This review examines recent advances in sample size planning, not only from the perspective of an individual researcher, but also with regard to the goal of developing cumulative knowledge. ...Psychologists have traditionally thought of sample size planning in terms of power analysis. Although we review recent advances in power analysis, our main focus is the desirability of achieving accurate parameter estimates, either instead of or in addition to obtaining sufficient power. Accuracy in parameter estimation (AIPE) has taken on increasing importance in light of recent emphasis on effect size estimation and formation of confidence intervals. The review provides an overview of the logic behind sample size planning for AIPE and summarizes recent advances in implementing this approach in designs commonly used in psychological research.
Diabetes-Related Emotional Distress Over Time Iturralde, Esti; Rausch, Joseph R; Weissberg-Benchell, Jill ...
Pediatrics (Evanston),
06/2019, Letnik:
143, Številka:
6
Journal Article
Recenzirano
Odprti dostop
Many adolescents with type 1 diabetes experience diabetes-related distress (DRD; the negative emotional reactions specific to managing diabetes), but most research on DRD among adolescents relies on ...cross-sectional data. We assess adolescents' longitudinal DRD patterns and predictors of chronic DRD.
This secondary analysis of data from a depression prevention clinical trial included 264 adolescents with type 1 diabetes randomly assigned to a resilience or education intervention (mean age: 15.7 ± 1.1 years; 59.8% female). Youth reported their DRD at 5 assessments over 16 months. Using latent class growth analysis, we classified adolescents into trajectory groups according to baseline starting point (intercept) and rate of change (slope) of DRD. We examined bivariate associations between trajectory group membership and demographic and clinical factors. Baseline predictors of chronic DRD were assessed via multiple logistic regression.
Participants were classified into 4 groups: stable high DRD (7.2%; high intercept, flat slope), stable moderate DRD (28.0%; above-average intercept, flat slope), improving DRD (33.7%; average intercept, downward slope), and low DRD (31.1%; below-average intercept, downward slope). Lower hemoglobin A1c, greater adherence, fewer socioemotional difficulties, and more adaptive coping distinguished the improving and low DRD trajectories. Chronic DRD patterns were associated with female sex and higher depressive symptoms and hemoglobin A1c.
In this study of adolescents' DRD trajectories during and after a psychoeducational intervention, one-third of youth were classified as having chronic, elevated DRD. Links with multiple clinical factors support efforts for routine DRD screening and comprehensive interventions for distressed youth.
CONTEXT Because of epilepsy's common occurrence, the narrow therapeutic and safety margins of antiepileptic medications, and the recognized complications of medication nonadherence in adults with ...epilepsy, identifying the rates, patterns, and predictors of nonadherence in children with epilepsy is imperative. The onset and evolution of antiepileptic drug nonadherence in children with newly diagnosed epilepsy remains unknown. OBJECTIVES To identify and characterize trajectories of adherence in children with newly diagnosed epilepsy over the first 6 months of therapy and to determine sociodemographic and epilepsy-specific predictors of adherence trajectories. DESIGN, SETTING, AND PATIENTS Prospective, longitudinal observational study of antiepileptic drug adherence in a consecutive cohort of 124 children (2-12 years old) with newly diagnosed epilepsy at Cincinnati Children's Hospital Medical Center. Patients were recruited from April 2006 through March 2009, and final data collection occurred in September 2009. MAIN OUTCOME MEASURE Objective adherence measured using electronic monitors. RESULTS Fifty-eight percent of children with newly diagnosed epilepsy demonstrated persistent nonadherence during the first 6 months of therapy. Group-based trajectory models identified 5 differential adherence patterns (Bayesian information criterion = −23611.8): severe early nonadherence (13%; 95% confidence interval CI, 8%-20%), severe delayed nonadherence (7%; 95% CI, 3%-12%), moderate nonadherence (13%; 95% CI, 8%-20%), mild nonadherence (26%; 95% CI, 19%-34%), and near-perfect adherence (42%; 95% CI, 33%-50%). The adherence pattern of most patients was established by the first month of therapy. Socioeconomic status was the sole predictor of adherence trajectory group status (χ24 = 19.3 n = 115; P < .001; partial r2 = 0.25), with lower socioeconomic status associated with higher nonadherence. CONCLUSION Five trajectory patterns were identified that captured the spectrum of nonadherence to antiepileptic drugs among children with newly diagnosed epilepsy; the patterns were significantly associated with socioeconomic status.
IMPORTANCE Early, safe, effective, and durable evidence-based interventions for children and adolescents with chronic migraine do not exist. OBJECTIVE To determine the benefits of cognitive ...behavioral therapy (CBT) when combined with amitriptyline vs headache education plus amitriptyline. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial of 135 youth (79% female) aged 10 to 17 years diagnosed with chronic migraine (≥15 days with headache/month) and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points were assigned to the CBT plus amitriptyline group (n = 64) or the headache education plus amitriptyline group (n = 71). The study was conducted in the Headache Center at Cincinnati Children’s Hospital between October 2006 and September 2012; 129 completed 20-week follow-up and 124 completed 12-month follow-up. INTERVENTIONS Ten CBT vs 10 headache education sessions involving equivalent time and therapist attention. Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit. In addition, follow-up visits were conducted at 3, 6, 9, and 12 months. MAIN OUTCOMES AND MEASURES The primary end point was days with headache and the secondary end point was PedMIDAS (disability score range: 0-240 points; 0-10 for little to none, 11-30 for mild, 31-50 for moderate, >50 for severe); both end points were determined at 20 weeks. Durability was examined over the 12-month follow-up period. Clinical significance was measured by a 50% or greater reduction in days with headache and a disability score in the mild to none range (<20 points). RESULTS At baseline, there were a mean (SD) of 21 (5) days with headache per 28 days and the mean (SD) PedMIDAS was 68 (32) points. At the 20-week end point, days with headache were reduced by 11.5 for the CBT plus amitriptyline group vs 6.8 for the headache education plus amitriptyline group (difference, 4.7 95% CI, 1.7-7.7 days; P = .002). The PedMIDAS decreased by 52.7 points for the CBT group vs 38.6 points for the headache education group (difference, 14.1 95% CI, 3.3-24.9 points; P = .01). In the CBT group, 66% had a 50% or greater reduction in headache days vs 36% in the headache education group (odds ratio, 3.5 95% CI, 1.7-7.2; P < .001). At 12-month follow-up, 86% of the CBT group had a 50% or greater reduction in headache days vs 69% of the headache education group; 88% of the CBT group had a PedMIDAS of less than 20 points vs 76% of the headache education group. Measured treatment credibility and integrity was high for both groups. CONCLUSIONS AND RELEVANCE Among young persons with chronic migraine, the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline. These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00389038
OBJECTIVE:To examine the relationship between previously identified nonadherence trajectories during the first 6 months of antiepileptic drug (AED) therapy and long-term seizure-free rates (defined ...as ≥1 year of seizure freedom at the 4 years postdiagnosis milestone) in a cohort of children with newly diagnosed epilepsy.
METHODS:A prospective longitudinal observational study of AED adherence and seizure freedom in a consecutive cohort of 124 children (ages 2–12 years) with newly diagnosed epilepsy was conducted. The association between previously identified AED adherence trajectories (i.e., near-perfect adherence e.g., average adherence = 96.8% vs nonadherent) and seizure freedom for ≥1 year at the 4 years postdiagnosis milestone was determined.
RESULTS:Children who exhibited nonadherence to AED therapy in the first 6 months of treatment were 3.24 times more likely not to have achieved ≥1 year of seizure freedom at the 4 years postdiagnosis milestone compared to children in the near-perfect adherence group (χ = 5.13; p = 0.02). Specifically, at the 4 years postdiagnosis milestone, only 12% of children in the near-perfect adherence group were continuing to experience seizures compared to 31% of children in the nonadherent group.
CONCLUSIONS:Children with epilepsy who achieved near-perfect adherence during the first 6 months of therapy experienced a higher rate of seizure freedom 4 years postdiagnosis compared with those children who demonstrated early nonadherence. This suggests that adherence intervention early in the course of treatment could play a role in improving long-term seizure freedom rates in children with epilepsy.
Contamination, when members of a comparison or control condition are exposed to the event or intervention under scientific investigation, is a methodological phenomenon that downwardly biases the ...magnitude of effect size estimates. This study tested a novel approach for controlling contamination in observational child maltreatment research. Data from The Longitudinal Studies of Child Abuse and Neglect (LONGSCAN; N = 1354) were obtained to estimate the risk of confirmed child maltreatment on trajectories of internalizing and externalizing behaviors before and after controlling contamination. Baseline models, where contamination was uncontrolled, demonstrated a risk for greater internalizing (b = .29, p < .001, d = .40) and externalizing (b = .14, p = .040, d = .19) behavior trajectories. Final models, where contamination was controlled by separating the comparison condition into subgroups that did or did not self-report maltreatment, also demonstrated risks for greater internalizing (b = .37, p < .001, d = .51) and externalizing (b = .22, p = .028, d = .29) behavior trajectories. However, effect size estimates in final models were 27.5%–52.6% larger compared to baseline models. Controlling contamination in child maltreatment research can strengthen effect size estimates for child behavior problems, aiding future child maltreatment research design and analysis.
Objective: For youth with spina bifida (SB) there is a growing need to understand how responsibilities for health care are transferred from family- to self-management over time. The current study ...examined trajectories of responsibility for medical tasks in youth with SB across adolescence, as well as executive functioning/attention and parenting behaviors as predictors of growth. Method: As part of a larger, longitudinal study, 140 youth with SB (ages 8-15 at time 1; Mage = 11.43) reported on their responsibility for relevant medical tasks across five time points. Attention and executive functioning were assessed via performance-based and parent/teacher-report methods. Parenting behaviors consisted of acceptance, behavioral control, and psychological control and were assessed via observational and parent-report. Results: Growth curve analyses revealed significant increases in youth medical responsibility across all SB tasks over time. Attention, executive functioning, maternal behavioral control, and paternal psychological control emerged as predictors of growth parameters in responsibility for communicating about SB and managing health care appointments. Conclusion: Results indicated that youth with SB obtain increasing responsibility for their health care over time. The transfer of responsibility for SB management may differ based on individual (i.e., the child's neuropsychological abilities) and family level (i.e., parenting behaviors) factors. Further research is needed to understand how growth in medical responsibility relates to changes in other aspects of SB self-management across development, such as medical adherence.
OBJECTIVE: To test models of unidirectional and bidirectional change between treatment adherence and glycemic control in youth with type 1 diabetes. RESEARCH DESIGN AND METHODS: We conducted a 2-year ...longitudinal, multisite study of 225 youth with type 1 diabetes recruited at the cusp of adolescence (aged 9–11 years) to describe the mutual influences of glycemic control as measured by HbA1c and treatment adherence as measured by blood glucose monitoring frequency (BGMF) during the transition to adolescence. RESULTS: HbA1c increased from 8.2 to 8.6% (P < 0.001) and BGMF decreased from 4.9 to 4.5 checks per day (P < 0.02) during the 2-year period. Changes in the BGMF slope predicted changes in HbA1c. A change (increase) in HbA1c was associated with a change (decrease) in BGMF of 1.26 (P < 0.001) after controlling for covariates. CONCLUSIONS: The magnitude of the effect of declining treatment adherence (BGMF) on glycemic control in young adolescents may be even greater than declines observed among older adolescents. BGMF offers a powerful tool for targeted management of glycemic control for type 1 diabetes during the critical transition to adolescence.
Summary
The primary aim was to examine the preliminary efficacy of a family tailored problem‐solving intervention to improve antiepileptic drug (AED) adherence in families of children with new‐onset ...epilepsy. Secondary aims were to assess changes in targeted mechanisms and treatment feasibility and acceptability. Fifty families (Mage = 7.6 ± 3.0; 80% Caucasian; 42% idiopathic localization related) completed baseline questionnaires and were given an electronic monitor to observe daily AED adherence. If adherence was ≤ 95% in the first 7 months of the study, families were randomized (Supporting Treatment Adherence Regimens (STAR): n = 11; Treatment as Usual (TAU): n = 12). Twenty‐one families were not randomized due to adherence being ≥95%. The STAR intervention included four face‐to‐face and two telephone problem‐solving sessions over 8 weeks. Significant group differences in adherence were found during active intervention (weeks 4–6; TAU = −12.0 vs. STAR = 18.1, p < 0.01; and weeks session 6–8: TAU = −9.7 vs. STAR = 15.3, p < 0.05). Children who received the STAR intervention exhibited improved adherence compared to children in the TAU group during active treatment. Significant changes in epilepsy knowledge and management were noted for the STAR group. Families expressed benefitting from the STAR intervention. Future studies should include a larger sample size and booster intervention sessions to maintain treatment effects over time.
To identify two-year trajectories of health-related quality of life (HRQOL) among children with newly diagnosed epilepsy, and evaluate key predictors of HRQOL trajectories.
This study is part of a ...prospective study of adherence and HRQOL outcomes in children with epilepsy. Caregivers completed an HRQOL questionnaire at one month post diagnosis and every three months thereafter for two years. Chart review and additional questionnaires were used to collect medical variables and seizure outcomes.
Participants included 120 children with epilepsy and their caregiver. Unique trajectories for overall HRQOL and PedsQL™ subscales were identified and were predominantly stable. A total side effects score emerged as a consistent predictor of all HRQOL domains. Other variables (i.e., socioeconomic status, seizures, internalizing and externalizing problems) uniquely predicted HRQOL domains.
Medical and psychosocial interventions should be implemented soon after treatment initiation to target modifiable factors (e.g., side effects, anxiety symptoms), which could improve HRQOL.