DSM-5 Field Trials Begin: Proposed Diagnostic Criteria Put to the Test

Deborah Brauser

October 19, 2010

October 19, 2010 — The American Psychiatric Association (APA) has announced that standardized field trials have now started in preparation for the upcoming fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

The trials were created to assess the practical use of proposed DSM-5 diagnostic criteria in real-world clinical settings before the manual is published in 2013.

Dr. David Kupfer

"The process for developing DSM-5 continues to be deliberative, thoughtful, and inclusive," said Darrel Regier, MD, MPH, vice chair of the DSM-5 Task Force and APA research director, in a release.

"Large-scale field trials are the next critical phase in this important process and will give us the information we need to ensure the diagnostic criteria are both useful and accurate," he added.

More than 8000 comments by clinicians, researchers, and advocates submitted on the DSM-5 Website regarding the draft criteria were reviewed by the DSM-5 Work Groups. The new field trials will reflect criteria adjustments based on these comments — and will have 2 separate study designs, depending on type of clinical setting.

Although all field trial clinicians will assess new and existing patients at different stages of treatment using the proposed DSM-5 diagnostic criteria and measures, academic and other large clinical settings will use one design, whereas individual practitioners and smaller clinical practices will follow the other.

"It is important that the proposed criteria are subjected to rigorous and empirically sound field trials," David Kupfer, MD, chair of the DSM-5 Task Force, said in the same release. "The 2 field trial designs will allow us to better understand how the proposed revisions affect clinicians' practices and, most importantly, patient care."

11 Large Centers

Of approximately 60 academic or large centers that responded to the APA's call for proposal, 11 pediatric and adult sites were selected. These include the following:

  • Baystate Medical Center in Springfield, Massachusetts;

  • Child Psychiatry Division, Columbia University/New York State Psychiatric Institute in New York City;

  • Lucile Packard Children's Hospital at Stanford University in Palo Alto, California;

  • The Children's Hospital in Aurora, Colorado;

  • Centre for Addiction and Mental Health in Toronto, Ontario, Canada;

  • Dallas Veterans Affairs Medical Center in Texas;

  • DeBakey Veterans Affairs Medical Center and Menniger Clinic, Baylor College of Medicine in Houston, Texas;

  • Mayo Clinic in Rochester, Minnesota;

  • University of California, Los Angeles;

  • University of Pennsylvania in Philadelphia; and

  • University of Texas Health Science Center in San Antonio

Field trial patient evaluations in these settings will start with a baseline assessment by a clinician followed by a second assessment 4 hours to 2 weeks later by a different clinicianto test the reliability of the proposed diagnostic criteria. At 4- to 12-week follow-up, the assessment will be repeated.

Clinicians in these larger settings will also be allowed to conduct videotaped evaluations for a small subset of patients.

In an article published in the October 15 issue of Psychiatric News, Dr. Kupfer writes that it is important that draft criteria are examined in sizable, diverse populations.

"These large settings provide an ideal backdrop for recruiting high volumes of psychiatric patients who represent a wide array of characteristics, including various ages, cultures and ethnicities, socioeconomic backgrounds, and potential diagnoses," he adds.

It is estimated that 2500 to 3000 patients will be recruited to participate in this setting.

Smaller Settings

A total of 3900 mental health professionals, including 1400 psychiatrists from a randomly selected sample of those registered with the American Medical Association Masterfile and 2500 volunteer clinicians (including psychiatrists, psychologists, social workers, and nurses), will participate in the field trials scheduled to be conducted in smaller, routine clinical settings.

Recruitment for these smaller settings will continue through October and November. Those selected will need to complete Web-based training before participating and will then recruit and evaluate 2 patients each.

"Having practitioners, such as solo clinicians and those in independent group practices, test proposed revisions is important for examining DSM-5 in the context of its everyday use," writes Dr. Kupfer.

The main difference between the 2 study designs is that the routine clinical settings will use just 2 evaluation visits for patients compared with 3 for the larger institutions.

"Although the use of 2 field-trial designs increases the complexity of this project, the tradeoff is a more precise understanding of how the future of psychiatric diagnosis might impact patients and clinicians," Dr. Kupfer adds.

Evaluation Measures

The DSM-5 Task Force reports that results from all field trials will address several important measures regarding the diagnostic criteria, including the following:

  • Feasibility: are the proposed criteria easy for clinicians to understand and use?

  • Clinical utility: do they help in describing psychiatric problems and in making treatment plan decisions?

  • Validity: how accurate are they in reflecting the mental disorders they are designed to describe? and

  • Reliability: are the same conclusions reached when the criteria are used by different doctors?

Severity measures, through the use of questionnaires and other tools to help assess patient symptom severity on a rating scale, will also be examined during the field trials, as will "cross-cutting dimensional measures." These are tools for "assessing symptoms that occur across a wide range of diagnoses, such as anxiety or sleep problems."

This first phase of field trials is scheduled to run through the end of March 2011, after which the results will be presented in scientific meeting presentations and in articles in scientific journals and DSM-5 source books.

After these initial field trials, another period of public comments through the DSM-5 Website, and more draft criteria adjustments by the Work Groups, a second set of field trials is scheduled to take place later in 2011 and in 2012.

More information on the proposed DSM-5 draft criteria and field trials is available at the APA's Website. Psychiatrists interested in participation can also register at the site.

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