Informed shared decision making about immunotherapy for patients with multiple sclerosis (ISDIMS): a randomized controlled trial.
OBJECTIVE
To evaluate the effects of an evidence-based patient decision aid (DA) on multiple sclerosis (MS) immunotherapy.


METHODS
Two hundred and ninety-seven MS patients who were considering or reconsidering immunotherapy participated in a randomized community-based controlled trial in Germany. An intervention group (IG) received the DA and a control group (CG) received standard information. Primary outcome measure was the match between the patient's preferred and actual roles during consultation with the physician. Secondary end-point was treatment choice. The course of the decision-making process and patients; evaluation of the decision were also evaluated. Data were collected at baseline, after receiving the information, after consultation with the physician and 6 months after baseline.


RESULTS
The percentage of preference matches did not differ between groups (IG 49%, CG 51%, P = 0.71). There were no differences in immunotherapy choices between groups. IG patients temporarily became more critical of immunotherapy and rated the information as significantly more helpful.


CONCLUSIONS
Although the intervention led to intensified processing of the information it affected neither the roles adopted in physician-patient encounters nor the immunotherapy choices made. Providing patients with balanced information may not be sufficient to alter the decision-making process.
Kasper
J
J
Institute of Neuroimmunology and Clinical MS-Research, University of Hamburg, Hamburg, Germany. k@sper.info
Köpke
S
S
Mühlhauser
I
I
Nübling
M
M
Heesen
C
C
D000328:Adult; D003627:Data Interpretation, Statistical; D003661:Decision Support Techniques; D005260:Female; D005858:Germany; D006801:Humans; D007167:Immunotherapy / Q000379:methods* / Q000523:psychology; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods; D010353:Patient Education as Topic; D010358:Patient Participation / Q000379:methods*; D017060:Patient Satisfaction; D010817:Physician-Patient Relations