It’s just over a year since I spoke with the Director of Guidelines at NICE. The telephone call was the result of an email to the Director asking that they might want to consider doing something positive about the problems with the Diagnosis and Treatment of Pernicious Anaemia. I received an email back asking for a time and date when we could have a 45 minutes Conference Call; incidentally, that was my first Conference Call and I haven’t had another….

During the conversation I outlined the problems with the current methods used to make a diagnosis. We discussed the Guidelines from the British Committee for Standards in Haematology (BCSH) and the results of our members survey. Both of these pieces of evidence point to some serious shortcomings in the current way Pernicious Anaemia is Diagnosed and Treated were published in 2014. The Guideline from the BCSH followed on from a meeting with the Dept. of Health in 2012. And the results of our survey, which was published in the British Journal of Nursing was the culmination of three years accumulating data and six months of analysis. So, the whole process of gathering data for use as evidence began back in 2009 – nine years ago. The outcome of that 45-minute telephone conversation was that I was sent a pro-forma for me to fill in; this would start the formal application to NICE to develop a Guideline on Diagnosing and Treating Pernicious Anaemia.

The formal request

The pro-forma was completed and returned only after I had consulted with our ‘round table’ of medical and health professionals and taken advantage of the kind offer from a statistician to put some financial data together. The Formal Request was sent via email on the last day of January this year (2018).

Then it all went quiet. I later learned that NICE had contacted the BCSH asking for any update and were told that there was nothing to add to the previous Guideline produced by them four years ago; this meant that they had nothing to recommend relating to more accurate tests or better treatments – in other words they passed the problem back to NICE.

Contrary to what I originally thought organisations like the Pernicious Anaemia Society will not have their application for a new Guideline considered. It is first referred to one of the Commissioning Bodies, NHS England or the Dept. of Health. The way this is done is that a topic selection oversight group at NICE considers topics for guideline development, taking into account whether there is an existing Guideline that could be used to address any problems identified (there isn’t) or ‘the priority given to the topic by commissioners and professional organisations, and organisations for people using services, their families and carers’. That’s where we scored a hit. We are an ‘organisation for people using services, their families and carers’.

NICE then discusses topics identified in this way with NHS England, the Department of Health and Public Health England, and a prioritised list is agreed by these 3 bodies. We must have made a good case because NHS England then formally referred our case to NICE who have scheduled it into NICE’s guideline development plans. You can see it sitting all alone here:

Questions about the diagnosis

The next step will be for NICE to form a Guidance Development Group (GDG) which will include Stakeholders (the PA Society), at least two Lay members (patients), Expert Witnesses and Health and Medical Professionals. This group will produce Review Questions which, if I have anything to do with it, will concentrate on questions about Diagnosis and Treatment. Here’s what NICE say about questions about Diagnosis:

‘Review questions about diagnosis are concerned with the performance of a diagnostic test or test strategy. A diagnostic test is a means of determining whether a patient has a particular condition (disease, stage of disease or subtype of disease). Diagnostic tests can include physical examination, history taking, laboratory or pathological examination and imaging tests.

Broadly, review questions that can be asked about a diagnostic test are of three types:
1. questions about the diagnostic accuracy of a test or a number of tests individually against a comparator (the reference standard)

2. questions about the diagnostic accuracy of a test strategy (such as serial testing) against a comparator (the reference standard)

3. questions about the clinical value of using the test.

Questions about a diagnostic test consider the ability of the test to predict the presence or absence of disease. In studies of the accuracy of a diagnostic test, the results of the test under study (the index test[s]) are compared with those of the best available test (the reference standard) in a sample of patients’.

And then there’s the Review Questions relating to Treatment:

‘The PICO framework should take into account the patient experience. Patient experience, which may vary for different patient populations (‘P’), covers a range of dimensions, including:

patient views on the effectiveness and acceptability of given interventions (‘I’)

patient preferences for different treatment options, including the option of foregoing treatment (‘C’)

patient views on what constitutes a desired, appropriate or acceptable outcome (‘O’).

The integration of relevant patient experiences into each review question therefore helps to make the question patient-centred as well as clinically appropriate.

It is also possible for review questions to ask about specific elements of the patient experience in their own right,…… Such review questions should be clear and focused, and should address relevant aspects of the patient experience at specific points in the care pathway that are considered to be important by the patient and carer members and others on the GDG. Such questions can address a range of issues, such as:

– patient information and support needs

– the specific needs of groups of patients who may be disadvantaged compared with others

– which outcomes reported in intervention studies are most important to patients’.

Development stages

So, you see it’s all there in black and white. However, I am not so naïve to believe that this is going to be all plain sailing. It will take three years for the Guideline to be developed and the whole process will need to be monitored which is what I will be doing for the next three years or so. Below are the stages the guideline will pass through over the next three years or so.


(This is where we are right now)

Developer Drafts Scope of the Guideline including Key Issues and Questions
Stakeholders Comment on Draft Scope
Final Scope Published

Structured Review Questions Agreed
Literature Search
Call for Evidence from Stakeholders if needed
Evidence Reviews and Economic and Economical Analysis Prepared
Committee Discusses Evidence Reviews & Expert Testimony and develops Draft Recommendations

Stakeholders Comment on Draft Guideline

Committee Revises Guidelines in Response to Stakeholders’ Comments

Quality Assurance by NICE Staff
Guidance Executive Sign Off Guidance

Confidential Advance Copy Released to Stakeholders that Commented on Draft Guideline
Guideline, NICE Pathway and any Key Message for the Public Published
Resources to Support Implementation Published

Regular Checks to Determine if Update Needed
Part or All of Guideline Updated according to Usual Process and Methods

As you can see, I’m going to be busy!
I will keep you updated.