| Methods |
A randomization schedule was produced using Statistical Analysis System (SAS) program with subjects blocked by race, age group, sex, and family structure (single versus 2 parents). Within each block, patients (n = 89) were randomly assigned to one of the 3 treatment groups: the standard care (SC) group (n = 28), the education (ED) group (n = 21), or the education and telephone case management (ED + TCM) group (n = 26). The group allocation for the remaining 14 patients (not included in the study analysis) was not described |
| Participants |
Patients had 2 consecutive glycosylated hemoglobin (HbA1c) results of 8.5% or higher, were aged 1 to 16 years, and had been diagnosed with Type 1 diabetes for at least 1 year |
| Interventions |
Patients in the SC group received standard care from a nurse practitioner and endocrinologist, typically every quarter. During the 30‐minute office visits, HbA1c value was obtained, blood glucose records were reviewed, problems were identified, target goals were determined, and education was provided as needed. Patients in the ED group received the standard care in the clinic. They also participated in a one‐time education session with the study co‐ordinator, a nurse, with the goal of providing families with basic diabetes management skills such as insulin administration and carbohydrate counting. Children older than 8 years were asked to participate in the education sessions. Families were given customized written guidelines including insulin doses for hyperglycemia and for varying carbohydrate loads. At the completion of the program, parents were expected to identify problems and to know when to call their nurse practitioner for assistance in insulin dose adjustment, for sick‐day management, or for advice in co‐ordination of the diabetes regimen. Patients in the ED + TCM group received both the standard care in clinic and the education program described above. They also received weekly telephone calls for 3 months or until the first clinic visit and then bimonthly calls for 3 months from the study co‐ordinator. At the time of enrolment, subjects were given an appointment 3 months after the start of study. For children younger than 13 years, telephone calls were between the study co‐ordinator and a designated parent. Some teens did elect to be involved in telephone calls as well. The study co‐ordinator talked with both the teen and parent to ascertain that plans were clear between child and parent. The study co‐ordinator followed a standardized telephone protocol to review blood sugars, safety issues related to hypoglycemia and hyperglycemia, problem‐solving skills, diet and meal planning, and changing insulin dose. The study co‐ordinator also discussed parenting and behavior management skills with parents as needed. Telephone calls were typically 5 to 15 minutes |
| Outcomes |
The ADH (an adherence questionnaire) was used to evaluate child/family behaviors related to diabetes safety and control. ADH was obtained at baseline and at the end of study. The HbA1c values were used as clinical measures and their levels were obtained at baseline, at 3 to 6 months, and at end of study |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random sequence. (pg 87) "A randomization schedule was produced using Statistical Analysis System (SAS) program with subjects blocked by race, age group, sex, and family structure (single vs. two parents). Within each block, subjects were randomly assigned to one of the three treatment groups." |
| Allocation concealment (selection bias) |
Unclear risk |
No mention of allocation concealment. (pg 87) "A randomization schedule was produced using Statistical Analysis System (SAS) program with subjects blocked by race, age group, sex, and family structure (single vs. two parents). Within each block, subjects were randomly assigned to one of the three treatment groups." |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
High risk |
Authors note the following(pg 91): "Recruiting 135 subjects from a single center became more difficult than was expected. Initially, the research team anticipated that approximately 10 subjects per week could be recruited for the study. In reality, less than half of these eligible subjects actually kept their scheduled visit. Further, because of the time constraints of a busy clinic, some subjects were not approached. Of those approached, less than half of these subjects followed up with the enrollment process (paper‐ work returned) or with the initial study intervention (education session). In the end, the research team recruited one to three subjects per month, with 89 subjects recruited over a 3‐year period. The attrition rate was 16%, with 14 subjects failing to complete the study protocol. One subject requested to leave the study. The remainder were dropped from the study after repeated attempts by the study coordinator to have the family complete the protocol with its required clinic visits, HbA1c blood work, and paperwork. Although the research design with its original sample size accounted for differences in subjects' ages, the smaller sample size could not. Because there was a big difference in diabetes management and parent and child interactions around diabetes depending on age, without the power of the original sample size, our results may not reflect accurate comparisons. As well, the subjects completing the study may have represented a biased sample because they were not necessarily representative of patients and families in poor control. Another limitation of the study was using unstandardized assessment tools versus standardized assessment tools. The research team elected to use the ADH, TEAM, and KNOW as they were assessment tools already integrated into the clinical practice of the Diabetes Center for Children. Data collection was simplified, however; these tools do not have the psychometric properties established for standardized tools. Obtaining data points at the times specified in the protocol proved to be difficult when done in real‐life terms with subjects and their families. The study was designed to obtain data at baseline and then in two 3‐month intervals. Although the study coordinator was very flexible in meeting families' scheduling needs, there were frequent b no‐shows Q in the clinic, thus, requiring rescheduling of appointments. The 3‐month interval at times stretched to 4‐ to 6‐month intervals between data points. Finally, the study design did not control for telephone contacts between clinicians and families in the ED or SC groups. Because all subjects were in relatively poor control, clinicians often elected to have families call in to review blood sugars. Whether and how much this occurred was not followed for this study. It is possible that the failure to see larger between‐group differences was because the interventions may not have been different enough." |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) CLINICIAN CHECKLIST (ADH) ‐ No mention of blinding of outcome assessors |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) HBA1C MEASUREMENT ‐ Objective measure ‐ unlikely that blinding will affect outcome |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) CLINICIAN CHECKLIST (ADH) ‐ No mention of blinding of patients; subjective outcome |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) HBA1C MEASUREMENT ‐ Objective measure ‐ unlikely that blinding will affect outcome |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) CLINICIAN CHECKLIST (ADH) ‐ No mention of blinding of study personnel |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) HBA1C MEASUREMENT ‐ Objective measure ‐ unlikely that blinding will affect outcome |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) CLINICIAN CHECKLIST (ADH) ‐ Rate of attrition is less than 20% but no mention of which group the dropouts were from or the reasons for dropping out |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) HBA1C MEASUREMENT ‐ Rate of attrition is less than 20%. However, sample size has only a 55% power calculation |
