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Patient-Centered	Perspective	on	Treatment
Outcomes	in	Chronic	Pain
Article		in		Pain	Medicine	·	October	2009
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ORIGINAL RESEARCH ARTICLES
Patient-Centered Perspective on Treatment
Outcomes in Chronic Painpme_685 6..15
Erin M. O’Brien, PhD,* Roland M. Staud, MD,†
Alisa D. Hassinger, MS,* Robert C. McCulloch,
PhD,* Jason G. Craggs, PhD,* James W. Atchison,
DO,†
Donald D. Price, PhD,‡
and
Michael E. Robinson, PhD*
*Department of Clinical and Health Psychology,
†
College of Medicine,
‡
Department of Oral and Maxillofacial Surgery,
University of Florida, Gainesville, Florida, USA
Reprint requests to: Michael E. Robinson, PhD,
Department of Clinical and Health Psychology,
University of Florida, Box 100165, Gainesville, FL
32610-0165, USA. Tel: 352-273-6153; Fax:
352-273-6156; E-mail: merobin@ufl.edu.
Abstract
Objective. To define patient-determined success
criteria for fibromyalgia and back pain treatment
across four outcome domains: pain, fatigue, emo-
tional distress, interference with daily activities.
Design. Retrospective correlational clinical sample
design.
Setting. Tertiary care clinics at health science
center.
Patients. 248 fibromyalgia patients and 52 back
pain patients.
Interventions. N/A.
Outcome Measures. Patient Centered Outcomes
Questionnaire, measures of usual pain intensity and
pain unpleasantness.
Results. Overall, for treatment to be considered
successful, fibromyalgia patients required pain
levels of 3.30 (54% reduction), fatigue levels of 3.08
(60% reduction), distress levels of 2.49 (60% reduc-
tion), and interference levels of 2.67 (63% reduction).
Comparatively, back pain patients required pain
levels of 2.23 (58% reduction), fatigue levels of 2.29
(57% reduction), distress levels of 1.65 (67% reduc-
tion), and interference levels of 1.81 (68% reduction).
Overall, both fibromyalgia and back pain patients
did not expect to meet their criteria for success.
Conclusions. Results highlight the importance of
assessing the patient’s view of successful outcome.
Both fibromyalgia and back pain patients appear to
have stringent criteria for success that existing
treatments are often unlikely to meet. Comparison
across groups indicated fibromyalgia patients have
higher usual levels of pain, fatigue, distress, and
interference. Interestingly, fibromyalgia patients
also require greater changes across domains in
order to consider treatment successful, despite
rating higher levels of pain, fatigue, distress, and
interference as successful. Recognizing patients’
success criteria and treatment expectations encour-
ages discussion and development of individualized
treatment goals, and wider implementation of indi-
vidualized treatment for chronic-pain populations is
encouraged.
Key Words. Treatment Outcome; Chronic Pain;
Patient Satisfaction; Back Pain; Fibromyalgia
Introduction
Chronic pain is one of the most frequent, costly, and
disabling medical conditions in the United States, often
resulting in substantial impairments in occupational and
social functioning. Epidemiological studies report that
15% of adults experience chronic pain [1]. The annual
incidence of back pain of moderate intensity and duration
was estimated at 10–15% among the adult population [2],
with research suggesting a lifetime prevalence of signifi-
cant back pain in 80% of adults [3]. Fibromyalgia is a
condition involving widespread musculoskeletal pain,
affecting approximately 2% of adults with chronic pain [4].
This condition is poorly understood, often leading to
patients and providers being dissatisfied with treatment.
Initial evidence suggested that a patient-centered treat-
ment approach resulted in beneficial outcomes among
fibromyalgia patients [5]. While pain is a prominent feature
in fibromyalgia, patients often experience significant
impairments in physical functioning and emotional distress
[6], as well as decreased quality of life [7]. Similarly, back
pain patients also experience impairments in mood and
functioning (e.g., [8,9]), in addition to pain.
The lack of highly effective treatment strategies for chronic
pain patients often frustrates these individuals and their
Pain Medicine 2010; 11: 6–15
© American Academy of Pain Medicine
6
healthcare providers. Importantly, patient dissatisfaction
may lead to more medical visits, more expensive and a
greater number of tests, and the perception of the patient
being “difficult” [5].
Traditionally, determinations about success criteria in
chronic pain treatment have been made predominantly by
healthcare providers. This “medical model” of treatment is
often derived and driven via nomothetic statistical analy-
ses, and does not provide much input for the incorpora-
tion of the patient’s perspective of successful outcome for
any particular course of treatment.
However, adopting a patient-centered treatment model
allows for much greater contributions by the patient to
determine the success of the treatment [10]. Indeed, a
large body of evidence demonstrates the importance of a
collaborative relationship between healthcare providers
and their patients [11]. Recent research has shown that a
patient-centered model of treatment promotes greater
satisfaction with healthcare, improves treatment compli-
ance, and increases maintenance of patient–provider rela-
tionships [12–14].
Data suggest that treatment strategies are increasingly
focusing on patient-derived success criteria. A patient-
centered treatment approach was more effective than a
provider-centered approach among a group of fibromy-
algia patients [5]. Further, another study using the Patient
Centered Outcomes Questionnaire, demonstrated that
knowledge of chronic back pain patients’ extremely high
treatment expectations resulted in improved communi-
cation with health care providers, leading to more real-
istic success criteria and use of these less stringent
criteria in making judgments about treatment success
[15].
Some limitations in the patient-centered outcome litera-
ture are noteworthy and are addressed by the present
study. Little is known about what specific factors chronic
pain patients consider important for successful treatment,
and whether differences exist in these factors across dif-
ferent populations of pain patients. The present study was
designed to describe and compare treatment success
criteria from the patients’ perspective among fibromyalgia
and back pain patients to address these limitations and
increase knowledge of treatment success criteria across
two populations of chronic pain patients.
Methods
Participants
Participants in this study included 248 patients with fibro-
myalgia seen at the Rheumatology outpatient clinic of the
University of Florida, and 52 patients with back pain seen at
the Spine Care Center of the University of Florida, during
their routine clinical care. These patient samples consisted
of consecutively referred patients from 2003–2007. Data
were collected retrospectively, with Institutional Review
Board approval. All medical evaluations and diagnostic
determinations for the fibromyalgia patients were made by
the Rheumatologist coinvestigator (RS) using the American
College of Rheumatology 1990 criteria [16]. All medical
evaluations for the back pain patients were made by the
patients’ treating orthopedist coinvestigator (JA). The par-
ticipants in the fibromyalgia group included 232 females
and 16 males (a 14.5:1 female to male ratio), ranging in age
from 18.15 years to 78.74 years (M = 46.85 years,
SD = 11.76 years). The male to female ratio in the present
sample is consistent with the literature, with 93.5% of
patients being female [6]. The racial composition of the
fibromyalgia sample is as follows: 86.7% Caucasian, 7.7%
Black/African American, 2.0% Hispanic, and 0.4% Asian,
0.8% American Indian, 0.4% Pacific Islander, and 0.8%
Multiracial. 1.2% of participants did not specify their race.
The participants in the back pain group included 30
females and 22 males, ranging in age from 18 years to 71
years (M = 46.12 years, SD = 15.56 years). The racial com-
position of the sample is as follows: 84.6% Caucasian,
9.6% Black/African American, 3.8% Hispanic, and 1.9%
Asian.
Procedure
Participants undergoing an initial evaluation completed
self-report measures about their pain as part of their
routine clinical care, as well as a patient-centered out-
comes (PCO) questionnaire that asked about the levels of
pain, fatigue, distress, and interference with daily activities
that patients usually had, the levels they would consider
successful after treatment, the levels they desired for each
of these areas, the levels they expected following treat-
ment, and how important it was that treatment address
each of these areas. Analyses are based on this cross-
sectional data, and all measures will be described in
greater detail below.
Measures
Patient Centered Outcomes (PCO) Questionnaire
The PCO questionnaire is a self-report questionnaire,
which assesses four domains relevant to chronic pain
populations (pain, fatigue, distress, and interference) on
an 11-point numerical rating scale (NRS) ranging from
0–10. The PCO Questionnaire asks patients to provide
ratings of their usual levels of each of these four domains,
as well as what levels they would consider to be a mini-
mally successful treatment outcome, what levels they
desire, and what levels they expect following treatment.
Patients also provide ratings for how important it is for
treatment to address each of these four domains. Instruc-
tions provided at the beginning of the PCO Questionnaire
are as follows: “Many people experience pain, fatigue (i.e.,
feeling tired), emotional distress (e.g., worries, feeling
sad), and interference with daily activities (e.g., not being
able to work or do household chores) as a result of their
medical condition. We would like to understand how you
have been impacted in each of these areas. We would
also like to learn more about what you want your treat-
ment to do for you.” In a previous unpublished pilot study
7
Patient-Centered Outcomes in Chronic Pain
acceptable test–retest reliability for the PCO questionnaire
was found (r = 0.84 to r = 0.90, P < 0.001; for usual levels
across the 4 domains). Concurrent validity for the PCO
questionnaire with standardized measures of pain, mood,
and disability has also been demonstrated [15]. Usual
pain ratings from the PCO questionnaire are correlated
with visual analog scale ratings of pain intensity (r = 0.52,
P < 0.001); usual emotional distress levels from the PCO
questionnaire are correlated with total scores from the
Beck Depression Inventory [17] (r = 0.65, P < 0.001) and
the Pain Anxiety Symptom Scale [18] (r = 0.72,
P < 0.001); and usual interference levels from the PCO
questionnaire are correlated with total scores from the
Pain Disability Index [19] (r = 0.75, P < 0.001). Importance
ratings from the PCO questionnaire have also been found
to be useful for discriminating subgroups within a mixed
group of chronic-pain patients [20]. Chronic pain popula-
tions are often considered to be relatively homogenous,
and are treated accordingly. However, previous investiga-
tions using patient-centered outcomes criteria have sug-
gested that there is heterogeneity among chronic pain
populations, which is related to their treatment expecta-
tions and response (e.g., [5,20]).
Visual Analogue Scales (VAS) for Pain Ratings
Fibromyalgia patients completed the Medical College of
Virginia (MCV) Pain Questionnaire [21], which consists of
visual analogue scales (VAS) for pain, mood, and function
dimensions, scored from 0 to 100. These dimensions
include measures of the pain experience itself, including
usual levels of pain intensity and pain unpleasantness
during the preceding week (anchored at the right end by
“the most intense pain imaginable” / “the most unpleasant
sensation imaginable”). In addition, negative feelings asso-
ciated with the pain experience (i.e., depression, anxiety,
frustration, fear, and anger) are also rated, in reference to
the previous week. Back pain patients also completed
visual analogue scales (VAS) for pain intensity and pain
unpleasantness, scored from 0–10, in reference to the
previous week (anchored at the right end by “the most
intense pain imaginable” / “the most unpleasant sensation
imaginable”). Due to differences in the routine clinical prac-
tices in each clinic, there were slight differences in the
measures completed by the fibromyalgia patients and
back pain patients. Visual analogue scales have been
demonstrated to yield ratio scale measurement of clinical
pain that is both internally consistent and able to differen-
tially assess pain intensity and pain unpleasantness
[21,22]. These measures of pain were included in the
present study to provide a comparison against which the
ratings from the PCO questionnaire could be examined, in
order to attest to the validity of the PCO ratings.
Statistical Analyses
The Statistical Package for the Social Sciences (SPSS,
version 15.0) was used for all statistical analyses. Descrip-
tive statistics were computed for demographic and clinical
variables across each chronic pain sample. Independent
samples t-tests (for continuous variables) and chi-square
analyses (for categorical variables) were conducted to
examine potential differences between fibromyalgia and
back pain patients on demographic and clinical variables.
Descriptive information was also computed for each of the
PCO domains across the two chronic pain groups. Analy-
ses of variance (ANOVAs) were conducted across groups
to examine whether differences existed in usual levels,
desired levels, expected levels, levels considered suc-
cessful, and importance ratings across domains, as well
as in the amount of change that was needed for treatment
to be considered successful. Sex was included as a factor
in the ANOVA analyses when it was found to be related to
any of these dependent variables (sex was the only demo-
graphic or clinical variable found to differ between pain
groups). A 2 ¥ 2 repeated-measures ANOVA, with group
and sex as between-subjects factors, was also conducted
to assess differences between patients’ expected
outcome ratings and their success criteria across
domains, as reported on the PCO. This analysis was
examined across groups, and then with group member-
ship in the model to determine whether there was any
interaction between group membership and differences in
individuals’ ratings between their success criteria and their
expected outcome ratings. Due to the number of analyses
conducted, a statistical significance level was set to
P < 0.01 in order to identify any significant findings.
Results
Demographic and clinical information for these two
patient groups is presented in Table 1. Available informa-
tion on age, sex, race, pain duration, education level,
marital status, and work status were compared across
the two pain groups. The only significant difference found
between groups was for sex. This variable was included
as a factor in subsequent PCO analyses, when sex was
related to the PCO variable being examined. Descriptive
information about fibromyalgia and back pain patients’
ratings for usual levels, desired levels, expected levels,
levels considered to be successful, and importance
ratings for each of the four PCO domains (pain, fatigue,
distress, and interference with daily activities) are pro-
vided in Table 2. Fibromyalgia patients reported a usual
pain level of 7.23 NRS, usual level of fatigue of 7.75 NRS,
usual level of distress of 6.21 NRS, and usual level of
interference of 7.25 NRS. Back pain patients reported a
usual pain level of 5.30 NRS, usual level of fatigue of 5.37
NRS, usual level of distress of 5.07 NRS, and usual level
of interference of 5.74 NRS. Sex was found to be related
to PCO usual levels of pain, fatigue, distress, and inter-
ference. Therefore, a series of 2 ¥ 2 analyses of variance
(ANOVAs), with group and sex as between-subjects
factors, were conducted to examine differences in these
variables across group. Results revealed a significant
main effect for group for PCO usual levels of pain
[F(1,296) = 20.26, P < 0.001], fatigue [F(1,296) = 43.11,
P < 0.001], and interference [F(1,296) = 14.48,
P < 0.001], but there was no significant difference
between groups on usual levels of distress. There were
no significant group ¥ sex interactions for PCO usual
levels across domains (see Table 3).
8
O’Brien et al.
One-way ANOVAs also demonstrated that the fibromyal-
gia patients reported significantly higher desired levels
(P < 0.01 to P < 0.001, across all four domains), and sig-
nificantly higher expected levels (following treatment) for
pain and fatigue (both P < 0.01), compared to the back
pain patients. Patients’ reported expected levels for dis-
tress and interference did not differ between groups.
Importance ratings did not differ between the two groups
(sex was included as a factor in the analysis for PCO
importance rating for fatigue; group ¥ sex interaction was
also nonsignificant). Fibromyalgia patients also indicated
significantly higher ratings for all four domains as “suc-
cessful” following treatment, compared to the back pain
patients, in ANOVA analyses. Sex was included as a factor
in the analysis for PCO success rating for pain following
treatment; however, the group ¥ sex interaction was non-
significant. Thus, the fibromyalgia group demonstrated
less stringent ratings for successful levels of pain, fatigue,
distress, and interference following treatment. These com-
parisons are presented in Table 4.
A final analysis examined the degree of change required
by fibromyalgia patients and back pain patients in each of
the four domains for patients to consider treatment suc-
cessful; this was determined via the difference between
participants’ usual ratings for each domain and their
ratings of what they would consider successful for each
domain following treatment. Overall, for treatment to
be considered successful, fibromyalgia patients required a
pain level of 3.30 (54% reduction), a fatigue level of 3.08
(60% reduction), a distress level of 2.49 (60% reduction),
and an interference level of 2.67 (63% reduction). By
comparison, back pain patients required a pain level of
2.23 (58% reduction), a fatigue level of 2.29 (57% reduc-
tion), a distress level of 1.65 (67% reduction), and an
interference level of 1.81 (68% reduction).
Results indicated that fibromyalgia patients required
greater changes in pain (3.94 point reduction vs 3.07
point reduction in back pain patients), fatigue (4.67 point
reduction vs 3.08 point reduction in back pain patients),
distress (3.72 point reduction vs 3.41 point reduction in
back pain patients), and interference with daily activities
(4.57 point reduction vs 3.93 point reduction in back
pain patients) in order to consider their treatment suc-
cessful. However, a series of 2 ¥ 2 ANOVAs, with group
Table 1 Demographic information for the 2 groups
Fibromyalgia Back Pain
tM SD M SD
Age 46.85 11.76 46.12 15.56 0.32
Pain duration (months) 148.66 157.47 69.35 113.52 2.67*
Education (years) 13.59 2.10 14.13 3.58 -0.91
% % c2
Sex
Female 93.5% 57.7% 49.96***
Male 6.5% 42.3%
Race
Caucasian 86.7% 84.6% 4.01
Black/African-American 7.7% 9.6%
Asian 0.4% 1.9%
Hispanic 2.0% 3.8%
American Indian 0.8% —
Pacific Islander 0.4% —
Multiracial 0.8% —
Marital status
Single/Never married 2.4% 23.1% 5.21
Married 8.9% 55.8%
Divorced 3.2% 15.4%
Widowed 0.4% 1.9%
Living with partner — 3.8%
Separated 0.8% —
Work status
Full-time 6.9% 30.8% 5.25
Part-time 2.8% 7.7%
Not employed 6.0% 61.5%
* P < 0.05; *** P < 0.001.
9
Patient-Centered Outcomes in Chronic Pain
and sex as between-subjects factors, indicated that
these differences were not significant, with the exception
of the changes in fatigue required between groups for
treatment to be considered successful [F(1,296) = 15.51,
P < 0.001]. None of the group ¥ sex interactions were
significant in any of these ANOVA analyses. Figure 1 pre-
sents the PCO ratings for usual levels, levels required to
be considered successful, and the amount of change
required by back pain and fibromyalgia patients to con-
sider treatment successful. The complete results of the
ANOVA analyses examining the amount of change in
PCO scores required to consider treatment successful
across the two groups of patients are provided in
Table 5.
Success Criteria vs Expected Outcomes
To assess whether patients expected to meet their
success criteria, expected outcome ratings were com-
pared with success criteria for each outcome domain
(pain, fatigue, distress, interference). A series of repeated
measures ANOVAs were conducted, first collapsed
across groups and then with group and sex included as
between-subjects factors in the model. Results revealed
that, collapsed across groups, patients’ expectations for
treatment fall short of success criteria for pain [F(1,294) =
8.37, P < 0.01], fatigue [F(1,294) = 13.65, P < 0.001], dis-
tress [F(1,294) = 16.71, P < 0.001], and interference
[F(1,294) = 21.91, P < 0.001]. When group membership
and sex were added to the model to test for differences
between success criteria and expected outcome across
groups and sex, no significant interactions were seen
across the four PCO domains. Table 2 shows the means
and standard deviations of success and expected ratings
for each chronic pain group.
Comparisons with Self-Reported Pain Measures
Ratings of pain intensity and pain unpleasantness were
computed for each of the chronic pain patient samples.
Fibromyalgia patients completed a VAS for usual pain
intensity and usual pain unpleasantness on the MCV Pain
Questionnaire, which ranges from 0 to 100; similarly, back
pain patient completed a VAS for average pain intensity
and average pain unpleasantness, ranging from 0 to 10.
Fibromyalgia patients reported a mean pain intensity of
60.79 (SD = 21.39) and a mean pain unpleasantness of
58.34 (SD = 22.40). Back pain patients reported a mean
pain intensity of 4.64 (SD = 3.10) and a mean pain
unpleasantness of 5.28 (SD = 3.17). After transforming
the usual pain intensity and usual pain unpleasantness
values across groups onto a common scale, a one-way
ANOVA revealed significantly higher usual pain intensity
ratings in the fibromyalgia group compared to the back
pain group [F(1,258) = 15.39, P < 0.001]. Usual pain
unpleasantness ratings were not significantly different
across groups. Importantly, the higher ratings for usual
levels of pain intensity reported by the fibromyalgia
patients, compared to the back pain patients, is consis-
tent with the usual pain ratings reported on the PCO
questionnaire. Additionally, large correlations were found
between fibromyalgia patients’ VAS pain ratings and PCO
usual ratings of pain (r = 0.64 to 0.67, P < 0.001), and
between back pain patients VAS pain ratings and PCO
usual ratings of pain (r = 0.73 to 0.78, P < 0.001). These
correlations are provided in Table 6.
Discussion
Consistent with previous research, the current findings
highlight the importance of assessing what patients con-
sider to be successful treatment outcomes. The current
sample of fibromyalgia patients required reductions of
3.94 points in pain, 4.67 points in fatigue, 3.72 points in
distress, and 4.57 (10-point maximum) points in interfer-
ence in order to consider treatment successful. The
Table 2 PCO questionnaire profiles for the 2
groups
Fibromyalgia Back Pain
M SD M SD
Usual levels
Pain 7.23 1.89 5.30 2.63
Fatigue 7.75 1.82 5.37 2.91
Distress 6.21 2.64 5.07 3.52
Interference 7.25 2.26 5.74 2.97
Desired
levels
Pain 1.45 1.95 0.36 0.93
Fatigue 1.35 1.92 0.42 0.94
Distress 1.04 1.58 0.21 0.64
Interference 1.04 1.74 0.32 0.82
Expected
levels
Pain 3.64 2.18 2.53 1.59
Fatigue 3.58 2.25 2.44 2.12
Distress 2.89 2.23 2.32 2.39
Interference 3.22 2.29 2.57 2.23
Successful
levels
Pain 3.30 1.64 2.23 1.46
Fatigue 3.08 1.65 2.29 1.80
Distress 2.49 1.76 1.65 1.78
Interference 2.67 1.75 1.81 1.60
Importance
levels
Pain 8.96 1.70 9.07 2.04
Fatigue 8.58 1.67 8.17 3.03
Distress 7.16 2.61 7.40 3.69
Interference 8.31 1.93 8.11 3.08
Amount of
Change
Required
Pain 3.94 2.00 3.07 1.97
Fatigue 4.67 2.06 3.08 2.34
Distress 3.72 2.49 3.41 3.10
Interference 4.57 2.43 3.93 2.72
10
O’Brien et al.
current sample of back pain patients required reductions
of 3.07 points in pain, 3.08 in fatigue, 3.41 in distress, and
3.93 in interference in order to consider treatment suc-
cessful. These patient-centered definitions of success
demonstrate the very high expectations of chronic pain
patients related to their medical treatments, but also indi-
cated that fibromyalgia patients require larger reductions
in usual levels of pain, fatigue, distress, and interference in
Table 3 Analyses of variance (ANOVAs) for PCO usual ratings across pain groups with sex as a factor
Dependent Variable
df
Between
df
Error
SS
Between SS Error
MS
Between
MS
Error F
PCO usual pain
Group 1 296 82.76 1,208.84 82.76 4.08 20.26***
Sex 1 296 22.45 1,208.84 22.45 4.08 5.50**
Group ¥ sex 1 296 1.76 1,208.84 1.76 4.08 0.43
PCO usual fatigue
Group 1 296 177.11 1,216.11 177.11 4.11 43.11***
Sex 1 296 17.29 1,216.11 17.29 4.11 4.21**
Group ¥ sex 1 296 20.53 1,216.11 20.53 4.11 5.00**
PCO usual distress
Group 1 296 25.48 2,313.90 25.48 7.82 3.26*
Sex 1 296 36.37 2,313.90 36.37 7.82 4.65**
Group ¥ sex 1 296 5.89 2,313.90 5.89 7.82 0.75
PCO usual interference
Group 1 296 82.38 1,684.21 82.38 5.69 14.48***
Sex 1 296 8.77 1,684.21 8.77 5.69 1.54
Group ¥ sex 1 296 19.23 1,684.21 19.23 5.69 3.38*
* P < 0.10; ** P < 0.05; *** P < 0.001.
Table 4 Analyses of variance (ANOVAs) for PCO ratings across pain groups, including sex as a factor
when correlated with the dependent variable
Dependent Variable
df
Between
df
Error
SS
Between SS Error
MS
Between
MS
Error F
PCO desired pain 1 298 51.62 987.09 51.62 3.31 15.58***
PCO desired fatigue 1 298 36.68 954.87 36.68 3.20 11.45**
PCO desired distress 1 298 29.53 640.27 29.53 2.15 13.74***
PCO desired interference 1 298 22.47 777.61 22.47 2.61 8.61**
PCO expected pain 1 295 50.46 1,290.27 50.46 4.37 11.54**
PCO expected fatigue 1 295 53.35 1,463.20 53.35 4.96 10.76**
PCO expected distress 1 295 13.33 1,502.69 13.33 5.09 2.62
PCO expected interference 1 295 17.31 1,530.30 17.31 5.19 3.34*
PCO success pain
Group 1 296 33.18 771.34 33.18 2.61 12.73***
Sex 1 296 0.64 771.34 0.64 2.61 0.25
Group ¥ sex 1 296 0.78 771.34 0.78 2.61 0.30
PCO success fatigue 1 298 26.98 840.06 26.98 2.82 9.57**
PCO success distress 1 298 29.90 923.73 29.90 3.10 9.65**
PCO success interference 1 296 31.97 880.91 31.97 2.98 10.74**
PCO importance pain 1 297 0.47 923.68 0.47 3.11 0.15
PCO importance fatigue
Group 1 295 7.68 1,122.47 7.68 3.81 2.02
Sex 1 295 12.04 1,122.47 12.04 3.81 3.16*
Group ¥ sex 1 295 13.65 1,122.47 13.65 3.81 3.59*
PCO importance distress 1 297 2.45 2,369.06 2.45 7.98 0.31
PCO importance interference 1 297 1.67 1,391.87 1.67 4.69 0.36
* P < 0.10; ** P < 0.01; *** P < 0.001.
11
Patient-Centered Outcomes in Chronic Pain
order to consider their treatment a success. This is con-
sistent with findings from a mixed sample of chronic pain
patients [20], where reductions of 3.35–4.30 points across
domains, and findings from a group of spine pain patients,
where reductions of 32.8–43.1 points (using a PCO ques-
tionnaire with a 101-point scale) across domains [15],
were required for treatment to be considered successful.
Our data also support the contention that patients may
require larger changes across multiple domains than pre-
viously believed, in order to consider their treatment suc-
cessful. Patients with fibromyalgia identified reductions
across domains in the range of 54–63% as clinically
meaningful and patients with back pain identified reduc-
tions of 57–68% across domains as clinically meaningful.
These reductions are approximately twice the amount
proposed in prior research [23].
Fibromyalgia patients required significantly larger reduc-
tions in fatigue, compared to back-pain patients, in order
to consider treatment successful. Fibromyalgia patients
also reported larger reductions in pain, distress, and inter-
ference in order to consider treatment successful,
although these differences did not reach the level of sta-
tistical significance set in this study. This pattern of find-
ings may be due in part to the higher usual ratings, across
all domains, reported by fibromyalgia patients. However,
compared to the back-pain patients, fibromyalgia patients
also identified less stringent success criteria across all
domains. The differential reduction specific to fatigue iden-
tified by fibromyalgia patients, in order for treatment to be
successful, may be due to the high levels of reported
fatigue common to this condition. Thus, patients may
experience fibromyalgia as particularly impairing, due to
this fatigue; this could impact other areas of their lives and
may be reflected in the larger, though non-significant,
reductions in pain, distress, and interference reported in
order to consider treatment successful. Also, as fibromy-
algia predominantly affects women, this differential reduc-
tion specific to fatigue required for successful treatment
may be related to differential gender-roles and the impact
on fibromyalgia on different gender-role activities.
Back pain and fibromyalgia patients required reductions
ranging from 3.08–4.67/10 in fatigue, distress, and inter-
ference in order to consider treatment successful, com-
pared to pain reductions of 3.07 and 3.94. This
underscores a need to adopt treatment approaches that
address the multidimensional nature of the pain experi-
ence and patients’ expectancies for improvements across
multiple domains (i.e., pain, fatigue, distress, and function-
ing) in order to consider treatment successful. Treatments
that neglect these other important areas of concern to
patients and focus solely on pain reduction, may contrib-
ute to treatment dissatisfaction and reports of continued
disability. Thus, not treating or under-treating areas iden-
tified as important by patients, may be related to poorer
outcomes and patient dissatisfaction.
Taken together, these findings not only highlight the impor-
tance of determining what patients are conceptualizing as
a “successful” treatment outcome, but also the need to
address any unrealistic expectations, in order to ensure
effective communication about the changes that are fea-
sible following treatment. It appears that both fibromyalgia
patients and back pain patients are relatively pessimistic
about treatment, since they do not expect treatment to
meet their success criteria. Identifying patients’ expecta-
tions and success criteria at the outset of treatment pro-
vides an avenue for providers to address unrealistic
expectations, discuss areas that patients feel are impor-
0
1
2
3
4
5
6
7
8
9
Pain group
PCOUsuallevel
Pain
Fatigue
Distress
Interference
0
1
2
3
4
5
6
7
8
9
PCOSuccesslevel
Pain
Fatigue
Distress
Interference
0
1
2
3
4
5
6
7
8
9
Back PainFibromyalgia
Pain group
Back PainFibromyalgia
Back PainFibromyalgia
Pain group
PCOAmountofChangerequired
Pain
Fatigue
Distress
Interference
t
p<.10; **p<.01; ***p<.001
***
***
**
*** ***
**
***
**
t
t
t
Figure 1 PCO ratings for usual levels, success
levels, and amount of change required for the 2 pain
groups.
12
O’Brien et al.
tant to address in treatment, and to promote communi-
cation about treatment options and realistic expectations
for outcomes. Information from the PCO could facilitate
referrals to providers for specific treatment addressing
mood or other issues if desired or warranted. It could also
guide treatment efforts, such as suggesting physical
therapy if high ratings of interference or pain appear to be
secondary to deconditioning, or arguing against prescrib-
ing medications with high overdose potential in patients
endorsing high levels of distress without any treatment for
this. Additionally, if complete pain relief is an unrealistic
treatment outcome, then use of acceptance-based (i.e.,
ACT/acceptance and commitment therapy) approaches
for pain management may provide a useful treatment
option for patients and providers.
These results also provide additional, ecologically valid
evidence that it is important for clinicians and researchers
to incorporate patient-centered definitions of success
into their procedures in order to prevent overestimating
the effectiveness of their interventions. Of note, the
present sample of fibromyalgia patients identified
success target scores in the range of 2.49/10 to 3.30/10
and the present sample of back pain patients identified
success target scores in the range of 1.65/10 to 2.29/10,
consistent with Robinson and colleagues’ (2005) findings
that patients with chronic pain do not require a complete
absence of symptoms in order to consider treatment
successful [20]. Thus, eliciting patients’ goals for treat-
ment will facilitate the identification of any potentially
unrealistic goals and enable providers to educate
patients about realistic expectations regarding treatment
outcomes. This can help to prevent patient dissatisfac-
tion with unrealistic treatment expectations, and can also
establish effective patterns of communication between
patients and providers from the outset of treatment.
Due to the cross-sectional nature of the analysis, several
limitations of this design should be noted. Detailed infor-
mation about any prior treatment these patients may have
received was unavailable; it is therefore beyond the scope
of this article to examine the impact that prior treatment
success or failure may have on PCOQ ratings. We were
also unable to examine PCOQ ratings throughout the
course of treatment, and therefore cannot determine if
patients adjust their ratings in response to treatment strat-
egies. Future research employing longitudinal data would
be valuable to identify whether fibromyalgia and back pain
Table 5 Analyses of variance (ANOVAs) for PCO change ratings across pain groups with sex as a factor
Dependent Variable
df
Between
df
Error
SS
Between SS Error
MS
Between
MS
Error F
Change in PCO pain required
Group 1 296 11.14 1,169.83 11.14 3.95 2.82*
Sex 1 296 15.49 1,169.83 15.49 3.95 3.92**
Group ¥ sex 1 296 0.20 1,169.83 0.20 3.95 0.05
Change in PCO fatigue required
Group 1 296 67.94 1,296.42 67.94 4.38 15.51***
Sex 1 296 23.81 1,296.42 23.81 4.38 5.44**
Group ¥ sex 1 296 10.58 1,296.42 10.58 4.38 2.42
Change in PCO distress required
Group 1 296 1.30 1,984.61 1.30 6.71 0.19
Sex 1 296 33.29 1,984.61 33.29 6.71 4.97**
Group ¥ sex 1 296 9.92 1,984.61 9.92 6.71 1.48
Change in PCO interference required
Group 1 294 18.97 1,784.35 18.97 6.07 3.13*
Sex 1 294 19.54 1,784.35 19.54 6.07 3.22*
Group ¥ sex 1 294 25.85 1,784.35 25.85 6.07 4.26**
* P < 0.10; ** P < 0.05; *** P < 0.001.
Table 6 Correlation between VAS pain ratings and PCO ratings for usual pain in each pain group
Fibromyalgia Back Pain
VAS pain
Intensity
VAS Pain
Unpleasantness
VAS pain
Intensity
VAS Pain
Unpleasantness
PCO usual pain 0.668*** 0.641*** 0.781*** 0.725***
*** P < 0.001.
13
Patient-Centered Outcomes in Chronic Pain
patients change their PCOQ ratings across treatment, and
how changes in PCOQ ratings may affect patients’ views
concerning treatment outcomes. Furthermore, as the
PCOQ remains a new questionnaire, additional research is
needed to examine its psychometric properties, and to
determine whether patient ratings of success fluctuate
with symptom severity, or remain consistent over time.
Research involving patient-centered outcomes has dem-
onstrated a substantial benefit to incorporating patients’
perspective into treatment evaluations [5,13,14]. This
study contributes additional data supporting the impor-
tance of using patient-centered success criteria when
working with patients who have chronic pain conditions.
Communication with patients about their definitions for
treatment success has the potential to help patients pri-
oritize their goals, make informed choices, and maintain
realistic expectations about their treatment. A thorough
understanding of the patient perspective is necessary to
guide healthcare providers in clinical decision-making and
promote better relationships with their patients. The
results, regardless of type of chronic pain condition, also
highlight the potential importance of assessing patient
expectations for treatment success. It is highly likely that
patients whose expectations significantly exceed likely
treatment outcomes will be disappointed with results and
with their care. Assessing these expectations during initial
evaluations, and prior to the initiation of treatment, may
contribute to better outcomes and more satisfied patients.
Recognizing the heterogeneity within chronic-pain patient
groups is consistent with a patient-centered model of
treatment; it also encourages discussion and develop-
ment of individualized treatment goals relevant to a par-
ticular patient. While the benefits of such patient-centered
approaches are well known, wider implementation of such
treatment approaches are needed in order to maximize
these benefits to the patient, the provider, and the health-
care system.
Acknowledgments
Support for this research was provided from Grant R01
NR010324 to Dr. Michael Robinson, from the National
Institute of Nursing Research.
Disclosure
None of the authors has any significant financial disclo-
sures to report.
References
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JM. Prevalence of chronic benign pain disorder among
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2 Andersson GB. Epidemiological features of chronic
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3 Lanes TC, Gauron EF, Spratt KF, et al. Long-term
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4 Robinson RL, Jones ML. In search of pharmacoeco-
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5 Alamo MM, Moral RR, Perula de Torres LA. Evaluation
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Patient-Centered Outcomes in Chronic Pain
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Patient centered-perspective-on-treatment-outcomes-in-chronic-pain

  • 1. See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/26791479 Patient-Centered Perspective on Treatment Outcomes in Chronic Pain Article in Pain Medicine · October 2009 DOI: 10.1111/j.1526-4637.2009.00685.x · Source: PubMed CITATIONS 76 READS 22 8 authors, including: Roland Staud University of Florida 261 PUBLICATIONS 7,543 CITATIONS SEE PROFILE Jason G Craggs University of Missouri 54 PUBLICATIONS 1,157 CITATIONS SEE PROFILE James Atchison Rehabilitation Institute of Chicago 56 PUBLICATIONS 642 CITATIONS SEE PROFILE Donald D Price University of Florida 329 PUBLICATIONS 28,923 CITATIONS SEE PROFILE All content following this page was uploaded by Jason G Craggs on 08 March 2016. The user has requested enhancement of the downloaded file. All in-text references underlined in blue are added to the original document and are linked to publications on ResearchGate, letting you access and read them immediately.
  • 2. ORIGINAL RESEARCH ARTICLES Patient-Centered Perspective on Treatment Outcomes in Chronic Painpme_685 6..15 Erin M. O’Brien, PhD,* Roland M. Staud, MD,† Alisa D. Hassinger, MS,* Robert C. McCulloch, PhD,* Jason G. Craggs, PhD,* James W. Atchison, DO,† Donald D. Price, PhD,‡ and Michael E. Robinson, PhD* *Department of Clinical and Health Psychology, † College of Medicine, ‡ Department of Oral and Maxillofacial Surgery, University of Florida, Gainesville, Florida, USA Reprint requests to: Michael E. Robinson, PhD, Department of Clinical and Health Psychology, University of Florida, Box 100165, Gainesville, FL 32610-0165, USA. Tel: 352-273-6153; Fax: 352-273-6156; E-mail: merobin@ufl.edu. Abstract Objective. To define patient-determined success criteria for fibromyalgia and back pain treatment across four outcome domains: pain, fatigue, emo- tional distress, interference with daily activities. Design. Retrospective correlational clinical sample design. Setting. Tertiary care clinics at health science center. Patients. 248 fibromyalgia patients and 52 back pain patients. Interventions. N/A. Outcome Measures. Patient Centered Outcomes Questionnaire, measures of usual pain intensity and pain unpleasantness. Results. Overall, for treatment to be considered successful, fibromyalgia patients required pain levels of 3.30 (54% reduction), fatigue levels of 3.08 (60% reduction), distress levels of 2.49 (60% reduc- tion), and interference levels of 2.67 (63% reduction). Comparatively, back pain patients required pain levels of 2.23 (58% reduction), fatigue levels of 2.29 (57% reduction), distress levels of 1.65 (67% reduc- tion), and interference levels of 1.81 (68% reduction). Overall, both fibromyalgia and back pain patients did not expect to meet their criteria for success. Conclusions. Results highlight the importance of assessing the patient’s view of successful outcome. Both fibromyalgia and back pain patients appear to have stringent criteria for success that existing treatments are often unlikely to meet. Comparison across groups indicated fibromyalgia patients have higher usual levels of pain, fatigue, distress, and interference. Interestingly, fibromyalgia patients also require greater changes across domains in order to consider treatment successful, despite rating higher levels of pain, fatigue, distress, and interference as successful. Recognizing patients’ success criteria and treatment expectations encour- ages discussion and development of individualized treatment goals, and wider implementation of indi- vidualized treatment for chronic-pain populations is encouraged. Key Words. Treatment Outcome; Chronic Pain; Patient Satisfaction; Back Pain; Fibromyalgia Introduction Chronic pain is one of the most frequent, costly, and disabling medical conditions in the United States, often resulting in substantial impairments in occupational and social functioning. Epidemiological studies report that 15% of adults experience chronic pain [1]. The annual incidence of back pain of moderate intensity and duration was estimated at 10–15% among the adult population [2], with research suggesting a lifetime prevalence of signifi- cant back pain in 80% of adults [3]. Fibromyalgia is a condition involving widespread musculoskeletal pain, affecting approximately 2% of adults with chronic pain [4]. This condition is poorly understood, often leading to patients and providers being dissatisfied with treatment. Initial evidence suggested that a patient-centered treat- ment approach resulted in beneficial outcomes among fibromyalgia patients [5]. While pain is a prominent feature in fibromyalgia, patients often experience significant impairments in physical functioning and emotional distress [6], as well as decreased quality of life [7]. Similarly, back pain patients also experience impairments in mood and functioning (e.g., [8,9]), in addition to pain. The lack of highly effective treatment strategies for chronic pain patients often frustrates these individuals and their Pain Medicine 2010; 11: 6–15 © American Academy of Pain Medicine 6
  • 3. healthcare providers. Importantly, patient dissatisfaction may lead to more medical visits, more expensive and a greater number of tests, and the perception of the patient being “difficult” [5]. Traditionally, determinations about success criteria in chronic pain treatment have been made predominantly by healthcare providers. This “medical model” of treatment is often derived and driven via nomothetic statistical analy- ses, and does not provide much input for the incorpora- tion of the patient’s perspective of successful outcome for any particular course of treatment. However, adopting a patient-centered treatment model allows for much greater contributions by the patient to determine the success of the treatment [10]. Indeed, a large body of evidence demonstrates the importance of a collaborative relationship between healthcare providers and their patients [11]. Recent research has shown that a patient-centered model of treatment promotes greater satisfaction with healthcare, improves treatment compli- ance, and increases maintenance of patient–provider rela- tionships [12–14]. Data suggest that treatment strategies are increasingly focusing on patient-derived success criteria. A patient- centered treatment approach was more effective than a provider-centered approach among a group of fibromy- algia patients [5]. Further, another study using the Patient Centered Outcomes Questionnaire, demonstrated that knowledge of chronic back pain patients’ extremely high treatment expectations resulted in improved communi- cation with health care providers, leading to more real- istic success criteria and use of these less stringent criteria in making judgments about treatment success [15]. Some limitations in the patient-centered outcome litera- ture are noteworthy and are addressed by the present study. Little is known about what specific factors chronic pain patients consider important for successful treatment, and whether differences exist in these factors across dif- ferent populations of pain patients. The present study was designed to describe and compare treatment success criteria from the patients’ perspective among fibromyalgia and back pain patients to address these limitations and increase knowledge of treatment success criteria across two populations of chronic pain patients. Methods Participants Participants in this study included 248 patients with fibro- myalgia seen at the Rheumatology outpatient clinic of the University of Florida, and 52 patients with back pain seen at the Spine Care Center of the University of Florida, during their routine clinical care. These patient samples consisted of consecutively referred patients from 2003–2007. Data were collected retrospectively, with Institutional Review Board approval. All medical evaluations and diagnostic determinations for the fibromyalgia patients were made by the Rheumatologist coinvestigator (RS) using the American College of Rheumatology 1990 criteria [16]. All medical evaluations for the back pain patients were made by the patients’ treating orthopedist coinvestigator (JA). The par- ticipants in the fibromyalgia group included 232 females and 16 males (a 14.5:1 female to male ratio), ranging in age from 18.15 years to 78.74 years (M = 46.85 years, SD = 11.76 years). The male to female ratio in the present sample is consistent with the literature, with 93.5% of patients being female [6]. The racial composition of the fibromyalgia sample is as follows: 86.7% Caucasian, 7.7% Black/African American, 2.0% Hispanic, and 0.4% Asian, 0.8% American Indian, 0.4% Pacific Islander, and 0.8% Multiracial. 1.2% of participants did not specify their race. The participants in the back pain group included 30 females and 22 males, ranging in age from 18 years to 71 years (M = 46.12 years, SD = 15.56 years). The racial com- position of the sample is as follows: 84.6% Caucasian, 9.6% Black/African American, 3.8% Hispanic, and 1.9% Asian. Procedure Participants undergoing an initial evaluation completed self-report measures about their pain as part of their routine clinical care, as well as a patient-centered out- comes (PCO) questionnaire that asked about the levels of pain, fatigue, distress, and interference with daily activities that patients usually had, the levels they would consider successful after treatment, the levels they desired for each of these areas, the levels they expected following treat- ment, and how important it was that treatment address each of these areas. Analyses are based on this cross- sectional data, and all measures will be described in greater detail below. Measures Patient Centered Outcomes (PCO) Questionnaire The PCO questionnaire is a self-report questionnaire, which assesses four domains relevant to chronic pain populations (pain, fatigue, distress, and interference) on an 11-point numerical rating scale (NRS) ranging from 0–10. The PCO Questionnaire asks patients to provide ratings of their usual levels of each of these four domains, as well as what levels they would consider to be a mini- mally successful treatment outcome, what levels they desire, and what levels they expect following treatment. Patients also provide ratings for how important it is for treatment to address each of these four domains. Instruc- tions provided at the beginning of the PCO Questionnaire are as follows: “Many people experience pain, fatigue (i.e., feeling tired), emotional distress (e.g., worries, feeling sad), and interference with daily activities (e.g., not being able to work or do household chores) as a result of their medical condition. We would like to understand how you have been impacted in each of these areas. We would also like to learn more about what you want your treat- ment to do for you.” In a previous unpublished pilot study 7 Patient-Centered Outcomes in Chronic Pain
  • 4. acceptable test–retest reliability for the PCO questionnaire was found (r = 0.84 to r = 0.90, P < 0.001; for usual levels across the 4 domains). Concurrent validity for the PCO questionnaire with standardized measures of pain, mood, and disability has also been demonstrated [15]. Usual pain ratings from the PCO questionnaire are correlated with visual analog scale ratings of pain intensity (r = 0.52, P < 0.001); usual emotional distress levels from the PCO questionnaire are correlated with total scores from the Beck Depression Inventory [17] (r = 0.65, P < 0.001) and the Pain Anxiety Symptom Scale [18] (r = 0.72, P < 0.001); and usual interference levels from the PCO questionnaire are correlated with total scores from the Pain Disability Index [19] (r = 0.75, P < 0.001). Importance ratings from the PCO questionnaire have also been found to be useful for discriminating subgroups within a mixed group of chronic-pain patients [20]. Chronic pain popula- tions are often considered to be relatively homogenous, and are treated accordingly. However, previous investiga- tions using patient-centered outcomes criteria have sug- gested that there is heterogeneity among chronic pain populations, which is related to their treatment expecta- tions and response (e.g., [5,20]). Visual Analogue Scales (VAS) for Pain Ratings Fibromyalgia patients completed the Medical College of Virginia (MCV) Pain Questionnaire [21], which consists of visual analogue scales (VAS) for pain, mood, and function dimensions, scored from 0 to 100. These dimensions include measures of the pain experience itself, including usual levels of pain intensity and pain unpleasantness during the preceding week (anchored at the right end by “the most intense pain imaginable” / “the most unpleasant sensation imaginable”). In addition, negative feelings asso- ciated with the pain experience (i.e., depression, anxiety, frustration, fear, and anger) are also rated, in reference to the previous week. Back pain patients also completed visual analogue scales (VAS) for pain intensity and pain unpleasantness, scored from 0–10, in reference to the previous week (anchored at the right end by “the most intense pain imaginable” / “the most unpleasant sensation imaginable”). Due to differences in the routine clinical prac- tices in each clinic, there were slight differences in the measures completed by the fibromyalgia patients and back pain patients. Visual analogue scales have been demonstrated to yield ratio scale measurement of clinical pain that is both internally consistent and able to differen- tially assess pain intensity and pain unpleasantness [21,22]. These measures of pain were included in the present study to provide a comparison against which the ratings from the PCO questionnaire could be examined, in order to attest to the validity of the PCO ratings. Statistical Analyses The Statistical Package for the Social Sciences (SPSS, version 15.0) was used for all statistical analyses. Descrip- tive statistics were computed for demographic and clinical variables across each chronic pain sample. Independent samples t-tests (for continuous variables) and chi-square analyses (for categorical variables) were conducted to examine potential differences between fibromyalgia and back pain patients on demographic and clinical variables. Descriptive information was also computed for each of the PCO domains across the two chronic pain groups. Analy- ses of variance (ANOVAs) were conducted across groups to examine whether differences existed in usual levels, desired levels, expected levels, levels considered suc- cessful, and importance ratings across domains, as well as in the amount of change that was needed for treatment to be considered successful. Sex was included as a factor in the ANOVA analyses when it was found to be related to any of these dependent variables (sex was the only demo- graphic or clinical variable found to differ between pain groups). A 2 ¥ 2 repeated-measures ANOVA, with group and sex as between-subjects factors, was also conducted to assess differences between patients’ expected outcome ratings and their success criteria across domains, as reported on the PCO. This analysis was examined across groups, and then with group member- ship in the model to determine whether there was any interaction between group membership and differences in individuals’ ratings between their success criteria and their expected outcome ratings. Due to the number of analyses conducted, a statistical significance level was set to P < 0.01 in order to identify any significant findings. Results Demographic and clinical information for these two patient groups is presented in Table 1. Available informa- tion on age, sex, race, pain duration, education level, marital status, and work status were compared across the two pain groups. The only significant difference found between groups was for sex. This variable was included as a factor in subsequent PCO analyses, when sex was related to the PCO variable being examined. Descriptive information about fibromyalgia and back pain patients’ ratings for usual levels, desired levels, expected levels, levels considered to be successful, and importance ratings for each of the four PCO domains (pain, fatigue, distress, and interference with daily activities) are pro- vided in Table 2. Fibromyalgia patients reported a usual pain level of 7.23 NRS, usual level of fatigue of 7.75 NRS, usual level of distress of 6.21 NRS, and usual level of interference of 7.25 NRS. Back pain patients reported a usual pain level of 5.30 NRS, usual level of fatigue of 5.37 NRS, usual level of distress of 5.07 NRS, and usual level of interference of 5.74 NRS. Sex was found to be related to PCO usual levels of pain, fatigue, distress, and inter- ference. Therefore, a series of 2 ¥ 2 analyses of variance (ANOVAs), with group and sex as between-subjects factors, were conducted to examine differences in these variables across group. Results revealed a significant main effect for group for PCO usual levels of pain [F(1,296) = 20.26, P < 0.001], fatigue [F(1,296) = 43.11, P < 0.001], and interference [F(1,296) = 14.48, P < 0.001], but there was no significant difference between groups on usual levels of distress. There were no significant group ¥ sex interactions for PCO usual levels across domains (see Table 3). 8 O’Brien et al.
  • 5. One-way ANOVAs also demonstrated that the fibromyal- gia patients reported significantly higher desired levels (P < 0.01 to P < 0.001, across all four domains), and sig- nificantly higher expected levels (following treatment) for pain and fatigue (both P < 0.01), compared to the back pain patients. Patients’ reported expected levels for dis- tress and interference did not differ between groups. Importance ratings did not differ between the two groups (sex was included as a factor in the analysis for PCO importance rating for fatigue; group ¥ sex interaction was also nonsignificant). Fibromyalgia patients also indicated significantly higher ratings for all four domains as “suc- cessful” following treatment, compared to the back pain patients, in ANOVA analyses. Sex was included as a factor in the analysis for PCO success rating for pain following treatment; however, the group ¥ sex interaction was non- significant. Thus, the fibromyalgia group demonstrated less stringent ratings for successful levels of pain, fatigue, distress, and interference following treatment. These com- parisons are presented in Table 4. A final analysis examined the degree of change required by fibromyalgia patients and back pain patients in each of the four domains for patients to consider treatment suc- cessful; this was determined via the difference between participants’ usual ratings for each domain and their ratings of what they would consider successful for each domain following treatment. Overall, for treatment to be considered successful, fibromyalgia patients required a pain level of 3.30 (54% reduction), a fatigue level of 3.08 (60% reduction), a distress level of 2.49 (60% reduction), and an interference level of 2.67 (63% reduction). By comparison, back pain patients required a pain level of 2.23 (58% reduction), a fatigue level of 2.29 (57% reduc- tion), a distress level of 1.65 (67% reduction), and an interference level of 1.81 (68% reduction). Results indicated that fibromyalgia patients required greater changes in pain (3.94 point reduction vs 3.07 point reduction in back pain patients), fatigue (4.67 point reduction vs 3.08 point reduction in back pain patients), distress (3.72 point reduction vs 3.41 point reduction in back pain patients), and interference with daily activities (4.57 point reduction vs 3.93 point reduction in back pain patients) in order to consider their treatment suc- cessful. However, a series of 2 ¥ 2 ANOVAs, with group Table 1 Demographic information for the 2 groups Fibromyalgia Back Pain tM SD M SD Age 46.85 11.76 46.12 15.56 0.32 Pain duration (months) 148.66 157.47 69.35 113.52 2.67* Education (years) 13.59 2.10 14.13 3.58 -0.91 % % c2 Sex Female 93.5% 57.7% 49.96*** Male 6.5% 42.3% Race Caucasian 86.7% 84.6% 4.01 Black/African-American 7.7% 9.6% Asian 0.4% 1.9% Hispanic 2.0% 3.8% American Indian 0.8% — Pacific Islander 0.4% — Multiracial 0.8% — Marital status Single/Never married 2.4% 23.1% 5.21 Married 8.9% 55.8% Divorced 3.2% 15.4% Widowed 0.4% 1.9% Living with partner — 3.8% Separated 0.8% — Work status Full-time 6.9% 30.8% 5.25 Part-time 2.8% 7.7% Not employed 6.0% 61.5% * P < 0.05; *** P < 0.001. 9 Patient-Centered Outcomes in Chronic Pain
  • 6. and sex as between-subjects factors, indicated that these differences were not significant, with the exception of the changes in fatigue required between groups for treatment to be considered successful [F(1,296) = 15.51, P < 0.001]. None of the group ¥ sex interactions were significant in any of these ANOVA analyses. Figure 1 pre- sents the PCO ratings for usual levels, levels required to be considered successful, and the amount of change required by back pain and fibromyalgia patients to con- sider treatment successful. The complete results of the ANOVA analyses examining the amount of change in PCO scores required to consider treatment successful across the two groups of patients are provided in Table 5. Success Criteria vs Expected Outcomes To assess whether patients expected to meet their success criteria, expected outcome ratings were com- pared with success criteria for each outcome domain (pain, fatigue, distress, interference). A series of repeated measures ANOVAs were conducted, first collapsed across groups and then with group and sex included as between-subjects factors in the model. Results revealed that, collapsed across groups, patients’ expectations for treatment fall short of success criteria for pain [F(1,294) = 8.37, P < 0.01], fatigue [F(1,294) = 13.65, P < 0.001], dis- tress [F(1,294) = 16.71, P < 0.001], and interference [F(1,294) = 21.91, P < 0.001]. When group membership and sex were added to the model to test for differences between success criteria and expected outcome across groups and sex, no significant interactions were seen across the four PCO domains. Table 2 shows the means and standard deviations of success and expected ratings for each chronic pain group. Comparisons with Self-Reported Pain Measures Ratings of pain intensity and pain unpleasantness were computed for each of the chronic pain patient samples. Fibromyalgia patients completed a VAS for usual pain intensity and usual pain unpleasantness on the MCV Pain Questionnaire, which ranges from 0 to 100; similarly, back pain patient completed a VAS for average pain intensity and average pain unpleasantness, ranging from 0 to 10. Fibromyalgia patients reported a mean pain intensity of 60.79 (SD = 21.39) and a mean pain unpleasantness of 58.34 (SD = 22.40). Back pain patients reported a mean pain intensity of 4.64 (SD = 3.10) and a mean pain unpleasantness of 5.28 (SD = 3.17). After transforming the usual pain intensity and usual pain unpleasantness values across groups onto a common scale, a one-way ANOVA revealed significantly higher usual pain intensity ratings in the fibromyalgia group compared to the back pain group [F(1,258) = 15.39, P < 0.001]. Usual pain unpleasantness ratings were not significantly different across groups. Importantly, the higher ratings for usual levels of pain intensity reported by the fibromyalgia patients, compared to the back pain patients, is consis- tent with the usual pain ratings reported on the PCO questionnaire. Additionally, large correlations were found between fibromyalgia patients’ VAS pain ratings and PCO usual ratings of pain (r = 0.64 to 0.67, P < 0.001), and between back pain patients VAS pain ratings and PCO usual ratings of pain (r = 0.73 to 0.78, P < 0.001). These correlations are provided in Table 6. Discussion Consistent with previous research, the current findings highlight the importance of assessing what patients con- sider to be successful treatment outcomes. The current sample of fibromyalgia patients required reductions of 3.94 points in pain, 4.67 points in fatigue, 3.72 points in distress, and 4.57 (10-point maximum) points in interfer- ence in order to consider treatment successful. The Table 2 PCO questionnaire profiles for the 2 groups Fibromyalgia Back Pain M SD M SD Usual levels Pain 7.23 1.89 5.30 2.63 Fatigue 7.75 1.82 5.37 2.91 Distress 6.21 2.64 5.07 3.52 Interference 7.25 2.26 5.74 2.97 Desired levels Pain 1.45 1.95 0.36 0.93 Fatigue 1.35 1.92 0.42 0.94 Distress 1.04 1.58 0.21 0.64 Interference 1.04 1.74 0.32 0.82 Expected levels Pain 3.64 2.18 2.53 1.59 Fatigue 3.58 2.25 2.44 2.12 Distress 2.89 2.23 2.32 2.39 Interference 3.22 2.29 2.57 2.23 Successful levels Pain 3.30 1.64 2.23 1.46 Fatigue 3.08 1.65 2.29 1.80 Distress 2.49 1.76 1.65 1.78 Interference 2.67 1.75 1.81 1.60 Importance levels Pain 8.96 1.70 9.07 2.04 Fatigue 8.58 1.67 8.17 3.03 Distress 7.16 2.61 7.40 3.69 Interference 8.31 1.93 8.11 3.08 Amount of Change Required Pain 3.94 2.00 3.07 1.97 Fatigue 4.67 2.06 3.08 2.34 Distress 3.72 2.49 3.41 3.10 Interference 4.57 2.43 3.93 2.72 10 O’Brien et al.
  • 7. current sample of back pain patients required reductions of 3.07 points in pain, 3.08 in fatigue, 3.41 in distress, and 3.93 in interference in order to consider treatment suc- cessful. These patient-centered definitions of success demonstrate the very high expectations of chronic pain patients related to their medical treatments, but also indi- cated that fibromyalgia patients require larger reductions in usual levels of pain, fatigue, distress, and interference in Table 3 Analyses of variance (ANOVAs) for PCO usual ratings across pain groups with sex as a factor Dependent Variable df Between df Error SS Between SS Error MS Between MS Error F PCO usual pain Group 1 296 82.76 1,208.84 82.76 4.08 20.26*** Sex 1 296 22.45 1,208.84 22.45 4.08 5.50** Group ¥ sex 1 296 1.76 1,208.84 1.76 4.08 0.43 PCO usual fatigue Group 1 296 177.11 1,216.11 177.11 4.11 43.11*** Sex 1 296 17.29 1,216.11 17.29 4.11 4.21** Group ¥ sex 1 296 20.53 1,216.11 20.53 4.11 5.00** PCO usual distress Group 1 296 25.48 2,313.90 25.48 7.82 3.26* Sex 1 296 36.37 2,313.90 36.37 7.82 4.65** Group ¥ sex 1 296 5.89 2,313.90 5.89 7.82 0.75 PCO usual interference Group 1 296 82.38 1,684.21 82.38 5.69 14.48*** Sex 1 296 8.77 1,684.21 8.77 5.69 1.54 Group ¥ sex 1 296 19.23 1,684.21 19.23 5.69 3.38* * P < 0.10; ** P < 0.05; *** P < 0.001. Table 4 Analyses of variance (ANOVAs) for PCO ratings across pain groups, including sex as a factor when correlated with the dependent variable Dependent Variable df Between df Error SS Between SS Error MS Between MS Error F PCO desired pain 1 298 51.62 987.09 51.62 3.31 15.58*** PCO desired fatigue 1 298 36.68 954.87 36.68 3.20 11.45** PCO desired distress 1 298 29.53 640.27 29.53 2.15 13.74*** PCO desired interference 1 298 22.47 777.61 22.47 2.61 8.61** PCO expected pain 1 295 50.46 1,290.27 50.46 4.37 11.54** PCO expected fatigue 1 295 53.35 1,463.20 53.35 4.96 10.76** PCO expected distress 1 295 13.33 1,502.69 13.33 5.09 2.62 PCO expected interference 1 295 17.31 1,530.30 17.31 5.19 3.34* PCO success pain Group 1 296 33.18 771.34 33.18 2.61 12.73*** Sex 1 296 0.64 771.34 0.64 2.61 0.25 Group ¥ sex 1 296 0.78 771.34 0.78 2.61 0.30 PCO success fatigue 1 298 26.98 840.06 26.98 2.82 9.57** PCO success distress 1 298 29.90 923.73 29.90 3.10 9.65** PCO success interference 1 296 31.97 880.91 31.97 2.98 10.74** PCO importance pain 1 297 0.47 923.68 0.47 3.11 0.15 PCO importance fatigue Group 1 295 7.68 1,122.47 7.68 3.81 2.02 Sex 1 295 12.04 1,122.47 12.04 3.81 3.16* Group ¥ sex 1 295 13.65 1,122.47 13.65 3.81 3.59* PCO importance distress 1 297 2.45 2,369.06 2.45 7.98 0.31 PCO importance interference 1 297 1.67 1,391.87 1.67 4.69 0.36 * P < 0.10; ** P < 0.01; *** P < 0.001. 11 Patient-Centered Outcomes in Chronic Pain
  • 8. order to consider their treatment a success. This is con- sistent with findings from a mixed sample of chronic pain patients [20], where reductions of 3.35–4.30 points across domains, and findings from a group of spine pain patients, where reductions of 32.8–43.1 points (using a PCO ques- tionnaire with a 101-point scale) across domains [15], were required for treatment to be considered successful. Our data also support the contention that patients may require larger changes across multiple domains than pre- viously believed, in order to consider their treatment suc- cessful. Patients with fibromyalgia identified reductions across domains in the range of 54–63% as clinically meaningful and patients with back pain identified reduc- tions of 57–68% across domains as clinically meaningful. These reductions are approximately twice the amount proposed in prior research [23]. Fibromyalgia patients required significantly larger reduc- tions in fatigue, compared to back-pain patients, in order to consider treatment successful. Fibromyalgia patients also reported larger reductions in pain, distress, and inter- ference in order to consider treatment successful, although these differences did not reach the level of sta- tistical significance set in this study. This pattern of find- ings may be due in part to the higher usual ratings, across all domains, reported by fibromyalgia patients. However, compared to the back-pain patients, fibromyalgia patients also identified less stringent success criteria across all domains. The differential reduction specific to fatigue iden- tified by fibromyalgia patients, in order for treatment to be successful, may be due to the high levels of reported fatigue common to this condition. Thus, patients may experience fibromyalgia as particularly impairing, due to this fatigue; this could impact other areas of their lives and may be reflected in the larger, though non-significant, reductions in pain, distress, and interference reported in order to consider treatment successful. Also, as fibromy- algia predominantly affects women, this differential reduc- tion specific to fatigue required for successful treatment may be related to differential gender-roles and the impact on fibromyalgia on different gender-role activities. Back pain and fibromyalgia patients required reductions ranging from 3.08–4.67/10 in fatigue, distress, and inter- ference in order to consider treatment successful, com- pared to pain reductions of 3.07 and 3.94. This underscores a need to adopt treatment approaches that address the multidimensional nature of the pain experi- ence and patients’ expectancies for improvements across multiple domains (i.e., pain, fatigue, distress, and function- ing) in order to consider treatment successful. Treatments that neglect these other important areas of concern to patients and focus solely on pain reduction, may contrib- ute to treatment dissatisfaction and reports of continued disability. Thus, not treating or under-treating areas iden- tified as important by patients, may be related to poorer outcomes and patient dissatisfaction. Taken together, these findings not only highlight the impor- tance of determining what patients are conceptualizing as a “successful” treatment outcome, but also the need to address any unrealistic expectations, in order to ensure effective communication about the changes that are fea- sible following treatment. It appears that both fibromyalgia patients and back pain patients are relatively pessimistic about treatment, since they do not expect treatment to meet their success criteria. Identifying patients’ expecta- tions and success criteria at the outset of treatment pro- vides an avenue for providers to address unrealistic expectations, discuss areas that patients feel are impor- 0 1 2 3 4 5 6 7 8 9 Pain group PCOUsuallevel Pain Fatigue Distress Interference 0 1 2 3 4 5 6 7 8 9 PCOSuccesslevel Pain Fatigue Distress Interference 0 1 2 3 4 5 6 7 8 9 Back PainFibromyalgia Pain group Back PainFibromyalgia Back PainFibromyalgia Pain group PCOAmountofChangerequired Pain Fatigue Distress Interference t p<.10; **p<.01; ***p<.001 *** *** ** *** *** ** *** ** t t t Figure 1 PCO ratings for usual levels, success levels, and amount of change required for the 2 pain groups. 12 O’Brien et al.
  • 9. tant to address in treatment, and to promote communi- cation about treatment options and realistic expectations for outcomes. Information from the PCO could facilitate referrals to providers for specific treatment addressing mood or other issues if desired or warranted. It could also guide treatment efforts, such as suggesting physical therapy if high ratings of interference or pain appear to be secondary to deconditioning, or arguing against prescrib- ing medications with high overdose potential in patients endorsing high levels of distress without any treatment for this. Additionally, if complete pain relief is an unrealistic treatment outcome, then use of acceptance-based (i.e., ACT/acceptance and commitment therapy) approaches for pain management may provide a useful treatment option for patients and providers. These results also provide additional, ecologically valid evidence that it is important for clinicians and researchers to incorporate patient-centered definitions of success into their procedures in order to prevent overestimating the effectiveness of their interventions. Of note, the present sample of fibromyalgia patients identified success target scores in the range of 2.49/10 to 3.30/10 and the present sample of back pain patients identified success target scores in the range of 1.65/10 to 2.29/10, consistent with Robinson and colleagues’ (2005) findings that patients with chronic pain do not require a complete absence of symptoms in order to consider treatment successful [20]. Thus, eliciting patients’ goals for treat- ment will facilitate the identification of any potentially unrealistic goals and enable providers to educate patients about realistic expectations regarding treatment outcomes. This can help to prevent patient dissatisfac- tion with unrealistic treatment expectations, and can also establish effective patterns of communication between patients and providers from the outset of treatment. Due to the cross-sectional nature of the analysis, several limitations of this design should be noted. Detailed infor- mation about any prior treatment these patients may have received was unavailable; it is therefore beyond the scope of this article to examine the impact that prior treatment success or failure may have on PCOQ ratings. We were also unable to examine PCOQ ratings throughout the course of treatment, and therefore cannot determine if patients adjust their ratings in response to treatment strat- egies. Future research employing longitudinal data would be valuable to identify whether fibromyalgia and back pain Table 5 Analyses of variance (ANOVAs) for PCO change ratings across pain groups with sex as a factor Dependent Variable df Between df Error SS Between SS Error MS Between MS Error F Change in PCO pain required Group 1 296 11.14 1,169.83 11.14 3.95 2.82* Sex 1 296 15.49 1,169.83 15.49 3.95 3.92** Group ¥ sex 1 296 0.20 1,169.83 0.20 3.95 0.05 Change in PCO fatigue required Group 1 296 67.94 1,296.42 67.94 4.38 15.51*** Sex 1 296 23.81 1,296.42 23.81 4.38 5.44** Group ¥ sex 1 296 10.58 1,296.42 10.58 4.38 2.42 Change in PCO distress required Group 1 296 1.30 1,984.61 1.30 6.71 0.19 Sex 1 296 33.29 1,984.61 33.29 6.71 4.97** Group ¥ sex 1 296 9.92 1,984.61 9.92 6.71 1.48 Change in PCO interference required Group 1 294 18.97 1,784.35 18.97 6.07 3.13* Sex 1 294 19.54 1,784.35 19.54 6.07 3.22* Group ¥ sex 1 294 25.85 1,784.35 25.85 6.07 4.26** * P < 0.10; ** P < 0.05; *** P < 0.001. Table 6 Correlation between VAS pain ratings and PCO ratings for usual pain in each pain group Fibromyalgia Back Pain VAS pain Intensity VAS Pain Unpleasantness VAS pain Intensity VAS Pain Unpleasantness PCO usual pain 0.668*** 0.641*** 0.781*** 0.725*** *** P < 0.001. 13 Patient-Centered Outcomes in Chronic Pain
  • 10. patients change their PCOQ ratings across treatment, and how changes in PCOQ ratings may affect patients’ views concerning treatment outcomes. Furthermore, as the PCOQ remains a new questionnaire, additional research is needed to examine its psychometric properties, and to determine whether patient ratings of success fluctuate with symptom severity, or remain consistent over time. Research involving patient-centered outcomes has dem- onstrated a substantial benefit to incorporating patients’ perspective into treatment evaluations [5,13,14]. This study contributes additional data supporting the impor- tance of using patient-centered success criteria when working with patients who have chronic pain conditions. Communication with patients about their definitions for treatment success has the potential to help patients pri- oritize their goals, make informed choices, and maintain realistic expectations about their treatment. A thorough understanding of the patient perspective is necessary to guide healthcare providers in clinical decision-making and promote better relationships with their patients. The results, regardless of type of chronic pain condition, also highlight the potential importance of assessing patient expectations for treatment success. It is highly likely that patients whose expectations significantly exceed likely treatment outcomes will be disappointed with results and with their care. Assessing these expectations during initial evaluations, and prior to the initiation of treatment, may contribute to better outcomes and more satisfied patients. Recognizing the heterogeneity within chronic-pain patient groups is consistent with a patient-centered model of treatment; it also encourages discussion and develop- ment of individualized treatment goals relevant to a par- ticular patient. While the benefits of such patient-centered approaches are well known, wider implementation of such treatment approaches are needed in order to maximize these benefits to the patient, the provider, and the health- care system. Acknowledgments Support for this research was provided from Grant R01 NR010324 to Dr. Michael Robinson, from the National Institute of Nursing Research. Disclosure None of the authors has any significant financial disclo- sures to report. References 1 Verhaak PF, Kerssens JJ, Dekker J, Sorbi MJ, Bensing JM. Prevalence of chronic benign pain disorder among adults: A review of the literature. Pain 1998;77(3): 231–9. 2 Andersson GB. Epidemiological features of chronic low-back pain. Lancet 1999;354(9178):581–5. 3 Lanes TC, Gauron EF, Spratt KF, et al. Long-term follow-up of patients with chronic back pain treated in a multidisciplinary rehabilitation program. Spine 1995;20(7):801–6. 4 Robinson RL, Jones ML. In search of pharmacoeco- nomic evaluations for fibromyalgia treatments: A review. Expert Opin Pharmacother 2006;7(8):1027– 39. 5 Alamo MM, Moral RR, Perula de Torres LA. Evaluation of a patient-centred approach in generalized muscu- loskeletal chronic pain/fibromyalgia patients in primary care. Patient Educ Couns 2002;48(1):23–31. 6 Wolfe F. Fibromyalgia. Rheum Dis Clin North Am 1990;16(3):681–98. 7 Nampiaparampil DE, Shmerling RH. A review of fibro- myalgia. Am J Manag Care 2004;10(11 Pt 1):794– 800. 8 Gallagher RM, Verma S. Managing pain and comorbid depression: A public health challenge. Semin Clin Neuropsychiatry 1999;4(3):203–20. 9 Verma S, Gallagher RM. The psychopharmacologic treatment of depression and anxiety in the context of chronic pain. Curr Pain Headache Rep 2002;6(1): 30–9. 10 Laine C, Davidoff F. Patient-centered medicine. A pro- fessional evolution. JAMA 1996;275(2):152–6. 11 Hall JA, Roter DL, Katz NR. Meta-analysis of corre- lates of provider behavior in medical encounters. Med Care 1988;26(7):657–75. 12 Hirsh AT, Atchison JW, Berger JJ, et al. Patient satis- faction with treatment for chronic pain: Predictors and relationship to compliance. Clin J Pain 2005;21(4): 302–10. 13 Fischer D, Stewart AL, Bloch DA, et al. Capturing the patient’s view of change as a clinical outcome measure. JAMA 1999;282(12):1157–62. 14 Masi AT, White KP, Pilcher JJ. Person-centered approach to care, teaching, and research in fibromy- algia syndrome: Justification from biopsychosocial perspectives in populations. Semin Arthritis Rheum 2002;32(2):71–93. 15 Brown JL, Edwards PS, Atchison JW, et al. Defining patient-centered, multidimensional success criteria for treatment of chronic spine pain. Pain Med 2008;9(7): 851–62. 16 Wolfe F, Smythe HA, Yunus MB, et al. The American College of Rheumatology 1990 Criteria for the Classi- 14 O’Brien et al.
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