Update on the status of the classification of PVFS, ME and CFS for ICD-11: Part Three: WHO rejects Dr Dua’s proposal

November 22, 2018 by

Post #346 Shortlink: https://wp.me/pKrrB-4wZ

Related posts:

Update on the status of the classification of PVFS, ME and CFS for ICD-11: Part One

Update on the status of the classification of PVFS, ME and CFS for ICD-11: Part Two

 

Part Three (and it’s good news, for once)

As reported in Parts One and Two, three proposals for the ICD-10 G93.3 legacy categories, Postviral fatigue syndrome; Benign myalgic encephalomyelitis; and Chronic fatigue syndrome have sat unprocessed in the ICD-11 Proposal Mechanism for over a year:

the proposal by Dimmock & Chapman (submitted March 26, 2017);

the proposal by Dr Lily Chu on behalf of the IACFS/ME (submitted March 31, 2017);

the proposal by Dr Tarun Dua (submitted November 06, 2017).

If you are not registered for access to the ICD-11 Proposal platform, click to download the proposal submitted by Dimmock & Chapman in PDF format.

 

Dr Tarun Dua’s proposal to kick the G93.3 legacy categories out of the Neurology chapter

Dr Tarun Dua is a medical officer working on the Program for Neurological Diseases and Neuroscience, Management of Mental and Brain Disorders, WHO Department of Mental Health and Substance Abuse. This WHO department has responsibility for both mental disorders and neurological diseases and disorders. Its Director is Dr Shekhar Saxena.

Dr Dua had acted as lead WHO Secretariat and Managing Editor for ICD Revision’s Topic Advisory Group (TAG) for Neurology, which was chaired by Prof Raad Shakir.

When Dr Dua submitted a proposal, last year, recommending that “Myalgic encephalitis/Chronic Fatigue Syndrome (ME/CFS)” [sic] should be removed from the Diseases of the nervous system chapter and reclassified in the Symptoms, signs chapter as a child under Symptoms, signs or clinical findings of the musculoskeletal system, it was initially unstated whose position this controversial recommendation represented.

Read Dr Dua’s proposal in PDF format from Page 5 of this November 2017 commentary.

TAG Neurology had ceased operations in October 2016, leaving proposals for the G93.3 legacy categories hanging and the terms still unaccounted for in the public version of the ICD-11 Beta draft. The terms were eventually restored to the draft in March 2017.

Since early 2017, we had been advised several times by senior WHO officers that decisions regarding these categories were “on hold” while an in-house evidence review was being undertaken.

Moreover, WHO senior classification expert, Dr Robert Jakob, had assured me (via email in March 2017) that WHO had no intention of dumping these categories in the Symptoms, signs chapter — yet here was Dr Dua calling for precisely that.

The key question being: Did this recommendation represent the outcome of a now concluded evidence review or did it represented only the position of Dr Dua?

Dr Dua eventually stated that “…the proposal [had] been submitted on behalf of Topic Advisory Group (TAG) on Diseases of the Nervous System, and reiterates the TAG’s earlier conclusions.” But neither Dr Dua nor her line manager, Dr Saxena, were willing to provide us with responses to other queries raised in relation to this proposal, including, crucially: How does this proposal relate to the in-house evidence review?

We were subsequently advised by WHO’s Dr John Grove (Director, Department of Information, Evidence and Research) that the systematic evidence review would determine if the terms needed to be moved to any other specific chapter of ICD-11 and that the outcomes would be provided for review by the Medical Scientific Advisory Committee (MSAC).

A formal response by Dimmock & Chapman to Dr Dua’s proposal can be read in PDF format here Response by Dimmock & Chapman to Dr Tarun Dua proposal of November 6, 2017.

 

WHO rejects Dr Dua’s proposal 

On November 19, the proposal was marked as Rejected by ICD-11 Proposal Mechanism admins:

Screenshot: Accessed November 20, 2018:

https://icd.who.int/dev11/proposals/f/en#/http://id.who.int/icd/entity/569175314

This decision to reject Dr Dua’s recommendation that the terms should be relocated under the Symptoms, signs chapter is accompanied by a brief rationale from ICD-11 Proposal Platform admins “Team3 WHO”:

Screenshot: Accessed November 22, 2018:

 

Importantly, the decision to retain the terms in the Disorders of the nervous system chapter is supported by the WHO MSAC and CSAC committees.

(See Reference 10 for WHO/ICD-11’s guiding principles for consideration of legacy terms and potential chapter relocations — guidance with which Dr Dua is familiar and has cited, herself, when drafting other proposals, but which she evidently chose to disregard in the case of the G93.3 legacy categories.)

 

This means that these ICD-10 legacy terms continue to stand as per the “Implementation” version of the ICD-11 MMS that was published in June 2018:

https://icd.who.int/browse11/l-m/en#/http%3a%2f%2fid.who.int%2ficd%2fentity%2f569175314

 

But we are not done yet…

It’s not known when the remaining proposals submitted by myself and jointly with Mary Dimmock will be processed.

There remains a backlog of over 1000 unprocessed proposals, a number of which had met the March 30, 2017 proposal deadline and were expected to have been processed last year, in time for consideration for inclusion in the June 2018 “Implementation” release.

According to summary reports of the WHO-FIC Network Council’s April 26 and September 26, 2018 teleconferences:

  • Between June 2018 and the 2019 [World Health Assembly] resolution, WHO will work to improve user guidance around the classification and any final sorting of the extension codes, but there is not an intention to “reopen the package” of ICD-11 or to make major changes
  • The codes will not change after June 2018, and the URIs [Unique Reference Identifiers] will remain the constant, immoveable identifiers for each concept that underpin the classification
  • An update cycle was agreed by JTF [Joint Task Force] last week, including ongoing update of foundation entities (e.g. index terms, synonyms, extension codes, etc.) with
    • annual updates for entities below the shoreline,
    • a 5-year cycle for update of entities above the shoreline, and
    • a 10-year cycles for updates to the rules.

and from the September 26, 2018 teleconference:

  • WHO has updated the proposal platform to allow voting by CSAC* members and to align the process with the historical practices of the URC [ICD-10 Update and Revision Committee].
  • 90 proposals have been identified from the platform for consideration by the CSAC this year, though not all of them can be reviewed in detail face-to-face during the WHO-FIC Network Annual Meeting 2018. A call may be held in advance to discuss some specific priorities.
  • Given the huge volume of proposals, the meeting will go through the new procedures for the CSAC, review the voting process and tools, overview the proposal platform and how to use it, and determine timelines and workload for after the meeting.
  • CSAC governance will also be presented together with the content of ICD-11 prior to submission of the report on ICD-11 to the WHO Governing Bodies for review by the WHO Executive Board [in January 2019]

Source: WHO-FIC Council Google platform: WHO-FIC Council Teleconferences

*The Classifications and Statistics Advisory Committee (CSAC) takes over the role of the ICD-10 Update and Revision Committee (URC). The last update for ICD-10 will be 2019.

 

The ICD-11 MMS is expected to be frozen again in January 2019 in preparation for submission of the report to the Executive Board (EB):

 

Beyond World Health Assembly adoption, ICD-11 will be subject to an update and maintenance cycle:

(See Reference Guide Annex 3.7.1 – 3.7.6 for detailed information on ICD-11 Updating Cycles and Proposal Workflows.)

I’ve been unable to confirm whether the first update released after the June 2018 “Implementation” version would be a January 2019 release, or whether the June 2018 version is intended to remain more or less stable for a further year, until January 2020.

If WHO were to accept any of the proposals contained within my individual submissions and my joint submissions with Mary Dimmock, for example, approving our recommendations for deprecating the prefix “Benign”; deprecating Postviral fatigue syndrome as lead Concept Title; assigning separate Concept Title codes to Myalgic encephalomyelitis and to Chronic fatigue syndrome; or approving Exclusions under Bodily distress disorder (BDD), any approved recommendations would appear initially in the orange ICD-11 Maintenance Platform pending their eventual incorporation into an “Implementation” release.

I will keep you apprised of any significant developments.

 

References:

1 G93.3 Postviral fatigue syndrome, ICD-10 Browser Version: 2016. Accessed November 22, 2018

2 World Health Organization finally releases next edition of the International Classification of Diseases (ICD-11) Dx Revision Watch, July 25, 2018

3 8E49 Postviral fatigue syndrome, ICD-11 for Mortality and Morbidity Statistics (ICD-11 MMS) 2018 version for preparing implementation. Accessed November 22, 2018

4 8E49 Postviral fatigue syndrome, ICD-11 (Mortality and Morbidity Statistics) Maintenance Platform. Accessed November 22, 2018 The content made available on this platform is not a released version of the ICD-11. It is a work in progress in between released versions.

5 A proposal for the ICD-10 G93.3 legacy terms for ICD-11: Part Two. Dx Revision Watch, April 3, 2017

6 PDF: Proposal: Revision of G93.3 legacy terms for ICD-11, Dimmock & Chapman, March 27, 2017

7 Proposal: Revision of G93.3 legacy terms for ICD-11, Dr Tarun Dua, November 6, 2017

8 Response by Dimmock & Chapman to Dr Tarun Dua proposal of November 6, 2017, February 15, 2018

9 ICD-11 Reference Guide June 2018

10 Extract from Response to Dr Dua Proposal of November 6 2017: 4. Compliance with WHO standards and other considerations on relocation, Dimmock & Chapman, February 15, 2018

Filed under CFS, Chronic fatigue syndrome, ICD revision process, ICD-10, ICD-11, ICD-11 MMS 2018, International Classification of Diseases, Myalgic encephalomyelitis, Postviral fatigue syndrome, WHO (World Health Organization) Tagged with , , , , , , , , ,

Update on the status of the classification of PVFS, ME and CFS for ICD-11: Part Two

August 17, 2018 by

Post #344 Shortlink: https://wp.me/pKrrB-4rs

Part Two

In Part One, I documented key developments around the potential revision of the G93.3 legacy categories for ICD-11. This report picks up from November 2017.

November 06, 2017: Dr Tarun Dua (Medical Officer, Program for Neurological Diseases and Neuroscience, Management of Mental and Brain Disorders, WHO Department of Mental Health and Substance Abuse) posts a new proposal for these terms on the ICD-11 proposal platform.

The proposal recommends moving “Myalgic encephalitis/Chronic Fatigue Syndrome (ME/CFS)” [sic] from the Diseases of the nervous system chapter to the Symptoms, signs chapter, as a child under Symptoms, signs or clinical findings of the musculoskeletal system.

Click here to read the full proposal Dr Dua November 06, 2017. (If you are not registered with the drafting platform, a copy of Dr Dua’s proposal is included at the end of this commentary.)

November 2017: Dr Dua and Dr Shekhar Saxena are approached by the Countess of Mar to provide clarifications. Dr Dua responds that “the proposal has been submitted on behalf of Topic Advisory Group (TAG) on Diseases of the Nervous System, and reiterates the TAG’s earlier conclusions.” but provides no other clarifications. Dr Saxena does not engage but passes the communication on to Dr Dua, who says she has forwarded the message to the TAG for its consideration. Nothing further is heard from any of them and the enquiries are left hanging.

January 29, 2018: “Team WHO” (an ICD Revision Admin account) posts this comment under the Dr Dua proposal:

“Any decisions regarding this entity are on hold until the results of a review become available.”

February 15, 2018: Dimmock and Chapman submit a robust counter analysis of Dr Dua’s proposal and submit further evidence on March 10.

December 2017 – March 2018: In response to the failure of WHO’s Dr Shekhar Saxena and Dr Tarun Dua to provide adequate clarifications in relation to this proposal, the Countess of Mar is advised to write to Dr John Grove, Director, Information, Evidence and Research and Revision Project Lead to put on record significant concerns for the way in which the potential revision of these ICD categories has been handled, the lack of transparency on the part of TAG Neurology, Revision Steering Group and Joint Task Force, and their unwillingness to engage in dialogue.

Over a number of exchanges, Dr Grove provides the following information:

A systematic evidence review will determine if “the category” needs to be moved to any other specific chapter of ICD-11.

The classification team organizes the review which is expected to be completed by mid April 2018.

The outcomes will be provided for review by the Medical Scientific Advisory Committee (MSAC) and will be posted together with the relevant detail on the proposal platform.

New proposals posted on the platform will become part of the workflows of the maintenance mechanism of ICD-11 and be processed in an annual cycle.

The “relevant category will in any case be kept separate from the generic ‘chronic fatigue’ (signs and symptoms).”*

 

*NB: there is no concept term, ‘chronic fatigue’ in ICD-11’s Symptoms, signs chapter. There is a concept term: Fatigue (which was Malaise and fatigue in ICD-10). In March 2017, a long-standing proposal of mine for the addition of exclusions for Benign myalgic encephalomyelitis and Chronic fatigue syndrome under Fatigue was approved by the Beta draft admins, although the request for exclusion of Postviral fatigue syndrome wasn’t actioned and remains unprocessed.

There are several speculative reasons for this: ICD Revision may be considering retiring the Postviral fatigue syndrome term for ICD-11; or retaining the term, but only as an Index Term. This might also account for Dr Dua’s reluctance to clarify what her proposal’s intentions are for the Postviral fatigue syndrome term.

There has been no indication whether any evidence review was concluded in mid April, what the outcome was, or whether any potential new proposals for these categories are currently with the MSAC. But no new proposals from ICD Revision, the MSAC or Dr Dua’s department have been posted on the proposal platform or entered directly into the development draft (now known as the “Maintenance Platform”).

Where does this currently leave these terms?

This is how the ICD-11 MMS stood for the release of the “advance preview” version, on June 18, 2018.

(Note the version of ICD-11 as released does not display the Foundation Component, nor are the current 15 Synonyms and Index terms displayed in this “advance preview” release):

https://icd.who.int/browse11/l-m/en#/http%3a%2f%2fid.who.int%2ficd%2fentity%2f569175314

 

As released in June 2018, the content of the ICD-11 MMS is planned to remain stable until January 2019, when it will be prepared for presentation at the May 2019 World Health Assembly.

The Proposal Mechanism will remain open for submission of new proposals from the MSAC, CSAC and public stakeholders. There is a backlog of over 1300 proposals waiting to be processed.

There are currently three proposals for PVFS, BME and CFS waiting to be reviewed:

The proposal submitted by Dimmock & Chapman (on March 26, 2017)

The proposal submitted by Dr Lily Chu on behalf of the IACFS/ME (on March 31, 2017)

The proposal submitted by Dr Tarun Dua (on November 06, 2017)

 

ICD Revision might potentially post new proposals for PVFS, ME and CFS via the Proposal Mechanism at any point in the future.

While new proposals are expected to be processed as part of the annual maintenance cycle, any approved proposal would not immediately be reflected in the released version of the ICD-11 MMS but carried forward for eventual incorporation into a later release, according to the update cycle for that particular class of change. (See Annex 3.7 of the Reference Guide for maintenance and update schedules, how “Minor” and “Major” changes are defined, guidance on submitting new proposals etc.)

My interpretation of the Reference Guide is that relocation of a category to another chapter would constitute a “Change a primary parent” and a “Structural Change” and would be classed as a “Major Change”, for incorporation on the 5 year update cycle, not the annual update cycle.

It is not yet clear in which year the first update cycle is anticipated to start, i.e., whether the next stable release would be published in January 2020, or if the first update cycle is not scheduled to start until a later year.

 

How soon will member states start using ICD-11?

World Health Assembly endorsement will not come into effect until January 01, 2022. After this date, member states can start using ICD-11 for reporting data when their health systems have transitioned to the new edition.

Dr Christopher Chute, chair of ICD-11’s Medical and Scientific Advisory Committee (MSAC), predicts that early implementers may require at least five years to prepare their countries’ health systems for transition. Member states using a “clinical modification” of ICD are likely to take longer to develop, test and roll out a country specific adaptation — particularly the United States.

There is no mandatory implementation date — member states will migrate to ICD-11 at their own pace. Global adoption will likely be a patchy and prolonged process and for a period of time, the WHO will be accepting data reported using both ICD-10 and the new ICD-11 code sets.

No countries have announced tentative implementation schedules.

NHS Digital says: “No decision has been made for the implementation of ICD-11 in England, however NHS Digital plan to undertake further testing of the latest release and supporting products that will inform a future decision.”

Until the UK has implemented ICD-11, the mandatory classification and terminology systems for use in the NHS are ICD-10 (Version: 2015) and SNOMED CT UK Edition.

Part One

 

References:

1 G93.3 Postviral fatigue syndrome, ICD-10 Browser Version: 2016. Accessed August 14, 2018

2 World Health Organization finally releases next edition of the International Classification of Diseases (ICD-11) Dx Revision Watch, July 25, 2018

3 8E49 Postviral fatigue syndrome, ICD-11 for Mortality and Morbidity Statistics (ICD-11 MMS) 2018 version for preparing implementation. Accessed August 14, 2018

4 8E49 Postviral fatigue syndrome, ICD-11 (Mortality and Morbidity Statistics) Maintenance Platform. Accessed August 14, 2018 The content made available here is not a released version of the ICD-11. It is a work in progress in between released versions.

5 ICD Revision Joint Task Force Meeting Report 22-22 January, 2017, Cologne, Germany. Page 39, Item 39: Chronic Fatigue Syndrome Advocacy Efforts. Accessed August 14, 2018

6 A proposal for the ICD-10 G93.3 legacy terms for ICD-11: Part Two. Dx Revision Watch, April 3, 2017

PDF: Proposal: Revision of G93.3 legacy terms for ICD-11, Dimmock & Chapman, March 27, 2017

7 Proposal: Revision of G93.3 legacy terms for ICD-11, Dr Tarun Dua, November 6, 2017

8 Response by Dimmock & Chapman to Dr Tarun Dua proposal of November 6, 2017, February 15, 2018

9 ICD-11 Reference Guide June 2018

10 Extract from Response to Dr Dua Proposal of November 6 2017: 4. Compliance with WHO standards and other considerations on relocation, Dimmock & Chapman, February 15, 2018

Filed under CFS, Chronic fatigue syndrome, ICD revision process, ICD-10, ICD-11, ICD-11 Beta Draft, International Classification of Diseases, Myalgic encephalomyelitis, Postviral fatigue syndrome, WHO (World Health Organization) Tagged with , , , , , , , , ,

Update on the status of the classification of PVFS, ME and CFS for ICD-11: Part One

August 17, 2018 by

Post #343 Shortlink: https://wp.me/pKrrB-4r3

Part One

In the World Health Organization’s ICD-10, Postviral fatigue syndrome is classified in the neurological chapter of the Tabular List (at G93.3, under parent block: G93 Other disorders of brain, in Chapter VI: Diseases of the nervous system).

Benign myalgic encephalomyelitis is the inclusion term under Postviral fatigue syndrome and takes the same code. Chronic fatigue syndrome isn’t included in the Tabular List but is indexed in the Alphabetical Index to the G93.3 code.

ICD-10 and ICD-11 do not include the composite terms: “myalgic encephalomyelitis/chronic fatigue syndrome”, “ME/CFS” or “CFS/ME” and composite terms will not be used in this report.

This is how the terms appear in the online browser version of the ICD-10 Tabular List. If you enter “Chronic fatigue syndrome” into the Search field, a drop down displays the code that Chronic fatigue syndrome is indexed to:

http://apps.who.int/classifications/icd10/browse/2016/en#/G93.3

 

Release of ICD-11

In Post #339 I reported on the release, in June 2018, of an “advance preview” version of ICD-11. This version has been released to enable countries to evaluate the new edition, plan for implementation, prepare translations and begin training health professionals. The WHO still has a lot of work to do before the full ICD-11 “implementation package” and companion publications are completed.

ICD-11 is scheduled for presentation at the World Health Assembly (WHA) in May 2019 for adoption by member states but WHA endorsement won’t come into effect until January 01, 2022. After that date, member states can begin using the new edition for data reporting — if their health systems are ready. There is no mandatory implementation date and member states will be migrating to ICD-11 at their own pace and according to their countries’ specific timelines, requirements and resources.

 

Update on classification for ICD-11

The progression of these three ICD-10 categories through the ICD-11 drafting process has been shambolic, mired in obfuscation, immensely frustrating for stakeholders — and still not resolved.

If you would prefer to jump to a report on how these three terms currently stand in ICD-11, as released in June 2018, and skip the key developments, go to Part Two

Key developments: tracking the progress of the ICD-10 G93.3 categories through the iCAT, Alpha and Beta drafting phases, between May 2010 and June 2018:

May 2010: The ICD-10 parent class, Other disorders of brain, is retired for ICD-11. Its retirement affects a number of categories that sit under it, not just Postviral fatigue syndrome.

A change of hierarchy between the three terms is proposed (Screenshot).

Chronic fatigue syndrome is proposed to replace Postviral fatigue syndrome as the new “Concept Title” term, with Benign myalgic encephalomyelitis specified as its inclusion term (Screenshot). Postviral fatigue syndrome is proposed to be relocated under Synonyms to new Concept Title, Chronic fatigue syndrome.

All three terms are later removed from under parent block: Other disorders of the nervous system and placed in a “holding pen” for categories for which decisions are needed to be made or while further chapter restructuring is being carried out.

February 2013: The Beta drafting platform admins or the managing editors for Topic Advisory Group for Neurology inexplicably remove CFS, BME and PVFS from the public version of the Beta platform. No rationale is provided for their removal. No comments or suggestions for edits can be submitted for these terms since the terms are no longer displaying in the draft. This is how proposals for the terms had stood in early 2013, at the point at which they were removed from the public draft (Screenshot).

July 2015: Following a teleconference with the WHO’s Dr Robert Jakob and Anneke Schmider, Chapman and Dimmock provide ICD Revision and Topic Advisory Group for Neurology with a list of neurological and immunological studies and other resources to inform the revision process and the literature review.

February 2017: The three terms have now been missing from the public version of the Beta drafting platform for over four years.

Advocates and international patient organizations lobby the co-chairs and members of the ICD Revision Joint Task Force to place the matter of the continued absence of these terms from the public Beta draft on the agenda for the Joint Task Force’s February 20-22, 2017 meeting, in Cologne.

These appeals do result in the matter being tabled for discussion, as noted in the Meeting Report (Item 39, p39). But no immediate action is taken to restore the missing terms to the Beta draft and no progress report on intentions for these terms is forthcoming.

March 26, 2017: PVFS, BME and CFS are finally restored to the Beta draft under Other disorders of the nervous system, but with this caveat from the Beta draft admin team:

While the optimal place in the classification is still being identified, the entity has been put back to its original place in ICD. Team WHO 2017-Mar-26 – 14:46 UTC

PVFS is restored as the lead (Concept Title) term, as it is in ICD-10. BME and CFS are both specified as Inclusion terms. There is a list of around 15 alternative and historical terms under Synonyms and Index Terms — but “the optimal place in the classification is still being identified.”

At this point, ICD-11 has been under development for nearly ten years but Topic Advisory Group for Neurology has yet to publish any progress reports on its proposals for these ICD-10 categories.

This is how the terms stood after they were restored to the Beta draft in March 2017:

 

March 27, 2017: Suzy Chapman and Mary Dimmock finalize and submit a detailed proposal and rationale for PVFS, BME and CFS via the Beta draft proposal platform. This submission meets the March 30, 2017 proposal deadline. The proposal and rationale is supported by international patient organizations and patients. Click to download a PDF of the Proposal and Rationale.

(This proposal remains unprocessed and uncommented on by ICD Revision despite having met the proposal deadline.)

November 06, 2017: A new proposal for these terms is posted by Dr Tarun Dua.

Dr Dua is Medical Officer, Program for Neurological Diseases and Neuroscience, Management of Mental and Brain Disorders, WHO Department of Mental Health and Substance Abuse. This WHO department has responsibility for both mental disorders and neurological diseases. Its Director is Dr Shekhar Saxena.

Dr Dua had acted as lead WHO secretariat and managing editor to the Topic Advisory Group for Neurology, which had been chaired by Prof Raad Shakir.

It is initially unclear who owns this proposal and whose position it represents since Topic Advisory Group for Neurology had ceased operations in October 2016, leaving proposals for these terms hanging. We had been advised by the WHO several times since early 2017 that a literature review was still in progress:

Is this proposal the outcome of a now concluded literature review and do these recommendations already have the approval of ICD Revision?

Or does this proposal represent only the position of Dr Dua or the Department of Mental Health and Substance Abuse?

Four weeks after submitting these recommendations, Dr Dua responds:

“…the proposal has been submitted on behalf of Topic Advisory Group (TAG) on Diseases of the Nervous System, and reiterates the TAG’s earlier conclusions.”

but neither Dr Dua, Dr Saxena or (what remains of) TAG Neurology will provide any responses to requests for additional clarifications.

 

Dr Tarun Dua’s proposal

The proposal recommends that “Myalgic encephalitis/Chronic Fatigue Syndrome (ME/CFS)” [sic] should be removed from the Diseases of the nervous system chapter and reclassified in the Symptoms, signs chapter, as a child under Symptoms, signs or clinical findings of the musculoskeletal system.

Note that Dr Dua has not taken the existing ICD category terms as her reference point — ICD does not use the term, “Myalgic encephalitis” or the composite terms, “Myalgic encephalitis/Chronic Fatigue Syndrome” or “ME/CFS.”

It is not evident from the proposal what Dr Dua/TAG Neurology intends to do with the current Concept Title, Postviral fatigue syndrome — which the proposal does not mention, at all. Nor can it be determined what new hierarchy is being proposed between the terms. Nor is any rationale provided for using different nomenclature to the existing ICD terms.

Leaving aside the proposal, per se, the rationales that accompany it, the misconceptions contained within it and the narrow range of studies it relies on, the submission is sloppy and not fit for purpose.

The rationale for the proposal includes:

“…the lack of evidence regarding any neurological etiopathogenesis of chronic fatigue syndrome…

“When there is sufficient evidence and understanding of the pathophysiological mechanisms, diagnostic biomarkers, and specific treatments, the syndrome can be appropriately classified within the proper block.

“The predominant symptom of those with ME/CFS present is severe fatigue, a manifestation of skeletal muscle dysfunction…

“Epidemiological and Pathophysiological evidence is limited, conflicting, and does not support ME/CFS as a disease of the nervous system or with a principally neurobiological underpinning…

“ME/CFS is thus not a disease of the nervous system. It should be categorized in the Signs and Symptoms chapter given the lack of clear evidence pointing to the etiology and pathophysiology of this syndrome until evidence to organ placement is clarified in years to come.”

 

Click here to read the full proposal Dr Dua November 06, 2017. (If you are not registered for access to the proposals platform, a copy of Dr Dua’s proposal is included at the end of this commentary for ease of access.)

One also has to question why this proposal was submitted at this point when advocates had been advised several times that an in-house evidence review was in progress.

This proposal from a staffer in the Department of Mental Health and Substance Abuse (submitted apparently on behalf of a retired external advisory group) appeared to sit outside that evidence review. But when questioned about the proposal’s status, no-one within WHO seemed to want to have to acknowledge its existence or clarify whether and how it related to the evidence review.

 

Lack of consensus between WHO staffers and ICD Revision

In March 2017, Dr Robert Jakob, Team Leader Classifications and Terminologies, had given the assurance, via an email sent to Suzy Chapman (Dx Revision Watch) and CCd to Stefanie Weber; Dr Christopher Chute; Linda Best; Molly Meri Robinson Nicol; Dr Geoffrey Reed; Dr Tarun Dua; Dr Ties Boerma and the Countess of Mar, that:

“As discussed earlier, chronic fatigue syndrome will not be lumped into the chapter ‘signs and symptoms.'”

Yet this proposal submitted by Dr Dua proposes to do just that.

Evidently, there is a lack of consensus between the WHO’s senior classification lead, Dr Robert Jakob, and Dr Dua/TAG Neurology.

Dr Dua’s proposal also fails to take into consideration WHO/ICD-11 guiding principles on relocation of legacy terms to other chapters. For an expanded commentary on ICD-11 principles concerning potential relocations see Extract from Response to Dr Dua Proposal of November 6 2017.

Nor do the recommendations consider any proposed relocation in the context of data collection, statistical analysis and backward compatibility with ICD-10 and its clinical modifications.

To continue with the status of these terms in the ICD-11 draft, up to its release in June 2018, go to Part Two

 

References:

1 G93.3 Postviral fatigue syndrome, ICD-10 Browser Version: 2016. Accessed August 14, 2018

2 World Health Organization finally releases next edition of the International Classification of Diseases (ICD-11) Dx Revision Watch, July 25, 2018

3 8E49 Postviral fatigue syndrome, ICD-11 for Mortality and Morbidity Statistics (ICD-11 MMS) 2018 version for preparing implementation. Accessed August 14, 2018

4 8E49 Postviral fatigue syndrome, ICD-11 (Mortality and Morbidity Statistics) Maintenance Platform. Accessed August 14, 2018 The content made available here is not a released version of the ICD-11. It is a work in progress in between released versions.

5 ICD Revision Joint Task Force Meeting Report 22-22 January, 2017, Cologne, Germany. Page 39, Item 39: Chronic Fatigue Syndrome Advocacy Efforts. Accessed August 14, 2018

6 A proposal for the ICD-10 G93.3 legacy terms for ICD-11: Part Two. Dx Revision Watch, April 3, 2017

PDF: Proposal: Revision of G93.3 legacy terms for ICD-11, Dimmock & Chapman, March 27, 2017

7 Proposal: Revision of G93.3 legacy terms for ICD-11, Dr Tarun Dua, November 6, 2017

8 Response by Dimmock & Chapman to Dr Tarun Dua proposal of November 6, 2017, February 15, 2018

9 ICD-11 Reference Guide June 2018

10 Extract from Response to Dr Dua Proposal of November 6 2017: 4. Compliance with WHO standards and other considerations on relocation, Dimmock & Chapman, February 15, 2018

Filed under CFS, Chronic fatigue syndrome, ICD revision process, ICD-10, ICD-11, ICD-11 Beta Draft, International Classification of Diseases, Myalgic encephalomyelitis, Postviral fatigue syndrome, WHO (World Health Organization) Tagged with , , , , , , , , ,

DSM-5 Somatic Symptoms Work Group submissions 2012: Last chance to tell SSD Work Group why it needs to ditch flawed, unsafe and unscientific proposals

May 4, 2012 by 1 Comment

DSM-5 Somatic Symptoms Work Group submissions 2012: Last chance to tell SSD Work Group why it needs to ditch unsafe and scientifically flawed proposals

Post #165 Shortlink: http://wp.me/pKrrB-26q

Under the guise of “eliminating stigma” and eradicating “terminology [that] enforces a dualism between psychiatric and medical conditions” the American Psychiatric Association appears hell bent on colonising the entire medical field by licensing the application of a mental health diagnosis to all medical diseases and disorders.

 

Last chance to tell the SSD Work Group why it needs to ditch its unsafe and scientifically flawed proposals

The third DSM-5 Development public review of proposals for revisions to DSM-IV categories and criteria runs through May 2 – June 15. This will be the last opportunity for stakeholders to submit feedback.

Register on the DSM-5 Development site to submit comment or use your previous user name and log in details if you submitted during the earlier reviews. For information on registration see this post from 2011.

One again, I’m collating copies of submissions to the Somatic Symptom Disorders Work Group on a dedicated page from international patient organizations, medical, allied health and other professional stakeholders, patients, advocates and professional bodies.

Any consumer groups, medical professionals, allied health professionals, social workers, lawyers etc with concerns for the Somatic Symptom Disorders proposals are welcome to forward copies of submissions for publication here.

If you are looking for submissions for the first and second public reviews, you need these pages:

Submissions to first public review (February 10 – April 20, 2010): http://wp.me/PKrrB-AQ

Submissions to second public review (May 4 – July 15, 2011): http://wp.me/PKrrB-19a

This year’s submissions are being collated here as they come to my attention:

DSM-5 SSD Work Group submissions 2012 

Shortlink for submissions page is: http://wp.me/PKrrB-1Ol

Today I am publishing UK patient and advocate, Peter Kemp’s submission to the SSD Work Group:

Submission from Peter Kemp, UK advocate

How people with M.E. and CFS (and other illnesses) could be misdiagnosed as Somatic Symptom Disorder using DSM-5

Misdiagnosis is a common occurrence by all accounts. Therefore medical definitions or criteria should not only assist diagnosis – they should positively aim to prevent or reduce misdiagnosis.

Somatic Symptom Disorder (SSD) as proposed for DSM-5 allows too many possibilities for misdiagnosis. Misdiagnosis that could have disastrous consequences. This is so readily foreseeable that this must be addressed.

Once a physician diagnoses SSD, they have effectively judged the patient incompetent to interpret their own symptoms. If the patient has an unrecognised disease that progresses, or develops a new disease and reports the new symptoms to the doctor, what will the doctor do? The patient is untrustworthy. The doctor is busy and has ‘real’ patients to treat.

It is inevitable that even patients that are correctly diagnosed with SSD will sooner or later present with actual physical disease. The diagnosis of SSD could predictably obstruct investigation and treatment of their disease. This obstruction could be directly attributed to the use of an SSD diagnosis.

SSD should not be included in DSM-5 unless specific guidance to prevent misdiagnosis are included and these have been proven effective.

Imagine a doctor with a patient presenting in the early stages of MS. MS can be difficult to diagnose. When Professor Poser reviewed 366 MS diagnoses made by board certified neurologists, he found that only 65% had been correctly diagnosed (http://www.cfids.org/archives/2000rr/2000-rr4-article03.asp ).

It can take years before the signs, symptoms and tests are clear enough to make a diagnosis (http://ms.about.com/popular.htm ). The symptoms of ‘pre-diagnosis’ MS can be very distressing and the lack of a laboratory test or firm diagnosis may add to a patient’s worries. The patient may try all sorts of strategies to try and find out about, and improve what is happening to them. They may appear to pester their GP, they may appear neurotic and irrational.

Now imagine that in accordance with DSM-5, a doctor gives them a diagnosis of the proposed SSD. The patient has an official diagnosis in their medical records that amounts to ‘hypochondriac’. What effect will that have on the patient’s chances of getting the necessary investigations as the disease progresses? How is it going to help them to cope with their distressing physical symptoms now they have been explained as psychosomatic? The time it will take for them to get a true diagnosis may be further prolonged, and the years spent waiting could be made even more harrowing because of inaccurate psychological labelling.

Therefore sensible doctors will avoid diagnosing SSD. Foolish doctors risk spending their time at professional disciplinary hearings and in court; and this still might not adequately reflect the amount of suffering their diagnosis of SSD could cause.

The rationale for SSD also states: “The proposed classification for Somatic Symptom Disorders deemphasizes the central role of medically unexplained symptoms. Instead, it defines disorders on the basis of positive symptoms (distressing somatic symptoms + excessive thoughts, feelings, and behaviors in response to these symptoms).”

I believe it safe to say that ‘positive symptoms’ does not mean ‘good symptoms’ or ‘symptoms with the right attitude’. I imagine it means definite, definable, testable and maybe even measurable. But when terms like ‘distressing’ and ‘excessive’ are used to measure symptoms, the definition is not a definition. It is not even a convincing concept.

The idea is right, to base the definition on signs and symptoms that are actually present, as long as these sufficiently differentiate the condition from other conditions and do not lead to too many misdiagnoses. Unfortunately, they would predictably fail to achieve this because the definition proposed is significantly subjective.

The ‘DSM-5 Proposed Revision’ could certainly misdiagnose M.E. This would be a serious matter as M.E. is classified by the WHO ICD as a neurological illness. A doctor whose diagnosis of SSD was contradicted by a doctor that diagnosed M.E could find themselves in an awkward legal situation. The implications to the proper care of a patient, due to misdiagnosing a serious neurological illness as a neurotic illness hardly bear thinking about. Hindering necessary investigations and treatment might only be a small part of the problems this might create.

The latest proposal states:

“Somatic Symptom Disorder

Criteria A, B, and C must all be fulfilled to make the diagnosis:”

“A. Somatic symptoms: One or more somatic symptoms that are distressing and/or result in significant disruption in daily life.”

The Myalgic Encephalomyelitis: International Consensus Criteria – states:
(http://www.meassociation.org.uk/?p=7173)

“A patient will meet the criteria for post-exertional neuroimmune exhaustion (A), at least one symptom from three neurological impairment categories (B), at least one symptom from three immune/gastro-intestinal/genitourinary impairment categories (C), and at least one symptom from energy metabolism/transport impairments (D).”

The Canadian Expert Consensus Panel Clinical Case Definition for ME/CFS states:
(http://www.cfids-cab.org/MESA/ccpccd.pdf)

“A patient with ME/CFS will meet the criteria for fatigue, post-exertional malaise and/or fatigue, sleep dysfunction, and pain; have two or more neurological/cognitive manifestations and one or more symptoms from two of the categories of autonomic, neuroendocrine and immune manifestations; and adhere to item 7.”

Therefore every patient with M.E. or CFS or ME/CFS will present with ample distressing and disruptive symptoms to satisfy DSM-5 Somatic Symptom Disorder Part A.

“B. Excessive thoughts, feelings, and behaviors related to these somatic symptoms or associated health concerns: At least one of the following must be present.

(1) Disproportionate and persistent thoughts about the seriousness of one’s symptoms.
(2) Persistently high level of anxiety about health or symptoms
(3) Excessive time and energy devoted to these symptoms or health concerns”

The NICE Guidelines for CFS/ME state:
(http://www.nice.org.uk/nicemedia/live/11824/36191/36191.pdf )

“People with mild CFS/ME are mobile, can care for themselves and can do light domestic tasks with difficulty. Most are still working or in education, but to do this they have probably stopped all leisure and social pursuits. They often take days off, or use the weekend to cope with the rest of the week.”

Therefore even the mildest form of CFS sees persons who have often greatly reduced or stopped socializing, hobbies, sports etc.; and spend much of the time formerly devoted to these pursuits in resting and recuperating their energy to continue working.

When this level of disruptive illness goes on for more than 6 months, people will naturally and rationally become worried. They will be fearful of what is happening and what is going to happen. They will be anxious about their responsibilities, their job, their family and friend connections – everything. They may quite naturally seek help from their GP. They may be given antidepressants, sleeping medications, pain killers, etc. All these combined with a chronic illness necessitate frequent visits to their GP. They may try alternative therapies (possibly after having found what their GP offered did not help them). They may alter their diet, take nutritional supplements, go for acupuncture, homeopathy or other type of therapy.

And here is the rub; if one does not believe they are actually physically ill, their ‘thoughts, feelings and behaviours’ will certainly appear ‘excessive’. This could apply not just to CFS, but many other high impact and distressing illnesses.

The ‘Rationale’ for SSD states: “Undifferentiated Somatoform Disorder has such a low threshold that it is applicable to a very large proportion of patients attending primary care. The same low threshold issue occurs with Somatoform Disorder NOS.”

The proposed definition does not address this problem. It might actually make it worse. If doctors believe that SSD has a valid definition they may start actually using it – then God help us.

If a person with just ‘mild’ CFS is justified in being worried, justified in resting so they can keep working, justified in searching for something that will improve their health – then anyone with the illnesses mentioned could meet the criteria to satisfy DSM-5 Somatic Symptom Disorder Part B.

The only proviso is that to some extent this could depend on interpretation of the subjective aspects of part B (there may be more detailed explanations elsewhere – this essay is based on what is included here). What is ‘excessive’, ‘persistantly’, ‘disproportionate’, ‘seriousness’?*

The same ‘Rationale’ for SSD remarks on: “The lack of positive psychological features in the definition”. Unfortunately the proposed criteria attempt to define “positive psychological features” based entirely upon a physician’s subjectivity. That is not, in any sense, a definition.

This is why I believe the circular-reasoning trap constructed with SSD makes it risible. They construct a concept for SSD. They construct criteria for the concept. Chicken-egg or egg-chicken, take your pick.

The problem with this approach is that it does not IDENTIFY the psychological condition they are trying to define. SSD cannot exist only by differentiating features, this is true. Yet differentiating is an essential step. SSD must discern from other anxiety or depressive disorders. It must be discern from normal or rational anxiety, whether that anxiety is acute, chronic or fluctuating. It must discern from anxiety or depressive disorders due to neurological illness or injury. It must discern from physical illness that has not yet been diagnosed, or from physical illness for which diagnosis is complex or often delayed. It must discern from new or emerging diseases. If SSD cannot discern from these, then misdiagnosis could be a common and predictable result.

The criteria should define the disorder but they don’t. They attempt to define the criteria. The disorder should inform the criteria, but it doesn’t. The disorder is lost in a confusion of subjective terms, ‘excessive’, ‘persistantly’, ‘disproportionate’, ‘seriousness’.

The only way it can work is if someone (and here’s another trap); someone who believes that SSD exists and is defined by the DSM, decides what ‘excessive’ and ‘disproportionate’ etc., mean. Then all they have to do, is reach exactly the same conclusion that every other physician using the DSM would reach in the same position. Bingo. A diagnosis that does not mean anything other than what the ‘diagnoser’ decides that it means. And they better hope they got it right, otherwise a good lawyer will wipe the floor with them.

“C. Chronicity: Although any one symptom may not be continuously present, the state of being symptomatic is persistent (typically >6 months).”

This is either synchronicity, or they got this direct from the NICE Guidelines for ‘CFS/ME’. The NICE Guidelines ‘Making a diagnosis’ state:

“The range of presenting symptoms is wide, and fatigue and pain may not always be the prominent disabling features at initial presentation.”

“Symptoms tend to vary in intensity and type over a period of weeks or months (and evolve into what is more clearly CFS/ME with time)”

Mild CFS will satisfy DSM-5 Somatic Symptom Disorder Part C. Therefore every person with M.E. or CFS could get a diagnosis of SSD unless they can convince any psychiatrist they encounter that they are not ‘excessive’, ‘persistent’, ‘disproportionate’, or that they don’t believe they are seriously ill.

A serious anomaly might arise with SSD in both M.E. and CFS. These illnesses can start with only fatigue or just a few symptoms. Extreme fatigue and pain might be all that a patient reports. However, if the illness continues over years, some symptoms may improve whilst new ones appear. Problems such as sensory impairments, bladder and bowel problems, immune dysfunction, and a host of neurological symptoms (to name but a few) can develop.

Will the M.E. or CFS patient then be vulnerable to having their previous diagnosis ‘cancelled-out’ by a new diagnosis of SSD, because they developed too many symptoms and are worried about them?

The SSD development group have repeated previous flaws they identified as creating the need for new definitions. They have not defined anything. Yet there may be some positive outcome from their efforts. I imagine that some medical insurance company executives must be rubbing their hands together in glee, but medical negligence lawyers should be turning cartwheels.

Peter Kemp

*Editor: Accompanying the first and second release of draft proposals for the Somatic Symptom Disorders categories, two quite lengthy PDF documents that expanded on the disorder descriptions and validity/rationales were published in conjunction with the webpage Proposed Revision, Rationale and Severity texts.

For this third draft, no PDFs have been published that reflect the Work Group’s revisons since release of the second draft, last May, or set out its rationales in detail. No draft DSM-5 textual content, more comprehensive disorder descriptions or field trial evaluations are available for public scrutiny other than brief, revised Rationale texts:

Criteria for Proposed Revision J00 Somatic Symptom Disorder

Rationale text for category J00 Somatic Symptom Disorder:

Related material:

1] DSM-5 proposals for Somatoform Disorders revised on April 27, 2012

2] DSM-5 Development site

3] Somatic Symptom Disorders proposals

Filed under American Psychiatric Association (APA), Criticism of DSM-V, DSM-5, DSM revision process, DSM-5 consultation, DSM-5 draft proposals, DSM-5 field trials, DSM-5 third draft, MUS, Somatic Symptom Disorder, Somatoform Disorders Tagged with , , , , , , , , ,