Eveline M. Bunge

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

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.

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

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.

Estimating the Effectiveness of Screening for Scoliosis: A Case-Control Study

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.

Bracing Patients with Idiopathic Scoliosis: Design of the Dutch Randomized Controlled Treatment Trial

BackgroundThe 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.MethodsA 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.DiscussionThe 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 registrationNederlands Trialregister ISRCTN36964733

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

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.

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

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).

Screening for scoliosis: Do we have indications for effectiveness?

Objective: The effectiveness of screening for scoliosis has not been established. This study investigated whether patients with adolescent idiopathic scoliosis detected by screening are detected in an earlier stage of the clinical course, and whether these patients have better outcome than otherwise detected patients. Setting: The study is a retrospective follow-up study of patients with adolescent idiopathic scoliosis who had completed treatment with a brace, by surgery, or with a brace followed by surgery. Of the 143 patients (born on or after 1 January 1984) consecutively recruited from 12 hospitals in the Netherlands, 125 (87%) agreed to participate. Of these, 51 patients were treated with a brace only and 74 patients were operated on. Screening for scoliosis is carried out in 80% of Dutch children. Methods: Data on being screen detected or otherwise detected and Cobb angle at diagnosis were collected using youth health-care files, medical files and interviews by telephone with the patients. Results: About 55% of the patients were detected by screening (programme sensitivity). Screen-detected patients had a significantly smaller Cobb angle at diagnosis (28° versus 40°; P<0.01) and had a 73% lower chance of having had surgery (45% versus 75%; P<0.01) than otherwise-detected patients. Conclusion: In the present study, two essential prerequisites necessary for a screening programme for scoliosis to be effective have been met. However, definite proof of the effectiveness of screening still needs to be established because length bias and over-treatment bias cannot be ruled out using this design.

Estimating the Effectiveness of Screening for Scoliosis: In Reply

We thank Richards et al for their comments. We also feel that screening may be justified if screening is effective in preventing surgery in adolescents with scoliosis. However, in our level II-2 evidence study1 (not IV), we did not find evidence for that, which is in line with an earlier case-control study.2 Richards et al mention that most studies have concluded that brace treatment is effective. However, they did not mention a number of studies that have raised doubt on its effectiveness.3–5 Dolan and Weinstein6 recently published a systematic review of clinical data concerning surgical rates. The pooled surgical …

Bracing patients with adolescent idiopathic scoliosis: design of the first randomised controlled treatment trial

Objectives The effectiveness of bracing patients with adolescent idiopathic scoliosis (AIS) has not been convincingly established due to lack of Randomised Controlled Trials (RCT). The aim of this study is to evaluate whether bracing patients with AIS in an early stage will result in at least five degrees less mean progression of the curvature compared to the control group after two years of follow up.