No single measure was identified for use across the range of FND symptoms in adults .
Across r and omised controlled trials ( k=40 ) and observational treatment studies ( k=40 ) , outcome measures most often assessed core FND symptom change .
Other domains measured commonly were additional physical and psychological symptoms , life impact ( ie , quality of life , disability and general functioning ) and health economics/cost-utility ( eg , healthcare re source use and quality -adjusted life years ) .
CONCLUSIONS There are few well-vali date d FND-specific outcome measures .
OBJECTIVES We aim ed to identify existing outcome measures for functional neurological disorder ( FND ) , to inform the development of recommendations and to guide future research on FND outcomes .
COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): a multicentre randomised controlled trial protocol
Background The evidence base for the effectiveness of psychological interventions for patients with dissociative non-epileptic seizures ( DS ) is currently extremely limited , although data from two small pilot r and omised controlled trials ( RCTs ) , including from our group , suggest that Cognitive Behavioural Therapy ( CBT ) may be effective in reducing DS occurrence and may improve aspects of psychological status and psychosocial functioning . Methods / Design The study is a multicentre , pragmatic parallel group RCT to evaluate the clinical and cost-effectiveness of specifically-tailored CBT plus st and ardised medical care ( SMC ) vs SMC alone in reducing DS frequency and improving psychological and health-related outcomes . In the initial screening phase , patients with DS will receive their diagnosis from a neurologist/epilepsy specialist . If patients are eligible and interested following the provision of study information and a booklet about DS , they will consent to provide demographic information and fortnightly data about their seizures , and agree to see a psychiatrist three months later . We aim to recruit ~500 patients to this screening stage . After a review three months later by a psychiatrist , those patients who have continued to have DS in the previous eight weeks and who meet further eligibility criteria will be told about the trial comparing CBT + SMC vs SMC alone . If they are interested in participating , they will be given a further booklet on DS and study information . A research worker will see them to obtain their informed consent to take part in the RCT . We aim to r and omise 298 people ( 149 to each arm ) . In addition to a baseline assessment , data will be collected at 6 and 12 months post r and omisation . Our primary outcome is monthly seizure frequency in the preceding month . Secondary outcomes include seizure severity , measures of seizure freedom and reduction , psychological distress and psychosocial functioning , quality of life , health service use , cost effectiveness and adverse events . We will include a nested qualitative study to evaluate participants ’ views of the intervention and factors that acted as facilitators and barriers to participation . Discussion This study will be the first adequately powered evaluation of CBT for this patient group and offers the potential to provide an evidence base for treating this patient group . Trial registration Current Controlled Trials IS RCT N05681227 Clinical Trials.gov
No single measure was identified for use across the range of FND symptoms in adults .
Across r and omised controlled trials ( k=40 ) and observational treatment studies ( k=40 ) , outcome measures most often assessed core FND symptom change .
Other domains measured commonly were additional physical and psychological symptoms , life impact ( ie , quality of life , disability and general functioning ) and health economics/cost-utility ( eg , healthcare re source use and quality -adjusted life years ) .
CONCLUSIONS There are few well-vali date d FND-specific outcome measures .
OBJECTIVES We aim ed to identify existing outcome measures for functional neurological disorder ( FND ) , to inform the development of recommendations and to guide future research on FND outcomes .