Mixed-methods research to support the use of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library.

BACKGROUND: No specific measures exist to assess patient-reported symptoms experienced by individuals with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle cell lymphoma (MCL). This study was conducted to elicit patient-reported CLL/SLL- and MCL-related symptoms and their impact on patients' lives. The study qualitatively and quantitatively evaluated sets of conceptually-selected EORTC Item Library items for assessing CLL/SLL- and MCL-related symptoms. METHODS: The qualitative component of the research included a literature review, clinician consultations, and patient interviews. Concepts important to patients were identified and coded; cognitive debriefing of the selected library items was completed with patients. CLL/SLL and MCL-related symptoms and impacts were organized in a structured conceptual model, which was mapped to item sets from the Item Library. The quantitative component comprised exploratory macro-level Rasch measurement theory (RMT) analysis conducted to provide supportive quantitative insight on the item sets. RESULTS: 41 patients (21-MCL; 20-CLL/SLL) and 5 clinicians participated in the qualitative study; 57 unique patients (30-MCL; 27-CLL/SLL) completed the EORTC items. The conceptual models generated from the qualitative work included symptoms and functional impacts of CLL/SLL and MCL. Symptom domains included swollen lymph nodes, B symptoms, abdominal issues, pain, fatigue, subjective cognitive impairment, anemia-related symptoms, bleeding, infection, and other issues (appetite loss, temperature fluctuation, rash, weight gain, sleep problems, cough). Impacts included physical function, role function, and other functions (psychological, social). Cognitive debriefing demonstrated that the separate item sets for CLL/SLL and MCL-related symptoms were well understood and aligned with patients' experiences. All selected items were included in the conceptual models. The exploratory RMT analysis showed that the item sets provided adequate coverage of the continuum of CLL/SLL- and MCL-related symptom severity. CONCLUSIONS: This study gathered qualitative and early quantitative evidence supporting use of the EORTC Item Library to assess CLL/SLL- and MCL-related symptoms and impacts. These items are promising candidates for measurement of patient-reported disease symptoms in these populations. A larger sample size will be essential to establish the psychometric properties necessary to support use in clinical trials. Patients who suffer from rare cancers of the blood, bone marrow, and lymph nodes can experience chronic and debilitating symptoms. At present, however, there are no dedicated instruments for assessing the patient's experience of symptoms of conditions like chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle cell lymphoma (MCL), or for assessing their impact on patients' lives. This research project aimed to address that need. The researchers selected relevant and clinically meaningful symptoms from the EORTC Item Library that assess fatigue, B symptoms, and CLL/SLL- and MCL-specific symptoms. Using patients and clinician interviews as well as quantitative analyses, the research revealed no major concerns with using these item sets to assess symptoms of CLL/SLL and MCL. Interviews with patients demonstrated that the separate item sets for CLL/SLL and MCL-related symptoms were well understood and aligned with patients' experiences. All selected items were included in the conceptual models. Item sets identified in this study can potentially be used to assess patient-reported symptom endpoints in clinical trial settings in these disease areas.

"I Can't Take off My Shirt or Do My Own Hair"-A Qualitative Investigation of the Symptoms and Impact Experience of Children and Adolescents with Fibrodysplasia Ossificans Progressiva (FOP).

INTRODUCTION: Fibrodysplasia ossificans progressiva (FOP) is an ultra-rare, severely disabling, autosomal dominant, congenital disease characterized by progressive multi-focal heterotopic ossification (HO) of skeletal muscle, ligaments, tendons, and fascia. Past FOP studies have focused on the clinical aspects of the disease; therefore, there is a paucity of qualitative research on the patient experience. Our objective was to better understand the experience of children and adolescents living with FOP from their and their parents' perspectives. METHODS: We conducted a qualitative research study comprising in-depth, open-ended interviews with children and adolescents with FOP and their parents. Semi-structured interviews were conducted via phone call or Microsoft Teams with parent-child dyads (n = 11), adolescents (n = 6), and two clinicians. Children/adolescents and their parents were asked open-ended questions to elicit their daily experience of FOP. RESULTS: Concepts were organized into two major themes: symptoms of FOP and the impact of FOP on daily life. Symptoms of FOP reported by children/adolescents, parents, and clinicians were pain, swelling, redness, and stiffness. Functional impacts of flares and FOP in general included accommodations, mobility, activities of daily living, daily activities, and social activities. Impacts were attributed to the difficulties children and adolescents faced living with a disease that prohibited common activities. CONCLUSIONS: This research documented the experience of children and adolescents with FOP and its effects on their daily lives. It provides a conceptual model for further exploration of the symptoms and impacts important to children and adolescents with FOP and their parents. Children and adolescents and their parents offered novel insights into life with the disease that have not previously been discussed in published literature. Future studies should build upon our conceptual model to create a holistic view of the patient experience of FOP, to inform clinical practice, and the assessment of the patient experience in clinical trials for the disease.

Patient-reported burden of dry eye disease in the UK: a cross-sectional web-based survey.

OBJECTIVES: To compare sociodemographics and vision-related quality of life (QoL) of individuals with or without dry eye disease (DED); and to explore the impact of DED symptom severity on visual function, activity limitations and work productivity. DESIGN: Cross-sectional web-based survey. SETTING: General UK population. PARTICIPANTS: Adults ≥18 years with (N=1002) or without (N=1003) self-reported DED recruited through email and screened. MAIN OUTCOME MEASURES: All participants completed the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25), with six additional questions (items A3-A8), and the EuroQol 5 dimensions 5 levels. DED participants also completed Impact of Dry Eye on Everyday Life questionnaire, 5-item Dry Eye Questionnaire and the Standardised Patient Evaluation of Eye Dryness questionnaire along with the Ocular Comfort Index, Work Productivity and Activity Impairment and the Eye Dryness Score (EDS), a Visual Analogue Scale. RESULTS: Baseline demographic and clinical characteristics were similar in participants with versus without DED (mean age, 55.2 vs 55.0 years; 61.8% vs 61.0% women, respectively) based on recruitment targets. Scores were derived from NEI VFQ-25 using the new 28-item revised VFQ (VFQ-28R) scoring. Mean (SD) VFQ-28R scores were lower in participants with versus without DED, indicating worse functioning (activity limitations, 73.3 (12.3) vs 84.4 (12.3); socioemotional functioning, 75.3 (21.5) vs 90.3 (16.2); total score, 71.6 (12.8) vs 83.6 (12.6)). Higher percentages of problems/inability to do activities were observed among those with versus without DED. The impact of DED on visual function was worse for participants with more severe DED symptoms, as assessed by EDS. In addition, a higher EDS was associated with worse symptoms on common DED scales and a worse impact on work productivity. CONCLUSIONS: DED symptoms were associated with negative effects on visual function, activities and work productivity, whereas worse DED symptoms had a greater impact on vision-related QoL and work productivity.

Value-Generating Exploratory Trials in Neurodegenerative Dementias.

Drug development for Alzheimer disease and other neurodegenerative dementias, including frontotemporal dementia, has experienced a long history of phase 2 and phase 3 clinical trials that failed to show efficacy of investigational drugs. Despite differences in clinical and behavioral characteristics, these disorders have shared pathologies and face common challenges in designing early-phase trials that are predictive of late-stage success. Here, we discuss exploratory clinical trials in neurodegenerative dementias. These are generally phase 1b or phase 2a trials that are designed to assess pharmacologic effects and rely on biomarker outcomes, with shorter treatment durations and fewer patients than traditional phase 2 studies. Exploratory trials can establish go/no-go decision points, support proof of concept and dose selection, and terminate drugs that fail to show target engagement with suitable exposure and acceptable safety profiles. Early failure saves valuable resources including opportunity costs. This is especially important for programs in academia and small biotechnology companies but may be applied to high-risk projects in large pharmaceutical companies to achieve proof of concept more rapidly at lower costs than traditional approaches. Exploratory studies in a staged clinical development program may provide promising data to warrant the substantial resources needed to advance compounds through late-stage development. To optimize the design and application of exploratory trials, the Alzheimer's Drug Discovery Foundation and the Association for Frontotemporal Degeneration convened an advisory panel to provide recommendations on outcome measures and statistical considerations for these types of studies and study designs that can improve efficiency in clinical development.

Mental Health Providers' Assessment of Parents' Reactions to their Children's Elevated Depressive Symptoms.

This study assessed parental reactions to the report of elevated depressive symptoms in a sample of 29 youth with type 1 diabetes (ages 8-17 years; 48% female) who scored ≥15 on the Center for Epidemiologic Studies Depression Scale for Children (CES-DC). We also assessed parental depressive symptoms and how the presence of such symptoms was linked to parental reactions to the report of a positive screening score in their children and subsequent acceptance of a mental health referral. Mental health professionals contacted parents to discuss elevated scores and offer a mental health referral. Two coders reviewed the documentation of phone contacts made by mental health professionals and categorized parental responses to their child's elevated CES-DC score and the disposition plan. Youth and parent depressive symptoms were modestly correlated (r = 0.21, P = .01). About half (55%, 16/29) of parents were unaware of their child's depressive symptoms. Only 14% (4/29) of youth were already receiving mental health care while 28% (8/29) of parents accepted a referral. Parents with depressive symptoms were frequently unaware of their child's symptoms. Findings provide insight into parental reactions to learning of their child's depressive symptoms and highlight the need for more research on parental mood and reactions to their child's positive screen for depressive symptoms, as a potential barrier to mental health referral acceptance.

Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder.

PURPOSE: Various clinical outcome assessments (COAs) are used in clinical research to assess and monitor treatment efficacy in pediatric attention-deficit/hyperactivity disorder (ADHD) trials. It is unclear whether the concepts assessed are those that are important to patients and their caregivers. The concepts measured by commonly used COAs in this population have not been explicitly compared. METHODS: We conducted reviews of the qualitative literature to extract information on pediatric ADHD-related concepts reported by pediatric patients, parents, and teachers. Using these concepts, we developed a conceptual framework of pediatric ADHD using both the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria and the additional symptoms and behavioral impacts identified in the literature. We searched for COAs that have been used in pediatric ADHD research and mapped their items based on their conceptual underpinning. RESULTS: Of the 27 COAs found in the empirical literature, 4 COAs assessed only DSM symptoms. The most comprehensive coverage of our conceptual framework was seen in the Swanson, Nolan, and Pelham Rating Scale-DSM-IV (SNAP-IV). Eighteen COAs were used in at least 1 clinical trial: ADHD-Rating Scale-IV (ADHD-RS-IV) was used most often (n=77), followed by SNAP-IV (n=50), Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP; n=31), Weiss Functional Impairment Rating Scale (WFIRS; n=24), and Vanderbilt ADHD Diagnostic Rating Scale (VADRS; n=15). CONCLUSION: We identified symptoms and behavioral impacts from qualitative studies in pediatric ADHD that are not included in DSM-based criteria. Most COAs used in pediatric ADHD clinical trials measure only those symptoms listed in the DSM. While these COAs can measure symptom severity, they may not assess the full range of symptoms and impacts important to patients and their caregivers. Future research is needed to measure all concepts important to patients and caregivers within ADHD clinical trials.

Patient-Reported Burden of Dry Eye Disease in the United States: Results of an Online Cross-Sectional Survey.

PURPOSE: To evaluate functional vision, general health status, and work productivity in individuals with and without dry eye disease (DED). DESIGN: Cross-sectional study. METHODS: Setting: General US population (2018). STUDY POPULATION: Adults ≥18 years with (n = 1003) or without (n = 1006) self-reported DED. MAIN OUTCOME MEASURES: All respondents completed the National Eye Institute Visual Function Questionnaire (VFQ) and the EuroQol 5-dimensions 5-levels (EQ-5D-5L). All respondents with DED completed the eye dryness score (EDS) visual analogue scale, Ocular Comfort Index (OCI), and Work Productivity and Activity Impairment (WPAI) questionnaire. Half of respondents with DED completed the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire; the other half completed the Dry Eye Questionnaire 5 (DEQ-5) and Standardized Patient Evaluation of Eye Dryness (SPEED), McMonnies, and Symptom Assessment in Dry Eye (SANDE) questionnaires. All analyses were descriptive. RESULTS: Respondents with DED reported more comorbidities, greater exposure to adverse environmental conditions, and lower (worse) mean (standard deviation) scores on the modified Rasch-scored 28-item VFQ (VFQ-28R) total score (68.8 [11.9] vs 81.2 [12.7]) and EQ-5D-5L (0.82 [0.13] vs 0.88 [0.14]) than respondents without DED. Respondents with DED and EDS ≥60 (highest discomfort) fared worse on OCI, VFQ-28R, and WPAI than respondents with DED and EDS <40 (lowest discomfort). Similar findings were observed with IDEEL, DEQ-5, SPEED, McMonnies, and SANDE scores. CONCLUSIONS: There is a substantial burden of DED on functional vision, general health status, and productivity; and further, these parameters appear to worsen with increasing EDS.

Assessing readiness for independent self-care in adolescents with type 1 diabetes: Introducing the RISQ.

AIM: To design and evaluate psychometrics of adolescent self-report and parent proxy-report questionnaires assessing readiness for independent self-care in adolescents with type 1 diabetes (RISQ-T and RISQ-P). METHODS: 178 adolescents with type 1 diabetes (ages 13-17 years) and their parents completed the 20-item RISQ-T and 15-item RISQ-P, along with diabetes-specific measures of parent involvement, self-efficacy, burden, and treatment adherence. Evaluation of psychometric properties included calculation of internal consistency, adolescent and parent agreement, test-retest reliability, concurrent and predictive validity. RESULTS: The RISQ-T (α = 0.78) and RISQ-P (α = 0.77) demonstrated sound internal consistency. Higher RISQ-T and RISQ-P scores (indicating more adolescent readiness for independent self-care) showed significant associations with less parent involvement in diabetes care (adolescent r = -0.34; parent r = -0.47; p < .0001), greater adolescent diabetes self-efficacy (adolescent r = 0.32; parent r = 0.54; p < .0001), less parent-endorsed diabetes-related burden (parent r = -0.30; p < .0001), and greater treatment adherence (adolescent r = 0.26, p = .0004; parent r = 0.31, p < .0001). Adolescent and parent scores were significantly correlated (r = 0.35; p < .0001); test-retest reliability was reasonable (ICC RISQ-T r = 0.66; RISQ-P r = 0.71). Higher baseline RISQ-P scores significantly predicted reduced family involvement after six months (ß = -0.14, p = .02). CONCLUSIONS: RISQ-T and RISQ-P demonstrate sound psychometric properties. Surveys may help inform diabetes teams of the level of support needed to facilitate shift to independent self-management.

Examination of Psychosocial and Physiological Risk for Bulimic Symptoms in Youth With Type 1 Diabetes Transitioning to an Insulin Pump: A Pilot Study.

Objectives: This study tested hypotheses drawn from a risk model positing that psychosocial risk plus disease-related and treatment factors contribute to bulimic symptoms in youth with type 1 diabetes (T1D) transitioning to an insulin pump. The goal of this study was to examine whether disease-related factors, particularly disease- and treatment-based disruption in hunger and satiety, contribute to report of bulimic symptoms in youth with T1D after accounting for psychosocial risk factors. Methods: 43 youth (ages 10-17, 54% female) with established T1D were recruited before transition from multiple daily injections to insulin-pump therapy from three tertiary pediatric diabetes centers. Participants completed measures of bulimic symptoms, depressive symptoms dietary restraint, and the Diabetes Treatment and Satiety Scale, a diabetes-specific questionnaire assessing hunger and satiety cues and eating behavior in response to blood glucose levels and treatment. Results: Hierarchical multiple regression was used to assess contributions of psychosocial and disease-based risk to report of bulimic symptoms. After assessing the contributions of body mass index, body image dissatisfaction, and dietary restraint, a significant 2-way interaction emerged between depression and diabetes-related uncontrollable hunger related to bulimic symptoms (ß = 1.82, p < .01). Conclusions: In addition to psychosocial risk, disease- and treatment-based hunger and satiety dysregulation appear to be important factors contributing to report of bulimic symptoms in youth with T1D. These preliminary findings have significant treatment implications for bulimic symptoms in youth with T1D.

Depressive Symptoms, Emotion Dysregulation, and Bulimic Symptoms in Youth With Type 1 Diabetes: Varying Interactions at Diagnosis and During Transition to Insulin Pump Therapy.

This study evaluated the associations between depressive symptoms, emotion dysregulation and bulimic symptoms in youth with type 1 diabetes (T1D) in the context of the diagnosis and treatment of T1D. Study participants were 103 youth in 2 distinct groups: newly diagnosed (New) or transitioning to pump therapy (continuous subcutaneous insulin infusion [CSII]; "Pump"), who completed questionnaires regarding symptoms of depression, emotion dysregulation, and bulimia. Glycemic control (A1c), height, weight, and questionnaires were evaluated within 10 days of diagnosis (n = 58) or at education/clinic visit before starting insulin utilizing CSII (n = 45). In the newly diagnosed group, only depression accounted for significant variance in bulimia scores (ß = .47, P < .01). For the group with disease treatment experience (Pump), but not for the newly diagnosed group (New), greater depressive symptoms and emotion dysregulation were associated with greater bulimic symptoms. Depressive symptoms and emotion dysregulation, an indicator of poor coping/behavioral control, could help explain adoption of disordered eating behaviors in youth with T1D who are transitioning to pump therapy.

[Prevalence of Disturbed Eating Behavior in Children and Adolescents with Type 1 Diabetes: Assessment and Comparison to Healthy Peers--Results of a Multicenter Questionnaire-based Study]. / Prävalenz gestörten Essverhaltens bei Typ 1 Diabetes im Kindes- und Jugendalter: Erfassungsmöglichkeiten und Vergleich mit gesunden Gleichaltrigen--Ergebnisse einer multizentrischen Fragebogenstudie.

INTRODUCTION: Published data on prevalence of disturbed eating behavior in youth with type 1 diabetes are heterogeneous. This study assesses the prevalence rate of disturbed eating behavior in a representative German sample of children and adolescents with type 1 diabetes. The prevalence rate is compared to the one published for a national sample of healthy peers. Furthermore prospects as well as limits of a generic screening tool used to identify disturbed eating behavior are compared to those of a diabetes specific screening tool. MATERIAL AND METHODS: A total of 246 children and adolescents (age: 11-19 years) with type 1 diabetes, from 6 pediatric diabetes centers in Germany, completed the generic SCOFF questionnaire and the diabetes specific Diabetes Eating Problem Survey-Revised (DEPS-R) to assess their eating behavior. Prevalence data were compared to representative data from a nationwide survey in Germany (KiGGS-study). RESULTS: A total of 16.3% of the children and adolescents with type 1 diabetes scored above the SCOFF cut-off (≥ 2) (24.2% of the girls and 8.9% of the boys). The percentages in the healthy controls were 28.9% for girls and 15.2% for boys. Compared to this the prevalence of disturbed eating behavior was lower in the diabetes group (p=0.017 and p<0.001). According to the diabetes specific DEPS-R 11.2% of the boys and 13.2% of the girls with type 1 diabetes practiced insulin-purging. The association between SCOFF-scores and the items referring to insulin-purging in DEPS-R, was stronger for girls than for boys (r=0.437 vs. r=0.144). Among the young people with type 1 diabetes DEPS-R-scores showed stronger associations to the quality of metabolic control (HbA1c) than the SCOFF (boys: r=0.357 vs. r=0.217 and girls: r=0.368 vs. r=0.131). DISCUSSION: Children and adolescents with type 1 diabetes are not more frequently affected by disturbed eating behavior than their healthy peers. Particularly boys with type 1 diabetes practicing insulin-purging, are not reliably detected by a generic screening tool. CONCLUSION: As part of long-term care a diabetes specific screening tool should be used to identify adolescents with type 1 diabetes and disturbed eating behavior more reliably.

Youth-Perceived Burden of Type 1 Diabetes: Problem Areas in Diabetes Survey-Pediatric Version (PAID-Peds).

BACKGROUND: Management of type 1 diabetes in childhood can be challenging and overwhelming. Despite availability of advanced treatments and new technologies, the burden has not decreased as current approaches to intensive therapy are not without need for patient involvement. This study aimed to design and validate a measure of youth-reported burden related to type 1 diabetes management. METHOD: A multidisciplinary pediatric diabetes team designed the survey, based on a previously validated parent measure of diabetes-related burden (PAID-PR); survey revisions and pilot testing followed. The 20-item PAID-Peds assesses burden over the past month. Youth with type 1 diabetes (N = 126, ages 8-17, intensively treated with insulin pump therapy or multiple daily injections) completed the new survey, along with other surveys; parents completed companion measures. Electronic medical records and blood glucose meter download provided other salient data. RESULTS: The PAID-Peds displayed excellent internal consistency (α = .94) and acceptable test-retest reliability (intraclass correlation .66, P < .0001). The PAID-Peds correlated significantly with both youth and parent reports of diabetes-specific family conflict, negative affect around blood glucose monitoring, depressive symptomatology, trait anxiety, and quality of life. It was not correlated with demographic or clinical characteristics of the youth. CONCLUSIONS: This new measure, the PAID-Peds, of youth-reported burden related to type 1 diabetes may have clinical and research utility, particularly in the current era of emerging diabetes technologies that require ongoing patient input.

Developmental changes in the roles of patients and families in type 1 diabetes management.

Developmentally-tailored diabetes self-care education and support are integral parts of contemporary multidisciplinary T1D care. The patient with T1D must have the support of the family and the diabetes team to maintain the rigors of diabetes management, but the specific roles of patients and families with regard to daily diabetes tasks change considerably throughout the developmental span of early childhood, middle childhood/school-age years, and adolescence. This review provides a framework of key normative developmental issues for each of these developmental stages. Within this context, ideal family diabetes management is reviewed within each developmental stage and anticipated challenges that can arise during these stages and that can adversely impact diabetes management are presented. This paper also summarizes empirical evidence for specific intervention and care strategies to support optimal diabetes management across these stages in order to maximize opportunities for a successful transfer of diabetes management tasks from parents to maturing youth. Finally, the review provides an emphasis on approaches to promote family teamwork and adolescent diabetes self-care adherence as well as opportunities to use novel technology platforms as a means to support optimal diabetes management.

Youth and parent measures of self-efficacy for continuous glucose monitoring: survey psychometric properties.

BACKGROUND: This study aimed to describe the development and psychometric evaluation of novel youth and parent measures of self-efficacy related to continuous glucose monitoring (CGM) in pediatric patients with type 1 diabetes. This evaluation also assessed the predictive validity of the CGM Self-Efficacy (CGM-SE) surveys on CGM use and hemoglobin A1c (HbA1c) levels. SUBJECTS AND METHODS: Study participants included 120 youth with type 1 diabetes for ≥1 year enrolled in a 2-year randomized clinical trial comparing CGM use with and without the addition of a family-focused CGM behavioral intervention. Youth and parents completed the CGM-SE surveys at randomization after a 1-week run-in to assess CGM tolerability. Analyses of predictive validity excluded the intervention group and included 61 youth in the control group in order to assess CGM use and HbA1c outcomes 3 and 6 months after randomization. RESULTS: At study entry, youth were 12.7±2.7 years old with a diabetes duration of 6.1±3.6 years and an HbA1c level of 8.0±0.8% (64±9 mmol/mol); blood glucose monitoring frequency was 6.8±2.4 times/day, and 84% received pump therapy. CGM-SE surveys had acceptable internal consistency (Cronbach's α=0.80 for youth and 0.82 for parents). Youth reporting higher baseline CGM self-efficacy (CGM-SE score of >80) had significantly greater CGM use and lower HbA1c level after 3 and 6 months compared with youth reporting lower baseline CGM self-efficacy (CGM-SE score of ≤80). CONCLUSIONS: The CGM-SE surveys appear to have strong psychometric properties. CGM self-efficacy may offer an opportunity to assess the likelihood of CGM adherence and glycemic improvement in youth with type 1 diabetes in clinical and research settings.

Text messaging intervention for teens and young adults with diabetes.

Adolescents and young adults use text messaging as their primary mode of communication, thus providing an opportunity to use this mode of communication for mobile health (mHealth) interventions. Youth with diabetes are an important group for these mHealth initiatives, as diabetes management requires an enormous amount of daily effort and this population has difficulty achieving optimal diabetes management. Goal setting and self-efficacy are 2 factors in the management of diabetes. We examined the feasibility of a healthy lifestyle text messaging program targeting self-efficacy and goal setting among adolescents and young adults with diabetes. Participants, ages 16-21, were assigned to either a text messaging group, which received daily motivational messages about nutrition and physical activity, or a control group, which received paper-based information about healthy lifestyle. Both groups set goals for nutrition and physical activity and completed a measure of self-efficacy. Participants' mean age was 18.7 ± 1.6 years old, with diabetes duration of 10.0 ± 4.6 years, and A1c of 8.7 ± 1.7%. The text messaging intervention was rated highly and proved to be acceptable to participants. Self-efficacy, glycemic control, and body mass index did not change over the course of the short, 1-month pilot study. Positive, daily, motivational text messages may be effective in increasing motivation for small goal changes in the areas of nutrition and physical activity. These interventions may be used in the future in youth with diabetes to improve diabetes care. Utilizing more targeted text messages is an area for future research.

Care utilization in a pediatric diabetes clinic: cancellations, parental attendance, and mental health appointments.

OBJECTIVE: To examine care utilization, family attendance, and hemoglobin A1c levels in a multidisciplinary pediatric diabetes clinic. STUDY DESIGN: This retrospective electronic record review of deidentified data included patients (99% with type 1 diabetes) with established diabetes care, aged <30 years (mean age, 15 ± 5.2 years), and duration of diabetes >1 year (mean 8.5 ± 5.1 years) at first visit during a 2-year period. Outcomes included care utilization, family attendance, and glycemic control, as indicated by hemoglobin A1c level. Analyses included t tests, ANOVA, χ2 tests, ORs and 95% CIs, and multivariate analyses. RESULTS: The study cohort comprised 1771 patients, with a mean of 5.8 ± 2.8 visits per patient. Roughly 15% of the scheduled appointments resulted in a cancellation or no-show; 61% of patients missed ≥1 visit. Patients with ≥2 missed appointments had higher A1c values and were older than those with <2 missed visits. Almost one-half of visits were attended by mothers alone; fathers attended 22% of visits. Patients whose fathers attended ≥1 visit had lower A1c values than patients whose fathers never attended. Eighteen percent of patients had onsite mental health visits. Patients with ≥1 mental health visit had higher mean A1c values, shorter duration of diabetes, and were younger compared with those with no mental health visits. CONCLUSION: Our observations suggest the need to encourage attendance at diabetes visits and to include fathers to improve A1c values. The high rate of missed visits, especially in patients with poor glycemic control, identifies wasted provider effort when late cancellations/no-shows result in vacant clinic time. It is important to explore reasons for missed visits and to identify approaches to maximizing attendance, such as extended evening/weekend clinic hours and virtual visits.

Technology to optimize pediatric diabetes management and outcomes.

Technology for diabetes management is rapidly developing and changing. With each new development, there are numerous factors to consider, including medical benefits, impact on quality of life, ease of use, and barriers to use. It is also important to consider the interaction between developmental stage and technology. This review considers a number of newer diabetes-related technologies and explores issues related to their use in the pediatric diabetes population (including young adults), with a focus on psychosocial factors. Areas include trend technology in blood glucose monitoring, continuous glucose monitoring, sensor-augmented insulin pumps and low glucose suspend functions, internet applications including videoconferencing, mobile applications (apps), text messaging, and online gaming.

Disordered eating behaviors in youth with type 1 diabetes: prospective pilot assessment following initiation of insulin pump therapy.

BACKGROUND: There is risk for disordered eating behaviors in type 1 diabetes, especially related to insulin manipulation. Implementation of insulin pump therapy may encourage either normalization of eating behaviors or a greater focus on food intake due to renewed emphasis on carbohydrate counting. There is need for prospective studies to assess disordered eating behaviors upon implementation of pump therapy using diabetes-specific measurement tools. SUBJECTS AND METHODS: In a multicenter pilot study, 43 youth with type 1 diabetes, 10-17 years old, were assessed prior to pump initiation and after 1 and 6 months of pump therapy. Youth completed the Diabetes-specific Eating Problems Survey-Revised (DEPS-R), a validated measure of risk for both diabetes-specific and general disordered eating behaviors. RESULTS: Youth (45% female), 13.3 years old with diabetes for 2.1 years, had a mean hemoglobin A1c of 8.3±1.3% (68±14.5 mmol/mol) at baseline. DEPS-R scores decreased over time (P=0.01). Overall rate of high risk for eating disorders was low. Overweight/obese youth endorsed more disordered eating behaviors than normal-weight participants. DEPS-R scores were correlated with z-score for body mass index at all three time points and with hemoglobin A1c after 1 and 6 months. Hemoglobin A1c did not change significantly over the 6 months and was higher in overweight/obese compared with normal-weight participants. CONCLUSIONS: Initiation of insulin pump therapy was associated with diminished endorsement of disordered eating behaviors in youth with type 1 diabetes. Longer follow-up studies are needed to assess the impact of insulin pump therapy on glycemic control, weight status, and disordered eating behaviors in this vulnerable population.

Transition to adult care for youth with type 1 diabetes.

Emerging adults with type 1 diabetes are at risk for poor glycemic control, gaps in medical care, and adverse health outcomes. With the increasing incidence in type 1 diabetes in the pediatric population, there will be an increase in the numbers of teens and young adults transferring their care from pediatric providers to adult diabetes services in the future. In recent years, the topic of transitioning pediatric patients with type 1 diabetes to adult diabetes care has been discussed at length in the literature and there have been many observational studies. However, there are few interventional studies and, to date, no randomized clinical trials. This paper discusses the rationale for studying this important area. We review both observational and interventional literature over the past several years, with a focus on new research. In addition, important areas for future research are outlined.

Psychosocial correlates of continuous glucose monitoring use in youth and adults with type 1 diabetes and parents of youth.

BACKGROUND: Continuous glucose monitoring (CGM) has been shown to improve glycemic control and reduce hypoglycemia with consistent use. Youth, however, are unlikely to use CGM consistently. We compared psychological characteristics of youth with type 1 diabetes, their parents, and adults with type 1 diabetes randomized to CGM or standard blood glucose monitoring (BGM). This study was an ancillary study, and participants completed the questionnaires at the 6-month visit of the main study. SUBJECTS AND METHODS: Participants enrolled at a single site of the Juvenile Diabetes Research Foundation CGM trial completed questionnaires and provided diabetes management data. Participants were randomized to the CGM or BGM group for 6 months. RESULTS: Parents in both groups reported more fear of hypoglycemia than youth in the corresponding groups. CGM youth and parents reported more negative affect around BGM than those in the BGM group. CGM youth reported more trait anxiety than BGM youth, whereas CGM adults reported less state and trait anxiety than BGM adults. CGM parent-proxy report of depression was significantly higher than that reported by BGM parents. CONCLUSIONS: Youth, their parents, and adults report different psychological impacts of CGM use. In some groups and with some variables, CGM use was associated with a positive psychosocial impact, whereas in others CGM use was associated with a negative psychosocial impact. Future research should explore the psychological consequences of CGM use.