Evaluating the Impact of a Training Program in Shared Decision-Making for Neurologists Treating People with Migraine.

INTRODUCTION: Migraine symptoms vary significantly between patients and within the same patient. Currently, an increasing number of therapeutic options are available for symptomatic and preventive treatment. Guidelines encourage physicians to use shared decision-making (SDM) in their practice, listening to patients' treatment preferences in order to select the most suitable and effective therapy. Although training for healthcare professionals could increase their awareness of SDM, results concerning its effectiveness are inconclusive. This study aimed to analyze the impact of a training activity to promote SDM in the context of migraine care. This was addressed by evaluating the impact on patients' decisional conflict (main objective), patient-physician relationship, neurologists' perceptions of the training and patient's perception of SDM. METHODS: A multicenter observational study was conducted in four highly specialized headache units. The participating neurologists received SDM training targeting people with migraine in clinical practice to provide techniques and tools to optimize physician-patient interactions and encourage patient involvement in SDM. The study was set up in three consecutive phases: control phase, in which neurologists were blind to the training activity and performed the consultation with the control group under routine clinical practice; training phase, when the same neurologists participated in the SDM training; and SDM phase, in which these neurologists performed the consultation with the intervention group after the training. Patients in both groups with a change of treatment assessment during the visit completed the Decisional conflict scale (DCS) after the consultation to measure the patient's decisional conflict. Also, patients answered the patient-doctor relationship questionnaire (CREM-P) and the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). The mean ± SD scores obtained from the study questionnaires were calculated for both groups and compared to determine whether there were significant differences (p < 0.05). RESULTS: A total of 180 migraine patients (86.7% female, mean age of 38.5 ± 12.3 years) were included, of which 128 required a migraine treatment change assessment during the consultation (control group, n = 68; intervention group, n = 60). A low decisional conflict was found without significant differences between the intervention (25.6 ± 23.4) and control group (22.1 ± 17.9; p = 0.5597). No significant differences in the CREM-P and SDM-Q-9 scores were observed between groups. Physicians were satisfied with the training and showed greater agreement with the clarity, quality and selection of the contents. Moreover, physicians felt confident communicating with patients after the training, and they applied the techniques and SDM strategies learned. CONCLUSION: SDM is a model currently being actively used in clinical practice for headache consultation, with high patient involvement in the process. This SDM training, while useful from the physician's perspective, may be more effective at other levels of care where there is still room for optimization of patient involvement in decision-making.

Characteristics of stroke units and stroke teams in Spain in 2018. Pre2Ictus project.

INTRODUCTION: The aim of this work is to describe the characteristics of stroke units and stroke teams in Spain. METHODS: We performed a cross-sectional study based on an ad-hoc questionnaire designed by 5 experts and addressed to neurologists leading stroke units/teams that had been operational for ≥ 1 year. RESULTS: The survey was completed by 43 stroke units (61% of units in Spain) and 14 stroke teams. A mean (standard deviation) of 4 (3) neurologists were assigned to each stroke unit/team; 98% of stroke units (and 38% of stroke teams) have an on-call neurologist available 24 hours a day, 98% of units (79% of stroke teams) included specialised nurses, 86% of units (71% of stroke teams) included a social worker, and 81% of units (71% of stroke teams) included a rehabilitation physician. Most stroke units (80%) had 4--6 beds with continuous non-invasive monitoring. The mean number of unmonitored beds was 14 (8) for stroke units and 12 (7) for stroke teams. The mean duration of non-invasive monitoring was 3 (1) days. All stroke units and 86% of stroke teams had intravenous thrombolysis available, and 81% of stroke units and 21% of stroke teams were able to perform mechanical thrombectomy, whereas the remaining centres had referral pathways in place. Telestroke systems were in place at 44% of stroke units, providing support to a mean of 4 (3) centres. Activity is recorded in clinical registries by 77% of stroke units and 50% of stroke teams, but less than 75% of data is completed in 25% of cases. CONCLUSIONS: Most stroke units/teams comply with the current recommendations. The systematic use of clinical registries should be improved to further improve patient care.

Patient-Reported Outcome Measures in Real-World Atopic Dermatitis Studies in Spain: A Systematic Review. / Medidas de los resultados percibidos por el paciente en estudios de vida real en dermatitis atópica en España: revisión sistemática de la literatura.

Atopic dermatitis (AD) is a chronic inflammatory skin disease with symptoms such as pruritus that can be a major burden for patients. Patient-reported outcomes (PRO) complement clinician-reported outcomes in AD. This systematic review aims to identify and describe patient-reported outcome measures (PROM) used in observational studies of AD over the last decade in Spain. Eighteen PROM were identified to measure 13 different PRO that assess multiple aspects of the disease, including symptoms and disease severity, impact on daily activities and on work productivity/functioning, psychosocial impact, patient empowerment, and health-related quality of life (HRQoL). HRQoL, symptoms (particularly pruritus), and anxiety/depression were the most frequently assessed PRO, and the Dermatology Quality of Life Index, the Visual Analogue Pruritus Scale, and the Hospital Anxiety and Depression Scale were the most frequently used PROM, respectively. The growing number of observational studies on AD including PROM in Spain suggests that PRO are becoming increasingly important in the management of AD.

Multidisciplinary expert consensus on secondary fracture prevention in Spain.

The study aimed to achieve expert consensus to optimize secondary fracture prevention in Spain. Relevant gaps in current patient management were identified. However, some aspects were considered difficult to apply. Future efforts should focus on those items with greatest divergences between importance and feasibility. PURPOSE: To establish a Spanish multidisciplinary expert consensus on secondary fracture prevention. METHODS: A two-round Delphi consensus was conducted, guided by a Scientific Committee. The 43-item study questionnaire was designed from a literature review and a subsequent multidisciplinary expert group (n = 12) discussion. The first-round questionnaire, using a 7-point Likert scale, assessed the experts' opinion of the current situation, their wish for items to happen, and their prognosis that items would be implemented within 5 years. Items for which consensus was not achieved were included in the second round. Consensus was defined as ≥ 75% agreement or ≥ 75% disagreement. A total of 102 experts from 14 scientific societies were invited to participate. RESULTS: A total of 75 (response rate 73.5%) and 69 (92.0%) experts answered the first and second Delphi rounds, respectively. Participants mean age was 51.8 years [standard deviation (SD): 10.1 years]; being 24.0% rheumatologists, 21.3% primary care physicians, 14.7% geriatricians, 8.0% internal medicine specialists, 8.0% rehabilitation physicians, and 8.0% gynecologists. Consensus was achieved for 79.1% of items (wish, 100%; prognosis, 58.1%). Effective secondary prevention strategies identified as requiring improvement included: clinical report standardization, effective hospital primary care communication (telephone/mail and case managers), health-related quality of life (HRQoL) questionnaires use, and treatment compliance monitoring (prognosis agreement 33.3%, 47.8%, 18.8%, and 55.1%, respectively). CONCLUSION: A consensus was reached by health professionals in their wish to implement strategies to optimize secondary fracture prevention; however, they considered some difficult to apply. Efforts should focus on those items with currently low application and those with greatest divergence between wish and prognosis.

Characteristics of stroke units and stroke teams in Spain in 2018. Pre2Ictus project. / Características de las unidades de ictus y equipos de ictus en España en el año 2018. Proyecto Pre2Ictus.

INTRODUCTION: The aim of this work is to describe the characteristics of stroke units and stroke teams in Spain. METHOD: We performed a cross-sectional study based on an ad hoc questionnaire designed by 5 experts and addressed to neurologists leading stroke units/teams that had been operational for ≥ 1 year. RESULTS: The survey was completed by 43 stroke units (61% of units in Spain) and 14 stroke teams. The mean (SD) number of neurologists assigned to each unit/team is 4±3. 98% of stroke units (and 38% of stroke teams) have a neurologist on-call available 24hours, 365 days. 98% of stroke units (79% of stroke teams) have specialised nurse, 95% of units (71% of stroke teams) auxiliary personnel, 86% of units (71% of stroke teams) social worker, 81% of stroke units (71% of stroke teams) have a rehabilitation physician and 81% of stroke units (86% of stroke teams) a physiotherapist. Most stroke units (80%) have 4-6 beds with continuous non-invasive monitoring. The mean number of unmonitored beds is 14 (8) for stroke units and 12 (7) for stroke teams. The mean duration of non-invasive monitoring is 3 (1) days. All stroke units and 86% of stroke teams have intravenous thrombolysis available, and 81% of stroke units and 21% of stroke teams are able to perform mechanical thrombectomy, whereas the remaining centres have referral pathways in place. Telestroke systems are available at 44% of stroke units, providing support to a mean of 4 (3) centres. Activity is recorded in clinical registries by 77% of stroke units and 50% of stroke teams, but less than 75% of data is completed in 25% of cases. CONCLUSIONS: Most stroke units/teams comply with the current recommendations. The systematic use of clinical registries should be improved to further improve patient care.

Patient-reported outcomes assessment tools for use in psoriasis in Spain: A systematic review. / Instrumentos para la valoración de los resultados percibidos por el paciente con psoriasis en España: revisión sistemática de la literatura.

OBJECTIVES: To review the literature on validated tools for measuring patient-reported outcomes (PROs) in psoriasis in Spain. To evaluate the psychometric properties of the tools and describe the results of their practical application. MATERIAL AND METHODS: Systematic review of studies validating or using instruments for assessing PROs in Spanish patients with psoriasis. Literature searches were performed in international (PubMed/Medline) and Spanish (Medes, Ibecs) databases. We also searched databases of instruments for measuring PROs (BiblioPRO, PROQOLID). The review included studies published in English or Spanish up to January 9, 2017. We also checked the reference lists of the key publications identified. The quality of the questionnaires was evaluated based on their psychometric properties (construct, transcultural adaptation, reliability, validity, feasibility, and sensitivity to change). RESULTS: Eighteen publications were included. Six articles described the validation of Spanish versions of 5 PROs tools: 4 health-related quality of life (HRQoL) questionnaires specific to psoriasis and dermatologic diseases and 1 questionnaire specific to satisfaction with treatment. Our assessment of the HRQoL tools' psychometric properties showed that the PSO-LIFE questionnaire received the highest scores, although specific properties varied from instrument to instrument. The 12 remaining articles were observational studies that used the validated instruments. In use, these tools detected the high impact of psoriasis on HRQoL, especially in young female patients with severe disease. CONCLUSIONS: We identified 5 specific instruments validated in Spain for scoring PROs in patients with psoriasis. The tools' psychometric properties vary, and it is essential to understand their strengths and weaknesses when selecting the right one for each situation. In use, these questionnaires are able to detect the high impact of psoriasis on patients' HRQoL. PROs provide useful information to complement routine clinical findings in psoriasis and may contribute to improving disease management.

The view of experts on initiatives to be undertaken to promote equity in the access to orphan drugs and specialised care for rare diseases in Spain: A Delphi consensus.

OBJECTIVES: To reach a consensus amongst experts on the most feasible actions to be undertaken to facilitate patient access to specialised care and orphan drugs (OD) in the public health sector in Spain. METHODS: Two Delphi rounds were completed. The questionnaire was based on a literature review and 2 focus groups. Agreement was sought on the desire (D) and prognosis (P) for the implementation within the next 5 years, on a 5-point Likert scale. Consensus was reached when ≥75% participants chose agreement (1-2) or disagreement options (4-5). RESULTS: 82 experts on rare disease (RD) participated. Agreement on the D and P was reached in 66.07% statements: OD pricing review [absence of clinical effectiveness (D:85.37%; P:85.90%), target population increase (D:79.27%; P:91.03%)]; reference team definition of referral protocols and clinical practice guidelines (D: 97.56%; P: 89.74%); and a unified, usable, etiology-based registry (D:97.56%; P:84.62%). D and P assessment diverged in 32.14% items: creation of a specific funding system for OD (D: 97.56%; P: 60.25%); and a network of medical teams to coordinate the care of RD patients (D: 99%; P: 62%). CONCLUSIONS: The results have shown the need to promote dialogue between stakeholders, introduce European recommendation to national and regional Spanish policies and set up priorities and undertake actions to drive relevant changes in current medical practice in managing RD patients.

Spanish consensus on treat to target for osteoporosis.

To reach a Spanish expert consensus on a treat-to-target strategy in osteoporosis, a Delphi Consensus Study has been developed. Most of the experts (59.8%) were rheumatologist with a mean clinical experience of 21.3 years (SD 8.5). Consensus was achieved for 70% of the items. Therapeutic objectives, patient follow-up scheme, treatment failure criteria, and appropriate treatment choice for use in T2T strategy in Spain have been defined. INTRODUCTION: The paper aims to achieve a Spanish expert consensus on a treat-to-target (T2T) strategy in osteoporosis. METHODS: A scientific committee led the project and was involved in expert panel identification and Delphi questionnaire development. Two Delphi rounds were completed. The first-round questionnaire included 24 items and assessed, using a seven-point Likert scale, the experts' wish (W) and prognosis (P) in 5 years for each topic (applicability, therapeutic objectives, patient follow-up, and possible treatment to be prescribed). Items for which there was no consensus in the first round were included in the second round. Consensus was defined as ≥75% agreement (somewhat/mostly/entirely agree) or disagreement (somewhat/mostly/entirely disagree) responses. RESULTS: Of the experts, 112 and 106 completed the first and second rounds, respectively. 59.8% were rheumatologists with a mean clinical experience of 21.3 years (SD 8.5). Consensus was achieved for 70% of the items, and was established regarding the utility of a T2T strategy to define therapeutic objectives, optimal follow-up, and therapeutic algorithm. Participants agreed on the utility of the bone mineral density (BMD) value (T-score >-2.5 SD for spine and >-2.5/-2.0 SD for femoral neck), lack of fractures, and fracture risk (FRAX) as therapeutic objectives. For measuring BMD changes, consensus was achieved on the suitability of hip and femoral neck locations. Experts agreed to consider treatment failure as when a significant BMD gain could not be achieved, or when a new fracture occurs within 2-3 years. There was consensus that all proposed therapies should achieve a therapeutic target through T2T strategy (treatments with the highest consensus scores were denosumab and teriparatide). CONCLUSION: The therapeutic objectives, patient follow-up scheme, treatment failure criteria, and appropriate treatment choice for use in T2T strategy in Spain have been established by a panel of experts. Some aspects nevertheless still require further analysis.

Análisis costo-efectividad de lenalidomida en combinación con dexametasona frente a bortezomib combinado con dexametasona en el tratamiento en segunda línea del mieloma múltiple en Chile / Cost-effectiveness of lenalidomide in combination with dexamethasone compared to bortezomib in combination with dexamethasone for the second-line treatment of multiple myeloma in Chile

CONTEXTO: El mieloma múltiple es una neoplasia de las células plasmáticas de la medula ósea. Las terapias disponibles no son curativas y la mayoría de los pacientes se vuelve refractario al tratamiento. Agentes como lenalidomida y bortezomib han demostrado su eficacia en el tratamien-to en segunda línea de estos pacientes. OBJETIVO: Evaluar el costo-efectividad de la combinación lenalidomida/dexametasona frente a bortezomib/dexametasona en pacientes con mieloma múltiple, no candidatos a trasplante, previamente tratados con bortezomib, desde la perspectiva del sistema nacional de salud chileno. METODOLOGÍA: Se empleó un modelo de Markov que simula la evolución de una cohorte de pacientes a través de cuatro estados de salud (preprogresión en tratamiento, preprogresión sin tratamiento, progresión o muerte) en un horizonte temporal de 25 años. Los datos de eficacia, uso de recursos y frecuencia de efectos adversos fueron extraídos de los ensayos sobre mieloma múltiple MM-009 y MM-010 y de un estudio retrospectivo de retratamiento con bortezomib. Todos los parámetros fueron validados por expertos. Se aplicó una tasa de descuento en costos y beneficios de 3%. La robustez de los resultados fue evaluada mediante un análisis de sensibilidad univariante y probabilístico. RESULTADOS: El tratamiento con lenalidomida/dexametasona proporciona 1,41 años de vida y 0,83 años de vida ajustados por calidad incrementales respecto a bortezomib/dexametasona, con un costo incremental de 11 864 597,86 pesos chilenos (19 589,86 dólares). La ratio de cos-to-efectividad y costo-utilidad incremental se cifró en 8 410 266,92 pesos chilenos (13 886,35 dólares) por año de vida ganado y 14 271 896,16 pesos chilenos (23 564,59 dólares) por año de vida ajustado por calidad respectivamente. CONCLUSIÓN: La lenalidomida/dexametasona representa una alternativa potencialmente costo-efectiva, desde la perspectiva del sistema nacional de salud chileno, para el tratamiento en segunda línea de pacientes con mieloma múltiple no candidatos a trasplante.

BACKGROUND: Multiple myeloma is a hematologic malignancy affecting bone marrow derived plasma cells. Current therapies are not able to eradicate the disease and most patients become refractory to the treatment. Lenalidomide and bortezomib have proved effective in the second-line treatment of these patients. OBJECTIVE: To evaluate the cost-effectiveness of lenalidomide in combination with dexamethasone compared to bortezomib in combination with dexamethasone in patients with multiple myeloma previously treated with bortezomib, from the perspective of the Chilean National Health Service. METHODOLOGY: A four-state Markov model (preprogression on treatment; preprogression off treatment, progression and death) was used to simulate the evolution of a cohort of multiple myeloma patients over a 25-year time horizon. Efficacy data, resource use and frequency of adverse events were extracted from MM009/010 studies and a retrospective analysis of retreatment with bortezomib. All inputs were validated by experts. A 3% annual discount rate was used for costs and health outcomes. The robustness of the results was evaluated through univariate and probabilistic sensitivity analyses. RESULTS: Lenalidomide in combination with dexamethasone treatment provided 1.41 incremental life years and 0.83 incremental quality-adjusted life years in comparison with bortezomib in combination with dexamethasone, with an incremental cost of 11 864 597.86 CLP (19 589.86 US$). The incremental cost-effectiveness and cost-utility ratio were estimated at 8 410 266.92 CLP (13 886,35 US$) / incremental life year and 14 271 896.16 CLP (23 564,59 US$)/incremental quality-adjusted life years, respectively. CONCLUSIONS: Lenalidomide in combination with dexamethasone represents a potentially cost-effective alternative for the second-line treatment of patients with multiple myeloma who are not eligible for transplantation, from the perspective of the Chilean National Health Service.

Adherence, satisfaction and preferences for treatment in patients with psoriasis in the European Union: a systematic review of the literature.

BACKGROUND AND OBJECTIVE: Adherence to treatment in patients with psoriasis is often poor. An investigation of patient preferences and satisfaction with treatment may be important, based on the expected correlation with therapy compliance. This paper aims to examine and describe the current literature on patient preferences, satisfaction and adherence to treatment for psoriasis in the European Union (EU). METHODS: Electronic searches were conducted using PubMed, ISI Web of Knowledge, Scopus, Spanish databases and Google Scholar. European studies published in English or Spanish between January 1, 2009 and December 31, 2014 regarding patient-reported outcomes in psoriatic patients were included. Studies conducted in non-EU countries, letters to the editor, editorials, experts' opinions, case studies, congress proceedings, publications that did not differentiate between patients with psoriasis and psoriatic arthritis or studies related to specific treatment were excluded. RESULTS: A total of 1,769 titles were identified, of which 1,636 were excluded as they were duplicates or did not provide any relevant information. After a full-text reading and application of the inclusion/exclusion criteria, 46 publications were included. This paper will describe publications on adherence (n=4), preferences (n=5) and satisfaction with treatment (n=7). Results related to health-related quality of life articles (n=30) have been published elsewhere. Adherence rates are generally low in psoriasis patients regardless of the type of treatment, severity of disease or methods used to measure adherence. Biologic therapy is associated with greater clinical improvement. There is a direct association between physician recommendations, patient preferences and several domains of treatment satisfaction. CONCLUSION: The results of this review support the conclusion that adherence rates in patients with psoriasis are suboptimal and highlight the need to improve patient compliance and satisfaction with treatment. Patients' preferences should be taken into account in the treatment decision-making process in order to improve patients' clinical outcomes by ensuring satisfaction and adherence.

Oral Alitretinoin in the Treatment of Severe Refractory Chronic Hand Eczema in the Spanish National Health System: Description and Analysis of Current Clinical Practice.

BACKGROUND AND OBJECTIVE: Hand eczema affects nearly 10% of the population. The condition becomes severe and chronic in 5% to 7% of cases and is refractory to topical corticosteroids in 2% to 4%. This study aimed to describe the current use of oral alitretinoin in treating Spanish national health system patients with hand eczema that is refractory to potent topical corticosteroids. MATERIALS AND METHODS: Observational, descriptive, exploratory, cross-sectional study based on the retrospective analysis of records for patients with hand eczema treated with alitretinoin in the Spanish national health system. RESULTS: We reviewed the records for 62 patients in 13 hospitals in 5 different administrative areas (autonomous communities) of Spain. Alitretinoin was usually used at a dosage of 30mg/d. In most cases the physician judged the clinical response to be satisfactory after a single cycle. The recorded adverse effects were foreseeable and of the type reported for systemic retinoids. The dermatologists agreed that the clinical benefits achieved with alitretinoin favored adherence to treatment and an early return to work. CONCLUSIONS: The results show that oral alitretinoin is being used according to established recommendations and that response is good, with few adverse effects. The dermatologists agreed that the benefits favored adherence and improved the patients' health related quality of life.