title: A randomised controlled trial on the effectiveness of bracing patients with idiopathic scoliosis: failure to include patients and lessons to be learnt.
abstract: Trials often do not succeed in including as many patients as anticipated beforehand. The aim of this paper was to describe why we were not able to include more than a few patients in our randomized controlled treatment trial on the effectiveness of bracing patients with idiopathic scoliosis, and to describe which lessons can be learnt. A pilot study on the willingness to participate in such a trial was conducted amongst 21 patients and their parents. A description of how we prepared and designed this trial, the problems we faced and how we tried to improve the inclusion are given. A total of four patients were included, and 14 refused to participate in an 18-month period. There were a lot less eligible patients than anticipated (40 instead of 100 per year), and the patients' participation rate was much lower than we had found in our pilot study (21% instead of 70%). The trial failed to include more than a few patients because of an overestimation of the number of eligible patients and because a lot less eligible patients were willing to participate compared to our pilot study. One reason for a low participation rate could be that this trial evaluated a frequently used existing treatment instead of a new treatment, and patients and parents might be afraid of not being treated (despite an intensive secure system for the control arm).
authors.affiliation: Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.
authors.forename: Eveline M
authors.initials: EM
authors.lastname: Bunge
authors.forename: J Dik F
authors.initials: JD
authors.lastname: Habbema
authors.forename: Harry J
authors.initials: HJ
authors.lastname: de Koning
mesh_terms: D001915:Braces; D006801:Humans; D010358:Patient Participation; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012600:Scoliosis / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome