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I was just reading this fun publication: 'Stepped care for functional neurological symptoms
A new approach to improving outcomes for a common neurological problem in Scotland.'
I came upon a section that reminded me of CFS spin:
I decided to try to find the trial to have a look, and it seems that it was a Sharpe one that found no difference between treatment and control groups in their primary outcome measure at six months, and the 'control' group was just usual care. What a great 'opportunity'.
The failure to attempt proper control groups for psychological RCTs just seems crazy (or corrupt), especially if you're relying upon subjective self-reported questionnaires as an outcome measure. That they still failed to reach significance at six months is embarrassing.... that this is still being presented as good evidence to justify the expansion of services is mystifying... and people are complaining about NHS cutbacks? Maybe we should be focusing on treatments where there's good evidence of efficacy at the moment?
Also, I was quite proud of this little bit from the Scottish report:
I'm probably fooling myself, but I imagined the writer thinking: "We know you weird CFS patients go around checking up on the claims in reports like these and getting angry... we're not saying that you don't fall within what should be our remit, but we're leaving you alone, so just leave us alone too. We'll even put the ME bit first!!"
A new approach to improving outcomes for a common neurological problem in Scotland.'
I came upon a section that reminded me of CFS spin:
In an attempt to overcome this problem, the Symptom Management Research Trial (SMART) in Neurology aimed to distil CBT into a more time efficient form of therapy using a therapy manual23 and 4 x 30 minutes of therapy time to guide patients through it. This model was tested in a randomised controlled trial in new neurology patients in Glasgow and Edinburgh4. The two therapists had nursing or psychology backgrounds. The therapy manual was designed to help patients gain a better understanding of their functional neurological symptoms and how these symptoms were arising in their body. There were exercises and ‘homework’ for the patients to complete between sessions. During the sessions the therapists could go over the material, dealing with questions arising and making further suggestions for changes in behaviour at home.
The patients recruited into the trial were more disabled than the typical patient with functional neurological symptoms in SNSS. One third had experienced their symptoms for more than 5 years and 45% were not working. However, there were clear benefits after treatment. Their presenting symptoms were significantly better at 3 and 6 months and their overall physical function was better at 6 months. Overall there was a 13% absolute difference in the numbers of patients who were ‘better’ or ‘much better’. This is an impressive result given the severity and duration of the symptoms and the brevity (and low cost) of the treatment.
This evidence suggests that a substantial number of patients would benefit from a brief and low cost, low intensity – but individually tailored – therapeutic intervention from a therapist specifically trained in the treatment of functional neurological symptoms. This creates an opportunity to provide a service to patients who currently do not have access to beneficial treatment, but have substantial disability and who are consuming unnecessary NHS resources in a largely fruitless search for help. However, it is well recognised that the routine implementation of research proven brief therapies often fails owing to a lack of a similar level of high quality supervision compared with the original trials. Therefore, the therapists should be under the supervision of a senior clinician within a national supporting framework to standardise delivery, and evaluate the outcomes, both in terms of effectiveness and cost-effectiveness.
I decided to try to find the trial to have a look, and it seems that it was a Sharpe one that found no difference between treatment and control groups in their primary outcome measure at six months, and the 'control' group was just usual care. What a great 'opportunity'.
Full text available here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149156/Guided self-help for functional (psychogenic) symptoms: a randomized controlled efficacy trial.
Sharpe M, Walker J, Williams C, Stone J, Cavanagh J, Murray G, Butcher I, Duncan R, Smith S, Carson A.
Source
University of Edinburgh, Edinburgh, Scotland, UK. michael.sharpe@psych.ox.ac.uk
Abstract
OBJECTIVES:
Functional (psychogenic or somatoform) symptoms are common in neurology clinics. Cognitive-behavioral therapy (CBT) can be an effective treatment, but there are major obstacles to its provision in practice. We tested the hypothesis that adding CBT-based guided self-help (GSH) to the usual care (UC) received by patients improves outcomes.
METHODS:
We conducted a randomized trial in 2 neurology services in the United Kingdom. Outpatients with functional symptoms (rated by the neurologist as "not at all" or only "somewhat" explained by organic disease) were randomly allocated to UC or UC plus GSH. GSH comprised a self-help manual and 4 half-hour guidance sessions. The primary outcome was self-rated health on a 5-point clinical global improvement scale (CGI) at 3 months. Secondary outcomes were measured at 3 and 6 months.
RESULTS:
In this trial, 127 participants were enrolled, and primary outcome data were collected for 125. Participants allocated to GSH reported greater improvement on the primary outcome (adjusted common odds ratio on the CGI 2.36 [95% confidence interval 1.17-4.74; p = 0.016]). The absolute difference in proportion "better" or "much better" was 13% (number needed to treat was 8). At 6 months the treatment effect was no longer statistically significant on the CGI but was apparent in symptom improvement and in physical functioning.
CONCLUSIONS:
CBT-based GSH is feasible to implement and efficacious. Further evaluation is indicated.
CLASSIFICATION OF EVIDENCE:
This study provides Class III evidence that CBT-based GSH therapy improves self-reported general health, as measured by the CGI, in patients with functional neurologic symptoms.
The failure to attempt proper control groups for psychological RCTs just seems crazy (or corrupt), especially if you're relying upon subjective self-reported questionnaires as an outcome measure. That they still failed to reach significance at six months is embarrassing.... that this is still being presented as good evidence to justify the expansion of services is mystifying... and people are complaining about NHS cutbacks? Maybe we should be focusing on treatments where there's good evidence of efficacy at the moment?
Also, I was quite proud of this little bit from the Scottish report:
Patients with organic neurological disease and co-morbid psychological problems clearly also have significant needs and require a separate strategy, not discussed here. Also we are not considering patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
I'm probably fooling myself, but I imagined the writer thinking: "We know you weird CFS patients go around checking up on the claims in reports like these and getting angry... we're not saying that you don't fall within what should be our remit, but we're leaving you alone, so just leave us alone too. We'll even put the ME bit first!!"