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1.  Empirically-derived Knowledge on Adolescent Assent to Pediatric Biomedical Research 
AJOB primary research  2013;4(3):15-26.
There has been a recent growth in empirical research on assent with pediatric populations, due in part, to the demand for increased participation of this population in biomedical research. Despite methodological limitations, studies of adolescent capacities to assent have advanced and identified a number of salient psychological and social variables that are key to understanding assent.
The authors review a subsection of the empirical literature on adolescent assent focusing primarily on asthma and cancer therapeutic research; adolescent competencies to assent to these studies; perceptions of protocol risk and benefit; the affects of various social context variables on adolescent research participation decision making; and the inter-relatedness of these psychological and social factors.
Contemporary studies of assent, using multivariate methods and updated approaches to statistical modeling, have revealed the importance of studying the intercorrelation between adolescents’ psychological capacities and their ability to employ these capacities in family and medical decision-making contexts. Understanding these dynamic relationships will enable researchers and ethicists to develop assent procedures that respect the authority of parents, while at the same time accord adolescents appropriate decision-making autonomy.
Reviews of empirical literature on the assent process reveal that adolescents possess varying capacities for biomedical research participation decision making depending on their maturity and the social context in which the decision is made. The relationship between adolescents and physician-investigators can be used to attenuate concerns about research protocols and clarify risk and benefit information so adolescents, in concert with their families, can make the most informed and ethical decisions. Future assent researchers will be better able to navigate the complicated interplay of contextual and developmental factors and develop the empirical bases for research enrollment protocols that will support increased involvement of adolescents in biomedical research.
PMCID: PMC3728675  PMID: 23914304
Assent; Pediatric Biomedical Research; Research Ethics; Informed Consent; Research Participation Decision-making
2.  The feasibility and cost of neonatal screening for prenatal alcohol exposure by measuring phosphatidylethanol in dried blood spots 
Accurate confirmation of prenatal alcohol exposure (PAE) is required as a diagnostic criterion for the majority of children adversely affected by PAE who do not manifest the physical features associated with Fetal Alcohol Syndrome. A number of ethanol biomarkers have been used to assess PAE, often with suboptimal results. The purpose of this study was to evaluate the feasibility and cost of PAE screening in newborns by measuring phosphatidylethanol (PEth) in dried blood spot (DBS) cards.
The feasibility of collecting an additional DBS card during routine newborn screening and the background prevalence of PAE were evaluated in a de-identified sample of newborn children delivered at the University of New Mexico Hospital. Electronic orders to collect DBS cards from newborns who continue to bleed after the routine newborn screen, glucose or hematocrit testing were initiated for all infants delivered during a 4-week timeframe. Specimens were sent to a contract laboratory for PEth analysis by liquid chromatography-tandem mass spectrometry. A cost analysis was conducted to compare the cost of PAE screening by PEth in DBS vs. PEth in conventional blood specimens and by meconium fatty acid ethyl esters (FAEE).
From 230 collected cards, 201 (87.4%) had at least one full blood spot (amount sufficient for PEth analysis), and 6.5% had PEth >20ng/mL indicative of potential PAE in late pregnancy. PAE screening by PEth in DBS is logistically simpler and less expensive compared to two other screening approaches.
These results indicate that screening for PAE in DBS cards is a feasible procedure and that a majority of infants have enough blood after the routine heel prick to fill an additional card. Moreover, screening by PEth analysis from DBS cards is cost-efficient. The acceptability of such screening by parents and corresponding ethical issues remain to be investigated.
PMCID: PMC3661684  PMID: 23421919
Newborn screening; Guthrie cards; Biomarkers; Alcohol; Pregnancy
3.  Predicting adolescent asthma research participation decisions from a structural equations model of protocol factors 
To examine similarities and differences in the process that parents and adolescents use to make decisions concerning participation in an asthma clinical trial. We hypothesized that a single conceptual model, tested through structural equations modeling, could explain adolescent assent and parent consent for adolescent research participation.
109 adolescents enrolled with at least one parent and received an asthma evaluation from a pediatric asthma specialist and then evaluated a hypothetical asthma research protocol. Family members independently evaluated the protocol and made research participation decisions.
Perceived risk, benefit and compensation were direct predictors of participation decisions for parents and adolescents. Adolescents perceived direct study benefit from the relationship with the physician, however parents did not. Parent decisions were most strongly associated with perceived risk, and parents associated discomfort with risk more strongly than did adolescents. Protocol procedures contributed to perceptions of benefit and discomfort for parents and adolescents.
Parent and adolescent research participation decisions are influenced by protocol variables in similar ways, although there are differences that account for disagreements within families. Findings may help investigators develop protocols that appeal to parents and adolescents and highlight issues of particular importance to address during the process of informed consent.
PMCID: PMC3628807  PMID: 22921135
asthma; biomedical-research-ethics; informed-consent; adolescent-assent; research-participation-decision-making; adolescent; child; research-support
4.  Conceptualizing the Role of Research Literacy in Advancing Societal Health 
Journal of health psychology  2011;17(5):724-730.
To provide a conceptual formulation for “research literacy” and preliminary evidence for the utility of the construct in enhancing knowledge of and ethical participation in research.
Examined the impact of a brief educational intervention on parents’ research knowledge and their research participation decisions.
Research-related knowledge was improved. Parents with greater knowledge were more comfortable with their research participation decisions. Enhanced understanding of child volition increased parents’ willingness to enroll their children in research.
The proposed research literacy model identifies methods to enhance population knowledge and appreciation of research, strengthening links between scientific advancement and health.
PMCID: PMC3643813  PMID: 22021275
5.  Predicting moderate improvement and decline in pediatric asthma quality of life over 24-months 
Determine factors associated with 24-month change in quality of life in children with asthma and their parents during the Childhood Asthma Management Program (CAMP).
Participants from 4 CAMP clinical centers were administered the Pediatric Asthma Quality of Life questionnaire and protocol measures of asthma symptoms, lung function, and psychological measures.
Multivariate logistic regression analyses determined predictors of moderate change in quality of life. Subclinical levels of depression predicted moderate improvement in child-reported quality of life. Level of depressed affect together with clinical asthma features predicted moderate decline. Improvement in parent quality of life was predicted by perception of illness burden, whereas family features and a child missing school predicted moderate decline.
This ancillary study provided an opportunity to examine the determinants of 24-month change in parent and child of quality of life within a subset of the CAMP participants. Moderate changes in quality of life occur in clinical studies and have both psychosocial correlates as well as illness characteristics.
PMCID: PMC3555223  PMID: 20680689
Asthma; Childhood Asthma Management Program; Quality of life
6.  Neurocognitive functioning and health-related behaviors in adult survivors of childhood cancer: A report from the Childhood Cancer Survivor Study 
Positive health-related behaviors are essential for the future wellbeing of childhood cancer survivors, though relatively few maintain healthy behaviors into adulthood.
Neurocognitive function and emotional distress were examined in 6,440 adult survivors from the Childhood Cancer Survivor Study, and used to predict rates of expected health-related behaviors. Covariates included cancer diagnosis, age, sex, body mass index, insurance status, income, and antidepressant medication use, and multivariable models were constructed adjusting for these factors.
In multivariable regression models, survivors with neurocognitive problems in task efficiency (RR=0.77, 95% CI=0.72–0.84) were less likely to meet the Centers for Disease Control guidelines for weekly physical activity. Survivors with neurocognitive impairment were more likely to engage in general survivor care (RR=1.20, 95% CI=1.10–1.30), and less likely to engage in dental care (RR=0.92, 95% CI=0.88–0.97). Obese survivors were less likely to report receiving a bone density exam (RR=0.67, 95% CI=0.54–0.82), a mammogram (RR=0.71, 95% CI=0.57–0.89), and a skin exam (RR=0.78, 95% CI = 0.68–0.89). Survivors reporting somatization, i.e. vague physical symptoms associated with anxiety, were more likely to report receiving echocardiograms (RR=1.53, 95% CI = 1.32–1.77).
These results support the link between neurocognitive and emotional problems and health-related behaviors in adult survivors of childhood cancer. Monitoring neurocognitive and emotional outcomes may help to identify survivors at risk for poor adherence to prescribed health behaviors and health screening exams.
PMCID: PMC3103640  PMID: 21458986
7.  Using Structural Equation Modeling to Understand Child and Parent Perceptions of Asthma Quality of Life 
Journal of Pediatric Psychology  2009;35(8):870-882.
Objective Using structural equation modeling, test a conceptual model of associations between constructs predicting parent and child asthma quality of life. Methods Children with a confirmed asthma diagnosis and their parents completed measures of health status and independently reported on psychological functioning, family functioning, and quality of life. Results Measurement and structural models for predicting parent and child quality of life provided a good fit of data to the conceptual model. Parent and child independent reports of quality of life are dependent upon family functioning and child psychological functioning. Long-term asthma symptom control is the only health status variable that impacts quality of life. Conclusions With minor modifications, both parent and child data fit the conceptual model. Child psychological functioning and long-term asthma control jointly contribute to quality of life outcomes. Findings suggest that both acute and long-term asthma health status outcomes have different determinants.
PMCID: PMC2924120  PMID: 20026568
asthma; quality of life; structural equation modeling
8.  Patterns of inhaled corticosteroid use and asthma control in the Childhood Asthma Management Program Continuation Study 
Daily controller medication use is recommended for children with persistent asthma to achieve asthma control.
To examine patterns of inhaled corticosteroid (ICS) use and asthma control in an observational study of children and adolescents with mild-to-moderate asthma (the Childhood Asthma Management Program Continuation Study).
We assessed patterns of ICS use during a 12-month period (consistent, intermittent, and none) and asthma control (well controlled vs poorly controlled). Multivariate logistic regression examined the association between pattern of ICS use and asthma control.
Of 914 patients enrolled, 425 were recommended to continue receiving ICS therapy in the Childhood Asthma Management Program Continuation Study. Of these patients, 46% reported consistent ICS use and 20% reported no ICS use during year 1. By year 4, consistent ICS use decreased to 20%, whereas no ICS use increased to 57%; poorly controlled asthma was reported in 18% of encounters. In multivariate models controlling for age, sex, forced expiratory volume in 1 second, and asthma severity assessment, patients reporting consistent ICS use during a 12-month period were more likely to report poor asthma control (odds ratio, 1.6; 95% confidence interval, 1.2–2.1) compared with those reporting no ICS use.
In this observational study of children and adolescents with mild-to-moderate asthma, most did not report continued use of ICS. Patients recommended to continue receiving ICS therapy and reporting consistent ICS use were less likely to report well-controlled asthma even after controlling for markers of asthma severity. Although residual confounding by severity cannot be ruled out, many children and adolescents may not achieve well-controlled asthma despite consistent use of ICS.
PMCID: PMC3040975  PMID: 20143642
9.  Enrolling adolescents in asthma research: Adolescent, parent, and physician influence in the decision-making process 
The factors influencing family decisions to participate in adolescent asthma research are not well understood. Legal and ethical imperatives require adolescent research participation to be voluntary. While parents and adolescents often agree about research decisions, disagreements may also occur with relatively frequency. Physician recommendations are also known to influence research participation decisions. Little attention has been given to how these dynamics may affect adolescents’ involvement in decisions to participate in research.
To examine the influence of family and physician-investigator relationships and recommendations on adolescent asthma clinical research participation decisions.
A statewide community sample of 111 adolescents aged 11–17, with a diagnosis of asthma, and their parents participated in this study. Adolescents received a medical evaluation from an asthma specialist and then the family was offered participation in a hypothetical asthma clinical trial. By random assignment, the research study was presented by either the same or an unknown asthma specialist and half the families in each group also received affirmative recommendations from the asthma specialist to participate in the hypothetical asthma clinical trial. Parents and adolescent made initial private decisions about participating in the trial. Then, following a family discussion of the clinical trial, a final research participation decision was made.
Thirty three percent of parents and adolescents initially disagreed about the research participation decision. When disagreements occurred, final decisions followed the parents’ initial views except when the physician-investigator was known and a recommendation was made. Families with initial disagreement about participating were less likely to enroll when the investigator was unknown or when no recommendation was made. Adolescents who initially disagreed with parents’ views were less likely to concur with the final research participation decision, felt less comfortable, and were less likely to feel they influenced the decision.
Parents’ views on research decisions take precedence over adolescents’ views in most circumstances. Physician-investigator relationships may reduce parental resistance to participation and enhance adolescent decision-making autonomy when research participation is desired by the adolescent.
PMCID: PMC2745933  PMID: 19544171
biomedical-research-ethics; adolescent-assent; research-participation-decision-making; patient-physician relationship
10.  Comparisons of Adolescent and Parent Willingness to Participate in Minimal and Above Minimal Risk Pediatric Asthma Research Protocols 
Much has been written about conceptual concern for voluntary assent with children and adolescents. However, little empirical data exists examining the frequency with which, or context in which, adolescents and parents disagree on research participation decisions. The purpose of this study was to compare parent and adolescent willingness to participate in minimal and above minimal risk pediatric asthma research protocols.
36 adolescents diagnosed with asthma and one of their parents independently rated their willingness to participate in 9 pediatric asthma research protocol vignettes. The selected protocols were chosen by an expert panel as representative of typical minimal and above minimal risk pediatric asthma studies.
Parents and adolescents were significantly less likely to agree to enroll in above minimal risk studies. However, this was qualified by a finding that adolescents were significantly more willing than parents to enroll in above minimal risk research. Across all 9 studies, parents and adolescents held concordant views on participation decisions approximately 60% of the time. Perception of potential study benefit was the most frequent reason provided for participation decisions by both parents and adolescents.
Parents and their adolescents report a consistent 40% discordance in their views about participating in asthma research across a variety of asthma research protocols, with adolescents more willing than their parents to enroll in above minimal risk studies. These differences of opinion highlight the need to carefully consider the process by which families are offered the option of adolescent research participation.
PMCID: PMC1993807  PMID: 16109343
informed consent; assent; adolescent research; biomedical research ethics; research participation decision making
11.  Family and physician influence on asthma research-participation decisions for adolescents: The effects of adolescent gender and research risk 
Pediatrics  2006;118(2):e356-e362.
To examine parent and adolescent perceptions of decision-making authority and sources of influence on adolescent research participation decisions, and determine whether perceptions of influence differ based on adolescent gender and level of research risk.
Study design:
Adolescents (n=36) with asthma and their parents reviewed 9 pediatric research protocols, decided whether they would choose to participate, rated the extent they would be responsible for the actual decision, and indicated the ability of family and physician to influence their decisions. Multivariate analyses of variance were used to evaluate differences in perceptions of decision-making authority and sources of influence on the decisions.
Adolescents were less willing to cede decision making authority to parents than parents anticipated. Parents and adolescents acknowledged a greater openness to influence from physicians than from family for above minimal risk studies. Parents were more willing to consider to opinions from male adolescents.
Adolescents desire responsibility for research participation decisions, though parents may not share these views. Physician's views on research participation are important to families, especially for above minimal risk studies. Parents may grant more decision-making autonomy to adolescent males than to females.
PMCID: PMC1950317  PMID: 16882778
asthma-drug-therapy; biomedical-research-ethics; informed-consent; adolescent-assent; research-participation-decision-making; adolescent; child; parents; female; humans; male; research-support

Results 1-11 (11)