OBJECTIVE: Is health-related quality of life 12 months after randomisation in participants with functional neurological symptoms better after discussion of the diagnosis by trained neurologists who schedule at least two follow-up visits (intervention group) than after the same discussion of the diagnosis by these neurologists and immediate referral to the general practitioner (control group)?
METHODS: A single-centre randomised controlled trial at one academic outpatient department of neurology. Participants were randomised 1:1, stratified for type of functional symptoms. The study sample consisted of 100 participants in the intervention group, and 95 participants in the control group. Primary outcome was the mean change 36-Item Short Form Health Survery (SF-36) scores from baseline to 12 months.
RESULTS: Participants in both treatment groups showed improvements on most SF-36 subscales and secondary outcomes measures but without significant between-group differences in mean change scores. Neither was there a difference between the treatment arms with regard to the number of participants who reported their symptoms at 12 months to have greatly improved compared with baseline: 29 participants (29/98=29.6%; two missing values) in the intervention group versus 31 participants (31/95=32.6%) in the control group (95% CI of the difference between proportions: from -16.1% to 10%).
CONCLUSION: This study showed that after a neurologist has established the diagnosis and briefly explained and thereafter has sent the patient to a neurologist with a special training who scheduled half an hour to discuss the diagnosis, more sessions by this neurologist do not improve outcome.
CLINICAL TRIAL REGISTRATION NUMBER: NTR 2570.