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Nevin Manimala Statistics

Home-based Intensive Nutrition Therapy improves Frailty and Sarcopenia in Patients with Decompensated Cirrhosis: A Randomized Clinical Trial

J Gastroenterol Hepatol. 2022 Oct 21. doi: 10.1111/jgh.16035. Online ahead of print.

ABSTRACT

BACKGROUND & AIMS: The majority of patients with decompensated cirrhosis suffer from malnutrition, a potentially modifiable contributor to frailty and sarcopenia. The present study investigated the impact of a six-month dietician-supported home-based intensive nutrition therapy (HINT) intervention on objective frailty and sarcopenia metrics in patients with decompensated cirrhosis.

METHODS: One hundred adult patients with decompensated cirrhosis, frailty, and sarcopenia at baseline were randomized 1:1 to receive standard medical therapy (SMT) plus HINT (intervention) versus SMT (control) alone. The primary outcome was an improvement in frailty as measured by the Liver Frailty Index (LFI). Secondary outcome measures included sarcopenia metrics, liver disease severity scores, hospitalization and death.

RESULTS: The LFI improved more in the intervention arm as compared to controls (0.8 versus 0.4;p<0.001). Baseline and end-of-study Skeletal Muscle Index (SMI) was available in a subset of thirty two male patients, with greater improvements seen in the intervention arm compared to controls(6.36 versus 0.80;p=0.02). Patients in the intervention arm had less hospitalizations over the 6-month follow-up(19(38%) vs. 29(58%)(p=0.04)). On subgroup analysis, in the 64% of patients who were adherent to calorie and protein intake targets at six months, significant improvement was seen in liver disease severity scores and survival (p<0.05).

CONCLUSION: In patients with decompensated cirrhosis, frailty and sarcopenia, a 6-month dietitian supported home-based intensive outpatient nutrition therapy was associated with statistically and clinically relevant improvement in frailty. The subgroup of adherent patients showed improvement in their liver disease scores and reduction in mortality. These findings support the key role of food as medicine in the management of cirrhosis.

PMID:36268614 | DOI:10.1111/jgh.16035

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Nevin Manimala Statistics

The effect of sacral massage on meconium-stained amniotic fluid and the duration of fetal descent in labor: A randomized controlled trial

J Obstet Gynaecol Res. 2022 Oct 21. doi: 10.1111/jog.15460. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to investigate the effect of sacral massage on the presence of meconium-stained amniotic fluid and the duration of fetal descent during labor in pregnant women.

METHODS: A total of 220 nulliparous women with singleton low-risk pregnancies in the vertex position at term were recruited. Eligible women were randomly assigned to either massage group or a control group. The massages were performed with friction and tapotement protocol. The massage was applied for 10 min each time by a midwife who is also an expert in the field, at the onset of contractions during the intrapartum period, when cervical dilatation reached 10 cm. The Wong-Baker faces pain rating scale was evaluated.

RESULTS: No significant difference was found between the length of the first stage of labor and the total length of delivery (p = 0.097 and 0.434), respectively. There was a significant difference between the two groups in terms of perineal injuries. Perineal injury was lower in the massaged group (p = 0.005). There was a low percentage of meconium-stained amniotic fluid in the massaged group. The difference between the groups was statistically significant. The duration of fetal descent was shorter in the massaged group (p < 0.001). A significant difference was found in Wong-Baker FACES pain rating scale scores. Lower scores were detected in the massaged group (p < 0.001).

CONCLUSION: Sacral massage has beneficial effects on mothers and babies in obstetric practice. In addition, applying massage during labor plays a significant role in reducing the presence of meconium-stained amniotic fluid and the duration of fetal descent.

PMID:36268587 | DOI:10.1111/jog.15460

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Left-atrial long-axis shortening allows effective quantification of atrial function and optimized risk prediction following acute myocardial infarction

Eur Heart J Open. 2022 Aug 12;2(5):oeac053. doi: 10.1093/ehjopen/oeac053. eCollection 2022 Sep.

ABSTRACT

AIMS: Deformation imaging enables optimized risk prediction following acute myocardial infarction (AMI). However, costly and time-consuming post processing has hindered widespread clinical implementation. Since manual left-ventricular long-axis strain (LV LAS) has been successfully proposed as a simple alternative for LV deformation imaging, we aimed at the validation of left-atrial (LA) LAS.

METHODS AND RESULTS: The AIDA STEMI and TATORT-NSTEMI trials recruited 795 patients with ST-elevation myocardial infarction and 440 with non-ST-elevation myocardial infarction. LA LAS was assessed as the systolic distance change between the middle of a line connecting the origins of the mitral leaflets and either a perpendicular line towards the posterior atrial wall (LAS90) or a line connecting to the LA posterior portion of the greatest distance irrespective of a predefined angle (LAS). Primary endpoint was major adverse cardiac event (MACE) occurrence within 12 months. There were no significant differences between LA LAS and LAS90, both with excellent reproducibility. LA LAS correlated significantly with LA reservoir function (Es, r = 0.60, P < 0.001). Impaired LA LAS resulted in higher MACE occurrence [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.82-0.88, P < 0.001]. LA LAS (HR 0.90, 95% CI 0.83-0.97, P = 0.005) and LV global longitudinal strain (GLS, P = 0.025) were the only independent predictors for MACE in multivariate analyses. C-statistics demonstrated incremental value of LA LAS in addition to GLS (P = 0.016) and non-inferiority compared with FT Es (area under the receiver operating characteristic curve 0.74 vs. 0.69, P = 0.256).

CONCLUSION: Left-atrial LAS provides fast and software-independent approximations of quantitative LA function with similar value for risk prediction compared with dedicated deformation imaging.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT00712101 and NCT01612312.

PMID:36268539 | PMC:PMC9574426 | DOI:10.1093/ehjopen/oeac053

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Equivariance Allows Handling Multiple Nuisance Variables When Analyzing Pooled Neuroimaging Datasets

Proc IEEE Comput Soc Conf Comput Vis Pattern Recognit. 2022 Jun;2022:10422-10431. doi: 10.1109/cvpr52688.2022.01018. Epub 2022 Sep 27.

ABSTRACT

Pooling multiple neuroimaging datasets across institutions often enables improvements in statistical power when evaluating associations (e.g., between risk factors and disease outcomes) that may otherwise be too weak to detect. When there is only a single source of variability (e.g., different scanners), domain adaptation and matching the distributions of representations may suffice in many scenarios. But in the presence of more than one nuisance variable which concurrently influence the measurements, pooling datasets poses unique challenges, e.g., variations in the data can come from both the acquisition method as well as the demographics of participants (gender, age). Invariant representation learning, by itself, is ill-suited to fully model the data generation process. In this paper, we show how bringing recent results on equivariant representation learning (for studying symmetries in neural networks) instantiated on structured spaces together with simple use of classical results on causal inference provides an effective practical solution. In particular, we demonstrate how our model allows dealing with more than one nuisance variable under some assumptions and can enable analysis of pooled scientific datasets in scenarios that would otherwise entail removing a large portion of the samples. Our code is available on https://github.com/vsingh-group/DatasetPooling.

PMID:36268536 | PMC:PMC9581465 | DOI:10.1109/cvpr52688.2022.01018

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Ratio of Two Independent Lindley Random Variables

J Stat Theory Appl. 2022 Oct 15:1-25. doi: 10.1007/s44199-022-00050-4. Online ahead of print.

ABSTRACT

The distribution of the ratio of two independently distributed Lindley random variables X and Y , with different parameters, is derived. The associated distributional properties are provided. Furthermore, the proposed ratio distribution is fitted to two applications data (COVID-19 and Bladder Cancer Data), and compared it with some well-known right-skewed variations of Lindley distribution, namely; Lindley distribution, new generalized Lindley distribution, new quasi Lindley distribution and a three parameter Lindley distribution. The numerical result of the study reveals that the proposed distribution of two independent Lindley random variables fits better to the above said data sets than the compared distribution.

PMID:36268516 | PMC:PMC9568952 | DOI:10.1007/s44199-022-00050-4

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Nevin Manimala Statistics

Efficacy of diet on fatigue, quality of life and disability status in multiple sclerosis patients: rapid review and meta-analysis of randomized controlled trials

BMC Neurol. 2022 Oct 20;22(1):388. doi: 10.1186/s12883-022-02913-w.

ABSTRACT

BACKGROUND: Multiple sclerosis is an inflammatory and neurodegenerative disease. People with multiple sclerosis (pwMS) experience chronic fatigue which is difficult to deal with therapeutically and greatly affects health-related quality of life (QOL). PwMS are aware of the lack of generalized dietary advice related to their disease, leading to self-experimentation with diet. It is necessary to provide objective information about dietary interventions for pwMS. We aim to provide an objective synthesis of the evidence for efficacy and safety of specific diets in pwMS through a rapid review and meta-analyses of randomized controlled trials (RCTs), examining symptomatic fatigue (MFIS), QOL, Expanded-Disability-Status-Scale (EDSS), and severe adverse events.

METHODS: We have carried out a rapid review (MEDLINE and EMBASE) up to December 2021, with PRISMA methodology, and meta-analyses, of (RCTs). All statistical analyses were performed using the comprehensive meta-analysis (CMA) -RStudio 4.1.3. The analysis used weighted mean differences (WMD) and a 95% confidence interval (CI) using a random-effects model to compare the effects of the dietary intervention with the control.

RESULTS: Eight studies met the inclusion criteria. Of these eight studies, five analyzed EDSS, three MFIS, and three QOL. A total of 515 patients were analyzed. These meta-analyses cumulative evidence support that dietary intervention is associated with a trend of reduction in fatigue (308 patients studied) -the difference between means (SMD) of the control group and intervention group was -2,033, 95%-IC (-3,195, -0,152), a p-value of 0.0341)-, an increase in QOL (77 patients studied), no significant effect on EDSS (337 patients studied), and no severe adverse events.

CONCLUSIONS: It is difficult to reach a high level of evidence in dietary studies. Our findings show that dietary intervention is associated with a trend of reduction in fatigue in MS. Taking into account the potential of dietary interventions and the benefit/risk ratio in their favor, neurologists must be aware of the great importance of making interventions on diet in MS if necessary. There are dietary interventions with some evidence of benefit for patients with MS, which could be chosen based on adherence, patient preferences, and individual outcomes. Large prospective clinical trials are needed to shed further light on this topic.

PMID:36266639 | DOI:10.1186/s12883-022-02913-w

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Nevin Manimala Statistics

Early feeding practices and body mass index z-score among Saudi preschoolers: a cross-sectional study

BMC Pediatr. 2022 Oct 20;22(1):609. doi: 10.1186/s12887-022-03666-8.

ABSTRACT

BACKGROUND: Feeding practices during early years may have long-lasting influences on eating behaviors, growth patterns and body mass index (BMI) trajectory. The objectives of this study were to characterize early feeding practices among mothers in Saudi Arabia and examine their associations with child birthweight and BMI z-score (BMIz) at preschool.

METHODS: This is a cross-sectional study including 209 mother-child dyads who were recruited from different preschools around the city of Jeddah, Saudi Arabia. Mothers completed the study questionnaire over the telephone and preschoolers’ anthropometric measurements were objectively measured using standardized procedures. Primary predictors included variables pertaining to breastfeeding initiation, breastfeeding duration, formula milk introduction, complementary feeding, and offering fruit juice, date syrup-milk mixture, and soda drinks in a baby bottle. The study’s primary outcome was BMIz at preschool. Mothers reported child’s birthweight and sociodemographic characteristics. Descriptive statistics were used to characterize early feeding practices. Bivariate analyses and linear regression analysis were used to examine the association of early feeding practices with child birthweight and BMIz at preschool.

RESULTS: About half of the mothers reported that they have offered fruit juice and/or date syrup-milk mixture in a baby bottle (52.2% and 45.9% respectively), with an average duration of 11.5 months (SD = 7.73) and 5.90 months (SD = 6.13), respectively. Children who were offered fruit juice and/or date syrup-milk mixture in a baby bottle had significantly lower birthweights compared to children who were not (M = 2.79, SD = 0.59 vs. M = 3.06, SD = 0.69, P < 0.01 and M = 2.79, SD = 0.67 vs. M = 3.03, SD = 0.62, P < 0.01, respectively). There was a negative association between introducing fruit juice in a baby bottle and child BMIz at preschool (β: -0.18, 95% confidence interval (CI): -0.83, -0.11); This association was not significant after adjusting for child birthweight and other covariates (β: -0.10, 95% CI: -0.64, 0.09).

CONCLUSION: A large proportion of mothers reported offering fruit juice and date syrup-milk mixture in a baby bottle. Additional research is needed to understand associations with child birthweight and BMIz. Longitudinal and interventions studies can help inform counseling guidelines and community campaigns in order to improve early feeding practices in the region.

PMID:36266622 | DOI:10.1186/s12887-022-03666-8

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Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study

BMC Infect Dis. 2022 Oct 20;22(1):793. doi: 10.1186/s12879-022-07774-9.

ABSTRACT

BACKGROUND: Monoclonal antibodies (mAbs) and antivirals have been approved for early therapy of coronavirus disease (COVID-19), however, in the real-life setting, there are difficulties to prescribe these therapies within few days from symptom onset as recommended, and effectiveness of combined use of these drugs have been hypothesised in most-at-risk patients (such as those immunocompromised) but data supporting this strategy are limited.

METHODS: We describe the real-life experience of SARS-CoV-2 antivirals and/or monoclonal antibodies (mAbs) and focus on the hospitalisation rate due to the progression of COVID-19. Clinical results obtained through our risk-stratification algorithm and benefits achieved through a strategic proximity territorial centre are provided. We also report a case series with an in-depth evaluation of SARS-CoV-2 genome in relationship with treatment strategy and clinical evolution of patients.

RESULTS: Two hundred eighty-eight patients were analysed; 94/288 (32.6%) patients were treated with mAb monotherapy, 171/288 (59.4%) patients were treated with antivirals, and 23/288 (8%) patients received both mAbs and one antiviral drug. Haematological malignancies were more frequent in patients treated with combination therapy than in the other groups (p = 0.0003). There was a substantial increase in the number of treated patients since the opening of the centre dedicated to early therapies for COVID-19. The provided disease-management and treatment appeared to be effective since 98.6% patients recovered without hospital admission. Moreover, combination therapy with mAbs and antivirals seemed successful because all patients admitted to the hospital for COVID-19 did not receive such therapies, while none of the most-at-risk patients treated with combination therapy were hospitalized or reported adverse events.

CONCLUSIONS: A low rate of COVID-19 progression requiring hospital admission was observed in patients included in this study. The dedicated COVID-19 proximity territorial service appeared to strengthen the regional sanitary system, avoiding the overwhelming of other services. Importantly, our results also support early combination therapy: it is possible that this strategy reduces the emergence of escape mutants of SARS-CoV-2, thereby increasing efficacy of early treatment, especially in immunocompromised individuals.

PMID:36266619 | DOI:10.1186/s12879-022-07774-9

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Allogeneic hematopoietic cell transplantation in patients with CML chronic phase in the era of third generation tyrosine kinase inhibitors: a retrospective study by the Chronic Malignancies Working Party of the EBMT

Am J Hematol. 2022 Oct 20. doi: 10.1002/ajh.26764. Online ahead of print.

ABSTRACT

Following the introduction of tyrosine kinase inhibitors (TKI), the number of patients undergoing allogeneic haematopoietic cell transplantation (allo-HCT) for chronic phase (CP) CML has dramatically decreased. Imatinib was the 1st TKI introduced to the clinical arena, predominantly utilised in the 1st line setting. In cases of insufficient response, resistance or intolerance, CML patients can subsequently be treated with either a 2nd or 3rd generation TKI. Between 2006 and 2016, we analyzed the impact of the use of 1, 2 or 3 TKI prior to allo-HCT for CP CML in 904 patients. A total of 323-, 371- and 210 patients had 1, 2 or 3 TKI prior to transplant respectively; imatinib (n=778), dasatinib (n=508), nilotinib (n=353), bosutinib (n=12) and ponatinib (n=44). The majority had imatinib as first TKI (n=747, 96%). Transplants were performed in CP1, n=549, CP2, n=306, and CP3, n=49. With a median follow-up of 52 months, 5-year OS for the entire population was 64.4% (95% CI 60.9-67.9 %), PFS 50% (95% CI 46.3-53.7%), RI 28.7% (95% CI 25.4-32.0%) and NRM 21.3% (95% CI 18.3-24.2%). No difference in OS, PFS, RI or NRM was evident related to the number of TKI prior to allo-HCT or to the type of TKI (p=ns). Significant factors influencing OS and PFS were >CP1 vs CP1 and Karnofsky performance (KPS) score > 80 vs ≤80, highlighting CP1 patients undergoing allo-HCT have improved survival compared to >CP1 and the importance of careful allo-HCT candidate selection. This article is protected by copyright. All rights reserved.

PMID:36266607 | DOI:10.1002/ajh.26764

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Combined trabeculotomy-trabeculectomy with and without augmentation in primary congenital glaucoma: triple-armed randomized controlled trial

Int Ophthalmol. 2022 Oct 20. doi: 10.1007/s10792-022-02558-1. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the efficacy and safety of using Mitomycin-C (MMC) or Ologen implant as an adjunct to combined trabeculotomy-trabeculectomy (CTT) surgery relative to non-augmented CTT surgery in achieving higher success rates in patients with primary congenital glaucoma (PCG).

STUDY DESIGN: A prospective triple-armed randomized controlled clinical trial was conducted in the period between April 2019 and May 2021, targeting 75 eyes of patients with PCG over one year, with patients being followed up for at least one whole year.

PATIENTS AND METHODS: The study included 75 eyes; only 70 fulfilled the inclusion criteria and were randomly assigned to one of the three study groups using a computer program to generate random number list. Eyes were treated by either CTT without augmentation, CTT augmented with MMC, or CTT augmented with Ologen implant. Only 63 eyes completed one year of follow-up and were evenly distributed among the three study groups; with 21 eyes in each group were statistically analyzed.

OUTCOME MEASURES: Our primary outcome measure is to report and compare the percentage of patients who demonstrated complete success with intraocular pressure (IOP) controlled and maintained below 21 mmHg without the use of antiglaucoma medications or additional glaucoma surgery over a one-year follow-up. Secondary outcome measures include reporting failure, intra- and postoperative complications of the three surgical modalities, postoperative corneal diameter, clearance of corneal edema, and postoperative cup/disk (C/D) ratio.

RESULTS: Complete success was achieved in 17 eyes (81.0%) in CTT group, 18 eyes (85.7%) in MMC group, and 17 eyes (81.0%) in Ologen group. Qualified success (IOP < 21 with or without antiglaucoma medications) was achieved in 18 eyes (85.7%) in both the CTT and the Ologen groups, with 19 eyes (90.5%) in the MMC group. Failure was observed in three eyes (14.3%) in both CTT and Ologen groups and two eyes (9.5%) in the MMC group. Based on survival analysis, CTT group had a cumulative success probability of 95.2% at three months, which dropped to 85.7% at six months and remained at that level for the 9th and 12th months of follow-up. With respect to the MMC group, the cumulative success probability at three months was 95.2%, dropped to 90.5% at six months, and remained at that level for the 9th and 12th months of follow-up. While in the Ologen group, the cumulative success probability at three months was 85.7% and remained at the same level during the 6th, 9th, and 12th months of follow-up, with p value = 0.862 using the logrank test.

CONCLUSION: CTT is a safe and effective primary surgical intervention in patients with PCG without the need for augmentation while preserving the augmented procedure’s use for recurrent cases.

PMID:36266601 | DOI:10.1007/s10792-022-02558-1