Bunge, E.M.

A randomised controlled trial on the effectiveness of bracing patients with idiopathic scoliosis: Failure to include patients and lessons to be learnt (Article)

2010-05-01T00:00:00Z

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).

Patients' preferences for scoliosis brace treatment: a discrete choice experiment (Article)

2010-01-01T00:00:00Z

Abstract STUDY DESIGN: Discrete choice experiment. OBJECTIVE: To investigate the reduction in the risk of surgery that scoliosis patients would require in order to consider brace treatment as acceptable, and to elicit the trade-offs individuals make between characteristics of brace treatment. SUMMARY OF BACKGROUND DATA: The effectiveness of brace treatment in idiopathic scoliosis patients has not been established in randomized controlled trials (RCTs). Treatment with a brace can be quite bothersome. Patients' preferences for brace treatment are unknown. Insight into patients' preferences for (characteristics of) brace treatment will be useful for future trials and for the development of braces that may optimize compliance with brace treatment. METHODS: A total of 197 patients who had completed treatment (brace and/or surgery) for scoliosis were approached for the study, of which 135 gave informed consent. A discrete choice experiment was designed in which patients had to choose between hypothetical brace treatment profiles that differed in following 4 treatment attributes: effectiveness, visibility, discomfort, and treatment duration. A multinomial logit model was used to analyze the relative importance of these attributes. Subgroup analyses were conducted for brace-only, brace-surgery, and surgery-only patients. RESULTS: The response rate was 86% (116/135). All treatment attributes proved to be important for patients' choices. All subgroups were prepared to initiate treatment with a Boston brace if the brace would reduce the need for surgery by 53%. Risk reductions in a range of 32% to 74% were required for acceptance of a treatment duration of 3 years. CONCLUSION: Scoliosis patients stated to be prepared to undergo brace treatment only if it provides sizeable reduction of the risk of surgery. Effectiveness and discomfort in wearing a brace were the most important determinants of the choices. These results are important if RCTs would conclusively establish that bracing is effective, and show directions for the further technical development of braces to increase the compliance with brace treatment.

Idiopathic Scoliosis: Evaluation of Screening and Treatment (Doctoral Thesis)

2009-03-06T00:00:00Z

Scoliosis is a rather common condition of the back. Scoliosis is a deformation of the spine consisting of a lateral curvature combined with a fixed rotation of one or more vertebrae and a rotational deformation of those vertebrae1 (Figure 1.1). The severity of scoliosis can be assessed by X-ray and is expressed in the size of the Cobb angle, which is the angle between the upper most inclined vertebra and the lower most inclined vertebra. Someone is being diagnosed to have scoliosis when the Cobb angle is larger than 10 degrees1. The most common type of scoliosis is idiopathic scoliosis (IS). As the name indicates, the cause of that type is unknown. There is, however, a known relationship with gender, age, maturity and familial predisposition. Progressive scoliosis occurs 5-10 times more often in girls than in boys2. Genetic research showed a significantly higher prevalence of scoliosis in first-degree family members3-5. Today, it is not fully known which genes are involved, but research on this topic is ongoing. Other types of scoliosis include neuromuscular scoliosis and congenital scoliosis. Neuromuscular scoliosis can occur in patients with neuropathic or myopathic conditions, such as cerebral palsy, poliomyelitis and Duchenne Muscular disease1. Congenital scoliosis is caused by the presence of vertebral anomalies, which develop during pregnancy. This thesis will deal with idiopathic scoliosis.

High affective risk perception is associated with more lung cancer-specific distress in CT screening for lung cancer (Article)

2008-12-01T00:00:00Z

Screening for cancer can cause distress. People who perceive their risk of cancer as high may be more vulnerable to distress. This study evaluated whether participants of a lung cancer Computed Tomography (CT) screening trial with a high affective risk perception of developing lung cancer had a higher level of lung cancer-specific distress during CT screening. Furthermore, we evaluated whether participants perceived their risk of developing lung cancer differently 6 months after screening compared with 1 day before screening. A total of 351 subsequent participants of the NELSON-trial (Dutch-Belgian randomized controlled trial for lung cancer screening in high-risk subjects), who were randomized to the screen arm, were asked to fill in questionnaires 1 day before and 6 months after screening. Lung cancer-specific distress (Impact of Event Scale (IES)), generic health-related quality of life (SF-12) and affective risk perception were assessed. One day before screening, the participants with a high affective risk perception (n = 47/321, 14.6%) had significantly higher (i.e., worse) median IES scores than participants with a low affective risk perception (11.5 vs. 2.0, p < 0.01). Although median IES scores were significantly lower 6 months after screening than 1 day before screening, participants with a high affective risk perception still showed significantly higher IES scores than participants with a low affective risk perception (6.5 vs. 1.0, p < 0.01). Six months after screening, significantly less participants (10.5%) felt that their risk of developing lung cancer was high than 1 day before screening (14.5%) (p < 0.01). Levels of distress were not severe, but were elevated compared to participants with a low affective risk perception, and therefore, attention for this group is recommended.

Impact of computed tomography screening for lung cancer on participants in a randomized controlled trial (NELSON trial) (Article)

2008-07-15T00:00:00Z

BACKGROUND. Computed tomography (CT) screening is an important new tool for the early detection of lung cancer. In the current study, the authors assessed the discomfort associated with CT scanning and the subsequent wait for results and health-related quality of life (HRQoL) over time. METHODS. A total of 351 participants in the Dutch-Belgian randomized controlled trial for lung cancer screening in high-risk subjects (the NELSON trial) who had an appointment for a baseline CT scan were asked to complete questionnaires regarding their experienced discomfort and HRQoL before, 1 day after, and approximately 6 months after the CT scan. HRQoL was measured as generic HRQoL (12-item Short Form [SF-12] and EuroQol questionnaire [EQ-5D]), generic anxiety (State-Trait Anxiety Inventory [STAI-6]), and lung cancer-specific distress (Impact of Event Scale [IES]). Approximately 76.9% of the participants completed all 3 questionnaires. RESULTS. Approximately 87% to 99% of participants reported experiencing no discomfort related to the CT scan. The median SF-12, EQ-5D, STAI-6, and IES scores did not appear to change relevantly over time. Approximately 46.0% and 51.3%, respectively, of the participants reported discomfort in connection with having to wait for the results of the CT scan and dreading those results. These patients had relevantly higher STAI-6 and IES scores (P < .01) (unfavorable) at all 3 assessments. CONCLUSIONS. The current evaluation of the potential adverse effects of CT screening for lung cancer on HRQoL demonstrated no negative effects. However, waiting for the CT scan results was reported to be discomforting by approximately half of the participants. Minimizing the waiting time for the test results is merefore recommended.

In reply (Article)

2008-06-01T00:00:00Z

Bracing patients with idiopathic scoliosis: Design of the Dutch randomized controlled treatment trial (Article)

2008-05-26T00:00:00Z

Background. The effectiveness of bracing patients with IS has not yet been convincingly established due to a lack of RCTs. Some authors suggest that their results confirm that bracing is effective; others conclude that the effectiveness of bracing is doubtful or recommend a RCT. The aim of this study was to establish whether bracing patients with idiopathic scoliosis (IS) in an early stage will result in at least 5 degrees less mean progression of the curvature compared to the control group after two years of follow-up. Methods. A randomized controlled trial was designed. Eligible patients are girls and boys in the age group 8-15 years whose diagnosis of IS has been established by an orthopedic surgeon, who have not yet been treated by bracing or surgery, and for whom further growth of physical height is still expected based on medical examination and maturation characteristics (Risser ? 2). The Cobb angle of the eligible patient should either be minimally 22 and maximally 29 degrees with established progression of more than 5 degrees, or should be minimally 30 and maximally 35 degrees; established progression for the latter is not necessary. A total of 100 patients will be included in this trial. The intervention group will be treated with full-time Boston brace wear; the control group will not be braced. Every four months, each patient will have a physical and an X-ray examination. The main outcomes will be the Cobb angle two years after inclusion and health-related quality of life. Discussion. The results of this trial will be of great importance for the discussion on early treatment for scoliosis. Furthermore, the result will also be important for screening for scoliosis policies. Trial registration. Nederlands Trialregister ISRCTN36964733.

Estimating the effectiveness of screening for scoliosis: a case-control study (Article)

2008-01-01T00:00:00Z

OBJECTIVE: The aim of this study was to test the hypothesis that screening for scoliosis is effective in reducing the need for surgical treatment. METHODS: The study was a case-control study. A total of 125 consecutive patients who were treated surgically for idiopathic scoliosis between January 2001 and October 2004 and who were born on or after January 1, 1984, were invited; 108 agreed to participate. A total of 216 control subjects were selected randomly and anonymously, matched with respect to age and gender. For 279 adolescents, exact screening exposure and outcomes could be analyzed. Case subjects were recruited from 4 university and 6 nonuniversity Dutch hospitals; control subjects were recruited from all 37 municipal health services in The Netherlands. RESULTS: Screen-detected patients received diagnoses at a significantly younger age than did otherwise-detected patients (10.8 +/- 2.6 vs 13.4 +/- 1.7 years). In total, 32.8% of the surgically treated patients had been screened between 11 and 14 years of age, compared with 43.4% of the control subjects. The odds ratio for being exposed to screening was 0.64. In total, 28% of the patients were diagnosed as having scoliosis before 11 years of age. CONCLUSIONS: Our results showed no evidence that screening for scoliosis reduced the need for surgery. Abolishing screening seems justified, especially because the effectiveness of early treatment with bracing is still strongly debated. A randomized, controlled trial on the effectiveness of treating patients with idiopathic scoliosis with bracing is urgently needed.

Answer to the Letter to the Editor of I. Aprile et al. concerning “Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: short-term effects after brace or surgical treatment” (by Bunge EM et al. Eur Spine J 16: 83–89, 2007) (Letter To Editor)

2007-11-01T00:00:00Z

This author’s reply refers to the article http://dx.doi.org/10.1007/s00586-007-0461-4

Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: Short-term effects after brace or surgical treatment (Article)

2007-01-01T00:00:00Z

For treatment of teenagers with progressive adolescent idiopathic scoliosis in an early stage, two options are generally considered: treatment with a brace or observation followed by surgery if necessary. Many doctors and patients prefer conservative treatment (i.e. brace treatment) to surgical treatment, because surgery of the spine is generally considered a drastic intervention. Because potential differences in health-related quality of life (HRQoL) after treatment between braced and surgically treated patients are not well explored, this study aimed to determine whether short-term differences exist in HRQoL between adolescents treated with a brace or treated surgically. A cross-sectional analysis of HRQoL was made of 109 patients with adolescent idiopathic scoliosis who, after completing treatment, filled out the Dutch SRS-22 Patient Questionnaire. All patients had been treated either with a brace or surgery, or with a brace followed by surgery. Patients treated surgically had significantly higher mean scores in the satisfaction with management domain than those treated with a brace. No other consistent differences in HRQoL were found between patients treated with a brace and patients treated surgically. Gender, curve type and curve size had no relevant effect on HRQoL. We conclude that short-term differences in HRQoL after treatment in adolescent patients with idiopathic scoliosis are negligible and cannot support preference of one treatment above the other.

Reliability and validity of health status measurement by the TAPQOL (Article)

2005-01-01T00:00:00Z

BACKGROUND: In addition to clinical measures in the evaluation of paediatric interventions, health related quality of life (HRQoL) is an important outcome. The TAPQOL (TNO-AZL Preschool children Quality of Life) was developed to measure HRQoL in preschool children. It is a generic instrument consisting of 12 scales that cover the domains physical, social, cognitive, and emotional functioning. AIMS: To evaluate the feasibility, score distribution, internal consistency, test-retest reliability, and discriminative and concurrent validity of the TAPQOL multi-item scales in preschool children, aged 2-48 months. Also to evaluate the feasibility, reliability, and validity separately for infants (2-12 months old) and toddlers (12-48 months old). METHODS: Parents of a random general population sample of 500 preschool children were sent a questionnaire by mail. A random subgroup of 159 parents who participated received a retest after two weeks. RESULTS: The response rate was 83% at the test and 75% at the retest. There were few missing answers. Six scales showed ceiling effects. Nine scales had Cronbach's alphas >0.70. In general, score distributions and Cronbach's alphas were comparable for infants and toddlers. Test-retest showed no significant differences in mean scale scores; two scales had intra-class correlations <0.50. Five scales showed significant differences between children with no conditions versus children with two or more parent reported chronic conditions. CONCLUSION: Results showed that the TAPQOL is a feasible instrument to measure HRQoL and support the reliability and discriminative validity of the majority of its scales for infants as well as toddlers.