Health-related quality of life in patients with psoriasis: a systematic review of the European literature.

PURPOSE: To summarize the data published over the last 5 years in the European Union related to the health-related quality of life (HRQoL) of patients with psoriasis and its conditioning factors. METHODS: International electronic databases and gray literature were searched to identify studies conducted on patient-reported outcomes in patients with psoriasis, published in Europe between January 1, 2009 and December 31, 2013. Bibliographic references were hand-searched. Editorials, letters, commentaries, opinion papers, and studies related to specific treatments were excluded. RESULTS: A total of 46 studies met the inclusion criteria, 27 of them reporting data related to HRQoL or its conditioning factors. The publications reviewed highlighted the substantial negative impact of psoriasis on patients' HRQoL. Most of the studies that analyzed the relationship between HRQoL and sociodemographic characteristics described a relation between gender (female) and age (young patients) and poorer HRQoL. An association between HRQoL impairment and visibility of skin lesions and disease activity and severity was also established. Skin discomfort and pruritus were identified as elements that negatively influenced HRQoL. Use of biological agents had a positive impact on HRQoL and on treatment satisfaction, a better HRQoL being seen in patients treated with systemic therapies and biologics. CONCLUSIONS: HRQoL has been broadly addressed in patients with psoriasis in Europe. Several disease- and patient-related factors contributed to its deterioration. Therapeutic measures with proven effectiveness in controlling disease symptoms and reducing PASI should be considered in patients with a severe disease who have a poorer HRQoL.

Do smoke-free policies in work and public places increase smoking in private venues?

OBJECTIVE: To evaluate the correlation between the implementation of tobacco control policies, particularly smoke-free bans at work and in public places, and smoking prevalence in private venues in the 27 countries of the European Union. DESIGN: Ecological study with the country as the unit of analysis. DATA SOURCES: Data analysis of tobacco control activities in European countries in 2007 as compiled in the Tobacco Control Scale (TCS) and information on the level of smoking permissiveness in houses and cars from the Special Eurobarometer on Tobacco conducted in 2009. ANALYSIS: Spearman rank-correlation coefficients (rsp) and their 95% confidence intervals (CIs) were calculated. RESULTS: The correlation between the TCS score and the prevalence of smoking in private venues (houses and cars) where smoking inside was always allowed was close to zero. A similar lack of association was observed between the TCS score of specific bans at work and in public places and smoking rules inside houses and cars. There was a non-significant direct correlation between the TCS score and the prevalence of smoke-free houses (rsp=0.21, 95% CI -0.19 to 0.55) and a non-significant inverse correlation with smoking allowed in certain rooms inside the house (rsp=-0.34; 95% CI -0.64 to 0.05). CONCLUSIONS: Smoke-free legislation in workplaces and public places is not correlated with increased smoking prevalence in private venues (houses and cars) at an ecological level.

Impact of a multi-level intervention to prevent secondhand smoke exposure in schoolchildren: a randomized cluster community trial.

OBJECTIVE: To assess the effectiveness of a multi-level (individual, family, and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a population of schoolchildren (12-14 years old). METHOD: This was a community trial with cluster randomization of schools to an intervention and comparison group (ClinicalTrials.Gov identifier NCT01881607). The intervention targeted schoolchildren in Terrassa (Catalonia, Spain). We assessed SHS exposure in different settings and tobacco consumption by means of a questionnaire before and one year after the intervention. RESULTS: We analyzed data from 1734 students with both baseline and follow-up data. The crude analysis showed that SHS exposure among students in the intervention group significantly decreased at school (-14.0%), at home (-19.9%), and on transportation (-21.8%). In the comparison group, SHS exposure significantly decreased only at home (-16.9%). After adjustment for potential confounders, the good accomplishment of the activities showed a possible trend towards a non-significant reduction in exposure at home, transportation, and leisure time. CONCLUSION: While this school-based multi-level intervention had no overall effect in SHS exposure, the improvement of the activities focused on preventing SHS would be needed in order to achieve a significant decrease in the proportion of children exposed to SHS.

Tobacco smoking, exposure to second-hand smoke, and asthma and wheezing in schoolchildren: a cross-sectional study.

AIM: To analyse the association between tobacco smoking, exposure to second-hand smoke (SHS) and reports of wheezing and asthma in a sample of schoolchildren. METHODS: A structured questionnaire was administered to 1766 students (7th grade, aged 12-13 years) at 25 schools in Terrassa, Spain (2006). We determined the prevalence of active smoking, exposure to SHS and reports of wheezing and asthma, and their association by means of prevalence odds ratios (OR) and 95% confidence intervals (CI). RESULTS: 97.5% of children were nonsmokers, 1.5% were experimental smokers and 1% were regular smokers. 41.1% of children reported exposure to SHS at home, 40.0% at school, 53.9% in their leisure time and 33.2% while using private or public transportation. Wheezing was reported by 9.2% of children, and 9.2% reported asthma. A significant association was found between smoking tobacco and wheezing: OR in experimental smokers = 3.0 (95% CI 1.2-7.7), and OR in active smokers = 4.2 (95% CI 1.4-12.5). Exposure to SHS while using transportation was associated with wheezing (OR = 1.4; 95% CI 1.0-2.0). Tobacco smoking and exposure to SHS were not associated with asthma. CONCLUSION: Active and experimental smokers, and those who reported exposure to SHS while using public or private transportation, had higher likelihood of reporting wheezing. No association between active or passive smoking and asthma was observed.

Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker.

PURPOSE: The detection of safety signals with medicines is an essential activity to protect public health. Despite widespread acceptance, it is unclear whether recently applied statistical algorithms provide enhanced performance characteristics when compared with traditional systems. Novartis has adopted a novel system for automated signal detection on the basis of disproportionality methods within a safety data mining application (Empirica™ Signal System [ESS]). ESS uses two algorithms for routine analyses: empirical Bayes Multi-item Gamma Poisson Shrinker and logistic regression (LR). METHODS: A model was developed comprising 14 medicines, categorized as "new" or "established." A standard was prepared on the basis of safety findings selected from traditional sources. ESS results were compared with the standard to calculate the positive predictive value (PPV), specificity, and sensitivity. PPVs of the lower one-sided 5% and 0.05% confidence limits of the Bayes geometric mean (EB05) and of the LR odds ratio (LR0005) almost coincided for all the drug-event combinations studied. RESULTS: There was no obvious difference comparing the PPV of the leading Medical Dictionary for Regulatory Activities (MedDRA) terms to the PPV for all terms. The PPV of narrow MedDRA query searches was higher than that for broad searches. The widely used threshold value of EB05 = 2.0 or LR0005 = 2.0 together with more than three spontaneous reports of the drug-event combination produced balanced results for PPV, sensitivity, and specificity. CONCLUSIONS: Consequently, performance characteristics were best for leading terms with narrow MedDRA query searches irrespective of applying Multi-item Gamma Poisson Shrinker or LR at a threshold value of 2.0. This research formed the basis for the configuration of ESS for signal detection at Novartis.

A cost-consequence analysis of the preferential use of secukinumab versus adalimumab for the treatment of psoriatic arthritis.

OBJECTIVES: To assess the efficiency of secukinumab compared to adalimumab as first biologic treatment for psoriatic arthritis (PsA) from the Spanish National Health System (SNHS) perspective. METHODS: A cost-consequence analysis of the cost and clinical response of two treatment strategies was conducted over a 2-year time horizon. A hypothetical cohort of 10 patients with PsA initiated treatment with secukinumab 150mg (cohort A) or adalimumab 40mg (cohort B), respectively. Patients achieving clinical response (ACR20/50/70) at week 24 continued the initial treatment, while patients with inadequate response switched to secukinumab 300mg. Pharmacological costs were calculated based on SmPC (notified ex-factory price). The lowest cost of adalimumab biosimilar was considered. Data on clinical response were extracted from the two matching-adjusted indirect comparison (MAIC) published comparing secukinumab vs adalimumab. Results were expressed as the cost difference between the two cohorts (€, 2019) and were calculated for each clinical response criteria (ACR20/50/70) and for each MAIC. Sensitivity analysis assessed the impact of potential discounts on the cost of adalimumab while maintaining the cost of secukinumab unchanged. RESULTS: Depending on the MAIC used, the cost of initiating biologic treatment for PsA with secukinumab 150mg was 18-33% lower than the one estimated for adalimumab 40mg, for ACR20, 18-28% for ACR50, and 16-23% for ACR70 response rate. Sensitivity analysis showed that it would be necessary a discount of 40-60%, 40-65% and 50-75% over the adalimumab cost to compensate for the differences in efficacy observed for ACR20/50/70, respectively, depending on the MAIC used. CONCLUSION: In patients with PsA, secukinumab could be considered a more efficient first-line biologic treatment compared to adalimumab, from the SNHS perspective.

Patient and retina specialists' preferences in neovascular age-related macular degeneration treatment. A discrete choice experiment.

INTRODUCTION AND OBJECTIVE: Neovascular age-related macular degeneration (nAMD) leads to severe and permanent visual impairment, significantly impacting patients' quality of life and functional independence. Although treatment with anti- vascular endothelial growth factor (VEGF) prevents and, in some cases, reverses visual damage, the need for frequent monitoring visits and intravitreal injections represents a significant burden on patients, caregivers and retina specialists. OBJECTIVE: To elicit preferences for nAMD treatment characteristics from the perspectives of patients and retina specialists. METHOD: A discrete choice experiment was conducted. Participants (patients > 50 years with nAMD receiving anti-VEGF drugs for at least 2 years and without previous experience with anti-VEGF and retina specialists working in the Spanish National Healthcare System) were asked to select one of two hypothetical treatments resulting from the combination of five attributes (effects on visual function, effects on retinal fluid, treatment regimen, monitoring frequency, and cost); their levels were identified by reviewing the literature and two focus groups. The relative importance (RI) given to each attribute was estimated using a mixed logit model. The marginal rates of substitution (MRS) were calculated taking cost as the risk attribute. RESULTS: A total of 110 patients (P) [aged 79.0 (SD:7.4) years; 57.3% women; 2.3 (SD:0.7) years with nAMD; 2.1 years (SD:0.1) in treatment] and 66 retina specialists (RS) participated in the study. Participants gave greater RI to improvements in their visual function [60.0% (P); 52.7% (RS)], lower monitoring frequency [20.2% (P); 27.1% (RS)] and reduction in retinal fluid [9.8% (P); 13.0%(RS)]. Patients and retina specialists would agree to an increase in cost by 65.0% and 56.5%, respectively, in exchange for improvements of visual function; and 25.5% and 43.3% on delaying monitoring frequency by one month. CONCLUSIONS: Efficacy of treatment, in terms of visual function improvements, is the main driver for treatment election for both patients and retina specialists. Treatment monitoring requirements are also considered, mainly from the retina specialist's perspective. These results suggest that the use of more efficacious anti-VEGF agents with a longer duration of action may contribute to aligning treatment characteristics with patients/specialists' preferences. A better alignment would facilitate better disease management, fulfilling the unmet needs of patients and retina specialists.

A Cost-Consequence Analysis of the Preferential Use of Secukinumab Versus Adalimumab for the Treatment of Psoriatic Arthritis.

OBJECTIVES: To assess the efficiency of secukinumab compared to adalimumab as first biologic treatment for psoriatic arthritis (PsA) from the Spanish National Health System (SNHS) perspective. METHODS: A cost-consequence analysis of the cost and clinical response of two treatment strategies was conducted over a 2-year time horizon. A hypothetical cohort of 10 patients with PsA initiated treatment with secukinumab 150mg (cohort A) or adalimumab 40mg (cohort B), respectively. Patients achieving clinical response (ACR20/50/70) at week 24 continued the initial treatment, while patients with inadequate response switched to secukinumab 300mg. Pharmacological costs were calculated based on SmPC (notified ex-factory price). The lowest cost of adalimumab biosimilar was considered. Data on clinical response were extracted from the two matching-adjusted indirect comparison (MAIC) published comparing secukinumab vs adalimumab. Results were expressed as the cost difference between the two cohorts (€, 2019) and were calculated for each clinical response criteria (ACR20/50/70) and for each MAIC. Sensitivity analysis assessed the impact of potential discounts on the cost of adalimumab while maintaining the cost of secukinumab unchanged. RESULTS: Depending on the MAIC used, the cost of initiating biologic treatment for PsA with secukinumab 150mg was 18-33% lower than the one estimated for adalimumab 40mg, for ACR20, 18-28% for ACR50, and 16-23% for ACR70 response rate. Sensitivity analysis showed that it would be necessary a discount of 40-60%, 40-65% and 50-75% over the adalimumab cost to compensate for the differences in efficacy observed for ACR20/50/70, respectively, depending on the MAIC used. CONCLUSION: In patients with PsA, secukinumab could be considered a more efficient first-line biologic treatment compared to adalimumab, from the SNHS perspective.

Multidisciplinary approach to psoriasis in the Spanish National Health System: A social return on investment study.

Introduction: Psoriasis is a chronic disease in which patients feel stigmatization, social rejection, and suffer from low self-esteem. There are still unmet needs that make it necessary to define a new multidisciplinary approach to provide benefits not only to patients and their families but also to the Spanish National Health System (SNHS) and society. The aim was to define a new approach to better address the unmet needs of patients with psoriasis within the SNHS and to measure its impact from a social perspective, that is, in clinical, health care, economic, and social terms. Methods: Multidisciplinary experts identified, agreed on, and selected several health care interventions that were feasible for implementation in the SNHS. This process was carried out in four different areas: diagnosis, mild psoriasis, moderate psoriasis, and severe psoriasis. To estimate investment and social return, the social return on investment (SROI) method was used. Results: The new approach to psoriasis management in the SNHS comprised 18 proposals. The investment needed for the implementation of this new approach would amount to €222.77 million and its return to €1,123.11 million. This would yield a SROI ratio of €5.04 for every euro invested. Conclusion: The new approach to psoriasis management would yield a positive social return. The results will allow optimal strategic planning adapted to each assistance situation, to achieve a comprehensive and multidisciplinary approach.

The social return on investment of a new approach to heart failure in the Spanish National Health System.

AIMS: We aim to agree on a set of proposals to improve the current management of heart failure (HF) within the Spanish National Health System (SNHS) and apply the social return on investment (SROI) method to measure the social impact that these proposals would generate. METHODS AND RESULTS: A multidisciplinary working team of 16 experts was set up, with representation from the main stakeholders regarding HF: medical specialists (cardiologists, internal medicine physicians, general practitioners, and geriatric physicians), nursing professionals, health management professionals, patients, and informal caregivers. This team established a set of proposals to improve the management of HF according to the main areas of HF care: emergency and hospitalization, primary care, cardiology, and internal medicine. A forecast-type SROI method, with a 1-year time frame, was applied to measure the social impact resulting from the implementation of these proposals. The required investment and social return were estimated and summarized into a ratio indicating how much social return could be generated for each euro invested. Intangible returns were included and quantified through financial proxies. The approach to improve the management of HF consisted of 28 proposals, including the implementation of a case management nurse network, standardization of operational protocols, psychological support, availability of echocardiography machines at emergency departments, stationary units and primary care, early specialist visits after hospital discharge, and cardiac rehabilitation units, among others. These proposals would benefit not only patients and their informal caregivers but also the SNHS. Regarding patients, proposals would increase their autonomy in everyday activities, decrease anxiety, increase psychological and physical well-being, improve pharmacological adherence and self-care, enhance understanding of the disease, delay disease progression, expedite medical assessment, and prevent the decrease in work productivity associated with HF management. Regarding informal caregivers, proposals would increase their quality of life; improve their social, economic, and emotional well-being; and reduce their care burden. The SNHS would benefit from shorter stays of HF patients at intensive care units and reduction of hospitalizations and admissions to emergency departments. The investment needed to implement these proposals would amount to €548m and yield a social return of €1932m, that is, €3.52 for each euro invested. CONCLUSIONS: The current management of HF could be improved by a set of proposals that resulted in an overall positive social return, varying between areas of analysis. This may guide the allocation of healthcare resources and improve the quality of life of patients with HF.

Efficacy and Safety of Treatment With Ferric Carboxymaltose in Patients With Cirrhosis and Gastrointestinal Bleeding.

Background: Patients with liver cirrhosis and gastrointestinal bleeding (GIB) often develop anemia. Ferric carboxymaltose (FCM) is an intravenous (i.v.) iron formulation approved for use in patients with iron deficiency with inadequate response to oral iron therapy or when oral iron cannot be used. Here we analyzed the efficacy and safety of FCM treatment in cirrhotic patients with anemia and GIB. Methods: Retrospective observational study of patients with cirrhosis and acute or chronic GIB treated with 1,000 mg FCM at the University Hospital Arnau de Vilanova (Lleida, Spain) that follows a restrictive-transfusion strategy. All data were obtained from the patients' medical records. We used the Wilcoxon test to evaluate statistical significance. Results: Patients with cirrhosis and GIB (n = 34) were treated with 1,000 mg FCM. Portal hypertension were present in 88.2% of the patients. For hospitalized patients (n = 21), median serum hemoglobin (s-Hb) levels increased by 3.0 g/dL (p < 0.02) and 3.9 g/dL (p < 0.07) for patients treated with FCM who had or had not received also a transfusion, respectively, compared to levels recorded upon admission. For outpatients (n = 13) the mean s-Hb levels was 9.8 ± 1.6 g/dL before FCM treatment and 11.3 ± 2.1 g/dL after treatment, demonstrating a mean increase of 1.5 g/dL (p < 0.001). No serious adverse reactions to FCM were observed. Conclusion: FCM administration achieved optimal s-Hb levels in most cirrhotic patients with acute or chronic GIB, suggesting that early FCM infusion improves and maintains optimal s-Hb levels in these patients and may be an appropriate first-line therapy to treat their anemia.

Patient-reported outcomes in European spondyloarthritis patients: a systematic review of the literature.

OBJECTIVE: This review aims to summarize the current literature on patient-reported outcomes (PROs) in spondyloarthritis (SpA). PATIENTS AND METHODS: We performed a systematic literature review to identify studies (original articles and narrative and systematic reviews) regarding PROs (health-related quality of life [HRQoL], satisfaction, preferences, adherence/compliance, and persistence) in SpA patients published in the European Union through December 2016. International databases (Medline/PubMed, Cochrane Library, ISI Web of Knowledge, Scopus) were searched using keywords in English. The methodological quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine criteria. RESULTS: A total of 26 publications met the inclusion criteria. Generally, studies indicated that SpA has a negative impact on patients' HRQoL. In patients with ankylosing spondylitis, physical domains were more affected than emotional ones, whereas for psoriatic arthritis, both physical and psychological factors were strongly affected by the disease. Data indicated that biological agents (BAs) greatly contributed to improvement in HRQoL in both ankylosing spondylitis and psoriatic arthritis patients. Findings on compliance with BAs were heterogeneous. However, persistence rates exceeded 50% irrespective of the BA administered. Results on preferences indicated that most SpA patients prefer being involved in decisions regarding their treatment and that besides efficacy and safety, frequency and route of administration may influence patients' preferences for BAs. CONCLUSION: Implementing management programs for SpA patients focuses on the physical, emotional, and social consequences of the disease, in addition to assessing and including patient preferences in the treatment decision-making process, could be crucial to improve patients' HRQoL and ensure their satisfaction and compliance with treatment.

Secukinumab is the most efficient treatment for achieving clear skin in psoriatic patients: a cost-consequence study from the Spanish National Health Service.

OBJECTIVE: To compare the cost consequence of biologic drugs for moderate-to-severe psoriasis from the perspective of the Spanish National Health System. METHODS: We built a decision tree with a two-year time horizon. Efficacy data for biologics (etanercept, infliximab, adalimumab, ustekinumab and secukinumab) were drawn from published meta-analyses: PASI75 for the induction phase and PASI90 for the rest of follow-up. Patients with PASI < 75 at week 10-16 were switched to another biologic agent. Efficacy at week 24 was considered the highest possible efficacy for each drug and assumed to remain constant throughout the two-year period. Only drug treatment costs were used. The number needed to treat (NNT), annual cost per patient, annual cost per patient with PASI90 (cost per responder) and cost of primary failure (PASI < 75 at first efficacy evaluation) were calculated. RESULTS: Secukinumab monotherapy was associated with the lowest cost per responder, followed by infliximab and ustekinumab. Treatment sequences starting with secukinumab were the most efficient, having the lowest NNT and cost per responder. Although the annual cost per treatment is similar for all drugs, there are huge differences in the cost per responder. CONCLUSIONS: Secukinumab as first-line biologic treatment is the most efficient treatment for moderate-to-severe plaque psoriasis in the short-to-medium term.

[Survey of the performance of anti-HIV antibody detection tests in laboratories in Catalonia [Spain]]. / Encuesta sobre la realización de las pruebas de detección de los anticuerpos anti-VIH en los laboratorios de Cataluña.

Quality assurance of HIV testing is essential to correctly assess the HIV epidemic. To describe the characteristics of HIV testing and identify features that could be improved, a questionnaire on the quality of HIV tests was sent to Catalan laboratories in 1998. The survey revealed variability in the procedures used by the participating laboratories when performing HIV tests. Some of the laboratories were still performing incorrect activities such as identifying HIV specimens with specific labels, extracting new specimens for a second test to confirm diagnosis, or failing to guarantee the confidentiality of the results. The criteria for HIV testing should be standardized according to the purpose of the test and the prevalence of the infection in the population analyzed. This approach would improve the quality of the results of diagnostic tests, since the overall concept of quality includes the entire process (pre-test, test and post-test).

Coverage of HIV testing among pregnant women in Catalonia, Spain: a comparison of self-reporting with medical records.

BACKGROUND: to estimate the coverage of HIV testing during pregnancy in Catalonia, to identify factors associated with testing during pregnancy and to assess the recording of screening in medical records and the women's awareness about being tested. METHODS: A survey was carried out in 2000 among pregnant women attending hospital, with face-to-face interview 24-48 hours post-delivery, and review of the medical records. RESULTS: Out of 2,132 participants, 76% were from public and 24% from private hospitals. Medical records showed that 88.3% of the participants had a HIV test (94% in public, 71% in private hospitals), while for 3.7% and 18.5% in private and public, respectively, this information was not documented. Overall, 67% of women reported having been tested for HIV during that pregnancy, and unawareness of having been tested was detected in 10.7%. Educational level and prenatal care are determinants for being tested. CONCLUSION: Catalonia has a good coverage of HIV testing among childbearing women, although it is lower in private hospitals. Frequently prenatal HIV testing is not documented in medical records and women are unaware of it. Improving the prenatal care and tailoring these programmes to specific populations, like migrants or marginalized groups, will result in a better understanding of HIV prevention and in an increase in HIV testing before delivery.