Tag: statistics

Waste Manag. 2021 Oct 8;136:11-17. doi: 10.1016/j.wasman.2021.09.031. Online ahead of print.

ABSTRACT

Nosocomial infections are a growing challenge at hospitals. This clinical study aimed to investigate the influence of waste container construction ((open (O), closed (C), and hands-free opening (HF)) on microbial air contamination in a hospital setting. The results are intended to help develop guidelines for waste containers for the collection of non-infectious waste at hospitals and medical facilities. The clinical experiment was conducted at the University Hospital Jena, Germany. Air Impactor samples were performed and microbiologically evaluated for bacteria and fungi both quantitatively and qualitatively. The results were statistically determined using generalized estimating equations. Quantitatively, the lowest bacterial counts in ambient air were found around closed waste containers (114.74 CFU/m³) in comparison to HF (129.28 CFU/m³) and O (126.28 CFU/m³). For fungi, the surrounding air of C (2.08 CFU/m³) and HF (1.97 CFU/m³) waste containers showed a lower impact of fungal air contamination than for O (2.32 CFU/m³). Overall, it was shown that C are more preferable to HF and O waste containers from the point of view of microbial air contamination at hospitals.

PMID:34634566 | DOI:10.1016/j.wasman.2021.09.031

J Vet Cardiol. 2021 Sep 2;37:71-80. doi: 10.1016/j.jvc.2021.08.005. Online ahead of print.

ABSTRACT

INTRODUCTION: Subaortic stenosis (SAS) is one of the most common congenital cardiac diseases in dogs. The objective of this study was to provide survival times on a large population of dogs with SAS and to propose a redefined pressure gradient (PG) scale to include a mild, moderate, severe and very severe disease group.

ANIMALS, MATERIALS AND METHODS: Dogs were divided into four groups based on the Doppler-derived PG across the stenosis. Disease severity was defined as follows: mild = PG < 50 mmHg; moderate = PG range 50-80 mmHg; severe = PG range 80-130 mmHg; and very severe = PG > 130 mmHg. Over the study period (1999-2011), 166 client-owned dogs were diagnosed with SAS of which 129 had follow-up information available.

RESULTS: Unadjusted median survival time for severity groups were as follows: mild 10.6 years; moderate 9.9 years; severe 7.3 years; and very severe 3.0 years. Univariable analysis examining the effect of the PG, age at diagnosis and sex found only the PG and age at diagnosis had a significant effect on survival. Adjusted survival curves showed that the survival time in the very severe group was decreased compared with all other groups.

CONCLUSION: Based on the results of this study, a revised SAS classification system with four PG groups is appropriate. Dogs with a PG > 130 mmHg were identified as those with the lowest median survival time.

PMID:34634578 | DOI:10.1016/j.jvc.2021.08.005

J Acad Nutr Diet. 2021 Oct 8:S2212-2672(21)01381-2. doi: 10.1016/j.jand.2021.10.014. Online ahead of print.

ABSTRACT

BACKGROUND: Breakfast consumption is often associated with improving cardiometabolic parameters and diet quality. However, literature evaluating breakfast consumption with these outcomes between the school and home environments is limited.

OBJECTIVE: This study examined relationships between breakfast consumption locations (home versus school) and cardiometabolic parameters, breakfast dietary intake, and daily dietary intake.

DESIGN: This cross-sectional study used baseline data from TX Sprouts, a one-year school-based gardening, nutrition, and cooking cluster-randomized trial, implemented in 16 elementary schools in Austin, TX, in 2016-2019.

PARTICIPANTS/SETTING: Analysis included 383 low-income, multi-racial/ethnic elementary school-aged children (mean age 9.2 years; 60.6% Hispanic; 70.5% free/reduced lunch; 58.5% home breakfast consumers).

MAIN OUTCOME MEASURES: Cardiometabolic parameters were obtained via fasting blood draws, and dietary intake was assessed using one 24-hour dietary recall conducted on a random, unannounced weekday. Cardiometabolic and dietary parameters (i.e., energy intake, macronutrients, and food group servings) for breakfast and for the day were evaluated.

STATISTICAL ANALYSES PERFORMED: Multivariate analysis of covariance was performed to examine cardiometabolic parameters and dietary intake between school and home breakfasts.

RESULTS: School breakfast consumers (SBC) had lower fasting triglyceride levels than home breakfast consumers (HBC) (89.0 mg/dL vs. 95.7 mg/dL; P = 0.03). SBC had lower total fat for the day (P = 0.02) and lower total and saturated fat, sodium, and refined grains at breakfast (P ≤ 0.01) than HBC. However, SBC had lower protein at breakfast (P = 0.01) and higher carbohydrates, total sugar, and added sugar for the day and at breakfast (P ≤ 0.03) than HBC.

CONCLUSION: SBC compared to HBC had lower fat intake, which may have contributed to the lower triglyceride level observed in SBC, but also had lower protein intake at breakfast and higher added sugar intake for the day and at breakfast. These results suggest dietary intake differed between the home and school environments, but more research is needed to evaluate if such differences are due to the School Breakfast Program guidelines.

PMID:34634512 | DOI:10.1016/j.jand.2021.10.014

Pathol Res Pract. 2021 Oct 5;227:153644. doi: 10.1016/j.prp.2021.153644. Online ahead of print.

ABSTRACT

OBJECTIVE: Angiogenesis produced by tumor microenvironment is play an important role in development of esophageal squamous cell carcinoma (ESCC). As a quantitative index of angiogenesis, literature has emerged contradictory results about the prognostic role of microvessel density (MVD) in ESCC. The aim of the study was to explore the impact of the correlation between MVD and the prognosis of ESCC based the published evidence.

METHODS: Pubmed and Web of science database were screened for the relationship of MVD with prognostic feature in ESCC up to March, 2021. 11 relevant articles were used for meta-analysis. The following data were extracted from the literature: author, year, country, the patients number of high/low MVD, tumor-node-metastasis (TNM) classification, clinical stage, lymphoid infiltrates, vessel invasion, invasive depth, differential degree and survival rate. The hazard ratio (HR) and odds ratios (OR) with 95% CI were used to assess the associations between MVD and overall survival (OS). Chi-squared test and I² statistics were completed to evaluate the heterogeneity in our study. A random-effects model was used when significant heterogeneity existed (I²>50% and p < 0.05). Egger test was used to calculate the publication bias. Subgroup analysis was stratified by antibody, region, sample capacity to explore the source of heterogeneity.

RESULTS: 11 studies with 1055 patients were analyzed. Our results suggested that high MVD is an important factor to advanced TNM classification and clinical stage, and the high MVD is positive correlation with the lymph node invasion and vascular invasion(p < 0.05) in ESCC, but irrelevant to poor differential and invasive depth(p > 0.05). The result also indicated that low MVD is a benefit factor to prolong the survival rate (p < 0.05). And the source of the heterogeneity maybe is that the antibody used to detect the MVD was not consistent, patient number was not large enough and the count method on MVD.

CONCLUSION: Across multiple studies, high MVD is correlated with clinicopathological criteria of poor prognosis and survival in ESCC. MVD could be the quantitative index to reactive angiogenesis and may play a pivotal role in ESCC development and progression. MVD may represent a valuable addition to current pathologic analysis and help to guide prognosis and treatment.

PMID:34634564 | DOI:10.1016/j.prp.2021.153644

Contemp Clin Trials. 2021 Oct 8:106589. doi: 10.1016/j.cct.2021.106589. Online ahead of print.

ABSTRACT

Waterfall plots have been increasingly used to visualize tumor response measurements in Phase II clinical trials. Despite the growing popularity of waterfall plots, quantitative summaries and distribution features of the data indicating antitumor activities are typically not reported. Statistical summaries from the raw and augmented data may provide valuable information for understanding such features. This issue has not been discussed adequately in the literature or fully recognized within the oncology community. In this article, we propose to augment the data using a statistical distribution system. Summary statistics of the data set corresponding to waterfall plot can be calculated using the original sample of the tumor changes or the augmentation sample, which may lead to additional insights into the treatment effect. We demonstrate the proposed method in numerical studies and in a Phase II clinical trial investigating the efficacy of a treatment for ovarian carcinoma. We recommend the proposed statistical analyses for making inferences in addition to the waterfall plot visualization.

PMID:34634476 | DOI:10.1016/j.cct.2021.106589

J Card Fail. 2021 Oct 8:S1071-9164(21)00396-1. doi: 10.1016/j.cardfail.2021.08.024. Online ahead of print.

ABSTRACT

BACKGROUND: Registries show international variations in the characteristics and outcome of patients with heart failure (HF) but national samples are rarely large, and case-selection may be biased due to enrolment in academic centres. National administrative datasets provide large samples with a low risk of bias. In this study, we compared the characteristics, healthcare resource utilization (HRU) and outcomes of patients with primary HF hospitalizations (HFH) using electronic health records (EHR) from four high-income countries (USA, UK, Taiwan, Japan) on three continents.

METHODS AND RESULTS: We used EHR to identify unplanned HFH between 2012-2014. We identified 231,512, 10,991, 36,900 and 133,982 patients with a primary HFH from USA, UK, Taiwan and Japan, respectively. HFH per 100,000 population was highest in USA and lowest in Taiwan. Patients in Taiwan and Japan were older but fewer were obese or had chronic kidney disease. LOHS was shortest in USA (median 4 days) and longer in UK, Taiwan and Japan (medians 7, 9 and 17 days, respectively). HRU during hospitalization was highest in Japan and lowest in UK. Crude and direct standardized in-hospital mortality was lowest in USA (direct standardized rates: 1.8 [95%CI:1.7-1.9]%)and progressively higher in Taiwan (direct standardized rates: 3.9 [95%CI:3.8-4.1]%), UK (direct standardized rates: 6.4 [95%CI:6.1-6.7]%) and Japan (direct standardized rates: 6.7 [95%CI:6.6-6.8]%). 30-day all-cause (25.8%) and HF (7.2%) readmissions were highest in USA and lowest in Japan (11.9% and 5.1% respectively).

CONCLUSION: Marked international variations in patient characteristics, HRU and clinical outcome exist; understanding them might inform health care policy and international trial design.

PMID:34634448 | DOI:10.1016/j.cardfail.2021.08.024

J Complement Integr Med. 2021 Oct 11. doi: 10.1515/jcim-2021-0390. Online ahead of print.

ABSTRACT

OBJECTIVES: To provide a broad evaluation of the efficacy and safety of Ayurveda interventions for the management of sinusitis.

METHODS: Five electronic databases for published research articles, three databases for the dissertation/doctoral thesis works, clinical trial registries, and hand searches were done till May 2021. All comparative clinical trials recruiting sinusitis patients of any age group, receiving Ayurveda intervention, regardless of forms, dosages, and ingredients, for not less than one week were included. The data extraction and the risk of bias (RoB) assessment were done by two reviewers independently.

RESULTS: A total of 2,824 records were identified, of which 09 randomized parallel arms trials met inclusion criteria. No studies were found comparing Ayurveda vs. placebo or non-Ayurveda interventions. Combined Ayurveda therapy (CT) was statistically more beneficial compared with either procedural or non-procedural Ayurveda therapy alone in reducing symptoms nasal discharge (standardized MD -0.71, 95% CI -1.16 to -0.26, I ² 58%, 210 participants) and headache (standardized MD -0.44, 95% CI -0.86 to -0.02, I ² 56%, 218 participants), however, no significant difference was found in reducing symptoms nasal obstruction and loss of smell. No data related to the safety of Ayurveda intervention was found. All the trials (09) were having ‘high’ to ‘some concern’ overall bias.

CONCLUSIONS: Although individual studies appeared to produce positive results, very low certainty of total effect hindered to arrive at any conclusion regarding efficacy or safety of Ayurveda interventions for sinusitis. There is a need for well-designed-executed-reported clinical studies on clinically relevant outcomes.

PROSPERO REGISTRATION NUMBER: CRD42018103995.

PMID:34634197 | DOI:10.1515/jcim-2021-0390

Clin Transplant. 2021 Oct 11:e14505. doi: 10.1111/ctr.14505. Online ahead of print.

ABSTRACT

BACKGROUND: The proportion of lung transplant (LTx) recipients older than 70 years is increasing, thus we assessed long-term survival after LTx in this cohort relative to younger counterparts.

PATIENTS AND METHODS: We retrospectively reviewed charts of patients who underwent LTx between 2012 and 2016 at our center and divided patients by age: group A (<65 years), B (65-69 years), and C (≥70 years). Survival statistics were evaluated using the Kaplan-Meier method and Cox regression.

RESULTS: The study included 375 LTx recipients: 221 (58.9%) in group A, 109 (29.1%) in group B, and 45 (12.0%) in group C. Group C was mostly men (37/45 [82.2%]; P = 0.003) and had the highest mean serum creatinine at listing (P = 0.02). Survival at 1, 3, and 5 years after transplant in group A (93.2%, 70.1%, 58.8%) was significantly higher than group B (83.5%, 59.6%, 44.0%; P = 0.005, 0.028, 0.006, log-rank test) and was similar to group C (86.7%, 64.4%, 57.8%), although trended higher at 1 year (P = 0.139, 0.274, 0.489, log-rank test). Groups B and C had comparable survival at all time points.

CONCLUSIONS: Although survival decreased after age 65, long-term survival was comparable between LTx recipients aged 65-69 years and recipients ≥70 years. This article is protected by copyright. All rights reserved.

PMID:34634161 | DOI:10.1111/ctr.14505

J Eur Acad Dermatol Venereol. 2021 Oct 11. doi: 10.1111/jdv.17738. Online ahead of print.

ABSTRACT

BACKGROUND: Oral finasteride is a well-established treatment for men with androgenetic alopecia (AGA), but long-term therapy is not always acceptable to patients. A topical finasteride formulation has been developed to minimize systemic exposure by acting specifically on hair follicles.

OBJECTIVES: To evaluate the efficacy and safety of topical finasteride compared with placebo, and to analyse systemic exposure and overall benefit compared with oral finasteride.

METHODS: This randomised, double-blind, double dummy, parallel-group, 24-week study was conducted in adult male outpatients with AGA at 45 sites in Europe. Efficacy and safety were evaluated. Finasteride, testosterone, and dihydrotestosterone (DHT) concentrations were measured.

RESULTS: Of 458 randomised patients, 323 completed the study and 446 were evaluated for safety. Change from baseline in target area hair count (TAHC) at Week 24 (primary efficacy endpoint) was significantly greater with topical finasteride than placebo (adjusted mean change 20.2 vs 6.7 hairs; p < 0.001), and numerically similar between topical and oral finasteride. Statistically significant differences favouring topical finasteride over placebo were observed for change from baseline in TAHC at Week 12 and investigator-assessed change from baseline in patient hair growth/loss at Week 24. Incidence and type of adverse events, and cause of discontinuation, did not differ meaningfully between topical finasteride and placebo. No serious adverse events were considered treatment related. As maximum plasma finasteride concentrations were >100 times lower, and reduction from baseline in mean serum DHT concentration was lower (34.5 vs 55.6%), with topical versus oral finasteride, there is less likelihood of systemic adverse reactions of a sexual nature related to a decrease in DHT with topical finasteride.

CONCLUSION: Topical finasteride significantly improves hair count compared to placebo and is well tolerated. Its effect is similar to that of oral finasteride, but with markedly lower systemic exposure and less impact on serum DHT concentrations.

PMID:34634163 | DOI:10.1111/jdv.17738

Cancer. 2021 Oct 11. doi: 10.1002/cncr.33959. Online ahead of print.

ABSTRACT

BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 Physical Functioning subscale is a widely used patient-reported outcome measure that quantifies cancer patients’ physical functioning. Strong floor/ceiling effects can affect a scale’s sensitivity to change. The aim of this study was to characterize floor/ceiling effects of the physical functioning domain in patients with advanced/metastatic breast cancer enrolled in commercial clinical trials and a community-based trial.

METHODS: The clinical trial cohort comprised patients from 5 registrational trials submitted to the Food and Drug Administration for review (2010-2017). The community cohort comprised a subgroup of patients from the Alliance Patient Reported Outcomes to Enhance Cancer Treatment (PRO-TECT) trial. The distribution of patient responses to Physical Functioning items and the summed score were assessed at the baseline and 3-month follow-up for both cohorts. Descriptive statistics were used to determine floor/ceiling effects at the item and scale levels.

RESULTS: The clinical trial cohort and the community cohort consisted of 2407 and 178 patients, respectively. Twenty-four percent or more of the respondents reported “not at all” for having trouble/needing help with each Physical Functioning item across both cohorts and measurement time points. Fourteen to twenty percent of the patients scored perfectly (100 of 100) on the Physical Functioning subscale summary measure (where higher scores indicated better physical functioning) across both cohorts and time points.

CONCLUSIONS: Minor floor effects and notable ceiling effects were found at the item and scale levels of the Physical Functioning subscale, regardless of cohort, and this creates some uncertainty about its ability to detect changes in physical functioning among high-functioning patients. Investigators may consider adding additional high-functioning items from the EORTC’s item library to more accurately describe the impact of anticancer treatment on patients’ physical functioning.

PMID:34634139 | DOI:10.1002/cncr.33959