CMO & childrens sub-group
Part 2, 16/6/99
Part 3, July 99
Joint Meeting of Key, Children's and Reference Group - Briefing - July 1999
Welfare Reform Reply Letter
New Rules on Decision Making and Appeals
Key Group - Briefing No 4 - November 1999
CMO Keygroup - Feb 2000

PART 1
               Chief Medical Officer's Working Group on CFS/ME

Terms of Reference: To review management and practice in the field of CFS/ME with the aim of providing best practice guidance for professionals, patients and carers to improve the quality of care and treatment for people with CFS/ME

The first meeting saw a full attendance of a very diverse group, a constructive and collaborative atmosphere and the establishment of key working principles. The nature of the end product was agreed as was a preliminary view of the scope of work to be undertaken To assist the first meeting, a Scoping Document was drawn up by Dr Derek Pheby This Scoping Document will be released with our next Briefing. It is anticipated that the Group will be in operation for at least 18 months.

1.    Key working principles:

The Group must have maximum transparency' i.e. as much information about its activities to be distributed as possible to all potential interested parties To this end a Briefing will be issued after each meeting, summarising discussion and highlighting issues for future work. The Briefing will aim to reflect agreement and disagreement in the Group, so readers have a good picture of debate. Distribution will be by Website and paper based (to interested organisations for them to reproduce).

From time to time it may also be appropriate to use the media. One early possibility might be to use ME Awareness Week

All Group members must be kept involved throughout. This requires respect for differing positions, willingness to listen, learn and even to change our minds. We will ensure we make full use of all members, including those on the Reference Group, where there is a wide range of knowledge and expertise, and also will seek to 'capture' a range of views, which goes even beyond the Reference Group..

o    We should seek to identify areas of agreement and disagreement. If we can identify what we agree upon (one suggestion was 'up to 80%'), we can then be far more efficient by focusing our work on those specific disagreements, which are relevant to the Group's objective. Meanwhile, areas of legitimate uncertainty or disagreement, for example on causation, may need to be accepted and respected, so long as they do not impede provision of care etc

o    We will need smaller 'sub-groups' to do discrete pieces of work to feed into the full group
2.    The end product.

o    A clear, concise, practical and easy to comprehend document (or possibly several, tailored to different users) giving guidance for diagnosis and management, which will be usable by patients, carers, professionals and health service Commissioners

3.    Scope of work:

Listed below is the immensely wide range of potential issues for consideration which the Group identified From this preliminary exercise a focused and specific work programme will be distilled.

o    Research and Information Gathering. The final report will need to be based on best available evidence, including the results of randomised controlled trials and patients' and clinicians' experience To avoid unnecessary repetition, we should capitalise on existing studies and reports where they are relevant and sufficient

Potential areas requiring research identified at the first meeting are - (a) an epidemiological study, (b) a systematic review of current literature to establish if there is research evidence of sub groups, (c) a systematic review of treatments, (d) a review of current training of health and social care professionals, (e) an attitude survey of health and social care professionals. (f) a study of existing good management practice (for which we will first have to agree a definition)

Funding of the research agenda needs to be discussed with NHS R&D

We also need to acquire a broad range of existing diagnostic and management guidance - from health professionals and patient organisations here, and from overseas (especially the US, Canada, New Zealand and Australia)

o   Service Provision and Commissioning: Future service provision should be fully multidisciplinary, so people don't fall through gaps or experience replication of effort, investigation In contrast to the present, we want to achieve a really 'national' service with equity in access to diagnosis, treatment/management, specialists with appropriate expertise, state benefits Services will need to be much more comprehensive than at present One issue identified was respite care for the severely ill

We should not forget that the Commissioners hold the purse strings and will need to 'buy into' any report we produce in the end

o   Diagnosis; The issues raised here were - (a) the need for uniform agreed diagnostic criteria (b) ME or CFS - the implications of the possibility of subgroups, (c) the hazards arising from having long delays between the onset
of illness and diagnosis, (d) a shortage of medical expertise in diagnosing the condition, plus frequent disbelief in the existence of the illness, (e) the relative lack of consultants who are able to accept referrals, (f) the current tendency to make patients 'prove' that they are ill, (g) the need to tackle the disability, not just the diagnostic label.

Management & Treatment. Issues mentioned here were (a) the importance of a multidisciplinary approach, (b) tailoring management to individuals' needs, (c) appropriate roles for primary carers, specialists and patient organisations, (d) the role of complementary therapies, (e) the appropriate role of CBT, (f) the meaning and relevance of the mind-body paradigm, (g) patients and carers being part of the treatment/management process, (h) the importance of helping people cope better, even if they may not be 'cured'

o    Doctors & Patients: Questions raised under this heading were (a) training for medical and social care professionals, both pre and post qualification (b) empowering both physicians and patients so they feel they have something to give, (c) ways of developing respect between professionals and patient organisations, and drawing on eachother's expertise (d) incorporating ME/CFS into a chronic disease model

o   Sociocultura/ Impact: This encompassed questions such as how/whether ethnicity, gender, age & class affect, diagnosis, treatment & access to benefits

o    Benefits & Insurance: Issues raised here were the unreasonable and disproportionate problems experienced by people with ME when being assessed for benefits or making health insurance claims.


Members of the Information Group who contributed to this Briefing. Simon Lawrence, Tony Pinching, Alison Round, Naomi Wayne. Peter White


Contact Point:    Dr Leslev Cooper, Secretary to the Working Group, do A ction for ME. 4 Deans Court, St Paul's Churchyard, London EC4V 5AA.


Key Group - Briefing No 2 - May 1999


Terms of Reference: To review management and practice in the field of CFS/ME with the aim of providing best practice guidance for professionals, patients and carers to improve the quality of care and treatment for people with CFS/ME


This Briefing provides an overview of the second meeting of the CMO Working
Group - Key Group, held on 16 April 1999. For Item 3 a representative of NHS
Research and Development was present to give advice.



1. CFS/ME and the Benefits System

The Group considered the first draft of a paper from Tony Pinching and Naomi Wayne. Most of it addressed on-going concerns about the interaction between people with CFS/ME and the benefits system. There was also a brief section about the Welfare Reform & Pensions Bill.

a) The current system: The basic philosophy underlying the Draft Paper was continuing commitment to the founding Beveridge Principle - 'work for those who can, security for those who cannot'. The paper identified a range of issues which possibly produce mismatches between that principle and the experience people with CFS/ME have of the benefits system.

b) Welfare Reform Bill: The paper identified two potential problems - the proposed Personal Capability Assessment which will be applied alongside the All Work Test, and the possible impact on people with CFS/ME who are required to go through the new Single Gateway Procedure in order to secure benefits.

Key Discussion Points:

o    Whether this issue comes within the Working Group 's remit: The CMO expects us to have a view about management of CFS/ME - which includes the Benefits System, but our concerns must remain within this framework.

o    Evidence: The Group could seek evidence from clinicians, patients and patient groups, social science research centres e.g. York & Canterbury, DSS statistics.

o    Action on the new Bill: As the Bill is still being debated and will be trialed round the country before full implementation, it was agreed to investigate possible early discussion with the DSS to explore areas of common concern.

o    Further comments: Written comments to come from Key Group members and further discussion at a joint Key/Children/Reference Group meeting in June



2.    Diagnostic Criteria

The Group reviewed current use of diagnostic criteria. Of eighteen leading clinicians consulted, seven used the CDC criteria. The rest relied on combinations of various definitions, the Oxford criteria, their own modified criteria, the Ramsay definition or their clinical experience rather than any definition.

Issues discussed included: whether there is a need for or possibility of universal criteria; the role of such criteria for specialists and for GPs; why clinicians use different criteria; the distinction between criteria used for research and those needed for the jobbing clinician; problems of consistent interpretation arising from terminology, especially regarding the concept of fatiguability; whether one condition or sub-groups are being diagnosed. It was agreed that this latter question would be revisited at a later date.



3.    Research - a Systematic Review

The DoH has agreed to support the Working Group by funding a Systematic Review. Criteria for deciding what to review are - priority attached to the question; availability of research material; relevance to the Group's remit; coherence of the field chosen. Two subjects which were considered were treatments and sub-groups.

Treatment effectiveness will depend on which groups have been treated, and different groups may vary in response to different treatments. It might be possible to kill two birds with one stone by examining research on treatments, since such a review should identify which patient groups have been outside the treatment programmes altogether and which treatments have been successful, (or unsuccessful, or even hazardous) for which patient groups - which may lead to an inference of the existence of sub-groups. Any such research would need to look 'behind' the published data, to include the 'grey' (unpublished) literature and to examine such material as is available on complementary as well as conventional therapies.

It was therefore agreed to ask for a systematic review of treatments to examine (a) the quality of evidence for effective treatment of CFS/ME, (b) the implications of that evidence, (c) whether there is reasonable quality evidence that there are differential effects of different treatments in different groups of patients. It was further agreed that a brief would be prepared as quickly as possible for NHS R&D so that tenders could be invited before the summer, and the work be commissioned and completed as rapidly as possible - preferably by spring 2000



4.    Organisation & Review of Progress

a) Database: The Group has been provided with a substantial database of CFS/ME research to which we will add papers received by the Working Group (published, unpublished, 'grey' literature etc). We will also develop a matrix recording key issues raised by letters sent to the Working Group, so that these issues can be addressed as the issues arise in the course of the Group's activities.

b) Reference Group: The crucial role of the Group is provide a resource of expertise which can be drawn upon as appropriate. Members of the Reference Group may be invited to join sub-groups set up to undertake particular tasks. In addition, it may be useful to invite participation in such sub-groups from people outside the Group altogether.

c) Work of sub-groups: They will be given a clear brief, reporting lines and methods of working including what sources of information and personnel they can call upon.

d) Finance: All expenditure, including that which sub-groups feel they may incur, has to be authorised by the chair in advance.


Members of the Information Group who contributed to this Briefing: Simon Lawrence, Tony Pinching, Alison Round, Naomi Wayne, Peter White


Contact Point: Dr Lesley Cooper, Secretary to the Working Group, P0 Box 5463, Wivenhoe CO7 9TG

***************************************************************************

Key Group - Briefing No 3 - July 1999


Terms of Reference: To review management and practice in the field of CFS/ME with the aim of providing best practice guidance for professionals, patients and carers to improve the quality of care and treatment for people with CFS/ME


This Briefing provides an overview of the third meeting of the Key Group, held on 16
June 1999. The main discussion item - Diagnostic Procedures - was presented by
Professor Tony Pinching.

1.    Diagnostic Procedures

Professor Pinching outlined an approach to the issue of Diagnostic Procedures for CFS/ME. The following is based on his presentation.

Diagnostic procedures used to assess the individual patient must be clearly distinguished from research procedures intended to improve understanding of what causes the disease. These latter are often of great interest, but they may need very different approaches, even if they are conducted on the same patients as part of the research. This distinction between clinical and research procedures is crucial in any medical condition, but is probably especially so where the disorder is less well understood as with CFS/ME.

Before examining the diagnostic role of any particular procedures, we need to identify a few assumptions and some background ideas. The starting assumptions are that:

1)    there is a disease entity of CFS/ME, which is distinct from other diseases, though it may co-exist with them
ii)    it has a spectrum of severity and of characteristics (possibly subgroups)
iii)    the cause and mechanisms of disease in CFS/ME remain largely unknown, but are the subject of current active investigation
iv)    CFS/ME may be associated with a variety of factors that can contribute to it
v)    it also has secondary consequences that may be important
vi)    CFS/ME may resemble other clinical conditions
vii)    there is no current validated specific test for CFS/ME

A diagnostic procedure can be defined as a formal tool that can help in making a diagnosis and has been shown to be valid for this purpose. Such procedures include:
taking a history, examining the patient, questionnaires, laboratory tests, X-rays and scans.

When a clinician makes a diagnosis, s/he is engaged in a sorting process, which takes the patient's symptoms and checks them against possible causes. This process is called differential diagnosis. A list of probable or possible diagnoses is developed, and then procedures can be used to refine this to identify the most likely diagnosis. This can involve ruling out some conditions, increasing the likelihood of a particular condition, or even confirming it (if there is a specific test). Such procedures may also identify subgroups of a disease, as well as some of the consequences of disease.
Diagnostic procedures may be expected to provide objective confirmation of what the patient is experiencing, but may not, in reality, be able to do so. they certainly don't in
CFS/ME'

If a particular test is proposed as a diagnostic procedure, it is vital that it be shown to serve that purpose. There are many procedures available, but unless they can distinguish between different conditions that may superficially resemble each other, they have no validity or usefulness. In particular, a test that can distinguish between people who are ill and people who are well is usually not sufficient!

For a procedure to be useful, it has to be shown in clinical practice to be able to make the distinctions that are needed in differential diagnosis. It will need to be good enough to avoid wrongly diagnosing a disease (false positive) and to avoid missing it (false negative), at least in most cases. There are very few medical conditions where the procedures are 100% satisfactory - sadly nothing is perfect! However, many can be diagnosed with a reasonably high level of confidence by a combination of the patient's history and examination, and a mix of tests.

It is also important to be able to recognise where several conditions occur together, or where a condition has secondary consequences that may complicate the picture. Patients with CFS/ME may develop symptoms that are due to something else, for example a slipped disc. They may become sufficiently upset by their illness (and some upset is perfectly normal), that their secondary psychological distress needs to be separately identified and treated.

We also need to remember that different systems of medicine may use the same terms, but to mean different things. For example, 'allergy' tests in 'conventional medicine' will be very different from those used by some alternative! complementary practitioners. This can be confusing for a patient, if, for example, s/he asks a clinician in one system to do, or to interpret, the tests done for another system.

At present, the crucial diagnostic procedure for CFS/ME is the clinical history. Sufficient time must be allowed for patients to give a narrative account of their illness experience. This will lead to the differential diagnosis. The physical examination often adds little, though it may be helpful to exclude some other conditions. A range of straightforward screening tests can then be done to exclude a wide range of conditions. These include: a full blood count, biochemistry tests on blood including sugar, kidney and liver function and simple urine analysis. In most patients, it is wise to check thyroid function and carry out screening tests for a range of rheumatic diseases, as these are usually in the differential list. All of these can be done in general practice.

Beyond them, certain specialised tests may be needed to exclude particular conditions that are suggested by specific types or mixtures of symptoms. These may include tests for certain endocrine (hormone) disorders, neurological conditions and so on.

Questionnaires can sometimes be useful to characterise a number of elements, including simple screening for anxiety or depression, quality of life or levels of functional disability.

There is a much longer list of research procedures, some of which may have been suggested as diagnostic procedures, but which have not been validated. These include:
tests for particular viruses, complex tests on the neuro-endocrine system, immunological tests, RNA-ase L analysis, various types of brain scans, metabolic studies on muscle, micronutrient tests, criterion-based scoring systems and so on. In due course, some of these may be established to be of diagnostic value, while others may help us to understand the disease but without proving useful in diagnosis. For the time being, they must be treated with caution, however interesting they may seem.

A discussion followed in which the key points were that:

o    the paper above focuses on process rather than end product. It was now necessary to fuse consideration of diagnostic procedures with deciding how to handle diagnostic criteria, especially as current criteria have been designed primarily for research and we are charged with advising on clinical practice. Possibly the way forward on criteria is to combine the best of what is around, in the light of clinical experience.
o    the diagnosis of CFS/ME can be useful to help people to receive appropriate treatment and information about their condition
o    as in the early days of AIDS, before identification of HIV, for CFS/ME we must still rely on clinical history and examination, unless and until a test is identified which demonstrates specificity. This is in line with normal medical practice - listen to the patient and acknowledge that s/he is telling you all you need to know. At the same time, it is essential to educate and support patients during the diagnostic process, including ensuring they understand the reasons for inclusion and exclusion of specific tests and procedures
o    the mind/body polarisation is unhelpful - need inclusive approach

It was agreed to establish a small group to work on diagnosis - to report back to the next Key
Group meeting. Members subsequently appointed are: Dr Nigel Hunt (chair), Professor
Tony Pinching, Dr Anthony Cleare, Roma Grant, Dr Harvey Marcovitch (Children's Group),
Naomi Wayne, Lesley Cooper (secretary)


2.    Progress Report - Chair, Professor Allen Hutchinson

o    Literature Database: Reminder that Lesley Cooper is holding a very large and wide ranging database, encompassing all aspects of literature on CFS/ME given by Prof. Simon Wessely. This is amended whenever new papers are sent in and constitutes the Group's Reference Library.

o    Good Practice Review: In hand. Will return to at a later date, when criteria for good practice have been developed.

o    Product: By next meeting, Group needs to start considering the nature of its eventual product in the light of its terms of reference.

o    Systematic review: Brief is not yet finalised, as it is being extended to include children. Once finalised, it will be distributed, together with an explanatory overview.

o    Draft Australian guidelines: As a useful model of what such guidance might look like in structural terms, not as a guide to content, this document will be sent to the Key Group with a questionnaire to ask for views.

Members of the Information Group who contributed to this Briefing: Simon lawrence, Tony Pinching. Alison

Round, Naomi Wayne

Contact Point: DrLesley Cooper, Secretary to the Working Group, P0 Box 5463. Wivenhoe C07 9TG

*******************************************************************************************

Joint Meeting of Key, Children's and Reference Group - Briefing - July 1999


Terms of Reference: To review management and practice in the field of CFS/ME with the aim ofproviding best practice guidance for professionals, patients and carers to improve the quality of care and treatment for people with CFS/ME


This Briefing provides an overview of a joint meeting of the Key, Children's and Reference Groups, held on 16 June 1999.


1.    Progress Report - Chair, Professor Allen Hutchinson

Key points made were in relation to:

o    The Working Group 's task: It must be emphasised that we need a clear definition of our task -to report to the CMO on good clinical practice.
o    Role of the three Groups: The Key Group will write the main report and make recommen-dations to the CMO. The Children's Group will be writing a section of that main report, working closely with the Key Group. The Reference Group gives views and comments on ideas and materials - i.e. acts as a sounding board, and (along with people of appropriate expertise outside all three groups) may also provide personnel to sit on the sub-groups which will be putting together working papers for consideration by the Key Group.
o    Timescale: Probably another 18 months. After the first six months, we are now starting to think about the nature and shape of our products.


2.    Progress Report - Chair, Children's Sub-Group, Judith Waterman

o    Scope of Sub-Group 's Work: The Children's Sub Group is coming to the end of its preliminary scoping and listening exercise. It is working in parallel with the Key Group on some issues but had extra matters to examine - not only clinical, but also educational and social services issues (including child protection - on which legal experts would be contributing), as well as child specific research. It will be setting up a small group to ensure that its work meshes in, both in content and methodologically with that of the Key Group.
o    Research: The Group is feeding into the systematic review on treatment and considering reviewing practice in paediatric clinics.
o    Parents and Children: A small group is organising a consultation exercise among parents and children to be held in September.


3.    Benefits

Accessing state benefits is frequently a problem for patients. This problem often then becomes an issue for clinicians, especially specialists, who have to devote considerable time to supporting their patients' benefits applications. This also raises the question of the understanding of
CFS/ME on the part of doctors employed by the Benefits Agency Medical Service. With these considerations in mind, the meeting divided into two groups to review a draft paper on CFS/ME and the Benefits System prepared by Tony Pinching and Naomi Wayne.

Key issues that arose in discussion were:

o    Technical problems - filling in a 53 page form, having to complete several claims forms at the same time, variability of the illness, insufficient flexibility in the system to allow for part time work, some working from home.
o    Problems in validating the diagnosis for benefits purposes - this leads to an immense amount of work for specialists in providing supporting statements.
o    The possibility of devising a functional test to assess the level of disability
o    The need to improve the training/increase knowledge and understanding of BAMS personnel.
o    Problems re access benefits whilst in higher education.
o    The one-year duration of awards.
o    The similarity of many benefits problems to those affecting permanent health insurance
o    Further comments, information, case studies, corrections are welcome and should be referred to Lesley Cooper.


4.    Diagnostic Criteria - Children with CFS/ME

Dr Alan Franklin presented a draft paper prepared by Dr Harvey Marcovitch who was unable to be present. Dr Franklin noted several points that needed to be made when considering diagnostic criteria for children. For instance, the six month 'qualifying time' for adults was clearly inappropriate - three months was generally long enough; difficulties with reading were extremely common; sleep patterns were frequently disturbed; nausea and anorexia were common symptoms which could be confused with other conditions.

Amongst the points discussed were: whether different symptoms should have different weightings, whether fatigue was the primary symptom, whether the term 'fatigue' should be used as it was not in common usage among children; the importance of children being assessed by a paediatrician, not an adult specialist physician; the need for flexibility in providing home tuition.


5.    General Matters

There was a discussion about the relationship of the Reference Group to the overall process. Some R.G. members were concerned that their knowledge was not being sufficiently utilised. However, at present, the nature of the task meant it was necessary and inevitable for work to proceed slowly - so that, so far, there had not yet been much to consult about. This was a time problem, more than anything else. It was certainly universally recognised that it was essential to draw fully on all available expertise, and this would happen over the coming 18 months.

Other issues raised for consideration by the Group were: Multiple Chemical Sensitivities, allergies, service provision for people in outlying areas.
Members of the information Group who contributed to this Briefing. Alan Franklin, Simon Lawrence, Tony Pinching.

Naomi Wayne

Contact Point: Dr Lesley Cooper, Secretary to the Working Group, P0 Box 5463, Wivenhoe C07 9TG

***********************************************************************

BA 8th Annual Forum - 29th June 1999

New Rules on Decision Making and Appeals

Key Points:

o    Customers have one calendar month in which to apply for revision or appeal a decision (this is a reduction from the current time limit of 3 months),

o    Customers can ask for an explanation at any time (inside or outside a calendar month),

o    If a customer requests a written statement of reasons within a calendar month of the decision being notified the statement will be issued within 14 days and the time to apply for revision or appeal is extended by 14 days,

o    If the customer applies for revision a reconsideration will take place,

        there are two potential outcomes:
            -    a "no change" reconsideration or
            -    the decision will be revised (either to the customer's advantage or not to the customer's advantage),

        if a "no change" reconsideration is made, the customer will be sent a notice in writing informing them thatthey have a further one calendar month in which to appeal,

        if the decision is changed on reconsideration a new "S of S decision" is issued with fresh dispute and appeal rights i.e. fresh revision and appeal rights (one calendar month),

o    a customer can appeal from the outset without applying for revision first,

o    any appeal will result in the BA reconsidering the decision in every case before an appeal submission is prepared,

o    an appeal can only lapse if this reconsideration results in a new "S of S decision" which is advantageous to the customer. N.B. A decision will be advantageous to the customer if their money increases of their award is extended. The new decision may not satisfy all or any of the grounds for appeal stated in their application. A new "S of S decision" will be issued with fresh revision and appeal rights (one calendar month).


Operation of Time Limits - Disputes Process

Example I - A request for explanation (not a formal request for a written statement of reasons)

1.    A customer requests an explanation of a decision two weeks after the decision is notified. The customer is given a telephone explanation and is asked at the end of the conversation whether they wish to apply for revision. The customer states that they do not wish to apply for revision or to appeal and no further action is agreed.

The dispute period is not extended as a result of the explanation - the dispute period is still one calendar month. If the customer asks for an explanation outside one calendar month they will still


34
24.8.99
BA 8th Annual Forum - 29th June 1999


receive a full explanation but would have to apply for a "late revision" or U late appeal" in order to have their decision reconsidered.

Example 2- Request for written statement of reasons

A customer requests a written statement of reasons (written explanation) for a decision within one calendar month of the decision notification and the original notification did not include a statement of reasons. The written statement of reasons is issued within 14 days and the dispute period is extended by 14 days.

This means that the customer will have had one calendar month plus 14 days in which to apply for revision. The written statement includes details of the revised time limits and states that no further action will be taken unless the customer contacts us (i.e. applies for a revision or lodges an appeal).

Example 3 - Application for revision - No change

A customer applies for revision three weeks after a decision is notified. The original decision is reconsidered and the decision maker is unable to change the decision.

A further notification is issued which informs the customer of the reconsideration result and tells them that we have been unable to alter the decision. The customer has a further calendar month in which to appeal against the decision.

Example 4- Application for revision - Decision revised

A customer applies for revision one week after a decision is notified. The original decision is reconsidered and the decision maker revises the decision. This revised decision may not alter the areas in dispute and decision may be either advantageous or not advantageous to the customer e.g. a DLA case may result in different components being altered - one removed and one given - the customer may not have disputed either of these issues and the result may increase or decrease their money.

A new outcome decision is issued with fresh dispute and appeal rights and no further action is taken regardless of whether the new decision is advantageous or disadvantageous to the customer.

Example 5 - Customer appeals - No change reconsideration or decision not advantageous

A customer appeals against a decision three and a half weeks after it is notified. The decision is still reconsidered prior to any appeal submission being prepared. The decision maker is either unable to change the decision or makes a decision which is not advantageous to the customer.

The appeal will continue and an appeal submission will be prepared. If the customer has been given a new decision that is not advantageous, the submission will be prepared on the new outcome decision and they will be given a further month in which to make fresh representations prior to the submission being issued.

BA 8th Annual Forum - 29th June 1999

Example 6 - Customer appeals - Reconsideration results in advantageous decision

A customer appeals against a decision one week after it is notified. The decision is reconsidered and the decision maker can change the decision to the customer's advantage. This revised decision may not alter the areas in dispute but will be advantageous to the customer.

The customer will be notified of the new outcome decision and the current appeal will lapse. The new decision will carry fresh revision and appeal rights.

Example 7 - Customer appeals - Appeal is late i.e. more than one calendar month after decision notified

A customer appeals against a decision five weeks after it is notified. Before the late appeal is sent to The Appeals Service the decision maker considers whether a late revision can be allowed. If a late revision is allowed (i.e. the customer had "special circumstances" for being late), the decision maker will reconsider the case. If a decision that is to the advantageous of the customer can be made the appeal will lapse. Otherwise, the appeal will be submitted to The Appeals Service to consider the late appeal.

***********************************************************************
Key Group - Briefing No 4 - November 1999


Terms of Reference: To review management and practice in the field of CFS/ME with the aim of providing best practice guidance for professionals, patients and carers to improve the quality of care and treatment for people with CFS/ME


This Briefing provides an overview of the fourth meeting of the Key Group, held on September
21 1999. The main discussion item - Methodology of Guidance Preparation - was presented by
Aileen McIntosh of Sheffield University School of Health & Related Research.


1.    Progress Report - Allen Hutchinson, Chair of Key Group

Meeting with Chief Medical Officer; The Chairs of the two Groups are to meet with the CMO in October to report on progress and discuss the scope of our remit and the nature of the product(s) which will emerge. It was noted that in this exercise, the process, in particular, the centrality of patient involvement, was as much part of the product as the final documents.

o    Systematic review: in the process of being commissioned by NHS R&D. Hope to have more firm information by next meeting and that work will start by January. It is expected that the Research Steering Group will include representation from the Working Group. Will also ask if it is possible to include review of evidence on diagnosis as well as management.

2.    Progress Report - Judith Waterman, Chair of Children 's Sub-Group

A good first year of super-scoping' for the Children's Group, with a marked increase in consensus. Before the end of 1999, there will be two more Group meetings and a sounding board event involving a substantial number of children with CFS/ME and their parents. The next Group meeting will look at interface of education and health, with the role of child/adolescent psychiatry being the main agenda item for the last Group meeting of the year.

Early in 2000 the smaller Development Group will hold meet to review information already gathered and put it into guidance mode. In some areas the Children's Group will work in parallel with the Key Group, while in others it will be working on specialist children issues.


3.    Progress Report on Group Management & Administration - Naomi Wayne

Much work done over the summer together with the Department of Health to clarify role of the
Reference Group and principles re the Working Group's approach to information delivery.
Currently a draft budget is being prepared for the Working Group's activities for year 2000.
4.    Producing Guidance -Aileen Mcintosh

Aileen described the methodology of guidance development, outlining the following core steps:

a)    Defining the scope of the problem: Examining the nature of the problem, what areas should be tackled and which audiences, were to be addressed.

b)    Reviewing the evidence - The guidance eventually produced needs to be evidence-based with acknowledgment that there are different types of valid evidence, which need to be given different weightings.

c)    Producing a scientific report: The emphasis here is on being systematic, both regarding the commissioned Systematic Review of evidence and the gathering of and reporting on patient opinion and experience.

d)    Reviewing/commenting/discussion of the scientific report: The report has to be peer reviewed, and in a structured manner, including, if necessary, structured voting.

e)    Producing a draft guidance document: Considering the evidence in its context and interpreting it.

f)    Reviewing the draft guidance document: Checking the professional, methodological and patient aspects of the document. The method of producing the document needs to be generally accepted and endorsed.

g)    Revising the draft: To take account of concerns, criticisms, reservations etc

h)    Guidance documents to CMO: The whole package of documents produced by the Group then goes to the CMO. This will include: the Systematic Review, patients' views, contextual documents etc. There will probably be pyramids of documents, including slightly different documents for different audiences, for instance clinicians and patients. A 'front end' document might be a short leaflet supported by these other layers of evidence.

Structured methodology: A discussion followed on how to use structured methodology to incorporate and encapsulate the wide range of experience, both clinical and patient that existed on CFS/ME. Various methods have been used in the past for gathering patient and clinical evidence such as focus groups of patients and carers or clinical opinion gathering sessions alongside patients. We could tap into the views of the forty to fifty clinicians that have substantial dealings with CFS/ME patients and have a great deal of experience and knowledge, say via a short structured questionnaire, seeking their experience as to what elements in management appear to make a difference.

However, methods of ensuring adequate and appropriate patient involvement up to now have not been very well developed - this was something the Working Group would try to take on board and improve upon. A variety of methods could be used - using Group members, evidence from patients outside the group, questionnaires etc.

Product Audiences: There was discussion as to whether there should be separate products directed towards primary and secondary care, whether diagnosis and management should be separated, whether patients and clinicians should be addressed separately. It was suggested that the core product should be available and accessible to as wide an audience as possible.
Implementation: While outside the Group's remit, inevitably, issues were arising with implementation implications, including: advice to educational services re the support of children with CFSIME; comments for the DSS re the experience of people with CFS/ME and the clinicians treating them of the operation of the benefits system (which comments the DSS were keen to receive); suggesting that CFSIME would be a useful example to use in the new problem-based approach to medical training; targeting the Health Improvement Programme developers (Health Authorities & Primary Care Groups), although these were probably too small to provide a base for developing specialist clinics (need information at national level); making broad recommendations about the services we need, given our current epidemiological knowledge and using existing work e.g. Task Force Report on NHS Services.


5.    Diagnosis Group October Meeting - Report

The Group considered Document Draft 7. This now included necessary material on children. In this context, it was agreed that the term 'anorexia' could be confused with 'anorexia nervosa' and should be replaced by 'appetite loss'.

There was also discussion about whether the document was sufficiently detailed, whether it was evidence based and the nature of that evidence base. These issues, plus the question of how to develop the work to date within a guidance framework, would be considered further at the next meeting of the Diagnosis Group.


6.    The Severely Affected - Lesley Cooper

The Group considered a short paper derived from material supplied by Jill Moss, AYME; Simon Lawrence, 25% Group and Ray Gibbons and Chris Richards, CHROME. Issues raised included: the difference between CFS and severe ME; treatment regimes - severely ill people may have very different needs and reactions to certain treatments; the need to examine the most common current practices for treating severely affected people; how best to service the needs of those too ill to leave home to be examined/treated; the relationship between patients and professionals; the collection of information from the bed-bound or housebound when they do not present at GP's surgeries or hospital clinics.

It was suggested that this material could be used as a component in a wider task of assessing patients' experiences and needs, and as part of the final report's context setting


Members of the Information Group who contributed to this Briefing: Tony Pinching, Alison Round, Naomi Wayne Contact Point DrLesley Cooper. Secretary to the Working Group, P0 Box 5463, Wivenhoe C07 9TG

Chief Medical Officer's Working Group on CFS/ME


Key Group - New Millennium Briefing - No 5 - February 2000

Terms of Reference: To review management and practice in the field of CFS/ME with the aim of providing best practice guidance for professionals, patients and carers to improve the quality of care and treatment for people with CFS/ME


This Briefing provides an overview of the fifth meeting of the Key Group, held on Nov 16 1999.


1.    Progress Report - Allen Hutchinson, Chair of Key Group

a)    Report of meeting between Allen Hutchinson, Judith Waterman and the Chief Medical Officer, Professor Liam Donaldson

The CMO was very supportive of the Group's work and looked forward to receiving its eventual report. Once the report is submitted, there will be discussions with civil service advisors and ministers to determine any implementation strategy.

Boundaries of the report: While the main target recipients of the report will be the wide range of clinicians who find themselves managing the illness, it is also envisaged that the report will provide useful information for patients and carers. It is intended to make the report widely available, possibly in different formats, suitable for different audiences.

o    Parallel Working Papers: Papers like the Scoping Document produced by Derek Pheby and the Benefits Review will not constitute a formal part of the final report itself, but will be made available as Working Papers and will be submitted to the appropriate Government Departments on advice from the civil service.

o    The context: It was agreed that there was a need for a substantial scene setting introductory chapter in the final report, explaining the nature and context of the issues, including prominently the views and experience of patients and clinicians.

o    Systematic Review: The importance of the report being evidence-based was reiterated. In this context it was very important for the Systematic Review to get underway.

o    Nomenclature: The report will continue to be designated as a report on CFS/ME. The debate about nomenclature would be properly acknowledged in the report, but its resolution could not be made on the national stage.

o    Resources: It was agreed that the Group needed a budget sufficient to enable it to fulfil all aspects of its work and carrying it from April 2000 to March 2001.

b)    Group membership: Unfortunately, Key Group member Jonathan Hull has found it necessary to resign. A replacement is currently being sought.

c)    Future Meetings: The date of the next meeting depends chiefly on the progress of the Systematic Review (see later). In the period before the next meeting, there will be regular Briefings (approx two /three monthly) giving information about on-going work.

d)    Consultation Day: It was agreed to organise an adult 'sounding board' event to discuss key issues, problems and potential solutions. Invitees will include Reference Group members, but we
may also draw more widely on a patient constituency. Judith Waterman will manage the event assisted by a small supporting sub-group. The day is planned for early in the next financial year.

e)    The CFSME debate: There was discussion about how to address concerns about whether there is a distinction between CFS and ME. It was suggested that members of the Key, Children's and Reference Groups could be formally asked to advise of evidence which demonstrates this distinction. Practical arrangements for implementing this suggestion are being examined.


2 Progress Report - Judith Waterman, Chair of Children's Group

o    CGMeeting: The October Children's Group meeting focused on education and was attended by a education experts with experience in disability & illness issues, including senior DfEE personnel. At present the DfEE is reviewing its policy on meeting the needs of children with chronic illnesses. The aim of joint work with the DfEE is ensuring services for children with CFS/ME are as good as those for children with other chronic illnesses. In year 2000 a DfEE/Children's Group Sub-Group will be taking this work forward by developing guidance for education personnel.

o    Sounding Board Event: This was a very successful event aiming to secure a user and carer perspective. It was attended by 23 children, with an age range from eleven to early twenties, plus 23 parents. The attendees were invited to identify major issues, suggest 'ideal' solutions and then to rethink these solutions into more realistic terms. In particular, they were asked them what they thought the NHS could do for them. Whilst most were looking for ways of the health and education services adapting to the young people's illness, a small number were more focused on the importance of finding a cure.

o    Panorama: The programme makers had been allowed to film the Children's Group at work for a recent programme as background, but neither further participation from the Group, nor any kind of statement was considered appropriate at this stage. A variety of concerns about the nature, content and possible (positive & negative) effects of the programme were expressed. It was noted that the majority of responses which were subsequently placed on the Panorama website reflected the acute misery experienced by young people with CFSIME and their families.


3.    Systematic Review: Starting this work had been delayed because of the current Departmental financial review. This was causing a serious problem for the Group's work.


4.    Diagnosis - Tony Pinching: There was increasing agreement regarding the material contained with the report produced by the Diagnosis Sub-Group - disagreements were largely on points of detail and emphasis, not overall content. There had been a useful recent meeting of the Sub-Group where the methodology to be used at the next stage bad been discussed and work would now be done to review the relevant research papers.


5.    Benefits - Naomi Wayne: Six Key Group and two Reference Group members had submitted written comments and contributions bad also been recorded from people at the June Key/Children! Reference Group Meeting. This material was currently being reviewed by Naomi Wayne and Tony Pinching, and necessary revisions were being incorporated, including acknowledging the different needs of people who are seriously ill and those for whom some work is feasible.

In addition, an LSE MSc student who was just completing a dissertation on the experience of people with CFS/ME in seeking to secure Disability Living Allowance was being made available to the Group and would be reviewed to see if it provided relevant material. It was hoped that the final draft would be completed (authors' time permitting) by the late spring.
& Action Plan -Aileen McIntosh: The following issues were considered - how evidence would, be assembled and systematically analysed, what kind of product the Group could expect to deliver, and how the Group could handle disagreement and secure consensus (see summary of process in Appendix 1).

o    Evidence gathering and analysis: The Systematic Review would be examining research evidence on management and treatment. Another key part of the report would be evidence regarding patients' and clinicians' views and experiences. Assembling this evidence would entail a process of qualitative analysis. Probably via a methodology called 'Framework' which is explicit about the precise stages and methods used, we would start by analysing into very specific issues and themes all the letters received by the Group, including correspondence from members of the Reference Group, which contain patients' views. In this way we would be able to establish how individual experiences are replicated and generalised. There was discussion about how representative this material was. The feasibility of carrying out a qualitative survey and of conducting a literature search of any published qualitative studies was also considered, although it was doubted that there would be sufficient time for the former. The Group was told that the ME Association might consider carrying out a survey.

o    The Product: The Group's final report for clinicians is expected to be quite lengthy. Its contents are likely to incorporate the following range of issues: Background & context; Diagnosis; Management; Prognosis; Non-clinical aspects of management. In addition to the report itself, various summary versions, perhaps in threefold leaflet form, will also be needed. In the course of producing its report, the Group will also look at intervention studies from other countries as well as the Royal Australian Colleges' Draft Report, the Quebec Medical Society guidelines and anything that the NIH had produced.

o    Consensus: It could be anticipated that there would be issues of disagreement within the Group. It was therefore necessary to develop methods of securing consensus. There were various methods of consensus building, ranging from completely informal to the highly formal and structured. The Group would probably not utilise the most formal method (called RAND) as it was extremely slow and time consuming. This meant the Group would, at a later stage, need to determine which method of consensus development to adopt.



STOP PRESS
Systematic Review: Following the Key Group meeting reported above, funds have now been
released and arrangements finalised. Commissioned by the Department of Health, the
Review is being carried out by the NHS Centre for Reviews and Dissemination at the
University of York and commenced in Jan. 2000. The brief for the Review is reproduced as
Appendix 2.

New Key Group Member: Tanya Harrison of BRAME, previously a member of the Reference Group, has agreed to join the Key Group as a replacement for Jonathan Hull


Members of the Information Group who contributed to this Briefing: Tony Pinching Alison Round Naomi Wayne Contact Point: DrLesley Cooper, Secretary to the Working Group, P0 Box 5463, Wivenhoe, C07 9TG
APPENDIX 2



OUTLINE COMMISSIONING BRIEF FOR A SYSTEMATIC REVIEW OF
CLINICAL EFFECTIVENESS OF TREATMENTS AND INTERVENTIONS
FOR CFSJME

Purpose

To conduct a systematic review of the efficacy of available treatments & interventions for CFS/ME.
The results from the review will be used by the Chief Medical Officer's Working Group for CFS/ME to assist in the development of clinical guidance, on the management of patients with CFS/ME, for a range of health professionals.

Rationale and Aims

CFSLME is a collection of symptom complexes which may have multiple causations. There is uncertainty over the effectiveness of existing treatments and interventions for the management of CFS/ME. Some treatments may be more effective for particular sub-groups of patients and, in the case of drug interventions, some therapies may have differing side-effects or levels of tolerance according to the type of patient.

The primary aim of this review is to determine which treatments and interventions are clinically effective for which patients by:

o    assessing the quality of the existing evidence on treatments and interventions for CFS/ME

o    evaluating the evidence that sub-groups of patients may respond differently to treatments, using the wide range of medical and psychosocial outcomes used as markers of treatment response

o    assessing the extent of any additive or combined effects of treatments where more than one therapy is utilised.

Timetable

A preliminary report of the review's progress will be required by March 2000 and a

full report will be expected by July 2000.

Scope of the review

Current research' suggests that a range of interventions, in many cases used in combination, may be valuable in the management of CFS/ME, but reviews to date have not been able to produce definitive advice as to which interventions should be recommended either to clinicians or to the NHS as a whole2.
This systematic review should examine the whole range of available interventions (or combination of interventions) for which good evidence exists. Literature for the medical and nursing professions, the professions allied to medicine and complementary therapists should be included when appropriate. Where good quality reviews exist they should be taken into account rather than replicated.

Since the symptom complex also affects children and there appears to be a continuum of symptoms between children and adults, the review will examine the effectiveness of interventions for both children and adults.

The review should be conducted following guidelines from the Centre for Reviews and Dissemination3. It should be confined to the English language. However, if the reviewers are aware of important studies in non-English language journals these should be referred to.

Advisory Group

A small advisory group will be set up in consultation with the chair of the Working Group. There will be a reporting mechanism to appraise the Working Group of emerging findings.
References

1)    Marlin, RG, Anchel, H, Gibson JC, et al. An evaluation of multidisciplinary intervention for chronic fatigue syndrome with long-term follow-up, and a comparison with untreated controls. American Journal of Medicine (1998):
.i2~(3 A) 1105-1145.
2)    Sutton GC. Too tired to go to the support group': A health needs assessment of myalgic encephalomyelitis. Journal of Public Health Medicine (1996):

3)    NHS Centre for Reviews and Dissemination (1996) Undertaking Systematic Reviews of Research on Effectiveness: CRD Guidelines for Those Carrying Out or Commissioning Reviews CRD Report No. 4 York: University of York

Appendix 1: Developing Evidence Based Guidance

define the scope of questions/areas to be addressed

review evidence

evidence about    interventions
evidence about    other aspects of management

systematic review (RCT's), non-RCT evidence
non-RCT evidence clinical opinion, patient opinion


production of scientific report

review/comment/discussion re scientific report

draft guidance document



review of guidance document


professional aspects

methodical aspects

patient aspects

revisions

final review

final revisions

guidance document to CMO

McIntosh, A., Hutchinson A. (1999)