Clinical, economic, and humanistic impact of a multidisciplinary medication review with follow-up for anticoagulated patients treated with vitamin K antagonists in primary care: A cluster randomised controlled trial.

BACKGROUND: Interdisciplinary collaboration between general practitioner, nurses and pharmacists can favour the control of patients treated with vitamin K antagonists (VKA), increasing their safety and effectiveness. The aim of the study was to evaluate the impact of pharmaceutical interventions on patients treated with VKA within the framework of a Pharmacotherapeutic Follow-up service on clinical, economic and humanistic outcomes. METHODS: Controlled and randomized study in patients from two health areas of Zaragoza in treatment with VKA with Time in Therapeutic Range (TTR) according to the Rosendaal method less than 70% in the last 6 months. Patients were recruited at the pharmacy and assigned to two groups: control and intervention. A Pharmacotherapeutic Follow-up Program was established for the intervention group for 6 months. The outcome variables were INR stability, pharmacological adherence, vitamin K intake, knowledge about the use of acenocoumarol, quality of life, satisfaction with treatment, associated costs and avoided costs. A descriptive analysis was performed, and the Students' T test or Mann-Whitney U test was used for the association between quantitative variables and Chi-square or Fisher's test for qualitative variables. RESULTS: A total of 123 patients were included, 65 in the intervention group (IG) and 58 in the control group (CG). A total of 108 interventions were conducted (1.7 interventions/patient) and the most common were those related to the proper taking of medications (41.0%). In IG, TTR (p = 0.019), adherence to treatment (p = 0.038) and knowledge about acenocoumarol (p = 0.031) improved, compared to CG. A higher proportion of patients in IG achieved a TTR>65% (p = 0.024). In addition, patients whose interventions were accepted by the physician (p = 0.027) and those who received vitamin K optimization interventions (p = 0.003) achieved TTR>65% in greater proportion. CONCLUSIONS: Community pharmacist medication review, in collaboration with general practitioners improve knowledge and adherence of patients treated with oral anti-vitamin K agents and enhances the achievement of their therapeutic INR ranges. Investment needed to achieve this clinical impact is low and patient satisfaction is high. TRIAL REGISTRATION: This study has been registered with Clinical Trials.gov dated 25/05/2017: NCT03154489.

Relationship between time from symptom's onset to diagnosis and prognosis in patients with symptomatic colorectal cancer.

BACKGROUND: Controversy exists regarding the relationship of the outcome of patients with colorectal cancer (CRC) with the time from symptom onset to diagnosis. The aim of this study is to investigate this association, with the assumption that this relationship was nonlinear and with adjustment for multiple confounders, such as tumor grade, symptoms, or admission to an emergency department. METHODS: This multicenter study with prospective follow-up was performed in five regions of Spain from 2010 to 2012. Symptomatic cases of incident CRC from a previous study were examined. At the time of diagnosis, each patient was interviewed, and the associated hospital and clinical records were reviewed. During follow-up, the clinical records were reviewed again to assess survival. Cox survival analysis with a restricted cubic spline was used to model overall and CRC-specific survival, with adjustment for variables related to the patient, health service, and tumor. RESULTS: A total of 795 patients had symptomatic CRC and 769 of them had complete data on diagnostic delay and survival. Univariate analysis indicated a lower HR for death in patients who had diagnostic intervals less than 4.2 months. However, after adjustment for variables related to the patient, tumor, and utilized health service, there was no relationship of the diagnostic delay with survival of patients with colon and rectal cancer, colon cancer alone, or rectal cancer alone. Cubic spline analysis indicated an inverse association of the diagnostic delay with 5-year survival. However, this association was not statistically significant. CONCLUSIONS: Our results indicated that the duration of diagnostic delay had no significant effect on the outcome of patients with CRC. We suggest that the most important determinant of the duration of diagnostic delay is the biological profile of the tumor. However, it remains the responsibility of community health centers and authorities to minimize diagnostic delays in patients with CRC and to implement initiatives that improve early diagnosis and provide better outcomes.

Multimodal therapy in aggressive pituitary tumors.

The concept of aggressive pituitary tumor (APT) has been precisely defined in recent years. These tumors are characterized by morphological (radiological or histopathological) data of invasion, proliferative activity superior to that of typical adenomas and a clinical behavior characterized by resistance to standard therapies and frequent recurrences. The absence of cerebrospinal or distant metastases differentiates them from the pituitary carcinoma. APTs account for about 10% of all pituitary neoplasm. Proper diagnostic implies participation not only of radiological and hormonal investigation but also a thorough pathological assessment including proliferation markers and immunohistochemistry for hormones and transcription factors. Surgical resection, aiming gross total resection or tumor debulking, is the mainstay initial therapy in most patients. Most patients with APTs need more than one surgical intervention, pituitary radiation, sometimes on more than one occasion, and multiple sequential or combined medical treatments, to finally be doomed to unusual treatments, such as alkylating agents (temozolomide alone or in combination), molecular targeted therapies, or peptide receptor radionuclide therapy. Multimodal therapy, implemented by experts, preferably in specialized centers with high volume caseload, is the only way to improve the prognosis of patients with these uncommon tumors. The research needs in this area are multiple and include a greater knowledge of the molecular biology of these tumors, establishment of protocols for monitoring and sequencing of treatments, development of multicenter studies and international registries.

Temozolomide for aggressive ACTH pituitary tumors: failure of a second course of treatment.

INTRODUCTION: Temozolomide (TMZ) is an oral alkylating agent that has been used over the past 8 years to treat aggressive pituitary tumors resistant to conventional therapy. To date, only 25 patients treated with TMZ for ACTH producing pituitary tumors (14 adenomas and 11 carcinomas) have been reported. MATERIALS AND METHODS: We present a retrospective review of the medical records of three patients with aggressive ACTH producing adenomas treated with TMZ. In the three cases there was evidence of progression to conventional therapy before starting TMZ. We used the conventional scheme for the treatment of gliomas until completing 7, 12 and 6 cycles respectively. Reduction in tumor size was evident after the 3rd, 5th and 4th cycle of TMZ and progression free survival was 25, 19 and more than 12 months in the three patients respectively. Improvement of the ocular and visual symptoms was evident after the 4th cycle of treatment in all cases. Normalization of urinary free cortisol levels was achieved after the 3rd and 9th cycle in the two cases with hypercortisolism. Two of the three patients received a second course of treatment when the disease progressed but it did not stop tumor progression. The principal side effects were G3 neutropenia, G1 and G2 thrombocytopenia, G1 lymphopenia, asthenia and nausea. CONCLUSION: The treatment with TMZ is effective and safe in patients with aggressive corticotrophin tumors resistant to conventional therapy. Nevertheless once the disease progresses, a second course of treatment does not seem to be effective.

[Validation of the Spanish version of the Screening for Somatoform Symptoms-2 scale for use in Primary Care]. / Validación de la versión española de la escala Screening for Somatoform Symptoms-2 para la evaluación de síntomas somáticos en Atención Primaria.

OBJECTIVE: To study the diagnostic validity and to provide the sensitivity, specificity, positive predictive value and negative predictive value of the Spanish version of the Screening for Somatoform Symptoms-2 (SOMS-2) scale in a PC population sample. DESIGN: Validation study. SETTING: PC centres in Aragon and Balearic Islands, Spain. PARTICIPANTS: A sample of 109 patients from a clinical trial with somatoform disorders and 56 patients without somatoform disorder were included for the scale validation. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive predictive value, negative predictive value and Cronbach's α coefficient. RESULTS: Of the total sample of 165 subjects, 75% were women and 60% had a diagnosis of somatization disorder and/or anxiety or depressive disorder. The 53-item version of the SOMS-2 with a cut-off point of 4 showed a sensitivity of 97%, a specificity of 68%, a positive predictive value of 85%, a negative predictive value of 92%, and high internal consistency (Cronbach α=0.926). CONCLUSIONS: The Spanish version of the SOMS-2 seems to be a reliable screening tool, easy to complete and useful for the assessment of somatoform disorders in PC settings. The results for specificity, sensitivity, and internal consistency are similar to previous studies in other European languages.

Changes in metabolites after treatment with memantine in fibromyalgia. A double-blind randomized controlled trial with magnetic resonance spectroscopy with a 6-month follow-up.

AIM: To evaluate the efficacy of memantine on metabolite levels in different areas of the brain and to determine whether changes in metabolite levels correlate with clinical variables in Fibromyalgia (FM) patients. METHODS: Doubled-blind parallel randomized controlled trial. Twenty-five patients diagnosed with FM were enrolled in the study. Patients were administered questionnaires on pain, anxiety, depression, quality of life, and cognitive impairment, and single-voxel MRS of the brain was performed. All assessments were performed at baseline and after 6 months of treatment with memantine or placebo. RESULTS: Patients treated with memantine exhibited a significant increase in the glutamate (P = 0.010), glutamate/creatine ratio (P = 0.013), combined glutamate + glutamine (P = 0.016) and total N-acetyl-aspartate (NAA+NAAG) (P = 0.034) in the posterior cingulate cortex compared with those on placebo. Furthermore, the memantine group exhibited increases in creatine (P = 0.013) and choline (Cho) (P = 0.025) in the right posterior insula and also a correlation between choline and the Fibromyalgia Impact Questionnaire (FIQ) in the posterior insula (P = 0.050) was observed. CONCLUSION: Memantine treatment resulted in an increase in cerebral metabolism in FM patients, suggesting its utility for the treatment of the illness.

Efficacy of memantine in the treatment of fibromyalgia: A double-blind, randomised, controlled trial with 6-month follow-up.

Fibromyalgia (FM) is a prevalent and disabling chronic disease. Recent studies have found elevated levels of glutamate in several brain regions, leading to hypotheses about the usefulness of glutamate-blocking drugs such as memantine in the treatment of FM. The aim of this study was to evaluate the efficacy of memantine in the treatment of pain and other clinical variables (global function, clinical impression, depression, anxiety, quality of life) in FM patients. A double-blind, parallel randomised controlled trial was developed. A total of 63 patients diagnosed with FM were recruited from primary health care centres in Zaragoza, Spain. Memantine was administered at doses of 20mg/d after 1 month of titration. Assessments were carried out at baseline, posttreatment, and 3- and 6-month follow-up. Compared with a placebo group, memantine significantly decreased ratings on a pain visual analogue scale (Cohen's d=1.43 at 6 months) and pain measured with a sphygmomanometer (d=1.05). All other secondary outcomes except anxiety also improved, with moderate-to-large effect sizes at 6 months. Compared with placebo, the absolute risk reduction obtained with memantine was 16.13% (95% confidence interval=2.0% to 32.6%), and the number needed to treat was 6.2 (95% confidence interval=3 to 47). Tolerance was good, with dizziness (8 patients) and headache (4 patients) being the most frequent side effects of memantine. Although additional studies with larger sample sizes and longer follow-up times are needed, this study provides preliminary evidence of the utility of memantine for the treatment of FM.

Gender differences on functioning in depressive patients.

BACKGROUND: Depression is one of the most common disorders in primary care and the fourth most disabling medical condition worldwide. Although gender differences in the prevalence of depression are well established, the little available data on gender-related differences in disabilities among depression patients gives controversial results. This study aims to analyse whether there are gender differences in the disabilities experienced by patients with depression. METHODS: A cross-sectional, multicentre, nationwide epidemiological study was conducted, with 1226 patients. A Case Report Form was used to collect sociodemographic data and the 12-item version of the World Health Organization Disability Assessment Schedule II (WHO-DAS-II) was used to assess functioning. Depression severity was assessed using the Quick Inventory of Depressive Symptomatology (QIDS). RESULTS: Non-statistically significant differences in functioning were found between males and females. An item-by-item analysis of the WHO-DAS-II shows significant differences between both sexes in specific areas. Women obtained higher scores than men for standing for long periods and walking a long distance. Males scored higher than women in dealing with people you did not know well and maintaining a friendship. LIMITATIONS: Given the descriptive and cross-sectional nature of the study, the results are limited, highlighting the need for further research. Also, other variables that might influence disability, such as medical illnesses, were not considered. CONCLUSIONS: The effect of depression on disability is similar for both sexes but not uniform in terms of the impact on different aspects of the quality of life. These findings could be an important factor in the assessment of functioning and management of depression.

[Health and social services used by the rural elderly]. / Servicios sanitarios y sociales utilizados por las personas mayores del medio rural.

OBJECTIVES: To describe the use of health and social services, and to analyze the influence of functional capacity for Instrumental Activities of Daily Living (IADL) and other factors in their use. METHOD: Cross-sectional study in a non-institutionalized population older than 64 years old in a basic rural health area of Zaragoza. DEPENDENT VARIABLES: use of different health and social services. Main independent variable: functional capacity for IADL according to the Lawton-Brody. Confounding variables: sociodemographic, physical exercise, comorbidity, self-perceived health, walking aids, social resources and economic resources (OARS-MAFQ). The relationship between the use of services and functional capacity for IADL was assessed using crude OR (ORC) and adjusted (adjusted OR) with CI95% by means of multivariate logistic regression models. RESULTS: The use of social and health services increased with age and worse functional capacity for IADL. The increased use of health services was related with bad stage of health, limited social and economic resources, physical inactivity and female. The increased use of home help services was related with limited social resources, low education level and male. Regular physical activity and using walking aids were associated with greater participation in recreational activities. CONCLUSIONS: The probability of using social and health services increased in older people with impaired functional capacity for IADL. The specific use of them changed according to differences in health, demographic and contextual features.

Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment.

Health related quality of life changes in somatising patients after individual versus group cognitive behavioural therapy: a randomized clinical trial.

OBJECTIVE: To assess changes in health related quality of life after a cognitive behavioural program for patients diagnosed with abridged somatization disorder in primary care. METHOD: A multicentre, randomized, parallel group, controlled trial was designed. 168 patients were recruited from 29 primary health care centres in Spain and were randomly assigned to one of the three study arms: treatment as usual improved with Smith's norms, individual cognitive behavioural treatment, and group cognitive behavioural treatment. Health-related quality of life was assessed using SF-36 Health Survey. RESULTS: Individual cognitive behavioural treatment achieves greater changes in health related quality of life than group cognitive behavioural therapy and treatment as usual. Improvement in health related quality of life was fully observed at 12 month, and partially at 6 months. The modality of intervention interacts with time in all dimensions except for Physical functioning and Vitality. Patients who received individual cognitive behavioural therapy treatment had better scores in Physical and Mental health summary measures at 12 month follow-up. CONCLUSIONS: Individual cognitive behavioural treatment is the most effective way to improve health related quality of life in abridged somatization disorder patients, and its effects are sustained over time. Also, regardless of the type of intervention, physical functioning improves compared with treatment as usual.

Effectiveness of group versus individual cognitive-behavioral therapy in patients with abridged somatization disorder: a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness and feasibility of a cognitive-behavioral program for patients in primary care units who were diagnosed as having abridged somatization disorder. METHOD: A multicenter, randomized controlled trial was designed. One hundred sixty-eight patients were recruited from 29 primary care units and randomly assigned to one of three arms: treatment as usual (TAU), individual cognitive-behavioral therapy (CBT), and group CBT. Somatic symptoms were measured using the Screening for Somatoform Disorders and the Severity of Somatic Symptoms scale. The Hamilton Anxiety Rating Scale and the Hamilton Depression Rating Scale were used to assess the severity of anxiety and depression. RESULTS: Individual CBT achieves greater changes in the Screening for Somatoform Disorders posttreatment compared with group CBT (mean [95% confidence interval], 14.17 [11.9-16.3] versus 11.63 [9.4-13.7], p < .001). These improvements were observed at 6 and 12 months (p < .001 and p < .001, respectively). For individual CBT versus TAU, the number-needed-to-treat was 8, whereas for group CBT versus TAU, the number-needed-to-treat was 9. Individual CBT treatment resulted in lower anxiety scores compared with group CBT and TAU (7.33 [5.4-9.2] versus 11.47 [9.4-13.9] versus 13.07 [10.9-15.2], p < .001) posttreatment. Individual CBT and group CBT were associated with sustained benefits at 12-month follow-up compared with TAU (8.6 [6.6-10.6] versus 9.28 [7.2-11.2] versus 16.2 [13.9-18.5], p < .001). Depressive symptoms were lower for individual CBT posttreatment than for TAU (6.96 [5.3-8.6] versus 10.87-12.7], p < .01). CONCLUSIONS: CBT in individual and group settings results in significant improvements in somatic symptoms among patients with somatoform abridged disorder compared with TAU. Individual CBT results in greater posttreatment improvements at 6-month and 12-month follow-ups. TRIAL REGISTRATION: current controlled trials identifier ISRCTN69944771.

Factors related with symptom duration until diagnosis and treatment of symptomatic colorectal cancer.

BACKGROUND: Colorectal cancer (CRC) survival depends mostly on stage at the time of diagnosis. However, symptom duration at diagnosis or treatment have also been considered as predictors of stage and survival. This study was designed to: 1) establish the distinct time-symptom duration intervals; 2) identify factors associated with symptom duration until diagnosis and treatment. METHODS: This is a cross-sectional study of all incident cases of symptomatic CRC during 2006-2009 (795 incident cases) in 5 Spanish regions. Data were obtained from patients' interviews and reviews of primary care and hospital clinical records. MEASUREMENTS: CRC symptoms, symptom perception, trust in the general practitioner (GP), primary care and hospital examinations/visits before diagnosis, type of referral and tumor characteristics at diagnosis. Symptom Diagnosis Interval (SDI) was calculated as time from first CRC symptoms to date of diagnosis. Symptom Treatment Interval (STI) was defined as time from first CRC symptoms until start of treatment. Nonparametric tests were used to compare SDI and STI according to different variables. RESULTS: Symptom to diagnosis interval for CRC was 128 days and symptom treatment interval was 155. No statistically significant differences were observed between colon and rectum cancers. Women experienced longer intervals than men. Symptom presentation such as vomiting or abdominal pain and the presence of obstruction led to shorter diagnostic or treatment intervals. Time elapsed was also shorter in those patients that perceived their first symptom/s as serious, disclosed it to their acquaintances, contacted emergencies services or had trust in their GPs. Primary care and hospital doctor examinations and investigations appeared to be related to time elapsed to diagnosis or treatment. CONCLUSIONS: Results show that gender, symptom perception and help-seeking behaviour are the main patient factors related to interval duration. Health service performance also has a very important role in symptom to diagnosis and treatment interval. If time to diagnosis is to be reduced, interventions and guidelines must be developed to ensure appropriate examination and diagnosis during both primary and hospital care.

Evaluation of the efficacy of memantine in the treatment of fibromyalgia: study protocol for a doubled-blind randomized controlled trial with six-month follow-up.

BACKGROUND: Fibromyalgia is a prevalent chronic rheumatic disease of great clinical importance. Recent studies have found raised levels of glutamate in the insula, hippocampus and posterior cingulate cortex regions of the brains of fibromyalgia (FM) patients. This finding has led researchers to speculate about the usefulness of glutamate-blocking drugs such as memantine in the treatment of fibromyalgia. The hypothesis of this study is that the administration of memantine will reduce the glutamate levels, and futhermore, will decrease the perceived pain. The aim of this study is to evaluate the efficacy of memantine in the treatment of pain (pain perception). A secondary objective is to evaluate the efficacy of memantine in the treatment of other clinical symptoms of FM, and to evaluate the efficacy of memantine in reducing brain levels of glutamate, and its effects on the central nervous system as a whole. METHOD/DESIGN: A double-blind parallel randomized controlled trial. Participants, Seventy patients diagnosed with FM will be recruited from primary health care centers in Zaragoza, Spain. Intervention. The subjects will be randomized in two groups: A) A treatment group (n = 35), which will receive 20 mg of memantine daily; B) A control group (n = 35), to which will be administered a placebo. There will be a six-month follow-up period (including a titration period of one month). Outcomes. The main efficacy variable of this study is pain (pain perception). The secondary efficacy variables are clinical symptoms (pain threshold, cognitive function, health status, anxiety, depression, clinical impression and quality of life) and glutamate levels in different regions of the brain, which will be assessed by magnetic resonance spectroscopy. Randomization and blinding. Randomization has been computer-generated, and the random allocation sequence will be implemented by telephone. Subjects of the study and the research assistants will be blinded to group assignment. DISCUSSION: There is a need for the development of innovative and more effective treatments for fibromyalgia. This clinical trial will determine whether memantine can be an effective pharmacological treatment for fibromyalgia patients. TRIAL REGISTRATION: Current Controlled Trials http://ISRCTN45127327 EUDRACT 2011-006244-73.

Low intensity vs. self-guided internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study.

BACKGROUND: Major depression will become the second most important cause of disability in 2020. Computerized cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy has been carried out. The aim of this study is to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system. METHODS: The study is made up of 3 phases: 1.- Development of a computerized cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed. DISCUSSION: The comparisons between low intensity and self-guided are infrequent, and also a comparative economic evaluation between them and compared with usual treatment in primary. The strength of the study is that it is a multicenter, randomized, controlled trial of low intensity and self-guided Internet-delivered psychotherapy for depression in primary care, being the treatment completely integrated in primary care setting. TRIAL REGISTRATION: Clinical Trials NCT01611818.

Effectiveness of cognitive behaviour therapy for the treatment of catastrophisation in patients with fibromyalgia: a randomised controlled trial.

INTRODUCTION: No randomised, controlled trials have been conducted to date on the efficacy of psychological and pharmacological treatments of pain catastrophising (PC) in patients with fibromyalgia. Our aim in this study was to assess the effectiveness of cognitive-behaviour therapy (CBT) and the recommended pharmacological treatment (RPT) compared with treatment as usual (TAU) at the primary care level for the treatment of PC in fibromyalgia patients. METHODS: We conducted a six-month, multicenter, randomized, blinded, parallel group, controlled trial in which patients were randomly assigned to one of three study arms: CBT (n = 57), RPT (n = 56) and TAU at the primary care level (n = 56). The major outcome of this study was PC in patients with fibromyalgia. The secondary variables were pain acceptance, depression, anxiety, pain, global function and quality of life. RESULTS: CBT significantly decreased global PC at the six-month follow-up examination with effect sizes of Cohen's d = 0.73 and 1.01 compared with RPT and TAU, respectively. CBT was also more effective than RPT and TAU at increasing pain acceptance at the six-month follow-up examination (effect sizes of Cohen's d = 0.77 and 0.80, respectively). Compared with RPT and TAU, CBT was more effective at improving global function based on the Fibromyalgia Impact Questionnaire (six-month effect sizes Cohen's d = 0.44 and 0.53, respectively) and quality of life based on the European Quality of Life Scale (six-month effect sizes Cohen's d = 0.11 and 0.40, respectively). There were no differences among the three treatments with regard to pain and depression. CONCLUSIONS: CBT shows higher efficacy than RPT and TAU not only in key outcomes in FM, such as function and quality of life, but also in relevant mediators of treatment effects, such as pain catastrophising and pain acceptance. TRIAL REGISTRATION: ISRCTN: ISRCTN10804772.

[Can the gender perspective be assessed in research projects?]. / ¿Se puede evaluar la perspectiva de género en los proyectos de investigación?

OBJECTIVE: Gender perspective is a theoretical approach that developed from feminist theories and whose main focus is the analysis of gender inequalities. Integration of this perspective is central to promoting equity in health. The aim of our study was to devise a protocol/questionnaire to assess whether gender is present in research projects and thus help to fill the gap in assessment tools. METHODS: We used a qualitative design with two techniques: group discussion and expert group meetings. The discussion group conducted a dialectical analysis of the basic concepts in research and gender and integrated the results of the discourse produced in the expert group meeting. The drafting of the protocol was organized around the pertinent questions that should be asked at each stage of a research project. RESULTS: The protocol consists of 15 questions: four in the introduction section, two in goals and hypotheses, three in methodology, three in purpose of the study and three to be implemented throughout the research project. CONCLUSIONS: The protocol identifies projects that include a gender perspective. Use of this protocol will improve the quality of research and will help to reduce gender inequities.

Stages of chronicity in fibromyalgia and pain catastrophising: a cross-sectional study.

BACKGROUND: Fibromyalgia (FM) is a prevalent and disabling disorder characterised by widespread pain and other symptoms such as insomnia, fatigue and depression. Catastrophisation is considered to be a key clinical symptom in FM; however, few studies have investigated how contextual factors, such as catastrophisation, might contribute to the duration of the pain. The present research examined the relationship among pain, catastrophic thinking and FM impact, as a function of stage of chronicity. METHODS: In this cross-sectional study, the sample of 328 patients diagnosed with FM was divided into 3 groups based on level of chronicity: Group A (6 months to 2 years, N = 46); Group B (2-4 years, N = 59); and Group C (more than 4 years, N = 223). The three subscales of the Pain Catastrophising Scale (PCS), rumination, magnification, and helplessness, were used as predictors of dysfunction. The Fibromyalgia Impact Questionnaire and the McGill Pain Questionnaire were also administered. A hierarchical regression analysis was performed on the entire sample and, subsequently, for each group to determine the effect of the continuous process variables (castastrophising and pain) on the stages of chronicity. RESULTS: Total score and PCS subscales were strongly associated with pain and impact in all the stages of chronicity in FM patients (r = 0.27-0.73, p < 0.05). For Group A, a regression analysis revealed that rumination predicted FM impact beyond the variance accounted for by age and pain. Both magnification and helplessness predicted impact in Group B, and helplessness was a significant predictor of impact in Group C. CONCLUSION: These findings provide preliminary evidence that stage of chronicity is an important moderator of psychological vulnerability for FM impact and should be taken into account by tailoring psychological interventions.

Localized 1H-NMR spectroscopy in patients with fibromyalgia: a controlled study of changes in cerebral glutamate/glutamine, inositol, choline, and N-acetylaspartate.

INTRODUCTION: The purpose of this study was to investigate whether single-voxel (SV) proton magnetic resonance spectroscopy (MRS), diffusion-weighted imaging (DWI), and diffusion tensor imaging (DTI) detected differences between fibromyalgia (FM) patients and healthy controls. We also searched for correlations between neuroimaging abnormalities and neuropsychological variables. METHODS: Ten patients with FM and 10 gender- and age-matched control subjects were studied. A neuropsychological examination, DWI, DTI, and proton MRS were performed on the brain areas known to be associated with pain processing. RESULTS: Compared with healthy controls, FM patients had significantly higher levels of glutamate + glutamine (Glx) (mean ± SD, 10.71 ± 0.50 arbitrary institutional units versus 9.89 ± 1.04; P = 0.049) and higher glutamate + glutamine/creatine (Glx/Cr) ratios (1.90 ± 0.12 versus 1.72 ± 0.23; P = 0.034) in the posterior gyrus. Myoinositol (Ins) levels of the right and left hippocampi were significantly lower in FM patients (4.49 ± 0.74 versus 5.17 ± 0.62; P = 0.008 and 4.91 ± 0.85 versus 6.09 ± 0.78; P = 0.004, respectively). In FM patients, decreased myoinositol/creatine (Ins/Cr) ratios were found in the left sensorimotor area (P = 0.05) and the left hippocampus (P = 0.002) and lower levels of choline (P = 0.019) and N-acetyl aspartate + N-acetyl aspartyl glutamate (NAA + NAG) (P = 0.034) in the left hippocampus. Significant correlations between depression, pain, and global function and the posterior gyrus Glx levels and Glx/Cr ratios were observed. CONCLUSIONS: Glx within the posterior gyrus could be a pathologic factor in FM. Hippocampal dysfunction may be partially responsible for the depressive symptoms of FM. Additional studies with larger samples are required to confirm these preliminary data.