ajp.psychiatryonline.org Am J Psychiatry 167:10, October 2010
“Field trial sites
will refl ect the
settings in which
DSM is actually
clinicians and pa-
tients from general
atric, and specialty
Moving Toward DSM-5: The Field Trials
The ongoing revision of APA’s Diagnostic and Statistical Manual of Mental Disorders
(DSM) began in 1999 and has a projected completion date of 2013. The longer produc-
tion time for the 5th edition (DSM-5) is one of many changes from earlier DSM revi-
sion processes. For example, special efforts were taken to avoid elitism and confl icts of
interest in the selection of members for the work groups charged with revisiting each
major diagnostic category. DSM-5 will also differ from previous versions by its inclusion
of dimensional measures (1, 2), meant to be sensitive to differences between patients
and to changes within patients. Some dimensional measures are crosscutting to capture
information provided by the patient that is not specifi c to any diagnosis but more gener-
ally useful for assessing mental health. While the work groups conferred in privacy, their
proposals have been widely disseminated through publications, presentations at profes-
sional meetings, and web postings. The fi rst draft of their diagnostic proposals was re-
cently posted, and the resulting public comments are now being considered by the work
groups for further revision of the proposed criteria. The next steps for the criteria are fi eld
trials. These DSM-5 fi eld trials have features that may be of interest to potential users.
A fi eld trial is an evaluation of a product in the context in which it will be used. The
DSM-5 diagnostic criteria are the product to be used as a basis for clinical decision
making and research to benefi t patients with men-
tal disorders. As was true for DSM-IV, the process for
constructing DSM-5 relies on the currently available
scientifi c and clinical evidence for the diagnostic fea-
tures of mental disorders. As occurred for DSM-III
and DSM-IV, fi eld trials are now needed to assess the
clinical utility of the criteria and their reliability when
used by different clinicians, but now additional focus
is on their test-retest reliability over time in the same
patient (precision) and on criterion validity, the extent
to which the application of the criteria matches expert
consensus diagnosis (accuracy).
Earlier fi eld trials were often conducted by the same
groups that developed the proposed criteria. Empha-
sis was on reliability within observers of the same in-
terview. Thus, major sources of diagnostic error, such
as variability in the use of the criteria by different in-
terviewers of the same patient and day-to-day inconsistency of response by the patient,
were not available for the calculation of reliability. Moreover, reliability was sometimes
estimated with patients selected because they demonstrated particular symptoms of
interest and by highly invested clinicians. Now, because a central group has designed
the fi eld tests for all work group diagnoses that involve new or controversial changes,
there will be uniformity in the approach to fi eld trials. Results will be analyzed centrally
and then delivered to the work groups to guide revisions. Field trial sites will refl ect
the heterogeneity of settings in which DSM is actually used, including clinicians and
patients from general medicine, psychiatric, and specialty psychiatric clinics.
Formal Field Trials in Large Clinical Settings
Formal fi eld trials will involve the testing of between two and fi ve specifi c diagnoses
at any one site. The diagnoses tested at a site will depend on their relative frequency
there. For example, major depressive disorder and complex somatic symptom disorder
Am J Psychiatry 167:10, October 2010 ajp.psychiatryonline.org
can be evaluated at a general medical clinic, but autism spectrum disorders require
evaluation in a specialty psychiatric clinic specializing in these disorders.
At each site, a research coordinator, trained and monitored centrally, will record each
successive entry to the clinic over a specifi c time period to provide necessary sampling
weights for that site’s variance in reliability and validity. DSM-IV diagnoses obtained for
clinical purposes at each site will be used to place each consenting patient into either
a stratum likely to be rich in a target diagnosis at that clinic or a stratum consisting of a
random sample of all other diagnoses. The goal is to recruit 50 patients per stratum per
site, a total of 150 to 300 patients for each diagnosis under evaluation, to have adequate
power for a site-specifi c determination of precision. Two DSM-5-trained clinicians who
are new to the patient will be assigned to conduct independent clinical interviews of
the same patient at least 4 hours, but not more than 2 weeks, apart. The attending cli-
nician will be able to observe the interviews. The interviewing clinicians will know the
target diagnoses at that site but will be blinded to the stratum to which each patient is
assigned and to the attending clinician’s diagnosis. The interviewing clinician at each
session will be provided the patient’s current crosscutting assessments, conduct a clini-
cal interview with the patient, make one or more categorical diagnoses using DSM-5
criteria, and complete associated dimensional severity ratings.
A random 20% of the interviews will be videotaped. The videotapes will be viewed by
the work group responsible for the proposed diagnosis to provide an expert consen-
sus or criterion diagnosis against which the criterion validity of the two diagnoses per
patient will be assessed. The videotaped interviews may also be used to assess interob-
The measure of reliability for each diagnosis at each site is the intraclass kappa coef-
fi cient, a measure of how well a fi rst diagnosis predicts a second independent one (3).
The measure of validity is Cohen’s kappa, which measures how well a diagnosis predicts
the criterion (3). The homogeneity of kappas across sites will be tested. Where there is
no strong indication of heterogeneity, kappas will be pooled across sites. The validity
estimate, based on 20% of the sample, will not be site specifi c. Confi dence intervals will
be provided for all estimations.
When the fi eld trial results are transmitted to the appropriate work groups, they will
have access to the accumulated data to address specifi c questions that might help their
understanding of the results as a basis of any necessary revision. If necessary, there will
be a second round of fi eld trials to assess substantially revised criteria.
Clinical Practice Field Trials
Many clinicians and patients for whom DSM-5 is intended are not in settings at
which formal reliability and validity testing is possible (4). To include such clinicians
in the fi eld trials, a representative sample of U.S. psychiatrists and other volunteer psy-
chiatrists, psychologists, social workers, and psychiatric nurses will be trained. Each
will be instructed how to select one new and one ongoing patient in their practice for
study enrollment to form a representative sample of U.S. patients. Clinicians will apply
DSM-5 diagnostic criteria to this sample and assess feasibility and clinical utility by
using the same assessments used in the fi eld trials in large clinical settings.
The purpose of successive DSM revisions is to incorporate the growing knowledge
base about mental disorders into diagnosis and to bring diagnostic criteria ever closer
to accurate and precise identifi cation of corresponding disorders (5). However, this goal
must be accomplished while maintaining the clinical utility of the diagnostic criteria for
purposes of ready, reliable, and valid use by both clinicians and researchers for preven-
tion, early identifi cation, and treatment. Field trials are the fi rst real-world, empirical
test of the success of these efforts in clinical settings.
1160 ajp.psychiatryonline.org Am J Psychiatry 167:10, October 2010
1. Helzer JE, Kraemer HC, Krueger RF, Wittchen H-U, Sirovatka PJ, Regier DA (eds): Dimensional Approaches in
Diagnostic Classifi cation: Refi ning the Research Agenda for DSM-V. Arlington, Va, American Psychiatric As-
2. Regier DA, Narrow WE, Kuhl EA, Kupfer DJ: The conceptual development of DSM-V. Am J Psychiatry 2009;
3. Kraemer HC, Periyakoil VS, Noda A: Tutorial in biostatistics: kappa coeffi cients in medical research. Stat Med
4. West JC, Wilk JE, Olfson M, Rae DS, Marcus S, Narrow WE, Pincus HA, Regier DA: Patterns and quality of
treatment for patients with schizophrenia in routine psychiatric practice. Psychiatr Serv 2005; 56:283–291
5. Kupfer DJ, Thase ME: Laboratory studies and validity of psychiatric diagnosis: has there been progress?
In The Validity of Psychiatric Diagnosis. Edited by Robbins LN, Barrett JE. New York, Raven Press, 1989,
HELENA CHMURA KRAEMER, PH.D.
DAVID J. KUPFER, M.D.
WILLIAM E. NARROW, M.D., M.P.H.
DIANA E. CLARKE, PH.D.
DARREL A. REGIER, M.D., M.P.H.
Address correspondence and reprint requests to Dr. Kupfer, Western Psychiatric Institute and Clinic, University
of Pittsburgh School of Medicine, 3811 O’Hara St., Pittsburgh, PA 15213; email@example.com (e-mail). Com-
mentary accepted for publication July 2010 (doi: 10.1176/appi.ajp.2010.10070962).
Dr. Regier is Executive Director of the American Psychiatric Institute for Research and Education (APIRE) and
oversees all federal and industry-sponsored research and research training grants in APIRE but receives no ex-
ternal salary funding or honoraria from any government or industry sources. Dr. Freedman has reviewed this
editorial and found no evidence of infl uence from these relationships. All other authors report no fi nancial
relationships with commercial interests.