Abstract
Background: Relatively little is known about parents' or children's attitudes toward recruitment for, and participation in, studies of new diabetes technologies immediately after diagnosis. This study investigated factors affecting recruitment of participants for studies in newly diagnosed youth with type 1 diabetes.Methods: Qualitative focus group study incorporating four recorded focus groups, conducted in four outpatient pediatric diabetes clinics in large regional hospitals in England. Participants comprised four groups of parents (n = 22) and youth (n = 17) with type 1 diabetes, purposively sampled on the basis of past involvement (either participation or nonparticipation) in an ongoing two-arm randomized trial comparing multiple daily injection with conventional continuous subcutaneous insulin infusion regimens from the onset of type 1 diabetes.Results: Stress associated with diagnosis presents significant challenges in terms of study recruitment, with parents demonstrating varied levels of willingness to be approached soon after diagnosis. Additional challenges arise regarding the following: randomization when study arms are perceived as sharply differentiated in terms of therapy effectiveness; burdens arising from study participation; and the need to surrender new technologies following the end of the study. However, these challenges were mostly insufficient to rule out study participation. Participants emphasized the benefits and reassurance arising from support provided by staff and fellow study participants.Conclusions: Recruitment to studies of new diabetes technologies immediately after diagnosis in youth presents significant challenges, but these are not insurmountable. The stress and uncertainty arising from potential participation may be alleviated by personalized discussion with staff and peer support from fellow study participants.
Highlights
Anumber of challenges surround studies of new diabetes technologies in youth, especially as children’s involvement in medical research is likely to include the involvement of, and in many cases obtaining consent from, parents or legal guardians
Research has shown that parents who lack understanding of research concepts such as randomization may be less likely to allow their children to participate in randomized trials and that parents of children randomized to control arms of randomized trials experience significant levels of disappointment—one of many factors that can limit future research participation.[2,3,4,5,6,7]
One study indicated that 51% of mothers and 41% of fathers of children newly diagnosed with type 1 diabetes met some or all of the diagnostic criteria for posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).[10]
Summary
Anumber of challenges surround studies of new diabetes technologies in youth, especially as children’s involvement in medical research is likely to include the involvement of, and in many cases obtaining consent from, parents or legal guardians. Randomized trials investigating the impact of technological treatments on disease progression frequently necessitate the recruitment of children immediately after diagnosis This period is a highly stressful time for children and parents, typically occurring with little warning and requiring multiple significant life changes in a very short time frame, with the threat of significant long-term morbidity, including microand macrovascular complications.[8,9] One study indicated that 51% of mothers and 41% of fathers of children newly diagnosed with type 1 diabetes met some or all of the diagnostic criteria for posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).[10] Parental stress arises from a number of possible sources, including traumatic events (e.g., hospitalization) surrounding the onset of type 1 diabetes, the threat of significant morbidity arising from the condition, and parental responsibility in terms of caring for a child with diabetes.[10] The self-care regimens required for intensive insulin therapy are complex and can lead to diabetes-based parent–child conflict, when parental involvement in care (e.g., to reduce the risk of hypoglycemia) conflicts with adolescents’ developing sense of autonomy.[11]. The stress and uncertainty arising from potential participation may be alleviated by personalized discussion with staff and peer support from fellow study participants
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