26%

1. Construct validity and clinical utility of current research criteria of DSM-5
somatic symptom disorder diagnosis in patients with
fibromyalgia syndrome
Winfried Häuser a,b,
⁎, Patric Bialas c
, Katja Welsch c
, Frederick Wolfe d,e
a
Ambulatory Health Care Center Pain Medicine Saarbrücken — St. Johann, Saarbrücken, Germany
b
Department Psychosomatic Medicine and Psychotherapy, Technische Universität München, München, Germany
c
Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany
d
National Data Bank for Rheumatic Diseases, Wichita, KS, United States
e
University of Kansas School of Medicine, Wichita, KS, United States
a b s t r a c ta r t i c l e i n f o
Article history:
Received 28 January 2015
Received in revised form 22 March 2015
Accepted 23 March 2015
Available online xxxx
Keywords:
fibromyalgia syndrome
somatic symptom disorder
validity
clinical utility
anxiety
depression
Objective: The validity and clinical utility of current research criteria of the DSM 5 category somatic symptom dis-
order (SSD) needs to be tested outside the setting of psychiatry.
Methods: Consecutive patients with an established diagnosis of fibromyalgia syndrome (FMS) were evaluated by
medical examination, psychiatric interview and self-report questionnaires in an outpatient pain medicine center.
The diagnosis of SSD was established using published research criteria. The discriminative concurrent criterion
validity of SSD was tested by comparing FMS-patients with and without SSD as to the amount of impairment
and of health care seeking. Two clinicians blinded as to the purpose of the study, assessed the medical reports
of patients after the evaluation for the determination of the need for psychotherapy based on the German
FMS — guideline recommendations (clinical utility).
Results: 25.6% of 156 patients met the criteria of SSD. Patients meeting SSD criteria scored significantly higher in a
self-report measure of disability. There were no significant differences in the number of patients on sick leave or
applying for disability pension and in self-reported doctor visits and physiotherapy in the previous six months.
95.0% of patients with SSD and 71.6% of patients without SSD met the criteria of a current anxiety or depressive
disorder as assessed by the psychiatric interview. 80.0% of patients with SSD and 66.7% of patients without SSD
received a recommendation for psychotherapy.
Conclusions: The construct validity and clinical utility of current research criteria of DSM 5 category SSD were
limited in German patients with FMS.
© 2015 Elsevier Inc. All rights reserved.
Introduction
One of the most important changes in the Diagnostic and Statistical
Manual of Mental Disorders (DSM) 5 [1] involved a reconceptualization
of the somatoform disorders and the creation of a newly defined
disorder, the somatic symptom disorder (SSD) [2]. SSD replaced the
former DSM 4 diagnoses of somatization disorder, undifferentiated
somatoform disorder and pain disorder. The diagnosis of SSD may be
made when there are persistent (i.e., typically longer than six months)
somatic symptoms that are distressing and/or significantly disrupt
daily life (criteria A and C) that are accompanied by excessive and
disproportionate symptom-related thoughts, feelings, and behaviors
regarding these symptoms (criteria B) [1]. The DSM 5 SSD workgroup
postulated that clinicians should diagnose and treat SSD because suc-
cessful treatment options (psychotherapy, psychotropic drugs) are
available [2].
Early US studies provided evidence concerning feasibility [3], reli-
ability [4], validity [5–7] and clinical utility [5,7,3] of the SSD diagnostic
category. A gold standard method of diagnosis, a structured interview of
the SSD criteria, does not yet exist. Preliminary research criteria have
been developed by recent studies [5–7]. These validation studies were
conducted in psychiatry or psychosomatic medicine centers with pa-
tients who were previously diagnosed with somatoform disorders
[5–7]. Developers of the SSD category stressed the necessity of further
studies on the validity and clinical utility of SSD diagnosis when applied
in other settings [2], e.g., internal or pain medicine.
The diagnosis of somatoform disorders was rarely used by non-
psychiatrists [8]. Somatic symptoms that suggested a general medical
condition and were not fully explained by a general medical condition,
Journal of Psychosomatic Research xxx (2015) xxx–xxx
⁎ Corresponding author at: Ambulatory Health Care Center Pain Medicine
Saarbrücken — St. Johann, Saarbrücken, Germany.
E-mail address: whaeuser@klinkum-saarbruecken.de (W. Häuser).
PSR-09000; No of Pages 7
http://dx.doi.org/10.1016/j.jpsychores.2015.03.151
0022-3999/© 2015 Elsevier Inc. All rights reserved.
Contents lists available at ScienceDirect
Journal of Psychosomatic Research
Please cite this article as: Häuser W, et al, Construct validity and clinical utility of current research criteria of DSM-5 somatic symptom disorder
diagnosis in patients with ..., J Psychosom Res (2015), http://dx.doi.org/10.1016/j.jpsychores.2015.03.151

2. by the direct effects of a substance, or by another mental disorder, are
usually considered by non-psychiatrists to be functional disorders and
functional somatic syndromes (FSSs) respectively [9]. Whether FSS
such as irritable bowel syndrome or fibromyalgia syndrome (FMS)
should be diagnosed as a somatoform disorder, in accordance with
DSM 4, has been a matter of debate [10,11]. Not surprisingly, a discus-
sion started on the application of the SSD diagnostic category to
FSS [12]. .
Given the uncertainties on the prevalence of SSD in FSS and the va-
lidity and usefulness of SSD diagnosis in patients with FSS, we assessed
how many patients diagnosed with FMS in a pain medicine setting met
the current research criteria of a SSD. Furthermore we tested the con-
struct validity and clinical utility of current research criteria of SSD in
these patients.
Methods
Setting
All examinations and interviews with the patients were conducted
by the first author (WH) in an outpatient ambulatory health care center
(secondary care level) for pain medicine. Patients were referred by
rheumatologists or general practitioners or made an appointment by
their own.
Patients
All consecutive patients who presented to the first author from
January 2, 2013 to December 31, 2014, for the evaluation and/or
management of chronic widespread pain/FMS were screened for eligi-
bility for the study. The inclusion criteria were as follows: 1. Medical
testing according to the German guideline on FMS [13] to exclude
somatic diseases fully explaining the symptoms was performed.
Patients with somatic diseases which could explain a part of pain sites
(e.g., osteoarthritis) were included. 2. Patients were designated as
having criteria positive fibromyalgia if they satisfied research criteria
for fibromyalgia [14,15]. 3. Patients were informed either by physicians
and/or by information seeking by their own that FMS is a) a disease
with a normal life expectancy and b) not a progressive illness
that leads to inability to function (e.g., to need a wheel chair). The
exclusion criteria were as follows: 1. Patients with a duration of
FMS-diagnosis b6 months, 2. Patients with concomitant FMS in
inflammatory rheumatic diseases under immunosuppressive treatment
(e.g., biologicals, corticosteroids, methotrexate). To our clinical experi-
ence, FMS-related fears of these patients cannot be disentangled from
fears regarding the course of the inflammatory rheumatic disease and/
or side effects of immunosuppressive therapies, 3. Patients in which
FMS was diagnosed for the first time by the author or which had not
been informed on the normal life expectancy and lack of progress to in-
ability to function in FMS. The German guideline on the management of
FMS recommends as a first of therapy after establishing the diagnosis of
FMS for the first time, that patients should be educated on these issues
to reduce potential symptom-related anxieties [13], and 4. Patients who
were unable to properly complete the questionnaires due to language
or intellectual barriers.
A battery of questionnaires was used by the first author for routine
clinical assessment. The questionnaires were sent to the patient before
the first appointment for completion at home. During the first appoint-
ment the results of the questionnaires were discussed with the patients
and additional questions, e.g., on longer symptom duration than indi-
cated in the self-report questionnaires were asked. The completed ques-
tionnaires were kept apart from medical charts in a separate room only
accessible to the first author. In addition, at the first appointment
patients were required to present records of medical diagnostic and
treatment relating to their symptoms.
Measures
Polysymptomatic distress scale (PSD)
The Widespread Pain Index (WPI) is a 0–19 count of painful body re-
gions. The Symptom Severity Score (SSS) is the sum of the severity
(0–3) of the three symptoms (fatigue, waking unrefreshed, cognitive
symptoms) plus the sum of the number of the following symptoms oc-
curring during the previous six months: headaches, abdominal pain,
and depression (0 = no, 1 = yes). The final score is between 0 and
12. For fatigue, waking unrefreshed, and cognitive problems, scoring is
0 No problem; 1 Slight or mild problems, generally mild or intermittent;
2 Moderate, considerable problems, often present and/or at a moderate
level; and 3 Severe: continuous, life-disturbing problems. The 0–19
widespread pain index and the 0–12 symptom severity score can be
combined by addition into a 0–31 PSD index. The PSD scale is a measure
of the intensity of FMS symptoms and correlates with all general mea-
sures of distress [14].
Patient Health Questionnaire-15
We used the Patient Health Questionnaire (PHQ) as a measure of so-
matic symptom burden [16] and as a generic measure of FMS severity
[17] with scores of 5, 10, and 15 representing cutoff points for low,
medium, and high somatic symptom (FMS) severity, respectively. We
used the validated German version of the PHQ 15 [18].
Patient Health Questionnaire-4
The 4-item Patient Health Questionnaire-4 (PHQ-4) comprises two
DSM-IV criteria of major depression as “0” (not at all) to “3” (nearly
every day) and two DSM-IV criteria of general anxiety disorder [19].
The total score of the PHQ- 4 (Minimum 0, Maximum 12) is a validated
measure of psychological distress [20]. We used the validated German
version of the PHQ-4 [20].
Whiteley Index
The Whiteley Index (WI) is a widely used instrument for measuring
hypochondriacal worries and beliefs. Fourteen questions can be an-
swered in a dichotomic format (yes/no) [21]. We used the validated
German version of the WI [22].
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) includes 13 items. Participants
are asked to indicate on a 5-point Likert scale the degree to which they
experience various thoughts and feelings on a painful experience. The
total score, indicating the degree of pain catastrophizing, ranges from
0–42. There are no validated cut-off scores of the PCS available neither
for chronic pain patients as a whole nor for fibromyalgia patients as a
subgroup. The authors of the PCS suggest that a total PCS score of 30 rep-
resents clinically relevant level of catastrophizing. In addition we de-
fined an additional cut-off score by the 75th percentile of the study
sample. The reliability and validity of the PCS have been demonstrated
in samples of clinical institutions and of the general population [23,
24]. We used the validated German version of the PCS [25].
Pain Disability Index
The Pain Disability Index (PDI) measures impairment by pain in
seven areas of daily living (family/home responsibilities, recreation, so-
cial activities, occupation sexual behavior, self-care, life-support activi-
ty) on an 11 point Likert scale. The total score of the PDI ranges from
0–70. Psychometric evaluations of the PDI in outpatients and inpatients
with chronic pain found high internal consistency, test–retest reliability
and good convergent validity in reference to pain characteristics
and pain behavior [26]. The validated German version of the PDI was
used [27].
2 W. Häuser et al. / Journal of Psychosomatic Research xxx (2015) xxx–xxx
Please cite this article as: Häuser W, et al, Construct validity and clinical utility of current research criteria of DSM-5 somatic symptom disorder
diagnosis in patients with ..., J Psychosom Res (2015), http://dx.doi.org/10.1016/j.jpsychores.2015.03.151

3. Demographic measures and health care use
The German Pain Questionnaire assesses data on demographics,
employment and disability (e.g., applying for disability pension),
pain, chronic somatic diseases, previous and current treatment of pain
and other diseases and health care seeking (number of doctor visits
within the last 6 months, number of physiotherapies during the last
6 months, number of doctors consulted because of chronic pain prob-
lems and number of hospital stays because of chronic pain problems)
[28]. The answers of the patients in the questionnaire were verified by
the interview and by the medical reports presented by the patient
and – if necessary – modified.
Structured psychiatric interview
Patients underwent a structured psychiatric interview for current
anxiety (including posttraumatic stress disorder [PTSD]) (ICD 10 F 40,
F 41, F 43.1) and depressive (ICD-10 F 32, F33, F 34) disorder using
the International Classification of the World Health Organization check-
list [29]. In addition, patients were asked to report any lifetime in- and
out-patient psychiatric and psychotherapeutic treatments. At least
three appointments with a psychiatrist with at least one prescription
of a psychotropic drug were required to define a psychiatric treatment
within the assessment of health care use. At least five sessions with a li-
censed psychotherapist were required to define a psychotherapeutic
treatment within the assessment of health care use.
Diagnoses of FMS and SSD
For patients to be diagnosed with FMS they had to have either a WPI
score ≥7 and SSS ≥5, or a WPI between 3–6 and SSS ≥9 (research
criteria of FMS) [15,16].
We referred to diagnostic criteria for DSM-5 diagnosis of SSD of
previous studies [5,7]:
a. For criterion A (distressing somatic symptom), patients had to re-
port to be bothered a lot by at least one symptom of the PHQ-15.
For each symptom reported in the PHQ-15, patients were addition-
ally asked if this symptom had been present during the last six
months, on at least half of the days, to assess criterion
b. We employed the WI [21,22] to measure criterion B2 (persistently
high level of anxiety about health or symptoms) by choosing a cut-
off score of 8. We did not use the cut-off score of 6 as previous
studies did [5,7] because two items of the WI, namely to be bothered
“by many different pains and aches” and “by many different symp-
toms” are diagnostic features of FMS [15]. To provide comparability
with previous studies, we report the prevalence rates of SSD using a
WI cut-off score of 6 too.
Recommendation for psychotherapy
Two specialists in pain medicine (one anesthesiologist [PB] and one
psychologist [KW]) experienced in the management of FMS-patients
were blinded to the purpose of the study. They checked independently
the anonymous medical reports wrote by the first author (WH) after the
first appointment. The medical report included the ICD10-diagnoses of
the patient, the medical and psychiatric history of the patients, the cur-
rent somatic and psychological symptoms, the ways of coping with the
symptoms by the patient, the impact of symptoms on daily life and the
results of previous medical and psychological treatments. The recom-
mendations for further management by the first author were removed
from the medical report. The two raters were blinded if the patients
met the criteria of a SSD. Based on the data of the medical report, the
raters assessed if they would recommend to start a psychotherapeutic
treatment to the patient or to continue an ongoing psychotherapeutic
treatment. The recommendations for psychotherapy were based on
the German guideline on the management of FMS which recommends
psychotherapy in the following clinical constellations: a) maladaptive
disease management (e.g., catastrophizing, inappropriate physical
avoidance behavior or dysfunctional perseverance) b) and/or relevant
modulation of the symptoms due to stress of daily life and/or interper-
sonal problems and/or c) comorbid mental disorders with negative im-
pact on FMS-symptoms and coping [30]. Discrepancies in the ratings
were resolved by consensus between the two raters, and if necessary
by the first author.
Hypotheses
Discriminative concurrent criterion validity
The DSM 5 working group on SSD postulated that the combination of
distressing somatic symptoms (A-criterion) and B-type criteria are as-
sociated with functional impairment and increased healthcare use [2].
Therefore we tested if FMS-patients meeting the SSD research criterion
reported higher levels of disability, sick leave and applying for disability
pension (if not housemaker or pensioner) and exhibited more health
care seeking than FMS-patients not meeting current SSD research
criteria.
Clinical utility
The DSM 5 working group on SSD postulated that the diagnosis of
SSD promotes the recommendations of psychological therapies [2].
Therefore we tested if FMS-patients meeting current SSD research
criteria received more recommendations for psychotherapeutic treat-
ment than FMS-patients not meeting the SSD research criteria by the
two blinded assessors.
Statistical analysis
All questionnaires were discussed with the patients and missing
items completed during the first appointment.
Statistical analyses were conducted with the SPSS 20.0 statistical
package. Absolute values and percentages were used for descriptive
statistics of categorical data and means with standard deviations for de-
scriptive statistics of continuous data. Group comparisons of categorical
data were performed by Chi2
-tests and of continuous data by the t-test.
Cohen's Kappa was used as a measure of interrater reliability. P-values
are reported unadjusted for multiple testing in the tables, permitting
the application of preferred methods of adjustment by the readers.
Twenty-five % of 375 patients of a German FMS multicentre study
applied for disability pension [31]. For our study, 54 patients per
group would be necessary to detect a difference of 25% in applying for
disability pension with 80% power and a 1-sided alpha level of 0.05.
Ethics
All participants were informed about the study procedures and gave
their informed consent. The study was reviewed and approved by the
institutional ethics review board of the Medical Faculty of the Ludwig-
Maximilian-University Munich (Project-Number 010-12). There was
no external funding for the study.
Results
Study sample
Of the 198 patients screened for eligibility, 42 were excluded due to exclusion criteria
(see Fig. 1). One hundred and fifty six patients were included into analyses. All patients
were Caucasians.
Prevalence of diagnoses of SSD
176 (99.4%) of patients reported to be bothered a lot by at least one of fifteen somatic
symptoms in the PHQ 15 (A-criterion). 46.8%, 33.3%, 25.6%, 13.5% and 6.4% respectively of
patients reached the WI cut-off scores of 6, 7, 8, 9 and ≥10.
3W. Häuser et al. / Journal of Psychosomatic Research xxx (2015) xxx–xxx
Please cite this article as: Häuser W, et al, Construct validity and clinical utility of current research criteria of DSM-5 somatic symptom disorder
diagnosis in patients with ..., J Psychosom Res (2015), http://dx.doi.org/10.1016/j.jpsychores.2015.03.151

4. 40 (25.6%) patients of the study sample met the predefined criteria of SSD (at least
one distressing symptom in the PHQ 15 and WI score ≥8).
Comparisons of patients with and without meeting SSD criteria
There were no significant differences between the two groups in demographic vari-
ables (age, gender, family status, highest educational level, current professional status)
(see Table 1).
The percentage of patients without job or sick leave (pensioners and homemakers
excluded) did not significantly differ between both groups (Chi2
= 0.1, P = .72). The
percentage of patients applying for disability pension (pensioners and homemakers
excluded) did not significantly differ between both groups (see Table 1).
There were no significant differences between the two groups in the duration of wide-
spread pain and time since FMS-diagnosis. Patients meeting SSD-criteria reported signifi-
cantly more symptoms in the PSD and PHQ 15, more psychological distress in the PHQ 4
and more pain catastrophizing in the PCS than patients not meeting SSD-criteria. Patients
meeting SSD-criteria reported significantly higher levels of disability in the PDI
(see Table 2).
Patients meeting SSD-criteria met significantly more frequently the criteria of a prob-
able current depressive or anxiety disorder by the PHQ 4. Patients meeting SSD-criteria
met significantly more frequently the criteria of current depressive disorder but not of a
current anxiety disorder in the psychiatric interview (see Table 3)
Patients meeting SSD-criteria did not report more doctor visits and physiotherapy
treatments in the previous six months. There were no significant differences between
the two groups in the frequency of previous in- and outpatient pain therapy, of previous
inpatient rehabilitation because of chronic pain and of previous in- and out-patient psy-
chotherapy due to any reason during lifetime. Patients meeting SSD-criteria reported
less current outpatient psychiatric treatment due to any reason than patients not meeting
SSD-criteria (see Table 4).
Cohen's kappa of the ratings for recommendation of psychotherapy was 0.64. 32/40
(80.0%) of patients with SSD and 64/116 (66.7%) of patients without SSD received a con-
sensus recommendation for psychotherapy (Chi2
= 7.8; P = .005).
Discussion
Summary of main results
25% of 156 German patients diagnosed with FMS met current re-
search criteria of a SSD (at least one very distressing somatic symptom
and persistently high level of anxiety about health symptoms). Patients
meeting SSD criteria scored significantly higher in a self-report measure
of disability. There were no significant differences in the number of pa-
tients on sick leave or applying for disability pension and in self-
reported doctor visits and physiotherapies in the previous six months.
Patients with SSD received more frequently a recommendation for
psychotherapy.
Characteristics of the study sample
The demographic data of the study sample with a preponderance of
middle aged women, the high percentage of patients with sick leave
and/or applying for disability pension are in line with the ones reported
by previous German FMS multicenter studies [31,32] as well as of re-
views of international studies [33]. The prevalence rates of (probable)
mental disorders of the study sample is similar to the ones we found
Assessed for eligibility
(n = 198)
Excluded (n=42)
Not meeting inclusion criteria
(n =42)
- First diagnosis of FMS (n=26)
- FMS diagnosis < 6 months
(n=9)
- No adequate education (n=2)
- Inflammatory rheumatic
disease with immuno-
suppressive medication (n=4)
- Language barrier (n=1)
Refused to participate
(n =0)
Other reasons (n =0)
EnrollmentAnalysis
Analyzed (n =156)
Excluded from analysis
(n =0)
Fig. 1. Study flow chart.
Table 1
Comparison of demographic and clinical variables of fibromyalgia syndrome patients with
and without meeting DSM 5 current research criteria of somatic symptom disorder.
Somatic
symptom
disorder
N = 40
No somatic
symptom
disorder
N = 116
Comparison;
P-value
Mean age (mean, SD) 51.6 (8.9) 49.8 (9.6) t = 0.94; .34
Female gender; N (%) 34 (85.0) 105 (90.5) Chi2
= 0.9; .33
Living with family/partner; N (%) 33 (82.5) 82 (71.3) Chi2
= 1.9; .16
Highest educational level Chi2
= 4.2; .38
None N (%) 0 (0) 4 (3.4)
Primary school N (%) 20 (50.0) 51 (44.0)
Secondary school N (%) 12 (30.0) 41 (35.3)
High school N (%) 2 (5.0) 11 (9.5)
University N (%) 6 (15.0) 9 (7.8)
Current professional status Chi2
= 7.0; .22
Working N (%) 12 (30.0) 45 (38.8)
Without job N (%) 10 (25.0) 15 (12.9)
Sick leave N (%) 6 (15.0) 19 (16.4)
Pension N (%) 8 (20.0) 22 (19.0)
Homemaker N (%) 4 (10.0) 15 (12.9)
Applying for disability pension
[pension and homemaker excluded]
N (%)
10 (35.7) 19 (24.0) Chi2
= 1.4; .23
4 W. Häuser et al. / Journal of Psychosomatic Research xxx (2015) xxx–xxx
Please cite this article as: Häuser W, et al, Construct validity and clinical utility of current research criteria of DSM-5 somatic symptom disorder
diagnosis in patients with ..., J Psychosom Res (2015), http://dx.doi.org/10.1016/j.jpsychores.2015.03.151

5. in previous German FMS multicenter studies [34] as well as of system-
atic reviews on FMS and mental disorders [35].
Prevalence of SSD
The percentage of patients meeting the current SSD research criteria
[5–7] would have been 47% in our study and similar to the rate of 52% in
German psychosomatic inpatients diagnosed with somatoform disor-
ders [5] if the same criteria for persistently high level of anxiety about
symptoms by a threshold of 6 on the WI would have been used. By in-
creasing the cut-off score of the WI to 8, the prevalence rate of SSD de-
creased to 25% in our sample. 5.7% of participants of a UK population
based sample reported both high somatic symptom burden (PHQ
15 ≥ 10) and high health anxiety (WI total score ≥ 5) [36]. To sum up,
the prevalence rates of SSD depend on the research criteria used, the
setting of the study and the underlying severity of the patients in the
study sample.
Validity of current SSD research criteria in patients with FMS in clinical
institutions
a. 97% of patients of our study sample reported more than one very
distressing symptom in the PHQ 15. Our data support the assump-
tion that the A-criterion of SSD might be overinclusive because it
requires only one very distressing symptom [37].
b. We question if some items in the WI are appropriate measures for
high levels of disease-related anxieties in FMS-patients. The research
criteria of FMS [15] require the self-reports of two WI items, namely
“to be bothered by many different pains and aches” and “by many
different symptoms”. After the publication on findings on small
fiber pathology in FMS [38], some patients of our study reported in
the interview that they often worried “about the possibility (to)
have a serious illness” or that “there is something seriously wrong
with (their) body”. Other patients worried “a lot about (their)
health” because they were afraid to lose their job because of sick
leave due to their FMS-problems.
The B1 (disproportionate and persistent thoughts about the serious-
ness of one's symptoms) – and B2 (persistently high level of anxiety
about health or symptoms) – diagnostic categories of SSD run the
risk to transform the uncertainties and controversies on FMS of the
scientific community [39] into a mental disorder of the patient.
Disease related thoughts and feelings are the result of the interaction
of the patient with significant others and the medical system [9].
Some FMS authors claim that “fibromyalgia is a persistent and debil-
itating disorder that can have a devastating effect on people's
lives”[40]. Patients searching for information in the internet with
the search term “fibromyalgia” will get 20 million hits in Google
with most prominent information on the seriousness (B1 criterion
of SSD of FMS-symptoms).
Concerns about the over-inclusive criteria of SSD[37], which risks to
mislabeling people as mentally ill, has been raised patients with
major medical diseases [41,42]. These concerns might also be valid
for patients diagnosed with FMS. The DSM 5 authors of SSD replied
to these concerns that “every. diagnosis relies on clinical experience
and judgment, as has always been the case”[43]. There was insuffi-
cient interrater reliability when somatic symptoms were not attrib-
utable to biomedical conditions for the diagnosis of a somatoform
disorder [2]. We speculate that the clinical judgment about
which thoughts, feelings and behaviors associated with FMS are
“excessive” or “disproportionate” for the diagnosis of a SSD will be
as arbitrary and less reliable than the clinical judgment if somatic
symptoms are not attributable to a biomedical condition for the
diagnosis of a somatoform disorder.
c. No research criteria have been defined for criterion B3 (excessive
time and energy devoted to these symptoms or health concerns)
until now. Health care use has been assessed in population-based
studies to support the concept of SSD [12,44]. We used this criterion
for the validation of SSD in our study too. However, national differ-
ences of health care systems and its use must be kept in mind. In ad-
dition, patients might understand “excessive” health care use to be
self-caring behavior. Based on this comment of a patient representa-
tive on the protocol of our Cochrane review on cognitive behavioral
Table 2
Comparison of somatic and psychological symptoms of fibromyalgia syndrome patients with and without meeting DSM 5 current research criteria of somatic symptom disorder.
Somatic symptom disorder
N = 40
No somatic symptom disorder
N = 116
Comparison; P-value
Mean years since chronic widespread pain (SD) 8.6 (6.4) 8.2 (7.1) t = 0.3; .80
Mean years since fibromyalgia diagnosis (SD) 3.6 (4.3) 3.3 (3.5) t = 0.5; .66
Mean number of pain sites polysymptomatic distress scale (SD) (0–19) 13.3 (3.9) 12.7 (3.5) t = 0.8; .40
Mean total score polysymptomatic distress scale (SD) (0–31) 23.3 (4.7) 21.1 (5.0) t = 2.4; .01
Mean somatic symptom burden PHQ 15 (SD) (0–30) 20.0 (4.3) 16.9 (5.6) t = 3.1; .002
Fibromyalgia severity PHQ 15 N (%) Chi2
= 6.5; .09
Slight (5–9) 0 8 (7.2)
Moderate (10–14) 5 (13.9) 31 (27.9)
Severe (15–30) 31 (86.1) 72 (64.9)
PHQ 15 total score ≥ 10 N (%) 40 (100) 106 (91.4) Chi2
= 3.6; .06
Mean psychological distress Patient Health Questionnaire 4 total score (SD) (0–12) 8.9 (2.6) 6.3 (3.6) t = 4.6; b.0001
Mean total score pain catastrophizing (SD) (0–42) 36.5 (7.8) 22.8 (11.6) t = 6.9; b.0001
N (%) ≥30 35 (87.5) 37 (31.9) Chi2
= 37.0; b.0001
N (%) ≥35 23 (57.5) 16 (16.0) Chi2
= 30.3;b.0001
Pain Disability Index total score (SD) (0–70) 45.9 (10.2) 36.6 (13.0) t = 4.1; b.0001
Significant differences are marked as bold.
Table 3
Comparison of (probable) mental disorder diagnoses of fibromyalgia syndrome patients with and without meeting DSM 5 current research criteria of somatic symptom disorder.
Somatic symptom disorder
N = 40
No somatic symptom disorder
N = 116
Comparison; P-value
Probable depressive disorder PHQ 4 N (%) 34 (91.3) 68 (61.3) Chi2
= 12.2; b.0001
Probable anxiety disorder PHQ 4 N (%) 36 (90.0) 64 (64.0) Chi2
= 15.7; b.0001
Current depressive disorder (F 32, F 33, F 34) by psychiatric interview N (%) 25 (62.3) 45 (38.8) Chi2
= 6.8; .009
Current anxiety disorder (F 40, F 41, F 43.1) by psychiatric interview N (%) 13 (32.5) 28 (24.1) Chi2
= 1.1; .30
No current depressive and anxiety disorder by psychiatric interview N (%) 2 (5.0) 33 (28.4) Chi2
= 9.4; .002
Significant differences are marked as bold.
5W. Häuser et al. / Journal of Psychosomatic Research xxx (2015) xxx–xxx
Please cite this article as: Häuser W, et al, Construct validity and clinical utility of current research criteria of DSM-5 somatic symptom disorder
diagnosis in patients with ..., J Psychosom Res (2015), http://dx.doi.org/10.1016/j.jpsychores.2015.03.151

6. therapies [45], the outcome “health care use” was not included into
the review (personal communication).
d. Our findings support the discriminative concurrent criterion validity
of SSD only for self-report measures of disability (PDI), but not for
objective measures of disability (sick leave, applying for disability
pension) and of health care use (number of doctor and physiothera-
pist visits in the previous six months). Of note, FMS-patients with
SSD reported also more (intensive) somatic and psychological
symptoms and pain catastrophizing that FMS patients without
SSD. Previous US and German studies demonstrated a tendency of
FMS patients to report (high intensities of) any type of somatic and
psychological symptoms [46,47]. Even if FMS can be conceptualized
to be the end of a continuum of biopsychosocial distress [48], people
diagnosed with FMS can be at the end or at the very end of the
continuum, that is to say, may report many or very many somatic
and psychological symptoms. The significant differences between
the two study subgroups in all self-report measures could therefore
be explained by differences in symptom reporting. In addition, the
differences in all self-report measures that we did find, though sig-
nificant, were not clinically important. Only 5% of FMS/SSD-
patients did not meet the criteria of an anxiety or depressive disor-
der. The strong association of FSS with anxiety and depression has
been demonstrated by systematic reviews [49]. Disproportionate
and persistent thoughts about the seriousness of one's symptoms
and persistently high level of anxiety about symptoms can also be
accounted for by a depressive or generalized anxiety disorder.
This view challenges the necessity of the diagnostic category of
a SSD in addition to the existing categories of anxiety (including
hypochondria) and depressive disorders.
Clinical utility of SSD research criteria in patients with FMS in clinical
institutions
In line with the hypothesis, FMS patients with SSD received more
frequently recommendations for psychotherapy by raters blinded for
the purpose of the study. The recommendation was based on the Ger-
man guideline on FMS [31]. However, the different rates of recommen-
dations for psychotherapy can be explained by the differences in the
frequency of current anxiety and depressive disorders which were one
criterion for the recommendation of psychotherapy. In addition, the dif-
ference was not clinically meaningful because two third of the patients
without SSD received a recommendation for psychotherapy by the
blinded assessors.
Limitations
a. We report results of a single center study of secondary care
level that limit the generalizability of the findings. However, the demo-
graphic and psychosocial characteristics of the study center did not
substantially differ from the ones of other German centers of different
settings in previous studies [32,33]. In addition, the psychosocial
characteristics of FMS patients of the study center did not significantly
differ from the ones of FMS-patients of private rheumatology practices
in Washington, D.C. [50]. b. Study findings on health care use in
Germany cannot be generalized to other health care systems. In contrast
to US and UK countries, inpatient and outpatient pain therapy and psy-
chiatric and psychotherapeutic treatmentsare easily available for
German patients. Therefore the study findings on health care use of
FMS-patients with and without SSD might be different in other coun-
tries. c. Our study was underpowered to detect smaller differences be-
tween the two groups in objective measures of disability and health
care use. However, our data question the clinical relevance of these
potential differences.
Conclusions
Current German guidelines categorized FMS as a FSS [14]. The guide-
lines stressed the importance of psychosocial factors in the etiology of
FMS, and the need of psychological therapies in case of mental disorders
or inappropriate coping with the symptoms [31]. Therefore the existing
diagnostic code of FMS (M79.7), located in the ICD classification system
in somatic diseases, and – if present – of comorbid ICD-10 mental
disorders, except somatoform disorder, may be sufficient for the classi-
fication of symptoms and for the management of FMS-patients.
The following five criteria have been suggested for possible inclusion
of a new category into DSM: Adequate literature, specified diagnostic
criteria, acceptable interclinician reliability, evidence that the criteria
form a syndrome, and differentiation from other categories [51]. More
studies with patients with somatic diseases and functional somatic syn-
dromes are necessary to test if current or modified research criteria of
SSD will meet these criteria or not [12,42,52] and if the diagnostic cate-
gory is useful in clinical practice or not.
Conflicts of interest
Winfried Häuser is a member of the medical board of the German
Fibromyalgia Association. The other authors of this article report no
conflict of interest.
Funding source
The study was conducted without external funding.
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