May 8, 2012 (Philadelphia, Pennsylvania) — Preliminary results are mixed for the recently completed field trials for the upcoming Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), according to the first public presentation of the findings here at the American Psychiatric Association's (APA's) 2012 Annual Meeting.
Diagnostic criteria for autism spectrum disorder, posttraumatic stress disorder (PTSD), and attention-deficit/hyperactivity disorder (ADHD) in children were found to be very reliable.
Conditions that did not do well included major depressive disorder (MDD), in adults and in children, and general anxiety disorder (GAD).
According to Darrel Regier, MD, vice-chair of the DSM-5 task force, the poor scores for MDD may be attributable to "co-travelers," such as PTSD, major cognitive disorder, or even a substance use disorder, which often occur concurrently with depression.
"Patients often don't come in a single, simple diagnosis in clinical practice," Dr. Regier told Medscape Medical News.
"If you have a patient with PTSD and major depression, the one that will probably get the most attention is PTSD. And that's what we found in our study."
He added that analysis of the field trials is ongoing and that the results presented at the meeting are preliminary.
Last Call for Public Comment
Members of the task force said they hope to publish the full results "within a month." However, the third and final public comment period for the manual opened last week and ends on June 15. Although the entire period is 6 weeks long, the public may only have 2 weeks to comment after the publication of the field trials' findings.
Although the entire period is 6 weeks long, the public may only have 2 weeks to comment after the publication of the field trials' findings.
However, according to Dr. Regier, the release of the field trials results has not been seen as linked to the public comment period.
"These preliminary data analyses were to directly inform the Work Groups on the results so that they could consider the reliability of their formulations as well as the clinical utility and feasibility of the proposed changes. Although the general public may be interested in these results, it is more important to have them reviewed by scientific peers before they are entered into the scientific literature," Dr. Regier told Medscape Medical News.
"These will form a part of the basis not only for the current revision but for future revisions as well. The analysis, peer-review, and publication process usually takes quite a bit more time than 2 weeks to a month. We will certainly make these findings available for clinicians, scientists, and the public as soon as possible — possibly online ahead of print if the chosen journal is able to provide this service. What we were able to do at the annual meeting is provide an overview and preliminary presentation of some of the most important findings. However, much more detailed information will be needed for a thorough evaluation of these findings in the peer review and publication process," he added.
From all accounts, the manual is still on track for publication right before next year's APA Annual Meeting in San Francisco.
As reported by Medscape Medical News, the field trials began in the fall of 2010 to test newly recommended diagnostic criteria in both academic and "routine" clinical settings.
A total of 11 academic sites — 7 that focused on adults, 4 that focused on children/adolescents — were involved in the process, which included a baseline assessment by a clinician followed by a second assessment within 2 weeks by a different clinician to test criteria reliability.
In addition, volunteer clinicians, including psychiatrists, psychologists, and social workers from smaller, clinical settings were included. These participants went through initial Web-based training and then selected and evaluated 2 patients each.
A total of 665 children and adolescent patients and 1593 adult patients were included in the field trials.
"No previous field trial had such a sophisticated design. And it has resulted in more statistically significant data for specific disorders," said Dr. Regier
The current DSM-5 field trials, as well as field trials for past manuals, use Kappa score as a statistical measure of criteria reliability. A Kappa score of 1.0 was considered perfect, a score of greater than .8 was considered almost perfect, a score of .6 to .8 was considered good to very good, a score of .4 to .6 was considered moderate, a score of .2 to .4 was considered fair and could be accepted, and a score of less than .2 was considered poor.
At adult sites, schizophrenia was shown to have a pooled Kappa score of .46. However, that is down from the .76 and .81 Kappa scores found in the DSM-IV and DSM-III, respectively, and it is less than the .79 score found in the International Classification of Diseases, Tenth Revision (ICD-10).
"It's important to realize in some ways that the Kappa in the current field trial was from a totally different design. This was a study of the entire random sample population. The ICD-10 was similar to the DSM-III design," said Dr. Regier.
"We really challenged schizophrenia at [the trial sites] because we gave them a set of options that included not only schizophrenia and schizoaffective disorder but also attenuated psychosis syndrome, schizotypal personality disorder, and borderline personality disorder. And they had to choose what the most important diagnosis was. Multiple diagnosis options, different methods, and different patient populations do affect Kappa," he added.
Poor Results for Major Depression, Anxiety
Schizoaffective disorder, which was assessed at only 1 site, had a Kappa score of .50, which is more in line with the .51 found in the ICD-10 and the .54 score found in both the DSM-IV and DSM-III.
Disorders that did very well include the following:
|Disorder||DSM-5 (95% CI)||DSM-IV||ICD-10||DSM-III|
|Major neurocognitive disorder||.78 (.68 - .87)||—||.66||.91|
|ASD||.69 (.58 - .80)||.59 - .85||.77||-.01|
|PTSD||.67 (.59 - .74)||.59||.76||.55*|
|Child ADHD||.61 (.51 - .72)||.59||.85||.50|
|Complex somatic disorder||.60 (.41 - .78)||—||.45||.42|
CI, confidence interval; ASD, autism spectrum disorder; PTSD, posttraumatic stress disorder; ADHD, attention-deficit/hyperactivity disorder
*From the DSM-III-R
"Major neurocognitive disorder in the DSM-III was for any organic mental disorder. They really didn't separate out that category," noted Dr. Regier.
Disorders that did okay include the following:
|BD||.54 (.43 - .65)||—||.69||—|
|Oppositional defiant disorder||.41 (.21 - .61)||.55||—||.66|
BD, bipolar disorder (not studied in DSM-III or DSM-IV field trials)
In addition, mild neurocognitive disorder had a Kappa score of .50 (95% CI, .40 - .60), and mild traumatic brain injury (TBI) had a Kappa score of .46 (.28 - .63).
"I think to make a reliable diagnosis of mild neurocognitive disorder, we're probably going to need to add some neuropsychological testing to distinguish between mild and normal," said Dr. Regier.
Alcohol use disorder had a Kappa score of .40 (95% CI, .27 - .54), which is down from the .71 and .80 Kappa scores found in the ICD-10 and DSM-III, respectively. However, the current field trial involved only 1 test site, which was at a Veterans Affairs hospital in Houston, Texas.
Hoarding had a Kappa score of .59, and binge eating had a Kappa score of .56, but with both disorders, the CIs were very wide (.17 - .83 and .32 - .78, respectively).
Borderline personality disorder, which was newly formulated in the DSM-5 and has been considered one of the most contentious diagnoses, had a Kappa score of .58 (95% CI, .46 - .71). A diagnosis of "any personality disorder" in the DSM-III had a Kappa score of .65, and a diagnosis of "emotionally unstable" in the ICD-10 had a Kappa score of .38.
The diagnosis of child disruptive mood dysregulation disorder was created because of the high number of cases of pediatric bipolar disorder that are being reported, said Dr. Regier.
"We wanted to focus on persistent irritability as opposed to episodic irritability that tends to characterize bipolar disorder. We tested this at several sites, but only 1 had a successful field trial," he reported.
The Kappa score for this disorder at the Children's Hospital in Aurora, Colorado, was .50 (95% CI, .32 - .66).
Disorders that did not do well include the following:
|MDD (in adults)||.32 (.24 - .40)||.59||.53||.80|
|GAD||.20 (.02 - .36)||.65||.30||.72|
In addition, MDD in children had a Kappa score of just .29 (.15 - .42).
Dr. Regier reported that at the Dallas Veterans Affairs Medical Center in Texas, patients often had major depression along with PTSD, antisocial personality disorder, and mild TBI.
"When other diagnoses were present, there tended to be a downplay of the reporting of depression in favor of the disorder considered more serious," he said.
Jan Fawcett, MD, chair of the Mood Disorders Work Group, noted in a separate session that depression comorbidities were not allowed in the DSM-IV field trials.
"It might be that that is the liability of that diagnosis in the real world," he said.
For GAD, we are looking at this condition very carefully. We're recommending some significant changes to its criteria due to its considerable overlap with major depression.
For GAD, "we are looking at this condition very carefully," said Dr. Regier. "We're recommending some significant changes to its criteria due to its considerable overlap with [MDD]."
Disorder diagnoses that were considered unreliable were mixed anxiety/depressive disorder in adults or children (with low Kappa scores ofaround .01 to .06), attenuated psychotic risk syndrome (because of extremely wide CIs), obsessive-compulsive personality disorder, antisocial personality disorder, and nonsuicidal self-injury (because of wide site discrepancies).
Assessing What Went Wrong
Task Force member William Narrow, MD, MPH, also reported on the use of dimensional measures in the field trials, including the examination of so-called "cross-cutting symptoms," which are symptoms that cut across diagnostic boundaries. Examples of cross-cutting symptoms include depression in schizophrenia, sleep problems in anxiety disorders, and anxiety in depression disorders.
As part of this process, a self-rated personality scale and the 36-item World Health Organization Disability Schedule, 2nd version (WHODAS 2.0) were used during the field trials.
Dr. Narrow reported that all of the traits on the personality inventory were reported to be in the "good to excellent" range for adult patients. For children older than 11 years, all domains that were measured were found to be good to excellent except for antagonism, which was found to be in the fair to excellent range.
The WHODAS "performed well with a couple of exceptions," including self-care, which was found to be fair to excellent for adults and poor at 2 child sites.
"Getting around" was found to be poor at 1 child site and fair according to parental report. "Non-school activities" was another measure found to be poor at 1 child site.
In adults, we need to look further at the domains of depression, anger, mania, alcohol use, and repetitive behaviors. In children, we need to look further at anger, mania, psychosis, attention, and suicidal ideation.
"Most cross-cutting symptom assessments did well. But in adults, we need to look further at the domains of depression, anger, mania, alcohol use, and repetitive behaviors. In children, we need to look further at anger, mania, psychosis, attention, and suicidal ideation," said Dr. Narrow.
He reported that ongoing work on the field trials will include assessing "what went wrong" with the poor reliability scores found, with attention given to developing final dimensional measures (including modifying or even dropping domains that performed poorly) and integrating the measures into the DSM-5 diagnostic assessment guidelines.
In addition, all results will be published as quickly as possible, said Dr. Regier. "We will report all that we have. We will be completely transparent."
No Final Decisions Yet
The latest criteria recommendations for the manual were listed on the DSM-5 development Web site on May 2.
During other presentations throughout the annual meeting, Work Group members presented recommendations in detail, including how and why they are different from those in the current DSM-IV. The presenters also reminded attendees that no final decisions have been made yet on any DSM-5 criteria.
During the Q&A period at the end of one of these sessions, an audience member asked whether the task force members are "just categorizing to make sense of the universe," and if clinicians should not just use symptoms or traits to help in diagnosing disorders.
Katherine A. Phillips, MD, chair of the Anxiety, Obsessive-Compulsive Spectrum, Post-Traumatic, and Dissociative Disorders Work Group, noted this was the reason the cross-cutting dimension measures had been added.
The thinking of the DSM-5 task force is that you don't have to choose between categories and dimensions. It's useful to use both. We're always trying to find better definitions and better boundaries. But that's true with the rest of medicine as well.
"Adding traits to personality disorder categories is a step in the right direction. The thinking of the DSM-5 task force is that you don't have to choose between categories and dimensions. It's useful to use both. We're always trying to find better definitions and better boundaries. But that's true with the rest of medicine as well," she said.
Dr. Regier noted that the DSM-5 task force has been in contact with chairs from the upcoming ICD-11 about the 2 organizations' respective proposals.
"We've initiated a series of chair calls with the ICD. And we will discuss any explicit discrepancies between their manual and ours and discuss the evidence. We're trying to avoid any accidental discrepancies. But when evidence is interpreted strongly by one group vs another, that's the only kind of discrepancy we'd like to see between the ICD and DSM approaches," he said.
Good for Science, But What About Patients?
At the end of this presentation, formal comment was provided by discussant Norman Sartorius, MD, PhD, FRCPsych, former president of the World Psychiatric Association and former director of the World Health Organization's Division of Mental Health.
Dr. Sartorius, who is now a professor in Geneva, Switzerland, was also involved with the 7th through 10th versions of the ICD and is an advisor to both the ICD-11 and the DSM-5 work groups.
"There are interesting differences between Eastern psychiatry and Western psychiatry. In much of Eastern Europe and Russia, there is an importance placed on course. That is mentioned in many of the things in the DSM. But the requirement of which course is being used is not, I think, sufficient," said Dr. Sartorius.
"It would be very important to think further how one can divide these diseases and classify them in terms of their long-term course and outcomes. We've seen that this makes a great difference in many situations."
In addition, he noted that the placement of schizoaffective or schizotypal disorders in the category of schizophrenia worries him with regard to stigma.
I know that for science, it's of great use to put conditions that probably belong together in the same group. But whether it's good for patients is another story.
"I know that for science, it's of great use to put conditions that probably belong together in the same group. But whether it's good for patients is another story. For conditions where you're not quite certain where they belong, they should, at least for clinical purposes, retain a certain amount of independence."
Discussions by the task force on duration in bipolar disorder "illustrated once more how arbitrary these decisions are," said Dr. Sartorius.
"We don't really have evidence for any of this; it's all a hypothesis. But difference in duration is often a difference between life and death, literally. It's between pension or no pension, continuing service and no service, between a type of treatment and no treatment. Duration is now becoming a deciding point. It's based upon our best experience, but not really on solid evidence."
Need for Treatment, Reimbursement, FDA Attention
With regard to not-otherwise-specified (NOS) categories, Dr. Sartorius said that these should include conditions that are not classified elsewhere, but that they should not be considered as subthreshold conditions.
"They deserve treatment, reimbursement, and FDA attention," he said.
Interestingly, he noted that PTSD does not have the same stigma in other countries that it has in the United States. In fact, sufferers in other countries often receive lifelong pensions.
"In the Balkans, for example, there are several hundred thousands of people who are receiving this. And they don't want real treatment because if they get better, their money goes away," reported Dr. Sartorius.
"Perhaps this is one instance where a condition would deserve a change in name. It's a little bit of an abnormality to have 'stress-related problems,' because many problems are related to stress."
Finally, he said that he takes exception to the people who have complained about the introduction of changes to the manual just because they do not like change.
"I think that perhaps we should turn the tables. For the next DSM, we should impose a duty on people to explain to us why they want to keep various classifications rather than have new ones. I think that would change the thinking," said Dr. Sartorius.
"Overall, there's been a great amount of work done [by the task force], and I hope that all of it will be published in great detail in a large series of publications. It would be a great pity if it ends only with the DSM. It is a great achievement and of vital importance."
The manual's latest criteria changes and recommendations are listed on the DSM5.org Web site .
The American Psychiatric Association's 2012 Annual Meeting.
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Cite this: DSM-5 Field Trials Generate Mixed Results - Medscape - May 08, 2012.