Background: In France the pertinence of including indirect costs in economic evaluations of therapeutic strategies is left to author judgment. However productivity losses represent a significant amount of resources in particular for chronic pediatric conditions when caregivers are involved in addition to patients. In order to explore how best to collect indirect cost information, we investigated whether or not a patient diary provided additional information compared to retrospective investigator-led interviews and whether a diary filled intermittently produced more or less information than a continuous diary. The main objective of this study was to identify which type of data collection was most effective to obtain information on indirect costs over a 9-month study period.
Methods : Start-In! is a randomized controlled trial comparing the efficacy of three strategies of real-time continuous glucose monitoring (CGM) for 12 months in children and adolescents with type 1 diabetes. We designed an ancillary study to compare three collection methods of indirect costs: 1) retrospectively by investigators during quarterly follow up visits and prospectively with diaries filled by children or families used 2) either continuously or 3) intermittently. Were collected the amount of information on absence from school and work, and carer time for diabetes cares, and compared to the information given to the investigator during the quarterly follow up visit in the case report form.
Results: At the end of the 9-month study 42% participants had not returned their diary, less than 10% of data were collected in patients’ diaries versus 82% in investigators’ filled case report forms.
Conclusions: Our study only supports the hypothesis that data collection by investigators during quarterly visits would lead to fewer missing data than a diary, that it be filled up on a trimester or every three months. Diaries might represent an important additional burden to children and their families. Trial registration: Start-In! trial registry name: Study of Insulin Therapy Augmented by Real Time Sensor IN Type 1 Children and Adolescents (START-IN!). ClinicalTrials.gov Identifier: NCT00949221. Registered on July 30, 2009.