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Assessment of predictors of the impact of fibromyalgia on health-related quality of life 12 months after the end of an interdisciplinary treatment
Author’s Accepted Manuscript Assessment of predictors of the impact of fibromyalgia on health-related quality of life 12 months after the end of an interdisciplinary treatment Josune Martín, Fernando Torre, Urko Aguirre, Angel Padierna, Begoña Matellanes, José M Quintana
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To appear in: Journal of Affective Disorders Received date: 5 April 2016 Revised date: 18 July 2016 Accepted date: 24 August 2016 Cite this article as: Josune Martín, Fernando Torre, Urko Aguirre, Angel Padierna, Begoña Matellanes and José M Quintana, Assessment of predictors of the impact of fibromyalgia on health-related quality of life 12 months after the end of an interdisciplinary treatment, Journal of Affective Disorders, http://dx.doi.org/10.1016/j.jad.2016.08.073 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Assessment of predictors of the impact of fibromyalgia on health-related quality of life 12 months after the end of an interdisciplinary treatment.
Josune Martín, PhD1,3*, Fernando Torre, MD2, Urko Aguirre, MSc 1,3, Angel Padierna, MD3,4, Begoña Matellanes, PhD5, José M Quintana, PhD MD1,3
1
Research Unit, Hospital Galdakao-Usansolo, Galdakao, Bizkaia, Spain.
2
Pain Treatment Unit, Hospital Galdakao-Usansolo, Galdakao, Bizkaia, Spain.
3
Health Services Research on Chronic Patients Network (REDISSEC), Galdakao,
Bizkaia, Spain. 4
Department of Psychiatry, Hospital Galdakao-Usansolo, Galdakao, Bizkaia, Spain.
5
Associate Professor of Psychology, Department of Psychology, Universidad Deusto,
Bilbao, Bizkaia, Spain. *
Correspondence should be addressed to Dra. Josune Martín, Unidad de Investigación,
9ª planta. Hospital Galdakao-Usansolo, Barrio Labeaga, s/n, 48960, Galdakao, Bizkaia, Spain.Tel.: +34-94-400-7105, Fax: [email protected] Abstract Objective: Fibromyalgia is a chronic pain disorder with a range of comorbid symptoms, including anxiety. We aimed to prospectively identify predictors of the long-term impact of fibromyalgia on health-related quality of life up to 12 months after the end of an interdisciplinary intervention. Methods: 138 patients with fibromyalgia, selected from a hospital pain management unit, participated in a 6-week interdisciplinary treatment that combined coordinated psychological, medical, educational, and physiotherapeutic interventions. Participants completed the Fibromyalgia Impact Questionnaire and the Hospital Anxiety and
1
Depression Scale at baseline and 6 weeks, 6 months, and 12 months after the intervention. Multivariable generalized linear mixed models were developed, using the Fibromyalgia Impact Questionnaire score as a continuous variable. Results: Variables that were significant predictors of the long-term impact of fibromyalgia on health-related quality of life in patients who completed a 6-week interdisciplinary treatment were marital status, the number of concurrent conditions, years since the onset of pain, and symptoms of anxiety. In the longitudinal analysis, patients with symptoms of anxiety had lower rates of improvement than those without symptoms of anxiety. Discussion: Our results suggest that patients with lower level of anxiety have less impact on their HRQoL. The results also provide evidence that starting interventions as soon as possible is an important factor for improving health-related quality of life. Keywords: fibromyalgia, HRQoL, predictors, interdisciplinary treatment
Introduction Fibromyalgia (FM) is a chronic disorder characterized by widespread pain and exaggerated tenderness on palpation in at least 11 of 18 tender points (Wolfe et al., 1990). Patients with FM frequently describe sensations of fatigue, disturbed sleep, morning stiffness, symptoms associated with irritable bowel syndrome, or symptoms of anxiety or depression (Aguglia et al., 2011). It is a persistent and debilitating disorder that can have a devastating effect on patients’ lives, affecting their ability to work and engage in everyday activities and relationships. It primarily affects women, with new diagnoses peaking between the ages of 40 and 49 years (Valverde et al., 2001). In Spain, the prevalence of FM is 2.4% (Carmona et al., 2001). This is in keeping with
2
estimates of 2.9% in five European countries (Branco et al., 2010) and 2% in the United States (Chakrabarty and Zoorob, 2007).
Characteristics of FM, such as its complex and unknown etiology, its wide range of symptoms and signs, and multiple comorbidities make identifying effective therapies particularly difficult. Indeed, no treatment to date has proven effective in fully alleviating its symptoms. Despite the chronic and complex nature of FM, several pharmacological
(Goldenberg
et
al.,
2004;
Häuser
et
al.,
2009a)
and
nonpharmacological interventions have demonstrated clinical benefit (Burckhardt, 2006; Häuser et al, 2009b; van Koulil et al., 2007). However, there is no consensus on the best therapeutic approach, and treatment of FM is a challenge for clinicians (Berger et
al.,
2007).
An integrated biopsychosocial approach that includes
both
nonpharmacological and pharmacological therapies has also been shown to improve outcomes (Burckhardt et al., 2005; Carville et al., 2008; García-Campayo et al., 2010; Häuser et al, 2009b; Lemstra and Olszynsky, 2005; Luedtke et al., 2005; Pfeiffer et al., 2003; Samwel et al., 2010; Sauer et al., 2011; Sim and Adams, 2002; Turk et al., 2008; van Koulil et al., 2007). Multidisciplinary programs for FM typically include education, cognitive and behavioral strategies, physical training, and medication (Burckhardt, 2006; Goldenberg et al., 2004). Although several studies of integrated therapies have been conducted, with promising results (Cedraschi et al., 2004; Kroese et al., 2009; Mannerkorpi et al., 2002; Worrel et al., 2001), some did not include a cognitivebehavioral component (Cedraschi et al., 2004; Kroese et al., 2009; Mannerkorpi et al., 2002) or a control group (Kroese et al., 2009; Mannerkorpi et al., 2002; Worrel et al., 2001). So far, there is no consensus on the effectiveness of this approach. One systematic review concluded that multidisciplinary therapy is effective for decreasing
3
the impact of FM (Burckhardt, 2006). A recent meta-analysis (Häuser et al, 2009b) concluded that there is strong evidence that multidisciplinary therapy alleviates some key symptoms of FM but these beneficial effects decline with time, while another systematic review concluded that the benefits of multidisciplinary therapy are limited and disappear over time (van Koulil et al., 2007). We developed an interdisciplinary treatment for FM based on the biopsychosocial model (Martín et al., 2013) that combines coordinated psychological, medical, educational, and physiotherapeutic components. We tested it in a randomized clinical trial among FM patients recruited from a hospital pain management unit (Martín et al., 2013). The trial demonstrated the efficacy of this interdisciplinary treatment and showed positive changes over time in biopsychosocial health and quality of life.
Given the paucity of available research to guide the management of FM, identifying factors that improve the response to treatment in this population would have significant clinical implications. Therefore, we aimed to prospectively identify predictors of the long-term impact of FM on health-related quality of life (HRQoL) after the end of interdisciplinary treatment for FM. A secondary goal was to examine longitudinally the impact of FM on HRQoL after an interdisciplinary intervention.
Materials and Methods Study participants The study population was prospectively drawn from patients referred to the pain management unit of the Hospital Galdakao-Usansolo, a 400-bed teaching hospital in the Basque Country (northern Spain) with a catchment population of 300,000. The hospital is part of the network of public hospitals of the Basque Health Service, which provides
4
unlimited free care to nearly 100% of the population. In this hospital, between 5% and 10% of patients newly diagnosed with FM are referred to the pain management unit, primarily from the departments of internal medicine and trauma.
To be eligible for the study, a patient must have been diagnosed with FM according to criteria of the American College of Rheumatology. These include widespread pain for at least 3 months in combination with pain on palpation in at least 11 of 18 specified tender points (Wolfe et al., 1990). Other eligibility criteria included age >18 years and having had continuous chronic pain for at least 6 months. Patients were excluded if they had a severe psychiatric or organic disease, could not complete the questionnaires because of language barriers, or were involved in employment-related legal proceedings related to their FM. Patients who agreed to participate were required to provide written informed consent.
The sample originated from the randomized controlled trial conducted by Martín et al. (2013). Between 2007 and 2009, 138 patients with FM referred to the pain management unit participated in a 6-week interdisciplinary treatment that combined coordinated psychological (PSY), medical (M), educational (E), and physiotherapeutic (PHY) interventions (PSYMEPHY). In brief, patients received what is currently the standard pharmacologic care for FM in Spain. They also received 6 weeks of interdisciplinary therapy delivered by a team that included a physician, a clinical psychologist, and a physiotherapist experienced in chronic pain management. Each patient attended twiceweekly group sessions for 6 weeks. These sessions covered educational activities focused on better understanding FM; cognitive-behavioral therapy to target the cognitive, physiological, and behavioral domains of FM; and a physiotherapeutic
5
component that included appropriate warm-up, exercise, and stretching routines for patients with FM.
Instruments and data collection At baseline, a physician associated with the pain management unit recorded sociodemographic data that included age, sex, marital status, level of education, and employment status. Patients’ medical histories were also recorded, including any diagnosed physical illnesses, number of years since the onset of pain, and number of tender points. A researcher who was not involved in providing treatment asked participants to complete two self-administered questionnaires that assessed the impact of FM on HRQoL, and symptoms of anxiety/depression.
Patients completed the Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt, 1991; Monterde et al., 2004; Rivera and González, 2004). This validated instrument uses visual analogue scales to measure how much FM affects functional capacity, such as the amount of pain and presence of anxiety or depression. The FIQ score can range from 0 to 100; the higher the score, the greater the impact of FM on HRQoL (Bennett, 2005). This questionnaire is considered to have good reliability and validity, justifying its use in clinical practice and research (Monterde et al., 2004). A version of the FIQ has been translated into and validated in Spanish (Rivera and González, 2004).
Patients also completed the Hospital Anxiety and Depression Scale (HADS), a 14-item instrument used to screen for anxiety and depression in nonpsychiatric settings (Zigmond and Snaith, 1983). It is divided into two subscales, one evaluating symptoms of anxiety (HADS-A), the other evaluating symptoms of depression (HADS-D). A
6
subscale score of 0 to 7 indicates the absence of anxiety or depression symptoms, a score of 8 to 10 indicates a possible case, and a score of 11 or above indicates the presence of anxiety or depression symptoms. The validity and reliability of the HADS has been confirmed (Herrmann, 1997), and the instrument has been adapted and validated in a Spanish population (Quintana et al., 2003).
Patients completed these instruments at baseline and again 6 weeks, 6 months, and 12 months after completing the interdisciplinary treatment.
Statistical analysis In an exploratory analysis of the data, we calculated means and standard deviations for continuous effects and frequencies, and percentages for categorical data of patients’ sociodemographic and clinical characteristics. The main outcome of this study—the FIQ score measured at baseline and three time periods after the intervention—was assessed at each measurement point as a continuous variable. To assess the unadjusted effects of the covariates on the main outcome (measured as a raw score), generalized linear mixed models were used. To this end, the FIQ score was set as the dependent variable and patients’ clinical and sociodemographic characteristics were considered as independent variables. Finally, we developed a multivariate linear mixed model to identify potential predictors of the evolution in the FIQ score over time. Values of the FIQ score were the outcome measures. Patient characteristics with p values < 0.20 were introduced into the multivariate model. In these models, random intercepts and unstructured variance-covariance matrix were used.
7
All statistical procedures were performed with SAS System v9.3. A variable was deemed to be significant at p<0.05. Figures were developed by means of the R 3.0 release.
Results Baseline data on patients with fibromyalgia who completed the Fibromyalgia Questionnaire. Sociodemographic and clinical characteristics of the participants are presented in Table 1. Of the 138 FM patients who completed the questionnaires at baseline, 92.75% were women, the mean age was 50 years (SD=9.27), and 54.35% were employed. Mean time since the onset of pain was 14.01 years (SD=9.97), with a range of 1 to 40 years. One hundred eight patients (78.3 %) completed the questionnaires 6 weeks after finishing the interdisciplinary PSYMEPHY therapy, 90 completed them at 6 months (65.2 %), and 93 completed them at 12 months (67.4%). No statistically significant differences were observed in anxiety and depression at baseline between patients who dropped out (n=45) and those who remained enrolled (n=93).
Influence of clinical and sociodemographic variables on the FIQ total score following interdisciplinary treatment for FM, during the follow-up Bivariate analysis of the evolution in the FIQ score according to sociodemographic and baseline clinical variables is shown in Table 2. A significantly greater improvement in the FIQ score was reported by patients who had a partner than those who were divorced or widowed (p=0.001), in patients with 1 or more additional physical illnesses than in patients without (p=0.01), and in patients in whom the onset of pain began 5 years earlier or less than in patients who had been living with pain for more than 5 years.
8
Figure 1. Evolution of the FIQ total score according to anxiety symptoms measured by the baseline HADS-A status. Patients with symptoms of anxiety showed worse evolution in the FIQ score during 12 months after interdisciplinary treatment than patients without symptons of anxiety (Figure 1). In patients with symptoms of anxiety, the FIQ total score was in the moderate range at baseline ( x =56.99; SD=16.20) and improved over time in the mild range ( x =36.02; SD=20.00).
Multivariate analysis of the evolution of the FIQ total score over time furng 12 months. In the multivariate analysis (Table 3), marital status, number of physical illnesses, years since the onset of pain, and symptoms of anxiety were significant predictors of evolution in the FIQ score. Improvement in the impact of FM on HRQoL was observed in married patients compared to those who were divorced or widowed, patients with 1 physical illnesses compared to those without any concurrent illnesses, patients in whom pain appeared 5 years previously or less compared to those living with pain for more than 5 years, and patients without symptoms of anxiety (HADS-A score of 7 or less) compared to those with symptoms of anxiety (HADS-A score greater than 7).
9
Discussion This prospective study identified predictors of the evolution on the impact of FM following 6 weeks of interdisciplinary treatment. These included marital status, number of comorbid physical illnesses, years since the onset of pain, and symptoms of anxiety. In addition, longitudinal analysis showed a decline in the impact of FM on HRQoL in patients without symptoms of anxiety.
Being married was associated with a lower impact of FM on long-term HRQoL. Reduced social support has been shown to have an important influence on physical and mental health in general (Kiecolt-Glaser and Newton, 2001). Being divorce or widowed disrupts the marital relationship and family life, and may lead to more limited social support. A partner’s responses may positively affect the adjustment of patients to living with FM, thus family interventions that help partners or other family members better understand FM could improve HRQoL for FM patients.
The presence of other physical illness was another variable that predicted the impact of FM on HRQoL during 12 months after the intervention. Patients who had other comorbidity were more likely to change severity groups on the FIQ total score. It is possible that FM patients who acquired coping skills during the PSYMEPHY treatment were able to apply them in their daily lives, and were thus better able to cope with their other condition(s), which would have been reflected in an improvement in HRQoL over time.
How long patients lived with chronic pain was another reliable predictor of treatment outcome. Patients whose pain began no more than 5 years before undergoing the
10
interdisciplinary treatment were more likely to have a lower impact of FM on HRQoL following treatment than patients whose onset of pain was greater than 5 years. That finding is in line with previous studies (van Koulil et al., 2007) which concluded that early interventions are far more likely to be effective than interventions administered in the later stages of the condition. The significance of early detection and treatment among patients who are at risk of developing persistent pain and related problems is increasingly recognized as an important component of pain management (Keefe et al., 2004). How long a patient has lived with pain is important for several reasons. First, FM is a condition associated with high levels of pain and diminished quality of life. Intervening early may help prevent the vicious cycle of long-term physical and psychological suffering (van Koulil et al., 2007). In addition, FM patients who have lived with pain for many years might have illness behaviors that are resistant to treatment, making it more difficult for them to change their behavior. Keel et al. (1998) indicated that the longer a patient has FM, the harder it is for him or her to make changes. This argues for starting interventions as soon as possible, and our results support such a strategy.
Patients who did not report symptoms of anxiety on the HAD scale at baseline had better rates of improvement in HRQoL during the evolution than those with anxiety symptoms. Given that anxiety is a frequent comorbidity in patients with FM, these findings suggest that FM patients with anxiety may need more intensive or different treatments. This finding is in line with other studies showing that anxiety is an important comorbidity of FM and requires assessment and treatment (Barros dos Santos et al., 2012). In our study, patients without symptoms of anxiety who underwent interdisciplinary FM treatment exhibited less impact of FM on HRQoL. A recent meta-
11
analysis (Häuser et al, 2009b) concluded that there is strong evidence of the efficacy of multidisciplinary therapy to reduce some key symptoms of FM, but that these positive effects were not maintained at 6 or 12 months. One important finding in our study is that patients without anxiety symptoms maintained improvements in HRQoL over time after interdisciplinary treatment for FM.
Strengths of our study include a reasonable sample size, a representative FM population seen in a hospital setting for treatment, and the use of disease-specific instruments for assessing HRQoL.
Limitations of the study must also be noted. Because all participants were selected from patients referred to a hospital pain management unit, it is possible that they may have experienced a greater impact of FM on HRQoL than patients treated in primary care. This could limit the generalization of our findings, and it would be important to investigate whether the interdisciplinary treatment is as successful in a wider context such as in primary care centers. However, the characteristics of the sample largely reflect the population affected by FM. Like (Häuser et al, 2009b), we were faced with the problem that there is no internationally accepted definition of multidisciplinary treatment, and no widely accepted standard for the minimum effective duration of multidisciplinary treatment. For future research it would be interesting to use the latest American College of Rheumatology criteria for FM (Wolfe et al., 2010) and the FIQRevised (Luciano et al., 2013), neither of which were available when this study was conducted. The FIQ-Revised may be more sensitive to change in HRQoL or function than the original version.
12
The results of our study have several implications for treatment planning. They suggest that symptoms of anxiety should be targeted for treatment as part of FM therapy. Future studies should examine multidisciplinary treatment in varying contexts to determine the direct and indirect costs of the intervention, as well as the potential savings that might accrue from it, data that are of crucial importance for policymakers.
Conclusions It is important to identify factors that improve or damage HRQoL after an intervention specifically designed to ease FM. In this prospective study, FM patients with anxiety symptoms who received an interdisciplinary treatment exhibited greater impact of FM on HRQoL up to 12 months after the intervention than patients without symptoms of anxiety. These results indicate that FM patients with symptoms of anxiety may benefit from a tailored treatment component that focuses on anxiety in addition to other FM treatments. Our findings also suggest that early interdisciplinary intervention may help improve HRQoL in patients with FM. Disclosure statement: All the authors declare no conflict of interests. Conflict of interest: All the authors declare no conflict of interests.
Acknowledgements: This study was carried out with funding from the Department of Health of the Basque Country (project nº 2006111057), “Improvement of the healthrelated quality of life of patients suffering from fibromyalgia using multidisciplinary treatment,” granted to Fernando Torre, the principal investigator. We also thank the Research Committee of the Galdakao-Usansolo Hospital for help editing this article, and acknowledge editorial assistance provided by Patrick Skerrett. We also would like to thank all the individuals with FM who participated in our study.
13
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Highlights
This study provides an identification of the predictors of the long-term impact of fibromyalgia on health-related quality of life up to 12 months after the end of an interdisciplinary intervention.
This study contributes to understanding that patients with symptoms of anxiety may benefit from a tailored treatment component that focuses on anxiety in addition to other FM treatments.
17
The findings of this study also suggest that early interdisciplinary intervention may help improve HRQoL in patients with FM
Figure 1. Evolution of the FIQ total score according to anxiety symptoms measured by the baseline HADS-A status. Note. The evolution of the FIQ total score is measured in the 3 groups of severity of baseline anxiety, measured by the HADS-A scale
Table 1. Baseline data on patients with fibromyalgia who completed the Fibromyalgia Impact Questionnaire. Total Patients (n =138) Age (years)* x (SD) Sex Female Male Marital status
n (%) 50.09 (9.27) 128 (92.75) 10 (7.25)
18
Single Married Divorced/ Widowed Level of Education Primary education Secondary education College or above Employment status Employed Non-paid work Disabled Retired Number of concurrent physical illnesses None One Two or more Years since the onset of pain* x (SD) Tender points <18 18 Total FIQ score* x (SD) Anxiety-HAD* x (SD) >11 8-10 0-7 Depression-HAD* x (SD) >11 8-10 0-7
7 (5.07) 117 (84.78) 14 (10.15) 74 (53.62) 52 (37.68) 12 (8.70) 75 (54.35) 27 (19.57) 21 (15.22) 15 (10.87) 48 (34.78) 57 (41.30) 33 (23.91) 14.01 (9.97) 72 (56.25) 56 (43.75) 75.72 (14.28) 13.78 (3.36) 115 (83.33) 18 (13.04) 5 (3.62) 10.65 (4.13) 64 (46.38) 47 (34.06) 27 (19.57)
Note. x = mean; SD= standard deviation. *Results showed as mean (standard deviation). FIQ: Fibromyalgia Impact Questionnaire. HAD: Hospital Anxiety and Depression Scale. 18 tender points is the maximum number of tender points according to the ACR diagnostic criteria of FM. Level of significance p< 0.05
Table 2. Influence of clinical and sociodemographic variables on the FIQ total score following interdisciplinary treatment for FM. Influence of clinical and sociodemographic variables on the FIQ total score following interdisciplinary treatment for FM, during the follow-up. FIQ total score Beta coefficient (se) p-value Gender Female Male
Reference 0.02 (0.09)
0.79 19
Age <45 45-55 >55 Marital status Spouse/partner Divorced/Widowed Single Educational level Primary education Secondary education Higher education Employment status Employed Non-paid work Disabled Retired Tender points <18 18 Number of concurrent illnesses 0 1 ≥2 Years since the onset of pain ≤5 6-10 11-15 >15 Anxiety (HAD) ≤7 8-10 ≥ 11 Depression (HAD) ≤7 8-10 ≥ 11
Reference 0.04 (0.06) 0.13 (0.07
0.50 0.07 .
Reference 0.23 (0.09) 0.15 (0.12)
0.001 0.23
Reference -0.10 (0.06) 0.06 (0.09)
0.09 0.55
Reference 0.09 (0.07) 0.06 (0.07) 0.11 (0.08)
0.21 0.44 0.18
0.07 (0.05) Reference
0.23
Reference -0.15 (0.06) -0.13 (0.07)
0.01 0.06
Reference 0.16 (0.07) 0.19 (0.09) 0.23 (0.06)
0.03 0.04 0.0005
Reference 0.25 (0.14) 0.25 (0.12)
0.08 0.05
Reference -0.01 (0.07) -0.05 (0.07)
0.50 0.87
Note. FIQ: Fibromyalgia Impact Questionnaire. HAD: Hospital Anxiety and Depression Scale. Beta coefficient obtained from the interaction of the variable with the Time effect. SE: Standard error. Reference: reference group. Level of significance p< 0.05
Table 3.Multivariate analysis of the evolution of the FIQ total score. Multivariate analysis of FIQ total score over time during 12 months of follow-up. Expected change Evolution in the FIQ total score β (SE)
p-value
Time *variables effect Marital status 20
Single vs married (Reference)
0.06 (0.12)
0.63
Divorced/widowed vs married (Reference)
0.25 (0.09)
0.005
1 vs 0 (Reference)
-0.12 (0.06)
0.03
≥2 vs 0 (Reference)
-0.13 (0.06)
0.04
6-10 vs ≤ 5 (Reference)
0.20 (0.07)
0.003
11-15 vs ≤ 5 (Reference)
0.19 (0.09)
0.03
>15 vs ≤ 5 (Reference)
0.22 (0.06)
0.0003
8-10 vs ≤ 7 (Reference)
0.30 (0.13)
0.02
≥ 11 vs ≤ 7 (Reference)
0.23 (0.12)
0.04
Number of concurrent physical illnesses
Years since the onset of pain
Anxiety (HAD)
Note. FIQ: Fibromyalgia impact on quality of life. Reference: reference group. HAD: Hospital Anxiety and Depression Scale. β= Beta. SE: Standard error. P-values in bold indicated a significance level of p<0.05.
21
PII: DOI: Reference:
www.elsevier.com/locate/jad
S0165-0327(16)30466-9 http://dx.doi.org/10.1016/j.jad.2016.08.073 JAD8554
To appear in: Journal of Affective Disorders Received date: 5 April 2016 Revised date: 18 July 2016 Accepted date: 24 August 2016 Cite this article as: Josune Martín, Fernando Torre, Urko Aguirre, Angel Padierna, Begoña Matellanes and José M Quintana, Assessment of predictors of the impact of fibromyalgia on health-related quality of life 12 months after the end of an interdisciplinary treatment, Journal of Affective Disorders, http://dx.doi.org/10.1016/j.jad.2016.08.073 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Assessment of predictors of the impact of fibromyalgia on health-related quality of life 12 months after the end of an interdisciplinary treatment.
Josune Martín, PhD1,3*, Fernando Torre, MD2, Urko Aguirre, MSc 1,3, Angel Padierna, MD3,4, Begoña Matellanes, PhD5, José M Quintana, PhD MD1,3
1
Research Unit, Hospital Galdakao-Usansolo, Galdakao, Bizkaia, Spain.
2
Pain Treatment Unit, Hospital Galdakao-Usansolo, Galdakao, Bizkaia, Spain.
3
Health Services Research on Chronic Patients Network (REDISSEC), Galdakao,
Bizkaia, Spain. 4
Department of Psychiatry, Hospital Galdakao-Usansolo, Galdakao, Bizkaia, Spain.
5
Associate Professor of Psychology, Department of Psychology, Universidad Deusto,
Bilbao, Bizkaia, Spain. *
Correspondence should be addressed to Dra. Josune Martín, Unidad de Investigación,
9ª planta. Hospital Galdakao-Usansolo, Barrio Labeaga, s/n, 48960, Galdakao, Bizkaia, Spain.Tel.: +34-94-400-7105, Fax: [email protected] Abstract Objective: Fibromyalgia is a chronic pain disorder with a range of comorbid symptoms, including anxiety. We aimed to prospectively identify predictors of the long-term impact of fibromyalgia on health-related quality of life up to 12 months after the end of an interdisciplinary intervention. Methods: 138 patients with fibromyalgia, selected from a hospital pain management unit, participated in a 6-week interdisciplinary treatment that combined coordinated psychological, medical, educational, and physiotherapeutic interventions. Participants completed the Fibromyalgia Impact Questionnaire and the Hospital Anxiety and
1
Depression Scale at baseline and 6 weeks, 6 months, and 12 months after the intervention. Multivariable generalized linear mixed models were developed, using the Fibromyalgia Impact Questionnaire score as a continuous variable. Results: Variables that were significant predictors of the long-term impact of fibromyalgia on health-related quality of life in patients who completed a 6-week interdisciplinary treatment were marital status, the number of concurrent conditions, years since the onset of pain, and symptoms of anxiety. In the longitudinal analysis, patients with symptoms of anxiety had lower rates of improvement than those without symptoms of anxiety. Discussion: Our results suggest that patients with lower level of anxiety have less impact on their HRQoL. The results also provide evidence that starting interventions as soon as possible is an important factor for improving health-related quality of life. Keywords: fibromyalgia, HRQoL, predictors, interdisciplinary treatment
Introduction Fibromyalgia (FM) is a chronic disorder characterized by widespread pain and exaggerated tenderness on palpation in at least 11 of 18 tender points (Wolfe et al., 1990). Patients with FM frequently describe sensations of fatigue, disturbed sleep, morning stiffness, symptoms associated with irritable bowel syndrome, or symptoms of anxiety or depression (Aguglia et al., 2011). It is a persistent and debilitating disorder that can have a devastating effect on patients’ lives, affecting their ability to work and engage in everyday activities and relationships. It primarily affects women, with new diagnoses peaking between the ages of 40 and 49 years (Valverde et al., 2001). In Spain, the prevalence of FM is 2.4% (Carmona et al., 2001). This is in keeping with
2
estimates of 2.9% in five European countries (Branco et al., 2010) and 2% in the United States (Chakrabarty and Zoorob, 2007).
Characteristics of FM, such as its complex and unknown etiology, its wide range of symptoms and signs, and multiple comorbidities make identifying effective therapies particularly difficult. Indeed, no treatment to date has proven effective in fully alleviating its symptoms. Despite the chronic and complex nature of FM, several pharmacological
(Goldenberg
et
al.,
2004;
Häuser
et
al.,
2009a)
and
nonpharmacological interventions have demonstrated clinical benefit (Burckhardt, 2006; Häuser et al, 2009b; van Koulil et al., 2007). However, there is no consensus on the best therapeutic approach, and treatment of FM is a challenge for clinicians (Berger et
al.,
2007).
An integrated biopsychosocial approach that includes
both
nonpharmacological and pharmacological therapies has also been shown to improve outcomes (Burckhardt et al., 2005; Carville et al., 2008; García-Campayo et al., 2010; Häuser et al, 2009b; Lemstra and Olszynsky, 2005; Luedtke et al., 2005; Pfeiffer et al., 2003; Samwel et al., 2010; Sauer et al., 2011; Sim and Adams, 2002; Turk et al., 2008; van Koulil et al., 2007). Multidisciplinary programs for FM typically include education, cognitive and behavioral strategies, physical training, and medication (Burckhardt, 2006; Goldenberg et al., 2004). Although several studies of integrated therapies have been conducted, with promising results (Cedraschi et al., 2004; Kroese et al., 2009; Mannerkorpi et al., 2002; Worrel et al., 2001), some did not include a cognitivebehavioral component (Cedraschi et al., 2004; Kroese et al., 2009; Mannerkorpi et al., 2002) or a control group (Kroese et al., 2009; Mannerkorpi et al., 2002; Worrel et al., 2001). So far, there is no consensus on the effectiveness of this approach. One systematic review concluded that multidisciplinary therapy is effective for decreasing
3
the impact of FM (Burckhardt, 2006). A recent meta-analysis (Häuser et al, 2009b) concluded that there is strong evidence that multidisciplinary therapy alleviates some key symptoms of FM but these beneficial effects decline with time, while another systematic review concluded that the benefits of multidisciplinary therapy are limited and disappear over time (van Koulil et al., 2007). We developed an interdisciplinary treatment for FM based on the biopsychosocial model (Martín et al., 2013) that combines coordinated psychological, medical, educational, and physiotherapeutic components. We tested it in a randomized clinical trial among FM patients recruited from a hospital pain management unit (Martín et al., 2013). The trial demonstrated the efficacy of this interdisciplinary treatment and showed positive changes over time in biopsychosocial health and quality of life.
Given the paucity of available research to guide the management of FM, identifying factors that improve the response to treatment in this population would have significant clinical implications. Therefore, we aimed to prospectively identify predictors of the long-term impact of FM on health-related quality of life (HRQoL) after the end of interdisciplinary treatment for FM. A secondary goal was to examine longitudinally the impact of FM on HRQoL after an interdisciplinary intervention.
Materials and Methods Study participants The study population was prospectively drawn from patients referred to the pain management unit of the Hospital Galdakao-Usansolo, a 400-bed teaching hospital in the Basque Country (northern Spain) with a catchment population of 300,000. The hospital is part of the network of public hospitals of the Basque Health Service, which provides
4
unlimited free care to nearly 100% of the population. In this hospital, between 5% and 10% of patients newly diagnosed with FM are referred to the pain management unit, primarily from the departments of internal medicine and trauma.
To be eligible for the study, a patient must have been diagnosed with FM according to criteria of the American College of Rheumatology. These include widespread pain for at least 3 months in combination with pain on palpation in at least 11 of 18 specified tender points (Wolfe et al., 1990). Other eligibility criteria included age >18 years and having had continuous chronic pain for at least 6 months. Patients were excluded if they had a severe psychiatric or organic disease, could not complete the questionnaires because of language barriers, or were involved in employment-related legal proceedings related to their FM. Patients who agreed to participate were required to provide written informed consent.
The sample originated from the randomized controlled trial conducted by Martín et al. (2013). Between 2007 and 2009, 138 patients with FM referred to the pain management unit participated in a 6-week interdisciplinary treatment that combined coordinated psychological (PSY), medical (M), educational (E), and physiotherapeutic (PHY) interventions (PSYMEPHY). In brief, patients received what is currently the standard pharmacologic care for FM in Spain. They also received 6 weeks of interdisciplinary therapy delivered by a team that included a physician, a clinical psychologist, and a physiotherapist experienced in chronic pain management. Each patient attended twiceweekly group sessions for 6 weeks. These sessions covered educational activities focused on better understanding FM; cognitive-behavioral therapy to target the cognitive, physiological, and behavioral domains of FM; and a physiotherapeutic
5
component that included appropriate warm-up, exercise, and stretching routines for patients with FM.
Instruments and data collection At baseline, a physician associated with the pain management unit recorded sociodemographic data that included age, sex, marital status, level of education, and employment status. Patients’ medical histories were also recorded, including any diagnosed physical illnesses, number of years since the onset of pain, and number of tender points. A researcher who was not involved in providing treatment asked participants to complete two self-administered questionnaires that assessed the impact of FM on HRQoL, and symptoms of anxiety/depression.
Patients completed the Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt, 1991; Monterde et al., 2004; Rivera and González, 2004). This validated instrument uses visual analogue scales to measure how much FM affects functional capacity, such as the amount of pain and presence of anxiety or depression. The FIQ score can range from 0 to 100; the higher the score, the greater the impact of FM on HRQoL (Bennett, 2005). This questionnaire is considered to have good reliability and validity, justifying its use in clinical practice and research (Monterde et al., 2004). A version of the FIQ has been translated into and validated in Spanish (Rivera and González, 2004).
Patients also completed the Hospital Anxiety and Depression Scale (HADS), a 14-item instrument used to screen for anxiety and depression in nonpsychiatric settings (Zigmond and Snaith, 1983). It is divided into two subscales, one evaluating symptoms of anxiety (HADS-A), the other evaluating symptoms of depression (HADS-D). A
6
subscale score of 0 to 7 indicates the absence of anxiety or depression symptoms, a score of 8 to 10 indicates a possible case, and a score of 11 or above indicates the presence of anxiety or depression symptoms. The validity and reliability of the HADS has been confirmed (Herrmann, 1997), and the instrument has been adapted and validated in a Spanish population (Quintana et al., 2003).
Patients completed these instruments at baseline and again 6 weeks, 6 months, and 12 months after completing the interdisciplinary treatment.
Statistical analysis In an exploratory analysis of the data, we calculated means and standard deviations for continuous effects and frequencies, and percentages for categorical data of patients’ sociodemographic and clinical characteristics. The main outcome of this study—the FIQ score measured at baseline and three time periods after the intervention—was assessed at each measurement point as a continuous variable. To assess the unadjusted effects of the covariates on the main outcome (measured as a raw score), generalized linear mixed models were used. To this end, the FIQ score was set as the dependent variable and patients’ clinical and sociodemographic characteristics were considered as independent variables. Finally, we developed a multivariate linear mixed model to identify potential predictors of the evolution in the FIQ score over time. Values of the FIQ score were the outcome measures. Patient characteristics with p values < 0.20 were introduced into the multivariate model. In these models, random intercepts and unstructured variance-covariance matrix were used.
7
All statistical procedures were performed with SAS System v9.3. A variable was deemed to be significant at p<0.05. Figures were developed by means of the R 3.0 release.
Results Baseline data on patients with fibromyalgia who completed the Fibromyalgia Questionnaire. Sociodemographic and clinical characteristics of the participants are presented in Table 1. Of the 138 FM patients who completed the questionnaires at baseline, 92.75% were women, the mean age was 50 years (SD=9.27), and 54.35% were employed. Mean time since the onset of pain was 14.01 years (SD=9.97), with a range of 1 to 40 years. One hundred eight patients (78.3 %) completed the questionnaires 6 weeks after finishing the interdisciplinary PSYMEPHY therapy, 90 completed them at 6 months (65.2 %), and 93 completed them at 12 months (67.4%). No statistically significant differences were observed in anxiety and depression at baseline between patients who dropped out (n=45) and those who remained enrolled (n=93).
Influence of clinical and sociodemographic variables on the FIQ total score following interdisciplinary treatment for FM, during the follow-up Bivariate analysis of the evolution in the FIQ score according to sociodemographic and baseline clinical variables is shown in Table 2. A significantly greater improvement in the FIQ score was reported by patients who had a partner than those who were divorced or widowed (p=0.001), in patients with 1 or more additional physical illnesses than in patients without (p=0.01), and in patients in whom the onset of pain began 5 years earlier or less than in patients who had been living with pain for more than 5 years.
8
Figure 1. Evolution of the FIQ total score according to anxiety symptoms measured by the baseline HADS-A status. Patients with symptoms of anxiety showed worse evolution in the FIQ score during 12 months after interdisciplinary treatment than patients without symptons of anxiety (Figure 1). In patients with symptoms of anxiety, the FIQ total score was in the moderate range at baseline ( x =56.99; SD=16.20) and improved over time in the mild range ( x =36.02; SD=20.00).
Multivariate analysis of the evolution of the FIQ total score over time furng 12 months. In the multivariate analysis (Table 3), marital status, number of physical illnesses, years since the onset of pain, and symptoms of anxiety were significant predictors of evolution in the FIQ score. Improvement in the impact of FM on HRQoL was observed in married patients compared to those who were divorced or widowed, patients with 1 physical illnesses compared to those without any concurrent illnesses, patients in whom pain appeared 5 years previously or less compared to those living with pain for more than 5 years, and patients without symptoms of anxiety (HADS-A score of 7 or less) compared to those with symptoms of anxiety (HADS-A score greater than 7).
9
Discussion This prospective study identified predictors of the evolution on the impact of FM following 6 weeks of interdisciplinary treatment. These included marital status, number of comorbid physical illnesses, years since the onset of pain, and symptoms of anxiety. In addition, longitudinal analysis showed a decline in the impact of FM on HRQoL in patients without symptoms of anxiety.
Being married was associated with a lower impact of FM on long-term HRQoL. Reduced social support has been shown to have an important influence on physical and mental health in general (Kiecolt-Glaser and Newton, 2001). Being divorce or widowed disrupts the marital relationship and family life, and may lead to more limited social support. A partner’s responses may positively affect the adjustment of patients to living with FM, thus family interventions that help partners or other family members better understand FM could improve HRQoL for FM patients.
The presence of other physical illness was another variable that predicted the impact of FM on HRQoL during 12 months after the intervention. Patients who had other comorbidity were more likely to change severity groups on the FIQ total score. It is possible that FM patients who acquired coping skills during the PSYMEPHY treatment were able to apply them in their daily lives, and were thus better able to cope with their other condition(s), which would have been reflected in an improvement in HRQoL over time.
How long patients lived with chronic pain was another reliable predictor of treatment outcome. Patients whose pain began no more than 5 years before undergoing the
10
interdisciplinary treatment were more likely to have a lower impact of FM on HRQoL following treatment than patients whose onset of pain was greater than 5 years. That finding is in line with previous studies (van Koulil et al., 2007) which concluded that early interventions are far more likely to be effective than interventions administered in the later stages of the condition. The significance of early detection and treatment among patients who are at risk of developing persistent pain and related problems is increasingly recognized as an important component of pain management (Keefe et al., 2004). How long a patient has lived with pain is important for several reasons. First, FM is a condition associated with high levels of pain and diminished quality of life. Intervening early may help prevent the vicious cycle of long-term physical and psychological suffering (van Koulil et al., 2007). In addition, FM patients who have lived with pain for many years might have illness behaviors that are resistant to treatment, making it more difficult for them to change their behavior. Keel et al. (1998) indicated that the longer a patient has FM, the harder it is for him or her to make changes. This argues for starting interventions as soon as possible, and our results support such a strategy.
Patients who did not report symptoms of anxiety on the HAD scale at baseline had better rates of improvement in HRQoL during the evolution than those with anxiety symptoms. Given that anxiety is a frequent comorbidity in patients with FM, these findings suggest that FM patients with anxiety may need more intensive or different treatments. This finding is in line with other studies showing that anxiety is an important comorbidity of FM and requires assessment and treatment (Barros dos Santos et al., 2012). In our study, patients without symptoms of anxiety who underwent interdisciplinary FM treatment exhibited less impact of FM on HRQoL. A recent meta-
11
analysis (Häuser et al, 2009b) concluded that there is strong evidence of the efficacy of multidisciplinary therapy to reduce some key symptoms of FM, but that these positive effects were not maintained at 6 or 12 months. One important finding in our study is that patients without anxiety symptoms maintained improvements in HRQoL over time after interdisciplinary treatment for FM.
Strengths of our study include a reasonable sample size, a representative FM population seen in a hospital setting for treatment, and the use of disease-specific instruments for assessing HRQoL.
Limitations of the study must also be noted. Because all participants were selected from patients referred to a hospital pain management unit, it is possible that they may have experienced a greater impact of FM on HRQoL than patients treated in primary care. This could limit the generalization of our findings, and it would be important to investigate whether the interdisciplinary treatment is as successful in a wider context such as in primary care centers. However, the characteristics of the sample largely reflect the population affected by FM. Like (Häuser et al, 2009b), we were faced with the problem that there is no internationally accepted definition of multidisciplinary treatment, and no widely accepted standard for the minimum effective duration of multidisciplinary treatment. For future research it would be interesting to use the latest American College of Rheumatology criteria for FM (Wolfe et al., 2010) and the FIQRevised (Luciano et al., 2013), neither of which were available when this study was conducted. The FIQ-Revised may be more sensitive to change in HRQoL or function than the original version.
12
The results of our study have several implications for treatment planning. They suggest that symptoms of anxiety should be targeted for treatment as part of FM therapy. Future studies should examine multidisciplinary treatment in varying contexts to determine the direct and indirect costs of the intervention, as well as the potential savings that might accrue from it, data that are of crucial importance for policymakers.
Conclusions It is important to identify factors that improve or damage HRQoL after an intervention specifically designed to ease FM. In this prospective study, FM patients with anxiety symptoms who received an interdisciplinary treatment exhibited greater impact of FM on HRQoL up to 12 months after the intervention than patients without symptoms of anxiety. These results indicate that FM patients with symptoms of anxiety may benefit from a tailored treatment component that focuses on anxiety in addition to other FM treatments. Our findings also suggest that early interdisciplinary intervention may help improve HRQoL in patients with FM. Disclosure statement: All the authors declare no conflict of interests. Conflict of interest: All the authors declare no conflict of interests.
Acknowledgements: This study was carried out with funding from the Department of Health of the Basque Country (project nº 2006111057), “Improvement of the healthrelated quality of life of patients suffering from fibromyalgia using multidisciplinary treatment,” granted to Fernando Torre, the principal investigator. We also thank the Research Committee of the Galdakao-Usansolo Hospital for help editing this article, and acknowledge editorial assistance provided by Patrick Skerrett. We also would like to thank all the individuals with FM who participated in our study.
13
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Highlights
This study provides an identification of the predictors of the long-term impact of fibromyalgia on health-related quality of life up to 12 months after the end of an interdisciplinary intervention.
This study contributes to understanding that patients with symptoms of anxiety may benefit from a tailored treatment component that focuses on anxiety in addition to other FM treatments.
17
The findings of this study also suggest that early interdisciplinary intervention may help improve HRQoL in patients with FM
Figure 1. Evolution of the FIQ total score according to anxiety symptoms measured by the baseline HADS-A status. Note. The evolution of the FIQ total score is measured in the 3 groups of severity of baseline anxiety, measured by the HADS-A scale
Table 1. Baseline data on patients with fibromyalgia who completed the Fibromyalgia Impact Questionnaire. Total Patients (n =138) Age (years)* x (SD) Sex Female Male Marital status
n (%) 50.09 (9.27) 128 (92.75) 10 (7.25)
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Single Married Divorced/ Widowed Level of Education Primary education Secondary education College or above Employment status Employed Non-paid work Disabled Retired Number of concurrent physical illnesses None One Two or more Years since the onset of pain* x (SD) Tender points <18 18 Total FIQ score* x (SD) Anxiety-HAD* x (SD) >11 8-10 0-7 Depression-HAD* x (SD) >11 8-10 0-7
7 (5.07) 117 (84.78) 14 (10.15) 74 (53.62) 52 (37.68) 12 (8.70) 75 (54.35) 27 (19.57) 21 (15.22) 15 (10.87) 48 (34.78) 57 (41.30) 33 (23.91) 14.01 (9.97) 72 (56.25) 56 (43.75) 75.72 (14.28) 13.78 (3.36) 115 (83.33) 18 (13.04) 5 (3.62) 10.65 (4.13) 64 (46.38) 47 (34.06) 27 (19.57)
Note. x = mean; SD= standard deviation. *Results showed as mean (standard deviation). FIQ: Fibromyalgia Impact Questionnaire. HAD: Hospital Anxiety and Depression Scale. 18 tender points is the maximum number of tender points according to the ACR diagnostic criteria of FM. Level of significance p< 0.05
Table 2. Influence of clinical and sociodemographic variables on the FIQ total score following interdisciplinary treatment for FM. Influence of clinical and sociodemographic variables on the FIQ total score following interdisciplinary treatment for FM, during the follow-up. FIQ total score Beta coefficient (se) p-value Gender Female Male
Reference 0.02 (0.09)
0.79 19
Age <45 45-55 >55 Marital status Spouse/partner Divorced/Widowed Single Educational level Primary education Secondary education Higher education Employment status Employed Non-paid work Disabled Retired Tender points <18 18 Number of concurrent illnesses 0 1 ≥2 Years since the onset of pain ≤5 6-10 11-15 >15 Anxiety (HAD) ≤7 8-10 ≥ 11 Depression (HAD) ≤7 8-10 ≥ 11
Reference 0.04 (0.06) 0.13 (0.07
0.50 0.07 .
Reference 0.23 (0.09) 0.15 (0.12)
0.001 0.23
Reference -0.10 (0.06) 0.06 (0.09)
0.09 0.55
Reference 0.09 (0.07) 0.06 (0.07) 0.11 (0.08)
0.21 0.44 0.18
0.07 (0.05) Reference
0.23
Reference -0.15 (0.06) -0.13 (0.07)
0.01 0.06
Reference 0.16 (0.07) 0.19 (0.09) 0.23 (0.06)
0.03 0.04 0.0005
Reference 0.25 (0.14) 0.25 (0.12)
0.08 0.05
Reference -0.01 (0.07) -0.05 (0.07)
0.50 0.87
Note. FIQ: Fibromyalgia Impact Questionnaire. HAD: Hospital Anxiety and Depression Scale. Beta coefficient obtained from the interaction of the variable with the Time effect. SE: Standard error. Reference: reference group. Level of significance p< 0.05
Table 3.Multivariate analysis of the evolution of the FIQ total score. Multivariate analysis of FIQ total score over time during 12 months of follow-up. Expected change Evolution in the FIQ total score β (SE)
p-value
Time *variables effect Marital status 20
Single vs married (Reference)
0.06 (0.12)
0.63
Divorced/widowed vs married (Reference)
0.25 (0.09)
0.005
1 vs 0 (Reference)
-0.12 (0.06)
0.03
≥2 vs 0 (Reference)
-0.13 (0.06)
0.04
6-10 vs ≤ 5 (Reference)
0.20 (0.07)
0.003
11-15 vs ≤ 5 (Reference)
0.19 (0.09)
0.03
>15 vs ≤ 5 (Reference)
0.22 (0.06)
0.0003
8-10 vs ≤ 7 (Reference)
0.30 (0.13)
0.02
≥ 11 vs ≤ 7 (Reference)
0.23 (0.12)
0.04
Number of concurrent physical illnesses
Years since the onset of pain
Anxiety (HAD)
Note. FIQ: Fibromyalgia impact on quality of life. Reference: reference group. HAD: Hospital Anxiety and Depression Scale. β= Beta. SE: Standard error. P-values in bold indicated a significance level of p<0.05.
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