Assessing patient-reported outcomes for automated insulin delivery systems: the psychometric properties of the INSPIRE measures.

AIM: Participants in clinical trials assessing automated insulin delivery systems report perceived benefits and burdens that reflect their experiences and may predict their likelihood of uptake and continued use of this novel technology. Despite the importance of understanding their perspectives, there are no available validated and reliable measures assessing the psychosocial aspects of automated insulin delivery systems. The present study assesses the initial psychometric properties of the INSPIRE measures, which were developed for youth and adults with Type 1 diabetes, as well as parents and partners. METHODS: Data from 292 youth, 159 adults, 150 parents of youth and 149 partners of individuals recruited from the Type 1 Diabetes Exchange Registry were analysed. Participants completed INSPIRE questionnaires and measures of quality of life, fear of hypoglycaemia, diabetes distress, glucose monitoring satisfaction. Exploratory factor analysis assessed factor structures. Associations between INSPIRE scores and other measures, HbA1c , and technology use assessed concurrent and discriminant validity. RESULTS: Youth, adult, parent and partner measures assess positive expectancies of automated insulin delivery systems. Measures range from 17 to 22 items and are reliable (α = 0.95-0.97). Youth, adult and parent measures are unidimensional; the partner measure has a two-factor structure (perceptions of impact on partners versus the person with diabetes). Measures showed concurrent and discriminant validity. CONCLUSIONS: INSPIRE measures assessing the positive expectancies of automated insulin delivery systems for youth, adults, parents and partners have meaningful factor structures and are internally consistent. The developmentally sensitive INSPIRE measures offer added value as clinical trials test newer systems, systems become commercially available and clinicians initiate using these systems.

Comparison of longitudinal point-of-care and high-performance liquid chromatography HbA1c measurements in a multi-centre trial.

AIMS: Point-of-care HbA(1c) is routine in clinical practice. Comparison of point-of-care HbA(1c) against laboratory measurements across sites and over time is warranted. METHODS: One hundred and twenty-one young persons with Type 1 diabetes from four centres provided 450 paired samples collected over 10 months for point-of-care HbA(1c) and central laboratory-based high-performance liquid chromatography (HPLC) HbA(1c) determinations. Change in HbA(1c) over time was assessed by difference from initial to final HbA(1c) and by growth modelling with annualized slope calculation. Change in HbA(1c) was categorized as improved (decrease of ≥ 0.5% or negative slope), no change (± 0.4% of initial HbA(1c) or slope = 0) or worsened (increase of ≥ 0.5% or positive slope). RESULTS: The 450 paired samples (median of four pairs/patient) were highly correlated (r = 0.97, P < 0.0001), as were time-specific and site-specific pairs (r = 0.94 to 0.98, P < 0.0001). Initial-to-final point-of-care HbA(1c) and HPLC HbA(1c) changes were 0.3 ± 1.1% (range -2.7 to 4.1) and 0.4 ± 1.2% (-3.9 to 4.5), respectively, with 21% of patients (n = 26) discordant for change categories. ΔHbA(1c) by point-of-care HbA(1c) vs. HPLC HbA(1c) differed across the HbA(1c) range and by ≥ 0.5% absolute difference in ΔHbA(1c) in 14 (54%) of the 26 patients discordant for HbA(1c) change categories. Mean annual HbA(1c) slope was 0.4 ± 1.5% (-5.4 to 4.8) for point-of-care HbA(1c) and 0.4 ± 1.6% (-6.9 to 5.2) for HPLC HbA(1c), with 18% (n = 22 pairs) discordant for change categories. CONCLUSIONS: Assessment of absolute HbA(1c) change may not be different for point-of-care HbA(1c) compared with HPLC HbA(1c); however, misclassification of patients by discrete cut-off values may occur with point-of-care HbA(1c) compared with HPLC HbA(1c) determinations.

Validation of an abbreviated adherence measure for young people with Type 1 diabetes.

AIMS: Adherence to diabetes-related tasks is an important construct. The Diabetes Self-Management Profile is a validated, semi-structured interview assessing adherence in paediatric patients with Type 1 diabetes. We created and validated a brief questionnaire version of the Diabetes Self-Management Profile called the Diabetes Self-Management Questionnaire. METHODS: Young people with Type 1 diabetes, ages 9-15 years (n = 338) and their parents provided data from chart review, interview and questionnaires. RESULTS: Diabetes Self-Management Questionnaire scores correlated significantly with Diabetes Self-Management Profile scores, HbA(1c) , blood glucose monitoring frequency and other measures associated with adherence and/or glycaemic control (P ≤ 0.01 for all). Young people and parent scores were correlated (r = 0.55, P < 0.0001). The Diabetes Self-Management Questionnaire demonstrated modest internal consistency (Cronbach's α = 0.59), adequate for a brief measure of multidimensional adherence. In addition, factor analysis confirmed one factor. CONCLUSIONS: This brief adherence questionnaire demonstrated construct validity in young people 9-15 years old and their parents and may have utility in clinical and research settings.

Pediatric health-related quality of life: Feasibility, reliability and validity of the PedsQL transplant module.

The measurement properties of the newly developed Pediatric Quality of Life Inventory (PedsQL) 3.0 Transplant Module in pediatric solid organ transplant recipients were evaluated. Participants included pediatric recipients of liver, kidney, heart and small bowel transplantation who were cared for at seven medical centers across the United States and their parents. Three hundred and thirty-eight parents of children ages 2-18 and 274 children ages 5-18 completed both the PedsQL 4.0 Generic Core Scales and the Transplant Module. Findings suggest that child self-report and parent proxy-report scales on the Transplant Module demonstrated excellent reliability (total scale score for child self-report alpha= 0.93; total scale score for parent proxy-report alpha= 0.94). Transplant-specific symptoms or problems were significantly correlated with lower generic HRQOL, supporting construct validity. Children with solid organ transplants and their parents reported statistically significant lower generic HRQOL than healthy children. Parent and child reports showed moderate to good agreement across the scales. In conclusion, the PedsQL Transplant Module demonstrated excellent initial feasibility, reliability and construct validity in pediatric patients with solid organ transplants.

Adolescent diabetes management and mismanagement.

OBJECTIVE: To document the existence and prevalence of adolescent-generated diabetes management techniques. RESEARCH DESIGN AND METHODS: One hundred forty-four adolescents completed the confidential questionnaire developed for this study. Glycohemoglobin was also obtained for each individual. RESULTS: Within the 10 days before their clinic visit, many adolescents admitted to engaging in various mismanagement behaviors, with 25% admitting to missing shots. Parents tend to underestimate adolescent mismanagement. Missing shots was significantly related to poor control (P < 0.01). Older adolescents engaged in more mismanagement than their younger cohorts (P < 0.001). The questionnaire factored into two subscales: blatant mismanagement and faking. CONCLUSIONS: This study shows the importance of recognizing the prevalence of mismanagement among adolescents.

Readmissions of children with diabetes mellitus to a children's hospital.

The characteristics of children with diabetes readmitted to Children's Hospital during a 5-year period, 1984 to 1989, were compared with those characteristics of new-onset patients admitted for stabilization and education and to outpatients in the Children's Hospital diabetes program to determine which characteristics were associated with patients who were readmitted. Changes in the frequency of readmissions were examined to determine whether the introduction of a diabetes team and a program that emphasizes the importance of ensuring that patients at risk of readmission consistently received insulin injections resulted in a reduction of readmissions. Readmissions occurred more frequently in patients who were black (71% compared with 38% of new-onset patients and 31% of outpatients) (P less than .001), from one-parent homes (56% compared with 27% of new-onset patients and 24% of outpatients) (P less than .001), and without third-party insurance (45% compared with 18% of new-onset patients and 15% of outpatients) (P less than .001). Readmissions were very common at 14 to 15 years of age (39% of readmissions vs 18% of outpatients) and very uncommon in children younger than age 9 (6% of readmissions vs 27% of outpatients) (P less than .001). Fewer readmissions for ketoacidosis occurred in the summer than in any other season (P less than .05). Readmissions fell by 47% over the 5-year period while new-onset patients increased by 85%. The reduction in frequency of readmissions was due to fewer readmissions for ketoacidosis and fewer readmissions in blacks, in patients from one-parent homes, and in patients without third-party insurance.(ABSTRACT TRUNCATED AT 250 WORDS)

The role of temperament in children with insulin-dependent diabetes mellitus.

Investigated the role of child temperament and diabetes-related environmental demands on the adjustment of children with insulin-dependent diabetes mellitus (IDDM) and investigated the role of these same variables on diabetes control. Parents of 117 children completed questionnaires assessing their child's temperament, diabetes-specific environmental demands, and psychosocial adjustment. Glycohemoglobin (HbA1C) and demographics were obtained. Analyses evaluated the incremental variance accounted for by temperament and environmental demands after controlling for the effects of the demographic variables. Results suggest that lower activity and greater flexibility were related to fewer behavior problems. Greater persistence and less distractibility were related to fewer social competence problems. Greater flexibility and negative moods were related to better metabolic control. Greater child responsibility for the diabetes regimen was related to more behavior problems.