The Cost of Psoriasis and Psoriatic Arthritis in 5 European Countries: A Systematic Review. / Coste de la psoriasis y artritis psoriásica en cinco países de Europa: una revisión sistemática.

INTRODUCTION: While the introduction of biologics has improved the quality of life of patients with psoriasis and psoriatic arthritis, it may have increased the economic burden of these diseases. OBJECTIVE: To perform a systematic review of studies on the costs associated with managing and treating psoriasis and psoriatic arthritis in 5 European countries: Germany, Spain, France, Italy, and the United Kingdom. METHODS: We undertook a systematic review of the literature (up to May 2015) using the MEDLINE and EMBASE databases. The methodological quality of the studies identified was evaluated using the Consolidated Health Economic Evaluation Reporting Standards checklist. We considered both direct costs (medical and nonmedical) and indirect costs, adjusted for country-specific inflation and converted to international dollars using purchasing power parity exchange rates for 2015 ($US PPP). RESULTS: The search retrieved 775 studies; 68.3% analyzed psoriasis and 31.7% analyzed psoriatic arthritis. The total annual cost per patient ranged from US $2,077 to US $13,132 PPP for psoriasis and from US $10,924 to US $17,050 PPP for psoriatic arthritis. Direct costs were the largest component of total expenditure in both diseases. The severity of these diseases was associated with higher costs. The introduction of biologics led to a 3-fold to 5-fold increase in direct costs, and consequently to an increase in total costs. CONCLUSIONS: We have analyzed the economic burden of psoriasis and psoriatic arthritis and shown that costs increase with the treatment and management of more severe disease and the use of biologics.

Factors affecting quality of life of asthma patients in Spain: the importance of patient education.

OBJECTIVES: Assessment of demographic and clinical factors that have an impact on the quality of life (QoL) of patients with asthma in Spain. PATIENTS AND METHODS: Multicenter, prospective, observational, cohort study, conducted in 40 Spanish Pneumology Units during a 12-month period. Data on sociodemographic, clinical variables, asthma treatment and QoL were collected in a case report form. RESULTS: 536 patients (64.6% women, mean age: 54) were recruited. Reported QoL was better for patients from Northern and Central Spain as compared with those from the South and the East (p<0.001), students and employed patients as compared with housewives and unemployed (p<0.01), for those who had received asthma information (p<0.01), for those with milder daytime symptoms (p<0.01) and for patients with higher level of education (p<0.05). CONCLUSIONS: Among the factors that have a significant effect on patients' QoL only symptom control and patient education on asthma control are modifiable. Therefore, all the strategies should be tailored to improve such factors when managing asthma patients.

Mental health self-assessment in patients with moderate to severe psoriasis: an observational, multicenter study of 1164 patients in Spain (the VACAP Study).

BACKGROUND: Poor self-assessed mental health appears to be related to the severity of psoriasis. OBJECTIVE: To evaluate the impact of psoriasis severity on mood and anxiety disorders. METHODS: A prospective, observational, multicenter study was conducted by 123 dermatologists in Spain. Patients (n=164; mean [SD] age, 45.11 [13.92] years; 60.8% males) with moderate to severe psoriasis were evaluated at baseline and 4 months later. Psoriasis severity was measured using the Psoriasis Area and Severity Index (PASI), with a score range of 0 (mild) to 72 (severe); body surface area involvement (BSA); and physician global assessment (PGA) scores, with a range of 1 (mild) to 7 (severe). Mental health was assessed using the Hospital Anxiety and Depression Scale (HADS), with a total possible score of 0-42 (higher scores representing worse mental health). Mean first and second visit scores were compared. RESULTS: Mean (SD) scores improved between the first and second visit as follows: 13.24 (9.50) to 5.07 (6.03) for PASI, 12.52 (7.92) to 10.78 (7.32) for overall HADS, 7.83 (4.55) to 6.85 (4.21) for the HADS anxiety subscale, and 4.72 (4.12) to 3.95 (3.76) for the HADS depression subscale (P<.001 in all cases). Multivariate analyses showed that the main factors related to anxiety were psoriasis severity, sex, and completion of graduate studies. The independent variables included in the model for depression were psoriasis severity, sex, and psoriasis located on the head. CONCLUSIONS: Reductions in disease severity improve self-assessed mood and anxiety disorders in patients with moderate to severe psoriasis.

Demographic characteristics and health-related quality of life of patients with moderate-to-severe psoriasis: The VACAP study.

BACKGROUND: Psoriasis is associated with a deterioration in the health-related quality of life (HRQoL) of affected patients. The aim of this study was to assess the HRQoL of patients with moderate-to-severe psoriasis. METHODS: A prospective observational study (the VACAP Study) was carried out in 123 centers in Spain with 1217 patients. Patients were evaluated at baseline (visit 1 [V1]) and again four months later (visit 2 [V2]). The severity of psoriasis was determined using the following indices: (i) Psoriasis Area and Severity Index (PASI) (score range 0-72, higher score indicates more severe disease), (ii) the body surface area (BSA) affected, and (iii) the Physicians Global Assessment (PGA) (range 1-7, higher score indicates more severe disease). Four questionnaires were used for the assessment of the HRQoL: (i) the Short-Form 36 quality-of-life questionnaire (SF-36) (score range 0-100, higher score indicates better HRQoL); (ii) Euroqol (EQ-5D) (range from 1 to 3, lower score indicates better HRQoL); (iii) Dermatology Life Quality Index (DLQI) (ranges 0-30; from best to worst HRQoL); and (iv) Psoriasis Disability Index (PDI) (ranges 0-45; higher score indicates better HRQoL). RESULTS: The mean (SD) age of the patients was 45.11 (13.92) years at V1. The mean age at the onset of psoriasis was 26.08 (14.19) years. The majority of patients were female (61%) and were employed (68%). The mean PASI score was 13.24 (9.50) at V1 and 5.07 (6.03) at V2 (P<.001). Scores from the generic HRQoL questionnaires (EQ-5D, SF-36) showed significant improvement between visits in all dimensions measured (P<.001). The disease-specific questionnaires also revealed overall improvements in quality of life over time: the DLQI mean total score was 8.97 (7.28) at V1 and 4.76 (5.72) at V2 (P<.001), and the PDI mean total score was 9.24 (8.76) V1 and 4.88 (6.65) at V2 (P<.001). Multivariate analysis using PDI as the dependent variable showed that the principal factors related to HRQoL were severity of psoriasis as measured by PASI (P<.001), and gender (P=.048). CONCLUSIONS: The principal factor related to HRQoL in patients with psoriasis is the severity of the disease.

Vinculación de la afectación artrósica, la discapacidad funcional y la calidad de vida mediante un modelo de ecuación estructural / Association between arthritis, functional disability and quality of life using a structural equation

Objetivos. Establecer un modelo conceptual que vincule la afectación artrósica, la discapacidad funcional en las actividades cotidianas y la calidad de vida (CdV). Métodos. Estudio multicéntrico, observacional y transversal. Se registró clínicamente la afectación artrósica (presencia/ausencia), según la localización; se valoró la discapacidad mediante el índice de discapacidad del cuestionario de evaluación de la salud y se determinó la CdV mediante el cuestionario EQ-5D-3L. El vínculo entre la artrosis, la discapacidad y la CdV se evaluó mediante la modelización de ecuación estructural (SEM). Resultados. Pacientes: 965 pacientes con artrosis (edad media=64 años; 75% mujeres). Artrosis: zonas medias afectadas: 2,8. Zonas afectadas con más frecuencia: rodillas (67%); columna lumbar (60%) y cervical (45%). CdV: la mayoría de los pacientes no refirió problemas graves en los 5 dominios evaluados. Discapacidad: «otras actividades» (media=1,2); «alcanzar» (media=1,1) y «caminar» (media=1,0) fueron las categorías que mostraron mayor discapacidad. La SEM presentó la artrosis, la discapacidad y la CdV como variables relacionadas latentes. Aunque el 92% de la CdV explicó la discapacidad, solo el 5% de la discapacidad se debió a la presencia/ausencia de artrosis. El modelo global que describió la artrosis como causante de discapacidad y discapacidad que afectaba a la CdV, tuvo un buen ajuste general (CMIN/DF=5,42; RMR=0,026; RMSEA=0,069). Conclusiones. La discapacidad funcional puede explicar la disminución de la CdV. En teoría, la artrosis se relaciona estrechamente con la discapacidad y la CdV, pero el modelo no consiguió explicar por completo este vínculo. Como las técnicas estadísticas requieren buenos modelos de medición para determinar correctamente las relaciones, los registros clínicos convencionales parecen insuficientes para este propósito. Se precisan otras mediciones válidas de la afectación artrósica para proporcionar pruebas de su efecto directo en la discapacidad y la CdV (AU)

Objectives. To establish a conceptual model that links arthritis, functional disability in activities of daily living, and quality of life (QoL). Methods. A multicentre, cross-sectional, observation study was performed. The location of the arthritis (presence/absence) was recorded. Disability was measured using the Health Assessment Questionnaire Disability Index and the QoL determined using the EQ-5D-3 Level questionnaire. The relationship between the arthritis, disability, and the QoL was evaluated using the structural equation model (SEM). Results. Patients: 965 patients with arthritis (mean age=64 years, with 75% females). Arthritis: mean areas affected: 2.8. Areas most frequently affected: knees (67%); lumbar spine (60%) and cervical spine (45%). QoL: The majority of patients did not mention serious problems in the five domains assessed. Disability: «other activities» (mean=1.2); «reach» (mean=1.1) and «walking» (mean=1.0) were the categories that demonstrated greater disability. The SEM showed arthritis, disability and QoL as associated latent variables. Although 92% of the QoL explained the disability, only 5% of the disability was due to the presence/absence of arthritis. The global model that describes arthritis as a cause of disability, and disability was affecting the QoL, had a reasonable goodness of fit (CMIN/DF=5.42; RMR=0.026; RMSEA=0.069). Conclusions. Functional disability can explain the decrease in QoL. In theory, arthritis is closely related with disability and QoL, but the model did not mange to fully explain this link. As statistical techniques required good measurement models to correctly determine relationships, conventional medical records seem to be insufficient for this purpose. Other valid measurements of arthritis are needed to provide tests of its direct effect on disability and QoL (AU)

Comparison of expected outcomes between patients and neurologists using Kano's methodology in symptomatic migraine treatment.

OBJECTIVES: Our objective was to evaluate the potential usefulness of the Kano conceptual model to assess expectations of patients and neurologists in Spain regarding symptomatic migraine treatment. METHODS: We performed a multicenter, cross-sectional study in adult migraine patients with at least 1 year of disease evolution and at least one prescription of anti-migraine drugs within the last year. Data collection was performed using questionnaires that included sociodemographic and treatment expectations. Using Kano's methodology, treatment attributes were classified as the following: Must-be; One-dimensional; Attractive; Indifferent; Reverse; or Questionable. RESULTS: A total of 204 migraine patients (mean age 39.2 years [SD 11.9]; 84.6% women) and 68 neurologists (mean age 44 years [SD 8.8]; 63.2% men) were surveyed. None of the treatment attributes evaluated by the patients showed a dominant Must-be feature. Among patients and neurologists, the attributes that led to a greater dissatisfaction when absent and that were ranked as the three most important attributes were those related to treatment safety (absence of long-term adverse effects), efficacy (pain relief achievement), and quality of life (possibility of resuming occupational or academic activities). Differences in attributes' classification were noted among patients and neurologists. The attribute that was considered most important by the patients was achievement of total disappearance of pain, whereas for neurologists the most important attribute was absence of long-term adverse effects. CONCLUSIONS: Kano's methodology is a useful tool to analyze differences in migraine treatment expectations among patients and neurologists. The main difference between patients and neurologists related to basic priorities. Therefore, when selecting treatment for migraine, physicians should invite the patient to participate in the decision making of which treatment is more appropriate.

Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients' quality of life.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) in cancer patients are common symptoms most feared by patients. The aim of this study was to analyze the impact of CINV associated to moderate/highly emetogenous chemotherapy regimens on patients' quality of life (QoL). PATIENTS AND METHODS: Open, multicenter, prospective observational study was performed. Each patient filled out a patient diary for each cycle from the day before chemotherapy and for the next 5 days that included the number of emetic episodes, the intensity of nausea, and QoL evaluation (functional living index-emesis questionnaire). RESULTS: Data from 202 consecutive patients from nine university hospitals were collected, but only data from 160 were analyzed (79.2 %). Most of the participants (70 %) were women with a mean age of 50 years (SD 1.2 years). The most frequent cancer site was breast (44 %) followed by lung (16 %) and 76.3 % were receiving highly emetogenous chemotherapy. Despite the use of antiemetic prophylaxis, patients experienced significant nausea and vomiting during 31 % (3.2 % during acute, 15.0 % during delayed phase, and 13.2 % during both phases) and 45.1 % (5.1 % only during the acute phase, 23.5 % only during the delayed phase and 16.5 % during both phases) of the cycles, respectively, having 44.5 % (nausea) and 39.3 % (emesis) of the cycles an impact on patients' QoL. CONCLUSIONS: The results of the study confirm the detrimental effect of CINV on patients' QoL despite the use of antiemetic prophylaxis (5HT(3) receptor antagonist, steroids, and dopamine receptor antagonists). It is mandatory to intensify the detection of CINV in order to improve the management of these important, albeit frequent, side effects of cancer treatments.

[Association between arthritis, functional disability and quality of life using a structural equation]. / Vinculación de la afectación artrósica, la discapacidad funcional y la calidad de vida mediante un modelo de ecuación estructural.

OBJECTIVES: To establish a conceptual model that links arthritis, functional disability in activities of daily living, and quality of life (QoL). METHODS: A multicentre, cross-sectional, observation study was performed. The location of the arthritis (presence/absence) was recorded. Disability was measured using the Health Assessment Questionnaire Disability Index and the QoL determined using the EQ-5D-3 Level questionnaire. The relationship between the arthritis, disability, and the QoL was evaluated using the structural equation model (SEM). PATIENTS: 965 patients with arthritis (mean age=64 years, with 75% females). Arthritis: mean areas affected: 2.8. Areas most frequently affected: knees (67%); lumbar spine (60%) and cervical spine (45%). QoL: The majority of patients did not mention serious problems in the five domains assessed. Disability: «other activities¼ (mean=1.2); «reach¼ (mean=1.1) and «walking¼ (mean=1.0) were the categories that demonstrated greater disability. The SEM showed arthritis, disability and QoL as associated latent variables. Although 92% of the QoL explained the disability, only 5% of the disability was due to the presence/absence of arthritis. The global model that describes arthritis as a cause of disability, and disability was affecting the QoL, had a reasonable goodness of fit (CMIN/DF=5.42; RMR=0.026; RMSEA=0.069). CONCLUSIONS: Functional disability can explain the decrease in QoL. In theory, arthritis is closely related with disability and QoL, but the model did not mange to fully explain this link. As statistical techniques required good measurement models to correctly determine relationships, conventional medical records seem to be insufficient for this purpose. Other valid measurements of arthritis are needed to provide tests of its direct effect on disability and QoL.

Evaluation of patients' and physicians' expectations and attributes of osteoarthritis treatment using Kano methodology.

PURPOSE: To evaluate expectations regarding osteoarthritis (OA) treatment of patients (PT) and physicians (PH) (Orthopedic Surgeons) in Spain. METHODS: Multicenter, cross-sectional study in adult patients with OA with at least 1 year of disease progression and with at least one prescription of anti-inflammatory drugs within the last year. Sociodemographic, clinical, and treatment characteristics as well as patient-reported outcomes were obtained by phone interview. Using a treatment expectations questionnaire and applying Kano methodology, treatment attributes were classified as: must-be; one-directional; attractive; indifferent; reverse or questionable. RESULTS: A total of 965 adult patients with OA [mean age: 64 years (SD: 11); 75% women] and 383 PH [mean age: 47 years (SD: 10); 14% women] were surveyed. None of the treatment attributes showed a dominant "must-be" characteristic. The attributes that led to a greater dissatisfaction when absent were non-occurrence of long-term adverse effects, no discomfort upon administration, and achievement of symptoms relief. The two attributes that were considered most important by PT were as follows: achievement of both total disappearance of the symptoms and lasting symptom relief. Conversely, for PH, the two most important attributes were related to short- and long-term safety. CONCLUSIONS: A clear different perspective regarding treatment expectation was noted among PT (effectiveness) and PH (safety). Therefore, when selecting the most appropriate treatment for OA, PH should invite PT to participate in the decision making.

Use of a structured migraine diary improves patient and physician communication about migraine disability and treatment outcomes.

Migraine is frequently undertreated, perhaps because impaired communication between patients and physicians underestimate the disability associated with migraine attacks. The purpose of this study was to evaluate the benefits of a structured migraine diary used during a prospective open-label study of triptan-naive patients in Spain for recording information on response to therapy for a pre-study migraine attack and three consecutive migraine attacks, the first and third treated with rizatriptan 10-mg wafer and the second with usual non-triptan therapy. Of 97 patients (83% women; mean age, 39 years) who completed the study, all reported moderate to severe pain, and two-thirds reported severe to total impairment during migraine attacks. At study end, 72% of patients reported that the migraine diary helped communication with their doctor about migraine, and 70% were more or much more satisfied than before the study with level of overall medical care provided by their doctor. Patients who reported the diary to be useful also reported higher overall satisfaction with medical care (p < 0.001). Most of the 22 physicians (91%) reported that the diary enabled them to better communicate with their patients about migraine, and all reported that it enabled them to assess differences in pain intensity and disability across patients. We conclude that a structured migraine diary can be a valuable aid for improving communication between physicians and patients regarding migraine disability and treatment outcomes.

Patient-reported benefits of rizatriptan compared with usual non-triptan therapy for migraine in a primary care setting.

The purpose of this open-label study was to compare rizatriptan with usual non-triptan therapy for migraine in patients who had never received a triptan. Patient-reported outcomes were examined for a prestudy migraine attack and after three consecutive study attacks, the first and third treated with rizatriptan 10 mg wafer and the second with usual non-triptan therapy. A total of 97 patients (83% women; mean age 39 years) completed the study. Two-thirds of patients reported severe or total disability during migraine attacks. All comparisons between rizatriptan therapy and usual non-triptan therapy significantly favoured rizatriptan (p < or = 0.01). Headache relief by 2 hours was reported by 78-83% of patients after rizatriptan and by 46-48% of patients after usual therapy; 41-47% and 12-18%, respectively, were pain free at 2 hours. Patient satisfaction and migraine-specific quality-of-life scores were also significantly better for attacks treated with rizatriptan. At study end, 62% and 17% of patients were very or completely satisfied with rizatriptan and usual non-triptan therapy, respectively. Among those patients who worked for pay, therapy with rizatriptan significantly reduced absenteeism and improved the amount and quality of time at work compared with usual non-triptan therapy. Allowing patients to have experience with rizatriptan may improve the level of medical care for migraine attacks.