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Biomedical subjects

Dennis Drotar

Publications and source records attributed to Dennis Drotar.

At least 19 recordsLinked to original sources

The role of the consent document in informed consent for pediatric leukemia trials.

PURPOSE: To examine both the use of the consent document during the informed consent process for pediatric leukemia clinical trials, as well as relationships between the use of the document and parental understanding of essential elements of informed consent. METHODS: Participants included 140 parents of children diagnosed with pediatric leukemia. Informed consent conferences in which randomized clinical trials were discussed were observed, audiotaped, and coded for specific behaviors. Parents were also interviewed within 48 h of their participation in informed consent conferences. RESULTS: Observations revealed that 74% of cases included explanation of consent documents during consent conferences. Parents who reported that they read the consent document were more likely to understand differences between the clinical trial and off study therapy and were more likely to understand the right to withdraw. Reading of the consent document was not associated with understanding of voluntariness. In comparison to racial/ethnic majority parents, racial/ethnic minority parents were less likely to report that they read the consent document, understand voluntariness or the right to withdraw, and were less likely to be able to distinguish between the clinical trial and off study therapy. Low SES was associated with a lower probability of reading the consent document and being able to distinguish between clinical trials and off study therapy. CONCLUSIONS: Attention to the importance of reading the consent document and improving communication during consent conferences is likely to enhance understanding of essential elements of informed consent.

Adolescent↗

The relationship between parent-reported social support and adherence to medical treatment in families of adolescents with type 1 diabetes.

OBJECTIVE: To investigate the relationships between both mother-reported spousal support and social network support, and mother-adolescent diabetes-related conflict, discrepancies in decision-making autonomy (DDMA), and adolescent adherence to diabetes treatment. METHOD: Fifty-one mothers of adolescents with IDDM completed self-report measures of social support, diabetes-related conflict, and adolescent autonomy for diabetes care. Analyses tested conflict and DDMA as mediators between mother-reported social support and adolescent adherence to treatment. RESULTS: Increased levels of mother-adolescent conflict were associated with poorer treatment adherence and both mother-reported diabetes-related conflict and DDMA predicted adolescents' glycemic control. Higher levels of mother-reported spousal support were associated with less conflict and greater adherence to treatment. Sobel's test indicated a statistical trend for conflict as a mediator between spousal support and adolescent treatment adherence (p < .07). DDMA did not predict mother-adolescent conflict and did not emerge as a mediator between mother-reported social support and adolescent adherence. CONCLUSIONS: This study highlights the role of spousal support for mothers of adolescents with IDDM and indicates that the level of spousal support mothers receive may play an important role in the health care behaviors of their adolescents.

Adolescent↗

Longitudinal relationships between early adolescent family functioning and youth adjustment: an examination of the moderating role of very low birth weight.

OBJECTIVE: To examine longitudinal relations between early adolescent family conflict and late adolescent psychosocial adjustment, and the moderating role of low birth weight. METHODS: Three groups of adolescents (48 with birth weight <750 g, 46 with birth weight 750-1499 g, and 51 term-born controls) and their parents completed ratings of family conflict at age 11 (Time 1). Parent, teacher, and youth reports of psychosocial functioning were obtained at ages 11 and 17 (Time 2). RESULTS: Birth weight moderated the relationship between Time 1 adolescent-perceived conflict and change in adolescent behavioral functioning. For adolescents with histories of <750 g birth weight, adolescent-perceived conflict predicted less adaptive changes in teacher-reported total behavior problems and externalizing problems. CONCLUSIONS: Small disruptions to the parent-child relationship have negative implications for the later well-being of adolescents with extreme levels of low birth weight. Clinical attention to resolving early adolescent conflict may promote adaptive adjustment.

Adjustment Disorders↗

Exploratory and confirmatory factor analysis of the Child Uncertainty in Illness Scale among children with chronic illness.

OBJECTIVE: To conduct an exploratory factor analysis (EFA) and a confirmatory factor analysis (CFA) of the Child Uncertainty in Illness Scale (CUIS) with a sample of children and adolescents with a chronic health condition. Developmental differences in factor structure were also examined. METHODS: A sample of 373 children aged 8-18 years with chronic conditions completed the CUIS as a part of a larger battery of measures. RESULTS: The EFA yielded a 16-item two-factor model termed Unpredictability/Ambiguity and Comprehension. The CFA yielded a 14-item two-factor model that fits the data very well, where chi2(df = 74) = 95.396, Comparative Fit Index (CFI) = .973, Tucker Lewis Index (TLI) = .967, and Root Mean Square error of approximation (RMSEA) = .038. No developmental differences were found in underlying factor structures: Deltachi2(df = 12) = 17.754, DeltaCFI = .004, DeltaTLI = -.001, and DeltaRMSEA = .000. CONCLUSIONS: The two-factor CUIS measure could be a useful tool for assessing illness uncertainty among children with chronic illness.

Adolescent↗

Decision-making competence and adherence to treatment in adolescents with diabetes.

OBJECTIVE: To examine decision-making competence (the ability to form effective plans for managing different situations) in a sample of adolescents with type I diabetes and their parents. We hypothesized that adolescent decision-making competence would mediate the relationship between parent-adolescent communication and adherence to treatment. METHODS: The sample consisted of 63 adolescents and their parents. Parent-adolescent communication during a problem-solving task was assessed, as well as adolescent maladaptive decision-making (adolescent report), adherence to treatment (parent and provider report; number of glucose tests), and metabolic control (HbA1C). RESULTS: Parent-adolescent communication was associated with adherence to treatment but not with adolescent decision-making. Poorer decision-making was associated with lower adherence per parent report but not provider report or the number of glucose tests. Decision-making competence did not mediate the relationships between parent-adolescent communication and adherence. CONCLUSIONS: These results are consistent with prior research demonstrating associations between parent-adolescent communication and adherence and identify adolescent decision-making competence as another potentially important correlate of adherence. These findings highlight several areas for future research.

Adolescent↗

A meta-analysis of the effects of psychological interventions in pediatric oncology on outcomes of psychological distress and adjustment.

OBJECTIVE: To estimate the effectiveness of psychological interventions in pediatric oncology on decreasing psychological distress and increasing psychological adjustment using meta-analytic methods. METHODS: A meta-analysis was conducted on 12 psychological intervention studies in pediatric oncology using a weighted least squares (WLS) approach and random effect models. RESULTS: Effect sizes significantly different from zero were found for parent distress (mean = 0.35, 95% CI = 0.20-0.49, n = 7) and parent adjustment (mean = 0.23, 95% CI = 0.07-0.40, n = 5). Effect sizes for child distress, child adjustment, parent-reported child distress, and parent-reported child adjustment were not significantly different from zero. CONCLUSIONS: Psychological interventions in pediatric oncology show promise in decreasing distress and improving the adjustment of parents of children with cancer but may have minimal effects for child outcomes. Methodological issues of intervention research are discussed.

Adolescent↗

Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent.

PURPOSE: To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding. METHODS: Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed. RESULTS: Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2. CONCLUSION: Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice.

Adult↗

How low is too low? Use of cluster analysis to define low levels of mercaptopurine metabolites.

BACKGROUND: To group patients receiving treatment for acute lymphoblastic leukemia (ALL) according to their oral mercaptopurine (6-MP) metabolite levels and to establish cut-off points to screen for potential poor clinical outcome. PROCEDURE: Methodological study using 6-MP metabolite levels from 48 adolescent ALL patients enrolled in a multicenter adherence study. Cluster analysis was the primary analytical technique. We used two validation methods (a split-sampling and a simulation technique) for validating the results. RESULTS: Four clusters were retained in our initial analysis using our first group of patients (n = 27). Three clusters (labeled 1, 2, and 4) exhibited the expected negative correlation between the two metabolites, that is, "high" values of one were associated with "low" values of the other. One cluster (labeled 3) had "low" levels for both TGN and MMP. Five of the 27 adolescents had their 6-MP "held" during the study. Post-hoc examination of the results revealed that all five grouped in Cluster 3 during the time that their medications were stopped, but grouped in other clusters at other times. The median ANC was highest in Cluster 3, consistent with low therapeutic drug levels. Parameters were reproducible with both validation methods. Values below the respective 75th centile for both TGN and MMP in Cluster 3 for the complete sample (n = 48) are suggested as representing a potentially higher risk for relapse. CONCLUSIONS: This study provides an objective method for identifying patients at risk for treatment failure due to suboptimal 6-MP therapy; the clinical significance of this approach should be examined in future studies.

Adolescent↗

Religion/spirituality and adolescent health outcomes: a review.

Religion/spirituality is important to adolescents, is usually considered a protective factor against a host of negative health outcomes, and is often included in adolescent health outcomes research. Previous reviews of the relationship among spirituality, religion, and adolescent health have been limited by scope, focusing primarily on distal aspects of religion/spirituality (e.g., attendance at religious services). We reviewed the literature examining proximal domains of religion/spirituality (e.g., spiritual coping) in adolescent health outcomes research. Constructs such as spiritual coping and religious decision-making were the ones most often studied and were generally positively associated with health outcomes. Measurement of proximal domains, associations of proximal domains with health outcomes, methodological issues and recommendations for future research were covered in this review.

Adaptation, Psychological↗

Neighborhood disadvantage as a risk factor for pediatric obstructive sleep apnea.

OBJECTIVE: Low socioeconomic status (SES) is associated with a range of health outcomes. Our objective was to study the relationship between residence in a neighborhood of severe socioeconomic disadvantage and childhood obstructive sleep apnea (OSA). STUDY DESIGN: Cross-sectional analysis of 843 (49% female, 36% African-American) children 8 to 11 years of age from a community-based cohort. Data on neighborhood conditions were obtained from the 2000 US Census. The main outcome measure was OSA, defined as an obstructive apnea hypopnea index >5 events per hour or an obstructive apnea index >1 event per hour. RESULTS: Residence in a neighborhood of severe socioeconomic disadvantage was significantly associated with OSA after adjusting for effects of previously established risk factors: premature birth, obesity, and African-American ethnicity (OR = 3.44, 95% CI = 1.53-7.75). Secondary analyses showed that neighborhood disadvantage remained significantly associated with OSA: (1) in the African-American subgroup, after controlling for effects of prematurity and obesity; and (2) after controlling for indicators of household-level SES or other health characteristics. CONCLUSIONS: Childhood OSA is associated with low SES as measured by an index describing severe neighborhood disadvantage, emphasizing the potential importance of environmental factors, particularly those associated with neighborhood distress, as risk factors for OSA.

Child↗

Perceived involvement in condition management among inner-city youth with asthma and their primary caregivers.

This study examined patterns of agreement versus disagreement in family perceptions of caregiver and youth involvement in asthma management tasks and associations of these patterns with youth asthma outcomes. Fifty-six caregiver-child dyads completed questionnaires of family involvement in asthma management and asthma health outcomes (i.e., symptom days, health care utilization, and medication adherence). Discrepancies were documented for perceptions of both caregiver and youth involvement. Caregiver overestimation of youth involvement in asthma management was associated with greater asthma severity and more asthma symptoms. Discrepancies in family perceptions of involvement pose salient challenges for effective clinical management and require clinical attention.

Adolescent↗

Consequences and risks of <1000-g birth weight for neuropsychological skills, achievement, and adaptive functioning.

A cohort of 219 children with extremely low birth weight (<1000 g, extremely low birth weight [ELBW]) born from 1992 to 1995 was followed to mean age 8 years to evaluate outcomes and identify risk factors. We compared 204 of these children with 176 term-born normal birth weight (NBW) controls on neuropsychological skills, academic achievement, and adaptive behavior. The ELBW group had worse outcomes than the NBW on all measures. Within the ELBW group, lower scores on NEPSY tests of executive function and memory were related to <750 g birth weight, B (SE) = -0.93 (0.36), p =.010; cranial ultrasound abnormality, B = -1.03 (0.22), p =.002; postnatal steroid therapy, B = -1.00 (0.33), p =.003; and necrotizing enterocolitis, B = -2.26 (0.75), p =.008. A lower score on the Test of Motor Proficiency was related to chronic lung disease, B = -7.33 (1.98), p <.001. Neuropsychological skills mediated the effects of neonatal risk on achievement and adaptive functioning. The findings document the neuropsychological consequences of ELBW at school age in a recently born cohort and identify risks for adverse outcomes.

Achievement↗

Family impact of neurodevelopmental late effects in survivors of pediatric cancer: review of research, clinical evidence, and future directions.

Children and adolescents who have survived childhood cancer are vulnerable to late effects of their disease and treatment experience, including both physical and psychological sequelae. The neurodevelopmental (ND) sequelae (e.g., difficulties with attention, memory, information processing, and other executive functions) faced by children surviving central nervous system (CNS) cancers or CNS treatments can have a range of effects on their psychological adjustment and quality of life as they reintegrate into school and social settings. Survivors facing such difficulties may be influenced by their family environment, and these struggles may in turn impact the perceived burden of their parents and family system, suggesting a bidirectional framework for understanding the impact of ND late effects within the family. The current study summarizes the following: Findings of family outcomes in children with ND late effects of cancer treatment; evaluation of methodological and measurement issues; the importance of examining bidirectional family-child influences; and implications for future survivorship research and clinical care addressing the role of ND late effects from a systems perspective.

Child↗

An interdisciplinary intervention for undertreated pediatric asthma.

STUDY OBJECTIVES: To examine the effectiveness of an interdisciplinary intervention for pediatric asthma. DESIGN: Randomized, controlled study. SETTING: Urban tertiary-referral pediatric hospital. PARTICIPANTS: One hundred seventy-five patients with asthma lacking written treatment plans and presenting with asthma-related emergency department visits (two or more) and/or hospitalizations (one or more) in the past year were randomized to a comparison group receiving medical care alone (n = 86) or to an interdisciplinary intervention group receiving medical care, asthma education, and problem-solving therapy (n = 89) INTERVENTION: All participants received written asthma management plans, peak flow meters, and spacer devices. The intervention group also received asthma education, an asthma risk profile assessment, brief problem-solving therapy, and access to a 24-h nurse advice line. The primary outcome measure was change in asthma symptoms, and secondary outcomes included health-care utilization and asthma-related quality of life. RESULTS: Both groups demonstrated significant reductions in asthma symptoms and improvements in quality of life without any between-group differences identified over the course of follow-up. In contrast, the intervention group demonstrated less frequent health-care utilization than the comparison group, with 28% of the intervention group requiring emergency department or inpatient services for asthma compared to 41% of the comparison group (adjusted odds ratio, 1.92; 95% confidence interval, 1.00 to 3.69) over the 12-month follow-up period. CONCLUSIONS: This study examined the effectiveness of an interdisciplinary intervention for undertreated asthma. The intervention did not result in improvements in asthma symptoms, but accomplished modest reductions in the utilization of acute medical care.

Anti-Asthmatic Agents↗

Health, neurologic, and cognitive status of HIV-infected, long-surviving, and antiretroviral-naive Ugandan children.

OBJECTIVE: The purpose of this study was to assess the health status and school-age neurodevelopmental progress of antiretroviral treatment (ARVT)-naive, HIV-infected Ugandan children who had been followed as part of cohorts of children born to HIV-infected and -noninfected mothers between 1989 and 1993. METHODS: Twenty-eight children, aged 6 to 12 years, vertically infected with HIV-1 and never treated with ARVT were evaluated in terms of health status, neurologic, and psychometric testing. A randomly selected group of 42 seroreverters and 37 HIV-1 negative children who were age- and gender-matched and who had been followed in the same cohorts were evaluated also. The families studied were homogenous in their socioeconomic status. None of the mothers or children had received ARVT or been exposed to illicit drugs. RESULTS: The HIV-infected children showed significantly more evidence of acute malnutrition. They also had more illness, especially parotitis, otitis media, upper respiratory infections, and lymphadenopathy. However, they did not differ significantly in neurologic and cognitive assessments when compared with age- and gender-matched seroreverter and HIV-negative children. They were in the normal range with respect to neurologic and psychometric development measures. CONCLUSIONS: These children seem to represent a significant subgroup of HIV-infected child survivors for whom the progress of the disease is less aggressive throughout early life. Given the fact that many infants, especially in developing countries, continue to be born without the benefit of perinatal ARVT, there will likely continue to be many older HIV-infected children in the same situation as those described in this follow-up study. They will not have been recognized as being HIV-infected. It is important that such children be identified and offered access to ARVT and other appropriate support services.

Anti-Retroviral Agents↗

The impact of extremely low birth weight on the families of school-aged children.

OBJECTIVE: The purpose of this study was to document the impact and burden of extremely low birth weight (<1000 g) and associated problems on the families of school-aged children in a controlled study. The study was also designed to document the salient predictors of individual differences of family impact within the extremely low birth weight group. METHODS: A prospective study was completed at 8 years of a cohort of 219 children with extremely low birth weight born 1992-1995 and 176 children with normal birth weight. Measures included the following predictor variables: socioeconomic status and parent risk, birth risk, neonatal risk, neurodevelopmental outcome, impairment in adaptive abilities, and functional impact of chronic conditions. The primary outcome measure was the Impact on Family scale. A measure of family stressors and resources (the Life Stressors and Social Resources Inventory) was also obtained. RESULTS: The primary finding was that the total family impact was greater in the extremely low birth weight group compared with controls. Moreover, the negative impact on family in specific domains was greater in the extremely low birth weight group in financial impact, caretaker burden, and familial burden. These differences were not attributable to general family stressors, socioeconomic status, child, gender, or race. Higher parent/socioeconomic risk, neurodevelopmental outcomes, and the functional impact of chronic conditions predicted greater family impact within the extremely low birth weight group, whereas birth and neonatal risk scores did not. CONCLUSIONS: Extremely low birth weight was associated with a negative impact on families. Socioeconomic parental risk, but most especially child-related factors such as neurodevelopmental and the functional impact of chronic conditions, predicted the negative family impact within the extremely low birth weight group. Findings underscore the need to develop and test interventions to provide support for families of extremely low birth weight infants to ameliorate the burden of extremely low birth weight and associated risk factors on families.

Family↗