Response to ACD Computerised Cognitive Behaviour Therapy for Depression and Anxiety (Review) by ST Solutions Ltd

1) Whether all the evidence available to the Committee has been appropriately taken into account regarding FEARFIGHTER (FF)?

NO. The ACD omits important findings sought by Guidance No. 51 from 7 FF studies, including 4 RCTs, which have great potential to promote the current NHS agenda and save costs. It unfairly re-evaluates clinical efficacy, which was already accepted as proven by NICE, on evidence restricted to the latest studies. This unfairness criticism is limited to the ACD

1.1.  

FF’s internet delivery enhances patient choice at the point of referral, giving 24/7 availability at home and anywhere else linked to the internet in complete privacy and obviating any requirement to go to a clinic. The net version of FF was developed and tested in response to a survey of several hundred patients which found a clear preference for CCBT at home to CCBT in a clinic. The ACD has paid only cursory attention to this demand from patients and the Internet technological breakthrough and the advantages it offers the NHS in delivering its patient choice agenda.

1.2.  

"So all in all FearFighter has surpassed all my expectations helping me than the one to one with the Psychologist has (emphasis added).” Mary aged 61, agoraphobia/panic sufferer for 45 years; April 10, 2005. Total 23 minutes of support via phone and email

1.3.  

A “hot topic” for all users of PC-based CCBT is throughput or lack of it. Most manufacturers are now converting their products to the internet. FearFighter is the only product appraised that has actual RCT data on an internet service, and its potential impact on throughput has not been adequately taken into account.

1.4. 

FF on the internet can help to deliver CBT as recommended in NICE’s Guideline on Dec 2004 on Anxiety to the whole population. This eliminates both the bottleneck and postcode lottery problems, as it is available to patients 24/7 from the smallest practices and it requires only telephone support and no equipment at the surgery.

1.5.  

Patients’ outcomes can be audited automatically via anonymous records on FF’s central server, enabling PCTs etc to deliver required NHS audit expectations automatically at low cost. In addition, the server enables research to be done routinely across PCTs on a wide scale at low cost.

1.6.  

FF-Education is a training tool for classroom and distance learning. In 2 RCT’s it enhanced knowledge in nursing and medical students almost as much as did face-to-face lectures and it also saved teacher time, so it can help train staff at practices with special interests (PwSIs). FF-Education’s e-learning together with FF enables primary care staff to deliver proven practice-based effective mental health care as effectively as specialist secondary care for phobias, panic, anxiety and co-morbid depression. This could help Local Enhanced Service initiatives now being developed by PCTs. The NHS training guidelines for Graduate workers mentions the potential of FF- Education but this ACD does not consider the major way in which FF-Education can reduce NHS skills deficits. The ACD misses an opportunity to recommend tested educational programs based on tested CCBT products could to help train staff about anxiety and phobias and to deliver and support CCBT.

1.7.  

FF research presented to NICE found that the mean time of unemployment and health-care resource use was 8 years for sufferers from a range of phobias. The ACD does not take such costs into account. The impact of these chronic patients on health and social care resources is considerable. It is not unusual for NICE to cite such costs when considering guidance.

1.8.  

The ACD does not give clearly transparent cost-effectiveness data on the products in a way that can be explained fairly and reasonably to NHS managers

1.9.  

The finding that FF users who suffered from co morbid depression improved on their depression ratings as much as on their phobia scores is overlooked in  the ACD both in terms of its clinical impact and cost saving.

1.10.

The findings by Kenwright that secondary referrals were reduced at the GP practice in London served by a CCBT Self Care Clinic and then increased when the clinic ceased to function are not taken into account

2. Whether the summaries of clinical effectiveness and cost effectiveness are reasonable interpretations of the evidence regarding FearFighter?

NO. The ACD does not use the same standards for all disorders. It disregards much of the evidence, and uses an economic model that does not reflect the real world relating to Internet delivery. Neither we nor health economists we consulted have a full understanding of the model and it would be very difficult to explain to NHS staff.

Clinical Effectiveness

2.1 

We are at a loss to fathom why the ACD recommends a depression CCBT package tried in only 20 patients with no comparators, yet does not recommend FF after its 7 trials including 4 RCT’s and strong comparators in hundreds of patients. We have spent 12 years researching and developing FF to meet NHS requirements. The ACD’s guidance does not encourage us to do more unfunded research for another 3 years before acceptance when it recommends other far-less-tested products. We ask that NICE guidance for every product be based on the same fair criteria.

2.2 

FearFighters’ clinical efficacy was accepted by NICE in Guidance No. 51, since when there has been new positive evidence. The ACD is perverse in now bringing FF’s clinical efficacy into question for no obvious reason.

2.3 

In July 2004 the NHS document “Organising and Delivering Psychological Therapies” was positive about CCBT and FearFighter in particular and suggested it should be considered for use. The NHS Chief Executive then asked all PCT’s to take note of this document in his monthly bulletin.

2.4 

The NICE guidance on depression in Dec 2004 is very positive on CCBT and mentions FearFighter as a product that has been well proven.

2.5

In Sept 2004 FearFighter was awarded the HUSITA prize for Best International Human Services Software by a peer review of International experts.

2.6 

The ACD criticises a FF RCT because it used relaxation treatment as a comparator but fails to say why this is unsatisfactory beyond an opaque allusion to “expert testimony” which is not clarified. The ACD says “Treatment as Usual” is “an appropriate comparator”. TAU generally means giving minimal or no support, relaxation, face to face CBT, or a prescription of benzodiazepines or other drugs.

2.7 

FF was effective when tested against TAU in the form of relaxation, face to face CBT, and other CCBT without exposure. The ACD dismisses this evidence by citing “clinical experts” but who are they? Published expert opinion including NICE’s own Guidance No. 51 said FF is efficacious, and NICE’s current Evaluation Report in the Appendix gives evidence that FF is clinically effective, as do the Royal College of Nursing, TOP-UK, and the Institute of Psychiatry.

2.8 

 In its latest RCT, FF was tested against CCBT without exposure, which patients would not know differed from usual CBT and CCBT. This is like a double blind study in CCBT research and should be recommended by NICE as a standard to beat rather than to be ignored.

2.9 

In addition this important study, unlike others the ACD commends, controlled for the use of an Internet system, which point is missed by the ACD.

2.10

There is a great lack of balance and fairness in the ADC. We have successfully tested our internet version yet the guidance as it stands will allow the untested wide propagation of future internet versions of BTB and of Overcoming Depression and will encourage large players to enter the market with poorly-tested programs.

Cost Effectiveness

2.11         

ST Solutions was disadvantaged in producing its best evidence for cost effectiveness by administrative issues at SCHARR. At a very late stage ScHARR refused to honour its promise made at NICE’s meeting on April 6, 2004 to discuss with us its economic models and data requirements. It emailed us on Sep 23, 2004 asking for raw data which was held by 9 researchers then in Switzerland, Ireland, UK, Japan and the US. On Oct 4 SCHARR phoned us to say it would exclude home-accessed Internet programs from its analysis! We objected and NICE reassured us that our net programs would be analysed after some delay. When the SchaRR report was published (dated early Dec 2004 but not distributed until mid-Jan 2005) we took advice and were told that it would take 3 months to evaluate our data and we only had 4 weeks. Had we known in April 2004 our economic analysis could have been completed and presented to the committee in good time. Our health economist can do this work and we are prepared to pay for it on the understanding that we are given enough time and that it will be taken into account in NICE’s guidance.

2.12         

Neither SCHARR nor the Evaluation Report team have completed their economic analysis of FearFighter to the same standard as that for Beating the Blues and although valiant efforts have been made in the Evaluation Report there remain significant shortfalls.

2.13         

The Assumption that CCBT is additional charge for FF but not for BTB is unfair and not supported by the evidence from Kenwright who found that the secondary care referrals from primary care were reduced when the self care clinic was in operation and subsequently increased when the clinic closed  

2.14         

The changing severity across group cost issue cannot be answered unless we are given more time to obtain a health economist’s evaluation

2.15         

No discounts appear to have been allowed for PC hardware, maintenance  and office space not being required

2.16         

The incremental cost for FF &BTS cannot be answered unless we are given more time to obtain a health economist’s evaluation

2.17 

A sensitivity analysis has not been undertaken, whilst the Evaluation Report acknowledges the provisional nature of the costings but the figures are given as exact numbers not presented as a range and confidence level

2.18         

Double treatment for failed patients calculation. In our experience of several hundred patients very few have been treated twice on FearFighter

2.19

We presented new evidence on costs as Guidance No. 51 requested. NICE have only used a cost model similar to that of our competitors and have not considered in full the strong evidence we have that FF is a lot cheaper than face to face CBT therapy

Results of the economic comparison