Tag: pubmed

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

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

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

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):e0258093. doi: 10.1371/journal.pone.0258093. eCollection 2021.

ABSTRACT

In order to propose a more precise definition and explore how to reduce ethical losses in randomized controlled clinical trials (RCTs), we set out to identify trial participants who do not contribute to demonstrating that the treatment in the experimental arm is superior to that in the control arm. RCTs emerged mid-last century as the gold standard for assessing efficacy, becoming the cornerstone of the value of new therapies, yet their ethical grounds are a matter of debate. We introduce the concept of unnecessary participants in RCTs, the sum of non-informative participants and non-responders. The non-informative participants are considered not informative with respect to the efficacy measured in the trial in contrast to responders who carry all the information required to conclude on the treatment’s efficacy. The non-responders present the event whether or not they are treated with the experimental treatment. The unnecessary participants carry the burden of having to participate in a clinical trial without benefiting from it, which might include experiencing side effects. Thus, these unnecessary participants carry the ethical loss that is inherent to the RCT methodology. On the contrary, responders to the experimental treatment bear its entire efficacy in the RCT. Starting from the proportions observed in a real placebo-controlled trial from the literature, we carried out simulations of RCTs progressively increasing the proportion of responders up to 100%. We show that the number of unnecessary participants decreases steadily until the RCT’s ethical loss reaches a minimum. In parallel, the trial sample size decreases (presumably its cost as well), although the trial’s statistical power increases as shown by the increase of the chi-square comparing the event rates between the two arms. Thus, we expect that increasing the proportion of responders in RCTs would contribute to making them more ethically acceptable, with less false negative outcomes.

PMID:34634062 | DOI:10.1371/journal.pone.0258093

PLoS One. 2021 Oct 11;16(10):e0258181. doi: 10.1371/journal.pone.0258181. eCollection 2021.

ABSTRACT

Mesophotic habitats could be sheltered from natural and anthropogenic disturbances and act as reproductive refuges, providing propagules to replenish shallower populations. Molecular markers can be used as proxies evaluating the connectivity and inferring population structure and larval dispersal. This study characterizes population structure as well as horizontal and vertical genetic connectivity of the broadcasting coral Pocillopora verrucosa from Ludao, a small oceanic island off the eastern coast of Taiwan. We genotyped 75 P. verrucosa specimens from three sites (Gongguan, Dabaisha, and Guiwan) at three depth ranges (Shallow: 7-15 m, Mid-depth: 23-30 m, and Deep: 38-45 m), spanning shallow to upper mesophotic coral reefs, with eight microsatellite markers. F-statistics showed a moderate differentiation (FST = 0.106, p<0.05) between two adjacent locations (Dabaisha 23-30 and Dabaisha 38-45 m), but no differentiation elsewhere, suggesting high levels of connectivity among sites and depths. STRUCTURE analysis showed no genetic clustering among sites or depths, indicating that all Pocillopora individuals could be drawn from a single panmictic population. Simulations of recent migration assigned 30 individuals (40%) to a different location from where they were collected. Among them, 1/3 were assigned to deeper locations, 1/3 to shallower populations and 1/3 were assigned to the right depth but a different site. These results suggest high levels of vertical and horizontal connectivity, which could enhance the recovery of P. verrucosa following disturbances around Ludao, a feature that agrees with demographic studies portraying this species as an opportunistic scleractinian.

PMID:34634065 | DOI:10.1371/journal.pone.0258181

PLoS Comput Biol. 2021 Oct 11;17(10):e1009479. doi: 10.1371/journal.pcbi.1009479. Online ahead of print.

ABSTRACT

A central question in neuroscience is how context changes perception. In the olfactory system, for example, experiments show that task demands can drive divergence and convergence of cortical odor responses, likely underpinning olfactory discrimination and generalization. Here, we propose a simple statistical mechanism for this effect based on unstructured feedback from the central brain to the olfactory bulb, which represents the context associated with an odor, and sufficiently selective cortical gating of sensory inputs. Strikingly, the model predicts that both convergence and divergence of cortical odor patterns should increase when odors are initially more similar, an effect reported in recent experiments. The theory in turn predicts reversals of these trends following experimental manipulations and in neurological conditions that increase cortical excitability.

PMID:34634035 | DOI:10.1371/journal.pcbi.1009479

PLoS One. 2021 Oct 11;16(10):e0258329. doi: 10.1371/journal.pone.0258329. eCollection 2021.

ABSTRACT

BACKGROUND: Back pain patients are more likely to suffer from depression, anxiety and reduced quality of life. Pain drawing is a simple, frequently used anamnesis tool that facilitates communication between physicians and patients. This study analysed pain drawings to examine whether pain drawing is suitable as a screening tool for signs of anxiety, depression or reduced quality of life, as the detection of these symptoms is essential for successful treatment.

METHODS: Pain drawings of 219 patients with lower back pain were evaluated retrospectively. Pain drawings are a schematic drawing of a human being. Six variables of the pain drawing were analysed. Subscales of the Hospital Anxiety and Depression Scale (HADS) and the Mental Component Summary (MCS) of the Short Form 12 (SF-12) were used to measure anxiety, depression and quality of life, respectively. Descriptive statistics, uni- and multivariate linear regression analyses and analysis of variance were performed. Logistic regression analyses were conducted for suitable variables.

RESULTS: We revealed significant positive correlations between the variables “filled body surface” and “number of pain sites” and the anxiety (HADS-A) and depression subscales (HADS-D) of the HADS (p<0.01). The same predictors had significant negative correlations with the MCS (p<0.01). However, the sensitivity and specificity of the variable “number of pain sites” were too low compared to those for existing screening tests to consider it as a screening tool for anxiety, depression and quality of life (HADS-A: sensitivity: 45.2%, specificity: 83.3%; HADS-D: sensitivity: 61.1%, specificity: 51%; MCS: sensitivity: 21.2%, specificity: 85.7%).

CONCLUSIONS: There were significant correlations between the amount of filled body surface and the number of pain sites in the pain drawing and anxiety, depression and quality of life. Although useful in routine clinical practice, pain drawing cannot be used as a screening tool based on our results.

PMID:34634060 | DOI:10.1371/journal.pone.0258329

J Pak Med Assoc. 2021 Aug;71(Suppl 5)(8):S51-S54.

ABSTRACT

OBJECTIVE: To compare the inter-observer reliability of Shatzker classification and Khan Classification of Tibial plateau fractures.

METHODS: This retrospective cohort study was conducted at The Indus Hospital, Karachi, Pakistan. Radiographs of 50 patients who presented with tibial plateau fractures from March 2015 to November 2016 were collected. Two observers classified these cases independently according to Shatzker and Khan Classification. Gwet’s AC1 statistics applied to assess inter-observer reliability of both the classification systems.

RESULTS: Moderate inter-observer agreement for Schatzker classification (p<0.001) and slight inter-observer agreement on Khan Classification (p=0.738) was observed.

CONCLUSIONS: Khan Classification is more comprehensive in classifying tibial plateau fractures and can be used for clinical research purpose, while Shatzker classification with better inter-observer reliability is applicable for routine clinical practice.

PMID:34634016