Lisa M. Ingerski

Health-Related Quality of Life across Pediatric Chronic Conditions

OBJECTIVE To compare health-related quality of life (HRQOL) across 8 pediatric chronic conditions, including 5 understudied populations, and examine convergence between youth self-report and parent-proxy report. STUDY DESIGN Secondary data from 589 patients and their caregivers were collected across the following conditions: obesity, eosinophilic gastrointestinal disorder, inflammatory bowel disease, epilepsy, type 1 diabetes, sickle cell disease, post-renal transplantation, and cystic fibrosis. Youth and caregivers completed age-appropriate self-report and/or parent-proxy report generic HRQOL measures. RESULTS Youth diagnosed with eosinophilic gastrointestinal disorder and obesity had lower HRQOL than other pediatric conditions by parent report. Caregivers reported lower HRQOL by proxy report than youth self-reported across most subscales. CONCLUSIONS Use of brief, easily administered, and reliable assessments of psychosocial functioning, such as HRQOL, may provide clinicians additional opportunities for intervention or services targeting improved HRQOL relative to the needs of each population.

Blood glucose monitoring and glycemic control in adolescence: contribution of diabetes-specific responsibility and family conflict.

PURPOSE To examine age and time trends in responsibility for diabetes management tasks and diabetes-specific family conflict and their relationship to blood glucose monitoring (BGM) frequency and blood glucose control (HbA1c). METHODS A sample of 147 adolescents (mean = 15.5 +/- 1.4 years) with type 1 diabetes and their caregivers completed measures of diabetes-specific responsibility and family conflict at baseline and 6 months. BGM frequency and HbA1c were measured during outpatient clinic appointments. RESULTS Responsibility for diabetes management tasks shifted from caregivers to adolescents with increasing age by adolescent and caregiver report. Diabetes-specific conflict was stable. Similar trends in responsibility and conflict were seen over the 6-month follow-up period. Less frequent BGM and higher HbA1c were also observed with increasing adolescent age. Multivariate analyses demonstrated adolescents taking greater responsibility for management tasks and experiencing greater family conflict at baseline reported lower BGM at 6 months. Family, demographic, psychosocial, and disease-specific variables accounted for 26% of the variance in BGM frequency by both adolescent and caregiver report. Adolescents reporting greater diabetes-specific family conflict at baseline experienced higher HbA1c values at 6 months. Variables accounted for 23% and 28% of the variance in HBA1c by adolescent and caregiver report respectively. CONCLUSIONS Diabetes-specific responsibility and conflict have important implications for improving disease outcomes. Interventions targeting responsibility and conflict (i.e., reducing conflict while keeping caregivers involved in diabetes management) may help prevent the deterioration in BGM and HbA1c frequently seen during adolescence.

Barriers to Oral Medication Adherence for Adolescents with Inflammatory Bowel Disease

OBJECTIVE To identify family-reported, adherence-related barriers for adolescents with inflammatory bowel disease (IBD) and examine their relationship to 6-MP/azathioprine and 5-ASA medication adherence. METHODS Participants included 74 adolescents, aged 13-17 years, diagnosed with IBD and their caregivers. Adolescents and caregivers jointly completed a measure of barriers to medication adherence. Adherence to medication was measured by family-report, pill-count, and serum assay. RESULTS Families endorsed one to seven total barriers to medication adherence. The most commonly reported barriers included forgetting, being away from home, and interference with an activity. Neither demographic nor disease severity variables were related to the total number of reported barriers. Fewer total reported barriers was related to better adherence by adolescent and maternal report. CONCLUSION Most families experience at least one barrier to treatment adherence. Effective problem-solving around these barriers and its integration into future treatment protocols may help improve medication adherence in the pediatric IBD population.

Electronic measurement of medication adherence in pediatric chronic illness: a review of measures.

In the United States 13% to 9% of children (ages 0–17 years) have special healthcare needs (1). Unfortunately, 50–55% of children and their families do not follow treatment plans as prescribed (2). Such high rates of nonadherence (i.e., extent to which a person’s behavior does not correspond with agreed upon recommendations from a healthcare provider (3)) have significant negative consequences, including: greater risk of relapse, increased morbidity and mortality, unnecessary changes to the regimen, development of drug resistance, decreased cost-effectiveness of medical care, and inaccurate clinical trial results (2, 4–7). Thus, documentation of nonadherence rates, identification of barriers to or strategies to improve adherence, and development and integration of adherence interventions are imperative. Regrettably, despite increased recognition that adherence is a significant issue across pediatric disease groups, there remains a lack of consensus regarding the “best” adherence measure. Patient, parent, and provider-report, pharmacy refill data, pill counts, serum assays, and electronic monitors have all been used to monitor medication adherence with varying success. Of note, even though there remains no clear “gold standard” measure of medication adherence (8), the use of electronic monitoring has increased and is often employed as the standard to which other measures of adherence are compared (e.g., (9–11)). Given increased recognition of the role of adherence in health outcomes, the use of electronic monitors to assess adherence, and the increasing use of electronic measures as key components in interventions to improve adherence, it is critical that objective evaluation of their utility and evidence of their functional capabilities in real world settings be made available. In order to aid decision making related to using electronic adherence monitors in future studies or incorporating such measures into clinical practice in order to improve adherence rates, this systematic review will 1) provide a brief description of currently available electronic measures of medication adherence, 2) discuss the strengths and weaknesses of these measures (and validation information when available), and 3) provide examples of their use and relevant empirical data for a subsample of measures from our own research. A systematic review was completed using PubMed (12) to identify previous studies that used electronic measures of medication adherence in pediatric populations through February 2010. Search terms included: (adherence OR compliance) AND (electronic, technology, MEMS, Doser, MDIlog, Smartinhaler, Medsignals, Pillphone, Nebulizer, Chronolog, Drug Exposure Monitor). Initial device names were included from the authors’ experiences; additional names were added as identified through other search terms. References of identified articles were examined to identify additional published studies. Final inclusion/exclusion criteria and article selection is further illustrated in the Figure. A summary of monitor use by disease group is provided in the Table. Figure Study selection flow diagram (60). Reasons for exclusion: (1) not written in English; (2) primary or original study data not included; (3) electronic monitor of oral medication adherence not included (not prescribed treatment regiment [eg, blood glucose ... Table 1 Electronic monitor by illness group and websites for additional product and pricing information

Responsibility Sharing between Adolescents with Type 1 Diabetes and Their Caregivers: Importance of Adolescent Perceptions on Diabetes Management and Control

OBJECTIVE To analyze associations between factor scores for caregiver responsibility for direct and indirect diabetes management tasks with glycemic control and blood glucose monitoring (BGM) frequency. METHODS Two hundred and sixty one adolescents with type 1 diabetes and their caregivers completed the Diabetes Family Responsibility Questionnaire (DFRQ). Data on diabetes management (e.g., BGM frequency) and glycemic control (e.g., A1c values) were obtained. RESULTS Confirmatory factor analysis of the DFRQ revealed two factors-direct and indirect management tasks. Multivariate analyses demonstrated that adolescent perception of greater responsibility sharing with caregivers on direct management tasks was significantly associated with higher BGM frequency. CONCLUSIONS Adolescents who perceive greater caregiver responsibility, particularly around direct management tasks, engage in better diabetes management. Implications of these findings include designing interventions that encourage and sustain caregiver responsibility through adolescence and make explicit the contribution of caregivers.

Treatment Factors Affecting Longitudinal Quality of Life in New Onset Pediatric Epilepsy

OBJECTIVES Recognizing the importance of patient-reported outcomes, this longitudinal, prospective study examined: Changes in health-related quality of life (HRQOL) over seven months following antiepileptic drug (AED) initiation and the relationship of seizures, AED side-effects, and AED type to HRQOL. METHOD Parents of 124 children with newly diagnosed epilepsy completed measures of HRQOL and side-effects at each clinic visit. Treatment information was also collected. RESULTS HRQOL remained stable over time; however, seizures and AED side-effects significantly affected multiple HRQOL domains. Higher seizure activity was associated with decreased Physical HRQOL. Side-effects were negatively associated with all HRQOL domains. Children taking carbamazepine who experienced higher side-effects early in therapy demonstrated declining emotional functioning compared to children experiencing no/some side-effects. CONCLUSIONS AED side-effects, AED type, and seizure frequency were associated with longitudinal HRQOL in children with newly-diagnosed epilepsy. Routine assessment of AED side-effects and HRQOL may be useful for clinical decision making.

Telehealth behavioral treatment for medication nonadherence: a pilot and feasibility study.

Objective To evaluate an individually tailored multicomponent nonadherence treatment protocol using a telehealth delivery approach in adolescents with inflammatory bowel disease. Methods Nine participants, age 13.71±1.35 years, completed a brief treatment online through Skype. Medication nonadherence, severity of disease, and feasibility/acceptability data were obtained. Results Adherence increased markedly from 62% at baseline to 91% for mesalamine (&dgr;=0.63), but decreased slightly from 61% at baseline to 53% for 6-mercaptopurine /azathioprine. The telehealth delivery approach resulted in cost savings of

Correlates of glycemic control and quality of life outcomes in adolescents with type 1 diabetes

100 in mileage and 4 h of travel time/patient. Treatment session attendance was 100%, and the intervention was rated as acceptable, particularly in terms of treatment convenience. Conclusion Individually tailored treatment of nonadherence through telehealth delivery is feasible and acceptable. This treatment shows promise for clinical efficacy to improve medication adherence and reduce costs. Large-scale testing is necessary to determine the impact of this intervention on adherence and health outcomes.

Evaluation of a group-based behavioral intervention to promote adherence in adolescents with inflammatory bowel disease.

Ingerski LM, Laffel L, Drotar D, Repaske D, Hood KK. Correlates of glycemic control and quality of life outcomes in adolescents with type 1 diabetes.

Individually tailored treatment of medication nonadherence.

Objective To pilot test the feasibility and acceptability of a family-based group behavioral intervention and to improve medication adherence in adolescents diagnosed with inflammatory bowel disease. Methods Participants were 40 adolescents aged 11–18 years diagnosed with inflammatory bowel disease and their primary caregivers, who were randomized to either a four-session Family-Based Group Behavioral Treatment or Usual Care over a 6-week period. Adherence was measured using a multi-method, multi-informant assessment involving caregiver-report and patient-report, pill count data, and electronic monitoring. Results Adherence rates ranged from 66 to 89% for 6-mercaptopurine/azathioprine and 51 to 93% for mesalamine across assessment methods. The intervention was feasible, as evidenced by the 99% treatment session attendance rate, and acceptable based on patient and caregiver report. Repeated measures analysis of variance tests revealed nonsignificant differences between the conditions from baseline to post-treatment assessments for pill count, electronic monitor, and primary caregiver-reported adherence (P’s>0.05). There was a statistically significant improvement in patient-reported mesalamine adherence represented by a significant main effect for Condition (F=22.24, P<0.01; &dgr;=0.79) and Condition×Time interaction (F=13.32, P<0.05; &dgr;=0.69). Conclusion Findings suggest potential for use of behavioral intervention to improve medication adherence in this population. This intervention may be more effective with more complex regimens (e.g. multiple doses per day) such as those prescribed with mesalamine. Further research is needed to examine this type of intervention in more diverse samples with more active disease. Use of alternative adherence measurement approaches, including electronic pill boxes and/or real-time self-report (e.g. by text messaging, electronic diaries, etc.) is also recommended.