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Nevin Manimala Statistics

The effect of obesity on cost of total laparoscopic hysterectomy

Aust N Z J Obstet Gynaecol. 2022 Apr 15. doi: 10.1111/ajo.13520. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: To test for the association between increasing patient body mass index (BMI) and the cost of total laparoscopic hysterectomy (TLH). Secondary outcomes include the relationship between increasing BMI and both peri- and post-operative morbidity.

MATERIALS AND METHODS: Retrospective cohort study of patients (N = 510) who underwent TLH between January 2017 and December 2018 at a single public tertiary teaching hospital.

RESULTS: Morbid obesity (n = 63) was associated with significantly higher total admission costs ($19 654 vs $17 475 Australian dollars, P = 0.002), operative costs ($9447 vs $8630, P = 0.017) and total costs including readmissions ($20 476 vs $18 399, P = 0.016) when compared to patients with normal BMI (n = 103) and adjusting for age, indication for surgery, additional procedures and conversion to total abdominal hysterectomy. Costs for overweight (n = 134) and obese (n = 210) BMI groups did not differ from costs for the normal BMI group. Increased operative costs observed in the morbidly obese group, were largely driven by the time associated with set-up, transfer and anaesthetic time while surgical and recovery times were not statistically significant.

CONCLUSION: The total cost of TLH is increased in the morbidly obese category of patients. The operative costs appear to be related to pre-operative measures such as theatre set-up and anaesthetic requirements. TLH in the obese and morbidly obese category group is not associated with increased intra-operative or post-operative complications. There may be a role for exploring improvements in managing morbidly obese patients in the pre-operative setting.

PMID:35426446 | DOI:10.1111/ajo.13520

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Nevin Manimala Statistics

Robust approach to combining multiple markers to improve surrogacy

Biometrics. 2022 Apr 15. doi: 10.1111/biom.13677. Online ahead of print.

ABSTRACT

Identifying effective and valid surrogate markers to make inference about a treatment effect on long-term outcomes is an important step in improving the efficiency of clinical trials. Replacing a long term outcome with short term and/or cheaper surrogate markers can potentially shorten study duration and reduce trial costs. There is a sizable statistical literature on methods to quantify the effectiveness of a single surrogate marker. Both parametric and nonparametric approaches have been well developed for different outcome types. However, when there are multiple markers available, methods for combining markers to construct a composite marker with improved surrogacy remain limited. In this paper, building on top of the optimal transformation framework of Wang et al. (2020), we propose a novel calibrated model fusion approach to optimally combine multiple markers to improve surrogacy. Specifically, we obtain two initial estimates of optimal composite scores of the markers based on two sets of models with one set approximating the underlying data distribution and the other directly approximating the optimal transformation function. We then estimate an optimal calibrated combination of the two estimated scores which ensures both validity of the final combined score and optimality with respect to the proportion of treatment effect explained (PTE) by the final combined score. This approach is unique in that it identifies an optimal combination of the multiple surrogates without strictly relying on parametric assumptions while borrowing modeling strategies to avoid fully non-parametric estimation which is subject to curse of dimensionality. Our identified optimal transformation can also be used to directly quantify the surrogacy of this identified combined score. Theoretical properties of the proposed estimators are derived and finite sample performance of the proposed method is evaluated through simulation studies. We further illustrate the proposed method using data from the Diabetes Prevention Program (DPP) study. This article is protected by copyright. All rights reserved.

PMID:35426444 | DOI:10.1111/biom.13677

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Phase II Trial Evaluating Esophageal Anastomotic Reinforcement with a Biologic, Degradable, Extracellular Matrix after Total Gastrectomy and Esophagectomy

J Am Coll Surg. 2022 May 1;234(5):910-917. doi: 10.1097/XCS.0000000000000113.

ABSTRACT

BACKGROUND: A biologic, degradable extracellular matrix (ECM) has been shown to support esophageal tissue remodeling, which could reduce the risk of anastomotic leak following total gastrectomy and esophagectomy. We evaluated the safety and efficacy of reinforcing the anastomosis with ECM in reducing anastomotic leak as compared to a matched cohort.

STUDY DESIGN: In this single-center, nonrandomized phase II trial, gastric or esophageal adenocarcinoma patients undergoing total gastrectomy or esophagectomy were recruited from November 2013 through December 2018. ECM was surgically wrapped circumferentially around the anastomosis. Anastomotic leak was assessed clinically and by contrast study and defined as clinically significant if requiring invasive treatment (grade 3 or higher). Anastomotic stenosis, other adverse events, symptoms, and dysphagia score were collected by standardized forms at regular follow-up visits at approximately postoperative days (POD) 21 and 90. Patients receiving ECM were compared to a cohort matched for surgery type and age.

RESULTS: ECM placement was not feasible in 9 of 75 patients (12%), resulting in 66 patients receiving ECM. Total gastrectomy was performed in 50 patients (76%) and esophagectomy in 16 (24%). Clinically significant anastomotic leak was diagnosed in 6 of 66 patients (9.1%) (3/50 [6.0%] after gastrectomy, 3/16 [18.8%] after esophagectomy); this rate did not differ from that in the matched cohort (p = 0.57). Stenosis requiring invasive treatment occurred in 8 patients (12.5%), and 10 patients (15.6%) reported not being able to eat a normal diet at POD 90. No adverse events related to ECM were reported.

CONCLUSIONS: Esophageal anastomotic reinforcement after total gastrectomy or esophagectomy with a biologic, degradable ECM was mostly feasible and safe, but was not associated with a statistically significant decrease in anastomotic leak.

PMID:35426405 | DOI:10.1097/XCS.0000000000000113

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Nevin Manimala Statistics

Psychosomatic symptoms in preschool children and how to treat them

Riv Psichiatr. 2022 Mar-Apr;57(2):88-93. doi: 10.1708/3790.37740.

ABSTRACT

BACKGROUND: Recent years saw an increase in children with emotional problems, which negatively affects not only their mental but also physical health. The current study aims to determine the structure of psychosomatic symptoms in preschool children and develop an effective treatment method for preschool teachers to deploy.

METHODS: A total of 259 children aged 4 to 5 years from Moscow preschools were divided into two groups: children (n=92) exposed to a standard education program and children (n=167) enrolled in the proposed education program for psychosomatic enhancement. The experiment lasted 6 months.

RESULTS: Using the proposed education program led to substantial improvements in the following KiddyKINDL subscales from baseline: Physical Well-being (1.19-fold increase, p<0.05), Emotional Well-being (1.24-fold increase, p<0.05), Self-esteem (1.21-fold increase, p<0.05), Family (1.17-fold increase, p<0.05), and Kiddy Parents (1.2-fold increase, p<0.05). The control group demonstrated slight but not significant improvements (p>0.05).

CONCLUSIONS: Therefore, the preschool teachers can use the proposed education program to enhance the psychosomatic health of preschool-aged children.

PMID:35426427 | DOI:10.1708/3790.37740

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Outcomes in Elderly Patients Undergoing Liver Transplantation Compared with Liver-Directed Ablative Therapy in Early-Stage Hepatocellular Carcinoma

J Am Coll Surg. 2022 May 1;234(5):892-899. doi: 10.1097/XCS.0000000000000135.

ABSTRACT

BACKGROUND: Orthotopic liver transplantation (OLT) is the accepted treatment in patients with unresectable, early-stage hepatocellular carcinoma (HCC) in the setting of cirrhosis. Due to increasing waitlist demand for OLT, determining optimal groups for transplant is critical. Elderly patients are known to have poorer postoperative outcomes. Considering the effectiveness of liver-directed therapies for HCC, we sought to determine whether elderly patients received survival benefit from OLT over liver-directed therapy alone.

STUDY DESIGN: The National Cancer Database participant use file was used to analyze data between 2004 and 2017. Only patients ≥70 years of age who received OLT or liver-directed therapy alone were included. Patients with alpha-fetoprotein >500 ng/mL or missing alpha-fetoprotein values were excluded. Baseline demographic variables, model for end-stage liver disease score, and overall survival from time of diagnosis were collected. Descriptive statistics, Kaplan-Meier survival, Cox proportional hazards model, and propensity score matching were used.

RESULTS: A total of 2,377 patients received ablative therapy alone, and 214 patients received OLT. Multivariable analysis and Kaplan-Meier showed that OLT conferred a significant survival benefit compared to liver-directed therapy alone. Age was also associated with a yearly 3% increase in risk of mortality. Propensity-matched analysis adjusting also demonstrated a significant survival benefit for elderly patients receiving OLT compared to liver-directed therapy alone.

CONCLUSION: Despite increased age and associated comorbidities being factors associated with poor outcomes, OLT confers a survival advantage compared to liver-directed ablative therapies alone in selected elderly patients with HCC. OLT should be offered in medically appropriate elderly patients with HCC.

PMID:35426403 | DOI:10.1097/XCS.0000000000000135

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Nevin Manimala Statistics

Area Deprivation Index and Rurality in Relation to Financial Toxicity among Breast Cancer Surgical Patients: Retrospective Cross-Sectional Study of Geospatial Differences in Risk Profiles

J Am Coll Surg. 2022 May 1;234(5):816-826. doi: 10.1097/XCS.0000000000000127.

ABSTRACT

BACKGROUND: Financial toxicity (FT) depicts the burden of cancer treatment costs and is associated with lower quality of life and survival in breast cancer patients. We examined the relationship between geospatial location, represented by rurality and Area Deprivation Index (ADI), and risk of FT.

STUDY DESIGN: A single-institution, cross-sectional study was performed on adult female surgical breast cancer patients using survey data retrospectively collected between January 2018 and June 2019. Chart reviews were used to obtain patient information, and FT was identified using the COmprehensive Score for Financial Toxicity questionnaire, which is a validated instrument. Patients’ home addresses were used to determine rurality using the Rural Urban Continuum Codes and linked to national ADI score. ADI was analyzed in tertiles for univariate statistical analyses, and as a continuous variable to develop multivariable logistic regression models to evaluate the independent associations of geospatial location with FT.

RESULTS: A total of 568 surgical breast cancer patients were included. Univariate analyses found significant differences across ADI tertiles with respect to race/ethnicity, marital status, insurance type, education, and rurality. In multivariable analysis, advanced cancer stage (odds ratio [OR] 2.26, 95% CI 1.15 to 4.44) and higher ADI (OR 1.012, 95% CI 1.01 to 1.02) were associated with worsening odds of FT. Increasing age (continuous) (OR 0.976, 95% CI 0.96 to 0.99), married status (vs unmarried) (OR 0.46, 95% CI 0.30 to 0.70), and receipt of bilateral mastectomy (OR 0.56, 95% CI 0.32 to 0.96) were protective of FT.

CONCLUSIONS: FT was significantly associated with areas of greater socioeconomic deprivation as measured by the ADI. However, in adjusted analyses, rurality was not significantly associated with FT. ADI can be useful for preoperative screening of at-risk populations and the targeted deployment of community-based interventions to alleviate FT.

PMID:35426394 | DOI:10.1097/XCS.0000000000000127

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Nevin Manimala Statistics

COVID-19 Vaccination Gap in Admitted Trauma Patients: A Critical Opportunity

J Am Coll Surg. 2022 May 1;234(5):727-735. doi: 10.1097/XCS.0000000000000133.

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccination is the core strategy for pandemic management. We hypothesized that a vaccination gap might exist between emergency department (ED) patients admitted for trauma and other ED patients.

STUDY DESIGN: This was an observational quality improvement study using electronic health record data at an academic level-1 trauma center. Participants were all patients presenting to the adult ED with a Tennessee home address between January 1 and June 1, 2021. We measured the proportional difference in vaccination between admitted trauma patients and other ED patients over time (by week) and association via Spearman’s rank correlation coefficient. Binary logistic regression facilitated covariate analysis to account for age, sex, race, home county, and ethnicity without and then with interaction between trauma admission and time. Geographic visual analysis compared county-level vaccination rates with odds of trauma admission by home county using a bivariate chloropleth map.

RESULTS: The proportional difference in vaccination between trauma-admitted and other ED patients increased over time (Spearman’s = 0.699). Adjusting for age, sex, race, home county, and ethnicity, there was a statistically significant vaccination difference between trauma-admitted and other ED patients (odds ratio = 0.53, 95% CI 0.43-0.65, p < 0.0001). Geographic analysis revealed increased trauma admission odds and lower vaccination rates in surrounding counties compared with Davidson County.

CONCLUSIONS: We observed a widening COVID-19 vaccination gap between trauma-admitted and other ED patients. Vaccine outreach during trauma admission may provide a valuable point of contact for unvaccinated patients.

PMID:35426382 | DOI:10.1097/XCS.0000000000000133

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Impact of Intraoperative Molecular Imaging after Fluorescent-Guided Pulmonary Metastasectomy for Sarcoma

J Am Coll Surg. 2022 May 1;234(5):748-758. doi: 10.1097/XCS.0000000000000132.

ABSTRACT

BACKGROUND: Intraoperative molecular imaging (IMI) has been shown to improve lesion detection during pulmonary sarcomatous metastasectomy. Our goal in this study was to evaluate whether data garnered from IMI-guided resection of pulmonary sarcoma metastasis translate to improved patient outcomes.

STUDY DESIGN: Fifty-two of 65 consecutive patients with a previous history of sarcomas found to have pulmonary nodules during screening were enrolled in a nonrandomized clinical trial. Patients underwent TumorGlow the day before surgery. Data on patient demographics, tumor biologic characteristics, preoperative assessment, and survival were included in the study analysis and compared with institutional historical data of patients who underwent metastasectomy without IMI. p values < 0.05 were considered significant.

RESULTS: IMI detected 42 additional lesions in 31 patients (59%) compared with the non-IMI cohort where 25% percent of patients had additional lesions detected using tactile and visual feedback only (p < 0.05). Median progression-free survival (PFS) for patients with IMI-guided pulmonary sarcoma metastasectomy was 36 months vs 28.6 months in the historical cohort (p < 0.05). IMI-guided pulmonary sarcoma metastasectomy had recurrence in the lung with a median time of 18 months compared with non-IMI group at 13 months (p < 0.05). Patients with synchronous lesions in the IMI group underwent systemic therapy at a statistically higher rate and tended to undergo routine screening at shorter interval.

CONCLUSIONS: IMI identifies a subset of sarcoma patients during pulmonary metastasectomy who have aggressive disease and informs the medical oncologist to pursue more aggressive systemic therapy. In this setting, IMI can serve both as a diagnostic and prognostic tool without conferring additional risk to the patient.

PMID:35426386 | DOI:10.1097/XCS.0000000000000132

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Transmission dynamics of COVID-19 in household and community settings in the United Kingdom, January to March 2020

Euro Surveill. 2022 Apr;27(15). doi: 10.2807/1560-7917.ES.2022.27.15.2001551.

ABSTRACT

BackgroundHouseholds appear to be the highest risk setting for COVID-19 transmission. Large household transmission studies in the early stages of the pandemic in Asia reported secondary attack rates ranging from 5 to 30%.AimWe aimed to investigate the transmission dynamics of COVID-19 in household and community settings in the UK.MethodsA prospective case-ascertained study design based on the World Health Organization FFX protocol was undertaken in the UK following the detection of the first case in late January 2020. Household contacts of cases were followed using enhanced surveillance forms to establish whether they developed symptoms of COVID-19, became confirmed cases and their outcomes. We estimated household secondary attack rates (SAR), serial intervals and individual and household basic reproduction numbers. The incubation period was estimated using known point source exposures that resulted in secondary cases.ResultsWe included 233 households with two or more people with 472 contacts. The overall household SAR was 37% (95% CI: 31-43%) with a mean serial interval of 4.67 days, an R0 of 1.85 and a household reproduction number of 2.33. SAR were lower in larger households and highest when the primary case was younger than 18 years. We estimated a mean incubation period of around 4.5 days.ConclusionsRates of COVID-19 household transmission were high in the UK for ages above and under 18 years, emphasising the need for preventative measures in this setting. This study highlights the importance of the FFX protocol in providing early insights on transmission dynamics.

PMID:35426357 | DOI:10.2807/1560-7917.ES.2022.27.15.2001551

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Nevin Manimala Statistics

Association between individual wheelchair skills and fitness in community-dwelling manual wheelchair users with spinal cord injuries

Disabil Rehabil Assist Technol. 2022 Apr 15:1-6. doi: 10.1080/17483107.2022.2061607. Online ahead of print.

ABSTRACT

PURPOSE: Wheelchair skills are a key component to promotion of community participation among persons with spinal cord injury (SCI). The objective of this secondary analysis was to examine the association between individual wheelchair skills from the Wheelchair Skills Test Questionnaire (WST-Q) and fitness among community-dwelling adults with SCI.

MATERIALS AND METHODS: Twenty-six adults were recruited to complete the WST-Q and a standard graded aerobic wheelchair exercise test on a motorized treadmill for assessing peak power output (POpeak).

RESULTS: Spearman Rho rank-order correlation (ρ) analyses indicated statistically significant correlations between POpeak and six basic (ρ = 0.41-0.57), eight intermediate (ρ = 0.44-0.59), and nine advanced (ρ = 0.42-0.80) WST-Q skill scores. After controlling for sex and injury level (Partial Spearman Rho rank order) significant correlations persisted for four advanced skills (i.e., descends high curb, turns in place in wheelie position, descends steep incline in wheelie position, descends high curb in wheelie position; ρ = 0.46-0.59) and one additional skill (i.e., ascends high curb ρ = 0.51).

CONCLUSIONS: More advanced wheelchair skills are significantly associated with fitness in persons with SCI. The directionality of the skills-fitness relationship, specifically whether wheelchair skills facilitate greater fitness or fitness is a prerequisite for certain wheelchair skills needs to be determined in future, larger studies. However, results from this study provide a comprehensive list of wheelchair skills that are associated with fitness that can be directly applied to guide further research and practice promoting community participation among persons with SCI.Implications for RehabilitationSignificant positive associations exist between advanced wheelchair skills (i.e., descends high curb, turns in place in wheelie position, descends steep incline in wheelie position, descends high curb in wheelie position and ascends high curb) and fitness in manual wheelchair users with spinal cord injury (SCI).This study provides a list of skills associated with fitness to guide clinical practice and areas for further rehabilitation research assessing the directionality of the relationship between fitness and wheelchair skills.

PMID:35426353 | DOI:10.1080/17483107.2022.2061607