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Patient-related	predictors	of	treatment
satisfaction	of	patients	with	fibromyalgia
syndrome:	Results	of	a	cross-sectional	survey
Article		in		Clinical	and	experimental	rheumatology	·	May	2013
Source:	PubMed
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S-34
1
Chair of Complementary and Integrative
Medicine, University of Duisburg-Essen,
Essen, Germany; 2
Department of Internal
Medicine I, Klinikum Saarbrücken,
Saarbrücken, Germany; 3
Department
of Psychosomatic Medicine and
Psychotherapy, Technische Universität
München, München, Germany;
4
Rheumatology Office, Neunkirchen,
Germany; 5
Psychosomatic Medicine and
Pain Therapy Office, Herford, Germany;
6
Psychosomatic Medicine and Pain
Therapy Medical Practice, Zweibrücken,
Germany; 7
Centre of Clinical Psychology
and Rehabilitation, Universität Bremen,
Bremen, Germany; 8
Outpatient Clinic
Mannheim Dr Weiss, Mannheim, Germany;
9
Algesiolgikum München, München,
Germany; 10
Department of Physical
Medicine and Rehabilitation, Klinikum der
Universität München, München, Germany;
11
Department of Internal and Integrative
Medicine, Kliniken Essen-Mitte, Essen,
Germany.
Romy Lauche, PhD
Winfried Häuser, MD, Priv.-Doz.
Eva Jung, MD
Brigitte Erbslöh-Möller, MD
Mechthild Gesmann, MD
Hedi Kühn-Becker, MD
Franz Petermann, PhD, Prof
Thomas Weiss, MD
Reinhard Thoma, MD
Andreas Winkelmann, MD
Jost Langhorst, MD, Prof.
Please address correspondence to:
Dr Romy Lauche,
Kliniken Essen-Mitte,
Department of Internal
and Integrative Medicine,
Am Deimelsberg 34a,
45276 Essen, Germany.
E-mail: r.lauche@kliniken-essen-mitte.de
Received on December 17, 2012; accepted
in revised form on February 13, 2013.
Clin Exp Rheumatol 2013; 31 (Suppl. 79):
S34-S40.
© Copyright Clinical and
Experimental Rheumatology 2013.
Key words: fibromyalgia, treatment
satisfaction, survey, cross-sectional
study
Competing interests: none declared.
ABSTRACT
Objectives. This study aimed to de-
termine patient-related predictors of
treatment satisfaction in fibromyalgia
syndrome (FMS)-patients.
Methods. In a cross-sectional survey,
participants with self-reported diagno-
sis of FMS were recruited by FMS-self
help organisations and clinical insti-
tutions. The patients answered demo-
graphic and medical questionnaires,
the Fibromyalgia Survey Questionnaire
(FSQ) including the Somatic Severity
Score (SSS) and Widespread Pain In-
dex (WPI), the Patient Health Ques-
tionnaire (PHQ-4), and rated their
treatment satisfaction on an 11-point
Likert scale. The impact of patient-re-
lated variables (age, gender, partner-
ship, educational level, time since on-
set of pain, time since FMS-diagnosis,
health status since diagnosis, member-
ship in FMS self-help organisations,
polysymptomatic distress, anxiety and
depression) and types of treatment on
treatment satisfaction were tested by a
multiple regression analysis.
Results. The study sample (n=1651
patients) was composed mainly of mid-
dle-aged women with a long disease
history, and 83.9% fulfilled the Ameri-
can College of Rheumatology diagnos-
tic criteria of 2010. There was con-
siderate variety regarding treatment
satisfaction in FMS-patients, 14.8%
reported no, 31.7% low, 40.8% moder-
ate and 12.7% high satisfaction. High-
er satisfaction was predicted by longer
time since FMS diagnosis (p=0.03),
improved health status since FMS-di-
agnosis (p<0.0001), lower depression
score (p=0.005) and higher amount of
active therapies (p<0.0001). Other so-
ciodemographic (age, gender etc.) and
disease-related variables (polysympto-
matic distress intensity) did not influ-
ence treatment satisfaction.
Conclusion. The results of the study il-
lustrate the influence of patient-related
factors on treatment satisfaction. Treat-
ing comorbid depression and enabling
patients to actively cope with the dis-
ease might prove successful in improv-
ing treatment satisfaction of FMS-pa-
tients.
Introduction
Patient-centred outcomes such as sat-
isfaction with received care (treatment
satisfaction) gained importance within
the past decades (1, 2). Treatment sat-
isfaction is often used as an indicator
of the quality of care (1) and evaluated
within quality assurance measures (3),
but studies have also found that there
is a direct association between satisfac-
tion and therapeutic success. Patients
whose expectations were not met by
the treatment report significantly less
satisfaction and also show less clinical
benefit from therapy (4).
Treatment satisfaction can be influ-
enced by many factors such as the
characteristics of the patients (e.g. de-
mographic characteristics, beliefs, pre-
vious treatment experiences, expecta-
tions), characteristics of the illness be-
ing treated (e.g. acute vs. chronic), and
the treatment modalities being used
(e.g. inpatient vs. outpatient therapy),
and the characteristics of the interac-
tion between patient and therapist (e.g.
authoritarian vs. tolerant therapist) (2,
5). For example, for patients with acute
musculoskeletal conditions the thera-
pist was the main predictor of therapy
satisfaction, whereas for patients with
chronic conditions it was mainly the
organisation of care (6). This study also
found differences between female and
male patients with females being more
satisfied the better the organisation
and communication was. Several oth-
er characteristics of the patients have
been proposed to influence satisfac-
tion, e.g. perceived health status (7) or
psychological conditions and distress
(8, 9). For gender and age (10), civil
Patient-related predictors of treatment satisfaction of patients
with fibromyalgia syndrome: results of a cross-sectional survey
R. Lauche1
, W. Häuser2,3
, E. Jung2,3
, B. Erbslöh-Möller4
, M. Gesmann5
, H. Kühn-Becker6
,
F. Petermann7
, T. Weiss8
, R. Thoma9
, A. Winkelmann10
, J. Langhorst1,11
S-35
Treatment satisfaction in fibromyalgia / R. Lauche et al.
status (11) and education, on the other
hand, the results are inconclusive.
Studies have pointed out the importance
of treatment satisfaction, they have
found that satisfied patients are more
compliant with the therapy and they
also report a higher quality of life (2).
Patients with fibromyalgia syndrome
(FMS), a chronic disorder characterised
by chronic widespread pain, fatigue,
depression, cognitive disturbances and
sleep disturbances and other symptoms
(12-15) as well as their physicians have
been described quite dissatisfied and
frustrated with the treatment outcome
(16, 17). In a multinational survey,
800 FMS-patients rated their satisfac-
tion with their current treatment fairly
satisfied on average (18). On the other
hand, a study with inpatients in a rheu-
matology clinic found higher levels of
satisfaction (19) than those of Choy et
al. (18). The degree of satisfaction was
associated with the general medical
regimen, special massage methods, and
contact with physician and psycholo-
gist and relaxation techniques (19).
Dissatisfaction was associated with
longer mean time to receiving a diag-
nosis and the degree of disability (18).
Patient-related predictors had not
been studied until now in FMS, to our
knowledge. Therefore, the aim of the
study was to assess FMS-patients treat-
ment satisfaction and potential patient-
related predictors in a multicentred
survey.
Methods
The study protocol had been approved
by the ethics committee of the Ludwig
Maximilian Universität München. The
requirements of data protection and
medical professional secrecy were re-
spected by all study investigators. Parts
of the data have previously been pub-
lished (20-22).
Study centres
Study participants were recruited by
the two largest German FMS-self help
organisations and several clinical in-
stitutions specialised in pain medicine
and psychotherapy (3), rheumatology
(2), complementary and alternative
medicine (2), physical therapy (1) and
pain therapy (1). The clinical settings
covered outpatient (6), inpatient (2)
and day care clinic (1). The levels of
care included secondary (6) and ter-
tiary care (1) and rehabilitation (1).
Organisation of the study
From November 1, 2010 to April 30,
2011 all consecutive patients of the
participating study centres with an es-
tablished FMS diagnosis were asked by
the physicians of these centres to take
part in the study. The questionnaires
were handed out by the physicians with
a standardised letter explaining the aim
of the study. The questionnaires were
returned by the patients anonymously
in a closed envelope and stored by
the physician away from the medical
charts. At the end of the study, all ques-
tionnaires were sent to the coordinating
study centre.
For the self-help organisations various
approaches were used to distribute the
questionnaires. Firstly, the central office
of the German League for people with
Arthritis and Rheumatism sent a package
of questionnaire to their regional offices
with the request to hand out the question-
naires during the group meetings.
Secondly, the questionnaire was sent
together with the 4/2010 issue of the
German Fibromyalgia Association
member journal “Optimist”, which
every member regularly receives via
mail. The questionnaires were returned
by mail to the central office of their
self-help organisation on the patients’
own expenses. Thirdly, the question-
naires were available on the home-
pages of both self-help organisations.
After downloading and completing the
questionnaires, they could be sent by
mail, fax or email to the central offices.
Employees of both central offices re-
moved the addressees’ information and
forwarded the questionnaires to the co-
ordinating study centre.
Neither investigators nor patients did
receive any reimbursement.
Inclusion and exclusion criteria
Members of the self-help organisations
had to confirm that the diagnosis of
FMS had been established by a physi-
cian. Because there is no gold standard
for the clinical diagnosis of FMS, the
physicians of the participating study
centres were free in the choice of
FMS-diagnostic criteria. Patients with
somatic diseases sufficiently explain-
ing the pain sites of the Widespread
Pain Index (WPI), e.g. highly active
inflammatory rheumatic disease were
excluded. Patients who were not able
to read German and who had received
a FMS diagnosis within the last month
were excluded. There were no other ex-
clusion criteria.
Questionnaires
Demographics (age, gender, fam-
ily status, educational level, current
professional status, membership in a
FMS-self-help organisation) and medi-
cal data (time since onset of chronic
widespread pain, time since FMS-di-
agnosis, time interval between onset of
pain and diagnosis) were assessed by
a questionnaire of a previous multicen-
tre FMS-study (23). Patients were fur-
ther asked how their health status has
changed since the diagnosis of FMS.
Satisfaction with current treatment was
rated on an 11-point Likert scale rang-
ing from 0 = “not at all satisfied” to 10
= “very satisfied”.
The Fibromyalgia Survey question-
naire (FSQ) included a Symptom Se-
verity Score (SSS) and the Widespread
Pain Index (WPI).
The Symptom Severity Score (SSS)
(14) includes 3 major symptoms (fa-
tigue, trouble thinking or remembering,
waking up tired or unrefreshed within
the past 3 months), each of which is rat-
ed from 0 = “not present” to 3 = “very
severe” and three additional symptoms
(pain or cramps in lower abdomen, de-
pression, headache within the past 6
months) with possible answers 0 = “not
present” and 1 = “present”, which are
indicative for somatic symptom burden.
The total SSS score ranges from 0–12.
For the present survey, the English ver-
sion of the SSS was forward- and back-
translated by four German physicians,
two of whom had worked for several
years in the US.
The Widespread Pain Index (WPI) (14,
24) includes a list of 19 non-articular
sites and patients indicate whether they
suffered from pain at those sites within
the past 3 months. The total WPI score
ranges 0–19. For the survey a validated
S-36
Treatment satisfaction in fibromyalgia / R. Lauche et al.
German version of the WPI was used
(25). The sum of the SSS and WPI
ranging 0–31 is a measure of poly-
symptomatic distress and fibromyalgia
severity, respectively (26).
To satisfy the Fibromyalgia Survey Di-
agnostic Criteria (FDSC) (21), a modi-
fied version of the Fibromyalgia Diag-
nostic Criteria by the American College
of Rheumatology (ACR) (14) patients
had to meet the following 3 conditions:
1) WPI ≥7/19 and SSS ≥5/12 or WPI be-
tween 3–6/19 and SSS ≥9/12; 2) symp-
toms have been present at a similar level
for at least 3 months; 3) no other dis-
order that would otherwise sufficiently
explain the pain (26).
The Patient Health Questionnaire-4
(PHQ-4) (27) is an ultra-brief self-
report questionnaire that consists of a
2-item depression scale (PHQ-2) and a
2-item anxiety scale (GAD-2). A score
of 3-or-greater on the depression sub-
scale represents a reasonable cut-point
for identifying potential cases of ma-
jor depression or other depressive dis-
orders; a score of 3-or-greater on the
anxiety subscale represents a reason-
able cut-point for generalised anxiety,
panic, social anxiety, and posttraumatic
stress disorders. The total PHQ-4 score
complements the subscale scores as an
overall measure of disability (27). For
the survey, the validated German ver-
sion of the PHQ-4 was used (28).
Current therapies were clustered for
analysis in the following way. Firstly,
they were divided into active, passive
and medicinal therapies. Active thera-
pies included physical exercises such
as walking, swimming, biking, hiking,
muscle stretching and strengthening,
mindfulness-based or relaxation meth-
ods such as yoga, qigong, tai chi, pro-
gressive muscle relaxation or medita-
tion. Number of therapies were summed
up and patients could reach scores
between 0 = “no active therapies” up
to 18. Passive therapies included all
kinds of physiotherapy, chiropractic,
ergotherapy and massages, application
of heat, spa and hydrotherapy. Score
for passive therapies ranges from 0 to
20. Drug therapies included all kinds
of medicals (e.g. non-steroidal anti-in-
flammatory drugs, opiod drugs, muscle
relaxants, antidepressants and psycho-
tropic drugs). Medication was clustered
into drug classes and the number of pre-
scribed drug classes (0–8) was counted.
Statistical analysis
The data were entered by four pairs of
study assistants into a preconstructed
excel-data sheet. The data entry was
checked by two authors at random as
well as during descriptive data analy-
sis by means of plausibility. Missing
items of the SSS, WPI and PHQ-4 were
coded as zero. Patients were excluded
from analysis if no item of SSS and/or
WPI and/or PHQ-4 was answered.
All analyses were conducted for the
whole sample as well as subsamples
according to the ACR criteria (21), i.e.
patients who fulfilled the ACR criteria
ACR(+) and those who did not ACR(-).
A direct multiple regression analysis
(without stepwise selection procedures)
was performed to assess the relative
predictive value of patient-related vari-
ables on patients’ treatment satisfac-
tion. The independent variables were
coded as follows: age (continuous),
gender (0=male, 1=female), living in
a family or partnership (0=no, 1=yes),
educational level (1=no school fin-
ished, 2=primary school, 3=secondary
school, 4=high school, 5=university),
current employment (0=not employed,
1=employed), time since FMS-diag-
nosis (continuous), time since onset of
chronic widespread pain (continuous),
subjective assessment of health status
since FMS diagnosis (1=very much
worse, 2=much worse, 1=slightly
worse, 4=unchanged, 5=slightly better,
6=much better, 7=very much better),
member of FMS self-help organisa-
tion (0=no, 1=yes), polysymptomatic
distress score (continuous), PHQ-4 de-
pression and anxiety sum scores (con-
tinuous), number of active, passive and
drug therapies (continuous).
Results
Study participants
Figure 1 shows the flowchart of patient
recruitment. There are no data available
regarding how many patients contacted
by the self-help organisation did not
meet the inclusion criteria or refused
to take part in the study. The German
League for people with Arthritis and
Rheumatism estimated that approxi-
mately 10.000 of their members were
FMS-patients. The German Fibromy-
algia Association reported to have ap-
proximately 4000 members with FMS.
123 patients of the clinical samples did
not meet the primary inclusion criteria
and 40 of contacted patients refused to
take part in the study. One thousand,
six hundred and ninety-four people
returned the questionnaires. Of these,
Fig. 1. Flowchart of patient recruitment.
S-37
Treatment satisfaction in fibromyalgia / R. Lauche et al.
1156 (68.2%) had been contacted via
self-help organisations. Forty-three
out of 1694 contacted persons were
excluded due to total missing items
in the WPI (n=40) or SSS (n=3). The
questionnaires of at least 10 people
who were excluded due to missing
WPI-items did not include the WPI
due to an organisational mistake. One
thousand six hundred and fifty-one
people were included in the final anal-
ysis. The ACR(+) subsample included
1386 patients (83.9%), the ACR(-) 265
(16.1%).
The study sample mainly consisted of
middle-aged women with a long du-
ration of CWP (16.6 years) and time
since FMS-diagnosis (6.6 years) (Table
I). The majority reported a deteriora-
tion of health status since FMS diag-
nosis. Treatment satisfaction is also
shown in Table I. Approximately 50%
of the patients were not/little or mod-
erately/highly satisfied with the current
treatment.
Comparisons between ACR(+) and
ACR(-) patients revealed that patients
in the ACR(+) sample were slight-
ly younger, reported more negative
changes of health status since diagno-
ses and were less satisfied than those in
the ACR(-) sample. They also suffered
from more severe symptoms, higher
levels of depression, anxiety and dis-
ability; and they received more active,
passive and drug therapies.
Predictors of
treatment satisfaction
Higher treatment satisfaction in the
complete sample was significantly pre-
dicted by the time since FMS diagnosis
Table I. Demographic and clinical characteristics of the total study sample and subsamples of patients according the ACR criteria (n=1651).
Variable	 n total	 Mean (SD), range	 n (%)	 No FMS according	 FMS according	 p-value
				 to ACR	 to ACR	
Sex, female	 1644			 1565	 (95.2)	 248	 (95.8)	 1317	 (95.1)	 0.75
Age	 1650	 54.3	 (9.8), 19–86			 57.8	 (10.3)	 53.6	 (9.6)	 <0.001
Living with partner/in family	 1638		 1263 (77.1)			
Educational level	 1636
No school finished				 27	 (1.6)
Primary school				 556	 (34.0)
Secondary school				 671	 (41.0)
High school				 130	 (7.9)
University			 	 252	 (15.4)			
Current professional status	 1635
School				 10	 (0.6)
Working without sick leave				 530	 (32.4)
Working, sick leave				 131	 (8.0)
Applying for early retirement due to FMS				 150	 (9.2)
Without job				 21	 (1.3)
Housewife				 179	 (10.9)
Pensioneer			 	 614	 (37.6)			
Member of a FMS self-help organisation	 1641			 1011	 (61.6)			
Time since onset of chronic widespread pain (in years)	 1625	 16.6	 (11.1), 0–61			 17.1	 (12.2)	 16.5	 (10.9)	 0.49
Time since FMS-diagnosis (in years) 	 1595	 6.6	 (5.5), 0–41			 6.9	 (5.6)	 6.6	 (5.4)	 0.36
Development of health status since FMS-diagnosis	 1493
Very much worse				 763	 (51.1)	 85	 (37.0)	 678	 (53.7)	 <0.001
Much worse				 262	 (17.5)	 30	 (13.0)	 232	 (18.4)
Slightly worse				 30	 (2.0)	 4	 (1.7)	 26	 (2.1)
Unchanged				 216	 (14.5)	 40	 (17.4)	 176	 (13.9)
Slightly better				 60	 (4.0)	 13	 (5.7)	 47	 (3.7)
Much better				 95	 (6.4)	 27	 (11.7)	 68	 (5.4)
Very much better				 67	 (4.5)	 31	 (13.5)	 36	 (2.9)	
Treatment satisfaction	 1423
No satisfaction (0)				 211	 (14.8)	 25	 (11.6)	 186	 (15.4)	 <0.001
Low satisfaction (1–3)				 451	 (31.7)	 55	 (25.5)	 396	 (32.8)
Moderate satisfaction (4–7)				 580	 (40.8)	 85	 (39.4)	 495	 (41.0)
High satisfaction (8–10)				 181	 (12.7)	 51	 (23.6)	 130	 (10.8)	
Polysymptomatic distress (0–31)	 1603	 19.9	 (5.6), 2–31			 11.4	 (3.9)	 21.3	 (4.6)	 <0.001
PHQ-4 Depression (0–6)	 1620	 3.0	 (1.7), 0–6			 1.6	 (1.4)	 3.2	 (1.7)	 <0.001
PHQ-4 Anxiety (0–6)	 1617	 2.9	 (1.8), 0–6			 1.5	 (1.5)	 3.2	 (1.8)	 <0.001
PHQ-4 Disability (0–12)	 1617	 5.9	 (3.2), 0–12			 3.1	 (2.6)	 6.4	 (3.1)	 <0.001
Active therapies, n	 1651	 3.6	 (2.5), 0–12			 3.1	 (2.4)	 3.7	 (2.5)	 <0.001
Passive therapies, n	 165	 13.9	 (2.4), 0–13			 3.3	 (2.3)	 4.0	 (2.3)	 <0.001
Prescribed drug classes, n	 1651	 1.6	 (1.1), 0–6			 1.3	 (1.0)	 1.6	 (1.1)	 <0.001
S-38
Treatment satisfaction in fibromyalgia / R. Lauche et al.
(p=0.03), improvement of health sta-
tus since diagnosis (p<0.001), lower
depression scores (p=0.005) and the
number of current active treatments
(p<0.001) (Table II). The results were
mainly the same as the ACR(+) sam-
ple (additional factor: shorter time
since onset of chronic widespread pain,
p=0.043) (see Table III). In the ACR(-)
sample the only significant predictor
was improvement of health status since
diagnosis (p<0.001) (Table IV).
Discussion
Summary of main findings
FMS-patients’ satisfaction with their
current treatment was assessed in a
multicentred cross-sectional survey.
There was considerate variety regard-
ing treatment satisfaction in the sample
with 50% of the patients, each being not
very or very satisfied. Higher treatment
satisfaction was predicted by longer
time since diagnosis of FMS, improve-
ment of health status since then, lower
depression scores and the number of
active therapies currently applied for
FMS treatment. In the ACR(+) sub-
sample a shorter time since onset of
chronic widespread pain also proved a
significant predictor.
Relation to other studies
Treatment satisfaction is an important
factor for both patients and providers.
Findings on FMS-patients’ treatment
satisfaction have been sparse and in-
conclusive. While Wild and Müller
(19) found high treatment satisfaction
in German FMS-patients after inpatient
rehabilitation, a multinational study by
Choy et al. (18) found that half of the
800 patients were fairly satisfied and
only one fifth was very satisfied with
treatment. Since the former study (19)
was conducted in patients after an in-
patient treatment programme, the treat-
ment satisfaction may have been over-
estimated due to the so-called “holiday
effect” of inpatient treatment. The
present study found that patients were
mainly low to moderately satisfied
with current treatment, which is more
in line with Choy et al. (18).
Treatment satisfaction was higher in
those patients with longer time since
FMS diagnosis. For the subsample
of ACR(+) patients, it was further as-
sociated with shorter time intervals
since onset of chronic widespread pain.
Nöller and Sprott (29) found that, de-
spite constant complaints, many FMS-
patients reported a better satisfaction
with their health status over time, which
might reflect some kind of mental ad-
justment to the disease and be in line
with observations that a certain disease
activity might be preferred over risk of
therapy changes (30). This does contra-
dict the present results.
The increased satisfaction in our sam-
ple might assumably be caused by the
fact that without a correct diagnosis a
patient might not receive proper treat-
ment. After diagnosis they should re-
ceive more effective therapies. Over
time patients might also figure out
which therapies they benefit from and
which therapies are ineffective. They
also have the possibility to connect
with other FMS-patients in self-help
organisations. On the other hand, the
Table II. Multiple regression analysis of patient-related predictors of FMS-patients’ treat-
ment satisfaction.
Independent variable	 β-	 Standard 	 Standardised	 T	 p-value
(predictor)	 coefficient	 error	 β-coefficient	
Constant	 2.54	 0.75		 3.37	 0.001
Age	 0.01	 0.01	 0.04	 1.05	 0.29
Gender	 0.21	 0.34	 0.02	 0.62	 0.54
Living situation	 0.05	 0.18	 0.01	 0.26	 0.79
Employment	 0.05	 0.18	 0.01	 0.27	 0.79
Educational level	 -0.04	 0.07	 -0.01	 -0.51	 0.61
Time since onset of chronic widespread pain	 -0.02	 0.01	 -0.06	 -1.93	 0.054
Time since FMS-diagnosis	 0.04	 0.02	 0.08	 2.23	 0.03
Polysymptomatic distress severity	 -0.01	 0.02	 -0.02	 -0.49	 0.62
Depression score	 -0.18	 0.06	 -0.11	 -2.81	 0.005
Anxiety score	 0.02	 0.06	 0.01	 0.30	 0.76
Membership in
self-help organisation	 -0.23	 0.17	 -0.04	 -1.35	 0.18
Health status since
FMS-diagnosis	 0.35	 0.04	 0.23	 7.91	 <0.001
Active therapies, n	 0.16	 0.04	 0.14	 4.50	 <0.001
Passive therapies, n	 0.02	 0.04	 0.01	 0.41	 0.68
Drug classes, n	 0.12	 0.07	 0.05	 1.58	 0.11
Significant results are marked in bold.
Table III. Multiple regression analysis of patient-related predictors of FMS-patients’ treat-
ment satisfaction in those patients fulfilling the ACR criteria.
						
Independent variable	 β-	 Standard	 Standardised	 T	 p-value
(predictor)	 coefficient	 error	 β-coefficient	
Constant	 2.06	 0.83		 2.482	 0.01
Age	 0.01	 0.01	 0.04	 1.01	 0.31
Gender	 0.18	 0.363	 0.02	 0.51	 0.61
Living situation	 0.04	 0.20	 0.01	 0.19	 0.85
Employment	 0.10	 0.18	 0.02	 0.52	 0.61
Educational level	 -0.07	 0.08	 -0.03	 -0.85	 0.40
Time since onset of chronic widespread pain	 -0.02	 0.01	 -0.07	 -1.98	 0.048
Time since FMS-diagnosis	 0.04	 0.02	 0.07	 2.02	 0.043
Polysymptomatic distress severity	 0.01	 0.02	 0.01	 0.40	 0.69
Depression score	 -0.20	 0.07	 -0.12	 -2.98	 0.003
Anxiety score	 0.06	 0.06	 0.04	 0.99	 0.32
Membership in self-help organisation	 -0.19	 0.18	 -0.03	 -1.07	 0.28
Health status since FMS-diagnosis	 0.32	 0.05	 0.20	 6.51	 <0.001
Active therapies, n	 0.16	 0.04	 0.14	 4.17	 <0.001
Passive therapies, n	 0.05	 0.04	 0.04	 1.09	 0.28
Drug classes, n	 0.15	 0.08	 0.06	 1.84	 0.07
Significant results are marked in bold.
S-39
Treatment satisfaction in fibromyalgia / R. Lauche et al.
longer the patients suffer from pain, the
less satisfied they might be.
Consistent with previous findings (18)
regarding FMS and the results from a
study that investigated patients with
somatoform disorders (31), the regres-
sion analysis for the complete sample
and the ACR(+) patients showed an
association between treatment satisfac-
tion and depressed mood. A systematic
review (13) demonstrated the negative
impact of depression on FMS-outcomes
such as disability, quality of life and
success of multicomponent treatment.
From the present study it can also be
concluded that depressive symptoms
are associated with decreased treat-
ment satisfaction. The association of
negative FMS-outcomes in depression
might be explained by the fact that a
negative view of the self and the own
(health) situation is a key feature of de-
pression (27).
Finally, the regression analysis revealed
that the amount of active therapies was
an important predictor for patients’
treatment satisfaction, i.e. the more pa-
tients participate in exercises or the like,
the more they were satisfied. Contrary
to the number of passive and drug ther-
apies, which did not seem to influence
patients’ satisfaction, the participation
in various kinds of exercises, relaxation
and self-help strategies seems to reflect
an effective coping style rather than just
display the absolute amount of thera-
pies or drugs received. Multimodality
of therapy that encourages patients to
become active and use self-help strate-
gies is considered important in chronic
diseases such as back pain (31) or head-
ache (32) and might be worthwhile for
treatment and further investigation in
FMS-patients (33, 34).
Interestingly for the ACR(-) patients
who showed a better health status than
the ACR(+) patients, no such associa-
tion could be found. In those patients
satisfaction was only related to the
change of health status after diagnosis.
Limitations
The results might be limited by several
factors such as the the sample itself,
which was mainly female, middle-aged
and by high proportion self-selected
over the self-help organisations. No
primary care centres were included in
the study; however, it can be assumed
that many patients from self-help
groups are treated by primary care phy-
cisians. This seems to be supported by
the data, i.e. patients from self-help or-
ganisation did actually report the same
amount of therapies as did the patients
from the clinical centres.
Of the patients analysed, 16.1% did
not meet the modified ACR 2010 di-
agnostic criteria at study entry. How-
ever, longitudinal studies demonstrate
that many patients with FMS diag-
nosed by a physician switched between
criteria-positive and criteria-negative
states in the long run (35). Moreover,
we performed a subgroup analysis of
criteria-positive and criteria-negative
patients and confirmed the results for
the ACR(+) subsample.
Another limitation concerns the het-
erogeneous patient samples, i.e. self-
help organisation members vs. clini-
cal patients, inpatients vs. outpatients,
conventional vs. complementary vs.
psychosomatic medicine. These dif-
ferent facilities might use different ap-
proaches to enable the patients to ac-
tively engage in their treatment, which
should influence their treatment satis-
faction. However, the analysis included
the amount of active, passive and drug
therapies as possible predictors.
Besides the patient-related variables
it has also been found that satisfaction
with treatment depends on other non-
patient-related outcomes such as change
of health care provider as well quality
of treatment (5, 36), however they were
not assessed in the present study.
Finally, the survey did not utilise a
validated translation of the patient sat-
isfaction questionnaire because these
questionnaires usually assess the sat-
isfaction with a medical consultation
and were therefore not considered ap-
plicable. The Symptom Severity Score
might also have benefited from pretest-
ing according to cross-cultural adap-
tion guidelines as did the Multidimen-
sional Fatigue Inventory (MFI) (37).
Diagnosis of FMS symptoms also re-
lied on patients report and no objective
confirmation of the diagnosis was pos-
sible.
Finally, health care systems and prob-
ably expectations of patients on thera-
pies differ in Europe. The results of our
study might not be valid for patients in
other European countries.
Conclusion
In conclusion, there was considerate
variety regarding treatment satisfac-
tion in FMS-patients. Higher treat-
ment satisfaction was predicted time
since diagnosis of FMS, improvement
of health status since diagnosis, lower
depression scores and the number of
Table IV. Multiple regression analysis of patient-related predictors of FMS-patients’ treat-
ment satisfaction in patients not fulfilling the ACR criteria.
					
Independent variable	 β-	 Standard	 Standardised	 T	 p-value
(predictor)	 coefficient	 error	 β-coefficient	
Constant	 3.35	 2.20		 1.52	 0.13
Age	 -0.01	 0.03	 -0.02	 -0.20	 0.84
Gender	 0.04	 0.99	 0.00	 0.04	 0.97
Living situation	 0.19	 0.58	 0.03	 0.33	 0.74
Employment	 -0.33	 0.61	 -0.05	 -0.54	 0.59
Educational level	 .03	 0.21	 0.01	 0.14	 0.89
Time since onset of chronic widespread pain	 -0.01	 0.03	 -0.05	 -0.43	 0.67
Time since FMS-diagnosis	 0.05	 0.05	 0.10	 0.88	 0.38
Polysymptomatic distress severity	 0.07	 0.07	 0.09	 1.02	 0.31
Depression score	 -0.09	 0.22	 -0.05	 -0.42	 0.67
Anxiety score	 -0.24	 0.19	 -0.13	 -1.31	 0.19
Membership in self-help organisation	 -0.39	 0.56	 -0.06	 -0.69	 0.49
Health status since FMS-diagnosis	 0.46	 0.11	 0.37	 4.20	 <0.001
Active therapies, n	 0.21	 0.11	 0.18	 1.90	 0.06
Passive therapies, n	 -0.15	 0.13	 -0.12	 -1.22	 0.23
Drug classes, n	 -0.08	 0.23	 -0.03	 -0.34	 0.74
Significant results are marked in bold.
S-40
Treatment satisfaction in fibromyalgia / R. Lauche et al.
active therapies currently applied for
FMS treatment. These results illustrate
the importance of patient-centred fac-
tors such as comorbid depression and
active coping for treatment satisfaction
in FMS.
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Clin exp rheumatol 2013 patient satisfaction fms

  • 1. See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/236947054 Patient-related predictors of treatment satisfaction of patients with fibromyalgia syndrome: Results of a cross-sectional survey Article in Clinical and experimental rheumatology · May 2013 Source: PubMed CITATIONS 3 READS 146 11 authors, including: Romy Lauche University of Technology Sydney 165 PUBLICATIONS 1,018 CITATIONS SEE PROFILE Franz Petermann Universität Bremen 1,883 PUBLICATIONS 9,980 CITATIONS SEE PROFILE Reinhard Thoma Algesiologikum Pain Medicine Centers 37 PUBLICATIONS 139 CITATIONS SEE PROFILE Jost Langhorst University Hospital Essen 189 PUBLICATIONS 2,640 CITATIONS SEE PROFILE All in-text references underlined in blue are linked to publications on ResearchGate, letting you access and read them immediately. Available from: Winfried Häuser Retrieved on: 06 September 2016
  • 2. S-34 1 Chair of Complementary and Integrative Medicine, University of Duisburg-Essen, Essen, Germany; 2 Department of Internal Medicine I, Klinikum Saarbrücken, Saarbrücken, Germany; 3 Department of Psychosomatic Medicine and Psychotherapy, Technische Universität München, München, Germany; 4 Rheumatology Office, Neunkirchen, Germany; 5 Psychosomatic Medicine and Pain Therapy Office, Herford, Germany; 6 Psychosomatic Medicine and Pain Therapy Medical Practice, Zweibrücken, Germany; 7 Centre of Clinical Psychology and Rehabilitation, Universität Bremen, Bremen, Germany; 8 Outpatient Clinic Mannheim Dr Weiss, Mannheim, Germany; 9 Algesiolgikum München, München, Germany; 10 Department of Physical Medicine and Rehabilitation, Klinikum der Universität München, München, Germany; 11 Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Essen, Germany. Romy Lauche, PhD Winfried Häuser, MD, Priv.-Doz. Eva Jung, MD Brigitte Erbslöh-Möller, MD Mechthild Gesmann, MD Hedi Kühn-Becker, MD Franz Petermann, PhD, Prof Thomas Weiss, MD Reinhard Thoma, MD Andreas Winkelmann, MD Jost Langhorst, MD, Prof. Please address correspondence to: Dr Romy Lauche, Kliniken Essen-Mitte, Department of Internal and Integrative Medicine, Am Deimelsberg 34a, 45276 Essen, Germany. E-mail: r.lauche@kliniken-essen-mitte.de Received on December 17, 2012; accepted in revised form on February 13, 2013. Clin Exp Rheumatol 2013; 31 (Suppl. 79): S34-S40. © Copyright Clinical and Experimental Rheumatology 2013. Key words: fibromyalgia, treatment satisfaction, survey, cross-sectional study Competing interests: none declared. ABSTRACT Objectives. This study aimed to de- termine patient-related predictors of treatment satisfaction in fibromyalgia syndrome (FMS)-patients. Methods. In a cross-sectional survey, participants with self-reported diagno- sis of FMS were recruited by FMS-self help organisations and clinical insti- tutions. The patients answered demo- graphic and medical questionnaires, the Fibromyalgia Survey Questionnaire (FSQ) including the Somatic Severity Score (SSS) and Widespread Pain In- dex (WPI), the Patient Health Ques- tionnaire (PHQ-4), and rated their treatment satisfaction on an 11-point Likert scale. The impact of patient-re- lated variables (age, gender, partner- ship, educational level, time since on- set of pain, time since FMS-diagnosis, health status since diagnosis, member- ship in FMS self-help organisations, polysymptomatic distress, anxiety and depression) and types of treatment on treatment satisfaction were tested by a multiple regression analysis. Results. The study sample (n=1651 patients) was composed mainly of mid- dle-aged women with a long disease history, and 83.9% fulfilled the Ameri- can College of Rheumatology diagnos- tic criteria of 2010. There was con- siderate variety regarding treatment satisfaction in FMS-patients, 14.8% reported no, 31.7% low, 40.8% moder- ate and 12.7% high satisfaction. High- er satisfaction was predicted by longer time since FMS diagnosis (p=0.03), improved health status since FMS-di- agnosis (p<0.0001), lower depression score (p=0.005) and higher amount of active therapies (p<0.0001). Other so- ciodemographic (age, gender etc.) and disease-related variables (polysympto- matic distress intensity) did not influ- ence treatment satisfaction. Conclusion. The results of the study il- lustrate the influence of patient-related factors on treatment satisfaction. Treat- ing comorbid depression and enabling patients to actively cope with the dis- ease might prove successful in improv- ing treatment satisfaction of FMS-pa- tients. Introduction Patient-centred outcomes such as sat- isfaction with received care (treatment satisfaction) gained importance within the past decades (1, 2). Treatment sat- isfaction is often used as an indicator of the quality of care (1) and evaluated within quality assurance measures (3), but studies have also found that there is a direct association between satisfac- tion and therapeutic success. Patients whose expectations were not met by the treatment report significantly less satisfaction and also show less clinical benefit from therapy (4). Treatment satisfaction can be influ- enced by many factors such as the characteristics of the patients (e.g. de- mographic characteristics, beliefs, pre- vious treatment experiences, expecta- tions), characteristics of the illness be- ing treated (e.g. acute vs. chronic), and the treatment modalities being used (e.g. inpatient vs. outpatient therapy), and the characteristics of the interac- tion between patient and therapist (e.g. authoritarian vs. tolerant therapist) (2, 5). For example, for patients with acute musculoskeletal conditions the thera- pist was the main predictor of therapy satisfaction, whereas for patients with chronic conditions it was mainly the organisation of care (6). This study also found differences between female and male patients with females being more satisfied the better the organisation and communication was. Several oth- er characteristics of the patients have been proposed to influence satisfac- tion, e.g. perceived health status (7) or psychological conditions and distress (8, 9). For gender and age (10), civil Patient-related predictors of treatment satisfaction of patients with fibromyalgia syndrome: results of a cross-sectional survey R. Lauche1 , W. Häuser2,3 , E. Jung2,3 , B. Erbslöh-Möller4 , M. Gesmann5 , H. Kühn-Becker6 , F. Petermann7 , T. Weiss8 , R. Thoma9 , A. Winkelmann10 , J. Langhorst1,11
  • 3. S-35 Treatment satisfaction in fibromyalgia / R. Lauche et al. status (11) and education, on the other hand, the results are inconclusive. Studies have pointed out the importance of treatment satisfaction, they have found that satisfied patients are more compliant with the therapy and they also report a higher quality of life (2). Patients with fibromyalgia syndrome (FMS), a chronic disorder characterised by chronic widespread pain, fatigue, depression, cognitive disturbances and sleep disturbances and other symptoms (12-15) as well as their physicians have been described quite dissatisfied and frustrated with the treatment outcome (16, 17). In a multinational survey, 800 FMS-patients rated their satisfac- tion with their current treatment fairly satisfied on average (18). On the other hand, a study with inpatients in a rheu- matology clinic found higher levels of satisfaction (19) than those of Choy et al. (18). The degree of satisfaction was associated with the general medical regimen, special massage methods, and contact with physician and psycholo- gist and relaxation techniques (19). Dissatisfaction was associated with longer mean time to receiving a diag- nosis and the degree of disability (18). Patient-related predictors had not been studied until now in FMS, to our knowledge. Therefore, the aim of the study was to assess FMS-patients treat- ment satisfaction and potential patient- related predictors in a multicentred survey. Methods The study protocol had been approved by the ethics committee of the Ludwig Maximilian Universität München. The requirements of data protection and medical professional secrecy were re- spected by all study investigators. Parts of the data have previously been pub- lished (20-22). Study centres Study participants were recruited by the two largest German FMS-self help organisations and several clinical in- stitutions specialised in pain medicine and psychotherapy (3), rheumatology (2), complementary and alternative medicine (2), physical therapy (1) and pain therapy (1). The clinical settings covered outpatient (6), inpatient (2) and day care clinic (1). The levels of care included secondary (6) and ter- tiary care (1) and rehabilitation (1). Organisation of the study From November 1, 2010 to April 30, 2011 all consecutive patients of the participating study centres with an es- tablished FMS diagnosis were asked by the physicians of these centres to take part in the study. The questionnaires were handed out by the physicians with a standardised letter explaining the aim of the study. The questionnaires were returned by the patients anonymously in a closed envelope and stored by the physician away from the medical charts. At the end of the study, all ques- tionnaires were sent to the coordinating study centre. For the self-help organisations various approaches were used to distribute the questionnaires. Firstly, the central office of the German League for people with Arthritis and Rheumatism sent a package of questionnaire to their regional offices with the request to hand out the question- naires during the group meetings. Secondly, the questionnaire was sent together with the 4/2010 issue of the German Fibromyalgia Association member journal “Optimist”, which every member regularly receives via mail. The questionnaires were returned by mail to the central office of their self-help organisation on the patients’ own expenses. Thirdly, the question- naires were available on the home- pages of both self-help organisations. After downloading and completing the questionnaires, they could be sent by mail, fax or email to the central offices. Employees of both central offices re- moved the addressees’ information and forwarded the questionnaires to the co- ordinating study centre. Neither investigators nor patients did receive any reimbursement. Inclusion and exclusion criteria Members of the self-help organisations had to confirm that the diagnosis of FMS had been established by a physi- cian. Because there is no gold standard for the clinical diagnosis of FMS, the physicians of the participating study centres were free in the choice of FMS-diagnostic criteria. Patients with somatic diseases sufficiently explain- ing the pain sites of the Widespread Pain Index (WPI), e.g. highly active inflammatory rheumatic disease were excluded. Patients who were not able to read German and who had received a FMS diagnosis within the last month were excluded. There were no other ex- clusion criteria. Questionnaires Demographics (age, gender, fam- ily status, educational level, current professional status, membership in a FMS-self-help organisation) and medi- cal data (time since onset of chronic widespread pain, time since FMS-di- agnosis, time interval between onset of pain and diagnosis) were assessed by a questionnaire of a previous multicen- tre FMS-study (23). Patients were fur- ther asked how their health status has changed since the diagnosis of FMS. Satisfaction with current treatment was rated on an 11-point Likert scale rang- ing from 0 = “not at all satisfied” to 10 = “very satisfied”. The Fibromyalgia Survey question- naire (FSQ) included a Symptom Se- verity Score (SSS) and the Widespread Pain Index (WPI). The Symptom Severity Score (SSS) (14) includes 3 major symptoms (fa- tigue, trouble thinking or remembering, waking up tired or unrefreshed within the past 3 months), each of which is rat- ed from 0 = “not present” to 3 = “very severe” and three additional symptoms (pain or cramps in lower abdomen, de- pression, headache within the past 6 months) with possible answers 0 = “not present” and 1 = “present”, which are indicative for somatic symptom burden. The total SSS score ranges from 0–12. For the present survey, the English ver- sion of the SSS was forward- and back- translated by four German physicians, two of whom had worked for several years in the US. The Widespread Pain Index (WPI) (14, 24) includes a list of 19 non-articular sites and patients indicate whether they suffered from pain at those sites within the past 3 months. The total WPI score ranges 0–19. For the survey a validated
  • 4. S-36 Treatment satisfaction in fibromyalgia / R. Lauche et al. German version of the WPI was used (25). The sum of the SSS and WPI ranging 0–31 is a measure of poly- symptomatic distress and fibromyalgia severity, respectively (26). To satisfy the Fibromyalgia Survey Di- agnostic Criteria (FDSC) (21), a modi- fied version of the Fibromyalgia Diag- nostic Criteria by the American College of Rheumatology (ACR) (14) patients had to meet the following 3 conditions: 1) WPI ≥7/19 and SSS ≥5/12 or WPI be- tween 3–6/19 and SSS ≥9/12; 2) symp- toms have been present at a similar level for at least 3 months; 3) no other dis- order that would otherwise sufficiently explain the pain (26). The Patient Health Questionnaire-4 (PHQ-4) (27) is an ultra-brief self- report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). A score of 3-or-greater on the depression sub- scale represents a reasonable cut-point for identifying potential cases of ma- jor depression or other depressive dis- orders; a score of 3-or-greater on the anxiety subscale represents a reason- able cut-point for generalised anxiety, panic, social anxiety, and posttraumatic stress disorders. The total PHQ-4 score complements the subscale scores as an overall measure of disability (27). For the survey, the validated German ver- sion of the PHQ-4 was used (28). Current therapies were clustered for analysis in the following way. Firstly, they were divided into active, passive and medicinal therapies. Active thera- pies included physical exercises such as walking, swimming, biking, hiking, muscle stretching and strengthening, mindfulness-based or relaxation meth- ods such as yoga, qigong, tai chi, pro- gressive muscle relaxation or medita- tion. Number of therapies were summed up and patients could reach scores between 0 = “no active therapies” up to 18. Passive therapies included all kinds of physiotherapy, chiropractic, ergotherapy and massages, application of heat, spa and hydrotherapy. Score for passive therapies ranges from 0 to 20. Drug therapies included all kinds of medicals (e.g. non-steroidal anti-in- flammatory drugs, opiod drugs, muscle relaxants, antidepressants and psycho- tropic drugs). Medication was clustered into drug classes and the number of pre- scribed drug classes (0–8) was counted. Statistical analysis The data were entered by four pairs of study assistants into a preconstructed excel-data sheet. The data entry was checked by two authors at random as well as during descriptive data analy- sis by means of plausibility. Missing items of the SSS, WPI and PHQ-4 were coded as zero. Patients were excluded from analysis if no item of SSS and/or WPI and/or PHQ-4 was answered. All analyses were conducted for the whole sample as well as subsamples according to the ACR criteria (21), i.e. patients who fulfilled the ACR criteria ACR(+) and those who did not ACR(-). A direct multiple regression analysis (without stepwise selection procedures) was performed to assess the relative predictive value of patient-related vari- ables on patients’ treatment satisfac- tion. The independent variables were coded as follows: age (continuous), gender (0=male, 1=female), living in a family or partnership (0=no, 1=yes), educational level (1=no school fin- ished, 2=primary school, 3=secondary school, 4=high school, 5=university), current employment (0=not employed, 1=employed), time since FMS-diag- nosis (continuous), time since onset of chronic widespread pain (continuous), subjective assessment of health status since FMS diagnosis (1=very much worse, 2=much worse, 1=slightly worse, 4=unchanged, 5=slightly better, 6=much better, 7=very much better), member of FMS self-help organisa- tion (0=no, 1=yes), polysymptomatic distress score (continuous), PHQ-4 de- pression and anxiety sum scores (con- tinuous), number of active, passive and drug therapies (continuous). Results Study participants Figure 1 shows the flowchart of patient recruitment. There are no data available regarding how many patients contacted by the self-help organisation did not meet the inclusion criteria or refused to take part in the study. The German League for people with Arthritis and Rheumatism estimated that approxi- mately 10.000 of their members were FMS-patients. The German Fibromy- algia Association reported to have ap- proximately 4000 members with FMS. 123 patients of the clinical samples did not meet the primary inclusion criteria and 40 of contacted patients refused to take part in the study. One thousand, six hundred and ninety-four people returned the questionnaires. Of these, Fig. 1. Flowchart of patient recruitment.
  • 5. S-37 Treatment satisfaction in fibromyalgia / R. Lauche et al. 1156 (68.2%) had been contacted via self-help organisations. Forty-three out of 1694 contacted persons were excluded due to total missing items in the WPI (n=40) or SSS (n=3). The questionnaires of at least 10 people who were excluded due to missing WPI-items did not include the WPI due to an organisational mistake. One thousand six hundred and fifty-one people were included in the final anal- ysis. The ACR(+) subsample included 1386 patients (83.9%), the ACR(-) 265 (16.1%). The study sample mainly consisted of middle-aged women with a long du- ration of CWP (16.6 years) and time since FMS-diagnosis (6.6 years) (Table I). The majority reported a deteriora- tion of health status since FMS diag- nosis. Treatment satisfaction is also shown in Table I. Approximately 50% of the patients were not/little or mod- erately/highly satisfied with the current treatment. Comparisons between ACR(+) and ACR(-) patients revealed that patients in the ACR(+) sample were slight- ly younger, reported more negative changes of health status since diagno- ses and were less satisfied than those in the ACR(-) sample. They also suffered from more severe symptoms, higher levels of depression, anxiety and dis- ability; and they received more active, passive and drug therapies. Predictors of treatment satisfaction Higher treatment satisfaction in the complete sample was significantly pre- dicted by the time since FMS diagnosis Table I. Demographic and clinical characteristics of the total study sample and subsamples of patients according the ACR criteria (n=1651). Variable n total Mean (SD), range n (%) No FMS according FMS according p-value to ACR to ACR Sex, female 1644 1565 (95.2) 248 (95.8) 1317 (95.1) 0.75 Age 1650 54.3 (9.8), 19–86 57.8 (10.3) 53.6 (9.6) <0.001 Living with partner/in family 1638 1263 (77.1) Educational level 1636 No school finished 27 (1.6) Primary school 556 (34.0) Secondary school 671 (41.0) High school 130 (7.9) University 252 (15.4) Current professional status 1635 School 10 (0.6) Working without sick leave 530 (32.4) Working, sick leave 131 (8.0) Applying for early retirement due to FMS 150 (9.2) Without job 21 (1.3) Housewife 179 (10.9) Pensioneer 614 (37.6) Member of a FMS self-help organisation 1641 1011 (61.6) Time since onset of chronic widespread pain (in years) 1625 16.6 (11.1), 0–61 17.1 (12.2) 16.5 (10.9) 0.49 Time since FMS-diagnosis (in years) 1595 6.6 (5.5), 0–41 6.9 (5.6) 6.6 (5.4) 0.36 Development of health status since FMS-diagnosis 1493 Very much worse 763 (51.1) 85 (37.0) 678 (53.7) <0.001 Much worse 262 (17.5) 30 (13.0) 232 (18.4) Slightly worse 30 (2.0) 4 (1.7) 26 (2.1) Unchanged 216 (14.5) 40 (17.4) 176 (13.9) Slightly better 60 (4.0) 13 (5.7) 47 (3.7) Much better 95 (6.4) 27 (11.7) 68 (5.4) Very much better 67 (4.5) 31 (13.5) 36 (2.9) Treatment satisfaction 1423 No satisfaction (0) 211 (14.8) 25 (11.6) 186 (15.4) <0.001 Low satisfaction (1–3) 451 (31.7) 55 (25.5) 396 (32.8) Moderate satisfaction (4–7) 580 (40.8) 85 (39.4) 495 (41.0) High satisfaction (8–10) 181 (12.7) 51 (23.6) 130 (10.8) Polysymptomatic distress (0–31) 1603 19.9 (5.6), 2–31 11.4 (3.9) 21.3 (4.6) <0.001 PHQ-4 Depression (0–6) 1620 3.0 (1.7), 0–6 1.6 (1.4) 3.2 (1.7) <0.001 PHQ-4 Anxiety (0–6) 1617 2.9 (1.8), 0–6 1.5 (1.5) 3.2 (1.8) <0.001 PHQ-4 Disability (0–12) 1617 5.9 (3.2), 0–12 3.1 (2.6) 6.4 (3.1) <0.001 Active therapies, n 1651 3.6 (2.5), 0–12 3.1 (2.4) 3.7 (2.5) <0.001 Passive therapies, n 165 13.9 (2.4), 0–13 3.3 (2.3) 4.0 (2.3) <0.001 Prescribed drug classes, n 1651 1.6 (1.1), 0–6 1.3 (1.0) 1.6 (1.1) <0.001
  • 6. S-38 Treatment satisfaction in fibromyalgia / R. Lauche et al. (p=0.03), improvement of health sta- tus since diagnosis (p<0.001), lower depression scores (p=0.005) and the number of current active treatments (p<0.001) (Table II). The results were mainly the same as the ACR(+) sam- ple (additional factor: shorter time since onset of chronic widespread pain, p=0.043) (see Table III). In the ACR(-) sample the only significant predictor was improvement of health status since diagnosis (p<0.001) (Table IV). Discussion Summary of main findings FMS-patients’ satisfaction with their current treatment was assessed in a multicentred cross-sectional survey. There was considerate variety regard- ing treatment satisfaction in the sample with 50% of the patients, each being not very or very satisfied. Higher treatment satisfaction was predicted by longer time since diagnosis of FMS, improve- ment of health status since then, lower depression scores and the number of active therapies currently applied for FMS treatment. In the ACR(+) sub- sample a shorter time since onset of chronic widespread pain also proved a significant predictor. Relation to other studies Treatment satisfaction is an important factor for both patients and providers. Findings on FMS-patients’ treatment satisfaction have been sparse and in- conclusive. While Wild and Müller (19) found high treatment satisfaction in German FMS-patients after inpatient rehabilitation, a multinational study by Choy et al. (18) found that half of the 800 patients were fairly satisfied and only one fifth was very satisfied with treatment. Since the former study (19) was conducted in patients after an in- patient treatment programme, the treat- ment satisfaction may have been over- estimated due to the so-called “holiday effect” of inpatient treatment. The present study found that patients were mainly low to moderately satisfied with current treatment, which is more in line with Choy et al. (18). Treatment satisfaction was higher in those patients with longer time since FMS diagnosis. For the subsample of ACR(+) patients, it was further as- sociated with shorter time intervals since onset of chronic widespread pain. Nöller and Sprott (29) found that, de- spite constant complaints, many FMS- patients reported a better satisfaction with their health status over time, which might reflect some kind of mental ad- justment to the disease and be in line with observations that a certain disease activity might be preferred over risk of therapy changes (30). This does contra- dict the present results. The increased satisfaction in our sam- ple might assumably be caused by the fact that without a correct diagnosis a patient might not receive proper treat- ment. After diagnosis they should re- ceive more effective therapies. Over time patients might also figure out which therapies they benefit from and which therapies are ineffective. They also have the possibility to connect with other FMS-patients in self-help organisations. On the other hand, the Table II. Multiple regression analysis of patient-related predictors of FMS-patients’ treat- ment satisfaction. Independent variable β- Standard Standardised T p-value (predictor) coefficient error β-coefficient Constant 2.54 0.75 3.37 0.001 Age 0.01 0.01 0.04 1.05 0.29 Gender 0.21 0.34 0.02 0.62 0.54 Living situation 0.05 0.18 0.01 0.26 0.79 Employment 0.05 0.18 0.01 0.27 0.79 Educational level -0.04 0.07 -0.01 -0.51 0.61 Time since onset of chronic widespread pain -0.02 0.01 -0.06 -1.93 0.054 Time since FMS-diagnosis 0.04 0.02 0.08 2.23 0.03 Polysymptomatic distress severity -0.01 0.02 -0.02 -0.49 0.62 Depression score -0.18 0.06 -0.11 -2.81 0.005 Anxiety score 0.02 0.06 0.01 0.30 0.76 Membership in self-help organisation -0.23 0.17 -0.04 -1.35 0.18 Health status since FMS-diagnosis 0.35 0.04 0.23 7.91 <0.001 Active therapies, n 0.16 0.04 0.14 4.50 <0.001 Passive therapies, n 0.02 0.04 0.01 0.41 0.68 Drug classes, n 0.12 0.07 0.05 1.58 0.11 Significant results are marked in bold. Table III. Multiple regression analysis of patient-related predictors of FMS-patients’ treat- ment satisfaction in those patients fulfilling the ACR criteria. Independent variable β- Standard Standardised T p-value (predictor) coefficient error β-coefficient Constant 2.06 0.83 2.482 0.01 Age 0.01 0.01 0.04 1.01 0.31 Gender 0.18 0.363 0.02 0.51 0.61 Living situation 0.04 0.20 0.01 0.19 0.85 Employment 0.10 0.18 0.02 0.52 0.61 Educational level -0.07 0.08 -0.03 -0.85 0.40 Time since onset of chronic widespread pain -0.02 0.01 -0.07 -1.98 0.048 Time since FMS-diagnosis 0.04 0.02 0.07 2.02 0.043 Polysymptomatic distress severity 0.01 0.02 0.01 0.40 0.69 Depression score -0.20 0.07 -0.12 -2.98 0.003 Anxiety score 0.06 0.06 0.04 0.99 0.32 Membership in self-help organisation -0.19 0.18 -0.03 -1.07 0.28 Health status since FMS-diagnosis 0.32 0.05 0.20 6.51 <0.001 Active therapies, n 0.16 0.04 0.14 4.17 <0.001 Passive therapies, n 0.05 0.04 0.04 1.09 0.28 Drug classes, n 0.15 0.08 0.06 1.84 0.07 Significant results are marked in bold.
  • 7. S-39 Treatment satisfaction in fibromyalgia / R. Lauche et al. longer the patients suffer from pain, the less satisfied they might be. Consistent with previous findings (18) regarding FMS and the results from a study that investigated patients with somatoform disorders (31), the regres- sion analysis for the complete sample and the ACR(+) patients showed an association between treatment satisfac- tion and depressed mood. A systematic review (13) demonstrated the negative impact of depression on FMS-outcomes such as disability, quality of life and success of multicomponent treatment. From the present study it can also be concluded that depressive symptoms are associated with decreased treat- ment satisfaction. The association of negative FMS-outcomes in depression might be explained by the fact that a negative view of the self and the own (health) situation is a key feature of de- pression (27). Finally, the regression analysis revealed that the amount of active therapies was an important predictor for patients’ treatment satisfaction, i.e. the more pa- tients participate in exercises or the like, the more they were satisfied. Contrary to the number of passive and drug ther- apies, which did not seem to influence patients’ satisfaction, the participation in various kinds of exercises, relaxation and self-help strategies seems to reflect an effective coping style rather than just display the absolute amount of thera- pies or drugs received. Multimodality of therapy that encourages patients to become active and use self-help strate- gies is considered important in chronic diseases such as back pain (31) or head- ache (32) and might be worthwhile for treatment and further investigation in FMS-patients (33, 34). Interestingly for the ACR(-) patients who showed a better health status than the ACR(+) patients, no such associa- tion could be found. In those patients satisfaction was only related to the change of health status after diagnosis. Limitations The results might be limited by several factors such as the the sample itself, which was mainly female, middle-aged and by high proportion self-selected over the self-help organisations. No primary care centres were included in the study; however, it can be assumed that many patients from self-help groups are treated by primary care phy- cisians. This seems to be supported by the data, i.e. patients from self-help or- ganisation did actually report the same amount of therapies as did the patients from the clinical centres. Of the patients analysed, 16.1% did not meet the modified ACR 2010 di- agnostic criteria at study entry. How- ever, longitudinal studies demonstrate that many patients with FMS diag- nosed by a physician switched between criteria-positive and criteria-negative states in the long run (35). Moreover, we performed a subgroup analysis of criteria-positive and criteria-negative patients and confirmed the results for the ACR(+) subsample. Another limitation concerns the het- erogeneous patient samples, i.e. self- help organisation members vs. clini- cal patients, inpatients vs. outpatients, conventional vs. complementary vs. psychosomatic medicine. These dif- ferent facilities might use different ap- proaches to enable the patients to ac- tively engage in their treatment, which should influence their treatment satis- faction. However, the analysis included the amount of active, passive and drug therapies as possible predictors. Besides the patient-related variables it has also been found that satisfaction with treatment depends on other non- patient-related outcomes such as change of health care provider as well quality of treatment (5, 36), however they were not assessed in the present study. Finally, the survey did not utilise a validated translation of the patient sat- isfaction questionnaire because these questionnaires usually assess the sat- isfaction with a medical consultation and were therefore not considered ap- plicable. The Symptom Severity Score might also have benefited from pretest- ing according to cross-cultural adap- tion guidelines as did the Multidimen- sional Fatigue Inventory (MFI) (37). Diagnosis of FMS symptoms also re- lied on patients report and no objective confirmation of the diagnosis was pos- sible. Finally, health care systems and prob- ably expectations of patients on thera- pies differ in Europe. The results of our study might not be valid for patients in other European countries. Conclusion In conclusion, there was considerate variety regarding treatment satisfac- tion in FMS-patients. Higher treat- ment satisfaction was predicted time since diagnosis of FMS, improvement of health status since diagnosis, lower depression scores and the number of Table IV. Multiple regression analysis of patient-related predictors of FMS-patients’ treat- ment satisfaction in patients not fulfilling the ACR criteria. Independent variable β- Standard Standardised T p-value (predictor) coefficient error β-coefficient Constant 3.35 2.20 1.52 0.13 Age -0.01 0.03 -0.02 -0.20 0.84 Gender 0.04 0.99 0.00 0.04 0.97 Living situation 0.19 0.58 0.03 0.33 0.74 Employment -0.33 0.61 -0.05 -0.54 0.59 Educational level .03 0.21 0.01 0.14 0.89 Time since onset of chronic widespread pain -0.01 0.03 -0.05 -0.43 0.67 Time since FMS-diagnosis 0.05 0.05 0.10 0.88 0.38 Polysymptomatic distress severity 0.07 0.07 0.09 1.02 0.31 Depression score -0.09 0.22 -0.05 -0.42 0.67 Anxiety score -0.24 0.19 -0.13 -1.31 0.19 Membership in self-help organisation -0.39 0.56 -0.06 -0.69 0.49 Health status since FMS-diagnosis 0.46 0.11 0.37 4.20 <0.001 Active therapies, n 0.21 0.11 0.18 1.90 0.06 Passive therapies, n -0.15 0.13 -0.12 -1.22 0.23 Drug classes, n -0.08 0.23 -0.03 -0.34 0.74 Significant results are marked in bold.
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