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Background RECIST criteria for progressive disease, partial response, and complete response, reflecting +20%, −30%, and −100% tumor size changes, respectively, are critical outcome variables in oncology clinical trials. Herein, we evaluated post-immunotherapy tumor size change correlation with outcomes. Methods We used a unique clinical trial data resource, a multicenter basket trial in patients with rare solid tumors treated with nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) between 2017 and 2023 (National Cancer Institute/Southwest Oncology Group-sponsored DART trial [NCT02834013]) (open at 1083 sites at its peak). Outcome associations were evaluated by survival analysis techniques including Martingale residuals. Results In 638 evaluable patients, we found strong linear relationships between percent change in tumor measurement up to a 40%-50% increase and progression-free (PFS) and overall survival (OS) (both Cox regression P  < .001; landmark analyses based on day 65). Pearson R correlation between survival estimates and tumor change category were −0.94, −0.89, and −0.89 (PFS) and −0.84, −0.90, and −0.90 (OS) for median, 6-month (PFS), and 1-year (OS) and for 1-year (PFS) and 2-year (OS) estimates. Conclusions Percent change in tumor measurement per RECISTv1.1 (the sum of longest dimensions of target lesions) has a linear association with PFS and OS up to a 40% to 50% increase in tumor measurement in this cohort of patients with rare cancers who received combination immune checkpoint blockade. Quantitative first scan tumor measurement changes include important information to evaluate the potential efficacy of a therapy beyond the proportion of patients who achieve an objective response. [ABSTRACT FROM AUTHOR]

The purpose of this paper was to introduce the theoretical basis of the causal mediation effect analysis and the specific method to realize an example by the causal mediation effect analysis with SAS. The theoretical basis of the causal mediation effect analysis included the following two aspects， the basic concept and defining the counterfactual framework of the causal mediation effect. The example was about whether the encouraging environment provided by parents would affect the cognitive development of children. The traditional multiple linear regression analysis， the causal mediation effect analysis without considering covariates and with considering covariates were used， respectively. By comparing the results obtained by the three analysis methods， the following conclusions were drawn： ① when there were the mediation variables in the data， it was not suitable to use traditional multiple linear regression analysis to replace the causal mediation effect analysis； ② when there were covariates in the data， it was not suitable to conduct causal mediation analysis under the condition of ignoring covariates.

The purpose of this paper was to introduce the theoretical basis of the causal mediation effect analysis and the specific method to realize an example by the causal mediation effect analysis with SAS. The theoretical basis of the causal mediation effect analysis included the following two aspects, the basic concept and defining the counterfactual framework of the causal mediation effect. The example was about whether the encouraging environment provided by parents would affect the cognitive development of children. The traditional multiple linear regression analysis, the causal mediation effect analysis without considering covariates and with considering covariates were used, respectively. By comparing the results obtained by the three analysis methods, the following conclusions were drawn when there were the mediation variables in the data, it was not suitable to use traditional multiple linear regression analysis to replace the causal mediation effect analysis when there were covariates in the data, it was not suitable to conduct causal mediation analysis under the condition of ignoring covariates. [ABSTRACT FROM AUTHOR]

Objective: Some of the requests of authorization to apply health claims in the context of oral health have received a negative scientific opinion from the European Food Safety Authority (EFSA). The main reasons refer to the design of human intervention studies, including the inappropriate choice of outcome variables (OVs) and of their methods of measurement (MMs). The present manuscript reports the results of an investigation aimed at collecting, collating and critically analysing the information in relation to claimed effects, OVs and MMs, in the area of oral health and compliant with Regulation (EC) 1924/2006. Methods: Claimed effects, OVs and the related MMs were collected from EFSA guidance documents and from the scientific opinions on the substantiation of health claims under Articles 13.5 and 14. The collection, collation and critical analysis of the relevant scientific literature consisted in a definition of the keywords, PubMed search strategies and in the creation of databases of references. Results and conclusions: The critical analysis of the OVs and their MMs was performed on the basis of the literature review and was aimed at defining the appropriateness of OVs and MMs in the context each specific claimed effect. Clinical significance: The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for health claims related to oral health, as well as to the stakeholders for the identification of existing and design of novel randomized controlled trials aimed at substantiating such health claims.

Objective: The use of psychoactive substances has been one of the most important global public health problems over the last few decades. Among the problems associated with substance use, dual diagnosis is one of the most relevant. This study aims to investigate the predictive validity of the GHQ-28 (General Health Questionnaire-28; "probable psychiatric cases") in relation to poor treatment outcome measured by (a) "early treatment dropout" and (b) "nonclinically relevant improvement at discharge." Methods: A longitudinal prospective design was used. A sample of 219 substance use disorder patients, who received treatment in a therapeutic community, was selected. Patients were assessed using the GHQ-28 and the outcome variables were registered. A hierarchical logistic regression model was performed to identify factors independently associated with the outcome measure ("early treatment dropout" and "nonclinically relevant improvement at discharge"). Results: Of the total sample, 79 subjects (36%) were considered "early treatment dropouts" and 56.6% (102) presented a "nonclinically relevant improvement at discharge." The two hierarchical logistic regression results show that being classified as a "probable psychiatric case" was significantly and directly associated with "early treatment dropout" and "nonclinically relevant improvement at discharge," as a poor in-treatment outcome indicator. Conclusions: The results of this study support the notion that the probable psychiatric cases identified by the GHQ-28 scale have a greater probability of "early treatment dropout" and have a greater probability of "nonclinically relevant improvement in discharge" of the therapeutic community. These data indicate that GHQ-28 is a suitable clinical instrument for predicting dropout and treatment effect in residential substance use disorder treatment. [ABSTRACT FROM AUTHOR]

Introduction: Any implicit and explicit biases that exist may alter our interpretation of people and events. Within the context of assessment, it is important to determine if biases exist and to decrease any existing biases, especially when rating student performance to provide meaningful, fair, and useful input. The purpose of this study was to determine if the experience and gender of faculty members contribute to their ratings of students in a military medical field practicum. This information is important for fair ratings of students. Three research questions were addressed: Were there differences between new versus experienced faculty raters? Were there differences in assessments provided by female and male faculty members? Did gender of faculty raters impact ratings of female and male students?.Materials and Methods: This study examined trained faculty evaluators' ratings of three cohorts of medical students during 2015-2017 during a medical field practicum. Female (n = 80) and male (n = 161) faculty and female (n = 158) and male (n = 311) students were included. Within this dataset, there were 469 students and 241 faculty resulting in 5,599 ratings for each of six outcome variables that relate to overall leader performance, leader competence, and leader communication. Descriptive statistics were computed for all variables for the first four observations of each student. Descriptive analyses were performed for evaluator experience status and gender differences by each of the six variables. A multivariate analyses of variance was performed to examine whether there were differences between gender of faculty and gender of students.Results: Descriptive analyses of the experience status of faculty revealed no significant differences between means on any of the rating elements. Descriptive analyses of faculty gender revealed no significant differences between female and male faculty ratings of the students. The overall MANOVA analyses found no statistically significant difference between female and male students on the combined dependent variables of leader performance for any of the four observations.Conclusions: The study revealed that there were no differences in ratings of student leader performance based on faculty experience. In addition, there were no differences in ratings of student leader performance based on faculty gender. [ABSTRACT FROM AUTHOR]

Background Fried's frailty phenotype is defined by five criteria: exhaustion, unexplained weight loss, weakness, slowness and low physical activity. Frailty can also affect obese people. Little is known about how body mass index [BMI] or waist-hip ratio [WHR] are associated with frailty or pre-frailty in the face of confounding factors, including markers of allostatic load which are known to be involved in frailty biology. We cross-sectionally examined these associations in a population-based study. Methods A cross-sectional analysis of data collected at Wave 1 (2010) of TILDA was undertaken. Participants aged <50 and those who did not have measurements of their BMI, WHR, chronic disease status, HbA1c, CRP, sex and educational status were excluded. Two multivariate logistic regression models (one with BMI and another one with WHR as measure of obesity) were computed adjusting for these covariates, with frail/pre-frail versus non-frail as the outcome variable. Results 4,568 participants were included: 3,277 non-frail and 1,291 frail/pre-frail. The frail/pre-frail group had a mean BMI of 29.2 (versus 28.3) kg/m2 and a mean WHR of 0.912 (versus 0.899). In the adjusted regression model, BMI had a significant association with frailty/pre-frailty (OR 1.02, 95% CI: 1.01-1.04, p=0.001). However, in the model using WHR, the latter had a stronger association with frailty (OR 4.52, 95% CI: 1.60-12.72, p=0.004). In both models, age, education, chronic disease status, HbA1c and CRP had the expected associations with frailty/pre-frailty. Female sex was significantly associated with frailty/pre-frailty in the WHR model (OR 1.26, 95% CI 1.06-1.50, p=0.008). Conclusion While obesity is associated with frailty, the distribution of body fat may be more important as a marker of frailty. These physical traits should not be overlooked in the over 50 population. The association between frailty, obesity and markers of 'inflammaging' could be examined longitudinally to further understand their complex biology. [ABSTRACT FROM AUTHOR]

Background and Aim: There is a need to improve utilization of cessation assistance in low- and middle-income countries (LMICs), and tobacco cessation research has been identified as priority in LMICs. This study evaluates the relationship between health care provider intervention and cessation assistance utilization in LMICs.Methods: Data from 13 967 participants (aged ≥15 years, 90.3% males) of the Global Adults Tobacco Survey conducted in 12 LMICs (74.3%-97.3% response rates) were analyzed with utilization of counseling/cessation clinic, WHO-recommended medications, and quitline as outcome variables. Health care provider intervention ("no intervention," only "tobacco screening," "quit advice") was the exposure variable. Weighted multiple logistic regression models were used to examine the relationship between each outcome variable and the exposure variable, adjusting for other covariates. Adjusted odds ratios (ORs) with 95% confidence intervals (CIs) are reported.Results: Approximately 52%, 8%, and 40% of participants received no intervention, only tobacco screening, and advice to quit, respectively. Overall, 0.4%, 1.9%, 3.0%, and 4.5% used quitline, WHO-recommended medications, counseling/cessation clinic, and any cessation assistance, respectively. Compared with no intervention, quit advice was associated with increased utilization of quitline (OR = 2.24, 95% CI = 1.2 to 4.4), WHO-recommended medications (OR = 1.67, 95% CI = 1.2 to 2.3), counseling/cessation clinic (OR = 4.41, 95% CI = 3.2 to 6.1), and any assistance (any of the three types) (OR = 2.80, 95% CI = 2.2 to 3.6).Conclusion: The findings of this study suggest that the incorporation of quit advice by health care providers in tobacco control programs and health care systems in LMICs could potentially improve utilization of cessation assistance to improve smoking cessation in LMICs.Implications: This first study of association between health care provider intervention and the utilization of cessation assistance in LMICs reports that there was a missed opportunity to provide quit advice to about 60% of smokers who visited a health care provider in the past year. The odds of utilization of counseling/cessation clinic, WHO-recommended medications, and quitline were significantly increased in participants who were advised to quit smoking. The results suggest that effective integration and implementation of advice to quit in tobacco control programs and the national health care systems may increase the use of cessation assistance to quit smoking. [ABSTRACT FROM AUTHOR]