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Nevin Manimala Statistics

Aortic valve neocuspidization using autologous pericardium compared to surgical aortic valve replacement

J Card Surg. 2022 Jul 23. doi: 10.1111/jocs.16800. Online ahead of print.

ABSTRACT

INTRODUCTION: Aortic valve neocuspidization (AVNeo) for trileaflet aortic valve reconstruction using autologous pericardium (Ozaki procedure) depicts an encouraging new technique for the surgical treatment of aortic valve pathologies. The current study analyzes the early hemodynamic outcome of AVneo compared with surgical aortic valve replacement (SAVR) using the Abbott/St. Jude Trifecta aortic valve biological prostheses.

METHODS: All patients who underwent either AVNeo or SAVR between March 2017 and April 2020 were included. Exclusion criteria were emergency cases, endocarditis, redo- or additional root procedures. Main endpoints were differences between the two groups in terms of the effective orifice area (EOA) and the effective orifice area index (EOAI) at discharge.

RESULTS: During the study period, 105 AVNeo patients and 458 SAVR patients met the inclusion criteria. EOA was significantly higher in the AVNeo group (2.4 cm2 ± 0.8 vs. 2.1 cm2 /m2 ± 0.6 in the SAVR group, respectively; p < .001). Multiple regression analysis, including AVNeo, annulus size, bicuspid valve, preoperative stenosis, left ventricular ejection fraction (LVEF), and diastolic diameter (LVEDD) found two factors, which favor larger EOA: Annulus size (p < .0001) and AVneo (p = .005). EOAI was significantly higher in the AVNeo group (1.23 ± 0.4 vs. 1.02 cm2 /m2 ± 0.3, respectively; p < .001). Multiple regression analysis for EOAI showed effects for AVneo (p = .005) and bicuspid valve (p = .029). Mean pressure gradients (MPG) were lower in the AVNeo group than in the SAVR group (AVNeo: MPG = 8.0 mmHg ± 3.6 vs. SAVR: MPG = 8.3 mmHg ± 3.6), but this finding did not reach statistical significance (p = .091).

CONCLUSIONS: AVNeo shows significantly larger EOA and EOAI compared to SAVR using the Abbott/St. Jude Trifecta aortic valve biological prostheses.

PMID:35870166 | DOI:10.1111/jocs.16800

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Nevin Manimala Statistics

Psoriasis and Progression of Parkinson’s Disease: a Mendelian Randomization Study

J Eur Acad Dermatol Venereol. 2022 Jul 23. doi: 10.1111/jdv.18459. Online ahead of print.

ABSTRACT

BACKGROUND: Epidemiological studies have suggested psoriasis was associated with an increased risk of Parkinson’s disease (PD). However, whether psoriasis has an effect on PD progression is not explored yet.

OBJECTIVES: To evaluate the causal role of psoriasis in PD progression.

METHODS: We conducted a two-sample Mendelian randomization analysis using summary statistics from genome-wide association study of psoriasis (N=33,394), age at onset (N=28,568) and progression (N=4,093) of PD.

RESULTS: One standard deviation increase in genetically determined psoriasis risk was significantly associated with faster progression to dementia (OR=1.07, 95 % CI: 0.1.03~1.1, P=4.71E-04). Meanwhile, higher psoriasis risk was nominally associated with faster progression of PD measured by time to Hoehn and Yahr stage 3 (OR=1.05, 95 % CI: 1.02~1.08, P=1.53E-03) and depression (OR=1.06, 95 % CI: 1.02~1.11, P=1.77E-03) of PD. The results were robust under all sensitivity analyses.

CONCLUSIONS: These results suggested psoriasis accelerated overall progression of PD, and increased risk of dementia and depression of PD. A deeper understanding of neuroinflammation and immune response is likely to elucidate the potential pathogenesis of PD progression and identify novel therapeutic targets.

PMID:35870136 | DOI:10.1111/jdv.18459

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Nevin Manimala Statistics

Response to Comment on: “Black Box Prediction Methods in Sports Medicine Deserve a Red Card for Reckless Practice: A Change of Tactics is Needed to Advance Athlete Care”

Sports Med. 2022 Jul 23. doi: 10.1007/s40279-022-01737-5. Online ahead of print.

NO ABSTRACT

PMID:35870107 | DOI:10.1007/s40279-022-01737-5

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Nevin Manimala Statistics

Health-related quality of life trajectories in melanoma patients after electrochemotherapy: real-world insights from the InspECT register

J Eur Acad Dermatol Venereol. 2022 Jul 23. doi: 10.1111/jdv.18456. Online ahead of print.

ABSTRACT

BACKGROUND: Electrochemotherapy (ECT) effectively controls skin metastases from cutaneous melanoma.

OBJECTIVES: This study aimed to evaluate health-related quality of life (HRQoL) in melanoma patients pre-/post-ECT and its effect on treatment outcome.

METHODS: The analysis included prospective data from the International Network for Sharing Practices of ECT register. Following the Standard Operating Procedures, patients received intravenous or intratumoural bleomycin (15,000 IU/m2 ; 1000 IU mL/cm3 ) followed by 100-microsecond, 1000-V/cm electric pulses. Endpoints included response (RECIST v3.0), local progression-free survival (LPFS), toxicity (CTCAE v5.0), and patient-reported HRQoL at baseline, one, two, four and ten months (EuroQol [EQ-5D-3L], including 5-item utility score [EQ-5D] and visual analogue scale for self-reported health state [EQ-VAS]). Comparisons within/between subgroups were made for statistical and minimal important differences (MID). HRQoL scores and clinical covariates were analysed to identify predictors of response in multivariate analysis.

RESULTS: Median tumour size was 2 cm. Complete response rate, G3 toxicity and one-year LPFS in 378 patients (76% of the melanoma cohort) were 47%, 5%, and 78%. At baseline, age-paired HRQoL did not differ from the general European population. Following ECT, both EQ-5D and EQ-VAS scores remained within MID boundaries, particularly among complete responders. A subanalysis of the EQ-5D items revealed a statistically significant deterioration in pain/discomfort and mobility (restored within four months), and self-care and usual activities (throughout the follow-up) domains. Concomitant checkpoint inhibition correlated with better EQ-5D and EQ-VAS trajectories. Baseline EQ-5D was the exclusive independent predictor for complete response (RR 14.76, p=0.001).

CONCLUSIONS: HRQoL of ECT melanoma patients parallels the general population and is preserved in complete responders. Transient deterioration in pain/discomfort and mobility and persistent decline in self-care and usual activities may warrant targeted support interventions. Combination with checkpoint inhibitors is associated with better QoL outcomes. Baseline HRQoL provides predictive information which can help identify patients most likely to respond.

PMID:35870122 | DOI:10.1111/jdv.18456

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Nevin Manimala Statistics

Fertility preservation practices for female oncofertility differ significantly across the USA: results of a survey of SREI members

J Assist Reprod Genet. 2022 Jul 23. doi: 10.1007/s10815-022-02567-0. Online ahead of print.

ABSTRACT

PURPOSE: The field of oncofertility has maintained an important focus on improving access, yet standardized practices are lacking. To assess how female cancer patients are provided oncofertility care, we sought to determine provider-level differences and whether there are physician or practice characteristics that predict these variations.

METHODS: A cross-sectional survey was sent to SREI members. The survey included fifteen questions about physician practice characteristics and oncofertility cryopreservation protocols. Topics included ovarian stimulation protocols, fertilization techniques, stage of embryo cryopreservation, routine use of pre-implantation genetic testing for aneuploidy (PGT-A), and ovarian tissue cryopreservation (OTC). Statistical analyses assessed whether practice setting, geographic region, time in practice, and mandatory state insurance coverage had effects on cryopreservation protocols.

RESULTS: A total of 141 (17%) from diverse REI practice backgrounds completed the survey. The median number of new female oncofertility consults per year was 30 (range 1 to 300). Providers in academic settings treated more patients (median 40 vs. 15, p < 0.001). Providers in academic settings more often use gonadotropin-releasing hormone agonists (85% vs. 52%, p < 0.001) and perform OTC (41% vs. 4%, p < 0.001). Providers in academic practices were less likely to perform intracytoplasmic sperm injection in every cycle (37% vs. 55%, p = 0.032) and less likely to usually advise PGT-A (21% vs. 36%, p = 0.001). Mandated state insurance coverage had no effect on oncofertility practices.

CONCLUSION: Oncofertility practices vary among providers. Factors such as practice setting and region may affect the services provided. We do not yet know the best practices in oncofertility patients, and future research is needed.

PMID:35870098 | DOI:10.1007/s10815-022-02567-0

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Male Predisposition in Cerebellar Mutism Syndrome: a Cohort Study

Cerebellum. 2022 Jul 23. doi: 10.1007/s12311-022-01449-6. Online ahead of print.

ABSTRACT

The aim of this study was to explore the association between sex and cerebellar mutism syndrome and to examine other potential risk factors. This ambispective cohort study examined 218 pediatric patients (132 boys) with a posterior fossa tumor who underwent tumor resection from July 2013 to March 2021. The patients’ demographics and tumor characteristics were examined and statistically analyzed to explore the associations among the variables. Multivariable and subgroup analyses were conducted to validate the independent risk factors for cerebellar mutism syndrome (CMS). The male and female patients did not differ significantly in terms of age, tumor size, tumor location, tumor consistency, VP shunt placement before resection, extent of resection, or surgeon, as well as with respect to the presence of hydrocephalus or paraventricular edema. The overall incidence of CMS was 32.6%. The incidence of CMS was significantly higher in male patients than that in female patients (41.7% vs. 18.6%; P = 0.001). In the multivariable analysis, male sex (adjusted odds ratio [OR], 3.27; P = 0.001), solid tumor consistency (adjusted OR, 5.61; P = 0.001), midline location (adjusted OR, 3.78; P = 0.004), and hydrocephalus (adjusted OR, 2.56; P = 0.047) were independent risk factors for the CMS. Chi-square analysis revealed that solid tumor consistency and midline location were associated with medulloblastoma (P < 0.001). Male patients had a higher risk of developing CMS after a posterior fossa tumor resection. Midline location, solid tumor consistency, and hydrocephalus were independent risk factors for CMS.

PMID:35870083 | DOI:10.1007/s12311-022-01449-6

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Nevin Manimala Statistics

Predictors of intraocular pressure reduction after femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery: a prospective trial

Int Ophthalmol. 2022 Jul 23. doi: 10.1007/s10792-022-02427-x. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the association between postoperative intraocular pressure (IOP) reduction and phacoemulsification parameters in patients who underwent both conventional phacoemulsification surgery (CPS) and femtosecond laser-assisted cataract surgery (FLACS).

METHODS: This was a prospective multicenter comparative study that enrolled 90 participants who underwent cataract surgery at the University of Maryland Medical System and the Wilmer Eye Institute. Patients underwent FLACS in one eye and CPS in the fellow eye. IOP was measured prior to surgery and monitored through six months postoperatively. Demographic, clinical, biometric, and intraoperative variables including cumulative dissipated energy (CDE), aspiration time, and phacoemulsification time were analyzed for any significant association with postoperative IOP. Postoperative IOP reduction was the primary outcome variable. A secondary goal of the study was to determine differences in postoperative IOP reduction between CPS and FLACS cohorts.

RESULTS: In total, 157 non-glaucomatous eyes were included. Using multivariable analysis, we found preoperative IOP to be consistently associated with postoperative IOP reduction in the entire cohort. At the 6-month follow-up visit, there was a 12.4% reduction in IOP (-2.2 ± 3.4 mm Hg) seen, with no statistically significant difference between FLACS and CPS (12.3% ± 19.4% vs 12.5% ± 19.3%, respectively, p = 0.32). FLACS reduced the CDE required for phacoemulsification (6.6 ± 4.4%-seconds vs 8.6 ± 6.9%-seconds, respectively, p < 0.05). CDE was a predictor of IOP response at 6 months, but subgroup analysis revealed that this trend was driven by seven eyes requiring high CDE, and for the majority of eyes, CDE did not influence the size of the decrease. The seven eyes experiencing highest CDE were less likely to show IOP reduction at 6 months.

CONCLUSION: Both FLACS and CPS resulted in similar and significant IOP reductions through 6 months after surgery. Preoperative IOP was significantly associated with IOP reduction, and CDE generally did not influence the size of the decrease.

PMID:35870049 | DOI:10.1007/s10792-022-02427-x

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Nevin Manimala Statistics

Geographic variation and association of risk factors with incidence of colorectal cancer at small-area level

Cancer Causes Control. 2022 Jul 23. doi: 10.1007/s10552-022-01607-5. Online ahead of print.

ABSTRACT

PURPOSE: Examining spatial distribution of colorectal cancer (CRC) incidence or mortality is helpful for developing cancer control and prevention programs or for generating hypotheses. Such an investigation involves describing the spatial variation of risk factors for CRC and identifying hotspots. The aim of this study is to identify county-level risk factors that may be associated with the incidence of CRC and to map hotspots for CRC in Florida.

METHODS: County-level CRC cases, recorded in 2018, were obtained from the Florida Department of Health, Division of Public Health Statistics & Performance Management (DPHSM). Data on county-level risk factors were also obtained from the same source. We used Bayesian spatial models for relative incidence rates and produced posterior predictive that indicates excess risk (hotspots) for CRC.

RESULTS: The county-level unadjusted incidence rates range from .462 to 3.142. After fitting a Bayesian spatial model to the data, the results show that a decreasing risk of CRC is strongly associated with an increasing median income, higher percentage of Black population, and higher percentage of sedentary life at county level. Using exceedance probability, it is also observed that there are clustering and hotspots of high CRC incidence rates in Charlotte County in South Florida, Hernando, Sumter and Seminole counties in central Florida and Union and Washington counties in north Florida.

CONCLUSION: Among few county-level variables that significantly explained the spatial variation of CRC, income disparity may need more attention for resource allocation and developing preventive intervention in high-risk areas for CRC.

PMID:35870048 | DOI:10.1007/s10552-022-01607-5

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Nevin Manimala Statistics

Establishing thresholds for meaningful within-individual change using longitudinal item response theory

Qual Life Res. 2022 Jul 23. doi: 10.1007/s11136-022-03172-5. Online ahead of print.

ABSTRACT

PURPOSE: Thresholds for meaningful within-individual change (MWIC) are useful for interpreting patient-reported outcome measures (PROM). Transition ratings (TR) have been recommended as anchors to establish MWIC. Traditional statistical methods for analyzing MWIC such as mean change analysis, receiver operating characteristic (ROC) analysis, and predictive modeling ignore problems of floor/ceiling effects and measurement error in the PROM scores and the TR item. We present a novel approach to MWIC estimation for multi-item scales using longitudinal item response theory (LIRT).

METHODS: A Graded Response LIRT model for baseline and follow-up PROM data was expanded to include a TR item measuring latent change. The LIRT threshold parameter for the TR established the MWIC threshold on the latent metric, from which the observed PROM score MWIC threshold was estimated. We compared the LIRT approach and traditional methods using an example data set with baseline and three follow-up assessments differing by magnitude of score improvement, variance of score improvement, and baseline-follow-up score correlation.

RESULTS: The LIRT model provided good fit to the data. LIRT estimates of observed PROM MWIC varied between 3 and 4 points score improvement. In contrast, results from traditional methods varied from 2 to 10 points-strongly associated with proportion of self-rated improvement. Best agreement between methods was seen when approximately 50% rated their health as improved.

CONCLUSION: Results from traditional analyses of anchor-based MWIC are impacted by study conditions. LIRT constitutes a promising and more robust analytic approach to identifying thresholds for MWIC.

PMID:35870045 | DOI:10.1007/s11136-022-03172-5

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Nevin Manimala Statistics

Development and validation of a novel nomogram to predict diabetic kidney disease in patients with type 2 diabetic mellitus and proteinuric kidney disease

Int Urol Nephrol. 2022 Jul 23. doi: 10.1007/s11255-022-03299-x. Online ahead of print.

ABSTRACT

PURPOSE: Differentiating between diabetic kidney disease (DKD) and non-diabetic kidney disease (NDKD) in patients with Type 2 diabetes mellitus (T2DM) is important due to implications on treatment and prognosis. Clinical methods to accurately distinguish DKD from NDKD are lacking. We aimed to develop and validate a novel nomogram to predict DKD in patients with T2DM and proteinuric kidney disease to guide decision for kidney biopsy.

METHODS: A hundred and two patients with Type 2 Diabetes Mellitus (T2DM) who underwent kidney biopsy from 1st January 2007 to 31st December 2016 were analysed. Univariate and multivariate analyses were performed to identify predictive variables and construct a nomogram. The discriminative ability of the nomogram was assessed by calculating the area under the receiver operating characteristic curve (AUROC), while calibration was assessed using the Hosmer-Lemeshow goodness-of-fit test and calibration plot. Internal validation of the nomogram was assessed using bootstrap resampling.

RESULTS: Duration of T2DM, HbA1c, absence of hematuria, presence of diabetic retinopathy and absence of positive systemic biomarkers were found to be independent predictors of DKD in multivariate analysis and were represented as a nomogram. The nomogram showed excellent discrimination, with a bootstrap-corrected C statistic of 0.886 (95% CI 0.815-0.956). Both the calibration curve and the Hosmer-Lemeshow goodness-of-fit test (p = 0.242) showed high degree of agreement between the prediction and actual outcome, with the bootstrap bias-corrected curve similarly indicating excellent calibration.

CONCLUSIONS: A novel nomogram incorporating 5 clinical parameters is useful in predicting DKD in type 2 diabetes mellitus patients with proteinuric kidney disease.

PMID:35870041 | DOI:10.1007/s11255-022-03299-x