1-s2.0-S0022399914000269-main

7232019 1-s20-S0022399914000269-main

httpslidepdfcomreaderfull1-s20-s0022399914000269-main 15

Patient Health Questionnaire 15 as a generic measure of severity in

1047297bromyalgia syndrome Surveys with patients of three different settings

Winfried Haumluser ab Elmar Braumlhler c Frederick Wolfe de Peter Henningsen b

a Department Internal Medicine I Klinikum Saarbruumlcken Saarbruumlcken Germanyb Department Psychosomatic Medicine Technische Universitaumlt Muumlnchen Muumlnchen Germanyc Department of Medical Psychology and Medical Sociology Universitaumlt Leipzig Germanyd National Data Bank for Rheumatic Diseases Wichita KS United Statese 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 22 January 2014

Accepted 29 January 2014

Keywords

Disability

Fibromyalgia syndrome

Functional somatic syndrome

Patient Health Questionnaire 15

Psychological distress

Severity grading

Validity

Objective Graduatedtreatment of patients with functional somatic syndromes (FSS) and1047297bromyalgia syndrome

(FMS) depending on their severity has been recommended by recent guidelines The Patient Health Question-

naire 15 (PHQ 15) is a validated measure of somatic symptom severity in FSS We tested the discriminant and

transcultural validity of the PHQ 15 as a generic measure of severity in persons with FMS

Methods Persons meetingrecognizedFMS-criteria of thegeneralGerman population (N = 98) of theUS National

Data Bank of Rheumatic Diseases (N = 440) and of a single German pain medicine center (N = 167) completed

validated self-report questionnaires on somatic and psychological distress (Polysymptomatic Distress Scale

Patient Health Questionnaire 4) health-related quality of life (HRQOL) (Short Form Health Survey 12 or 36) and

disability (Pain Disability Index) In addition self-reports of working status were assessed in the clinical setting

Overall severity of FMS was de1047297ned by PHQ 15 scores mild (0ndash9) moderate (10ndash14) and severe (15ndash30)

Results Persons with mild moderate and severe FMS did not differ in age and gender Irrespective of the setting

persons with severe FMS reported more pain sites fatigue depressed mood impaired HRQOL and disability

than persons with moderate or mild FMS Patients with severe FMS in the NDB and in the German clinical center

reported more work-related disability than patients with mild FMS

Conclusion The PHQ 15 is a valid generic measure of overall severity in FMScopy 2014 Elsevier Inc All rights reserved

Introduction

The de1047297nition and content of 1047297bromyalgia syndrome (FMS) have

changed repeatedly in the last 100 years [1] The most important

change was the requirement for multiple tender points and chronic

widespread pain that arose from the 1047297bromyalgia classi1047297cation criteria

of theAmerican College of Rheumatology [2] By 2010 a secondshift oc-

curred with the preliminary American College of Rheumatology (ACR)

diagnostic criteria [3] and the research criteria of 1047297bromyalgia [4] that

excluded tender points and placed reliance on patient-reported symp-

toms with chronic widespread pain fatigue and cognitive dif 1047297culties

(lsquo1047297bro fogrsquo) as main and abdominal pain depression and headache as

minor symptoms The new diagnostic criteria [34] indexed FMS into

functional somatic syndromes (FSS) which are de1047297ned by a typical

cluster of chronic somatic symptoms and the exclusion of somatic dis-

eases suf 1047297cient to explain the symptoms [5] FSS are frequently

associated with each other (eg FMS and irritable bowel syndrome)

and with anxiety and depressive disorders [67]

Recent evidence-based guidelines on FSS [8] and on FMS [910] rec-

ommended a graduated treatment approach based on severity Clinical

criteria for severity are based on the amount of somatic and psycholog-

ical distress disability and health care use [8ndash10] However the lack of

an internationally accepted instrument for severity grading of FSS and

FMS is one major obstacle in their de1047297nition and management [1011]

The Polysymptomatic Distress Scale (PSD) [4] and the Fibromyalgia Im-

pact Questionnaire (FIQ) [12] have been proposed as disease-speci1047297c

measures of FMS-severity However cut-off values of the PSD have

not beendetermined and the FIQ isdif 1047297cult to analyze in routine clinical

care

ThePatient HealthQuestionnaire (PHQ15) is an easy to usemeasure

of somatic symptom intensity It provides cut-off scores for mild

moderate and severe somatic intensity In 6000 unselected primary

care patients higher PHQ-15 scores were strongly associated with

worsening function on all six Short Form Health Survey-20 scales as

well as increased disability days and health care utilization [1314]

Recently population-based cross-sectional studies demonstrated that

the total somatic symptom score measured by the PHQ 15 was a valid

Journal of Psychosomatic Research 76 (2014) 307ndash311

Corresponding author at Klinikum Saarbruumlcken gGmbH Winterberg 1 D-66119

Saarbruumlcken Germany Tel +49 681 9632020 fax +49 681 9632022

E-mail address whaeuserklinikum-saarbrueckende (W Haumluser)

0022-3999$ ndash see front matter copy 2014 Elsevier Inc All rights reserved

httpdxdoiorg101016jjpsychores201401009

Contents lists available at ScienceDirect

Journal of Psychosomatic Research

7232019 1-s20-S0022399914000269-main


predictor of health status and healthcare use over and above the effects

of anxiety depression and general medical diseases [15] The PHQ 15

has been proposed for the grading of severity of somatic symptom

disorder (SSD) by the Diagnostic and Statistical Manual of Psychiatric

Diseases DSM V [16] Therefore the total score of the PHQ 15 might be

suited as a generic measure of overall severity of patients diagnosed

with FSS including those with FMS

We tested if thecut-off scoresfor mild moderate and severesomatic

intensity measured by PHQ 15 provide a valid grading of overall severityof FMS We hypothesized that FMS-speci1047297c measures of severity such as

number of pain sites and fatigue as well as psychological distress and

disability would increase with PHQ 15-de1047297ned severity (discriminant

validity) and that these 1047297ndings could be demonstrated in patients of

different settings and countries (transcultural validity)

Methods

Patients and settings

We analyzed the data of three different settings

a FMS-cases within a cross-sectional survey of the general German

population conducted between May and June 2008 [17]

b 2012 survey of the US National Data Bank of Rheumatic Disease(NDB) longitudinal study of rheumatic diseases outcomes [18] Par-

ticipants were volunteers recruited primarily from the practices of

US rheumatologists who complete mailed or Internet question-

naires at 6-month intervals They were not compensated for their

participation

c Consecutive FMS-patients of a German center of pain and psychoso-

matic medicine between January 2011 to December 2013

Questionnaires

Demographic questionnaires

Age and sex were assessed in all surveys TheNDB study determined

work disability by self-report Self-report for disability rather than re-

ceipt of a disability pension was used as all patients are not eligible fora pension because of age or previous work history limitations Duration

of chronic widespread pain time since FMS-diagnosis partnership and

professional status were assessed in the patients of the German clinical

setting study Long-term sick leave was de1047297ned as sick leave Nfour

weeks

Patient Health Questionnaire 15 (PHQ 15)

The PHQ-15 contains 13 somatic and 2 psychological (fatigue sleep

problems) symptoms Each symptom is scored from 0 (not bothered at

all) to 2 (bothered a lot) PHQ-15 scores of 5 10 and 15 represent cutoff

points for low medium and highsomatic symptom severityrespective-

ly The usefulness of the PHQ-15 in screening for somatization syn-

dromes and in monitoring somatic symptom severity in clinical

practice and research has been demonstrated in numerous studies[1314]

Polysymptomatic Distress Scale (PSD)

The PSD includes the Widespread Pain Index (WPI) and the Symp-

tom Severity Score (SSS) The WPI is a 0ndash19 count of painful body

regions The SSS is the sum of the severity (0 ndash3) of the 3 symptoms

(fatigue waking unrefreshed cognitive symptoms) plus the sum of the

number of the following symptoms occurring during the previous

6 months headaches abdominal pain and depression The 1047297nal score

is between 0 and 12 For fatigue waking unrefreshed and cognitive

problems scoring was0 No problem 1 Slight or mild problems general-

ly mild or intermittent 2 Moderate considerable problems often pres-

ent andor at a moderate level 3 Severe continuous life-disturbing

problems Soon after the publication of the 2010 ACR criteria it was

suggested that the 2 components of the 2010 criteria the 0 ndash19 Wide-

spread Pain Index and the 0ndash12 Symptom Severity Score could be com-

bined by addition into a 0ndash31 index termed the ldquoPolysymptomatic

Distressrdquo Scale (PSD) [4] We used the validated German version of the

PSD [19]

Regional Pain Scale (RPS)

The RPS includes the WPI and 0 ndash10 Visual Analog Scale [20] We

used the validated German version of the RPS [21]The Short Form Health Survey SF is a generic measure of health relat-

ed quality of life (HRQOL) Physical and mental health composite scores

(PCS MCS) arecomputedusingthe scores of twelvequestions andrange

from 0 to 100 where a zero score indicates the lowest level of health

measured by the scales and 100 indicates the highest level of health

The reliability and validity of the SF-36 and SF-12 had been proved in

numerous studies [2223] We used the validated German version of

the SF-12 [23] in the survey of the general German population

The Pain Disability Index (PDI) measures disability by pain in seven

areas of daily living (familyhome responsibilities recreation social ac-

tivities occupation sexual behavior self-care life-support activity) on

an 11 point Likert scale The total score of the PDI ranges from 0 to 70

Psychometric evaluations of the PDI in outpatients and inpatients with

chronic pain found high internal consistency testndashretest reliability and

good convergent validity in reference to pain characteristics and pain

behavior [24] We used the validated German version of the PDI [25]

PHQ 4

The 2-item depression scale of the 4-item Patient Health

Questionnaire-4 (PHQ-4) which scores two DSM-IV criteria of major de-

pression as ldquo0rdquo (not at all) to ldquo3rdquo (nearly every day) was used to screen

for a potential depressive disorder Withreference to the Structured Clin-

ical Interview for DSM-IV (SCID) a score of 3-or-greater on the depres-

sion subscale had a sensitivity of 87 and a speci1047297city of 78 for major

depression disorder and a sensitivity of 79 and a speci1047297city of 86 for

any depressive disorders [26] We used the validated German version

of the PHQ 4 [27] We did not use the PHQ 9 [28] which could overesti-

mate depression in FMS because of the inclusion of key symptoms of

FMS (fatigue sleeping and concentration problems)

Self-reports of mental disease

Patients of the NDB also self-reported current and lifetime ldquomental

illnessrdquo (not de1047297ned further in the questionnaire) and the presence

now and ever of ldquodepressionrdquo and ldquodrug or alcohol abuserdquo We classi1047297ed

a patientas havinga ldquopsychiatric illnessrdquo (current or past) if any ldquomental

illnessrdquo ldquodepressionrdquo or ldquodrug or alcohol abuserdquo was endorsed

Structured psychiatric interview

Patients of the single center German study underwent a structured

psychiatric interview for current anxiety and depressive disorder

using the International Classi1047297cation of the World Health Organization

checklist [29]

Diagnoses

a Persons of the general German population FMS-cases were de1047297ned

by the Katz criteria (N=8 pain sites in the WPI and fatigue score

N=6 on VAS 0ndash10 during last week) [30] The setting of the study

excluded a medical examination

b NDB Diagnoses of the NDB-patients were made by the patients

rheumatologist or con1047297rmed by the patients physician in cases

that were self-referred [18] However to be classi1047297ed as FMS pa-

tientsthey were required to satisfy research criteria for1047297bromyalgia

The research criteria [4] were a modi1047297cation of the 2010 American

College of Rheumatologypreliminary diagnostic criteria for1047297bromy-

algia [3] to allow the use of self-report questionnaires for research

For patients to be diagnosed with 1047297bromyalgia they had to have

either a Widespread Pain Index(WPI) ge7 and Symptom Severity

308 W Haumluser et al Journal of Psychosomatic Research 76 (2014) 307 ndash 311

7232019 1-s20-S0022399914000269-main


Score (SSS) ge5 or a Widespread Pain Index between 3 and 6 and

Symptom Severity Score ge9 Because of the scoring rules of the

1047297bromyalgia criteria criteria positive individuals will always have

a PSD score of at least 12 [4] Patients with secondary FMS (FMS in

osteoarthritis and rheumatoid arthritis) were not included in the

analyses

c Patients of the German single center Patients were included into

analysis if they met the research criteria of FMS [4] and there were

no other medical diseases which could suf 1047297ciently explain the

majority of pain sites of the patient

Statistical analysis

Because b 5 of items were missing in all samples we did not use

imputation methods [31]

To assess differences between groups we compared mean scores of

continuous with the α-value set at 005 All analyses were conducted

with SPSS Version 180 statistical package

Ethics

All participants were informed about the study procedures and

signed an informed consent form The studies were approved by the

local ethic committees

Results

Sample composition

The initial sample from the German population consisted of 4064 subjects of whom

2524 (621) fully participated Reasons for dropout included the following three unsuc-

cessful attempts to contact the household or selected household member (77) the

household or selected household member disagreed to participate (158) and the

household member was on a holiday break (41) Furthermore 12 of the participants

were excluded because they were not able to follow the interview because of illness

90 refused to 1047297nish the interview [17] The NDB study included 440 patients without

concomitant in1047298ammatory rheumatic disease who met the research criteria at the time

of the study 286 patients without concomitant in1047298ammatory rheumatic disease who

did not meet the research criteria of FMS at the time of the survey were excluded from

the analysis Three patients each of the single center German study were excluded from

analysis because they did not meet the research criteria of FMS at the time of study eval-

uation or suffered from concomitant in1047298ammatory rheumatic disease 23 patients could

not be analyzed because they did complete the PHQ 15 for organizational reasons There

were no differences in age and gender ration between patients who were included and

excluded in the NDB-study and in the German clinical center study

Demographics

Patients with mild moderate and severe FMS according to PHQ 15 scores did not

differ signi1047297cantly in all three settings in age and sex ratio (see Tables 1ndash3) There were

no signi1047297cant differences in the percentage of pensioners in the German population sam-

ple between the three FMS-severity groups Because of an average age N 60 years in all

three FMS-severity groups we did not perform an analysis of active working status in

this sample (see Table 1) In the NDB-sample the percentage of patients with self-

reported work disability was higher in patients with severe FMS compared to patients

with mild FMS (see Table 2) Correspondingly the percentage of patients with long-

term sick leave andor without job was greater in patients with severe FMS compared to

those with mild FMS in the German clinical sample (see Table 3)

Fibromyalgia

There were no signi1047297cant differences in the duration of CWP and time since FMS-

diagnoses in the German clinical sample between the three PHQ 15 groups (seeTable 3) In all three samples there was a signi1047297cant difference between the three groups

in thenumber of painsites and the total score of the PSD The scores were highest in per-

sons with severe FMS and lowest in persons with mild FMS (see Tables 1ndash3) The same

pattern was detectable for fatigue scores in three samples (see Tables 1ndash3) and in the

physical and mental summary scores of the SF in the NDB-sample (see Table 2)


The frequency of a probable depressive disorder as de1047297ned by the PHQ 2 increased

with FMS-severity in the general German population and in the clinical sample (see

Tables 1 and 3) as did the frequency of a self-reported psychiatric illness in the NDB-

sample (see Table 2) and the frequency of an anxiety and or depressive disorder as

assessed by a psychiatric interview in the single center German study (see Table 3)

Table 1

Demographic and clinical variables of FMS-cases (according to Katz criteria) in a survey of the general German population grouped by somatic symptom intensity of the Patient Health

Questionnaire 15

Minimal and low

(PHQ 15 scores 0ndash9)a

N = 42

Moderate

(PHQ 15 scores 10ndash14)

N = 39

High


N = 15

Overall comparison

Group comparison

Female gender (N ) 25 (595) 22 (564) 5 (333) Chi2 = 32 p = 20

Age (mean SD) 606 (145) 614 (139) 629 (144) F = 01 p = 87

Pensioner (N ) 25 (595) 18(462) 10 (667) Chi2 = 142 p = 17

Widespread Pain Index (0ndash19) (mean SD) 106 (27) 129 (38) 148 (36) F = 91 p b 001 1 b 2 b 3Fatigue score (0ndash10) (mean SD) 73 (09) 76 (12) 81 (11) F = 45 p = 03 3 N 1

Physical component summary scale SF-12 (50ndash0) (mean SD) 400 (99) 361 (70) 322 (67) F = 52 p = 007 1 N 3

Mental component summary scale SF-12 (50ndash0) (mean SD) 490 (145) 427 (98) 364 (95) F = 106 p b 001 1 N 2 N 3

Potential depressive disorder (PH2 score N=3) 4 (95) 12 (406) 8(467) Chi2 = 100 p = 007 3 N 2 N 1

a 3 persons with PHQ 15 scores b5

Table 2Demographic and clinical variables of US patients with primary FMS according to the 2010 American College of Rheumatology based research criteria grouped by somatic symptom in-

tensity of the Patient Health Questionnaire 15

Minimal and low


N = 84

Moderate


N = 209

High


N = 147

Overall comparison

Group comparison

Female gender (N ) 71 (845) 192 (919) 132 (898) F = 33 p = 19

Age (mean SD) 654 (102) 609 (120) 561 (129) F = 170 p b 001 1 N 2 N 3

Disabled (self-reported working status) (N ) 18 (214) 52 (249) 54 (367) 3 vs 1 Chi2 = 82 p = 02

Widespread Pain Index (0ndash19) (mean SD) 108 (41) 112 (41) 133 (48) F = 124 p b 001 3 N 1 N 2

Fatigue (0ndash10) (mean SD) 60 (21) 71 (20) 79 (18) F = 231 p b 001 3 N 2 N 1

Polysymptomatic Distress Scale score (0ndash31) (mean SD) 188 (50) 198 (47) 227 (54) F = 376 p b 001 3 N 2 N 1

Physical component summary scale SF-36 (50ndash0) (mean SD) 319 (9) 291 (83) 276 (70) F = 73 p b 001 1 N 2 N 3


Lifetime self-reported psychiatric illness (N ) 62 (738) 162 (775) 130 (884) 3 N 1 p = 005

a

6 patients had PHQ 15 scores b

5

309W Haumluser et al Journal of Psychosomatic Research 76 (2014) 307 ndash 311

7232019 1-s20-S0022399914000269-main


Health-related quality

Physical and mental summary scores of the SF 12 were lower in persons with severe

PHQ than with mild PHQ in the German population sample (see Table 1) Physical and

mental summary scores of the SF 36 were lower in persons with severe PHQ than with

moderate than with mild PHQ in the NDB sample (see Table 2) Pain disability scores

were highest in patients with severe FMS and lowest in patients with mild PHQ in the

German single center study (see Table 3)

Discussion

The cut-off scores of mild moderate andsevere somatic symptom in-

tensity of PHQ15 provided a validgenericmeasureof theoverall severity

in persons meeting FMS-criteria Somatic and psychological distress and

disability increased with PHQ 15-de1047297ned FMS severity (discriminant va-

lidity) The results were consistent in persons meeting FMS-criteria of

different settings (general population patient data bank clinical institu-

tion) and countries (Germany USA) (transcultural validity)

In a population based study in Germany we have shown that FMS

can be considered to be a dimensional or continuum disorder ratherthan a discrete illness and that the PSD scale provided a general useful

measure of the 1047297bromyalgia continuum [32] The PHQ-15 and the PSD

were correlated at 074 The essential difference between the scales is

that the Polysymptomatic Distress Scale weights pain as measured by

the Widespread Pain Index more than the PHQ-15 does [32]

Likewise in US-studies which used the ACR 1990 classi1047297cation

criteria [2] the somatic and psychological symptom burden of FMS-

persons of the general population is lower than that of patients in clin-

ical settings [33] A substantial number of patients reported not only

FMS-symptoms (multiple pain sites fatigue sleeping problems) but

also cardiovascular gastrointestinal and depressive symptoms These

1047297ndings are consistent with the recommendations of the FSS- and

FMS-guidelines that general practitioners and specialistsof somatic spe-

cialties should screen FMS-patients for other FSS (eg irritable bowelsyndrome) and for mental comorbidities and that the management of

patients with severe FSS should include the treatment of mental comor-

bidities by mental health specialists [834]

In addition our 1047297ndings with high PHQ 15 scores in most FMS-

patients of clinical settings support the concept of FMS as a bodily dis-

tress syndrome along with chronic fatigue syndrome irritable bowel

syndrome and similar disorders because they share a common set of

symptoms This model does not supplant but rather incorporates indi-

vidual somatic symptoms and syndromes in an umbrella category that

recognizes many commonalities [35]

The following limitations of the study have to be considered Even if

we studiedpatients diagnosed of different settings withFMS the1047297ndings

might have been different in other clinical settings eg rheumatology of-

1047297ces However we did not 1047297nd major differences in somatic and

psychological symptom burden ndash except higher rates of potential depres-

sive disorder in settings of psychosomaticmedicine ndash in patients of differ-

ent specialties in Germany [7] We did not assess health care use as

outcome of severity because health care use might be determined by

other variables than FSS-severity eg local availability of medical care

We selected the PHQ 15 as ldquoonerdquo ndash easily available and usable ndash measure

of severityWe did not test the utility ofother measures(eg SF-36 FIQ)of

severity in FMS The cut-off points of thePHQ 15 which we used were not

rigorously de1047297ned We did not test if other cut-off values of the PHQ 15

would perform better

We conclude that the PHQ 15 is a widely available and easy to use

measure that may be a good overall severity surrogate in FMS The utility

and validity of the PHQ 15 as a generic measure of severity in FMS and

other FSS need to be tested in future studies including patients of differ-

ent settings and countries Most importantly the cost-effectiveness of

graduated treatment approaches compared to standard usual care in

patients with FMS needs to be determined

Con1047298ict of interest

The authors of this article report no con1047298ict of interest

Funding source

The study was conducted without external funding

References

[1] Wolfe F Walitt B Culture science and the changing nature of 1047297bromyalgia Nat RevRheumatol 20139751ndash5

[2] Wolfe F Smythe HA Yunus MB Bennett RM Bombardier C Goldenberg DL et alThe American College of Rheumatology 1990 criteria for the classi1047297cation of 1047297bro-myalgia Report of the multicenter criteria committee Arthritis Rheum 199033160ndash72

[3] Wolfe F Clauw DJ Fitzcharles MA Goldenberg DL Katz RS Mease P et al TheAmerican College of Rheumatology preliminary diagnostic criteria for 1047297bromyalgiaand measurement of symptom severity Arthritis Care Res 201062600ndash10

[4] Wolfe F Clauw DJFitzcharles MAGoldenberg DLHaumluser W Katz RSet al Fibromy-algia criteria and severity scales for clinical and epidemiological studies a modi1047297ca-tion of the ACR preliminary diagnostic criteria for 1047297bromyalgia J Rheumatol2011381113ndash22

[5] Mayou R Farmer A ABC of psychological medicine functional somatic symptomsand syndromes BMJ 2002325265ndash8

[6] Henningsen P Zimmermann T Sattel H Medically unexplained physical symptomsanxiety and depression a meta-analytic review Psychosom Med 200365528 ndash33

[7] Galek A Erbsloumlh-Moumlller B Koumlllner V Kuumlhn-Becker H Langhorst J Petermann F et alMental disorders in patients with 1047297bromyalgia syndrome screening in centres of different medical specialties Schmerz 201327296ndash304

[8] Schaefert R Hausteiner-Wiehle C Haumluser W Ronel J Herrmann M Henningsen PNon-speci1047297c functional and somatoform bodily complaints Dtsch Arztebl Int

2012109803ndash

13

Table 3

Demographicand clinical variables of German FMS-patients of a singlepain and psychosomatic medicine center grouped by somatic symptom intensityof thePatient Health Questionnaire

15 FMS according to the 2010 American College of Rheumatology based research criteria grouped by somatic symptom intensity of the Patient Health Questionnaire 15

Minimala and low


N = 14

Moderate


N = 37

High


N = 116

Overall comparison

Group comparison (p b 05)


Age (mean SD) 474 (72) 512 (93) 493 (85) F = 121 p = 30

Long-term sick leave andor without job (N )

(pensioners and homemaker excluded)

110 (100) 1429 (483) 4680 (575) 3 N 1 Chi2 = 81 p = 005

Years since chronic widespread pain (mean SD) 58 (65) 71 (70) 81 (69) F = 081 p = 45

Years since FMS diagnosis (mean SD) 17 (30) 19 (27) 22 (26) F = 027 p = 76



Pain Disability Index (0ndash70) (mean SD) 228 (132) 399 (158) 434 (134) F = 1366 p b 0001 3 N 2 N 1

Potential depressive disorder (PH2 score N=3) 5 (357) 22 (595) 95(819) Chi2 = 1800 p b 0001 3 N 1 2 N 1

Cur rent anxiety and or depressive disorder in psychiatric inter view 4 ( 286) 24 ( 649) 98 (845) Chi2 = 1995 p b 0001 3 N 1 2 N 1

a 3 patients with PHQ 15 scores b5


7232019 1-s20-S0022399914000269-main


[9] Ablin J N Amital H Ahrenfeld M Buskila D Guidelines for the diagnosis and treat-ment of the 1047297bromyalgia syndrome Harefuah 2013152(12)742ndash7 [article inHebrew English abstract]

[10] Eich W Haumluser W Arnold B Bernardy K Bruumlckle W Eidmann U et alArbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften(Fibromyalgia syndrome General principles and coordination of clinical care andpatient education) Schmerz 201226268ndash75

[11] Henningsen P Zipfel S Herzog W Management of functional somatic syndromesLancet 2007369946ndash55

[12] Silverman S Sadosky A Evans C Yeh Y Alvir JM Zlateva G Toward characterizationand de1047297nition of 1047297bromyalgia severity BMC Musculoskelet Disord 20101166

[13] Kroenke K Spitzer RL Williams JB The PHQ-15 validity of a new measure forevaluating the severity of somatic symptoms Psychosom Med 200264258ndash66[14] Kroenke K Spitzer RL Williams JB Loumlwe B The Patient Health Questionnaire somatic

anxiety and depressive symptom scales a systematic review Gen Hosp Psychiatry201032345ndash59

[15] Tomenson B Essau C Jacobi F Ladwig KH Leiknes KA Lieb R et al Total somaticsymptom score as a predictor of health outcome in somatic symptom disorders Br

J Psychiatry 2013203373ndash80[16] Dimsdale JECreedF Escobar J Sharpe M WulsinL BarskyA et alSomatic symptom

disorder an important change in DSM J Psychosom Res 201375223ndash8[17] Haumluser W Schmutzer G Braumlhler E Glaesmer H A cluster within the continuum

of biopsychosocial distress can be labeled ldquo1047297bromyalgia syndromerdquomdashevidencefrom a representative German population survey J Rheumatol 2009362806ndash12httpdxdoiorg103899jrheum090579

[18] Wolfe F Michaud K The National Data Bank for rheumatic diseases a multi-registryrheumatic disease data bank Rheumatology (Oxford) 20115016ndash24

[19] Haumluser W Jung E Erbsloumlh-Moumlller B Gesmann M Kuumlhn-Becker H PetermannF et alValidation of the Fibromyalgia Survey Questionnaire withina cross-sectional surveyPLoS One 20127e37504

[20] Wolfe F Pain extent and diagnosis developmentand validation of the Regional PainScale in 12 995 patients J Rheumatol 200330369ndash78

[21] HaumluserW SchildS Kosseva M Hayo S vonWilmowski H AltenR et al Validationof the German version of the Regional Pain Scale for the diagnosis of 1047297bromyalgiasyndrome Schmerz 201024226ndash35

[22] Wagner AK Gandek B Aaronson NK Acquadro C Alonso J Apolone G et al Cross-culturalcomparisons of thecontent of SF-36 translations across10 countriesresultsfrom the IQOLA Project International Quality of Life Assessment J Clin Epidemiol199851925ndash32

[23] Gandek B Ware J Aaronson N Apolone G Bjorner J Brazier J et al Cross-validationof item selection and scoring for the SF-12 Health Survey in nine countries resultsfrom the IQOLA project J Clin Epidemiol 1998511171ndash8

[24] Tait RC Chibnall JT Krause S The Pain Disability Index psychometric propertiesPain 199040171ndash82

[25] Dillmann U Nilges P Saile H Gerbershagen HU Assessing disability in chronic painpatients Schmerz Jun 19948100ndash10 [German]

[26] Kroenke K Spitzer RL Jannett BW Williams DSW Loumlwe B An ultra-brief screeningscale for anxiety and depression the PHQ-4 Psychosomatics 200950613ndash21[27] Loumlwe B Wahl I RoseM Spitzer C Glaesmer H Wingenfeld K et alA 4-item measure

of depression and anxiety validation and standardization of the PatientHealth Questionnaire-4 (PHQ-4) in the general population J Affect Disord 201112286ndash95

[28] Kroenke K SpitzerRL Williams JB The PHQ-9 validity of a brief depression severitymeasure J Gen Intern Med 200116606ndash13

[29] Janca A Ustun TB van Drimmelen J Dittmann V Isaac M ICD-10symptom checklistfor mental disorders version 11 Geneva Division of Mental Health World HealthOrganization 1994

[30] Katz RS Wolfe F Michaud K Fibromyalgia diagnosis a comparison of clinicalsurvey and American College of Rheumatology criteria Arthritis Rheum 200654169ndash76

[31] Rabung S How to deal with missing data Psychother Psychosom Med Psychol201060485ndash6

[32] Wolfe F Braumlhler E Hinz A Haumluser W Fibromyalgia prevalence somatic symptomreporting and the dimensionality of polysymptomatic distress results from asurvey of the general population Arthritis Care Res 201365777ndash85

[33] Wolfe F RossK AndersonJ RussellIJ HebertL Theprevalence andcharacteristicsof 1047297bromyalgia in the general population Arthritis Rheum 19953819ndash28

[34] Fink P Schroumlder A One single diagnosis bodily distress syndrome succeeded tocapture 10 diagnostic categories of functional somatic syndromes and somatoformdisorders J Psychosom Res 201068415ndash26


7232019 1-s20-S0022399914000269-main


predictor of health status and healthcare use over and above the effects

of anxiety depression and general medical diseases [15] The PHQ 15

has been proposed for the grading of severity of somatic symptom

disorder (SSD) by the Diagnostic and Statistical Manual of Psychiatric

Diseases DSM V [16] Therefore the total score of the PHQ 15 might be

suited as a generic measure of overall severity of patients diagnosed

with FSS including those with FMS

We tested if thecut-off scoresfor mild moderate and severesomatic

intensity measured by PHQ 15 provide a valid grading of overall severityof FMS We hypothesized that FMS-speci1047297c measures of severity such as

number of pain sites and fatigue as well as psychological distress and

disability would increase with PHQ 15-de1047297ned severity (discriminant

validity) and that these 1047297ndings could be demonstrated in patients of

different settings and countries (transcultural validity)

Methods

Patients and settings

We analyzed the data of three different settings

a FMS-cases within a cross-sectional survey of the general German

population conducted between May and June 2008 [17]

b 2012 survey of the US National Data Bank of Rheumatic Disease(NDB) longitudinal study of rheumatic diseases outcomes [18] Par-

ticipants were volunteers recruited primarily from the practices of

US rheumatologists who complete mailed or Internet question-

naires at 6-month intervals They were not compensated for their

participation

c Consecutive FMS-patients of a German center of pain and psychoso-

matic medicine between January 2011 to December 2013

Questionnaires

Demographic questionnaires

Age and sex were assessed in all surveys TheNDB study determined

work disability by self-report Self-report for disability rather than re-

ceipt of a disability pension was used as all patients are not eligible fora pension because of age or previous work history limitations Duration

of chronic widespread pain time since FMS-diagnosis partnership and

professional status were assessed in the patients of the German clinical

setting study Long-term sick leave was de1047297ned as sick leave Nfour

weeks

Patient Health Questionnaire 15 (PHQ 15)

The PHQ-15 contains 13 somatic and 2 psychological (fatigue sleep

problems) symptoms Each symptom is scored from 0 (not bothered at

all) to 2 (bothered a lot) PHQ-15 scores of 5 10 and 15 represent cutoff

points for low medium and highsomatic symptom severityrespective-

ly The usefulness of the PHQ-15 in screening for somatization syn-

dromes and in monitoring somatic symptom severity in clinical

practice and research has been demonstrated in numerous studies[1314]

Polysymptomatic Distress Scale (PSD)

The PSD includes the Widespread Pain Index (WPI) and the Symp-

tom Severity Score (SSS) The WPI is a 0ndash19 count of painful body

regions The SSS is the sum of the severity (0 ndash3) of the 3 symptoms

(fatigue waking unrefreshed cognitive symptoms) plus the sum of the

number of the following symptoms occurring during the previous

6 months headaches abdominal pain and depression The 1047297nal score

is between 0 and 12 For fatigue waking unrefreshed and cognitive

problems scoring was0 No problem 1 Slight or mild problems general-

ly mild or intermittent 2 Moderate considerable problems often pres-

ent andor at a moderate level 3 Severe continuous life-disturbing

problems Soon after the publication of the 2010 ACR criteria it was

suggested that the 2 components of the 2010 criteria the 0 ndash19 Wide-

spread Pain Index and the 0ndash12 Symptom Severity Score could be com-

bined by addition into a 0ndash31 index termed the ldquoPolysymptomatic

Distressrdquo Scale (PSD) [4] We used the validated German version of the

PSD [19]

Regional Pain Scale (RPS)

The RPS includes the WPI and 0 ndash10 Visual Analog Scale [20] We

used the validated German version of the RPS [21]The Short Form Health Survey SF is a generic measure of health relat-

ed quality of life (HRQOL) Physical and mental health composite scores

(PCS MCS) arecomputedusingthe scores of twelvequestions andrange

from 0 to 100 where a zero score indicates the lowest level of health

measured by the scales and 100 indicates the highest level of health

The reliability and validity of the SF-36 and SF-12 had been proved in

numerous studies [2223] We used the validated German version of

the SF-12 [23] in the survey of the general German population

The Pain Disability Index (PDI) measures disability by pain in seven

areas of daily living (familyhome responsibilities recreation social ac-

tivities occupation sexual behavior self-care life-support activity) on

an 11 point Likert scale The total score of the PDI ranges from 0 to 70

Psychometric evaluations of the PDI in outpatients and inpatients with

chronic pain found high internal consistency testndashretest reliability and

good convergent validity in reference to pain characteristics and pain

behavior [24] We used the validated German version of the PDI [25]

PHQ 4

The 2-item depression scale of the 4-item Patient Health

Questionnaire-4 (PHQ-4) which scores two DSM-IV criteria of major de-

pression as ldquo0rdquo (not at all) to ldquo3rdquo (nearly every day) was used to screen

for a potential depressive disorder Withreference to the Structured Clin-

ical Interview for DSM-IV (SCID) a score of 3-or-greater on the depres-

sion subscale had a sensitivity of 87 and a speci1047297city of 78 for major

depression disorder and a sensitivity of 79 and a speci1047297city of 86 for

any depressive disorders [26] We used the validated German version

of the PHQ 4 [27] We did not use the PHQ 9 [28] which could overesti-

mate depression in FMS because of the inclusion of key symptoms of

FMS (fatigue sleeping and concentration problems)

Self-reports of mental disease

Patients of the NDB also self-reported current and lifetime ldquomental

illnessrdquo (not de1047297ned further in the questionnaire) and the presence

now and ever of ldquodepressionrdquo and ldquodrug or alcohol abuserdquo We classi1047297ed

a patientas havinga ldquopsychiatric illnessrdquo (current or past) if any ldquomental

illnessrdquo ldquodepressionrdquo or ldquodrug or alcohol abuserdquo was endorsed

Structured psychiatric interview

Patients of the single center German study underwent a structured

psychiatric interview for current anxiety and depressive disorder

using the International Classi1047297cation of the World Health Organization

checklist [29]

Diagnoses

a Persons of the general German population FMS-cases were de1047297ned

by the Katz criteria (N=8 pain sites in the WPI and fatigue score

N=6 on VAS 0ndash10 during last week) [30] The setting of the study

excluded a medical examination

b NDB Diagnoses of the NDB-patients were made by the patients

rheumatologist or con1047297rmed by the patients physician in cases

that were self-referred [18] However to be classi1047297ed as FMS pa-

tientsthey were required to satisfy research criteria for1047297bromyalgia

The research criteria [4] were a modi1047297cation of the 2010 American

College of Rheumatologypreliminary diagnostic criteria for1047297bromy-

algia [3] to allow the use of self-report questionnaires for research

For patients to be diagnosed with 1047297bromyalgia they had to have

either a Widespread Pain Index(WPI) ge7 and Symptom Severity


7232019 1-s20-S0022399914000269-main







analyses











Ethics




Results

Sample composition

















Demographics











Fibromyalgia













Table 1


Questionnaire 15

Minimal and low


N = 42

Moderate


N = 39

High


N = 15

Overall comparison

Group comparison


Age (mean SD) 606 (145) 614 (139) 629 (144) F = 01 p = 87

Pensioner (N ) 25 (595) 18(462) 10 (667) Chi2 = 142 p = 17








Minimal and low


N = 84

Moderate


N = 209

High


N = 147

Overall comparison

Group comparison


Age (mean SD) 654 (102) 609 (120) 561 (129) F = 170 p b 001 1 N 2 N 3








a


5


7232019 1-s20-S0022399914000269-main









Discussion























































Funding source


References









2012109803ndash

13

Table 3



Minimala and low


N = 14

Moderate


N = 37

High


N = 116

Overall comparison



Age (mean SD) 474 (72) 512 (93) 493 (85) F = 121 p = 30



110 (100) 1429 (483) 4680 (575) 3 N 1 Chi2 = 81 p = 005










7232019 1-s20-S0022399914000269-main






























7232019 1-s20-S0022399914000269-main







analyses











Ethics




Results

Sample composition

















Demographics











Fibromyalgia













Table 1


Questionnaire 15

Minimal and low


N = 42

Moderate


N = 39

High


N = 15

Overall comparison

Group comparison


Age (mean SD) 606 (145) 614 (139) 629 (144) F = 01 p = 87

Pensioner (N ) 25 (595) 18(462) 10 (667) Chi2 = 142 p = 17








Minimal and low


N = 84

Moderate


N = 209

High


N = 147

Overall comparison

Group comparison


Age (mean SD) 654 (102) 609 (120) 561 (129) F = 170 p b 001 1 N 2 N 3








a


5


7232019 1-s20-S0022399914000269-main









Discussion























































Funding source


References









2012109803ndash

13

Table 3



Minimala and low


N = 14

Moderate


N = 37

High


N = 116

Overall comparison



Age (mean SD) 474 (72) 512 (93) 493 (85) F = 121 p = 30



110 (100) 1429 (483) 4680 (575) 3 N 1 Chi2 = 81 p = 005










7232019 1-s20-S0022399914000269-main






























7232019 1-s20-S0022399914000269-main









Discussion























































Funding source


References









2012109803ndash

13

Table 3



Minimala and low


N = 14

Moderate


N = 37

High


N = 116

Overall comparison



Age (mean SD) 474 (72) 512 (93) 493 (85) F = 121 p = 30



110 (100) 1429 (483) 4680 (575) 3 N 1 Chi2 = 81 p = 005










7232019 1-s20-S0022399914000269-main






























7232019 1-s20-S0022399914000269-main






























Documents

1-s2.0-S0022399914000269-main