The impact of lowering the study design significance threshold to 0.005 on sample size in randomized cancer clinical trials.

The proposal of improving reproducibility by lowering the significance threshold to 0.005 has been discussed, but the impact on conducting clinical trials has yet to be examined from a study design perspective. The impact on sample size and study duration was investigated using design setups from 125 phase II studies published between 2015 and 2022. The impact was assessed using percent increase in sample size and additional years of accrual with the medians being 110.97% higher and 2.65 years longer respectively. The results indicated that this proposal causes additional financial burdens that reduce the efficiency of conducting clinical trials.

Global trends indicate increasing consumption of dietary sodium and fiber in middle-income countries: A study of 30-year global macrotrends.

According to the Global Burden of Disease Study, 3 million deaths were attributable to high sodium intake and low intake of whole grains. With the rapid evolution of the food industry, we hypothesize that dietary intake of sodium has increased and that dietary intake of whole grains or fibers has decreased because of easier access to highly processed food. Country-level data on dietary factors and country income levels from 1990 to 2018 were collected from 3 public databases. The trend of dietary intake was modeled using the linear mixed model accounting for random effects of individual countries. The country-level differences in dietary factors between males and females were calculated, and the trends were also modeled accounting for the random effects of countries. Both males and females consumed increasing amounts of dietary sodium from 1990 to 2018 in high-income, middle- to high-, middle-, and low-income countries. Dietary fiber intake increased in low-to-middle, middle-, and middle-to-high income countries for both men and women over the past 3 decades. Men tend to consume more sodium and less fiber and whole grains in their diets than women, the trend of which is statistically significant in middle-income countries. Over the past 3 decades, the macrotrend of dietary sodium has increased around the globe. To reduce the sodium intake level, nutrition policy should emphasize sodium reduction, especially in high-income, middle- to high-income, middle-income, and low-income countries.

Optimizing palliative care and support for pets -perspectives of the pet-parent and the veterinarian.

As animals benefit from improved chronic disease care, more pet-parents and veterinarians face issues of late life and terminal care. Management of life limiting disease commonly considers the timing of euthanasia, often overlooking the role of supportive palliative care. Necessary communications between vet and pet-parents are rarely emphasized. However, as in human palliative care, the central role of good communications is critical. In particular, three communication elements are primary, namely: empathic communication and shared decision-making; managing progressive symptoms, and; advanced directives. Moreover, focusing only on euthanasia can easily discount the profound emotional legacy of bereavement. This Perspective illustrates how communications policies derived from human palliative care are exemplified in the management of a case of canine lung cancer, to the wider practice benefits of pets, pet-parents and veterinary practice staff.

Randomized Control Trial of the Impact of Patient Decision Aid Developed for Chinese Primary Open-Angle Glaucoma Patients.

INTRODUCTION: Patient decision aid (PDA) is a tool to prompt shared decision-making. The aim of this study was to evaluate the impact of a PDA on Chinese primary open-angle glaucoma patients. METHODS: All subjects were randomized into control and PDA group. The questionnaires, including 1) glaucoma knowledge; 2) 8-item Morisky medication adherence scale (MMAS-8); 3) 10-item glaucoma medication adherence self-efficacy scale (GMASES-10); and 4) 16-item decision conflict scale (DCS), were evaluated at baseline, 3- and 6-month follow-up. RESULTS: Totally, 156 subjects participated in this study, including 77 in the control group and 79 in the PDA group. Compared to the control group, PDA group showed around 1 point more improvement in disease knowledge at both 3 and 6 months (both p < 0.05), 2.5 (95% CI: [1.0, 4.1]) and 1.9 (95% CI: [0.2, 3.7]) points more improvement in GMASES-10 at 3 and 6 months, respectively, and reduction in DCS by 8.8 (95% CI: [4.6, 12.9]) points more at 3 months and 13.5 (95% CI: [8.9, 18.0]) points more at 6 months. No difference was detected in MMAS-8. CONCLUSION: PDA led to improvement in disease knowledge and self-confidence in medication adherence and reduced decision conflict compared to control group for at least 6 months.

An Evaluation of Gene-Diet Interaction Statistical Methods and Discovery of rs7175421-Whole Grain Interaction in Lung Cancer.

Dietary factors show different effects on genetically diverse populations. Scientific research uses gene-environment interaction models to study the effects of dietary factors on genetically diverse populations for lung cancer risk. However, previous study designs have not investigated the degree of type I error inflation and, in some instances, have not corrected for multiple testing. Using a motivating investigation of diet-gene interaction and lung cancer risk, we propose a training and testing strategy and perform real-world simulations to select the appropriate statistical methods to reduce false-positive discoveries. The simulation results show that the unconstrained maximum likelihood (UML) method controls the type I error better than the constrained maximum likelihood (CML). The empirical Bayesian (EB) method can compete with the UML method in achieving statistical power and controlling type I error. We observed a significant interaction between SNP rs7175421 with dietary whole grain in lung cancer prevention, with an effect size (standard error) of -0.312 (0.112) for EB estimate. SNP rs7175421 may interact with dietary whole grains in modulating lung cancer risk. Evaluating statistical methods for gene-diet interaction analysis can help balance the statistical power and type I error.

Antimicrobial Resistance Policy Protagonists and Processes-A Qualitative Study of Policy Advocacy and Implementation.

Antimicrobial resistance (AMR) fundamentally weakens societal foundations economically and in health care. The development of well-considered policies against AMR is important. However, in many places, AMR policy implementation remains elusive. This study aims to identify enablers and deterrents as well as processes and conditions in AMR policy advocacy. It also aims to identify AMR implementation conditions where AMR national policies are adopted and, to a certain extent, formulated and implemented. This study adopts qualitative research methodology and applies the Grounded Theory Framework to identify thematic findings from interviews conducted in China, Japan, Norway, the United Kingdom (UK), and the United States of America (US). It was identified that AMR policy protagonists are critical to filtering AMR issues and identifying policies "fit to prioritize" and "fit to implement". They have helped move policy prioritization needles in the UK and the US and engaged in diplomatic efforts in the UK. In these cases, no clientelism was considered. In the US, protagonists who talked to the right decision-makers in the right office at the right time both moved AMR issues from individuals to institutional agenda and from social norms to policy agenda. To conclude, there are three thematic policy conditions that are significant to AMR policy advocacy and implementation: committed personal championship, institutionalization of policies, and social norms facilitate AMR policy advocacy and implementation.

A Retrospective Study of Antimicrobial Resistant Bacteria Associated with Feline and Canine Urinary Tract Infection in Hong Kong SAR, China-A Case Study on Implication of First-Line Antibiotics Use.

Urinary tract infection (UTI) is a common clinical diagnosis for which empirical antibiotics are used in veterinary medicine. For veterinarians, the description of canine and feline antibiograms can help with making prudent use decisions and guideline formulation. For public health officers and epidemiologists, a urinary antibiogram overview helps track and trend antimicrobial resistance (AMR). There is currently a knowledge gap in AMR prevalence associated with urinary tract infection in feline and canine patients and the resistance percentage of these microbes against some of the over-the-counter antibiotics available to local pet owners. This study has two aims. First, it aims to investigate the frequency of the bacteria and bacterial-resistance pattern in urine samples obtained from feline and canine patients. Second, it aims to determine the resistance of Escherichia coli (E. coli), the most frequently isolated bacteria, to first-line antibiotics. Results: We identified the five most-frequently isolated bacterial species and determined these isolates' antibiotic sensitivity and resistance. The most-frequently isolated bacteria in feline and canine patients was Escherichia coli (E. coli). E. coli was identified, on average, in 37.2% of canine and 46.5% of feline urine samples. Among feline urinary samples, Enterococcus (14.7%) and Staphylococcus (14.5%) spp. were isolated more frequently, followed by Pseudomonas (4.8%) and Klebsiella (5.2%) spp. (). In canine samples, Proteus (17.9%) and Staphylococcus (13.2%) spp. were isolated more frequently, followed by Enterococcus (10.0%) and Klebsiella (8.59%) spp. Among these isolates, 40 to 70% of Staphylococcus spp. bacterial isolates from feline and canine patients were resistant to amoxicillin and ampicillin. During the three-year study period, among canine patients, 10 to 20% of Staphylococcus spp. bacterial isolates were resistance to fluoroquinolones, other quinolones, and third-generation cephalosporins. Among feline patients, 10% of Staphylococcus spp., 15 to 20% of E. coli, 50 to 60% of Klebsiella spp., and 90% of Pseudomonas spp. were resistant to cefovecin, a commonly used antibiotic.

What is the prevalence of fear of cancer recurrence in cancer survivors and patients? A systematic review and individual participant data meta-analysis.

OBJECTIVE: Care for fear of cancer recurrence (FCR) is considered the most common unmet need among cancer survivors. Yet the prevalence of FCR and predisposing factors remain inconclusive. To support targeted care, we provide a comprehensive overview of the prevalence and severity of FCR among cancer survivors and patients, as measured using the short form of the validated Fear of Cancer Recurrence Inventory (FCRI-SF). We also report on associations between FCR and clinical and demographic characteristics. METHODS: This is a systematic review and individual participant data (IPD) meta-analysis on the prevalence of FCR. In the review, we included all studies that used the FCRI-SF with adult (≥18 years) cancer survivors and patients. Date of search: 7 February 2020. Risk of bias was assessed using the Joanna Briggs Institute critical appraisal tool. RESULTS: IPD were requested from 87 unique studies and provided for 46 studies comprising 11,226 participants from 13 countries. 9311 respondents were included for the main analyses. On the FCRI-SF (range 0-36), 58.8% of respondents scored ≥13, 45.1% scored ≥16 and 19.2% scored ≥22. FCR decreased with age and women reported more FCR than men. FCR was found across cancer types and continents and for all time periods since cancer diagnosis. CONCLUSIONS: FCR affects a considerable number of cancer survivors and patients. It is therefore important that healthcare providers discuss this issue with their patients and provide treatment when needed. Further research is needed to investigate how best to prevent and treat FCR and to identify other factors associated with FCR. The protocol was prospectively registered (PROSPERO CRD42020142185).

Risk perception, treatment adherence, and personality during COVID-19 pandemic: An international study on cancer patients.

OBJECTIVE: To explore the role of personality traits in moderating the relation between COVID-19 risk perception and treatment adherence, and between risk perception and psychosocial distress in patients diagnosed with cancer. METHODS: An online survey (n = 1281) was conducted worldwide in seven countries (Austria, Germany, Hong Kong, Italy, Spain, Sweden, and Turkey). Inclusion criteria were to be 18 years of age or older, have received a cancer diagnosis, and be in treatment or follow-up. A few moderated regression models were performed with both personality traits and Hierarchical Taxonomy of Psychopathology super-spectra as moderators. RESULTS: Detachment, negative affectivity, psychoticism and all the super-spectra significantly moderated the relation between coronavirus risk perception and psychosocial distress, after the adjusting effect of confidence in safeguards. Only negative affectivity moderated the association between coronavirus risk perception and treatment adherence. CONCLUSIONS: Personality traits may foster the understanding of how a patient might adjust to cancer treatment and, more generically, to highly stressful events such as the COVID-19 pandemic. Further research is needed to confirm the results in different cancer stages and types.

Community psychological and behavioural responses to coronavirus disease 2019 over one year of the pandemic in 2020 in Hong Kong.

Monitoring community psychological and behavioural responses to coronavirus disease 2019 (COVID-19) is important for informing policy making and risk communication to sustain public compliance with challenging precautionary behaviours and mitigating the psychological impacts. Monthly telephone-based cross-sectional surveys in January-April 2020 and then weekly surveys from May through December 2020 were conducted to monitor changes in public risk perception of COVID-19, personal efficacy in self-protection, confidence in government's ability to control the pandemic, precautionary behaviours, perceived impact of precautionary behaviours, psychological fatigue and distress in Hong Kong, and examine their inter-relationships. While worry about contracting COVID-19 increased, personal efficacy and confidence in government declined as the community incidence of COVID-19 increased. The public maintained high compliance with most precautionary behaviours throughout but relaxed behaviours that were more challenging when disease incidence declined. Public confidence in government was persistently low throughout, of which, a lower level was associated with more psychological fatigue, lower compliance with precautionary behaviours and greater psychological distress. Perceived greater negative impact of precautionary behaviours was also associated with more psychological fatigue which in turn was associated with relaxation of precautionary behaviours. Female, younger and unemployed individuals reported greater psychological distress throughout different stages of the pandemic. Risk communication should focus on promoting confidence in self-protection and pandemic control to avoid helplessness to act when the pandemic resurges. Policy making should prioritize building public trust, enhancing support for sustaining precautionary behaviours, and helping vulnerable groups to adapt to the stress during the pandemic.

Role of dietary carbohydrates on risk of lung cancer.

OBJECTIVES: Inconsistent findings have been reported on the link between dietary carbohydrates and lung cancer. This study aims to comprehensively evaluate the role of dietary carbohydrates on lung cancer risk. MATERIALS AND METHODS: The prospective study is based on the PLCO trial, which recruited 113,096 eligible participants across the United States. Participants had to have completed baseline and diet history questionnaires. The incidence of lung cancer was acquired through self-report and medical record follow-up. A multivariable logistic model adjusted for confounders was used to estimate odds ratios (ORs) and 95 % confidence intervals (CIs) of dietary carbohydrates, fiber, whole grains, glycemic index (GI) and glycemic load (GL) for lung cancer. Similar methods were applied in analyzing the carbohydrates and fiber from different food sources. Multinomial logistic models were used for sensitivity analysis with lung cancer subtypes as outcomes. RESULTS: Dietary carbohydrates and GL were inversely associated with lung cancer incidence in the PLCO population. Among various carbohydrates, 30-g daily consumption of dietary fiber was related to a lower risk of lung cancer (fourth vs first quartile OR: 0.62, 95 % CI: 0.54-0.72) compared with 8.8-g. Furthermore, consuming whole grains 2.3 servings per day as opposed to 0.3 servings per day was associated with a lower risk of lung cancer (OR: 0.73, 95 % CI: 0.64-0.83). A higher risk of lung cancer was seen for the consumption of high-GI food (OR: 1.19, 95 % CI: 1.05-1.35) and refined carbohydrates from soft drinks (OR: 1.23, 95 % CI: 1.04-1.46). CONCLUSION: Carbohydrates and fiber from fruits, vegetables and whole grains are associated with lower lung cancer risk. Refined carbohydrates from processed food, such as soft drinks, appear to increase risk.

Management of Cancer and Health After the Clinic Visit: A Call to Action for Self-Management in Cancer Care.

Individuals with cancer and their families assume responsibility for management of cancer as an acute and chronic disease. Yet, cancer lags other chronic diseases in its provision of proactive self-management support in routine, everyday care leaving this population vulnerable to worse health status, long-term disability, and poorer survival. Enabling cancer patients to manage the medical and emotional consequences and lifestyle and work changes due to cancer and treatment is essential to optimizing health and recovery across the continuum of cancer. In this paper, the Global Partners on Self-Management in Cancer puts forth six priority areas for action: Action 1: Prepare patients and survivors for active involvement in care; Action 2: Shift the care culture to support patients as partners in cocreating health and embed self-management support in everyday health-care provider practices and in care pathways; Action 3: Prepare the workforce in the knowledge and skills necessary to enable patients in effective self-management and reach consensus on core curricula; Action 4: Establish and reach consensus on a patient-reported outcome system for measuring the effects of self-management support and performance accountability; Action 5: Advance the evidence and stimulate research on self-management and self-management support in cancer populations; Action 6: Expand reach and access to self-management support programs across care sectors and tailored to diversity of need and stimulation of research to advance knowledge. It is time for a revolution to better integrate self-management support as part of high-quality, person-centered support and precision medicine in cancer care to optimize health outcomes, accelerate recovery, and possibly improve survival.

Radiomics analysis using stability selection supervised component analysis for right-censored survival data.

Radiomics is a newly emerging field that involves the extraction of massive quantitative features from biomedical images by using data-characterization algorithms. Distinctive imaging features identified from biomedical images can be used for prognosis and therapeutic response prediction, and they can provide a noninvasive approach for personalized therapy. So far, many of the published radiomics studies utilize existing out of the box algorithms to identify the prognostic markers from biomedical images that are not specific to radiomics data. To better utilize biomedical images, we propose a novel machine learning approach, stability selection supervised principal component analysis (SSSuperPCA) that identifies stable features from radiomics big data coupled with dimension reduction for right-censored survival outcomes. The proposed approach allows us to identify a set of stable features that are highly associated with the survival outcomes in a simple yet meaningful manner, while controlling the per-family error rate. We evaluate the performance of SSSuperPCA using simulations and real data sets for non-small cell lung cancer and head and neck cancer, and compare it with other machine learning algorithms. The results demonstrate that our method has a competitive edge over other existing methods in identifying the prognostic markers from biomedical imaging data for the prediction of right-censored survival outcomes.

Differential myocardial fibrosis of the systemic right ventricle and subpulmonary left ventricle after atrial switch operation for complete transposition of the great arteries.

BACKGROUND: This study aimed to assess diffuse myocardial fibrosis of the systemic right ventricle and subpulmonary left ventricle in patients after Senning or Mustard operation for complete transposition of the great artery (TGA) using cardiac magnetic resonance (CMR) T1 mapping. METHODS: Thirty-one adult TGA patients after Senning (n = 24) or Mustard (n = 7) operation were studied at the age of 33.3 ± 4.0 years. Systemic right ventricular (RV) and subpulmonary left ventricular (LV) volumes, ejection fraction, and myocardial T1 values and extracellular volume fraction (ECV) were determined using CMR. RESULTS: The RV and LV ejection fractions were 47.0 ± 10.9% and 61.3 ± 7.4%, respectively. Compared to published normative values, patients had significantly greater RV and LV native T1 and ECV values (all p < 0.001). For each of the basal, mid, and apical segments, the LV native T1 and ECV values were significantly greater in the left than the right ventricle (all p < 0.05). There is a significant trend on progressive increase in ECV value from the basal towards the apical segments in both the right (p = 0.002) and the left (p < 0.001) ventricle. Modestly strong correlations were found between RV and LV native T1 (r = 0.60, p < 0.001) and ECV (r = 0.49, p = 0.005) values but not with ejection fractions of the respective ventricles. CONCLUSIONS: Differential myocardial fibrosis, with greater involvement of the subpulmonary left ventricle than the systemic right ventricle, is present in patients with TGA after atrial switch operation. Associations between the magnitude of RV and LV fibrosis suggests adverse ventricular-ventricular interaction at the cardiac extracellular matrix level.

Bacteriophage of the Skin Microbiome in Patients with Psoriasis and Healthy Family Controls.

The bacteriophage (phage) component of the skin microbiome in patients with psoriasis has not been systematically explored. The purpose of this study is to investigate phage and bacterial components of the skin microbiome in patients with psoriasis and in healthy family controls. Lesional skin swabs of four different locations (elbow, forearm, knee, and scalp) were taken from patients with psoriasis. Healthy skin swabs of matched locations were taken from contralateral non-lesional skin and healthy family controls. Skin microbiomes were investigated using next-generation shotgun metagenomics sequencing. 81 skin microbiome samples (27 lesional skin samples and 54 healthy skin samples from contralateral non-lesional skin and family controls) obtained from 16 subjects with psoriasis and 16 matched family controls were sequenced and analyzed. Among phage species with abundant host bacteria, two significantly differential abundant phage species, Acinetobacter phage Presley and Pseudomonas phage O4 (adjusted P < 0.05), between psoriasis lesional skin and healthy skin were identified. Samples with high levels of these phage species had their host bacteria abundance suppressed (P = 0.03 and P < 0.001). Differential phage composition between lesional skin in patients with psoriasis and healthy skin from contralateral non-lesional sites and family controls, as well as the suppression of bacteria host of the respective phage, suggest possible avenues for probiotic phage therapeutics.