Preference Assessment of Recruitment into a Randomized Trial for Adolescent Idiopathic Scoliosis

Abstract

Background: Randomized controlled trials are powerful tools to evaluate the outcomes of clinical treatments. However,

Determinants of decision-making and patient participation in paediatric clinical trials: A literature review

“…Parents have been described to feel dependent on clinicians and to experience considerable unease in making decisions about trial participation [34,41,56]. Parents' communications with physicians focus more extensively on the child's illness, treatment, risks or benefits than on the RCT with its risks or procedures such as randomization [12,41,53].…”

“…Other reasons for participation which were less frequent were: "To help other people with problems" [51,56,60], "My doctor told me to be in the study" [51,60], or "My parents told me to be in the study" [60].…”

“…Also relevant were organisational reasons such as the existence of appointments which were made for the initial medical therapy so that participation won't take much effort or the location of the clinic [42,51,56,61,62].…”

“…Adolescents' reasons for declining participation included increased clinic visits, increased number treatment interventions [73], increased frequency of diagnostic procedures, transportation issues and the opposition to randomization [56,73].…”

Effects of Bracing in Adolescents with Idiopathic Scoliosis

“…26 Therefore, the relatively low enrollment rate and the need to include the preference cohort were not unexpected but resulted in a primary analysis that was an as-treated assessment rather than an intention-to-treat assessment. Potential bias due to nonrandom treatment assignment in this analysis is expected to be minimized, but is not eliminated, by the use of propensityscore adjustment.…”