized 13 C produced metabolites in the python, and this lack of signal was possibly due to the low metabolism of reptiles compared with mammals, preventing quantification of alanine and bicarbonate production with the experimental setup used in this study. Spatial quantification of the [1-13 C]lactate was only possible in postprandial snakes (with high metabolism), where a statistically significant difference between the heart and liver was observed.

CONCLUSION: We confirm the large postprandial rise in the wet mass of most visceral organs, except for the heart, and demonstrated that it is possible to image the [1-13 C]pyruvate uptake and intracellular conversion to [1-13 C]lactate in ectothermic animals.

PMID:35426467 | DOI:10.1002/mrm.29239

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The effect of obesity on cost of total laparoscopic hysterectomy

Aust N Z J Obstet Gynaecol. 2022 Apr 15. doi: 10.1111/ajo.13520. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: To test for the association between increasing patient body mass index (BMI) and the cost of total laparoscopic hysterectomy (TLH). Secondary outcomes include the relationship between increasing BMI and both peri- and post-operative morbidity.

MATERIALS AND METHODS: Retrospective cohort study of patients (N = 510) who underwent TLH between January 2017 and December 2018 at a single public tertiary teaching hospital.

RESULTS: Morbid obesity (n = 63) was associated with significantly higher total admission costs ($19 654 vs $17 475 Australian dollars, P = 0.002), operative costs ($9447 vs $8630, P = 0.017) and total costs including readmissions ($20 476 vs $18 399, P = 0.016) when compared to patients with normal BMI (n = 103) and adjusting for age, indication for surgery, additional procedures and conversion to total abdominal hysterectomy. Costs for overweight (n = 134) and obese (n = 210) BMI groups did not differ from costs for the normal BMI group. Increased operative costs observed in the morbidly obese group, were largely driven by the time associated with set-up, transfer and anaesthetic time while surgical and recovery times were not statistically significant.

CONCLUSION: The total cost of TLH is increased in the morbidly obese category of patients. The operative costs appear to be related to pre-operative measures such as theatre set-up and anaesthetic requirements. TLH in the obese and morbidly obese category group is not associated with increased intra-operative or post-operative complications. There may be a role for exploring improvements in managing morbidly obese patients in the pre-operative setting.

PMID:35426446 | DOI:10.1111/ajo.13520

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Robust approach to combining multiple markers to improve surrogacy

Biometrics. 2022 Apr 15. doi: 10.1111/biom.13677. Online ahead of print.

ABSTRACT

Identifying effective and valid surrogate markers to make inference about a treatment effect on long-term outcomes is an important step in improving the efficiency of clinical trials. Replacing a long term outcome with short term and/or cheaper surrogate markers can potentially shorten study duration and reduce trial costs. There is a sizable statistical literature on methods to quantify the effectiveness of a single surrogate marker. Both parametric and nonparametric approaches have been well developed for different outcome types. However, when there are multiple markers available, methods for combining markers to construct a composite marker with improved surrogacy remain limited. In this paper, building on top of the optimal transformation framework of Wang et al. (2020), we propose a novel calibrated model fusion approach to optimally combine multiple markers to improve surrogacy. Specifically, we obtain two initial estimates of optimal composite scores of the markers based on two sets of models with one set approximating the underlying data distribution and the other directly approximating the optimal transformation function. We then estimate an optimal calibrated combination of the two estimated scores which ensures both validity of the final combined score and optimality with respect to the proportion of treatment effect explained (PTE) by the final combined score. This approach is unique in that it identifies an optimal combination of the multiple surrogates without strictly relying on parametric assumptions while borrowing modeling strategies to avoid fully non-parametric estimation which is subject to curse of dimensionality. Our identified optimal transformation can also be used to directly quantify the surrogacy of this identified combined score. Theoretical properties of the proposed estimators are derived and finite sample performance of the proposed method is evaluated through simulation studies. We further illustrate the proposed method using data from the Diabetes Prevention Program (DPP) study. This article is protected by copyright. All rights reserved.

PMID:35426444 | DOI:10.1111/biom.13677

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Nevin Manimala Statistics

Psychosomatic symptoms in preschool children and how to treat them

Riv Psichiatr. 2022 Mar-Apr;57(2):88-93. doi: 10.1708/3790.37740.

ABSTRACT

BACKGROUND: Recent years saw an increase in children with emotional problems, which negatively affects not only their mental but also physical health. The current study aims to determine the structure of psychosomatic symptoms in preschool children and develop an effective treatment method for preschool teachers to deploy.

METHODS: A total of 259 children aged 4 to 5 years from Moscow preschools were divided into two groups: children (n=92) exposed to a standard education program and children (n=167) enrolled in the proposed education program for psychosomatic enhancement. The experiment lasted 6 months.

RESULTS: Using the proposed education program led to substantial improvements in the following KiddyKINDL subscales from baseline: Physical Well-being (1.19-fold increase, p<0.05), Emotional Well-being (1.24-fold increase, p<0.05), Self-esteem (1.21-fold increase, p<0.05), Family (1.17-fold increase, p<0.05), and Kiddy Parents (1.2-fold increase, p<0.05). The control group demonstrated slight but not significant improvements (p>0.05).

CONCLUSIONS: Therefore, the preschool teachers can use the proposed education program to enhance the psychosomatic health of preschool-aged children.

PMID:35426427 | DOI:10.1708/3790.37740

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Phase II Trial Evaluating Esophageal Anastomotic Reinforcement with a Biologic, Degradable, Extracellular Matrix after Total Gastrectomy and Esophagectomy

J Am Coll Surg. 2022 May 1;234(5):910-917. doi: 10.1097/XCS.0000000000000113.

ABSTRACT

BACKGROUND: A biologic, degradable extracellular matrix (ECM) has been shown to support esophageal tissue remodeling, which could reduce the risk of anastomotic leak following total gastrectomy and esophagectomy. We evaluated the safety and efficacy of reinforcing the anastomosis with ECM in reducing anastomotic leak as compared to a matched cohort.

STUDY DESIGN: In this single-center, nonrandomized phase II trial, gastric or esophageal adenocarcinoma patients undergoing total gastrectomy or esophagectomy were recruited from November 2013 through December 2018. ECM was surgically wrapped circumferentially around the anastomosis. Anastomotic leak was assessed clinically and by contrast study and defined as clinically significant if requiring invasive treatment (grade 3 or higher). Anastomotic stenosis, other adverse events, symptoms, and dysphagia score were collected by standardized forms at regular follow-up visits at approximately postoperative days (POD) 21 and 90. Patients receiving ECM were compared to a cohort matched for surgery type and age.

RESULTS: ECM placement was not feasible in 9 of 75 patients (12%), resulting in 66 patients receiving ECM. Total gastrectomy was performed in 50 patients (76%) and esophagectomy in 16 (24%). Clinically significant anastomotic leak was diagnosed in 6 of 66 patients (9.1%) (3/50 [6.0%] after gastrectomy, 3/16 [18.8%] after esophagectomy); this rate did not differ from that in the matched cohort (p = 0.57). Stenosis requiring invasive treatment occurred in 8 patients (12.5%), and 10 patients (15.6%) reported not being able to eat a normal diet at POD 90. No adverse events related to ECM were reported.

CONCLUSIONS: Esophageal anastomotic reinforcement after total gastrectomy or esophagectomy with a biologic, degradable ECM was mostly feasible and safe, but was not associated with a statistically significant decrease in anastomotic leak.

PMID:35426405 | DOI:10.1097/XCS.0000000000000113

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Nevin Manimala Statistics

Outcomes in Elderly Patients Undergoing Liver Transplantation Compared with Liver-Directed Ablative Therapy in Early-Stage Hepatocellular Carcinoma

J Am Coll Surg. 2022 May 1;234(5):892-899. doi: 10.1097/XCS.0000000000000135.

ABSTRACT

BACKGROUND: Orthotopic liver transplantation (OLT) is the accepted treatment in patients with unresectable, early-stage hepatocellular carcinoma (HCC) in the setting of cirrhosis. Due to increasing waitlist demand for OLT, determining optimal groups for transplant is critical. Elderly patients are known to have poorer postoperative outcomes. Considering the effectiveness of liver-directed therapies for HCC, we sought to determine whether elderly patients received survival benefit from OLT over liver-directed therapy alone.

STUDY DESIGN: The National Cancer Database participant use file was used to analyze data between 2004 and 2017. Only patients ≥70 years of age who received OLT or liver-directed therapy alone were included. Patients with alpha-fetoprotein >500 ng/mL or missing alpha-fetoprotein values were excluded. Baseline demographic variables, model for end-stage liver disease score, and overall survival from time of diagnosis were collected. Descriptive statistics, Kaplan-Meier survival, Cox proportional hazards model, and propensity score matching were used.

RESULTS: A total of 2,377 patients received ablative therapy alone, and 214 patients received OLT. Multivariable analysis and Kaplan-Meier showed that OLT conferred a significant survival benefit compared to liver-directed therapy alone. Age was also associated with a yearly 3% increase in risk of mortality. Propensity-matched analysis adjusting also demonstrated a significant survival benefit for elderly patients receiving OLT compared to liver-directed therapy alone.

CONCLUSION: Despite increased age and associated comorbidities being factors associated with poor outcomes, OLT confers a survival advantage compared to liver-directed ablative therapies alone in selected elderly patients with HCC. OLT should be offered in medically appropriate elderly patients with HCC.

PMID:35426403 | DOI:10.1097/XCS.0000000000000135

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Nevin Manimala Statistics

Area Deprivation Index and Rurality in Relation to Financial Toxicity among Breast Cancer Surgical Patients: Retrospective Cross-Sectional Study of Geospatial Differences in Risk Profiles

J Am Coll Surg. 2022 May 1;234(5):816-826. doi: 10.1097/XCS.0000000000000127.

ABSTRACT

BACKGROUND: Financial toxicity (FT) depicts the burden of cancer treatment costs and is associated with lower quality of life and survival in breast cancer patients. We examined the relationship between geospatial location, represented by rurality and Area Deprivation Index (ADI), and risk of FT.

STUDY DESIGN: A single-institution, cross-sectional study was performed on adult female surgical breast cancer patients using survey data retrospectively collected between January 2018 and June 2019. Chart reviews were used to obtain patient information, and FT was identified using the COmprehensive Score for Financial Toxicity questionnaire, which is a validated instrument. Patients’ home addresses were used to determine rurality using the Rural Urban Continuum Codes and linked to national ADI score. ADI was analyzed in tertiles for univariate statistical analyses, and as a continuous variable to develop multivariable logistic regression models to evaluate the independent associations of geospatial location with FT.

RESULTS: A total of 568 surgical breast cancer patients were included. Univariate analyses found significant differences across ADI tertiles with respect to race/ethnicity, marital status, insurance type, education, and rurality. In multivariable analysis, advanced cancer stage (odds ratio [OR] 2.26, 95% CI 1.15 to 4.44) and higher ADI (OR 1.012, 95% CI 1.01 to 1.02) were associated with worsening odds of FT. Increasing age (continuous) (OR 0.976, 95% CI 0.96 to 0.99), married status (vs unmarried) (OR 0.46, 95% CI 0.30 to 0.70), and receipt of bilateral mastectomy (OR 0.56, 95% CI 0.32 to 0.96) were protective of FT.

CONCLUSIONS: FT was significantly associated with areas of greater socioeconomic deprivation as measured by the ADI. However, in adjusted analyses, rurality was not significantly associated with FT. ADI can be useful for preoperative screening of at-risk populations and the targeted deployment of community-based interventions to alleviate FT.

PMID:35426394 | DOI:10.1097/XCS.0000000000000127