Evidence-based patient-information before diagnostic testing and in the early phase of multiple sclerosis - Results of a cohort study and outline of a randomised-controlled trial

Parallel to the establishment of early treatments in multiple sclerosis (MS) new diagnostic criteria have made an earlier diagnosis possible. While there is ongoing discussion about possible benign courses and only partial effective treatments, so far there have been no attempts to facilitate shared decision making on diagnostic testing between patients with suspected MS and their physicians. We developed and validated a leaflet for persons with suspected MS to engage them in a diagnostic decision making process. The leaflet was presented to a retrospective cohort (n=87) of patients being diagnosed within the last 2 years as well as to a prospective cohort of n=51 patients with MS suspicious symptoms. In both cohorts about 70% of patients wanted to be informed about a possible MS before testing while 10% did not. The leaflet did not elicit worries and concerns. Patients felt encouraged to be more actively involved in decision making. Based on this work and our previous studies showing altered health behaviour in educated MS patients, we have developed an evidence based patient education programme on MS diagnosis, prognosis, and early treatment for patients with possible or definitive MS within the first year of the disease which was tested in pilot study groups (n=30). We hypothesize that the educational programme comprising a 60 pages brochure and 4 small group training increases relevant disease‐related risk‐knowledge and promotes informed choice. Also, it is supposed to increase sense of control, decision autonomy and satisfaction and furthermore to reduce anxiety and depression. A ran‐domized‐controlled trial starting in May 2009 at 5 university centres in Germany will compare the intervention to an unspecific stress management programme. Informed choice, defined as congruency between attitude and decision together with sufficient risk knowledge, will be the primary endpoint. Intervention concept and early evaluation data as well as trial design outline and recruitment status will be presented.