Cost-utility of cognitive behavioral therapy versus U.S. Food and Drug Administration recommended drugs and usual care in the treatment of patients with fibromyalgia: an economic evaluation alongside a 6-month randomized controlled trial

Introduction:- Cognitive behavioral therapy (CBT) and U.S. Food and Drug Administration (FDA)-recommended pharmacologic treatments (RPTs; pregabalin, duloxetine, and milnacipran) are effective treatment options for fibromyalgia (FM) syndrome and are currently recommended by clinical guidelines. We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT (combination of pregabalin + duloxetine) and usual care (TAU) groups in the treatment of FM. Methods:- The economic evaluation was conducted alongside a 6-month, multicenter, randomized, blinded, parallel group, controlled trial. In total, 168 FM patients from 41 general practices in Zaragoza (Spain) were randomized to CBT (n = 57), RPT (n = 56), or TAU (n = 55). The main outcome measures were Quality-Adjusted Life Years (QALYs, assessed by using the EuroQoL-5D questionnaire) and improvements in health-related quality of life (HRQoL, assessed by using EuroQoL-5D visual analogue scale, EQ-VAS). The costs of healthcare use were estimated from patient self-reports (Client Service Receipt Inventory). Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves (CEACs). Results:- On average, the total costs per patient in the CBT group (1,847€) were significantly lower than those in patients receiving RPT (3,664€) or TAU (3,124€). Patients receiving CBT reported a higher quality of life (QALYs and EQ-VAS scores); the differences between groups were significant only for EQ-VAS. From a complete case-analysis approach (base case), the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed, by using both QALYs and EQ-VAS as outcomes. These findings were confirmed by bootstrap analyses, net-benefit curves, and CEACs. Two additional sensitivity analyses (intention-to-treat analysis and per-protocol analysis) indicated that the results were robust. The comparison of RPT with TAU yielded no clear preference for either treatment when using QALYs, although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS. Conclusions:- Because of lower costs, CBT is the most cost-effective treatment for adult FM patients. Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT. Trial registration:- Current Controlled Trials ISRCTN10804772. Registered 29 September 2008

Cost-utility of group acceptance and commitment therapy for fibromyalgia versus recommended drugs: an economic analysis alongside a 6-month randomised controlled trial conducted in Spain (EFFIGACT study)

The aim of this study was to analyse the cost-utility of a group-based form of Acceptance and Commitment Therapy (GACT) in patients with fibromyalgia (FM) compared to patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, an RCT that focused on clinical outcomes. Health economic outcomes included health-related quality of life and healthcare use at baseline and at 6-month follow-up using the EuroQol (EQ-5D-3L) and the Client Service Receipt Inventory (CSRI), respectively. Analyses included Quality-Adjusted Life Years (QALYs), direct and indirect cost differences, and incremental cost-effectiveness ratios (ICERs). A total of 156 FM patients were randomized (51 GACT, 52 RPT, 53 WL). GACT was related to significantly less direct costs over the 6 month study period compared to both control arms (GACT €824.2 ± 1,062.7 vs. RPT €1,730.7 ± 1,656.8 vs WL €2,462.7 ± 2,822.0). Lower direct costs for GACT in comparison to RPT were due to lower costs from primary care visits and FM-related medications. The ICERs were dominant in the completers’ analysis and remained robust in the sensitivity analyses. In conclusion, ACT appears to be a cost-effective treatment in comparison to RPT in patients with FM

Cost-utility and biological underpinnings of Mindfulness-Based Stress Reduction (MBSR) versus a psychoeducational programme (FibroQoL) for fibromyalgia: a 12-month randomised controlled trial (EUDAIMON study)

Background: The EUDAIMON study focuses on fibromyalgia syndrome (FMS), a prevalent chronic condition characterized by pain, fatigue, cognitive problems and distress. According to recent reviews and meta-analyses, Mindfulness-Based Stress Reduction (MBSR) is a promising therapeutic approach for patients with FMS. The measurement of biomarkers as part of the analysis of MBSR effects would help to identify the neurobiological underpinnings of MBSR and increase our knowledge of FMS pathophysiology. The main objectives of this 12-month RCT are: firstly, to examine the effectiveness and cost-utility for FMS patients of MBSR as an add-on to treatment as usual (TAU) versus TAU + the psychoeducational programme FibroQoL, and versus TAU only; secondly, to examine pre-post differences in brain structure and function, as well as levels of specific inflammatory markers in the three study arms and; thirdly, to analyse the role of some psychological variables as mediators of 12-month clinical outcomes. Methods: Effectiveness, cost-utility, and neurobiological analyses performed alongside a 12-month RCT. The participants will be 180 adult patients with FMS recruited at the Sant Joan de Déu hospital (St. Boi de Llobregat, Spain), randomly allocated to one of the three study arms: TAU + MBSR vs. TAU + FibroQol vs. TAU. A comprehensive assessment to collect functional, quality of life, distress, costs, and psychological variables will be conducted pre-, post-intervention, and at 12-month post-intervention. Fifty per cent of study participants will be evaluated at pre- and post-treatment using Voxel-Based Morphometry, Diffusion Tensor Imaging, pseudo-continuous Arterial Spin Labeling, and resting state fMRI. A cytokine multiplex kit of high-sensitivity will be applied (cytokines IL-6, IL-8, IL-10 + high-sensitivity CRP test). Discussion: The findings obtained from this RCT will indicate whether MBSR is potentially cost-effective for FMS and contribute to knowledge of any brain and inflammatory changes associated with MBSR in FMS patients. Specifically, we will determine whether there are morphometric and functional changes associated with participation in MBSR in brain regions related to meta-awareness, body awareness, memory consolidation-reconsolidation, emotion regulation and in networks postulated to underpin the sensory-discriminative, cognitive-evaluative and affective-motivational aspects of the pain experience. Trial registration: NCT02561416. Registered 23 September 201

El problema de la no-iniciació de tractament farmacològic prescrit a l'atenció primària

Tractament farmacològic prescrit; Prescripció de medicaments; Atenció primària;Prescribed pharmacological treatment; Prescription drugs; Primary care;Tratamiento farmacológico prescrito; Prescripción de medicamentos; Atención primaria;La no iniciació es defineix com el rebuig a començar un tractament farmacològic prescrit per primera vegada a un pacient. La no iniciació podria empitjorar el quadre clínic i afectar la qualitat de vida dels pacients, i també augmentar la despesa sanitària, donat que augmenta la probabilitat de fer una baixa laboral i la durada de la mateixa

Psychometric Properties of the Cognitive Emotion Regulation Questionnaire (CERQ) in Patients with Fibromyalgia Syndrome

Given that Fibromyalgia Syndrome (FMS) is associated with problems in emotion regulation, the importance of assessing this construct is widely acknowledged by clinical psychologists and pain specialists. Although the Cognitive Emotion Regulation Questionnaire (CERQ) is a self-report measure used worldwide, there are no data on its psychometric properties in patients with FMS. This study analyzed the dimensionality, reliability, and validity of the CERQ in a sample of 231 patients with FMS. Given that “fibrofog” is one of the most disabling FMS symptoms, in the present study, items in the CERQ were grouped by dimension. This change in item presentation was conceived as an efficient way of facilitating responses as a result of a clear understanding of what the items related to each dimension are attempting to measure. The following battery of measures was administered: the CERQ, the Revised Fibromyalgia Impact Questionnaire, the Pain Catastrophizing Scale, the Center for Epidemiologic Studies Depression Scale, and the State-Trait Anxiety Inventory. Four models of the CERQ structure were examined and confirmatory factor analyses supported the original factor model, consisting of nine factors—Self-blame, Acceptance, Rumination, Positive refocusing, Refocus on planning, Positive reappraisal, Putting into perspective, Catastrophizing, and Other-blame. There was minimal overlap between CERQ subscales and their internal consistency was adequate. Correlational and regression analyses supported the construct validity of the CERQ. Our findings indicate that the CERQ (items-grouped version) is a sound instrument for assessing cognitive emotion regulation in patients with FMS

Psychometric Properties of the Cognitive Emotion Regulation Questionnaire (CERQ) in Patients with Fibromyalgia Syndrome

Given that Fibromyalgia Syndrome (FMS) is associated with problems in emotion regulation, the importance of assessing this construct is widely acknowledged by clinical psychologists and pain specialists. Although the Cognitive Emotion Regulation Questionnaire (CERQ) is a self-report measure used worldwide, there are no data on its psychometric properties in patients with FMS. This study analyzed the dimensionality, reliability, and validity of the CERQ in a sample of 231 patients with FMS. Given that "fibrofog" is one of the most disabling FMS symptoms, in the present study, items in the CERQ were grouped by dimension. This change in item presentation was conceived as an efficient way of facilitating responses as a result of a clear understanding of what the items related to each dimension are attempting to measure. The following battery of measures was administered: the CERQ, the Revised Fibromyalgia Impact Questionnaire, the Pain Catastrophizing Scale, the Center for Epidemiologic Studies Depression Scale, and the State-Trait Anxiety Inventory. Four models of the CERQ structure were examined and confirmatory factor analyses supported the original factor model, consisting of nine factors-Self-blame, Acceptance, Rumination, Positive refocusing, Refocus on planning, Positive reappraisal, Putting into perspective, Catastrophizing, and Other-blame. There was minimal overlap between CERQ subscales and their internal consistency was adequate. Correlational and regression analyses supported the construct validity of the CERQ. Our findings indicate that the CERQ (items-grouped version) is a sound instrument for assessing cognitive emotion regulation in patients with FM

Psychometric properties of the Cognitive Emotion Regulation Questionnaire (CERQ) in patients with fibromyalgia syndrome

Given that Fibromyalgia Syndrome (FMS) is associated with problems in emotion regulation, the importance of assessing this construct is widely acknowledged by clinical psychologists and pain specialists. Although the Cognitive Emotion Regulation Questionnaire (CERQ) is a self-report measure used worldwide, there are no data on its psychometric properties in patients with FMS. This study analyzed the dimensionality, reliability, and validity of the CERQ in a sample of 231 patients with FMS. Given that "fibrofog" is one of the most disabling FMS symptoms, in the present study, items in the CERQ were grouped by dimension. This change in item presentation was conceived as an efficient way of facilitating responses as a result of a clear understanding of what the items related to each dimension are attempting to measure. The following battery of measures was administered: the CERQ, the Revised Fibromyalgia Impact Questionnaire, the Pain Catastrophizing Scale, the Center for Epidemiologic Studies Depression Scale, and the State-Trait Anxiety Inventory. Four models of the CERQ structure were examined and confirmatory factor analyses supported the original factor model, consisting of nine factors-Self-blame, Acceptance, Rumination, Positive refocusing, Refocus on planning, Positive reappraisal, Putting into perspective, Catastrophizing, and Other-blame. There was minimal overlap between CERQ subscales and their internal consistency was adequate. Correlational and regression analyses supported the construct validity of the CERQ. Our findings indicate that the CERQ (items-grouped version) is a sound instrument for assessing cognitive emotion regulation in patients with FM

Cost-utility of a psychoeducational intervention in fibromyalgia patients compared with usual care: an economic evaluation alongside a 12-month randomized controlled trial

Objective: To determine the effectiveness of adding psychoeducational treatment implemented in general practice to usual care for patients with fibromyalgia (FM), and to analyze the cost-utility of the intervention from health care and societal perspectives. Methods: Twelve-month randomized controlled trial. A total of 216 primary care patients meeting the American College of Rheumatology criteria for FM participated in the study. The intervention included 9, 2-hour sessions of psychoeducation (5 sessions of education about the illness + 4 sessions of autogenic relaxation) added to usual care provided by a multidisciplinary group in general practice was compared to usual care in the public health system. Results: At 12-month follow-up, patients who received psychoeducation showed greater improvement in global functional status (Cohen d = 0.36; -2.49 to 3.81), physical functioning (Cohen d = 0.56; 0.08 to 1.00), days feeling well (Cohen d = 0.40; -0.16 to 1.02), pain (Cohen d = 0.35; -0.04 to 0.80), morning fatigue (Cohen d = 0.24; -0.20 to 0.76), stiffness (Cohen d = 0.34; -0.10 to 0.87), and depression (Cohen d = 0.30; -0.26 to 0.93). Mean incremental cost per person receiving the intervention was €-215.49 (-615.13 to 287.81) from the health care perspective, and €-197.32 (-785.12 to 395.74) from the societal perspective. The incremental gain in quality-adjusted life-years per person was 0.12 (0.06 to 0.19), yielding a "dominant" intervention from both perspectives. The sensitivity analysis suggested that the intervention was cost-effective even imputing all missing data. Discussion: Our findings demonstrate the long-term clinical effectiveness of a psychoeducational treatment program for FM implemented at primary care level and the cost-utility from a health care and societal perspective