Dementia Guidelines: research and clinical criteria are not simply “interchangeable”

Published as BMJ rapid-response – 9 December 2013

By Dr Peter J. Gordon and Dr Sian F. Gordon

It was encouraging to read that the G8 summit on dementia to be held this week in London will discuss the rising impact of dementia on the world’s population and economy, in an effort to generate an international response to increase research into the disease.[1] That research into dementia needs to progress and to be funded deserves wide support. However it was concerning to find that the extensive pre-summit publicity made no mention of person-centred approaches and well-being in dementia and that the language used tended to return to notions of burden, cost and epidemic. It is essential to maintain a balance between biomedical research and investigating the simple day-to-day approaches which can make a huge difference to those living with dementia and their carers.

Dementia is a clinical syndrome with a number of causes, the commonest of which is Alzheimer’s disease. Alzheimer’s disease is defined in terms of brain pathology found post mortem. It is quite clear that many people die with evidence of the pathology of Alzheimer’s disease in their brain who never demonstrated any symptoms of dementia whatsoever[2]. Of the drugs used to treat dementia, donepezil, galantamine and memantine are licensed only for use in “dementia in Alzheimer’s disease” and rivastigmine for “dementia in Alzheimer’s disease or Parkinson’s disease”. It is therefore disappointing that, with reference to its CG42 Dementia guideline[3] the National Institute for Health and Care Excellence (NICE) states that “the guideline group, both in discussion and in the guideline, tended to use the terms Alzheimer’s dementia and disease interchangeably[4].” Similar confusion exists in the equivalent Scottish Guideline, SIGN 86: The Management of dementia[5]. The concern is that these influential documents might change the general approach to the diagnosis of dementia away from the clinical syndrome of dementia. This has no basis in currently available evidence, and ignores the ethics, complexity and uncertainty in this area, particularly in the most elderly.

All stakeholders should have a say in guideline development. This is rooted in the ethical theory of principlism, a term that covers all clinical (diagnostic or therapeutic) decisions that need to balance potential benefits and harms.

In a recent systematic review of 12 national Clinical guidelines for dementia[6] “low mean rates of explicit coverage of ethical issues” were found. SIGN 86 Guideline on the management of Dementia rated poorly for inclusion of ethical issues. The rate of disease-specific ethical issues (DSEIs) that were explicitly addressed by SIGN86 was 22% with a worldwide median of 49.5%. Only Switzerland scored more poorly. When adding all implicitly addressed DSEIs the NICE guidelines for dementia (England & Wales) rated highest at 91% and the SIGN 86 guidelines (Scotland) the lowest at 35%. This appears to confirm an imbalance between the consideration of bio-medical aspects of dementia and those which focus on more general aspects of care. Just because the latter are harder to measure does not make them any less important. General aspects of care are also less likely to receive research support from industry.

SIGN confirms that for all its guidelines it “is committed to open declaration of competing interests in all its activities[7]”.  However it is also stated that “in line with our records management policy, the Declarations of Interest are retained on record for three years after publication of the guideline and then destroyed. Since it is over 3 years since this guideline was published the Declarations have been destroyed[8].” Thus we can only be left to speculate regarding any potential for bias. Recently this has been a subject of consideration as exemplified by recent articles on clinical guidelines[9] [10].

Whilst most clinicians would agree that acetylcholinesterase inhibitors have a potential role for mild symptomatic relief in dementia of an Alzheimer’s type, there are legitimate concerns that the impact of these drugs has been overstated. For example, in a study with large power published in the Lancet, in a sample of 565 patients with dementia of the Alzheimer’s type Courtney and colleagues found that donepezil is not cost-effective, with benefits below minimally relevant thresholds[11]. There has never been reproducible evidence in humans that cholinesterase inhibitors delay progression of either Alzheimer’s disease or dementia of an Alzheimer’s type.

The Dementia 8 Summit is about to begin. Let it promote objective and transparent science and person-centred care. Research and innovation must flourish but in a way that is to the benefit of all those living with dementia and those who care for them.