Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

Psychosocial Staffing and Implementation of the International Society for Pediatric and Adolescent Diabetes Psychological Care Guidelines in U.S. Pediatric Diabetes Clinics.

Background: Few studies have examined the implementation of the International Society for Pediatric and Adolescent Diabetes (ISPAD) Clinical Practice Consensus Guidelines for the Psychological Care of Children and Adolescents with Type 1 Diabetes. Objective: To collect benchmark data on psychosocial staffing and implementation of the ISPAD guidelines across U.S. pediatric diabetes clinics. Methods: Medical (n = 95; 77 endocrinologists and 18 advance practice providers) and psychosocial (n = 86; 43 social workers and 43 psychologists) providers from 98 of 115 contacted clinics completed an online survey (85% response rate). Providers reported the number of psychosocial staff and rated the adequacy of psychosocial staffing, quality of psychosocial care, and adherence to the ISPAD guidelines in their clinics. χ2 Tests and ANOVA were used to examine differences across clinic size and across medical and psychosocial providers. Results: Clinics averaged a total of ∼4 hours per week of psychosocial provider time per 100 patients with type 1 diabetes. Only 27% of providers agreed that psychosocial staffing was adequate, and 35% described their psychosocial care as comprehensive. Implementation of the ISPAD guidelines varied across clinics, with minimal differences across clinic size. Medical providers reported that evidence-based psychological assessment and interventions were delivered consistently by <55% of clinics. Psychosocial, compared with medical, providers were more likely to report frequent implementation of psychosocial assessment and intervention guidelines. Conclusion: Psychological care in U.S. pediatric type 1 diabetes clinics does not consistently meet the ISPAD guidelines, and many clinics lack adequate psychosocial staff. These benchmark data are a foundational step to improve psychosocial care for pediatric patients with type 1 diabetes.

Development and Evaluation of the Pediatric Diabetes Routine Questionnaire for Parents of Young Children with Type 1 Diabetes.

This study describes the development and psychometric evaluation of the Pediatric Diabetes Routines Questionnaire for Parents of Young Children (PDRQ-PYC) with type 1 diabetes, a measure adapted from the school-age and adolescent versions of the PDRQ, to measure diabetes-specific routines in families with children under age 6 years with type 1 diabetes. Participants included 173 parents of young children with type 1 diabetes (YC-T1D) who completed measures of diabetes-specific routines, diabetes adjustment, self-efficacy, benefit finding, depression, child behavior problems, spousal support, and T1D treatment engagement. Exploratory factor analysis supported a one-factor model consisting of a unidimensional PDRQ-PYC total score. The PDRQ-PYC total score demonstrated good internal consistency, convergent validity, and criterion validity. The present study demonstrates that PDRQ-PYC is a valuable and feasible tool for measuring the consistency and regularity with which families of YC-T1D perform T1D management tasks. Along with the school-age and adolescent versions of the PDRQ, the PDRQ-PYC now provides the ability to assess diabetes-specific routines from early childhood through adolescence and findings support the notion that routines are associated with engagement in diabetes tasks.ClinicalTrials.gov Identifier NCT03222180 (first posted July 19, 2017).

The association between pediatric mental health disorders and type 1 diabetes-related outcomes.

OBJECTIVE: Transition from pediatric to adult healthcare systems is a difficult process for young adults with Type 1 Diabetes (T1D) and most patients experience a deterioration in disease control. Mental health (MH) disorders are common in individuals with T1D and are believed to play a role in disease control and transition of care. We evaluated the association between the presence of pediatric MH disorder and measures of success in diabetes care in young adults who recently transitioned to adult care. RESEARCH DESIGN AND METHODS: Retrospective cohort study of young adults in a large adult endocrinology system who transitioned from a pediatric hospital system after 2009. MH disorders were diagnosed by clinical pediatric psychologists during routine care at the pediatric hospital. Measurements of Hemoglobin A1c, diabetes-related emergencies, clinic attendance and intervals in transition were assessed and compared between the pediatric and adult hospital systems. RESULTS: 237 young adults were identified and 100 (42%) of these were diagnosed with a MH disorder during pediatric care. Presence of a MH disorder was associated with higher Hemoglobin A1c levels prior to transition and increased rates of diabetes-related hospitalizations during the transition interval. Patients with a MH disorder were less likely to establish a pattern of consistent follow up after transition (p = 0.021). CONCLUSIONS: MH disorders are common and predict greater challenges with diabetes management and less effective transition into the adult endocrinology system. Early recognition of MH disorders may allow for allocation of more proactive and intensive support for affected patients.

Feasibility of Implementing a Pediatric Diabetes Clinic via Telehealth.

OBJECTIVE: In response to the coronavirus disease 2019 (COVID-19) pandemic and social distancing guidelines, our pediatric diabetes team rapidly changed the format of conducting diabetes clinic from in person to telehealth. We compared the actual number and rate of completed, canceled, and no-show visits between an 8-week period in 2019, when we exclusively conducted visits in person and the same 8-week period in 2020, during the COVID-19 quarantine, when we exclusively conducted visits via telehealth. METHODS: We used electronic health record data for all patients, as well as Dexcom continuous glucose monitoring data collected for a subset of youths during the COVID-19 quarantine and the immediate pre-COVID-19 period. RESULTS: Although there was a difference in the absolute number of in-person versus telehealth visits canceled during these two time periods, there was no difference in the rates of completed, canceled, and no-show visits completed in person or via telehealth. This finding suggests that, despite a rapid shift to a completely new health care delivery model, our providers completed a similar rate of patient care via telehealth during the COVID-19 quarantine and that telehealth may be a feasible method for providing diabetes care. However, our results also suggested that youths' glucose management was less optimal during the quarantine period. CONCLUSION: COVID-19 presented an opportunity to adopt and test the feasibility of using a telehealth delivery model for routine diabetes care. Yet, to make telehealth a viable treatment delivery alternative will likely involve the uptake of new clinic procedures, investment in institutional infrastructure, and team-based flexibility.

Erratum: Feasibility of Implementing a Pediatric Diabetes Clinic via Telehealth. Diabetes Spectrum 2021;34:190-197 (https://doi.org/10.2337/ds20-0060).

[This corrects the article on p. 190 in vol. 34, PMID: 34149260.].

Benefit finding among parents of young children with type 1 diabetes.

Benefit finding, perceived positive effects of adversity, has been associated with psychological well-being in people with chronic illnesses and with better adherence for adolescents with type 1 diabetes (T1D). Our qualitative research with parents of young children (< 6 years old) with T1D indicated that benefit finding (BF) is a common parental coping mechanism, but no tools exist to measure BF in parents. We determined psychometric properties of the Diabetes Benefit Finding Scale for Parents (DBFS-P), a 16-item questionnaire adapted from the validated adolescent version. Parents of young children with T1D (n = 172) were participants in a randomized trial of an online intervention. We examined the DBFS-P factor structure through principal component analysis (PCA); internal consistency through Cronbach's alpha; convergent validity via bivariate correlations between the DBFS-P and measures of parental depression, anxiety, T1D self-efficacy, and hypoglycemia fear; and discriminant validity via bivariate correlations between the DBFS-P and measures of parental somatization and child behavior problems. PCA revealed one factor (56.47% variance) with Cronbach's α = 0.95. Convergent validity of the DBFS-P was supported by significant correlations with parental depression (r = -0.35, P < 0.001), anxiety (r = -0.20, P = 0.008), T1D self-efficacy (r = 0.36, P < 0.001), and hypoglycemia fear (r = 0.27, P < 0.001). Non-significant correlations with parental somatization (r = -0.06, P = 0.42) and child behavior problems (r = -0.12, P = 0.14) support its discriminant validity. The DBFS-P demonstrated good psychometric properties as a tool for assessing BF among caregivers.

Development and Validation of the Pediatric Diabetes Routines Questionnaire for Adolescents.

This study describes the development and psychometric evaluation of an adolescent self-report version of the Pediatric Diabetes Routines Questionnaire (PDRQ:A), a measure of diabetes-specific routines for youth with type 1 diabetes, and further validation of the parent-version (PDRQ:P) in an adolescent sample. Participants included 120 parent-adolescent dyads (ages 12-17) and an additional 24 parents who completed measures of diabetes-specific adolescent routines, general adolescent routines, diabetes self-care, and family support of youth diabetes care. The PDRQ:P/A demonstrated good internal consistency, test-retest reliability, and parent-child agreement, and adequate validity coefficients. Confirmatory factor analysis supported a one-factor model. Promising results were obtained. The PDRQ:P/A is a clinically feasible parent- and self-report measure that can provide valuable information regarding how frequently adolescents engage in their diabetes management tasks in a consistent manner. Addition of an adolescent report format will enhance the utility of the measure for clinical and research use.

Type 1 diabetes in very young children: a model of parent and child influences on management and outcomes.

The incidence of type 1 diabetes (T1D) in very young children (YC-T1D) is increasing globally. Managing YC-T1D is challenging from both a medical and psychosocial perspective during this vulnerable developmental period when complete dependence upon parental caretaking is normative and child behavior is unpredictable. The consequences of suboptimal glycemic control during this age range are substantial since these children will have T1D for many years and they are prone to adverse neuropsychological sequelae. Poor adaptation to T1D during these early years may engender a persistent trajectory of negative outcomes that can be very resistant to change. The empirical research on the YC-T1D population (age <6 yr) has indicated multiple mechanisms through which parent characteristics, parent coping skills, and child characteristics interact to yield a pattern of T1D management behaviors that affect T1D outcomes. However, this research has not yet led to a well-conceived conceptual model for identifying and understanding these mechanisms or for specifying research gaps and future research directions. The aim of this review is to propose such a conceptual model linking parent characteristics, parent coping, and child characteristics to T1D management behaviors and outcomes. This article reviews the literature focusing on research pertinent to YC-T1D and elements of our proposed model, identifies and discusses gaps in the literature, offers directions for future research, and considers a range of possible interventions targeting the unique needs of this special population.

Health Care Transition for Young Adults With Type 1 Diabetes: Stakeholder Engagement for Defining Optimal Outcomes.

Objectives: Research on the transition to adult care for young adults with type 1 diabetes (T1D) emphasizes transition readiness, with less emphasis on transition outcomes. The relatively few studies that focus on outcomes use a wide variety of measures with little reliance on stakeholder engagement for measure selection. Methods: This study engaged multiple stakeholders (i.e., young adults with T1D, parents, pediatric and adult health care providers, and experts) in qualitative interviews to identify the content domain for developing a multidimensional measure of health care transition (HCT) outcomes. Results: The following constructs were identified for a planned measure of HCT outcomes: biomedical markers of T1D control; T1D knowledge/skills; navigation of a new health care system; integration of T1D into emerging adult roles; balance of parental involvement with autonomy; and "ownership" of T1D self-management. Discussion: The results can guide creation of an initial item pool for a multidimensional profile of HCT outcomes.

The Ups and Downs of Parenting Young Children With Type 1 Diabetes: A Crowdsourcing Study.

Objectives: Parenting young children with type 1 diabetes (YC-T1D) entails pervasive challenges; parental coping may influence child and parent outcomes. This study used a qualitative descriptive design to describe these challenges comprehensively to inform the user-centered design of an Internet coping resource for parents. Methods: A "Parent Crowd" of 153 parents of children with T1D onset at ≤ 5 years old submitted textual responses online to open-ended questions about parenting YC-T1D. Systematic coding organized responses into domains, themes, and examples. A supplemental focus group of racial/ethnic minority parents enhanced the sample's diversity and validated findings from the Parent Crowd. Results: Similar domains and themes emerged from responses of crowdsourcing and focus group participants. In each domain, parenting YC-T1D was challenging, but there was also substantial evidence of positive coping strategies and adaptability. Conclusions: The study yielded rich data to inform user-centered design of an Internet resource for parents of YC-T1D.

Topical Review: Advancing Research on the Transition to Adult Care for Type 1 Diabetes.

OBJECTIVE: To acknowledge and address the gaps in health care transition (HCT) in type 1 diabetes (T1D) literature by proposing an expanded model that could guide future research. METHOD: Topical literature review. RESULTS: Empirical research examining the outcomes of HCT in T1D is limited by methodological and interpretive problems. The relevant evidence indicates that HCT outcomes are both multi-systemic and multidimensional; the authors propose an expanded model that incorporates multiple stakeholder perspectives of HCT outcomes. CONCLUSIONS: The development and validation of a standard index of HCT outcomes based on the expanded model of HCT outcomes could provide a means for assessing relations between HCT readiness and outcomes, facilitate the design of longitudinal studies to determine the predictive validity of HCT readiness assessment and the efficacy of HCT interventions, and inform the design and evaluation of appropriate interventions targeting those mechanisms.

Parent and adolescent perspectives on a novel transdisciplinary model of healthcare delivery for type 1 diabetes.

Objective: We aimed to obtain pre-adolescent/adolescent and parent input on a proposed transdisciplinary model for routine type 1 diabetes (T1D) healthcare in which an advanced practice nurse, dietitian, and psychologist with expertise in T1D and extensive cross-discipline training co-deliver care during quarterly T1D care visits using a family-focused approach. Methods: Participants were 17 parent-youth dyads plus one additional adolescent who responded to open-ended questions about the structure and format of the proposed transdisciplinary care model via an online, private social network. A six-member coding team developed and revised a codebook, coded question responses through iterative cycles of inductive coding, and distilled major recurring themes to obtain perspectives on the transdisciplinary care model and feedback on improving the model. Results: We identified nine themes regarding reactions to our proposed transdisciplinary care model, which fell into three broad categories: 1) General Perceptions of Transdisciplinary Care (e.g., Transdisciplinary Care may facilitate improved communication and collaboration among providers and result in more holistic care); 2) Perceptions about Transdisciplinary Care Providers (e.g., Perspectives on the inclusion of dietitians and psychologists as members of the transdisciplinary care team were mixed); and 3) Suggestions for Improving the Transdisciplinary Care Model (e.g., Ensure care is patient/family centered and holistic). Conclusions: The present findings provided important feedback to modify our transdisciplinary care model and on parent and youth preferences for T1D healthcare delivery.

Early Results of an Innovative Scalable Digital Treatment for Diabetes Distress in Families of School-Age Children with Type 1 Diabetes.

OBJECTIVE: This paper reports on the initial outcomes of a new mHealth intervention to reduce diabetes distress (DD) in families of school-age children living with type 1 diabetes (T1D) entitled, 'Remedy to Diabetes Distress' (R2D2). METHODS: We randomized 34 families (mean child age = 10 ± 1.4 years; 53% male, 85% White, mean HbA1c = 7.24 ± 0.71%) to one of three delivery arms differing only by number of telehealth visits over a 10-week period: zero visits = self-guided (SG), three visits = enhanced self-guided (ESG), or eight visits = video visits (VV). All families had 24 × 7 access to digital treatment materials for 10 weeks. We examined the feasibility and acceptability of R2D2. We used the Problem Areas in Diabetes-Child (PPAIDC and PAIDC, parent and child, respectively) to examine treatment effects by time and delivery arm. We performed sensitivity analyses to characterize families who responded to R2D2. RESULTS: It was feasible for families to access R2D2 mHealth content independently, though attendance at telehealth visits was variable. Parents and children reported high satisfaction scores. There were significant pre-post reductions in PPAIDC (p = 0.026) and PAIDC (p = 0.026) scores but no differences by delivery arm. There were no differences in child age, sex, race, or pre-treatment HbA1c for responders versus non-responders, though families who responded reported higher PPAID-C scores pre-treatment (p = 0.01) and tended to report shorter diabetes duration (p = 0.08). CONCLUSIONS: Initial results support the acceptability and treatment effects of R2D2 regardless of the frequency of adjunctive virtual visits. Characterizing responders may help to identify families who could benefit from R2D2 in the future.

Parental diabetes distress is a stronger predictor of child HbA1c than diabetes device use in school-age children with type 1 diabetes.

INTRODUCTION: Diabetes distress (DD) describes the unrelenting emotional and behavioral challenges of living with, and caring for someone living with, type 1 diabetes (T1D). We investigated associations between parent-reported and child-reported DD, T1D device use, and child glycated hemoglobin (HbA1c) in 157 families of school-age children. RESEARCH DESIGN AND METHODS: Parents completed the Parent Problem Areas in Diabetes-Child (PPAID-C) and children completed the Problem Areas in Diabetes-Child (PAID-C) to assess for DD levels. Parents also completed a demographic form where they reported current insulin pump or continuous glucose monitor (CGM) use (ie, user/non-user). We measured child HbA1c using a valid home kit and central laboratory. We used correlations and linear regression for our analyses. RESULTS: Children were 49% boys and 77.1% non-Hispanic white (child age (mean±SD)=10.2±1.5 years, T1D duration=3.8±2.4 years, HbA1c=7.96±1.62%). Most parents self-identified as mothers (89%) and as married (78%). Parents' mean PPAID-C score was 51.83±16.79 (range: 16-96) and children's mean PAID-C score was 31.59±12.39 (range: 11-66). Higher child HbA1c correlated with non-pump users (r=-0.16, p<0.05), higher PPAID-C scores (r=0.36, p<0.001) and higher PAID-C scores (r=0.24, p<0.001), but there was no association between child HbA1c and CGM use. A regression model predicting child HbA1c based on demographic variables, pump use, and parent-reported and child-reported DD suggested parents' PPAID-C score was the strongest predictor of child HbA1c. CONCLUSIONS: Our analyses suggest parent DD is a strong predictor of child HbA1c and is another modifiable treatment target for lowering child HbA1c.

Remedy to Diabetes Distress (R2D2): Development protocol for a scalable screen-to-treat program for families of school-age children.

BACKGROUND: School-age children with type 1 diabetes (T1D) need help from parents or other adult caregivers (caregivers) to effectively manage T1D, resulting in greater vulnerability to Diabetes Distress (DD) for both children and caregivers. Unfortunately, there are no scalable screen-to-treat programs for clinics to adopt to identify and treat DD in school-age families. METHODS AND ANALYSES: We aim to design a scalable, clinic-based screen-to-treat program for DD in families of school-age children and to test whether our new program to reduce caregiver and child DD also reduces child glycemic levels. Our Remedy to Diabetes Distress (R2D2) program will target caregivers and children with T1D who are between 8 and 12 years old. It will merge routine and automated surveillance of DD in the clinical setting with at home digital delivery of a theory-based behavioral and psychological treatment of DD. We will use the ORBIT Model for Behavioral Intervention development to guide four small and cost-effective formative studies to develop our R2D2 program and assess initial treatment effects. In tandem, we will implement clinic-based DD screening in school-age families and assess feasibility and acceptability of our screening platform as a Quality Improvement activity. The study started in September 2020 and is scheduled to conclude in 2025. CONCLUSIONS: The study will use a single Institutional Review Board (IRB) with Children's Mercy-Kansas City operating as the IRB of record. We will disseminate study results through presentations at scientific conferences and through peer-reviewed journals read by the psychology and diabetes care communities.

School-based Screening to Identify Children At Risk for Attention-Deficit/Hyperactivity Disorder: Barriers and Implications.

This report describes a school-based screening project to improve early identification of children at risk for attention-deficit/hyperactivity disorder (ADHD) and communicate these concerns to parents, recommending that they contact their child's primary care provider (PCP). Of 17,440 eligible children in first through fifth grades in five school districts, 47.0% of parents provided required written consent, and teachers completed 70.4% of the online screeners (using the Vanderbilt AD/HD Diagnostic Teacher Rating Scale). Of 5,772 screeners completed, 18.1% of children (n = 1,044) were identified as at risk. Parents of at-risk children were contacted to explain risk status and recommended to visit their child's PCP for further evaluation. It was not possible to contact 39.1% of parents of at-risk children. Of the 636 parents of at-risk children who could be contacted, 53.1% (n = 338) verbally accepted the recommendation to follow-up with their PCP, which was not related to ADHD symptom severity. Parents of children with IEPs or related services were more likely to accept the recommendation to visit the PCP. Our exploration of the potential for school-based screening for ADHD identified a number of barriers to successful execution, but the data also indicated that this is an important problem to address.