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Nevin Manimala Statistics

Association Between Neonatal Intensive Care Unit Type and Quality of Care in Moderate and Late Preterm Infants

JAMA Pediatr. 2023 Jan 17. doi: 10.1001/jamapediatrics.2022.5213. Online ahead of print.

ABSTRACT

IMPORTANCE: A higher level of care improves outcomes in extremely and very preterm infants, yet the impact of neonatal intensive care unit (NICU) level on moderate and late preterm (MLP) care quality is unknown.

OBJECTIVE: To examine the association between NICU type and care quality in MLP (30-36 weeks’ gestation) and extremely and very preterm (25-29 weeks’ gestation) infants.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study was a prospective analysis of 433 814 premature infants born in 465 US hospitals between January 1, 2016, and December 31, 2020, without anomalies and who survived more than 12 hours and were transferred no more than once. Data were from the Vermont Oxford Network all NICU admissions database.

EXPOSURES: NICU types were defined as units with ventilation restrictions without surgery (type A with restrictions, similar to American Academy of Pediatrics [AAP] level 2 NICUs), without surgery (type A) and with surgery not requiring cardiac bypass (type B, similar to AAP level 3 NICUs), and with all surgery (type C, similar to AAP level 4 NICUs).

MAIN OUTCOMES AND MEASURES: The primary outcome was gestational age (GA)-specific composite quality measures using Baby-Measure of Neonatal Intensive Care Outcomes Research (Baby-MONITOR) for extremely and very preterm infants and an adapted MLP quality measure for MLP infants. Secondary outcomes were individual component measures of each scale. Composite scores were standardized observed minus expected scores, adjusted for patient characteristics, averaged, and expressed with a mean of 0 and SD of 1. Between May 2021 and October 2022, Kruskal-Wallis tests were used to compare scores by NICU type.

RESULTS: Among the 376 219 MLP (204 181 [54.3%] male, 172 038 [45.7%] female; mean [SD] GA, 34.2 [1.7] weeks) and 57 595 extremely and very preterm (30 173 [52.4%] male, 27 422 [47.6%] female; mean [SD] GA, 27.7 [1.4] weeks) infants included, 6.6% received care in type A NICUs with restrictions, 29.3% in type A NICUs without restrictions, 39.7% in type B NICUs, and 24.4% in type C NICUs. The MLP infants had lower MLP-QM scores in type C NICUs (median [IQR]: type A with restrictions, 0.4 [-0.1 to 0.8]; type A, 0.4 [-0.4 to 0.9]; type B, 0.1 [-0.7 to 0.7]; type C, -0.7 [-1.6 to 0.4]; P < .001). No significant differences were found in extremely and very preterm Baby-MONITOR scores by NICU type. In type C NICUs, MLP infants had lower scores in no extreme length of stay and change-in-weight z score.

CONCLUSIONS AND RELEVANCE: In this cohort study, composite quality scores were lower for MLP infants in type C NICUs, whereas extremely and very preterm composite quality scores were similar across NICU types. Policies facilitating care for MLP infants at NICUs with less complex subspecialty services may improve care quality delivered to this prevalent, at-risk population.

PMID:36648939 | DOI:10.1001/jamapediatrics.2022.5213

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Nevin Manimala Statistics

A Protocol to Investigate Deep Brain Stimulation for Refractory Tinnitus: From Rat Model to the Set-Up of a Human Pilot Study

Audiol Res. 2022 Dec 31;13(1):49-63. doi: 10.3390/audiolres13010005.

ABSTRACT

BACKGROUND: Chronic tinnitus can have an immense impact on quality of life. Despite recent treatment advances, many tinnitus patients remain refractory to them. Preclinical and clinical evidence suggests that deep brain stimulation (DBS) is a promising treatment to suppress tinnitus. In rats, it has been shown in multiple regions of the auditory pathway that DBS can have an alleviating effect on tinnitus. The thalamic medial geniculate body (MGB) takes a key position in the tinnitus network, shows pathophysiological hallmarks of tinnitus, and is readily accessible using stereotaxy. Here, a protocol is described to evaluate the safety and test the therapeutic effects of DBS in the MGB in severe tinnitus sufferers.

METHODS: Bilateral DBS of the MGB will be applied in a future study in six patients with severe and refractory tinnitus. A double-blinded, randomized 2 × 2 crossover design (stimulation ON and OFF) will be applied, followed by a period of six months of open-label follow-up. The primary focus is to assess safety and feasibility (acceptability). Secondary outcomes assess a potential treatment effect and include tinnitus severity measured by the Tinnitus Functional Index (TFI), tinnitus loudness and distress, hearing, cognitive and psychological functions, quality of life, and neurophysiological characteristics.

DISCUSSION: This protocol carefully balances risks and benefits and takes ethical considerations into account. This study will explore the safety and feasibility of DBS in severe refractory tinnitus, through extensive assessment of clinical and neurophysiological outcome measures. Additionally, important insights into the underlying mechanism of tinnitus and hearing function might be revealed.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03976908 (6 June 2019).

PMID:36648926 | DOI:10.3390/audiolres13010005

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Nevin Manimala Statistics

Development of a Bedside Tool to Predict the Diagnosis of Cerebral Palsy in Term-Born Neonates

JAMA Pediatr. 2023 Jan 17. doi: 10.1001/jamapediatrics.2022.5177. Online ahead of print.

ABSTRACT

IMPORTANCE: Cerebral palsy (CP) is the most common abnormality of motor development and causes lifelong impairment. Early diagnosis and therapy can improve outcomes, but early identification of infants at risk remains challenging.

OBJECTIVE: To develop a CP prognostic tool that can be applied to all term neonates to identify those at increased risk of developing CP.

DESIGN, SETTING, AND PARTICIPANTS: This case-control study used data from the Canadian Cerebral Palsy Registry (data collected from January 2003 to December 2019) for children with CP and the Alberta Pregnancy Outcomes and Nutrition study (mothers enrolled from May 2009 to September 2012; data extracted in 2020) for controls. There were 2771 children with CP and 2131 controls evaluated; 941 and 144, respectively, were removed for gestational age less than 37 weeks at birth, 565 with CP removed for incomplete data, and 2 controls removed for a diagnosis of CP. Data were analyzed from April to August 2022.

EXPOSURES: Potential risk factors were selected a priori based on the literature, including maternal, intrapartum, and infant characteristics.

MAIN OUTCOMES AND MEASURES: Diagnosis of CP, defined as a disorder of motor function due to a nonprogressive brain abnormality before age 1 year and classified by Gross Motor Function Classification System levels I to V.

RESULTS: Of 3250 included individuals, 1752 (53.9%) were male, and the median (IQR) gestational age at birth was 39 (38-40) weeks. Encephalopathy was present in 335 of 1184 infants with CP (28%) and 0 controls. The final prediction model included 12 variables and correctly classified 75% of infants, with a sensitivity of 56% (95% CI, 52-60) and specificity of 82% (95% CI, 81-84). The C statistic was 0.74 (95% CI, 71-76). Risk factors were found to be additive. A proposed threshold for screening is probability greater than 0.3, with a sensitivity of 65% (95% CI, 61-68) and specificity of 71% (95% CI, 69-73). The prognostic tool identified 2.4-fold more children with CP than would have presented with encephalopathy (odds ratio, 13.8; 95% CI, 8.87-22.65; P < .001).

CONCLUSIONS AND RELEVANCE: In this case-control study, a prognostic model using 12 clinical variables improved the prediction of CP compared with clinical presentation with encephalopathy. This tool can be applied to all term newborns to help select infants for closer surveillance or further diagnostic tests, which could improve outcomes through early intervention.

PMID:36648921 | DOI:10.1001/jamapediatrics.2022.5177

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Nevin Manimala Statistics

Cross-Sectional Analysis of Fall-Related Factors with a Focus on Fall Prevention Self-Efficacy and Self-Cognition of Physical Performance among Community-Dwelling Older Adults

Geriatrics (Basel). 2023 Jan 14;8(1):13. doi: 10.3390/geriatrics8010013.

ABSTRACT

This study aimed to determine how fall prevention self-efficacy and degree of deviation in self-cognition of physical performance, which have recently received attention for their potential to explain falls in combination with a wide variety of fall-related factors, as well as affect falls. Older adults using day-care services (n = 27 with six men, mean age: 81.41 ± 7.43 years) were included in this study. Fall history in the past year, the modified fall efficacy scale (MFES), and physical performance and cognition errors were examined by evaluating the functional reach test (FRT), the stepping over test, and the timed up and go test (TUG), along with a questionnaire. In the fall (n = 14) and non-fall (n = 13) groups, logistic regression analysis using Bayesian statistical methods was used to identify factors associated with falls. The odds ratios for the MFES ranged from 0.97 to 1.0, while those of cognition-error items ranged from 3.1 to 170.72. These findings suggested that deviation in self-cognition of physical performance, particularly overestimation of timed cognitive ability, was a factor with more explanatory power for fall history. Future studies should analyze differences by disease and age group, which were not clarified in this study, to identify more detailed fall risk factors.

PMID:36648918 | DOI:10.3390/geriatrics8010013

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Nevin Manimala Statistics

Outpatient Service Use in Korean Older Adult Women with Degenerative Arthritis Based on Andersen’s Model

Geriatrics (Basel). 2023 Jan 6;8(1):9. doi: 10.3390/geriatrics8010009.

ABSTRACT

To ensure that older adults (aged 65 years or older) can experience a healthy life, they should use medical services that are appropriate, both quantitatively and qualitatively. This study aimed to identify the factors affecting outpatient service use by older adult women with degenerative arthritis using Andersen’s model. A survey was conducted among 232 older adult women with degenerative arthritis in two university hospitals in Seoul. The Korean Activities of Daily Living, Korean Instrumental Activities of Daily Living, and the Geriatric Depression Scale Short Form were used. Data were analyzed using descriptive statistics, χ2-test, t-test, and multiple logistic regression analysis. Among the participants, 69.8% used outpatient services and 30.2% did not. In the univariate analyses, age, marital status, residency, household income, chronic diseases, subjective health status, and disability were significant. Age (odds ratio [OR] = 5.53, p &lt; 0.001), annual household income (OR = 5.64, p &lt; 0.001), chronic diseases (OR = 11.06, p &lt; 0.001), and disability (OR = 3.56, p = 0.016) significantly affected outpatient service use. The results suggest that health promotion interventions for Korean older adult women should focus on predicting outpatient service use according to the patient’s characteristics.

PMID:36648914 | DOI:10.3390/geriatrics8010009

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Nevin Manimala Statistics

Effects of a Combined Intradialytic Exercise Training Program on Functional Capacity and Body Composition in Kidney Transplant Candidates

J Funct Morphol Kinesiol. 2023 Jan 11;8(1):9. doi: 10.3390/jfmk8010009.

ABSTRACT

Chronic kidney disease (CKD) leads to gradual muscle mass loss, which is strongly associated with lower functional capacity, which limits a patient’s daily activities. The aim of the present study is to examine the effects of a 4-month intradialytic exercise program on the functional capacity and body composition of kidney transplant (KT) candidates. Twenty-nine male patients on hemodialysis (HD) waiting for a kidney transplant, with a mean age of 53.86 ± 9.56 years old and BMI 27.11 ± 5.55 kg/m2, were randomly assigned into the following two groups: A (nA = 15 HD patients), who followed a 4-month intradialytic exercise program combining aerobic and resistance training, with a supervised, progressively increasing workload, and B (nB = 14 HD patients), who continued to receive usual care. At baseline and the end of the study, the KT candidates underwent a 6-min walking distance (6-MWD), and a 10-repetition sit-to-stand test (10-STS) to access physical function, a handgrip strength (HGS) test to evaluate the muscle strength of the non-fistula hand. Moreover, the bioelectrical impedance analysis (BIA) was performed to assess body composition indices, such as body fat (BF), body fat mass index (BFMI), fat-free mass index (FFMI), body cell mass (BCM), basal metabolic rate (BMR), extracellular water (ECW), intracellular water (ICW), total body water (TBW) and phase angle (PhA). Following the exercise program, group A showed favorable improvements in HGS (from 26.59 ± 9.23 to 28.61 ± 9.58 kg, p &lt; 0.05) and 6-MWD (from 427.07 ± 7.66 to 468.16 ± 11.39 m, p &lt; 0.05). Intergroup results from 6-MWD showed a statistically significant difference (Δp = 0.04), at the end of the study. Moreover, group A results from BIA revealed a significant increase of BMR by 2.4% (p &lt; 0.05), ECW by 3.6% (p = 0.01), ICW by 3.8% (p = 0.01), TBW by 4.1% (p = 0.01), lean mass by 2.7% (p = 0.01), and PhA by 13.3% (p = 0.04), while a reduction in BF by 5.0% (p = 0.01) and BFMI by 6.6% (p = 0.03) was also noticed. At the end of the study, group A showed statistical differences in BMR (Δp = 0.01), BMR/BW (Δp = 0.01), dry lean (Δp = 0.01), and PhA (Δp = 0.03), compared to the group B. Linear regression analysis in group A after training showed positive correlations between HGS and both PhA (r = 0.52, p = 0.04) and FFMI (r = 0.64, p = 0.01), and a strong negative correlation between 6-MWT and BF (r = -0.61, p = 0.01). In conclusion, a 4-month intradialytic exercise program can enhance body composition and some physical parameters in HD patients awaiting kidney transplantation.

PMID:36648901 | DOI:10.3390/jfmk8010009

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Nevin Manimala Statistics

Survival in Patients with Relapsed-Refractory Multiple Myeloma: Indirect Comparison of Six New Treatments

Hematol Rep. 2023 Jan 13;15(1):57-65. doi: 10.3390/hematolrep15010006.

ABSTRACT

In recent years, new treatments have been studied for relapsed-refractory multiple myeloma (RRMM), including two CAR-T products and a variety of non-CAR-T agents. Since direct comparisons between these innovative treatments are not available, indirect comparisons can be of interest. Reconstruction of individual patient data from Kaplan-Meier graphs (e.g., according to the Shiny method) has been the subject of numerous reports that have fully validated their performance. In the present systematic review, we evaluated six treatments proposed for RRMM, including two CAR-T products (ciltacabtagene autoleucel and idecabtagene vicleucel) and four treatments not based on a CAR-T (melflufen plus dexamethasone, isatuximab plus dexamethasone, selinexor, and belantamab). The endpoint was overall survival (OS). Our results showed statistically significant differences in OS across these treatments. In particular, ciltacabtagene autoleucel showed better OS than idecabtagene vicleucel. As regards non-CAR-T treatments, the ranking in OS was headed by isatuximab plus dexamethasone, followed by belantamab, selinexor, and melflufen plus dexamethasone. In conclusion, while the Shiny method has confirmed its validity in reconstructing individual patient data, our indirect comparisons have offered some original clues to interpret the results of OS published in these studies.

PMID:36648884 | DOI:10.3390/hematolrep15010006

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Nevin Manimala Statistics

A Statistical Shape Model of Infrarenal Aortic Necks in Patients With and Without Late Type Ia Endoleak After Endovascular Aneurysm Repair

J Endovasc Ther. 2023 Jan 16:15266028221149913. doi: 10.1177/15266028221149913. Online ahead of print.

ABSTRACT

PURPOSE: Hostile aortic neck characteristics, including short length, severe suprarenal and infrarenal angulation, conicity, and large diameter, have been associated with increased risk for type Ia endoleak (T1aEL) after endovascular aneurysm repair (EVAR). This study investigates the mid-term discriminative ability of a statistical shape model (SSM) of the infrarenal aortic neck morphology compared with or in combination with conventional measurements in patients who developed T1aEL post-EVAR.

MATERIALS AND METHODS: The dataset composed of EVAR patients who developed a T1aEL during follow-up and a control group without T1aEL. Principal component (PC) analysis was performed using a parametrization to create an SSM. Three logistic regression models were created. To discriminate between patients with and without T1aEL, sensitivity, specificity, and the area under the receiver operating characteristic (ROC) curve (AUC) were calculated.

RESULTS: In total, 126 patients (84% male) were included. Median follow-up time in T1aEl group and control group was 52 (31, 78.5) and 51 (40, 62.5) months, respectively. Median follow-up time was not statistically different between the groups (p=0.72). A statistically significant difference between the median PC scores of the T1aEL and control groups was found for the first, eighth, and ninth PC. Sensitivity, specificity, and AUC values for the SSM-based versus the conventional measurements-based logistic regression models were 79%, 70%, and 0.82 versus 74%, 73%, and 0.85, respectively. The model of the SSM and conventional measurements combined resulted in sensitivity, specificity, and AUC of 81%, 81%, and 0.92.

CONCLUSION: An SSM of the infrarenal aortic neck determines its 3-dimensional geometry. The SSM is a potential valuable tool for risk stratification and T1aEL prediction in EVAR. The SSM complements the conventional measurements of the individual preoperative infrarenal aortic neck geometry by increasing the predictive value for late type Ia endoleak after standard EVAR.

CLINICAL IMPACT: A statistical shape model (SSM) determines the 3-dimensional geometry of the infrarenal aortic neck. The SSM complements the conventional measurements of the individual pre-operative infrarenal aortic neck geometry by increasing the predictive value for late type Ia endoleaks post-EVAR. The SSM is a potential valuable tool for risk stratification and late T1aEL prediction in EVAR and it is a first step toward implementation of a treatment planning support tool in daily clinical practice.

PMID:36647185 | DOI:10.1177/15266028221149913

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Nevin Manimala Statistics

Non-suicidal self-injury, suicidal thoughts and behaviors in individuals with an eating disorder relative to healthy and psychiatric controls: A systematic review and meta-analysis

Int J Eat Disord. 2023 Jan 16. doi: 10.1002/eat.23880. Online ahead of print.

ABSTRACT

OBJECTIVE: Eating disorders (ED) may be associated with an increased prevalence of non-suicidal self-injury (NSSI) and suicidal thoughts and behaviors (STBs) relative to healthy (HC) and psychiatric (PC) controls. However, precise estimates of differences in prevalence between individuals with EDs and controls are unclear. We compared the prevalence of NSSI, suicidal ideation (SI), suicide attempts (SA), and deaths by suicide in controls and individuals with EDs.

METHOD: We searched MEDLINE, PsycINFO, EMBASE, and CINAHL for peer-reviewed publications reporting the prevalence of NSSI and/or STBs in EDs and HC or PC group (PROSPERO: CRD42021286754). A series of random-effects meta-analyses were conducted to estimate pooled odds ratios (ORs) for NSSI, SI, SA, and death by suicide in EDs.

RESULTS: Across 32 studies, individuals with an ED had a significantly increased prevalence of NSSI (HC: OR = 6.85 [95% CI: 3.60, 13.04]; PC: OR = 2.74 [95% CI: 1.49, 5.06]), SI (HC: OR = 3.63 [95% CI: 2.43, 5.41]; PC: OR = 3.10 [95% CI: 2.01, 4.78]), and SA (HC: OR = 5.16 [95% CI: 4.27, 6.24]; PC: OR = 1.37 [95% CI: 0.37, 4.99]) relative to HC and PC groups. A 2.93-times increased odd of death by suicide did not achieve statistical significance. There was a high-level of heterogeneity between studies.

DISCUSSION: Our findings indicate that ED populations have an increased prevalence of NSSI, SI, and SA but not death by suicide compared to controls and emphasize the need for effective clinical strategies to address these behaviors in ED populations.

PUBLIC SIGNIFICANCE: This review provides evidence for an increased prevalence of non-suicidal self-injury, suicidal ideation, and suicide attempts in populations with eating disorders compared to controls. Our findings emphasize the need for effective clinical strategies to address these behaviors in patients with eating disorders.

PMID:36647184 | DOI:10.1002/eat.23880

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Nevin Manimala Statistics

Geography and elevation as drivers of cloacal microbiome assemblages of a passerine bird distributed across Sulawesi, Indonesia

Anim Microbiome. 2023 Jan 16;5(1):4. doi: 10.1186/s42523-022-00219-3.

ABSTRACT

BACKGROUND: Empirical field studies allow us to view how ecological and environmental processes shape the biodiversity of our planet, but collecting samples in situ creates inherent challenges. The majority of empirical vertebrate gut microbiome research compares multiple host species against abiotic and biotic factors, increasing the potential for confounding environmental variables. To minimize these confounding factors, we focus on a single species of passerine bird found throughout the geologically complex island of Sulawesi, Indonesia. We assessed the effects of two environmental factors, geographic Areas of Endemism (AOEs) and elevation, as well as host sex on the gut microbiota assemblages of the Sulawesi Babbler, Pellorneum celebense, from three different mountains across the island. Using cloacal swabs, high-throughput-amplicon sequencing, and multiple statistical models, we identified the core microbiome and determined the signal of these three factors on microbial composition.

RESULTS: The five most prevalent bacterial phyla within the gut microbiome of P. celebense were Proteobacteria (32.6%), Actinobacteria (25.2%), Firmicutes (22.1%), Bacteroidetes (8.7%), and Plantomycetes (2.6%). These results are similar to those identified in prior studies of passeriform microbiomes. Overall, microbiota diversity decreased as elevation increased, irrespective of sex or AOE. A single ASV of Clostridium was enriched in higher elevation samples, while lower elevation samples were enriched with the genera Perlucidibaca (Family Moraxellaceae), Lachnoclostridium (Family Lachnospiraceae), and an unidentified species in the Family Pseudonocardiaceae.

CONCLUSIONS: While the core microbiota families recovered here are consistent with other passerine studies, the decreases in diversity as elevation increases has only been seen in non-avian hosts. Additionally, the increased abundance of Clostridium at high elevations suggests a potential microbial response to lower oxygen levels. This study emphasizes the importance of incorporating multiple statistical models and abiotic factors such as elevation in empirical microbiome research, and is the first to describe an avian gut microbiome from the island of Sulawesi.

PMID:36647179 | DOI:10.1186/s42523-022-00219-3