Benefit and risk information for medications in multiple sclerosis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: The intervention in the study is the evidence‐based protocol. This protocol will be used to provide information about medication risks and benefits from findings in the literature, and the observational studies that have been conducted by the authors. The control in the study is information as usual. This involves providing information about medication risks and benefits using presentation methods used in current consultations. Both the control condition and the intervention condition will be provided to patients verbally and in written format (leaflets) ‐ thus, there will be a total of four conditions: 1. Consultation as usual provided in a verbal format (control verbal) 2. Consultation as usual provided with written information (control written) 3. Evidence‐based protocol provided in a verbal format (intervention verbal) 4. Evidence‐based protocol with written information (intervention written) Patients in this study will be assigned to all four conditions in turn, but the allocation to the particular order of conditions will be randomised using a random number generator. All patients will be blinded to the conditions they receive. All information provided during the study will be for hypothetical medications, but the risk and benefit information will closely mimic the current disease‐modifying medications in multiple sclerosis. CONDITION: Multiple sclerosis ; Nervous System Diseases ; Multiple sclerosis PRIMARY OUTCOME: Patients' decisional conflict, assessed using the Decisional Conflict Scale directly after each condition (i.e. four times in total) SECONDARY OUTCOME: Patients' understanding of the information provided during the study, assessed using an author‐designed questionnaire directly after each condition (i.e. four times in total) INCLUSION CRITERIA: 1. Diagnosis of relapsing‐remitting multiple sclerosis (RRMS) by a consultant neurologist to best current criteria (i.e. not clinically isolated syndrome (CIS), likely Polman et al., 2011) 2. Able and willing to give informed consent 3. Able to meet tasks demands of study in terms of sensorimotor abilities 4. Ages 18 to 60
Epistemonikos ID: 214b5078875a056b7d76967a686cff66914d4ba0
First added on: Aug 24, 2024