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Objective: The objective of this study was to examine the impact of preinjury attention-deficit/hyperactivity disorder (PADHD) and secondary ADHD (SADHD) on outcomes after pediatric traumatic brain injury (TBI)., Methods: Two hundred eighty-four individuals aged 11 to 18 years hospitalized overnight for a moderate-to-severe TBI were included in this study. Parents completed measures of child behavior and functioning and their own functioning. Linear models examined the effect of ADHD status (PADHD vs SADHD vs no ADHD) on the child's executive functioning (EF), social competence, and functional impairment, and parental depression and distress., Results: ADHD status had a significant effect on EF [F(2,269] = 9.19, p = 0.0001), social competence (F[2,263] = 32.28, p < 0.0001), functional impairment (F[2,269] = 16.82, p < 0.0001), parental depression (F[2,263] = 5.53, p = 0.005), and parental distress (F[2,259] = 3.57, p = 0.03). PADHD and SADHD groups had greater EF deficits, poorer social competence, and greater functional impairment than the no ADHD group. The SADHD group had greater levels of parental depression than the no ADHD and PADHD groups, and the SADHD group had higher parental distress than the no ADHD group., Conclusion: The results highlight the importance of early identification and management of ADHD symptoms after injury to mitigate downstream functional problems. Supporting parents managing new-onset ADHD symptoms may also be important., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Communicating official public health information about infectious diseases is complicated by the fact that individuals receive much of their information from their social contacts, either via interpersonal interaction or social media, which can be prone to bias and misconception., Objective: This study aims to evaluate the effect of public health campaigns and the effect of socially communicated health information on learning about diseases simultaneously. Although extant literature addresses the effect of one source of information (official or social) or the other, it has not addressed the simultaneous interaction of official information (OI) and social information (SI) in an experimental setting., Methods: We used a series of experiments that exposed participants to both OI and structured SI about the symptoms and spread of hepatitis C over a series of 10 rounds of computer-based interactions. Participants were randomly assigned to receive a high, low, or control intensity of OI and to receive accurate or inaccurate SI about the disease., Results: A total of 195 participants consented to participate in the study. Of these respondents, 186 had complete responses across all ten experimental rounds, which corresponds to a 4.6% (9/195) nonresponse rate. The OI high intensity treatment increases learning over the control condition for all symptom and contagion questions when individuals have lower levels of baseline knowledge (all P values ≤.04). The accurate SI condition increased learning across experimental rounds over the inaccurate condition (all P values ≤.01). We find limited evidence of an interaction between official and SI about infectious diseases., Conclusions: This project demonstrates that exposure to official public health information increases individuals' knowledge of the spread and symptoms of a disease. Socially shared information also facilitates the learning of accurate and inaccurate information, though to a lesser extent than exposure to OI. Although the effect of OI persists, preliminary results suggest that it can be degraded by persistent contradictory SI over time., (©Elias Assaf, Robert M Bond, Skyler J Cranmer, Eloise E Kaizar, Lauren Ratliff Santoro, Susumu Shikano, David J Sivakoff. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 23.11.2021.)

Political elites both respond to public opinion and influence it. Elite policy messages can shape individual policy attitudes, but the extent to which they do is difficult to measure in a dynamic information environment. Furthermore, policy messages are not absorbed in isolation, but spread through the social networks in which individuals are embedded, and their effects must be evaluated in light of how they spread across social environments. Using a sample of 358 participants across thirty student organizations at a large Midwestern research university, we experimentally investigate how real social groups consume and share elite information when evaluating a relatively unfamiliar policy area. We find a significant, direct effect of elite policy messages on individuals' policy attitudes. However, we find no evidence that policy attitudes are impacted indirectly by elite messages filtered through individuals' social networks. Results illustrate the power of elite influence over public opinion., Competing Interests: The authors have declared that no competing interests exist.

Objective: To examine the frequency of behavioral problems after childhood traumatic brain injury (TBI) and their associations with injury severity, sex, and social environmental factors., Setting: Children's hospitals in the Midwestern/Western United States., Participants: 381 boys and 210 girls with moderate (n = 359) and severe (n = 227) TBI, with an average age at injury of 11.7 years (range 0.3-18) who were injured ≤3 years ago., Design: Secondary data analysis of a multistudy cohort., Main Measures: Child Behavior Checklist (CBCL) administered pretreatment., Results: Thirty-seven percent had borderline/clinical elevations on the CBCL Total Problem Scale, with comparable rates of Internalizing and Externalizing problems (33% and 31%, respectively). Less parental education was associated with higher rates of internalizing, externalizing, and total problems. Time since injury had a linear association with internalizing symptoms, with greater symptoms at longer postinjury intervals. Younger boys had significantly higher levels of oppositional defiant symptoms than girls, whereas older girls had significantly greater attention-deficit hyperactivity disorder symptoms than boys., Conclusions: Pediatric TBI is associated with high rates of behavior problems, with lower socioeconomic status predicting substantially elevated risk. Associations of higher levels of internalizing symptoms with greater time since injury highlight the importance of tracking children over time.

Objectives: We conducted joint analyses from five randomized clinical trials (RCTs) of online family problem-solving therapy (OFPST) for children with traumatic brain injury (TBI) to identify child and parent outcomes most sensitive to OFPST and trajectories of recovery over time., Methods: We examined data from 359 children with complicated mild to severe TBI, aged 5-18, randomized to OFPST or a control condition. Using profile analyses, we examined group differences on parent-reported child (internalizing and externalizing behavior problems, executive function behaviors, social competence) and family outcomes (parental depression, psychological distress, family functioning, parent-child conflict)., Results: We found a main effect for measure for both child and family outcomes [F(3, 731) = 7.35, p < .001; F(3, 532) = 4.79, p = .003, respectively], reflecting differing degrees of improvement across measures for both groups. Significant group-by-time interactions indicated that children and families in the OFPST group had fewer problems than controls at both 6 and 18 months post baseline [t(731) = -5.15, p < .001, and t(731) = -3.90, p = .002, respectively, for child outcomes; t(532) = -4.81, p < .001, and t(532) = -3.80, p < .001, respectively, for family outcomes]., Conclusions: The results suggest limited differences in the measures' responsiveness to treatment while highlighting OFPST's utility in improving both child behavior problems and parent/family functioning. Group differences were greatest at treatment completion and after extended time post treatment.

A series of five randomized controlled clinical trials (RCTs) conducted between 2002 and 2015 support the potential efficacy of online family problem-solving treatment (OFPST) in improving both child and parent/family outcomes after pediatric traumatic brain injury (TBI). However, small sample sizes and heterogeneity across individual studies have precluded examination of potentially important moderators. We jointly analyzed individual participant data (IPD) from these five RCTs, involving 359 children and adolescents between the ages of 5 and 18 years, to confirm the role of previously identified moderators (child's age and pre-treatment symptom levels, parental education) and to examine other potential moderators (race, sex, IQ), using IPD meta-analysis. This reanalysis revealed statistically strong evidence that parental education, child age at baseline, IQ, sex, and parental depression level pre-treatment moderated the effect of OFPST on various outcomes. In particular, children of parents with a less than high school education exhibited fewer internalizing problems and better social competence. Children injured at an older age exhibited fewer externalizing behaviors and less executive dysfunction following OFPST. Child IQ moderated the effect of OFPST on social competence, with significantly better competence for children with lower IQ who received OFPST. Lower levels of parental depression followed OFPST among subgroups with lower IQ, boys, and higher parental depression scores at baseline. Our findings indicate that the optimal application of OFPST is likely to involve older children, those with lower IQ scores, or those from families with lower socioeconomic status (SES).

Background and Objectives: To determine whether online family problem-solving treatment (OFPST) is more effective in improving behavioral outcomes after pediatric traumatic brain injury with increasing time since injury., Methods: This was an individual participant data meta-analysis of outcome data from 5 randomized controlled trials of OFPST conducted between 2003 and 2016. We included 359 children ages 5 to 18 years who were hospitalized for moderate-to-severe traumatic brain injury 1 to 24 months earlier. Outcomes, assessed pre- and posttreatment, included parent-reported measures of externalizing, internalizing, and executive function behaviors and social competence., Results: Participants included 231 boys and 128 girls with an average age at injury of 13.6 years. Time since injury and age at injury moderated OFPST efficacy. For earlier ages and short time since injury, control participants demonstrated better externalizing problem scores than those receiving OFPST (Cohen's d = 0.44; P = .008; n = 295), whereas at older ages and longer time since injury, children receiving OFPST had better scores (Cohen's d = -0.60; P = .002). Children receiving OFPST were rated as having better executive functioning relative to control participants at a later age at injury, with greater effects seen at longer (Cohen's d = -0.66; P = .009; n = 298) than shorter (Cohen's d = -0. 28; P = .028) time since injury., Conclusions: OFPST may be more beneficial for older children and when begun after the initial months postinjury. With these findings, we shed light on the optimal application of family problem-solving treatments within the first 2 years after injury., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2018 by the American Academy of Pediatrics.)

Multiple imputation is a popular method for addressing missing data, but its implementation is difficult when data have a multilevel structure and one or more variables are systematically missing. This systematic missing data pattern may commonly occur in meta-analysis of individual participant data, where some variables are never observed in some studies, but are present in other hierarchical data settings. In these cases, valid imputation must account for both relationships between variables and correlation within studies. Proposed methods for multilevel imputation include specifying a full joint model and multiple imputation with chained equations (MICE). While MICE is attractive for its ease of implementation, there is little existing work describing conditions under which this is a valid alternative to specifying the full joint model. We present results showing that for multilevel normal models, MICE is rarely exactly equivalent to joint model imputation. Through a simulation study and an example using data from a traumatic brain injury study, we found that in spite of theoretical differences, MICE imputations often produce results similar to those obtained using the joint model. We also assess the influence of prior distributions in MICE imputation methods and find that when missingness is high, prior choices in MICE models tend to affect estimation of across-study variability more than compatibility of conditional likelihoods. Copyright © 2017 John Wiley & Sons, Ltd., (Copyright © 2017 John Wiley & Sons, Ltd.)

Although randomized controlled trials are considered the 'gold standard' for clinical studies, the use of exclusion criteria may impact the external validity of the results. It is unknown whether estimators of effect size are biased by excluding a portion of the target population from enrollment. We propose to use observational data to estimate the bias due to enrollment restrictions, which we term generalizability bias. In this paper, we introduce a class of estimators for the generalizability bias and use simulation to study its properties in the presence of non-constant treatment effects. We find the surprising result that our estimators can be unbiased for the true generalizability bias even when all potentially confounding variables are not measured. In addition, our proposed doubly robust estimator performs well even for mis-specified models., (Copyright © 2013 John Wiley & Sons, Ltd.)

Randomized controlled trials (RCTs) are the traditional gold standard evidence for medical decision-making. However, protocols that limit enrollment eligibility introduce selection error that severely limits a RCT's applicability to a wide range of patients. Conversely, high quality observational data can be representative of entire populations, but freedom to choose treatment can bias estimators based on this data. Cross design synthesis (CDS) is an approach to combining both RCT and observational data in a single analysis that capitalizes on the RCT's strong internal validity and the observational study's strong external validity. We proposed and assessed a simple estimator of effect size based on the CDS approach. We evaluated its properties within a formal framework of causal estimation and compared our estimator with more traditional estimators based on single sources of evidence. We show that under ideal conditions the simple CDS estimator is unbiased whenever the observational data-based estimators' treatment selection error is constant across those who are and are not eligible for RCT participation. Whereas this assumption may not often hold in practice, assumptions required for the unbiasedness of usual single-source estimators may also be implausible. We show that, under some reasonable data assumptions, our simple CDS estimator has smaller bias and better coverage than commonly used estimates based on randomized or observational studies alone., (Copyright © 2011 John Wiley & Sons, Ltd.)

Introduction: This systematic review evaluated root resorption as an outcome for patients who had orthodontic tooth movement. The results could provide the best available evidence for clinical decisions to minimize the risks and severity of root resorption., Methods: Electronic databases were searched, nonelectronic journals were hand searched, and experts in the field were consulted with no language restrictions. Study selection criteria included randomized clinical trials involving human subjects for orthodontic tooth movement, with fixed appliances, and root resorption recorded during or after treatment. Two authors independently reviewed and extracted data from the selected studies on a standardized form., Results: The searches retrieved 921 unique citations. Titles and abstracts identified 144 full articles from which 13 remained after the inclusion criteria were applied. Differences in the methodologic approaches and reporting results made quantitative statistical comparisons impossible. Evidence suggests that comprehensive orthodontic treatment causes increased incidence and severity of root resorption, and heavy forces might be particularly harmful. Orthodontically induced inflammatory root resorption is unaffected by archwire sequencing, bracket prescription, and self-ligation. Previous trauma and tooth morphology are unlikely causative factors. There is some evidence that a 2 to 3 month pause in treatment decreases total root resorption., Conclusions: The results were inconclusive in the clinical management of root resorption, but there is evidence to support the use of light forces, especially with incisor intrusion., (Copyright (c) 2010 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.)

For the results of randomized controlled clinical trials (RCTs) and related meta-analyses to be useful in practice, they must be relevant to a definable group of patients in a particular clinical setting. To the extent this is so, we say that the trial is generalizable or externally valid. Although concern about the generalizability of the results of RCTs is often discussed, there are few examples of methods for assessing the generalizability of clinical trial data. In this paper, we describe and illustrate an approach for making what we call generalizability judgments and illustrate the approach in the context of a case study of the risk of suicidality among pediatric antidepressant users., (Copyright (c) 2008 John Wiley & Sons, Ltd.)

Background: Little is known regarding how prescribing patterns of hormonal contraceptives to adolescents in the United States have changed over time as new formulations become available and knowledge of thrombosis risk increases. Desogestrel and high-dose estrogen-containing formulations have been associated with a higher risk of thrombosis than other methods., Study Design: We used the National Ambulatory Medical Care/National Hospital Ambulatory Medical Care surveys to describe trends in contraception prescriptions for 11- to 21-year-old females between 1993 and 2004., Results: The majority of prescriptions arose from obstetrics/gynecology clinics. The proportion of desogestrel-containing prescriptions was approximately 10% throughout the study period. Ortho Evra (transdermal norelgestromin, ethinyl estradiol) and Yasmin (oral drospirenone, ethinyl estradiol) accounted for a steadily increasing proportion of prescriptions., Conclusion: With regard to contraception and thrombosis risk, a significant minority of adolescents are prescribed desogestrel-containing contraceptives, and a greater number are exposed to higher levels of estrogen from transdermal contraception. Future studies are needed to evaluate the absolute risk of thrombosis in adolescents using these formulations so clinicians have accurate safety information when prescribing to this unique population.

Purpose: Relationships between body weight and disease are not straightforward. Central obesity appears to be a relatively greater cardiovascular risk factor than generalized obesity. The purpose of this study was to evaluate body mass index (BMI) and waist circumference and the association of obesity distribution with blood estrogen levels (estradiol, bioavailable estradiol, and estrone)., Methods: The study cohort consisted of 207 postmenopausal women enrolled in the Women's Ischemia Syndrome Evaluation (WISE) undergoing angiography for evaluation of suspected ischemia., Results: Both BMI and waist circumference were positively associated with all three blood estrogen levels (p < 0.01), with the highest estrogen levels found in the obese women with large waists (p < 0.01). Results from regression analyses confirmed significant associations of BMI and waist circumference with the estrogen levels., Conclusions: These results demonstrate differing relationships between blood estrogen levels and obesity distribution in a cohort of postmenopausal women with chest pain undergoing coronary angiography. The differing levels by general and central obesity may help explain in part observed epidemiological relationships between obesity and disease.

Background: To quantify the risk of suicidal behavior/ideation (suicidality) for children who use antidepressants, the FDA collected randomized placebo-controlled trials of antidepressant efficacy in children. Although none of the 4487 children completed suicide, 1.7% exhibited suicidality. The FDA meta-analyzed these studies and found sufficient evidence of an increased risk to require a black-box warning on antidepressants for children., Purpose: The FDA considered different drug formulations and psychiatric diagnoses to be equivalent in their effect on suicidality. If this assumption does not hold, the FDA analysis may have underestimated the variance of the risk estimate. We investigate the consequences of relaxing these assumptions., Methods: We extend the FDA analysis using a Bayesian hierarchical model that allows for a study-level component of variability and facilitates extensive sensitivity analyses., Results: We found an association between antidepressant use and an increased risk of suicidality in studies where the diagnosis was major depressive disorder (odds ratio 2.3 [1.3, 3.8]), and where the antidepressant was an SSRI (odds ratio 2.2 [1.3, 3.6]). We did not find evidence for such an association in the complement sets of trials. Although the results based on the hierarchical model are insensitive to model perturbations, the robustness of the FDA's meta-analysis to model assumptions is less clear. These data have limited generalizability due to exclusion of patients with baseline risk of suicide and the use of relatively short duration trials., Conclusions: Because of model specification and interpretation issues raised in this paper, we conclude that the evidence supporting a causal link between antidepressant use and suicidality in children is weak. The use of Bayesian hierarchical models for meta-analysis has facilitated the incorporation of potentially important sources of variability and the use of sensitivity analysis to assess the consequences of model specifications and their impact on important regulatory decisions.