Nevin Manimala

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

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

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

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

Clin Transplant. 2021 Oct 11:e14503. doi: 10.1111/ctr.14503. Online ahead of print.

ABSTRACT

BACKGROUND: Sarcopenia has gained momentum as a potential risk-stratification tool in liver transplantation (LT). While LT recipients recently have more advanced end-stage liver disease, the impact of sarcopenia in high acuity recipients with a high model for end-stage liver disease (MELD) score remains unclear.

METHODS: We retrospectively assessed sarcopenia by calculating skeletal muscle index (SMI) from cross sectional area at third lumbar vertebra (cm² ) and height (m² ) in 296 patients with a CT ≤ 30 days prior to LT. Sex-specific SMI cut-offs were developed, and its impact was assessed in patients with MELD ≥ 35.

RESULTS: In patients with MELD ≥ 35 (n = 217), men with a SMI<30 cm² /m² had significantly higher rates of bacteremia (p = 0.021) and a longer hospital stay (p < 0.001). Women with a SMI<34 cm² /m² had a longer hospital stay (p = 0.032). There were no relationships between SMI and survival in men and women with MELD ≥ 35.

CONCLUSIONS: This series examined sarcopenia with a focus on high MELD patients. Although decreased SMI contributed to higher post-LT hospital stay, it did not impact patient survival, suggesting that while SMI alone may not aid in patient selection for LT, it certainly may guide perioperative care-planning in this challenging patient population. This article is protected by copyright. All rights reserved.

PMID:34634157 | DOI:10.1111/ctr.14503

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

J Forensic Sci. 2021 Oct 11. doi: 10.1111/1556-4029.14914. Online ahead of print.

ABSTRACT

Recent advances in complex automated handwriting identification systems have led to a lack of understandability of these systems’ computational processes and features by the forensic handwriting examiners that they are designed to support. To mitigate this issue, this research studied the relationship between two systems: FLASH ID^® , an automated handwriting/black box system that uses measurements extracted from a static image of handwriting, and MovAlyzeR^® , a system that captures kinematic features from pen strokes. For this study, 33 writers each wrote 60 phrases from the London Letter using cursive writing and handprinting, which led to thousands of sample pairs for analysis. The dissimilarities between pairs of samples were calculated using two score functions (one for each system). The observed results indicate that dissimilarity scores based on kinematic spatial-geometric pen stroke features (e.g., amplitude and slant) have a statistically significant relationship with dissimilarity scores obtained using static, graph-based features used by the FLASH ID^® system. Similar relationships were observed for temporal features (e.g., duration and velocity) but not pen pressure, and for both handprinting and cursive samples. These results strongly imply that both the current implementation of FLASH ID^® and MovAlyzeR^® rely on similar features sets when measuring differences in pairs of handwritten samples. These results suggest that studies of biometric discrimination using MovAlyzeR^® , specifically those based on the spatial-geometric feature set, support the validity of biometric matching algorithms based on FLASH ID^® output.

PMID:34634133 | DOI:10.1111/1556-4029.14914

PLoS One. 2021 Oct 11;16(10):e0258282. doi: 10.1371/journal.pone.0258282. eCollection 2021.

ABSTRACT

In the absence of widespread vaccination for COVID-19, governments and public health officials have advocated for the public to wear masks during the pandemic. The decision to wear a mask in public is likely affected by both beliefs about its efficacy and the prevalence of the behavior. Greater mask use in the community may encourage others to follow this norm, but it also creates an incentive for individuals to free ride on the protection afforded to them by others. We report the results of two vignette-based experiments conducted in the United States (n = 3,100) and Italy (n = 2,659) to examine the causal relationship between beliefs, social norms, and reported intentions to engage in mask promoting behavior. In both countries, survey respondents were quota sampled to be representative of the country’s population on key demographics. We find that providing information about how masks protect others increases the likelihood that someone would wear a mask or encourage others to do so in the United States, but not in Italy. There is no effect of providing information about how masks protect the wearer in either country. Additionally, greater mask use increases intentions to wear a mask and encourage someone else to wear theirs properly in both the United States and Italy. Thus, community mask use may be self-reinforcing.

PMID:34634089 | DOI:10.1371/journal.pone.0258282