Kroenke, K. Et Al (2002) The PHQ-15 - Validity of A New Measure For Evaluating The Severity of Somatic Symptoms
Kroenke, K. Et Al (2002) The PHQ-15 - Validity of A New Measure For Evaluating The Severity of Somatic Symptoms
Kroenke, K. Et Al (2002) The PHQ-15 - Validity of A New Measure For Evaluating The Severity of Somatic Symptoms
Symptoms
KURT KROENKE, MD, ROBERT L. SPITZER, MD,
AND
Objective: Somatization is prevalent in primary care and is associated with substantial functional impairment and
healthcare utilization. However, instruments for identifying and monitoring somatic symptoms are few in number
and not widely used. Therefore, we examined the validity of a brief measure of the severity of somatic symptoms.
Methods: The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic
instrument for common mental disorders. The PHQ-15 comprises 15 somatic symptoms from the PHQ, each
symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The PHQ-15 was administered to 6000 patients
in eight general internal medicine and family practice clinics and seven obstetrics-gynecology clinics. Outcomes
included functional status as assessed by the 20-item Short-Form General Health Survey (SF-20), self-reported sick
days and clinic visits, and symptom-related difficulty. Results: As PHQ-15 somatic symptom severity increased,
there was a substantial stepwise decrement in functional status on all six SF-20 subscales. Also, symptom-related
difficulty, sick days, and healthcare utilization increased. PHQ-15 scores of 5, 10, 15, represented cutoff points for
low, medium, and high somatic symptom severity, respectively. Somatic and depressive symptom severity had
differential effects on outcomes. Results were similar in the primary care and obstetrics-gynecology samples.
Conclusions: The PHQ-15 is a brief, self-administered questionnaire that may be useful in screening for somatization and in monitoring somatic symptom severity in clinical practice and research. Key words: somatization,
somatization disorder, depression, screening, quality of life, utilization.
DSM-IV ! Diagnostic and Statistical Manual of Mental Disorders, fourth edition; PHQ-9 ! Patient Health
Questionnaire depressive symptom severity scale;
PHQ-15 ! Patient Health Questionnaire somatic
symptom severity scale; SF-20 ! 20-item Short-Form
General Health Survey.
INTRODUCTION
Somatic symptoms account for more than half of all
outpatient encounters (1), and at least one third of
these somatic symptoms are medically unexplained
(2 6). Somatization is the association of medically
unexplained somatic symptoms with psychological
distress and health-seeking behavior and is present in
at least 10% to 15% of primary care patients (711).
Indeed, somatization together with depression and
anxiety constitute the three most common psychiatric
problems seen in primary care (8, 12, 13). The detrimental impact of somatization on multiple domains of
health-related quality of life remains considerable
even after controlling for comorbid depression and
From the Regenstrief Institute for Health Care and Department of
Medicine (K.K.), Indiana University, Indianapolis, IN; and the New
York State Psychiatric Institute and Department of Psychiatry
(R.L.S., J.B.W.), Columbia University, New York, NY.
Address reprint requests to: Kurt Kroenke, MD, Regenstrief Institute for Health Care, RG-6 1050 Wishard Blvd., Indianapolis, IN
46202. Email: [email protected]. For a complimentary copy
of reproducible PHQ materials, contact: Robert L. Spitzer, MD.
Email: [email protected]
Received for publication February 27, 2001; revision received
June 11, 2001.
258
0033-3174/02/6402-0258
Copyright 2002 by the American Psychosomatic Society
anxiety (79, 11). Moreover, compared with depression and anxiety, somatization results in more healthcare utilization and greater clinician frustration (6,
14 17). Although somatization is often comorbid with
depression and/or anxiety (just as depression and anxiety frequently coexist), a third or more of patients
have somatization alone (8, 10 12, 18). The importance of recognizing and evaluating somatization has
been heightened by recent evidence of the effectiveness of specific treatment strategies (19 21).
Measures to identify and monitor somatic symptoms are important if researchers are to study somatization and clinicians are to evaluate and manage it.
Unlike depressive symptom measures, measures to assess somatic symptoms are less well established. Limitations of existing measures (11, 2225) include one
or more of the following: their length, the need to
inquire about lifetime as well as current symptoms, a
predominant focus on identifying DSM-IV somatization disorder (which accounts for only a small proportion of clinically significant somatization in primary
care), validation in psychiatric rather than general
medical patient populations, and an assessment of
symptom counts alone rather than both the severity
and number of somatic symptoms. The few studies
comparing multiple somatic symptom measures in the
same sample have not demonstrated the superiority of
any one particular measure (26, 27). Consensus is further complicated by the ongoing debate about the optimal classification of somatoform disorders (17,
28 32).
PRIME-MD (Pfizer Inc, New York, NY) is a brief
instrument for making criteria-based diagnoses of
mental disorders commonly encountered in primary
care (8, 33). The Patient Health Questionnaire (PHQ) is
Patient Characteristic
No. of subjects
Established clinic patient, %
Age (mean " SD), y
Women, %
Race, %
White
African American
Hispanic
Marital status, %
Married
Never married
Divorced, separated, widowed
Education, %
College graduate
Partial college
High school graduate only
Less than high school
Physical disorders, %
Hypertension
Arthritis
Diabetes
Pulmonary
Study 1
PHQ Primary Care
Study 2
ObstetricsGynecology
3000
80
46 " 17
66
3000
71
31 " 11
100
79
13
4
39
15
39
48
23
29
52
33
15
27
27
33
13
16
25
32
27
25
11
8
7
2
1
1
2
259
K. KROENKE et al.
Analysis
The PHQ-15 is intended to function as a continuous measure of
somatic symptom severity. For this article the PHQ-15 score was
divided into several categories to illustrate more clearly the relationship between graded increases in somatic symptom severity and
various health outcomes. The categories were minimal (PHQ-15
score ! 0 4), low (score ! 59), medium (score ! 10 14), and high
(score ! 1530) levels of somatic symptom severity. These categories were chosen for several reasons. The first was pragmatic: the
cutoff points of 5, 10, and 15 are simple for clinicians to remember
and apply. The second reason was empiric: using different cutoff
points did not noticeably change the associations between increasing PHQ-15 severity and measures of construct validity. The third
reason is that patients with the most severe symptoms (score of 15 or
higher) constituted approximately 10% of the sample, a prevalence
comparable with the lower boundary of prevalence estimates for
clinically significant somatization in primary care (7, 8, 11).
The internal reliability of the PHQ-15 was assessed using Cronbachs !. Construct validity of the PHQ-15 as a measure of somatization severity was assessed by examining functional status (the six
SF-20 scales), disability days, symptom-related difficulty, and
healthcare utilization (clinic visits) over the four PHQ-15 intervals.
The independent effects of somatic symptoms, depressive symptoms, and medical comorbidity on functional status and other outcomes were assessed using stepwise linear regression models. The
PHQ has a nine-item depressive symptom severity scale (the PHQ-9)
that ranges from 0 to 27. The PHQ-15 score, PHQ-9 score, and
number of physical disorders were entered as independent variables
in each model, adjusting for age, gender, minority status, education,
and study site.
RESULTS
Distribution and Reliability of PHQ-15 Scores
Table 2 shows the distribution of PHQ-15 scores.
Each sample was roughly divided into thirds, with
TABLE 2.
Distribution of PHQ-15 Somatic Symptom Severity Scores and Patient Characteristics in Primary Care and ObstetricsGynecology Samples
Patient Characteristic
Primary care sample
No. of patientsa
Percentage of patients
Mean age, y
Women, %
White, %
Some college education, %
Mean no. of physical disorders
Obstetrics-gynecology sample
No. of patientsa
Percentage of patients
Mean age, y
Women, %
White, %
Some college education, %
Mean no. of physical disorders
a
59
1014
1530
1012
35
47.6
57
81
58
0.9
1012
35
45.1
69
79
56
1.0
594
20
44.5
74
79
51
1.1
291
10
44.0
78
75
43
1.2
1021
36
31.7
100
39
44
0.1
1036
36
30.6
100
43
43
0.2
562
20
30.0
100
44
42
0.2
250
9
31.7
100
44
35
0.3
Total is less than 3000 per sample because of missing PHQ-15 items for some patients.
260
Relationship Between PHQ-15 Somatic Symptom Severity and SF-20 Functional Status
82 (14)
72 (18)
61 (21)
51 (23)
82 (15)
74 (17)
63 (20)
56 (21)
94 (17)
86 (23)
71 (31)
53 (34)
92 (21)
88 (23)
78 (29)
67 (30)
91 (25)
78 (38)
55 (45)
36 (36)
91 (27)
84 (33)
74 (40)
50 (46)
76 (20)
61 (24)
45 (24)
29 (22)
80 (18)
67 (23)
53 (25)
39 (25)
76 (24)
60 (25)
44 (23)
35 (21)
81 (21)
66 (23)
54 (24)
40 (22)
88 (20)
77 (25)
64 (28)
50 (29)
88 (22)
82 (21)
75 (23)
63 (25)
a
SF-20 scores are adjusted for age, sex, education, and number of physical disorders. Means are presented with standard deviations in
parentheses. Most pairwise comparisons of mean SF-20 scores between adjacent PHQ-9 levels within each scale were highly significant (p #
.001).
the primary care sample; results for the obstetricsgynecology sample (not shown) were similar.
Table 4 shows the association between PHQ-15 severity levels and three other measures of construct
validity: self-reported disability days, clinic visits, and
the amount of difficulty patients globally attribute to
their symptoms. Greater levels of somatization severity
were associated with a stepwise increase in disability
days, healthcare utilization, and symptom-related difficulty in activities and relationships.
Independent Effects of Somatic and Depressive
Symptoms
Fig. 1. Relationship between somatic symptom severity as measured by the PHQ-15 and decline in functional status as
measured by the six subscales of the SF-20. The decrement
in SF-20 scores are shown as the difference between each
PHQ-15 severity group and the reference group (ie, those
with PHQ-15 scores of 0 4). SF-20 scores are adjusted for
age, sex, education, and number of physical disorders. Effect size is the difference in adjusted means divided by the
pooled standard deviation for that scale.
261
K. KROENKE et al.
TABLE 4.
Relationship Between PHQ-15 Somatic Symptom Severity and Disability Days, Symptom-Related Difficulty, and Clinic
Visits
Level of Somatic
Symptom
Severity (PHQ15 Score)
Minimal (14)
Low (59)
Medium (1014)
High (1530)
Primary Care
ObstetricsGynecology
Primary Care
ObstetricsGynecology
Primary Care
ObstetricsGynecology
1.4 (1.11.7)
4.7 (3.95.5)
8.7 (7.310.1)
18.2 (14.721.7)
1.6 (1.32.0)
4.0 (3.44.6)
5.2 (4.46.1)
12.0 (9.314.7)
1.4
7.8
17.3
28.0
0.7
3.6
10.9
21.7
0.8 (0.70.9)
1.4 (1.21.6)
1.9 (1.72.1)
2.9 (2.43.4)
0.7 (0.70.9)
1.2 (1.01.4)
1.2 (1.01.3)
1.9 (1.62.3)
a
Disability days refers to number of days in past 3 months that symptoms interfered with usual activities. Physician visits refers to past 3
months also. Both are based on self-report. Means are adjusted for age, sex, education, and number of physical disorders.
b
Response to single question: How difficult have these problems made it for you to do your work, take care of things at home, or get along
with other people? The four response categories are not difficult at all, somewhat difficult, very difficult, and extremely difficult.
Symptom-related difficulty in this table refers to those patients reporting very or extremely difficult.
TABLE 5.
Proportion of Variance in Health Outcomes Attributable to Somatic Symptoms, Depressive Symptoms, and Number of
Physical Disorders
Percentage of Variance in Health Outcome Explained bya
Health Outcome
Primary
Care
ObstetricsGynecology
Primary
Care
ObstetricsGynecology
Primary
Care
ObstetricsGynecology
35.2
28.2
21.2
20.5
4.1
0.2
7.8
1.4
26.9
29.2
11.4
9.7
0.8
0.2
4.5
5.3
1.1
3.3
27.2
54.4
0.9
16.2
0.5
1.6
12.5
43.5
2.4
9.5
4.5
1.3
9.7
3.1
1.5
0.3
0.8
0.5
0.1
1.3
1.1
1.2
0.6
1.3
0.4
Partial R2 from stepwise linear regression model, which included as independent variables PHQ-15 score, PHQ-9 score, number of physical
disorders, age, gender, minority status, education, and study site.
262
PHQ-15 scores was somewhat less in the obstetricsgynecology sample. The differences in magnitude of
effect are probably due to demographic and comorbidity differences between the two samples, although the
possibility of some other unmeasured construct cannot
be excluded.
One limitation of the PHQ-15 as a self-administered
measure is that it cannot distinguish between medically explained and unexplained symptoms, a distinction that typically requires a directed interview and
clinical judgment. The PHQ-15 is therefore best characterized as a measure of somatic symptom severity
rather than a diagnostic instrument for somatoform
disorders. Patients who have high screening scores on
the PHQ-15 should be further questioned to determine
which symptoms might be medically unexplained.
Unexplained symptom counts are more specific for
somatoform disorders and predict adverse health consequences at lower thresholds. Still, total symptom
higher level of severity typically represented a moderate effect size for all functional status domains. In
particular, scores of 15 or higher were associated with
considerable impairment and high utilization. The fact
that 8% to 10% of patients in the two samples have
scores of 15 or greater is notable in that this is also the
lower boundary of prevalence estimates for clinically
significant somatization in primary care (79, 11).
Table 6 shows how the symptom coverage provided
by the PHQ-15 compares favorably with other screeners for somatization: the World Health Organization
Screener for Somatoform Disorders (22), the somatization scale from the Hopkins Symptom Checklist (23),
and two screeners for somatization disorder developed
by Swartz et al. (24) and Othmer and DeSouza (25).
The PHQ-15 assesses 9 of the 12 WHO items, 7 of the
12 Hopkins items, 8 of the 11 Swartz et al. screen
items, and 4 of the 7 Othmer and DeSouza screen
items. This concordance rate of the PHQ-15 with the
other instruments is superior to that of any two other
Characteristic
No. of symptoms
Time frame of symptoms
Symptoms includedb
Joint or limb pain
Dizziness
Fatigue
Headaches
Back pain
Abdominal pain
Chest pain
Breathing trouble
Fainting
Gas or indigestion
Sleeping trouble
Palpitations
Menstrual problems
Diarrhea (constipation)
Sexual pain/problems
Vomiting
Numbness or tingling
Weakness
Lump in throat
Nausea
Heavy- or light-headedness
Dry mouth
Heaviness of arms/legs
Hot or cold spells
Feeling sickly
Amnesia
PHQ-15
WHO SSD
SCL-12
Swartz et al.
Othmer and
DeSouza
15
1 mo
12
6 mo
12
1 wk
11
Lifetime
7
Lifetime
X
X
X
X
X
X
X
X
X
12
X
X
X
X
X
X
X
X
X
X
X
X
12
X
X
X
X
X
X
X
12
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
12
X
X
X
X
X
X
a
WHO-SSD ! World Health Organization Schedule for Somatoform Disorders screener; SCL-12 Hopkins Symptom Checklist somatization
scale; Swartz et al. (24) and Othmer and DeSouza (25) represent 11-item and 7-item screeners, respectively, for somatization disorder.
b
X indicates that this symptom (or equivalent) is included on the scale; 12 indicates that the two symptoms so designated constitute a single
item for the scale; X indicates that a symptom close in type to that in the table is represented on the scale.
263
K. KROENKE et al.
instruments with one another. Of note, other measures
designed to assess particular domains of somatization
(eg, hypochondriasis and somatosensory amplification) or to screen for the somatic manifestations of
depressive and anxiety disorders also correlate highly
with one another (43). Although core diagnostic symptoms for depression, fatigue and sleep complaints are
included in the PHQ-15 for several reasons. First, they
are also included in one or more other somatization
screening measures (Table 6). Second, 40% to 50% of
primary care patients with fatigue or sleep complaints
do not have a depressive or anxiety disorder diagnosis
(44 46).
Somatic and depressive symptoms have differential
effects on various measures of health. The results in
our two PHQ studies are similar to findings from the
original PRIME-MD study, where somatoform disorders were most strongly associated with general health
perceptions, bodily pain, role functioning, and clinic
visits (17, 47). By controlling for depression severity
and number of physical disorders, we have shown that
the adverse consequences of somatic symptoms as
measured by the PHQ-15 are not entirely mediated
through coexisting depressive symptoms or medical
comorbidity. There has been a long-standing focus in
general medicine on treatment of physical disorders
and recent attention to improved detection and management of depression. Our findings suggest that in
certain subgroups of patients, that is, high utilizers or
those with poor self-rated health, persistent pain, or
impaired role functioning, the identification and management of residual or unresolved somatic symptoms
may also be important.
The association between number of physical disorders
and various health outcomes is surprisingly weak. In part
this may be because we used a simple count of physical
disorders rather than a more sophisticated medical comorbidity measure that can capture the severity as well
as number of disorders. Also, it may be only those disorders that are symptomatic (and the severity of those
symptoms) that determines impairment. Many physical
disorders (eg, hypertension, well-controlled diabetes,
and stable coronary artery disease) are minimally symptomatic and thus produce less impairment than mental
disorders or symptomatic physical disorders (47, 48). In
both our samples, there was only a weak correlation
between the number of physical disorders and somatic
symptoms. Also, the conventional wisdom that somatic
symptoms in medical patients commonly are secondary
to the side effects of prescribed medications is challenged by studies showing that symptom prevalence may
be equally high in patients receiving placebo or no medication (49 51).
Valid measures for assessing somatization severity
264
are important given the emerging evidence for effective treatments. Two recent critical reviews of the literature have shown that somatizing disorders can respond to antidepressants (96 controlled trials) as well
as cognitive-behavioral therapy (31 controlled trials)
(20, 21). Although depression also responds to these
types of treatment, there may still be reasons for differentiating somatization and depression. First, the
benefits of these two treatment modalities in reducing
somatic symptoms do not appear to be mediated entirely through amelioration of depressive or other psychological symptoms (20, 21). Second, the majority of
antidepressant trials conducted in patients with somatic symptom disorders have focused on specific
symptom syndromes rather than patients with multiple unexplained complaints. Third, the cognitions and
behaviors targeted in depressed patients receiving cognitive-behavioral therapy may be differ from those emphasized in somatizing patients.
Nonpharmacologic treatments other than cognitivebehavioral therapy, including operant behavioral therapy, relaxation therapy, biofeedback, and problemsolving therapy, may also be beneficial for patients
with chronic symptoms, especially pain (5256).
There may be more to offer the somatizing patient than
the rather noninterventionist approach shown by
Smith et al. (19, 57) to reduce costs with modest to no
impact on the patients quality of life. In patients with
milder or less chronic versions of somatization, even
simple measures, such as attention to symptom-specific concerns and expectations, reassurance, and follow-up, may be useful (58 60).
Treatment trials of somatizing patients using the
PHQ-15 as an outcome measure are necessary to establish its sensitivity to change. Also, test-retest reliability
should be evaluated because it is possible that somatization, like depression, may peak the day of the primary care visit and diminish shortly afterward before
treatment can potentially have an effect. Additional
somatization measures may be warranted in some trials because patients with multiple somatic symptoms
frequently have one or several symptoms that cause
greater distress or impairment than the others. Thus,
instruments that focus on the predominant symptom(s), such as 1-to-10 severity scales (61) or other
symptom-specific measures (62), may complement generic somatization scales such as the PHQ-15 in monitoring treatment outcomes. Meanwhile, our validation
data from two studies involving a total of 6000 patients
establish the PHQ-15 as a promising measure for identifying patients with potential somatization in clinical
practice as well as assessing somatic symptom counts
and severity in clinical research.
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APPENDIX
Patient Health Questionnaire 15-Item Somatic
Symptom Severity Scale
During the past 4 weeks, how much
Not
Bothered Bothered
have you been bothered by any of the bothered
a little
a lot
following problems?
at all
a. Stomach pain
b. Back pain
c. Pain in your arms, legs, or joints
(knees, hips, etc.)
d. Menstrual cramps or other problems
with your periods [Women only]
e. Headaches
f. Chest pain
g. Dizziness
h. Fainting spells
i. Feeling your heart pound or race
j. Shortness of breath
k. Pain or problems during sexual
intercourse
l. Constipation, loose bowels, or
diarrhea
m. Nausea, gas, or indigestion
n. Feeling tired or having low energy
o. Trouble sleeping
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