‘Informed consent is a fundamental principle underlying all healthcare’

A recent Independent Review for NHS Scotland stated that: “Informed consent is a fundamental principle underlying all healthcare”

The Cabinet Secretary for Health and Sport, Shona Robison stated to the Scottish Parliament (17 March 2017): “Informed consent and shared decision making are expected prior to any procedure being carried out.”

On the 20th April 2017, I wrote to Healthcare Improvement Scotland 
about Patient consent in NHS Scotland:

I have just completed my annual Appraisal which is a General Medical Council requirement as part of 5 yearly Revalidation. As part of this I was informed by my Appraiser that I must comply with all the LearnPro modules which I have now done.

The following screenshot comes from the NHS Lothian mandatory LearnPro module on Capacity and Consent:

I apologise as the text is small, so I have reproduced verbatim what it states to me as an NHS Lothian employee:

“Consent is both a legal requirement and an ethical principle and requires to be obtained by healthcare professionals, prior to the start of any examination, treatment, therapy or episode of care.”

“In Scotland, everyone over the age of 16 is an adult. The law assumes that adults can make their own decisions and can sign legal documents, such as consent to medical treatment (in some circumstances this also can apply to children under the age of 16) provided they have the capacity. This means that they are able to understand what is involved in the proposed treatment, retain the information, be able to weigh up the information needed to make the decision and then communicate that decision. Treatment might be delivered in a hospital, clinic or in someone’s home.”

In years past I have written about consent for older adults in hospital in NHS Scotland:

Do we care enough about consent?

‘OPAC tools are working’

I am writing to Healthcare Improvement Scotland as I find myself confused.

Do I follow the mandatory requirements of my employers on consent? Or do I follow the National Improvement requirements of OPAC-HIS where consent is not required for assessments such as the 4AT assessment test? (formerly called “4AT screening tool”)

I know, from the re-drafted Care Standards, that Healthcare Improvement Scotland take consent very seriously.

I should state that I am writing in my own capacity and in my own time.

12 May 2017 - I sent this update to Healthcare Improvement Scotland:

Forgive me for this further correspondence but I felt that I should update you on the learning that I received as part of my attendance for Continuing Medical Education (CME) yesterday.

This CME event was for the Royal College of Psychiatrists in Scotland – Faculty of Old Age Psychiatry and was held in Falkirk.

At this event the Chair of Old Age Psychiatry for the Royal College of Psychiatry was giving a talk and when the time came for questions I asked about the wide use of haloperidol in older adults in hospitals in NHS Scotland. Dr Thompsell replied “evidence has found that Haloperidol actually worsens the outcome of delirium”.

Another lecturer at this meeting, who was giving a talk on her area of expertise: anti-psychotics and older adults, was Dr Suzanne Reeve. She replied: “Haloperidol does increase mortality in older people compared with other antipsychotics. That message has been out for a while but has not really got across.”

The next talk was entitled “Successes of Old Age Psychiatry Liaison team” and one of the slides shown had the headline “Compliance with 4AT”. The impressive “compliance” figures then followed. The dictionary definition of compliance is “the act of yielding”.

My concern here is for patient harm and indeed increased patient mortality. National Improvement work undertaken by HIS has been instrumental in increasing “compliance” with tools such as the 4AT and it is clear that no consent is deemed necessary. I have argued that this is not ethical as these tools are often the beginning of “pathways” and “protocols” that may result in the administration of haloperidol.

I am genuinely worried that National Improvement work undertaken by Healthcare Improvement Scotland has not properly considered ethics, available evidence and the potential for unforeseen consequences. You will understand that I am also nervous about writing this letter given the consequences for me when I first “spoke up” three years ago:

I would very much value your advice. I am not sure that I can work in a profession if it loses sight of Hippocrates and “first do no harm”.

This is the response from Healthcare Improvement Scotland,
dated 17th May 2017:

“Thank you for your letter of the 20th April and your letter of 12th May, in which you raise the interesting issue of taking consent in relation to cognitive screening.

I understand from staff involved in the inspections of older people’s care in hospital that taking of written consent prior to initial assessment for frailty is not routinely undertaken. Assessment at the point of admission, or where a change in a patient’s cognitive presentation is giving cause for concern, can alert staff to possible increased risk and enables planning of care for the patient. In these circumstances staff adopt a proportionate approach such as asking, for example, if they may ask some questions.

For absolute clarity though, as an employee of NHS Lothian, the requirements set out in the Board’s policies and mandatory training are those that you should follow.”

 

Re-labelling (and a bit)

I read this book recently [below].

I am approaching fifty. With age-related sight changes I find that my arms need to be longer!. So if I have misread “Sixty and a bit”  please do forgive me:

Now we are sixty and a bit

This book reminded my of a protocol issued by an NHS Board in Scotland:

4 april 2014 all over 65 MUST

As a doctor who tries his best to follow evidence-based medicine, I argued against this approach. I found that neither this NHS Board nor indeed NHS Scotland shared my concerns:

Brian Robson

With the recent publication of the Care Standards for Older People, the Chair of Healthcare Improvement Scotland confirmed:

Letter4b

It would appear to me that this “screening instrument” has been re-labelled by Healthcare Improvement Scotland

The 4AT was developed and promoted as:

010Tools

Recently the 4AT has been re-labelled as:

4AT validated UK Gov

The authors  4AT describe its key features:

(1) “brevity” (takes less than 2 minutes”), and

(2) that “no special training is required”

I should confirm that I use rating scales with patients as part of my daily professional life.

However I would never start out with a rating scale. To me, that would seem most disrespectful.

Rating scales can add to wider medical understanding. This is why, despite my awareness of any intrinsic shortcomings, that I continue to feel that they can be helpful.

The 4AT has recently been re-branded an “assessment test”. The 4AT was promoted for several years, with the support of Healthcare Improvement Scotland, as a “screening tool”. The validation studies, still underway, describe the 4AT as a “screening” tool.

Given that there has been no change to the test itself, I would suggest that this is re-labelling (and a  bit.)

Do we care enough about consent?

This leaflet is widely available to patients in NHS Scotland including in the waiting room outside my consulting room: 039

Its first page defines consent as follows:038

This is the front page of the current BMJ:021

It is reporting on a legal ruling which has implications for consent as summarised by the editor:051052 053 054

Previously Sokol has said:013

I have had a longstanding interest in consent:015

Consideration of patient consent goes back to the earliest days of the NHS (and indeed before):032

I have previously highlighted how this difficult area becomes even more complex when we are considering cognitive screening:014

Scotland led the way with an incentivised target-based approach to the “early diagnosis” of dementia. The following is from one of the earliest expert meetings:First Dementia Strategy Meeting

A few years later the Scottish Government were sharing widely league tables:002

The Scottish Government commended its own approach to the Westminster Government:How to improvegeoff-huggins4 Geoff Huggins3

It was this robust approach that led me to consider whether the consent to assessment of the individual patient might be significantly affected by an external target. It was at this stage I contacted the National Clinical Leads for dementia, specifically highlighting my concerns about consent:Dementia Leads1

The Scottish Lead for Dementia replied:Dementia Leads2

I was delighted to attend this Conference in Glasgow which culminated in the signing of a rights-based approach to dementia:034044

At this Conference, the Chief Executive of the Mental Welfare Commission gave an address. Mr Colin McKay reminded us that for any individual deemed to lack capacity certain principles should apply. This includes having one’s own wishes listened to:
020

The previous Chief Executive of the Mental Welfare Commission offered his personal view on consent to examination. For many reasons I believe that cognitive screening is a very different activity to measuring blood pressure:056

I have also been in conversation with parliamentarians regarding consent to cognitive screening. In my letter to Dr Simpson, MSP, I highlighted the following points:

  • my concerns are specifically about obtaining consent to cognitive screening
  • Cognitive screening does not fulfill World Health Organisation criteria (Wilson & Jungner)
  • the UK National Screening Committee do not advise screening for cognitive impairment

Richard Simpson2

This is the view of the former Cabinet Minister for Health & Wellbeing:At liberty

I have also asked the UK’s leading Dementia charities about consent:042

I have recently written to Alzheimer Scotland about their current campaign: “Lets talk about dementia”. Disappointingly this appears to have back-tracked from the Glasgow Declaration and is advocating early rather than timely diagnosis. The “difficult conversation” as suggested by Alzheimer Scotland appears to me to trivialize consent:033

I have also had a number of “difficult conversations” when trying to raise issues of consent:Dr Brian Robson

One of the many reasons why this matters is that cognitive screening is not risk-free. 046047

Off-label anti-psychotic prescribing has increased year-on-year in the elderly across Scotland.

It is my view that those promoting improvement methodologies in NHS Scotland are currently not taking consent sufficiently seriously. It appears that I am not alone in having found these conversations “difficult”:061

The following post was about improvement work in the elderly on the Ayrshire Health blog. The full post and all responses to it can be read here:Flying without wings1

I submitted a reply which outlined my considerations about obtaining consent for cognitive screening. In response to my considerations, the Associate Nurse Director of Mental Health Services in NHS Ayrshire and Arran and Chair of the Mental Health Nursing Forum Scotland, appeared to remain unsure of the basis of my concerns:Flying without wings2

Professor June Andrews, Director of the Dementia Services Development Centre offered the following advice:June Andrews3

A service user shared my concerns about patient consent and raised the matter with the Ethics Committee of the Royal College of Psychiatrists:    John Sawkins

Over a decade ago, NHS Scotland published this Expert Group report:Adding life to years, 2002 aAdding life to years, 2002 cAgeism in NHS Scotlandc

This blog post asks if we care enough about consent? My view is that the principle of patient consent should be a fundamental right for all ages. It is the case that consent is a complex area but this is not a good enough reason for marginalising it. I would argue strongly that wider discussion particularly involving all of our elders is long overdue.

“At Liberty” (cognitive screening)

A Scottish citizen, over the age of 65 years, recently wrote to a Parliamentarian with concerns about mandatory cognitive screening in Scotland’s acute hospitals.

Following this a helpful letter was received from the former Cabinet Minister for Health and Wellbeing, Alex Neil. The letter is three pages long and goes on to describe how Scotland has done “rather well” in every area. Here is an extract about “delirium screening”:

At-liberty

This letter from Alex Neil confirms that “patients are perfectly at liberty to decline participation”. Here reference is made to the 4AT test which is a “brief screening tool” that is registered to screen for delirium and “cognitive impairment”.

It would have perhaps been even more helpful if our Cabinet Minister for Health & Wellbeing had confirmed if this “liberty” might also apply to other cognitive “screening tools” used in Scottish hospitals.

I have given my thoughts regarding consent to screening tests in my reply to the new Draft Care Standards.

Healthcare Improvement Scotland, based on Inspections to all our acute hospital have made cognitive screening of all our “elderly” admitted to hospital a key recommendation. As part of the inspection process “compliance” with the use of screening has been measured. My experience is that individual NHS Boards will wish to follow the recommendations of Healthcare Improvement Scotland as fully as possible.

Areas for improvement 2014

Those who have read my writings on cognitive screening will know that I share fully every understanding of just how serious delirium, dementia or cognitive impairment can be. I may have been misunderstood, but I share the determination to improve assessment, care and treatment.

My concern is specifically with screening as a starting point, using brief and reductionist “tools”. I worry about the potential consequences of departing from time-honoured professional nursing and medical assessment. Here I use cognitive rating scales as an important additional aspect to most assessments.  I explain to every patient the limitations of such tests, with advice on the benefits and the potential harms. I do not call tests “tools” even if this is how they have been so named.

Screening in other areas of medicine has raised considerable debate e.g. breast screening, PSA screening to name but a few. I see no reason why screening of our cognition should be free from such critical appraisal. As thinking beings, we can all agree that our cognition (how we think and feel) is most complex and not solely “shaped” by our brain.

I am not apologetic for raising concerns about reductionist approaches. I fully appreciate that such approaches are well-intentioned. I also refute the charge, made by a very senior professional in NHS Scotland , that I am “scaremongering”.

I have recently seen older patients discharged from hospital with wrongful diagnoses. The consequences have been significant for those concerned and upsetting to witness.

Here are some of the potential consequences of screening:

(1) false-negative diagnosis of delirium/dementia

(2) false-positive diagnosis of delirium/dementia

(3) over-simplification of complex and serious conditions

(4) heightening of fear in our elders

(5) increased reliance on pathways started with said “screening tool”

(6) medical confusion: that the ‘parabolic distribution of cognition with age’ risks being turned completely into disease

(7) risk of even greater prescribing of anti-psychotics (by following said pathways)

(8)  loss of autonomy:  a reductionist basis to “capacity”

Through the eyes of Liberty from omphalos on Vimeo.

a-part