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Data sharing is highly advocated in the scientific community, with numerous organizations, funding agencies, and journals promoting transparency and collaboration. However, limited research exists on actual data sharing practices. We conducted a comprehensive analysis of the intent to share individual participant data (IPD) in a total of 313,990 studies encompassing clinical trials and observational studies obtained from ClinicalTrials.gov, spanning the period from 2000 to 2023. Our study found that only 10.3% of principal investigators (PIs) expressed intent to share IPD. Clinical trials were more likely to share data than observational studies (odds ratio, OR = 1.98, 95% CI: 1.92–2.04). Large sample size studies were 1.69 times more likely to share data than small ones (95% CI: 1.65–1.73). Studies registered after 2018 were 1.6 times more likely to share data (95% CI: 1.57–1.64) than before 2019. NIH and other US Federal agency-funded studies had 1.49 times higher odds of sharing data (95% CI: 1.43–1.55) than other funders. USA-based studies were 1.53 times more likely to share data (95% CI: 1.49–1.57) than out of USA. Biological trials were 1.58 times more likely to share data than drug and other trials (95% CI: 1.51–1.66). Phase III trials had the highest odds, 2.47 times, of sharing data (95% CI: 2.38–2.56) than non-Phase III trials. [ABSTRACT FROM AUTHOR]

Objectives Clinical trial data sharing is crucial for promoting transparency and collaborative efforts in medical research. Differential privacy (DP) is a formal statistical technique for anonymizing shared data that balances privacy of individual records and accuracy of replicated results through a "privacy budget" parameter, ε. DP is considered the state of the art in privacy-protected data publication and is underutilized in clinical trial data sharing. This study is focused on identifying ε values for the sharing of clinical trial data. Materials and Methods We analyzed 2 clinical trial datasets with privacy budget ε ranging from 0.01 to 10. Smaller values of ε entail adding greater amounts of random noise, with better privacy as a result. Comparison of rates, odds ratios, means, and mean differences between the original clinical trial datasets and the empirical distribution of the DP estimator was performed. Results The DP rate closely approximated the original rate of 6.5% when ε > 1. The DP odds ratio closely aligned with the original odds ratio of 0.689 when ε ≥ 3. The DP mean closely approximated the original mean of 164.64 when ε ≥ 1. As ε increased to 5, both the minimum and maximum DP means converged toward the original mean. Discussion There is no consensus on how to choose the privacy budget ε. The definition of DP does not specify the required level of privacy, and there is no established formula for determining ε. Conclusion Our findings suggest that the application of DP holds promise in the context of sharing clinical trial data. [ABSTRACT FROM AUTHOR]

Objective: We employed machine learning algorithms to discriminate insulin resistance (IR) in middle-aged nondiabetic women. Methods: The data was from the National Health and Nutrition Examination Survey (2007–2018). The study subjects were 2084 nondiabetic women aged 45–64. The analysis included 48 predictors. We randomly divided the data into training (n = 1667) and testing (n = 417) datasets. Four machine learning techniques were employed to discriminate IR: extreme gradient boosting (XGBoosting), random forest (RF), gradient boosting machine (GBM), and decision tree (DT). The area under the curve (AUC) of receiver operating characteristic (ROC), accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and F1 score were compared as performance metrics to select the optimal technique. Results: The XGBoosting algorithm achieved a relatively high AUC of 0.93 in the training dataset and 0.86 in the testing dataset to discriminate IR using 48 predictors and was followed by the RF, GBM, and DT models. After selecting the top five predictors to build models, the XGBoost algorithm with the AUC of 0.90 (training dataset) and 0.86 (testing dataset) remained the optimal prediction model. The SHapley Additive exPlanations (SHAP) values revealed the associations between the five predictors and IR, namely BMI (strongly positive impact on IR), fasting glucose (strongly positive), HDL-C (medium negative), triglycerides (medium positive), and glycohemoglobin (medium positive). The threshold values for identifying IR were 29 kg/m2, 100 mg/dL, 54.5 mg/dL, 89 mg/dL, and 5.6% for BMI, glucose, HDL-C, triglycerides, and glycohemoglobin, respectively. Conclusion: The XGBoosting algorithm demonstrated superior performance metrics for discriminating IR in middle-aged nondiabetic women, with BMI, glucose, HDL-C, glycohemoglobin, and triglycerides as the top five predictors. [ABSTRACT FROM AUTHOR]

Donor human milk (DHM) from a milk bank is the recommended feeding method for preterm infants when the mother's own milk (MOM) is not available. Despite this recommendation, information on the possible contamination of donor human milk and its impact on infant health outcomes is poorly characterised. The aim of this systematic review is to assess contaminants present in DHM samples that preterm and critically ill infants consume. The data sources used include PubMed, EMBASE, CINAHL and Web of Science. A search of the data sources targeting DHM and its potential contaminants yielded 426 publications. Two reviewers (S. T. and D. L.) conducted title/abstract screening through Covidence software, and predetermined inclusion/exclusion criteria yielded 26 manuscripts. Contaminant types (bacterial, chemical, fungal, viral) and study details (e.g., type of bacteria identified, study setting) were extracted from each included study during full‐text review. Primary contaminants in donor human milk included bacterial species and environmental pollutants. We found that bacterial contaminants were identified in 100% of the papers in which bacterial contamination was sought (16 papers) and 61.5% of the full data set (26 papers), with the most frequently identified genera being Staphylococcus (e.g., Staphylococcus aureus and coagulase‐negative Staphylococcus) and Bacillus (e.g., Bacillus cereus). Chemical pollutants were discovered in 100% of the papers in which chemical contamination was sought (eight papers) and 30.8% of the full data set (26 papers). The most frequently identified chemical pollutants included perfluoroalkyl substances (six papers), toxic metal (one paper) and caffeine (one paper). Viral and fungal contamination were identified in one paper each. Our results highlight the importance of establishing standardisation in assessing DHM contamination and future studies are needed to clarify the impact of DHM contaminants on health outcomes. Key messages: Research regarding chemical contamination in donor human milk (DHM) is limited and needs to be studied further to draw appropriate conclusions on reducing potential risks for infants.Parents/guardians should be educated on the availability of DHM as a supplemental feeding option and made aware of the current research in the field.DHM use requires further standardisation both within the United States and abroad. This standardisation should ensure that risks are not overemphasised and DHM is a cost‐effective, accessible resource as a short‐term intervention when used appropriately as part of optimal lactation and breastfeeding support. [ABSTRACT FROM AUTHOR]

AbstractClinical trial selection bias is a common issue, as patients are typically not selected randomly from a target population. Various statistical approaches have been proposed to adjust for this bias, including IPW (inverse probability weights), SPS (subclassification with propensity scores), and EVB (external validity bias). However, there has been very little statistical research to compare the performance of these methods in clinical trials. To bridge this gap, we conducted a simulation study using a patient population with seven covariates and a true treatment effect size of 0.5 (Cohen’s d). Next, we assessed the efficacy of the three statistical methods on nonrandom clinical trial samples with varying sizes and covariates. Based on our simulation results, EVB is the most effective method for adjusting clinical trial selection bias when there are seven covariates. SPS is the most effective method for adjusting clinical trial selection bias when there are three and five covariates. However, we observed that IPW's performance was inadequate, indicating that it may not be a suitable option for selection bias adjustment in clinical trials. In summary, our study sheds light on the effectiveness of various statistical methods in mitigating selection bias in clinical trials. [ABSTRACT FROM AUTHOR]

Purpose: While stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT) is an effective service delivery model, understanding predictors of Step One, a parent-led therapist-assisted treatment, will help inform how to best match children at baseline to treatments. Method : Potential predictor variables were explored from 63 parent–child Step One participants with 43 responders and 20 non-responders. Baseline tailoring variables explored were anticipated critical life events, demographics, trauma-related variables, and child and parent outcomes. Results: Predictors of Step One non-response were parental depression, child anger outbursts and Hispanic/Latino parents even after controlling for child demographics, child post-traumatic stress, severity, and impairment. Conclusions: Parents with depression and children with high anger outbursts should consider starting with Step Two, therapist-led TF-CBT. Step One may benefit from including TF-CBT culturally modified strategies for Hispanic/Latino parents. If preference is to start with Step One, these parents and children should be closely monitored for treatment progress. [ABSTRACT FROM AUTHOR]

Hierarchical linear models were used to examine trajectories of impulsivity and capability between ages 10 and 25 in relation to suicide attempt in 770 youths followed longitudinally: intercepts were set at age 17. The impulsivity measure assessed features of urgency (e.g., poor control, quick provocation, and disregard for external constraints); the capability measure assessed aspects of self-esteem and mastery. Compared to nonattempters, attempters reported significantly higher impulsivity levels with less age-related decline, and significantly lower capability levels with less age-related increase. Independent of other risks, suicide attempt was related significantly to higher impulsivity between ages 10 and 25, especially during the younger years, and lower capability. Implications of those findings for further suicidal behavior and preventive/intervention efforts are discussed.

Background: Schools are key social contexts for shaping development and behavior in youths; yet, little is known of their influence on adolescent personality disturbance. Method: A community-based sample of 592 adolescents was assessed for family and school experiences, Axis I psychiatric disorders, and Axis II personality disorder (PD) symptoms, and followed into young adulthood. Multiple regression analysis was used to estimate associations between adolescent-reported school climate and young adult PD symptoms independent of age, sex, family socioeconomic status; childhood maltreatment; Axis I disorder, PD symptoms, academic grades, and parental punishment in adolescence; and four dimensions of school climate. Results: Schools characterized as high in learning focus were related to cluster B (antisocial, borderline, histrionic, and narcissistic PD) symptom declines, whereas schools characterized as high in opportunities for student autonomy were related to cluster A (paranoid, schizoid, and schizotypal PD) symptom declines. In contrast, schools characterized as conflictual or supporting interpersonal informality/familiarity among students and teachers were related to increases in cluster A symptoms and cluster C (avoidant, dependent, and obsessive-compulsive PD) symptoms. Conclusions: Schools may exert both positive and negative influences on continuity of adolescent personality disturbance. The role of the school in guiding young people toward more favorable developmental pathways and alleviating personality disturbance is discussed.

Background: The long-term prognosis associated with adolescent symptoms of borderline personality disorder (BPD) in the general population is virtually unknown. In this study, the relationship of early borderline symptoms to subsequent psychosocial functioning and attainment was investigated based on data from the Children in the Community cohort. Method: Using multilevel linear regression, symptoms of BPD at mean age 14 were employed as predictors of work/school/homemaker role function, social function (social support, relationship quality), and life satisfaction over the subsequent 20 years. Borderline symptoms were also employed as predictors of attainment at 20-year follow-up. Results: On average, those with higher levels of early adolescent borderline symptoms scored consistently lower in role function, social function, and life satisfaction from mid-adolescence through mid-adulthood. Borderline symptoms predicted lower academic and occupational attainment, less partner involvement, and fewer attained adult developmental milestones. Adolescent borderline symptoms were also associated with adult borderline symptoms, borderline diagnosis, general impairment, and need for services at mean age 33. These effects were evident despite symptom decline with age and were independent of adolescent Axis I disorders. Conclusions: Adverse prognosis associated with youth symptoms of BPD appeared early and persisted in important and interrelated life domains. These findings lend support to the utility of DSM-IV BPD symptoms assessed by self-report in early adolescence.

We investigated age-based changes in mothers' complaints about offspring behavioral opposition, and offspring reports of opposition in a prospective longitudinal design (N = 821). Maternal complaints declined from pre-adolescence to early adulthood, but more slowly in low socioeconomic status (SES) and single-parent families. Mothers complained more about first- than later-born children, but showed no average differences for offspring gender, race, SES, or single parent status. Complaints covaried with youth-reported opposition, but effects involving SES, single-parent status, and birth order remained significant after opposition was controlled; this finding is interpreted to reflect social contextual differences in maternal beliefs. Youth opposition was stable to age 16, then decreased; higher levels were associated with earlier birth order and low SES among European-Americans. Our results have implications for parenting interventions, indicating that parents may benefit from education about the normative, gradual increase in concordance between their own expectations and their child's behavior from early to late adolescence. Further, parenting interventions may be strengthened by actively attending to social contextual factors that shape parental belief systems and values.

Purpose Flexible fiber-optic bronchoscope-guided orotracheal intubation is a valuable technique with demonstrated benefits in the management of difficult airways. Despite its popularity with anesthesia providers, the technique is not fail-safe and airway-related complications secondary to failed intubation attempts remain an important problem. We sought to determine the effect of incorporating lingual traction on the success rate of fiber-optic bronchoscope-guided intubation in patients with anticipated difficult airways. Methods In this prospective, randomized, cohort study, we enrolled 91 adult patients with anticipated difficult airways scheduled for elective surgery to undergo fiber-optic bronchoscope-guided orotracheal intubation alone or with lingual traction by an individual anesthesiologist after induction of general anesthesia and neuromuscular blockade. A total of 78 patients were randomized: 39 patients to the fiber-optic bronchoscope-guided intubation with lingual traction group and 39 patients to the fiber-optic bronchoscope-guided intubation alone group. The primary endpoint was the rate of successful first attempt intubations. The secondary outcome was sore throat grade on post-operative day 1. Results Fiber-optic intubation with lingual traction compared to fiber-optic intubation alone resulted in a higher success rate (92.3 vs. 74.4 %, [chi].sup.2 = 4.523, p = 0.033) and greater odds for successful first attempt intubation (OR 4.138, 95 % CI 1.041-16.444, p = 0.044). Sore throat severity on post-operative day 1 was not significantly different but trended towards worsening grades with lingual traction. Conclusions In this study, lingual traction was shown to be a valuable maneuver for facilitating fiber-optic bronchoscope-guided intubation in the management of patients with anticipated difficult airways., Author(s): Yiu-Hei Ching[sup.1] , Rachel A. Karlnoski[sup.1] [sup.2] , Henian Chen[sup.3] [sup.4] , Enrico M. Camporesi[sup.1] [sup.2] , Vimal V. Shah[sup.2] , Tapan A. Padhya[sup.5] , Devanand Mangar[sup.2] Author Affiliations: [...]

Equivalence tests establish whether treatments are similar in their intended outcomes. This is in contrast to superiority tests, which establish whether a new treatment is better than a standard treatment or placebo. Few equivalence trials have employed a cluster randomized design, but they are subject to some of the same analysis pitfalls that are common to superiority trials—namely, a failure to adjust for either cluster effects or covariate imbalances resulting from randomization. Using real and simulated data from a cluster randomized trial comparing exercise protocols among U.S. Army soldiers, this study empirically demonstrates the consequences for power and Type I error rates when either or both of these effects have been ignored in the analysis. Analysis of real trial data showed that equivalence test outcomes can change depending on whether appropriate adjustments are applied. Simulations demonstrated that failing to adjust for important baseline covariates severely reduces statistical power, and failing to adjust for cluster effects increases the risk of false declarations of equivalence. As cluster randomized designs are increasingly employed for equivalence trials, analysts must be aware of the importance of adjusting for cluster effects and covariate imbalances to avoid false conclusions. [ABSTRACT FROM AUTHOR]

Data from the Children in the Community Transitions Study, a prospective longitudinal investigation, were used to examine the association between adolescent personality disorder (PD) traits and conflict with family members during the transition to adulthood. PD traits at mean age 16 years were associated with elevated contact and conflict with family members between ages 17 and 27 years after Axis I disorders were controlled. There was a significant association between frequent contact and elevated conflict with family members. Both declined gradually during the transition to adulthood. Reduced family contact was associated with reduced family conflict, particularly among individuals who had numerous PD traits during adolescence. Among individuals who had a high level of family conflict during adolescence, reduced family contact between ages 17 and 22 years was associated with a subsequent reduction in conflict with family members between ages 22 and 27 years.

Examined autonomy and individuation levels within financial, residential, romantic, and family formation domains among 17- to 27-year-olds in a community-based longitudinal study. Found that subgroup differences related to family socioeconomic status, parental divorce, gender, or race were not generally attributable to educational enrollment. Both within and between domains, many individuals showed dramatic changes in assumption of adult roles, returning to more dependent, other-determined roles for short or extended periods. (Author/KB)

Previous research is inconsistent about the effects of prenatal famine exposure on risk of adult hypertension. Follow-up of persons exposed to the 1959-1961 Chinese famine, the largest in human history, provides an opportunity to examine the long-term impact of prenatal famine exposure on adult cardiovascular disease (CVD). We investigated the effects of fetal-infant exposure to the famine on risk of hypertension in adulthood. We included 1,415 participants from the 2009 China Health and Nutrition Survey born September 1, 1956-December 31, 1964. Blood pressure (BP) measurements, self-reported previous diagnosis of hypertension and current anti-hypertension drug use were obtained from the survey. Differences in mean BP and risk of adult hypertension by famine exposure status were determined using linear and logistic regression analyses, after adjusting for confounders. Women with fetal-infant exposure to famine had higher mean systolic blood pressure (4.24 mmHg; 95% confidence interval (CI) 1.50-6.98) than those unexposed. They also had increased odds of a prior diagnosis of hypertension (odds ratio (OR) 2.16; 95% CI 1.16-4.02), and were more likely to be currently taking anti-hypertensive medications (OR 2.81; 95% CI 1.32-5.97) than unexposed women after adjusting for covariates. No statistically significant increases in mean BP or hypertension were seen among men. Exposure to famine during the fetal-infant period or early childhood has deleterious effects on adult health, but the effects may be greater for women. Gender-specific intervention strategies for CVD may be warranted for populations exposed to under-nutrition during critical time periods of fetal development. Keywords Fetal exposure * Gender difference * Hypertension * Blood pressure * Chinese famine, Introduction A growing body of literature suggests that increased risk of chronic diseases in adulthood may actually originate from adverse exposures or under nutrition during the fetal period [1, 2]. [...]

The purpose of this study was to evaluate the mutual impact of community and individual factors on youth's perceptions of community safety, using structural equation modeling (SEM) conceptualized by syndemic theory. This study used survey data collected from a county wide sample of middle and high school students (N=25,147) in West Central Florida in 2015. The outcome variable was youth's perceptions of community safety. Predictors were latent individual and community factors constructed from 14 observed variables including gun accessibility, substance use, depressive symptoms, and multiple neighborhood disadvantage questions. Three structural equation models were conceptualized based on syndemic theory and analyzed in Mplus 8 using weighted least squares (WLS) estimation. Each model's goodness of fit was assessed. Approximately seven percent of youth reported feeling unsafe in their community. After model modifications, the final model showed a good fit of the data and adhered to the theoretical assumption. In the final SEM model, an individual latent factor was implied by individual predictors measuring gun accessibility without adult's permission (β=0.70), sadness and hopelessness (β=0.52), alcohol use (β=0.79), marijuana use (β=0.94), and illegal drug use (β=0.77). Meanwhile, a community latent factor was indicated by multiple community problems including public drinking (β=0.88), drug addiction (β=0.96), drug selling (β=0.97), lack of money (β=0.83), gang activities (β=0.90), litter and trash (β=0.79), graffiti (β=0.91), deserted houses (β=0.86), and shootings (β=0.93). A second-order syndemic factor that represented the individual and community factors showed a very strong negative association with youth's safe perception (β=-0.98). This study indicates that individual risk factors and disadvantaged community conditions interacted with each other and mutually affected youth's perceptions of community safety. To reduce these co-occurring effects and improve safe perceptions among youth, researchers and practitioners should develop and implement comprehensive strategies targeting both individual and community factors. [ABSTRACT FROM AUTHOR]

Associations of 6-week postpartum maternal self-criticism and dependency with 4-month mother--infant self- and interactive contingencies during face-to-face play were investigated in 126 dyads. Infant and mother face, gaze, touch, and vocal quality were coded second by second from split-screen videotape. Self- and interactive contingencies were defined as auto- and lagged cross-correlation, respectively, using multilevel time-series models. Statistical significance was defined as p < .05. Regarding self-contingency, (a) more self-critical mothers showed primarily lowered self-contingency, whereas their infants showed both lowered and heightened, and (b) infants of more dependent mothers showed primarily lowered self-contingency, whereas findings were absent in mothers. Regarding interactive contingency, (a) more self-critical mothers showed lowered attention and emotion contingencies but heightened contingent touch coordination with infant touch, and (b) more dependent mothers and their infants showed heightened facial/vocal interactive contingencies. Thus, maternal self-criticism and dependency have different effects on mother--infant communication. Keywords: mother--infant contingency, maternal self-criticism, maternal dependency, mother--child relations

Growth curve modeling was used to examine the impact of social role experiences (e.g., marital support, occupational prestige) and birth cohort on mean-level differences and age-related changes in positive personality traits indicative of either femininity or masculinity in 758 mothers heterogeneous in age, assessed 4 times over 2 decades. Both femininity and masculinity increased significantly from mean ages 39 through 59; each was predictive of an age change in the other. Low masculinity was associated with a more rapid increase in femininity, whereas high occupational prestige decreased the magnitude of association between masculinity and femininity. Femininity increased with more marital support but decreased with unmarried status, more children at home, and working full or part time; among full-time workers, that effect was modified by marital support. Masculinity increased with full-time work and high occupational prestige. A trend for differing levels of femininity, and contrasting associations of masculinity with femininity and marital conflict in women born after 1944 compared with those born earlier, suggests shifting social norms and gender relations in the marital role. Keywords: middle age, women, femininity, masculinity, marital role

Data from the Children in the Community Transitions Study were used to examine gender differences in the impact of family contact on the development of finance and romance instrumentality from ages 17 to 27 years. Family contact decreased among both men and women across emerging adulthood, although it decreased more rapidly in men than in women. Both finance and romance instrumentality increased for men and women across emerging adulthood. The growth rate did not differ between men and women in either domain, although men tended to be characterized by higher levels of instrumentality than women. There were noteworthy gender differences in the impact of family contact on the development of instrumentality. At age 17, family contact was negatively associated with instrumentality for both men and women; at age 27, the impact of family contact on instrumentality was less negative for women and was positive for men. Keywords: finance and romance instrumentality, gender differences, family contact, emerging adulthood, gender roles

Objectives. We sought to separate age and cohort associations with depression, assessed 3 times within a 10-year period in 701 women born between 1928 and 1958. Methods. We used regression analysis to examine age differences in women with depression in 2 birth cohorts, pre-1945 and post-1944, who were assessed at comparable ages. Multilevel modeling was used to estimate changes with age in successive birth year cohorts. Results. An age by cohort interaction indicated more depression among younger than older women in the post-1944 cohort but a flat age profile in the pre-1945 cohort. Longitudinal analyses indicated declines in depression with age in more recent cohorts but increases in earlier ones. Conclusions. Increases in depression in younger women in successive cohorts may be offset by decreases in middle age. (Am J Public Health. 2003;93:2061-2066)

An unselected sample of 543 children was followed over 20 years to test the independent effects of parenting, exposure to domestic violence between parents (ETDV), maltreatment, adolescent disruptive behavior disorders, and emerging adult substance abuse disorders (SUDs) on the risk of violence to and from an adult partner. Conduct disorder (CD) was the strongest risk for perpetrating partner violence for both sexes, followed by ETDV, and power assertive punishment. The effect of child abuse was attributable to these 3 risks. ETDV conferred the greatest risk of receiving partner violence; CD increased the odds of receiving partner violence but did not mediate this effect. Child physical abuse and CD in adolescence were strong independent risks for injury to a partner. SUD mediated the effect of adolescent CD on injury to a partner but not on injury by a partner. Prevention implications are highlighted.