Allen Frances and Robert Spitzer on DSM-5 Scientific Review Work Group and DSM-5 Field Trials and deadlines

Allen Frances, MD and Robert Spitzer, MD write to the APA Board of Trustess re DSM-5 Scientific Review Work Group; Frances on DSM-5 Field Trials and deadlines

Post #54 Shortlink: http://wp.me/pKrrB-Ru

On 10 December 2009, the American Psychiatric Association (APA) issued a news release announcing a revised timeline for the publication of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The anticipated release date for DSM-5 was being shifted from May 2012 to May 2013.

According to the DSM-5 Development Timeline:

[Timeline superceded by revised Timeline]

But field trials are barely underway.

Allen Frances, MD, currently professor emeritus at Duke, had chaired the DSM-IV Task Force. Frances maintains the blog DSM5 in Distress at Pyschology Today and also writes for Psychiatric Times where he’s been documenting and commenting on the development of DSM-5 since June 2009. Robert Spitzer had chaired the DSM-III Task Force.

Links to two recent commentaries by Allen Frances on DSM-5 deadlines and a joint letter by Frances and Spitzer to the APA Board of Trustees in response to the APA’s appointment of a DSM-5 Scientific Review Work Group, below:

DSM5 in Distress

The DSM’s impact on mental health practice and research.
by Allen Frances, M.D.

Letter To Board Of Trustees of the American Psychiatric Association sent December 6, 2010

Published on December 13, 2010

We are delighted that you have appointed a DSM-5 Scientific Review Work Group and charged it with assessing the quality of evidence supporting the DSM 5 proposals. This is great news, probably the last hope to weed out proposals that could do great harm to the Association, our field, and to our patients. Our relief and hope are tempered only by several problems with the process as you have established it:

CONTINUED SECRECY: Given all of the negative publicity surrounding the DSM-5 confidentiality agreements, we are amazed to see the following statement in the charge to the Scientific Review committee: “Deliberations and reports to the BOT will be confidential. The existence of the committee (work group) will be public.” Why on earth is this case? What is the possible harm of making this esteemed committee’s final report public? While we can appreciate the need for the committee to be able to deliberate candidly and not feel constrained by the possibility that every aspect of their deliberations will be made public, it is essential that the final report containing the committee’s assessment of the scientific merits of the proposals be made public.

COMPOSITION OF WORK GROUP: The announcement makes an ambitious claim, namely, that this review will be equivalent to an independent NIMH peer review. This desirable standard cannot possibly be met by the DSM-5 Scientific Review Work Group as you have constituted it. The people chosen are all well-respected, but all but two of the committee members have been involved with DSM 5 or its oversight. To have credibility, a review committee must be completely unattached to the work that has already been done on DSM 5. Preferably, APA should contract out the review process to experts in evidence based medicine who would be both fully independent and also able to apply the standards of scientific proof used across all medical specialties. At the very least, the membership of the committee needs to be broadened to guarantee both the reality and the appearance of a truly unbiased and independent review process.

CHARGE: Although labeled a “Scientific Review Work Group”, the charge needs to go beyond just being a scientific review and include a thorough risk/ benefit analysis of all suggestions. That such an analysis is planned in suggested by the statement in the charge that “issues of clinical utility, public health, and potential impact on patients should also be considered.” We applaud this plan to conduct a risk/benefit analysis but are concerned that such a review requires broader experience in primary care, public policy, health economics, and forensics that goes beyond the current composition of the Workgroup. At a minimum, close consultation with such experts should be part of the planned review process.

METHOD: It appears the assessments will be limited to evidence already generated by the work groups, with no check to determine if their reviews have been comprehensive and balanced. Since there was no standard operating procedure in the literature review process, the work group reviews are variable in quality and method. A recheck to ensure that all pertinent references have been included is necessary.

TIMING: This scientific review is occurring unbelievably late in the DSM 5 process- it should have been completed more than a year ago, not after the field trials have already begun. There is little purpose to be doing expensive field testing on proposal likely to be eliminated because of limited scientific support. Every step in the DSM 5 process has missed its deadline, sometimes by a year or more. We are concerned that the momentum of the DSM 5 process and limited time left for its review will result in the rushed inclusion of proposals that are both risky and unsupported by evidence.

All these serious concerns notwithstanding, The DSM 5 Scientific Review Work Group has our very best wishes. It is in a key position to do a great service for our field and for our patients and to save APA from further embarrassment.

Robert Spitzer and Allen Frances

DSM5 in Distress

The DSM’s impact on mental health practice and research.
by Allen Frances, M.D.

DSM 5 Field Trials-Part 1 Missed Deadlines Have Troubling Consequences
DSM 5 is falling far behind its schedule.

Published on November 15, 2010

This is a sad tale of completely unrealistic timetables, poorly executed work effort, consistently missed deadlines, and what will undoubtedly be a rushed and botched DSM 5. It all started at the annual meeting of the American Psychiatric Association in May 2009, when the DSM 5 leadership blithely announced it was ready to begin field testing in the early summer of 2009…

…It was patently obvious from the moment of its announcements that the new DSM 5 field test timetable was also a product of fantasy that would not be met in the real world. First off, it should have been clear that the field trials could not possibly start on time two months after their announcement. Recruiting the sites, training the personnel, gaining human rights approvals, and pilot testing always take at least six months. Predictably, we are already in mid Nov 2010 and it is still not at all clear when the DSM 5 field tests will actually begin to enroll patients at all its sites.

Read full commentary: DSM 5 Field Trials-Part 1 Missed Deadlines Have Troubling Consequences

DSM5 in Distress

The DSM’s impact on mental health practice and research.
by Allen Frances, M.D.

The DSM 5 Field Trials, Part 2: Asking The Wrong Question Will Lead To Irrelevant Answers
A waste of talent, time, and money.

Published on November 23, 2010

…Field tests also fail to account for the pressures that will lead to systematic, future misuse-especially the drug company marketing of mental disorders that leads to over-diagnosis.

…What do I mean? DSM 5 has made a number of radical suggestions for change, particularly the inclusion of many new diagnoses at the threshold of normality. These have the potential to reclassify as mentally disordered tens of millions of people currently considered normal. The only relevant questions are the overall rates of these disorders in the general population and the risks of false negative over-diagnosis.

…At the end of the DSM 5 field trials, we will have no idea whatever whether its suggestions will create false epidemics of misidentified pseudo-patients.

Read full commentary: Part 2: Asking The Wrong Question Will Lead To Irrelevant Answers

ICD-11

Implementation of the WHO’s ICD-11 is scheduled for 2014. Earlier this year, I asked ICD Revision to clarify for stakeholders whether any form of Alpha Draft for ICD-11 will be placed in the public domain, when this will be released and in what formats. 

In October, ICD Revision stated via its Facebook site, that there will be no publication of an ICD-11 Alpha Draft for public scrutiny and that a public Beta Draft is still targeted for May 2011.

ICD-11 targets also slipping 

According to the September iCamp2 meeting PowerPoint presentation, Frequent Criticisms and this iCamp2 YouTube, targets for the population of content for the ICD-11 Alpha Draft had not been reached.   

Less that 80% of Terminology Definitions had been uploaded to the iCAT and less than the 20% target for full Content Model completion for the thousands of diseases and disorders classified within ICD had been met at that point. [The Content Model identifies the basic properties needed to define any ICD concept (unit, entity or category) through the use of multiple parameters.] Not all Topic Advisory Groups were at a similar developmental stage and ICD-11 Beta Plans were behind schedule.   (See Post #48)

International Advisory Group for the Revision of ICD-10 Mental and Behavioural Disorders

The APA participates with the WHO in the International Advisory Group for the Revision of ICD-10 Mental and Behavioural Disorders and the DSM-ICD Harmonization Coordination Group.

The International Advisory Group for the Revision of the ICD-10 Chapter for Mental and Behavioural Disorders (currently ICD-10 Chapter V but will be Chapter 5 in ICD-11) was constituted by the WHO with the primary task of advising the WHO on all steps leading to the revision of the mental and behavioural disorders classification in ICD-10, in line with the overall ICD revision process.

The Group is chaired by Steven E Hyman, MD, Harvard University, Cambridge, Massachusetts. Steven E Hyman, MD is also a member of the APA’s DSM-5 Task Force.

There is already a degree of correspondence between DSM-IV and Chapter V of ICD-10. For the next editions, the APA and the WHO have committed as far as possible:

To facilitate the achievement of the highest possible extent of uniformity and harmonization between ICD-11 mental and behavioural disorders and DSM-V disorders and their diagnostic criteria.

with the objective that

The WHO and APA should make all attempts to ensure that in their core versions, the category names, glossary descriptions and criteria are identical for ICD and DSM.

The Advisory Group has published no Summary Reports of its meetings since its fourth meeting in December 2008. A fifth meeting of the group was held on 28 – 29 September 2009.  Over a year later, no Summary Report has been published for that meeting. It is uncomfirmed whether any meetings of the Advisory Group were held in 2010.

Topic Advisory Group for Neurology

The lead WHO Secretariat for Topic Advisory Group (TAG) for Neurology is Dr Tarun Dua, Management of Mental and Brain Disorders, Department of Mental Health and Substance Abuse, WHO, Geneva.

The TAG for Neurology is chaired by Raad Shakir, MD, Imperial College London. For further information on TAG Neurology see this page.