The Impact of COVID-19 Lockdown on Adults with Major Depressive Disorder from Catalonia: A Decentralized Longitudinal Study.

The present study analyzes the effects of each containment phase of the first COVID-19 wave on depression levels in a cohort of 121 adults with a history of major depressive disorder (MDD) from Catalonia recruited from 1 November 2019, to 16 October 2020. This analysis is part of the Remote Assessment of Disease and Relapse-MDD (RADAR-MDD) study. Depression was evaluated with the Patient Health Questionnaire-8 (PHQ-8), and anxiety was evaluated with the Generalized Anxiety Disorder-7 (GAD-7). Depression's levels were explored across the phases (pre-lockdown, lockdown, and four post-lockdown phases) according to the restrictions of Spanish/Catalan governments. Then, a mixed model was fitted to estimate how depression varied over the phases. A significant rise in depression severity was found during the lockdown and phase 0 (early post-lockdown), compared with the pre-lockdown. Those with low pre-lockdown depression experienced an increase in depression severity during the "new normality", while those with high pre-lockdown depression decreased compared with the pre-lockdown. These findings suggest that COVID-19 restrictions affected the depression level depending on their pre-lockdown depression severity. Individuals with low levels of depression are more reactive to external stimuli than those with more severe depression, so the lockdown may have worse detrimental effects on them.

Improving Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care: Pilot trial of a complex intervention.

Introduction: The Initial Medication Adherence (IMA) intervention is a multidisciplinary and shared decision-making intervention to improve initial medication adherence addressed to patients in need of new treatments for cardiovascular diseases and diabetes in primary care (PC). This pilot study aims to evaluate the feasibility and acceptability of the IMA intervention and the feasibility of a cluster-RCT to assess the effectiveness and cost-effectiveness of the intervention. Methods: A 3-month pilot trial with an embedded process evaluation was conducted in five PC centers in Catalonia (Spain). Electronic health data were descriptively analyzed to test the availability and quality of records of the trial outcomes (initiation, implementation, clinical parameters and use of services). Recruitment and retention rates of professionals were analyzed. Twenty-nine semi-structured interviews with professionals (general practitioners, nurses, and community pharmacists) and patients were conducted to assess the feasibility and acceptability of the intervention. Three discussion groups with a total of fifteen patients were performed to review and redesign the intervention decision aids. Qualitative data were thematically analyzed. Results: A total of 901 new treatments were prescribed to 604 patients. The proportion of missing data in the electronic health records was up to 30% for use of services and around 70% for clinical parameters 5 months before and after a new prescription. Primary and secondary outcomes were within plausible ranges and outliers were barely detected. The IMA intervention and its implementation strategy were considered feasible and acceptable by pilot-study participants. Low recruitment and retention rates, understanding of shared decision-making by professionals, and format and content of decision aids were the main barriers to the feasibility of the IMA intervention. Discussion: Involving patients in the decision-making process is crucial to achieving better clinical outcomes. The IMA intervention is feasible and showed good acceptability among professionals and patients. However, we identified barriers and facilitators to implementing the intervention and adapting it to a context affected by the COVID-19 pandemic that should be considered before launching a cluster-RCT. This pilot study identified opportunities for refining the intervention and improving the design of the definitive cluster-RCT to evaluate its effectiveness and cost-effectiveness. Clinical trial registration: ClinicalTrials.gov, identifier NCT05094986.

Complex multidisciplinary intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): mixed-methods process evaluation protocol.

INTRODUCTION: Medication non-initiation, or primary non-adherence, is a persistent public health problem that increases the risk of adverse clinical outcomes. The initial medication adherence (IMA) intervention is a complex multidisciplinary intervention to improve adherence to cardiovascular and diabetes treatments in primary care by empowering the patient and promoting informed prescriptions based on shared decision-making. This paper presents the development and implementation strategy of the IMA intervention and the process evaluation protocol embedded in a cluster randomised controlled trial (the IMA-cRCT) to understand and interpret the outcomes of the trial and comprehend the extent of implementation and fidelity, the active mechanisms of the IMA intervention and in what context the intervention is implemented and works. METHODS AND ANALYSIS: We present the protocol for a mixed-methods process evaluation including quantitative and qualitative methods to measure implementation and fidelity and to explore the active mechanisms and the interactions between the intervention, participants and its context. The process evaluation will be conducted in primary care centres and community pharmacies from the IMA-cRCT, and participants include healthcare professionals (general practitioners, nurses and community pharmacists) as well as patients. Quantitative data collection methods include data extraction from the intervention operative records, patient clinical records and participant feedback questionnaires, whereas qualitative data collection involves semistructured interviews, focus groups and field diaries. Quantitative and qualitative data will be analysed separately and triangulated to produce deeper insights and robust results. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Research Ethics Comittee (CEIm) at IDIAP Jordi Gol (codeCEIm 21/051 P). Findings will be disseminated through publications and conferences, as well as presentations to healthcare professionals and stakeholders from healthcare organisations. TRIAL REGISTRATION NUMBER: NCT05026775.

Assessment of a Primary Support Program: family physicians and mental health professionals' perspective.

BACKGROUND: Mental health (MH) disorders are increasingly prevalent in primary care (PC) and this has generated, in recent years, the development of strategies based on the collaborative model and the stepped care model. The Primary Support Program (PSP) was implemented in the community of Catalonia (Spain) during 2006 to improve, from the first level of care, treatment of the population with mild-moderate complexity MH problems along with identification and referral of severe cases to specialized care. The aim of the present study was to identify the strengths and limitations of the PSP from the perspective of health professionals involved in the programme. METHODS: An explanatory qualitative study based on Grounded Theory. We conducted group semistructured interviews with 37 family physicians and 34 MH professionals. A constant comparative method of analysis was performed. RESULTS: Operation of the PSP is influenced by internal factors, such as the programme framework, MH liaison, management of service supply and demand, and the professional team involved. Additionally, external factors which had an impact were related to the patient, the professionals, the Health System, and community resources. CONCLUSIONS: The operation of the PSP could benefit from a review of the programme framework and optimization of MH liaison. Improvements are also proposed for MH training in PC, intraprofessional coordination, use of community resources, and creation of efficient continuous assessment systems.

Non-initiation of prescribed medication from a Spanish health professionals' perspective: A qualitative exploration based on Grounded Theory.

We explore, from the perspective of primary care health professionals, the motivations that lead patients to not initiate prescribed treatments, by developing a qualitative study in Spanish primary care. Six focus groups (N = 46) were conducted with general practitioners, nurse practitioners, social workers and community pharmacists and carried out in primary care (PC) of Barcelona Province, from April to July of 2018. The 46 participants were identified by three general practitioners and two pharmacists. In the interviews, the reasons for non-initiation of PC patients' medication were explored. Triangulated content analysis was performed. Patients' perspective, analysed in a previous study, and professionals' perspective agree on most of the factors that affect non-initiation. New factors were categorized into existent categories, confirming, and supplementing the model developed with patients. Health professionals identified some new factors which were not present in the patients' discourse, such as stigma related to the drug, hidden reasons for consultation, the role of nurses in prescription and support, the role of the pharmacy technician, illiteracy and lack of social support. The professionals confirm and expand on the Theoretical Model of Medication Non-Initiation. Primary care professionals should consider the factors described when prescribing a new medication. Knowledge contributed by the model should guide the design of interventions to improve initiation.

Pediatric Medication Noninitiation in Spain.

OBJECTIVES: To estimate medication noninitiation prevalence in the pediatric population and identify the explanatory factors underlying this behavior. METHODS: Observational study of patients (<18 years old) receiving at least 1 new prescription (28 pharmaceutical subgroups; July 2017 to June 2018) in Catalonia, Spain. A prescription was considered new when there was no prescription for the same pharmaceutical subgroup in the previous 6 months. Noninitiation occurred when a prescription was not filled within 1 month or 6 months (sensitivity analysis). Prevalence was estimated as the proportion of total prescriptions not initiated. To identify explanatory factors, a multivariable multilevel logistic regression model was used, and adjusted odds ratios were reported. RESULTS: Overall, 1 539 003 new prescriptions were issued to 715 895 children. The overall prevalence of 1-month noninitiation was 9.0% (ranging from 2.6% [oral antibiotics] to 21.5% [proton pump inhibitors]), and the prevalence of 6-month noninitiation was 8.5%. Noninitiation was higher in the youngest and oldest population groups, in children from families with a 0% copayment rate (vulnerable populations) and those with conditions from external causes. Out-of-pocket costs of drugs increased the odds of noninitiation. The odds of noninitiation were lower when the prescription was issued by a pediatrician (compared with a primary or secondary care clinician). CONCLUSIONS: The prevalence of noninitiation of medical treatments in pediatrics is high and varies according to patients' ages and medical groups. Results suggest that there are inequities in access to pharmacologic treatments in this population that must be taken into account by health care planners and providers.

Use of Mental Health Services for Patients Diagnosed with Major Depressive Disorders in Primary Care.

Major depressive disorder (MDD) is one of the most disabling diseases worldwide, generating high use of health services. Previous studies have shown that Mental Health Services (MHS) use is associated with patient and Family Physician (FP) factors. The aim of this study was to investigate MHS use in a naturalistic sample of MDD outpatients and the factors influencing use of services in specialized psychiatric care, to know the natural mental healthcare pathway. Non-randomized clinical trial including newly depressed Primary Care (PC) patients (n = 263) with a 12-month follow-up (from 2013 to 2015). Patient sociodemographic variables were assessed along with clinical variables (mental disorder diagnosis, severity of depression or anxiety, quality of life, disability, beliefs about illness and medication). FP (n = 53) variables were also evaluated. A multilevel logistic regression analysis was performed to assess factors associated with public or private MHS use. Subjects were clustered by FP. Having previously used MHS was associated with the use of MHS. The use of public MHS was associated with worse perception of quality of life. No other sociodemographic, clinical, nor FP variables were associated with the use of MHS. Patient self-perception is a factor that influences the use of services, in addition to having used them before. This is in line with Value-Based Healthcare, which propose to put the focus on the patient, who is the one who must define which health outcomes are relevant to him.

Initiation and Single Dispensing in Cardiovascular and Insulin Medications: Prevalence and Explanatory Factors.

BACKGROUND: Adherence problems have negative effects on health, but there is little information on the magnitude of non-initiation and single dispensing. OBJECTIVE: The aim of this study was to estimate the prevalence of non-initiation and single dispensation and identify associated predictive factors for the main treatments prescribed in Primary Care (PC) for cardiovascular disease (CVD) and diabetes. METHODS: Cohort study with real-world data. Patients who received a first prescription (2013-2014) for insulins, platelet aggregation inhibitors, angiotensin-converting enzyme inhibitors (ACEI) or statins in Catalan PC were included. The prevalence of non-initiation and single dispensation was calculated. Factors that explained these behaviours were explored. RESULTS: At three months, between 5.7% (ACEI) and 9.1% (antiplatelets) of patients did not initiate their treatment and between 10.6% (statins) and 18.4% (ACEI) filled a single prescription. Body mass index, previous CVD, place of origin and having a substitute prescriber, among others, influenced the risk of non-initiation and single dispensation. CONCLUSIONS: The prevalence of non-initiation and single dispensation of CVD medications and insulin prescribed in PC in is high. Patient and health-system factors, such as place of origin and type of prescriber, should be taken into consideration when prescribing new medications for CVD and diabetes.

Cost-effectiveness of antidepressants versus active monitoring for mild-to-moderate major depressive disorder: a multisite non-randomized-controlled trial in primary care (INFAP study).

BACKGROUND: The purpose of this study was to evaluate the cost-effectiveness of antidepressants vs active monitoring (AM) for patients with mild-moderate major depressive disorder. METHODS: This was a 12-month observational prospective controlled trial. Adult patients with a new episode of major depression were invited to participate and assigned to AM or antidepressants according to General Practitioners' clinical judgment and experience. Patients were evaluated at baseline, and 6 and 12-month follow-up. Quality-adjusted life years (QALYs) gained were estimated and used to calculate incremental cost-utility ratios (ICUR) from the healthcare and government perspective. To minimize the bias resulting from non-randomization, a propensity score-based method was used. RESULTS: At 6 and 12-month follow-up, ICUR was 2549 €/QALY and 6,142 €/QALY, respectively, in favor of antidepressants. At 6 months, for a willingness to pay (WTP) of 25,000 €/QALY, antidepressants had a probability of 0.89 (healthcare perspective) and 0.81 (government perspective) of being more cost-effective than AM. At 12 months, this probability was 0.86 (healthcare perspective) and 0.73 (government perspective). CONCLUSIONS: Incremental cost-utility ratios favor pharmacological treatment as a first-line approach for patients with mild-moderate major depressive disorder. While our results should be interpreted with caution and further real world research is needed, clinical practice guidelines should consider antidepressant therapy for mild-moderate major depressive patients as an alternative to active monitoring in PC.

Effect of copayment policies on initial medication non-adherence according to income: a population-based study.

OBJECTIVE: Copayment policies aim to reduce the burden of medication expenditure but may affect adherence and generate inequities in access to healthcare. The objective was to evaluate the impact of two copayment measures on initial medication non-adherence (IMNA) in several medication groups and by income level. DESIGN: A population-based study was conducted using real-world evidence. SETTING: Primary care in Catalonia (Spain) where two separate copayment measures (fixed copayment and coinsurance) were introduced between 2011 and 2013. PARTICIPANT: Every patient with a new prescription issued between 2011 and 2014 (3 million patients and 10 million prescriptions). OUTCOMES: IMNA was estimated throughout dispensing and invoicing information. Changes in IMNA prevalence after the introduction of copayment policies (immediate level change and trend changes) were estimated through segmented logistic regression. The regression models were stratified by economic status and medication groups. RESULTS: Before changes to copayment policies, IMNA prevalence remained stable. The introduction of a fixed copayment was followed by a statistically significant increase in IMNA in poor population, low/middle-income pensioners and low-income non-pensioners (OR from 1.047 to 1.370). In high-income populations, there was a large statistically non-significant increase. IMNA decreased in the low-income population after suspension of the fixed copayment and the introduction of a coinsurance policy that granted this population free access to medications (OR=0.676). Penicillins were least affected while analgesics were affected to the greatest extent. IMNA to medications for chronic conditions increased in low/middle-income pensioners. CONCLUSION: Even nominal charge fixed copayment may generate inequities in access to health services. An anticipation effect and expenses associated with IMNA may have generated short-term costs. A reduction in copayment can protect from non-adherence and have positive, long-term effects. Copayment scenarios could have considerable long-term consequences for health and costs due to increased IMNA in medication for chronic physical conditions.

Impact of initial medication non-adherence to SSRIs on medical visits and sick leaves.

BACKGROUND: Initial medication non-adherence (IMNA) to antidepressants, which are commonly used to treat depression in primary care (PC), is around 6-12%. Although it is well known that post-initial non-adherence to antidepressants increases the cost of depression, the impact of IMNA on cost is unknown. The aim of this study is to assess the impact of IMNA to Selective Serotonin Reuptake Inhibitors (SSRI) on medical visits and sick leave in patients with depression treated in PC in Catalonia (Spain). METHODS: This was a four-year retrospective register-based study (2011-2014). All PC patients of working age who received a new SSRI prescription and had a diagnosis of depression were included (N = 79,642). Treatment initiation, number of visits and days on sick leave were gathered from the database. We assessed the impact of IMNA on costs with ordered logistic regressions. RESULTS: The 3-year incidence of IMNA was 15%. Initially non-adherent patients made a lesser number of GP visits (OR = 0.82; 95% CI = 0.79-0.84) but had more days on sick leave (OR = 1.25; 95% CI = 1.20-1.31). There were no differences in the number of specialist visits (OR = 1.04; 95% CI = 0.99-1.08). LIMITATIONS: Differences between adherent and non-adherent patients could be explained by non-observed variables. GP recognition and documentation of depression might be inaccurate. Costs of unpaid work and use of hospital services were not considered. CONCLUSIONS: Although IMNA decreases the use of medical PC services, it increases the number of days on sick leave. This could also indicate worse health status. These consequences are currently overlooked when considering post-initial medication non-adherence.

Impact of initial medication non-adherence on use of healthcare services and sick leave: a longitudinal study in a large primary care cohort in Spain.

BACKGROUND: Initial medication non-adherence is highly prevalent in primary care but no previous studies have evaluated its impact on the use of healthcare services and/or days on sick leave. AIM: To estimate the impact of initial medication non-adherence on the use of healthcare services, days of sick leave, and costs overall and in specific medication groups. DESIGN AND SETTING: A 3-year longitudinal register-based study of all primary care patients (a cohort of 1.7 million) who were prescribed a new medication in Catalonia (Spain) in 2012. METHOD: Thirteen of the most prescribed and/or costly medication subgroups were considered. All medication and medication subgroups (chronic, analgesics, and penicillin) were analysed. The number of healthcare services used and days on sick leave were considered. Multilevel multivariate linear regression was used. Three levels were included: patient, GP, and primary care centre. RESULTS: Initially adherent patients made more use of medicines and some healthcare services than non-adherent and partially adherent patients. They had lower productivity losses, producing a net economic return, especially when drugs for acute diseases (such as penicillins) were considered. Initial medication non-adherence resulted in a higher economic burden to the system in the short term. CONCLUSION: Initial medication non-adherence seems to have a short-term impact on productivity losses and costs. The clinical consequences and long-term economic consequences of initial medication non-adherence need to be assessed. Interventions to promote initial medication adherence in primary care may reduce costs and improve health outcomes.

Initial medication non-adherence: prevalence and predictive factors in a cohort of 1.6 million primary care patients.

AIMS: Adherence to medicines is vital in treating diseases. Initial medication non-adherence (IMNA) - defined as not obtaining a medication the first time it is prescribed - has been poorly explored. Previous studies show IMNA rates between 6 and 28% in primary care (PC). The aims of this study were to determine prevalence and predictive factors of IMNA in the most prescribed and expensive pharmacotherapeutic groups in the Catalan health system. METHODS: This is a retrospective, register-based cohort study which linked the Catalan PC System (Spain) prescription and invoicing databases. Medication was considered non-initiated when it was not collected from the pharmacy by the end of the month following the one in which it was prescribed. IMNA prevalence was calculated using July 2013-June 2014 prescription data. Predictive factors related to patients, general practitioners and PC centres were identified through multilevel logistic regression analyses. Missing data were attributed using simple imputation. RESULTS: Some 1.6 million patients with 2.9 million prescriptions were included in the study sample. Total IMNA prevalence was 17.6% of prescriptions. The highest IMNA rate was observed in anilides (22.6%) and the lowest in angiotensin-converting-enzyme (ACE) inhibitors (7.4%). Predictors of IMNA are younger age, American nationality, having a pain-related or mental disorder and being treated by a substitute/resident general practitioner in a resident-training centre. CONCLUSIONS: The rate of IMNA is high when all medications are taken into account. Attempts to strengthen trust in resident general practitioners and improve motivation to initiate a needed medication in the general young and older immigrant population should be addressed in Catalan PC.

Functional Status, Quality of Life, and Costs Associated With Fibromyalgia Subgroups: A Latent Profile Analysis.

OBJECTIVES: Although fibromyalgia syndrome (FM) is considered a heterogeneous condition, there is no generally accepted subgroup typology. We used hierarchical cluster analysis and latent profile analysis to replicate Giesecke's classification in Spanish FM patients. The second aim was to examine whether the subgroups differed in sociodemographic characteristics, functional status, quality of life, and in direct and indirect costs. MATERIALS AND METHODS: A total of 160 FM patients completed the following measures for cluster derivation: the Center for Epidemiological Studies-Depression Scale, the Trait Anxiety Inventory, the Pain Catastrophizing Scale, and the Control over Pain subscale. Pain threshold was measured with a sphygmomanometer. In addition, the Fibromyalgia Impact Questionnaire-Revised, the EuroQoL-5D-3L, and the Client Service Receipt Inventory were administered for cluster validation. RESULTS: Two distinct clusters were identified using hierarchical cluster analysis ("hypersensitive" group, 69.8% and "functional" group, 30.2%). In contrast, the latent profile analysis goodness-of-fit indices supported the existence of 3 FM patient profiles: (1) a "functional" profile (28.1%) defined as moderate tenderness, distress, and pain catastrophizing; (2) a "dysfunctional" profile (45.6%) defined by elevated tenderness, distress, and pain catastrophizing; and (3) a "highly dysfunctional and distressed" profile (26.3%) characterized by elevated tenderness and extremely high distress and catastrophizing. We did not find significant differences in sociodemographic characteristics between the 2 clusters or among the 3 profiles. The functional profile was associated with less impairment, greater quality of life, and lower health care costs. DISCUSSION: We identified 3 distinct profiles which accounted for the heterogeneity of FM patients. Our findings might help to design tailored interventions for FM patients.

Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study).

BACKGROUND: Clinical practice guidelines for the treatment of major depressive disorder (MDD) recommend antidepressants for patients with moderate-severe depression and active monitoring for patients with mild-moderate symptoms. The feasibility and efficiency of active monitoring has not been proven conclusively. The aim of this study is to evaluate the cost-effectiveness of active monitoring in comparison to antidepressants for primary care patients with mild-moderate MDD. METHODS/DESIGN: This is a 12-month follow-up multicenter observational prospective controlled trial. Patients are enrolled in 12 primary care centers in Barcelona (Spain). Eligible patients are adults (≥18 years-old) with a new episode of MDD that sign a written consent to participate. This is a naturalistic study in which general practitioners (GPs) use their professional judgment to allocate patients into active monitoring or antidepressants groups. GPs treat the patients following their clinical criteria. At baseline, GPs complete a questionnaire (sociodemographic/job characteristics, training, attitude towards depression, interest on mental health and participation in communication groups). Patients' measurements take place at baseline and after six and 12 months. Main outcome measures include severity of depression (PHQ-9), health-related quality of life (EuroQol-5D) and use of healthcare and social care services (Client Service Receipt Inventory). Secondary outcomes include diagnosis of MDD according to DSM-IV diagnostic criteria (SCID-I), disability (WHO-DAS), anxiety (BAI), comorbidities, medication side-effects and beliefs about medicines (BMQ). The analysis will be done according to the intention to treat analysis. Missing data will be imputed using multiple imputation by chained equations. To minimize the bias resulting from the lack of randomization, a propensity score will be used. Incremental effects and costs between groups will be modelled in each of the imputed databases using multivariate generalized linear models and then combined as per Rubin's rules. Propensity scores will be used to adjust the models. Incremental cost-effectiveness ratios will be calculated by dividing the difference in costs between groups by the difference in effects. To deal with the uncertainty, resampling techniques with bootstrapping will be used and cost-effectiveness planes and cost-effectiveness acceptability curves will be constructed. A series of sensitivity analyses will be performed. DISCUSSION: Given the high burden and costs generated by depressive disorder, it is important that general practitioners treat major depression efficiently. Recent evidence has suggested that antidepressants have low benefits for patients with mild to moderate major depression. For such cases of depression, active monitoring exists as a treatment option, but it is not without difficulties for implementation and its effectiveness and efficiency have not been demonstrated conclusively. The results of the study will provide information on which is the most efficient approach to treat patients with mild to moderate major depression in primary care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02245373.

Clinical dimensions of fibromyalgia symptoms and development of a combined index of severity: the CODI index.

BACKGROUND: Although a large body of work indicates that fibromyalgia (FM) is not a discrete entity, few studies have attempted to classify the heterogeneity of FM symptoms. The objectives of the present study were to confirm the existence of two latent dimensions underlying FM symptoms (Core-FM symptoms and Distress) by means of factor analysis techniques, and to develop and validate a new combined index of symptom severity (the CODI). METHODS: We analyzed and combined the baseline scores on six visual analog scales of the FIQ (pain, general fatigue, morning fatigue, stiffness, anxiety, and depression) and on the STAI-T (trait anxiety) of 216 Spanish patients diagnosed with FM (97.7% women) who were participating in a randomized, controlled trial. RESULTS: The principal component analysis indicated the presence of two correlated factors (labeled as Core-FM symptoms and Distress) that explained 64% of total variance. The subsequent confirmatory factor analysis yielded more empirical support for the two-factor model than the one-factor model (all items loading on one latent dimension). The two factors possessed adequate internal consistency and construct validity given the pattern of significant correlations with the Euroqol items. The Core-FM dimension had a stronger relationship with mobility, self-care, usual activities, and pain/discomfort than with anxiety/depression, whereas the Distress dimension showed the opposite pattern. Finally, summing the standardized scores of the two dimensions, a new combined index of symptom severity (the CODI) was developed. CONCLUSION: The clinical implications and utility of the CODI are discussed in relation to previous research on FM.

Effectiveness of a psychoeducational treatment program implemented in general practice for fibromyalgia patients: a randomized controlled trial.

OBJECTIVES: A recent meta-analysis concluded that multicomponent treatments are effective for some fibromyalgia (FM) symptoms. The objective of this study was to examine whether a psychoeducational intervention implemented in primary care is more effective than usual care for improving the functional status of patients with FM. METHODS: This study was based on a randomized controlled trial. The 484 patients with FM included in a database of the Viladecans Hospital (Barcelona, Spain) were eligible for screening. Finally, 108 patients were randomly assigned to the intervention and 108 patients were assigned to usual care. The intervention comprised nine 2-hour sessions (5 sessions of education and 4 sessions of autogenic relaxation). The patients were assessed before and after the intervention with a battery of instruments (measuring sociodemographic data, medical comorbidities, functional status, trait anxiety, and social desirability). RESULTS: The posttreatment drop-out rate was 9.7% (intervention: 6.5%; control: 13%). The intention-to-treat analyses showed significant differences between the groups at posttreatment: the intervention group improved in physical impairment, days not feeling well, pain, general fatigue, morning fatigue, stiffness, anxiety, and depression (medium effect size in most cases). The patients who responded to the intervention reported less trait anxiety at baseline than nonresponders. The absolute risk reduction with the intervention was 36.1% (95% confidence interval: 23.3-48.8) and the number needed to treat was 3 (95% confidence interval: 2.0-4.3). DISCUSSION: A 2-month psychoeducational intervention improves the functional status of FM patients to a greater extent than usual care, at least in the short-term. The social desirability bias did not explain the reported outcomes. Trait anxiety was associated with response to treatment.