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).

Polish validation of Brace Questionnaire

“…AIS can lead to multiple impairments, non-only of physical but also of psychosocial character [7, 9]. The effectiveness of the conservative scoliosis treatment has been demonstrated to be dependent on the patients’ treatment compliance [10, 11]. …”

“…Misterska et al [13] described Polish adaptation of the BSSQ. However, the BSSQ is not able to measure the influence of family, school environment or physical activity on patient’s QoL [11]. The BrQ is the first questionnaire specially developed and validated to measure the quality of life of adolescent currently being under conservative scoliosis treatment with a corrective brace [6].…”

Braces for Idiopathic Scoliosis in Adolescents

“…Seven articles met our inclusion criteria: five were planned as RCTs [59,[63][64][65][66], and two as prospective controlled trials [60,67]. Two RCTs failed due to very low recruitment of participants [65,68].…”

“…Bunge 2010 [68] aimed to recruit adolescents and compare braces with observation only; the study failed completely during the recruitment phase; so we excluded it from further consideration. second group firmly believed that a brace was ineffective and thus managed people with careful observation; two centres of this last group treated adolescents with lateral electrical surface stimulation.…”

Does brace treatment impact upon the flexibility and the correctability of idiopathic scoliosis in adolescents?

“…Second, this study is not a prospective randomized one and fails to exclude any possible inherent differences in the initial curve characteristics between the bracing and non-bracing groups, despite the age and curve magnitude criterion being well matched. To clarify this, a prospective RCT is expected, which is however not feasible currently based on the study of Bunge EM et al [4]. Third, this study also lacks comparisons on the quality of life after surgery between groups A and B.…”