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Nevin Manimala Statistics

Prospective Evaluation of Transanal Irrigation With a Validated Pediatric Neurogenic Bowel Dysfunction Scoring System

J Pediatr Gastroenterol Nutr. 2022 Jan 18. doi: 10.1097/MPG.0000000000003383. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the efficacy of transanal irrigation (TAI) in pediatric patients with Neurogenic Bowel Dysfunction (NBD) who were treatment naïve to catheter-based TAI using Peristeen® device (Coloplast).

METHODS: Prospective recruitment of patients with NBD who were unsatisfied with their bowel regimen or had no bowel regimen in place, were assessed using the Neurogenic Bowel Dysfunction score (NBDS) before initiating treatment (Time 0) with Peristeen®. NBDS scores were reassessed twice: within the first 6 months (Time 1) of initiation of Peristeen® and again after greater than 6 months of usage with Peristeen® (Time 2).

RESULTS: Over a 26 month period, 104 patients with NBD were enrolled. Mean age was 10.6 years ± 4.7 (range 3-18 years). The NBDS at Time 1 had an average reduction of 14 points from the original score. A similar trajectory was seen at Time 2, with an average reduction of 13 points from original score. There was a statistically significant decrease of 14 points, p < 0.001 at Time 1 and this response was sustained at Time 2 with a statistically significant decrease in scores from initiation by 13 points, p < 0.001. Improved patient satisfaction and quality of life with Peristeen® was seen at Time 1 and Time 2.

CONCLUSION: Our results suggest that Peristeen® can improve quality of life in pediatric patients with NBD. Significant improvement in NBDS occurred in our pediatric patients with NBD when initiated on Peristeen®. Lower scores were seen at both Time 1 and Time 2, which indicated an improvement in their overall NBD.

An infographic is available for this article at:http://links.lww.com/MPG/C658.

PMID:35045561 | DOI:10.1097/MPG.0000000000003383

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Nevin Manimala Statistics

External Validation of Postpartum Hemorrhage Prediction Models Using Electronic Health Record Data

Am J Perinatol. 2022 Jan 19. doi: 10.1055/a-1745-1348. Online ahead of print.

ABSTRACT

OBJECTIVE: A recent study leveraging machine learning methods found that postpartum hemorrhage (PPH) can be predicted accurately at the time of labor admission in the U.S. Consortium for Safe Labor (CSL) dataset, with a C-statistic as high as 0.93. These CSL models were developed in older data (2002-2008) and used an estimated blood loss (EBL) of ≥1000 mL to define PPH. We sought to externally validate these models using a more recent cohort of births where blood loss was measured using quantitative blood loss (QBL) methods.

STUDY DESIGN: Using data from 5,261 deliveries between February 1, 2019 to May 11, 2020 at a single tertiary hospital, we mapped our electronic health record (EHR) data to the 55 predictors described in previously published CSL models. PPH was defined as QBL ≥1000 mL within 24 hours after delivery. Model discrimination and calibration of the four CSL models were measured using our cohort. In a secondary analysis, we fit new models in our study cohort using the same predictors and algorithms as the original CSL models.

RESULTS: The original study cohort had a substantially lower rate of PPH, 4.8% (7,279/228,438) vs. 25% (1,321/5,261), possibly due to differences in measurement. The CSL models had lower discrimination in our study cohort, with a C-statistic as high as 0.57 (logistic regression). Models refit in our study cohort achieved better discrimination, with a C-statistic as high as 0.64 (random forrest). Calibration improved in the refit models as compared to the original models.

CONCLUSION: The CSL models’ accuracy was lower in a contemporary EHR where PPH is assessed using QBL. As institutions continue to adopt QBL methods, further data are needed to understand the differences between EBL and QBL to enable accurate prediction of PPH.

PMID:35045573 | DOI:10.1055/a-1745-1348

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Nevin Manimala Statistics

Optimization of Preoperative Anemia in Lower Limb Joint Replacement Surgery: Assessing the Rates of Allogenic Blood Transfusion and Duration of Hospital Stay

Orthop Nurs. 2022 Jan-Feb 01;41(1):15-20. doi: 10.1097/NOR.0000000000000815.

ABSTRACT

BACKGROUND: Orthopaedic procedures such as total hip and total knee replacements carry a significant risk of postoperative anemia, necessitating allogenic blood transfusions (ABTs), and an increased hospital length of stay.

AIM: Our aim was to investigate whether the implementation of a local protocol designed to detect and treat preoperative anemia resulted in reduced ABT rates and a shorter duration of length of hospital stay (LOS).

METHODS: We retrospectively audited 683 patients undergoing primary hip and knee replacements. We collated data for all patients about hospital length of stay and blood transfusions received. Both descriptive statistics and univariate analysis were performed.

RESULTS: Approximately 21.6% of the cohort within the study who were anemic at preoperative clinic had a significantly increased median LOS of 2 days (p < .001) and an increased packed red cell transfusion rate compared with non-anemic patients (26.1% vs. 2.21%, p < 001). However, treatment of preoperative anemia did not show any significant difference in transfusion rates compared with patients who did not receive corrective treatment. The median LOS was higher by 1 day in the treated group compared with the nontreated cohort (p = .005).

CONCLUSION: There is significant evidence to suggest that preoperative anemia can increase LOS and increase the risk of requiring postoperative blood transfusions. However, anemia should be regarded as a characteristic that can add to the outcome in a cumulative manner, as opposed to an isolated factor. Further research is needed on how to better manage preoperative anemia in order to improve patients’ outcomes.

PMID:35045537 | DOI:10.1097/NOR.0000000000000815

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Nevin Manimala Statistics

Trends and Disparities in Pediatric Nonalcoholic Fatty Liver Disease-Associated Hospitalizations in the United States

J Pediatr Gastroenterol Nutr. 2022 Jan 18. doi: 10.1097/MPG.0000000000003384. Online ahead of print.

ABSTRACT

OBJECTIVE: Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of disease characterized by accumulation of fat in the liver and is associated with co-morbidities linked to metabolic syndrome. The prevalence of NAFLD in children has increased in the U.S. over time and with marked racial differences observed in geographically limited studies. This study aims to provide a current, nation-wide analysis of temporal trends of pediatric NAFLD-related hospitalizations and associated co-morbidities as well as assess for racial/ethnic disparities.

METHODS: A cross-sectional study was conducted using the National Inpatient Sample (NIS) from 2004 – 2018 and included NAFLD-associated hospitalizations of children aged 0-17 years of age based on ICD-9/10 diagnosis codes. Rates and patient characteristics analyzed via descriptive statistics and associations via survey logistic regression. Temporal trends assessed via joinpoint regression.

RESULTS: There was an overall increase in pediatric NAFLD-associated hospitalizations with an average annual percent change (AAPC) of 6.6 with highest rates among Hispanic patients (AAPC = 11.1) compared to NH-White (AAPC = 4.1) and NH-Black (AAPC = 2.1). Analysis of race/ethnicity and NAFLD hospitalization showed an increased association in Hispanic patients (OR = 1.64, 95% CI = 1.51-1.77) and a decreased association in Non-Hispanic (NH)-Black patients (OR = 0.49, 95% CI = 0.45-0.54) when compared to NH-White patients.

CONCLUSION: Utilizing a nation-wide database we demonstrated significant increases in NAFLD-associated hospitalizations with highest prevalence and rates seen in Hispanic patients. In addition, gender and comorbidities showed notable correlation to these hospitalization rates displaying the need for further studies on these relationships and highlights the potential for interventions aimed at high-risk groups.

An infographic is available for this article at:http://links.lww.com/MPG/C656.

PMID:35045557 | DOI:10.1097/MPG.0000000000003384

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Nevin Manimala Statistics

The Effect of Preoperative Education Prior to Hip or Knee Arthroplasty on Immediate Postoperative Outcomes

Orthop Nurs. 2022 Jan-Feb 01;41(1):4-12. doi: 10.1097/NOR.0000000000000814.

ABSTRACT

There is ample research demonstrating improved patient outcomes when using an enhanced recovery program. However, the literature reporting the impact of preoperative education alone prior to hip and knee arthroplasty is conflicting. With the number of these surgical procedures expected to increase in the next few years, the identification of strategies that positively impact outcomes is important. The aim of this study was to evaluate immediate postoperative physical therapy (PT) performance following a total hip or knee arthroplasty in patients who attended a preoperative education class compared with those who did not. This study was a retrospective chart review of 707 hip and knee arthroplasty patients, comparing outcomes based on preoperative educational session attendance. Demographics, comorbidities, length of stay (LOS), discharge disposition, and PT performance were collected from the chart review. Patients who attended the preoperative education class had significantly greater ambulation distances (p < .001), greater degrees of knee flexion (p < .001), and greater degrees of hip flexion (p = .012) on postoperative Day 1. Both hip (p < .001) and knee (p < .001) patients who attended the class had a significantly shorter LOS. The cost benefit analysis indicated a savings of $921.57 in direct costs per knee arthroplasty in those who attended a class. Patients who received preoperative education had greater mobility in the immediate postoperative period and reduced LOS for both hip and knee arthroplasties. Based on this study’s results, preoperative education is effective in improving outcomes and reducing the cost of hip and knee arthroplasties.

PMID:35045535 | DOI:10.1097/NOR.0000000000000814

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Influence of Articular Geometry and Tibial Tubercle Location on Patellofemoral Kinematics and Contact Mechanics

J Appl Biomech. 2022 Jan 19:1-9. doi: 10.1123/jab.2021-0162. Online ahead of print.

ABSTRACT

Trochlear groove geometry and the location of the tibial tubercle, where the patellar tendon inserts, have both been associated with patellofemoral instability and can be modified surgically. Although their effects on patellofemoral biomechanics have been investigated individually, the interaction between the two is unclear. The authors’ aim was to use statistical shape modeling and musculoskeletal simulation to examine the effect of patellofemoral geometry on the relationship between tibial tubercle location and patellofemoral function. A statistical shape model was used to generate new knee geometries with trochlear grooves ranging from shallow to deep. A Monte Carlo approach was used to create 750 knee models by randomly selecting a geometry and randomly translating the tibial tubercle medially/laterally and anteriorly. Each knee model was incorporated into a musculoskeletal model, and an overground walking trial was simulated. Knees with shallow trochlear geometry were more sensitive to tubercle medialization with greater changes in lateral patella position (-3.0 mm/cm medialization shallow vs -0.6 mm/cm deep) and cartilage contact pressure (-0.51 MPa/cm medialization shallow vs 0.04 MPa/cm deep). However, knees with deep trochlear geometry experienced greater increases in medial cartilage contact pressure with medialization. This modeling framework has the potential to aid in surgical decision making.

PMID:35045394 | DOI:10.1123/jab.2021-0162

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Nursing Management-Associated Factors Associated with Urinary Tract Infection in Residents from Nursing Home Based on LTCfocus Database

Urol Int. 2022 Jan 19:1-13. doi: 10.1159/000520813. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of the study was to identify nursing management-associated factors correlated with urinary tract infection (UTI) in residents from nursing homes.

METHODS: The data of 3,393 nursing homes were extracted from LTCfocus database. Variables statistically correlated with UTI rate were identified by Spearman correlation analysis. Tobit regression model was used for finding the factors associated with UTI rate.

RESULTS: The number of beds (β = 0.03, 95% CI: 0.02-0.05), number of occupied beds/the total number of beds (β = 0.05, 95% CI: 0.03-0.07), number of admissions/total number of beds (β = 0.27, 95% CI: 0.11-0.43), the proportions of residents whose primary support is Medicare (β = 0.03, 95% CI: 0.01-0.06), women residents (β = 0.04, 95% CI: 0.02-0.06), White residents (β = 0.02, 95% CI: 0.01-0.03), patients with bladder incontinence (β = 0.03, 95% CI: 0.02-0.05), hypertension patients (β = 0.03, 95% CI: 0.01-0.05), and long-stay residents with daily pain (β = 0.16, 95% CI: 0.12-0.19), hospitalizations per resident year (β = 0.76, 95% CI: 0.30-1.21), and average daily census (β = -0.02, 95% CI: -0.03 to 0.00) were factors associated with UTI rate.

CONCLUSIONS: Nursing homes with more females, White people, and patients with bladder incontinence, hypertension, or daily pain should be cared more and the number of occupied beds and admissions should be controlled to reduce the occurrence of UTI.

PMID:35045413 | DOI:10.1159/000520813

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The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis

Contemp Clin Trials. 2022 Jan 16:106681. doi: 10.1016/j.cct.2022.106681. Online ahead of print.

ABSTRACT

IMPORTANCE: The COVID-19 pandemic has impacted clinical research due to safety measures such as social distancing and lockdowns. However, developing treatments for COVID-19 relies on conducting clinical trials. Using telemedicine or virtual methods may support ongoing trials and limit the pandemic’s impact on clinical research.

OBJECTIVE: To examine the use of virtual methods among ongoing and discontinued COVID-19 clinical trials.

DESIGN: In this cross-sectional analysis, we performed a systematic search of ClinicalTrials.gov for COVID-19 related trials registered since the pandemic began. In masked, duplicate fashion, authors extracted data from included studies, noting whether trialists reported using telecommunication, virtualization, or remote data collection to deliver interventions and monitor outcome measures. The authors also coded the use of virtual methods for recruitment, enrollment, or follow-up visits. Chi-square tests and Kruskal-Wallis tests were used to assess differences in the use of virtual methods between ongoing and discontinued studies and differences between intervention types.

RESULTS: Our search returned 2549 clinical trials, of which 2383 were included. Of included studies, 2109 (88.5%) were ongoing and 274 (11.5%) were discontinued. Overall, 519 (24.6%) ongoing COVID-19 trials reported using virtual methods for trial conduct and 43 (15.7%) discontinued trials reported using virtual methods. There was a statistically significant difference in the rate of reporting virtual methods between discontinued and ongoing trials (X21 = 27.2, P < .001). Studies listed as Behavioral or Other were more likely to report using virtual methods for delivering interventions compared to other intervention types (X21 = 751.88, P < .001).

CONCLUSIONS AND RELEVANCE: The COVID-19 pandemic has necessitated an unprecedented need for safe and efficient clinical trial conduct. Nearly a quarter of ongoing COVID-19 clinical trials in our sample reported using virtual methods for supporting trial progress. Ongoing trials were more likely to report virtual methods compared to discontinued trials. Developing strategies that allow for continuing trials during emergencies may limit trial disruption. Exploring and developing remote trial methods may continue to be valuable in light of emerging COVID-19 variants and may persist beyond the pandemic.

PMID:35045363 | DOI:10.1016/j.cct.2022.106681

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Nevin Manimala Statistics

Cost-effectiveness of treatment strategies for spinal metastases

Pract Radiat Oncol. 2022 Jan 16:S1879-8500(22)00002-9. doi: 10.1016/j.prro.2021.12.012. Online ahead of print.

ABSTRACT

PURPOSE: We analyze the cost-effectiveness of standard palliative external beam radiation (EBRT, 8 Gy in 1 fraction), stereotactic body radiation therapy (SBRT, 24 Gy in 2 fractions), and radiofrequency ablation (RFA) for painful spinal metastases. Single-fraction SBRT (delivering 24 Gy) is also assessed.

METHODS AND MATERIALS: A Markov state transition model was constructed. Key model parameters were derived from prospective clinical trial data. Strategies were compared using the incremental cost-effectiveness ratio (ICER), with effectiveness in quality-adjusted life years (QALYs) and a willingness-to-pay (WTP) threshold of $100,000 per QALY gained. Costs included both hospital and professional costs using 2020 Medicare reimbursement.

RESULTS: The base case demonstrated that 2-fraction SBRT was not cost-effective compared to single-fraction EBRT, with an ICER of $194,145/QALY gained. RFA was a dominated treatment strategy (more costly and less effective) in this model. Probabilistic sensitivity analysis demonstrated that EBRT was favored in 66% of model iterations. If median survival were improved after SBRT, two-fraction SBRT became cost-effective, with ICER of $80,394, $57,062, and $47,038 for 3, 6, and 9-month improvements in survival. Because two-fraction SBRT data reported 18% of patients with indeterminant pain response at 3 months, and two-fraction SBRT is infrequently used in clinical practice, single-fraction SBRT data was also assessed. Single-fraction SBRT delivering 24 Gy was cost-effective compared to single-fraction EBRT, with an ICER of $92,833/QALY gained.

CONCLUSIONS: For appropriately chosen patients, single-fraction SBRT is more cost-effective than conventional EBRT or RFA. Conventional EBRT remains a cost-effective treatment for patients with poor expected survival.

PMID:35045365 | DOI:10.1016/j.prro.2021.12.012

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Nevin Manimala Statistics

Combining diffusion kurtosis imaging and clinical data for predicting the extramural venous invasion of rectal adenocarcinoma

Eur J Radiol. 2022 Jan 11;148:110155. doi: 10.1016/j.ejrad.2022.110155. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study is to investigate the diagnostic ability of diffusion kurtosis imaging (DKI) -derived parameters combining with clinical data as risk factors for EMVI’s involvement status in rectal adenocarcinoma.

MATERIALS AND METHODS: Preoperative MR examination including DKI and conventional diffusion-weighted imaging (DWI) was performed on 154 rectal adenocarcinoma patients enrolled in this respective study. Kmean, Dmean, and apparent diffusion coefficient (ADC) values were calculated. Clinical information, serum tumor markers, MR and pathological assessment of EMVI were recorded. The Shapiro-Wilk test, two-sample t-test, Mann-Whitney U test, Spearman’s rank-order correlation, univariate and multivariate logistic regression analyses were used for statistical analysis. Receiver operating characteristic (ROC) curve analyses were performed to identify risk factors in EMVI involvement.

RESULTS: Of the 154 patients, pEMVI-positive rectal tumors had significantly higher Kmean values, lower ADCmean values compared to pEMVI-negative rectal tumors. Kmean values positively correlated with mrEMVI scores, whereas ADCmean values showed a negative correlation with mrEMVI scores. However, there was no significant correlation between the Dmean values and the mrEMVI scores. Univariate analysis demonstrated increased Kmean values, decreased ADCmean values, nodal involvement, an advanced tumor stage, and a G2 tumor grade were significantly related to the pEMVI of rectal adenocarcinoma. The multivariate analysis demonstrated that the Kmean values, lymph node involvement and an advanced tumor stage (T3) were independent risk factors for EMVI.

CONCLUSION: The potential for diffusion kurtosis imaging as a biomarker for evaluating the EMVI of rectal cancer is feasible, especially given DKI’s capability of detecting tumor heterogeneity noninvasively.

PMID:35045353 | DOI:10.1016/j.ejrad.2022.110155