Table 2.
Schematic overview of written information for (parents of) patients with idiopathic scoliosis
| Subject | Short explanation |
| Background | - explanation what idiopathic scoliosis is - treatment options in early stages: brace or observation - effectiveness of brace treatment not established yet |
| Purpose | - establish whether early treatment with a brace prevents curve progression - evaluate the influence of treatment (brace vs. observation) on health-related quality of life |
| Design | - randomly assigned to brace or observation group by computer, no influence of patient, parent, orthopedic surgeon or researcher. 50–50% chance - all patients examined every four months, both groups same protocol - 4 times asked to fill in some questionnaires |
| Advantages and disadvantages | - not known yet who will have most advantages. brace group: maybe treated with effective brace; control group: delayed/no uncomfortable treatment of which effect has not been established |
| Risks | - both patients treated with a brace as patients being observed have risk on surgery; not yet known whether the risk is different between the groups - regular check-up; in case of progression > 10 degrees in patient in control group, the patient is available for brace |
| Closure | - end results after two years - depending on the results, again asked to give permission for follow-up until maturity |
| Voluntary participation | - participation is voluntarily, in case of refusal, the usual treatment in that hospital will be provided - can withdraw permission at any time of the study |
| Costs and incentive | - no extra costs for patients - no extra incentive for orthopedic surgeons for participation of a certain patient |
| Confidentiality | - all data will be treated confidentially - no names or data that can lead to identification will be used in rapports etc. - protocol was approved by medical ethical review board |
| Insurance | - Since no other treatment than currently used in the Netherlands is applied, an extra insurance for patients' safety was not necessary |
| Further information | - contact information of the researcher and an independent physician was supplied |
| Complaints | - contact information of a committee that handles complaints about the study |