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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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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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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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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

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High intake of dietary phytochemical index may be related to reducing risk of diabetic nephropathy: a case-control study

BMC Nutr. 2023 Jan 16;9(1):14. doi: 10.1186/s40795-023-00676-2.

ABSTRACT

OBJECTIVE: Diabetic nephropathy (DN) is involved in 40% of patients with type 2 diabetes, Phytochemical index (PI) foods are known as antioxidant and anti-inflammatory agents. Higher intake of phytochemicals can improve glucose tolerance, hypertension and complications of DN. This study sought to discern the relationship between dietary PI and DN.

METHODS: This was a case-control study which was conducted between 210 diabetic women. General characteristics, blood pressure, biochemical serum levels, and anthropometric measurements were evaluated. Physical activity and dietary intakes were assessed via short form of physical activity questionnaire and 147 items-validated food frequency questionnaires, respectively. Then, PI was calculated through method of McCarty and divided to 2 groups of lower and higher of median. Independent samples T tests were used to identify differences in quantitative variables. To investigate the relationship between dietary PI and risk of DN, logistic regression was used. The odds ratio (OR) of DN, and its 95% confidence interval (CI), in each groups of PI were shown.

RESULTS: The percentage of daily intake of energy from fruits and vegetables were higher than the other sources of phytochemical rich foods. Higher consumption of vitamin A was seen in higher group of PI among the control group, after adjusting for energy intake. In the higher adherence of median of dietary PI group, intake of fruits, vegetables, legumes, grains, and olives of controls were higher than cases. In addition, soy consumption was statistically different between lower and higher adherence of median of dietary PI among cases. There was an inverse relationship between dietary PI and risk of DN (OR = 0.44; 95% CI: 0.25-0.77; P = 0.04). After adjusting for potential confounders, the association remained significant, albeit with lower odds of having DN (OR = 0.15; 95% CI: 0.06-0.36; P < 0.001).

CONCLUSION: Finally, the present study found evidence indicating an inverse relationship between consumption of foods rich in phytochemicals and risk of DN in this sample.

PMID:36647176 | DOI:10.1186/s40795-023-00676-2

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One-stage vs two-stage bilateral THA in Lombardy: a cost-effectiveness analysis

Cost Eff Resour Alloc. 2023 Jan 16;21(1):3. doi: 10.1186/s12962-023-00418-y.

ABSTRACT

BACKGROUND: Total hip arthroplasty (THA) is the most common treatment for primary and secondary end-stage hip osteoarthritis (OA). Almost 20% of all patients undergoing primary THA suffer from bilateral hip OA and, consequently, will need a contralateral procedure to be performed in the following years. The aim of this study is to evaluate the cost-effectiveness and the reliability of one-stage bilateral THA (1-BTHA) compared to two-stage bilateral THA (2-BTHA), in low-risk patients, performed with anterior minimally invasive surgery (AMIS).

METHODS: Single patient’s costs were obtained by dividing the annual costs report by the number of hospitalizations, considering the diagnosis related group (DRG) of the two procedures. Then, 16 patients undergoing 1-BTHA and 8 undergoing 2-BTHA were examined. Hemoglobin (Hb) values before surgery and before discharge, transfusion rate and the occurrence of post-operative complications were observed.

RESULTS: Procedural costs were divided in different subgroups: pre-hospitalization, operating room, hospital stay, post-operative follow-up and other costs. 1-BTHA total costs amount to 5.754,82€, while performing 2-BTHA costs 7.624,32€. However, considering DRG reimbursement, the hospital’s profit margin following 1-BTHA is lower than that following 2-BTHA (6.346,18€ versus 9.261,68€). Surgical time was found not to be significantly different between 1-BTHA and 2-BTHA (141,13 ± 26,1 min vs 164,8 ± 44,3 min; p = 0,111). The two groups showed a statistically significant difference in Hb decrease (4,8 ± 1,3 g/dl vs 3,3 ± 0,9; p = 0,001), despite no variances in transfusion rate. No further complications were observed in either group.

CONCLUSIONS: This study demonstrates how, in carefully selected patients, 1-BTHA performed with AMIS is a cost-effective and safe technique compared to 2-BTHA, resulting in a shorter OR time, LOS and lower overall costs.

LEVEL OF EVIDENCE: III.

PMID:36647163 | DOI:10.1186/s12962-023-00418-y

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Osteoarthritis or arthritis? Toward understanding of primary Sjögren’s syndrome patients with arthralgia

J Orthop Surg Res. 2023 Jan 16;18(1):41. doi: 10.1186/s13018-023-03513-1.

ABSTRACT

OBJECTIVE: To identify primary Sjögren’s syndrome (pSS) patients with arthralgia at risk for osteoarthritis (OA) or arthritis.

METHODS: This study included 368 pSS patients admitted to a mono-centric from March 2010 to December 2020. Patients were divided into groups according to whether complicated with OA or arthritis. Data were analyzed to determine the differences in demographical characteristics, symptoms, and laboratory examination.

RESULTS: The involvement of the OA joints was predominately knee and spine sites (including cervical and lumbar spine degeneration). When diagnosing arthritis, it was mainly peripheral symmetric polyarthritis, the most affected sites were the interphalangeal and metacarpophalangeal joints. There were significant differences in age, disease duration, uric acid (UA), and total cholesterol (TC) between pSS-OA and pSS-nOA patients (P < 0.050). Logistic regression analysis showed that age (OR = 1.965; P = 0.009) and joint pain (OR = 3.382; P < 0.001) were dangerous factors associated with OA. Interestingly, although the level of UA, TC, and triglycerides (TG) was shown to be positive with OA, there was no statistical significance after the OR was computed in the four-cell table. In pSS-arthritis, EULAR Sjögren’s syndrome disease activity index (ESSDAI) (P = 0.011), the frequency of joint pain (P < 0.001), and muscular involvement (P = 0.037) were higher than non-arthritis group. In pSS patients only presenting with joint pain, arthritis patients had higher ESSDAI and system involvements, but lower UA and TG levels compared with OA group (P < 0.050).

CONCLUSION: In pSS patients with arthralgia, OA accounted for the majority. pSS patients with advanced age and more pronounced metabolic characteristics, such as elevated blood lipids and uric acid, was a key factor in groups at risk for OA. However, arthritis patients had higher rates of dry mouth and eye, higher disease activity, antibodies positive, and more organs damage. In the future, it may be necessary to be more cautious in the diagnosis of joint manifestations in pSS patients in order to make the appropriate treatments.

PMID:36647153 | DOI:10.1186/s13018-023-03513-1

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Automated deep-learning system in the assessment of MRI-visible prostate cancer: comparison of advanced zoomed diffusion-weighted imaging and conventional technique

Cancer Imaging. 2023 Jan 17;23(1):6. doi: 10.1186/s40644-023-00527-0.

ABSTRACT

BACKGROUND: Deep-learning-based computer-aided diagnosis (DL-CAD) systems using MRI for prostate cancer (PCa) detection have demonstrated good performance. Nevertheless, DL-CAD systems are vulnerable to high heterogeneities in DWI, which can interfere with DL-CAD assessments and impair performance. This study aims to compare PCa detection of DL-CAD between zoomed-field-of-view echo-planar DWI (z-DWI) and full-field-of-view DWI (f-DWI) and find the risk factors affecting DL-CAD diagnostic efficiency.

METHODS: This retrospective study enrolled 354 consecutive participants who underwent MRI including T2WI, f-DWI, and z-DWI because of clinically suspected PCa. A DL-CAD was used to compare the performance of f-DWI and z-DWI both on a patient level and lesion level. We used the area under the curve (AUC) of receiver operating characteristics analysis and alternative free-response receiver operating characteristics analysis to compare the performances of DL-CAD using f- DWI and z-DWI. The risk factors affecting the DL-CAD were analyzed using logistic regression analyses. P values less than 0.05 were considered statistically significant.

RESULTS: DL-CAD with z-DWI had a significantly better overall accuracy than that with f-DWI both on patient level and lesion level (AUCpatient: 0.89 vs. 0.86; AUClesion: 0.86 vs. 0.76; P < .001). The contrast-to-noise ratio (CNR) of lesions in DWI was an independent risk factor of false positives (odds ratio [OR] = 1.12; P < .001). Rectal susceptibility artifacts, lesion diameter, and apparent diffusion coefficients (ADC) were independent risk factors of both false positives (ORrectal susceptibility artifact = 5.46; ORdiameter, = 1.12; ORADC = 0.998; all P < .001) and false negatives (ORrectal susceptibility artifact = 3.31; ORdiameter = 0.82; ORADC = 1.007; all P ≤ .03) of DL-CAD.

CONCLUSIONS: Z-DWI has potential to improve the detection performance of a prostate MRI based DL-CAD.

TRIAL REGISTRATION: ChiCTR, NO. ChiCTR2100041834 . Registered 7 January 2021.

PMID:36647150 | DOI:10.1186/s40644-023-00527-0

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Transcriptome analysis reveals the differential inflammatory effects between propofol and sevoflurane during lung cancer resection: a randomized pilot study

World J Surg Oncol. 2023 Jan 16;21(1):8. doi: 10.1186/s12957-023-02891-4.

ABSTRACT

BACKGROUND: Propofol and sevoflurane are two commonly used perioperative anesthetics. Some studies have found that these anesthetic drugs affect tumorigenesis. Previous studies have mostly focused on in vitro experiments, and the specimens collected were mainly peripheral body fluids, lacking direct evidence of the impact of anesthetic drugs on human tissues. This study aimed to elucidate the effects of propofol and sevoflurane on lung cancer using next-generation sequencing through an in vivo experiment.

METHODS: Patients were randomly assigned to a group receiving either propofol or sevoflurane during surgery. Then, the patients’ tumor and paired normal samples were collected and sequenced by next-generation sequencing. Differentially expressed genes (DEG) were analyzed by two statistical models, followed by cluster analysis, PCA, Gene Ontology, and KEGG pathway analysis. Candidate genes were confirmed by qRT-PCR.

RESULTS: The demographic data of the two study groups were not statistically significant. Through single-factor model analysis, 810 DEG in the propofol group and 508 DEG in the sevoflurane group were obtained. To better reflect the differential effects between propofol and sevoflurane while reducing the false-positive DEG, we used multifactor model analysis, which resulted in 124 DEG. In PCA and cluster analysis, four groups (propofol cancer group, propofol normal group, sevoflurane cancer group, sevoflurane normal group) were separated adequately, indicating the accuracy of the analysis. We chose seven significant pathways (cellular response to interleukin-1, chemokine-mediated signaling pathway, chemokine signaling pathway, cytokine-cytokine receptor interaction, inflammatory response, immune response, and TNF signaling pathway) for downstream analysis. Based on the pathway analysis, three candidate genes (CXCR1, CXCL8, and TNFAIP3) were chosen, and their qRT-PCR results were consistent with the sequencing results.

CONCLUSIONS: Through RNA-seq analysis, the effects of propofol and sevoflurane during lung cancer resection were different, mainly in inflammatory-related pathways, which might be possibly by targeting CXCL8.

TRIAL REGISTRATION: Trial registry number was ChiCTR1900026213 .

PMID:36647133 | DOI:10.1186/s12957-023-02891-4

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Five-year follow-up of mitral valve repair versus replacement: a propensity score analysis

J Cardiothorac Surg. 2023 Jan 16;18(1):27. doi: 10.1186/s13019-023-02144-1.

ABSTRACT

BACKGROUND: Mitral valve repair (MVRe) is considered to have a superior outcome compared to replacement (MVRp) in patients with mitral valve regurgitation (MVR). It was the aim of the study to analyse the clinical results and identify risk factors for short and long-term mortality.

METHODS: In a retrospective single-center analysis, patients undergoing an isolated mitral valve procedure from June 2010 to December 2016 were identified. These were subsequently homogenized using 10 baseline characteristics for propensity-score matching. Comparative analyses were performed for early and long-term results, using adequate statistical tools, and identifying risk factors for the investigated endpoints, primary end-point: all-cause mortality within 5 years and secondary end-points: recurrent MVR, reoperation, endocarditis and/or mortality with 30 days, 1, 3 and 5 years.

RESULTS: 241 patients were identified in the entire patient cohort. After matching, patients were divided into 2 groups of 64 each respectively. The median age was similar in the two groups. There was a significant interaction between early mortality risk of MV in patients with coronary artery disease (CAD) (OR 11.94, 95% CI 1.49-285.92, p = 0.04) and late mortality in patients with higher EuroSCORE II (HR 1.14, 95% CI 1.06-1.23, p < 0.001). The primary end-point showed 5-year survival rate was significantly higher in MVRe versus MVRp (90.06% vs. 79.54% respectively, p = 0.04). The secondary end-point demonstrated recurrent MVR not to be statistically significant between the 2 groups (p = 0.09) as well as reoperation (p = 0.28). Endocarditis was observed in one patient after MVRp.

CONCLUSIONS: We concluded MVRe to be associated with lower operative and 5-year mortality and good postoperative outcomes compared to patients undergoing MVRp. Concomitant CAD was identified as one of the risk factors for increasing the in-hospital mortality rate. There was no significant difference in rehospitalisation over the follow-up period. MVRe should be the treatment of choice for severe MVR and should remain a central aspect in valve centers’ treatment algorithms and quality measures.

PMID:36647129 | DOI:10.1186/s13019-023-02144-1