The Impact of a Group-Based Multidisciplinary Rehabilitation Program on the Quality of Life in Patients With Fibromyalgia

Results From the QUALIFIBRO Study

Herlinde Jacobs, MD; Martine Bockaert, MSc; Jan Bonte, MD; Mark D'Haese, MD; Jan Degrande, MD; Line Descamps, MSc; Ulrike Detaeye, MSc; Willem Goethals, MD; Jo Janssens, MSc; Koen Matthys, MD; Lieve Muller, MSc; Hilde Van deWalle, MSc; Ilse Viane, MSc; Barbara Vlieghe, MD; Michiel Grillet, MD; Rachael Asher, MSc; Bernard Grillet, MD, PhD,; Dirk De Bacquer, PhD

Disclosures

J Clin Rheumatol. 2020;26(8):313-319. 

In This Article

Methods

Participants

Recruitment for the open uncontrolled QUALlIFIBRO study to evaluate the short-term and long-term impact of a multidisciplinary rehabilitation program on FM patients' HRQoL, ran from September 2016 to January 2018. During this period, all patients older than 18 years diagnosed with FM at the Unit of Physical Medicine of the AZ Maria Middelares Hospital (Ghent, Belgium) were invited to attend an information session within the month following their diagnosis. During this event, more information on the disease itself was shared, and its potential impact on patients' daily life was discussed together with current approaches to manage FM. At the end of this information session, patients expressing interest in enrolling in the program were able to make an appointment with the psychologist who evaluated potential exclusion criteria. Patients who had undergone similar CBT treatment before were excluded from the study. Patients exhibiting underlying psychiatric symptoms were referred for specialized treatment. In addition, the patients' motivation for participating in the program was assessed, as well as their willingness to make changes to their lifestyles by setting achievable individual goals. Patients who remained focused on finding a strictly medical solution to their complaints were also not included. During the recruitment period, 387 patients attended the information sessions; 189 patients (49%) expressed interest in participating and made an appointment with the psychologist. Half of them (n = 96) were found eligible for enrollment in the study; 2 patients finally withdrew because of practical reasons.

The remaining 94 patients with confirmed FM, clinically diagnosed according to the American College of Rheumatology (ACR) 1990 classification criteria (pain in at least 11 of the 18 tender points), agreed to join after giving an informed consent.[17] To assess our intervention program, we preferred the more robust, restrictive, and objective ACR 1990 classification criteria in selecting our group of FM patients in order to include as few false positives as possible and to end up with a more homogenous patient sample. The median waiting time, that is, from diagnosis to entry in our rehabilitation program, for newly diagnosed FM patients who consented to participate, was approximately 5 months (0.44 years).

Baseline Assessment

Before entering the multidisciplinary rehabilitation program, the 94 patients with confirmed FM additionally completed a set of self-administered questionnaires to screen for symptoms of depression, anxiety, and burnout and pain-coping behavior.

The Hospital Anxiety and Depression Scale (HADS) contains 14 items each using a 4-point response scale.[18] Seven items are related to feelings of anxiety, and 7 to feelings of depression. Item scores are summated to obtain separate scores for both dimensions. The Burnout Measure Short Version (BMS-10) was used to assess occupational burnout, addressing the frequency of experiencing symptoms of emotional, mental, and physical exhaustion.[19] The questionnaire contains 10 items each scored on a Likert-type 7-point scale ranging from "never" to "always." The total BMS-10 score is obtained by averaging the scores for the 7 items. Previous studies in FM patients have indicated that part of the observed heterogeneity in treatment success may be related to cognitive-behavioral differences in pain-coping mechanisms.[20,21] We used the screening instrument proposed and validated by van Koulil et al.[22] to differentiate patients showing a "pain-avoidance pattern" from those showing a "pain-persistence pattern." This instrument is based on the 5-item subscale "resting when in pain" of the validated Pain Coping Inventory, which reflects the level of pain-avoidance behavior when coping with pain in daily life.[22,23]

Multidisciplinary Rehabilitation Program

The multidisciplinary rehabilitation program was mainly based on CBT, relaxation, and graded physical exercise. The aim of the program was to improve HRQoL despite the presence of pain and fatigue by defining meaningful goals and promoting self-care, accepting one's own boundaries by changing the focus from restrictions to capabilities, managing stress, finding a good balance between rest and activity, and reengaging in routine movement or exercise.

The program, led by a multidisciplinary team including a psychologist, a physiotherapist, an occupational therapist, and a nutritionist, ran over a period of 8 weeks and consisted of 32 group-based sessions. We deliberately chose to limit the groups to a maximum of 8 patients in order to find the correct balance between adequate group therapy with its interactions and peer support and individual patient needs. Sessions lasted for 2 hours and were clustered on Tuesdays and Thursdays. During the 8 weeks, participants received an introductory session, 15 sessions of graded activity and relaxation, 9 acceptance-based CBT sessions offered by a psychologist with emphasis on coping (acceptance, stress management, making choices, setting goals, augmenting social support), 6 sessions of occupational therapy including energy/activity management and ergonomics, and 1 session covering nutritional aspects. To keep the focus on self-care and positive experiences and capabilities, no information or specific advice on the use or titration of pain medication was given during the course of the program. The patients' partner and family were also invited to a 1-time information session. During this session, important aspects of the disease were discussed highlighting its impact in the context of family and social networks. Three months after ending the program, groups gathered again for an evaluation and further coaching to achieve self-imposed goals. Finally, all staff members of the multidisciplinary team primarily focused on improving patients' self-efficacy and self-care skills, each from their own disciplinary perspective; they met on a regular basis to plan patient care, evaluate group interaction, and adjust the program when needed.

Primary Outcome—Quality-of-life Assessment

The participants' HRQoL was assessed through the widely used 36-Item Short-Form Health Survey (SF-36) (version 2) instrument, which has been translated and validated in the Dutch language.[24] This generic questionnaire is composed of 36 questions organized into 8 multi-item scales: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The 8 raw scores were linearly converted to a 0- to 100-point scale, with higher scores indicating better levels of functioning or well-being. To aid interpretation, a norm-based scoring algorithm was applied to these 8 subscales using the 1998 US population as reference with a mean of 50 and SD of 10.[25] Scoring based on US norms has been shown to make a minimal difference compared with scoring using country-specific norms, if available.[26] Finally, 2 summary scales were derived from these t-score norm-based scores: the physical component summary (PCS) and mental component summary (MCS) scores.[25] Data on Minimal Clinically Important Differences in SF-36 scores were not yet available for the particular population of FM patients, but differences of 3 to 5 points on any given SF-36 scale have been considered clinically relevant in various disease settings.[27] To evaluate the short- and long-term impact of the multidisciplinary rehabilitation program, the HRQoL assessment was performed at 4 different points in time: at the start (baseline) and the end (8 weeks) of the program, at 6 months and at 1 year.

Since the focus of our study was on assessing patients' overall well-being, we restricted data collection during follow-up to the generic SF-36 instrument with the intention to spare our patients the burden of completing too many questionnaires and to control potential attrition bias.

Statistical Methods

As indicated by Prieto et al.,[28] power calculations indicate that a sample of 64 patients is required to demonstrate a minimum effect size of 0.5, defined as the anticipated change in SF-36 scores over 1 year divided by their SD at baseline. We assumed 2-tailed testing, an α level of 0.05, and a statistical power of 80%. We used proportions, means, SDs, medians, and interquartile ranges (P25–P75) to describe the distribution of the different variables. Associations between continuous variables were studied according to Spearman ρ correlations. The impact of the rehabilitation program on HRQoL scores in the participating FM patients was statistically evaluated according to linear mixed regression modeling with a random intercept at the patient level, time as fixed factor, and an unstructured covariance matrix. Results are presented as estimated changes (at 8 weeks, 6 months, 1 year) from baseline scores, their SEs, and Bonferroni-adjusted significance levels. Goodness-of-fit statistics for all models demonstrated acceptable fit to the data. In our analyses, we considered a 2-sided p < 0.05 to indicate statistical significance. All analyses were performed using SAS software, version 9.4 (SAS Institute, Cary, NC).

Ethical Procedures

The QUALIFIBRO study was approved by the Ethics committee of the Antwerp University Hospital (no. 16/6/60) and registered at http://www.clinicaltrials.be as trial B300201628295. All patients signed a written informed consent prior to entering the program.

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