Field Trial Results Guide DSM Recommendations
by David J. Kupfer, M.D.
Written with Helena C. Kraemer, Ph.D.
Two years ago this month, APA announced the start of field trials that would subject proposed diagnostic criteria for the future DSM-5 to rigorous, empirically sound evaluation across diverse clinical settings. And now, as the first comprehensive analyses of that effort are published, what’s clear is just how well the field trials did their job…
For the majority of disorders, the reliability of their criteria was as good as, if not better than, that of medical diagnosis in general – results that reflected the extraordinary work done throughout the lengthy DSM-5 development process. Yet while the strong findings were welcome validation, the less positive findings were equally instructive. We’ll focus on examples of both.Fourteen diagnoses ranked in the top categories of "good" or "very good" reliability, among them criteria for schizophrenia, attention-deficit/hyperactivity disorder, and post-traumatic stress disorder, as well as for new entries such as somatic symptom disorder and autism spectrum disorder. The results for the latter were gratifying given the concerns of advocates and parents that many children could be adversely affected, and we hope they now feel reassured. On the other side of the line were three diagnoses that fell into the category of "unacceptable" reliability; each has since undergone substantial revision or is no longer proposed for inclusion. That leaves six additional diagnoses, which finished with acceptable but low reliability. Several already have been revised or, in the case of attenuated psychosis syndrome, recommended to be moved to the section of the manual that stipulates further study is needed.Still, some DSM-5 detractors have spotlighted the six as indicative of flaws in the field trials, especially because this group included major depressive disorder and generalized anxiety disorder, two of the most commonly diagnosed conditions. The opposite is closer to the truth. Rather than discrediting the field trials, the outcome here reveals the critical value of how the trials were constructed and conducted and how we are moving forward. Ironically, both major depressive disorder and generalized anxiety disorder were tested not because they were being modified for the next manual, but because they were remaining relatively unchanged and could serve as reference disorders from the DSM-IV trials. But as part of that process two decades ago, patients were carefully screened, and participating clinicians received special training and explicit direction on how to perform evaluations. In contrast, the DSM-5 field trials accepted patients as they came and asked clinicians to work as they usually did – to mirror the circumstances in which most diagnosing takes place.
We believe the DSM-5 results represent the truer picture of the difficulty clinicians may have in reliably diagnosing both conditions, either because they often occur with other conditions or because they are accompanied by symptoms that can fluctuate greatly. Regardless of why, we acknowledge that the relatively low reliability of major depressive disorder and generalized anxiety disorder is a concern for clinical decision-making. Strategies need to be developed to address the problem as the manual evolves into a living document that incorporates revisions and additions as research and clinical practices advance. The good news is that we’re now inherently better prepared for this challenge; the DSM-5 field trials have laid the groundwork for how such strategies and future changes should be judged…When the next manual is presented in December for the APA Board of Trustees review, thanks to the field trials, it will be ready.
The seeds for the DSM-5 were planted at the time when they thought they could abandon the non-etiologic descriptive paradigm and finally realize the dream from St. Louis, a neuroscience based diagnostic system with real biomarkers just like the rest of medicine – a paradigm shift. The foundation for this neurobiological base was laid, but sometimes if you build it, it doesn’t come – and this was such a time. They were left with an unrevised DSM-IV and some quirky idiosyncratic add-ons like the Psychosis Risk Syndrome. When their predecessors and later throngs of other critics cried foul, their response varied between demeaning and placating, but lacked signs of genuine engagement and they barreled ahead. The Field Trials demonstrated both the non-viability of the add-ons and their failure to seriously engage the existing problems like MDD and GAD. The comments above go beyond rationalization into the realm of some real nose-growing b.s. And what do their dismal kappas say to the FDA or the Third Party carriers who use these central diagnostic categories for billion dollar decisions? Both essentially flunked reliability 101 in the Field Trials – a prerequisite for the very existence of the DSM 1980+ in the first place.