Pre/post effectiveness evaluation of updated additional risk minimisation measures for an orphan disease: Myozyme (alglucosidase alfa) Safety Information Packet.

BACKGROUND: The alglucosidase alfa (Myozyme®) Safety Information Packet ("previous SIP") was updated to improve readability and content ("updated SIP"). We compared the previous and updated SIPs. METHODS: A two-wave pre-post multicountry survey was conducted among health care professionals (HCPs) who prescribed or monitored patients on alglucosidase alfa in the largest European Union ("EU5") countries and Poland. Wave (W) 2 started 15 months after completion of W1 and the implementation of the updated SIP. Changes between the waves were analysed. RESULTS: Forty-six HCPs (34 physicians/12 nurses) participated in W1 and 52 in W2 (42 physicians/10 nurses); 22 participated in both waves. Nonsignificant differences were observed between waves 1 and 2 for awareness (75.6% in W1 and 82.4% in W2) and receipt (77.7% in W1 and 74.5% in W2) of the SIP, reading (88.6% in W1 and 89.5% in W2) and usage (88.2% in W1 and 89.5% in W2) among receivers of the SIP, or the overall knowledge about immunological testing (61.1% in W1 vs 55.1% in W2). Frequency of performance of immunological testing was significantly higher in W2 than in W1 (50.3% vs 34.4%; P = .024) with a tendency for increases in the appropriate performance of all types of testing in W2. CONCLUSIONS: Both versions of the SIP showed relatively high awareness, receipt, reading, and usage, with an overall trend for most measures to improve numerically in W2. The updated SIP did not require further changes.

Social, economic, and health impact of the respiratory syncytial virus: a systematic search.

BACKGROUND: Bronchiolitis caused by the respiratory syncytial virus (RSV) and its related complications are common in infants born prematurely, with severe congenital heart disease, or bronchopulmonary dysplasia, as well as in immunosuppressed infants. There is a rich literature on the different aspects of RSV infection with a focus, for the most part, on specific risk populations. However, there is a need for a systematic global analysis of the impact of RSV infection in terms of use of resources and health impact on both children and adults. With this aim, we performed a systematic search of scientific evidence on the social, economic, and health impact of RSV infection. METHODS: A systematic search of the following databases was performed: MEDLINE, EMBASE, Spanish Medical Index, MEDES-MEDicina in Spanish, Cochrane Plus Library, and Google without time limits. We selected 421 abstracts based on the 6,598 articles identified. From these abstracts, 4 RSV experts selected the most relevant articles. They selected 65 articles. After reading the full articles, 23 of their references were also selected. Finally, one more article found through a literature information alert system was included. RESULTS: The information collected was summarized and organized into the following topics: 1. Impact on health (infections and respiratory complications, mid- to long-term lung function decline, recurrent wheezing, asthma, other complications such as otitis and rhino-conjunctivitis, and mortality; 2. Impact on resources (visits to primary care and specialists offices, emergency room visits, hospital admissions, ICU admissions, diagnostic tests, and treatments); 3. Impact on costs (direct and indirect costs); 4. Impact on quality of life; and 5. Strategies to reduce the impact (interventions on social and hygienic factors and prophylactic treatments). CONCLUSIONS: We concluded that 1. The health impact of RSV infection is relevant and goes beyond the acute episode phase; 2. The health impact of RSV infection on children is much better documented than the impact on adults; 3. Further research is needed on mid- and long-term impact of RSV infection on the adult population, especially those at high-risk; 4. There is a need for interventions aimed at reducing the impact of RSV infection by targeting health education, information, and prophylaxis in high-risk populations.

Delphi consensus statement: Quality Indicators for Inflammatory Bowel Disease Comprehensive Care Units.

BACKGROUND AND AIMS: While it is commonly accepted that Inflammatory bowel disease (IBD) Comprehensive Care Units (ICCUs) facilitate the delivery of quality care to Crohn's disease and ulcerative colitis patients, it remains unclear how an ICCU should be defined or evaluated. The aim of the present study was to develop a comprehensive set of Quality Indicators (QIs) of structure, process, and outcomes for defining and evaluating an ICCU. METHODS: A Delphi consensus-based approach with a standardized three-step process was used to identify a core set of QIs. The process included an exhaustive search using complementary approaches to identify potential QIs, and two Delphi voting rounds to select the QIs defining the core requirements for an ICCU. RESULTS: The consensus selected a core set of 56 QIs (12 structure, 20 process and 24 outcome). Structure and process QIs highlighted the need for multidisciplinary management and continuity of care. The minimal IBD team should include an IBD nurse, gastroenterologists, radiologists, surgeons, endoscopists and stoma management specialists. ICCUs should be able to provide both outpatient and inpatient care and admission should not break the continuity of care. Outcome QIs focused on the adequate prophylaxis of disease complication and drug adverse events, the need to monitor appropriateness of treatment and the need to reinforce patient autonomy by providing adequate information and facilitating the patients' participation in their own care. CONCLUSIONS: The present Delphi consensus identified a set of core QIs that may be useful for evaluating and certifying ICCUs.

Percepciones, actitudes y vivencias de los familiares de pacientes con enfermedades músculo-esqueléticas: una aproximación cualitativa / Perceptions, attitudes and experiences of family caregivers of patients with musculoskeletal diseases: a qualitative approach

Objetivo. Conocer las percepciones, las actitudes y las vivencias de los familiares que cuidan a los pacientes con enfermedades músculo-esqueléticas (EME). Métodos. Estudio cualitativo, descriptivo y exploratorio. Se realizaron 2 grupos de discusión con cuidadores seleccionados mediante las variables: sexo, edad del cuidador (de 31 a 45 años/de 46 a 65 años), diagnóstico (artritis reumatoide/espondilitis anquilosante) y situación laboral del paciente (amas de casa/pacientes con al menos 3 episodios de baja laboral/pacientes que abandonaron su trabajo/pacientes con incapacidad declarada). Se hizo un análisis de contenido basado en la Grounded Theory para detectar las categorías emergentes. Resultados. Las dimensiones emergentes fueron: alteraciones en la vida cotidiana, necesidad de apoyo del cuidador, repercusiones físicas y psicológicas sobre el cuidador, características del paciente y descripción de los cuidados. Entre las vivencias destaca que el diagnóstico de una EME altera la vida del paciente y los familiares, repercute en la esfera laboral, económica, social, psicológica y física llegando a necesitar ayuda para las actividades básicas de la vida diaria. Las EME diagnosticadas a edades tempranas o muy incapacitantes, exigen dedicación y esfuerzo en los cuidados que aumentan con el tiempo. Esto produce una gran sobrecarga emocional en el familiar, modulada por el apoyo recibido para cuidar. Conclusión. Las principales consecuencias detectadas para los cuidadores son pérdida de poder adquisitivo, problemas laborales, aislamiento social y su sobrecarga emocional. Se precisa desarrollar programas de apoyo domiciliario eficaces, con trámites oficiales ágiles para poder clasificar rápidamente el grado de discapacidad y así poder tramitar ayudas oficiales (AU)

Objective: To determine the perceptions, attitudes and experiences among family caregivers of patients with musculoskeletal diseases (MSD). Methods: Descriptive, exploratory, qualitative study. Two discussion groups were organized with family caregivers of MSD patients, representing the caregiver profile: gender (men/women) and age (31-45 years/46-65 years); and patient profiles: MSD type (rheumatoid arthritis/ankylosing spondylitis), work status (yes or no for the variables housewife, at least 3 episodes of sick leave, patients who abandoned their work, and patients with permanent work disability). A content analysis based on the Grounded Theory was done to detect and explore emerging categories. Results: The emerging dimensions were: alterations in daily life activities, need for caregiver support, physical and psychological impact on the caregiver, characteristics of the patient, and several aspects of care. Relevant experiences mentioned were: the diagnosis of a MSD changes the patient and their family members’ life affecting work, financial, social, psychological and physical spheres, making it necessary help for basic activities of daily living. Early age at onset or severe MSDs require dedication and effort on the part of caregivers which increases with time. This leads to a great emotional overload on the caregivers, which may be modulated by the support they receive when providing care. Conclusion: The primary consequences for caregivers are loss of purchasing power, work problems, social isolation and emotional stress. Programs for effective at-home support need to be developed with streamlined administrative processes to quickly classify the level of disability and provide official assistance (AU)

Conocimiento de la población española de las enfermedades músculo-esqueléticas / Knowledge on musculoskeletal diseases by the Spanish population

Objetivo: Explorar el conocimiento sobre enfermedades músculo-esqueléticas (EME) en la población española. Métodos: Estudio transversal, dirigido a la población general española mediante encuesta telefónica a 1.009 sujetos mayores de 18 años estratificados por tamaño del hábitat, edad, género y zona geográfica. Con un cuestionario estructurado, se recogió información de los sujetos, su conocimiento general de las EME (CG), su conocimiento específico de EME concretas (CE) y su conocimiento del impacto social (CIS). Se elaboraron indicadores sintéticos (escala 0-1) de nivel de conocimiento para analizar, mediante análisis univariante y multivariante, las variables asociadas al nivel de conocimiento. Resultados: El nivel de CIS es medio-alto (media: 0,62 ± 0,16) y recoge el reconocimiento mayoritario de las EME como incapacitantes, que afectan a la capacidad laboral y provocan un alto coste personal y social. El nivel de CG es intermedio (media: 0,50 ± 0,17), un 60% conoce algo sobre las EME, aunque el 54% califica su información como mala/muy mala. El nivel de CE es bajo (media: 0,18 ± 0,10), existiendo EME muy poco conocidas (lupus y espondilitis). Ser hombre, jubilado o presentar una EME, se asocia con más conocimiento sobre las EME. Conclusión: La población espa˜nola tiene un nivel medio de conocimiento de la frecuencia y medida en que las EME afectan el desempeño de las actividades de quienes las presentan. Las identifican suficientemente, conociendo a grandes rasgos su sintomatología, aunque saben poco de ellas. El nivel de conocimiento varía según los factores sociodemográficos y la experiencia directa e indirecta de presentación de EME(AU)

Objective: To explore knowledge on musculoskeletal-diseases (MSDs) by the Spanish population. Methods: This was a cross-sectional study of the general population (> 18 years) using a telephone survey of 1,009 subjects stratified by habitat size, age, sex, and geographic area. A structured questionnaire was used to collect information on the subjects, their general knowledge of MSDs (GK), their specific knowledge of particular MSDs (SK), and their knowledge of their social impact (KSI). Synthetic indicators of the level of knowledge were used to analyze, using univariate and multivariate models, variables associated to the level of knowledge. Results: The KSI level ranges from medium-high (mean: 0.62 ± 0.16 out of 1), suggesting that most subjects recognize MSDs as disabling conditions which affect the ability to work and have a high personal and social cost. The GK level is intermediate (mean: 0.50 ± 0.17); 60% of subjects know something about MSDs, but 54% state that their information is poor/very poor. The SK level is low (mean: 0.18 ± 0.10), and there are some MSDs that are little known (lupus, spondylitis). Being male or retired or having a MSD is associated to a greater knowledge of MSDs. Conclusion: The Spanish population has a medium level of knowledge of the frequency and extent to which MSDs affect performance of activities by those who suffer them. They identify them adequately and have a GK of their symptoms, but have little information about them. The level of knowledge varies depending on social and demographic factors and on whether or not the subject has direct or indirect experience of what a MSD means(AU)

Development of quality standards in inflammatory bowel disease management and design of an evaluation tool of nursing care.

BACKGROUND AND AIMS: nursing management of inflammatory bowel disease (IBD) is highly relevant for patient care and outcomes. However, there is evidence of substantial variability in clinical practices. The objectives of this study were to develop standards of healthcare quality for nursing management of IBD and elaborate the evaluation tool "Nursing Care Quality in IBD Assessment" (NCQ-IBD) based on these standards. METHODS: a 178-item healthcare quality questionnaire was developed based on a systematic review of IBD nursing management literature. The questionnaire was used to perform two 2-round Delphi studies: Delphi A included 27 IBD healthcare professionals and Delphi B involved 12 patients. The NCQ-IBD was developed from the list of items resulting from both Delphi studies combined with the Scientific Committee´s expert opinion. RESULTS: the final NCQ-IBD consists of 90 items, organized in13 sections measuring the following aspects of nursing management of IBD: infrastructure, services, human resources, type of organization, nursing responsibilities, nurse-provided information to the patient, nurses training, annual audits of nursing activities, and nursing research in IBD. Using the NCQ-IBD to evaluate these components allows the rating of healthcare quality for nursing management of IBD into 4 categories: A (highest quality) through D (lowest quality). CONCLUSION: the use of the NCQ-IBD tool to evaluate nursing management quality of IBD identifies areas in need of improvement and thus contribute to an enhancement of care quality and reduction in clinical practice variations.

Perceptions, attitudes and experiences of family caregivers of patients with musculoskeletal diseases: a qualitative approach.

OBJECTIVE: To determine the perceptions, attitudes and experiences among family caregivers of patients with musculoskeletal diseases (MSD). METHODS: Descriptive, exploratory, qualitative study. Two discussion groups were organized with family caregivers of MSD patients, representing the caregiver profile: gender (men/women) and age (31-45 years/46-65 years); and patient profiles: MSD type (rheumatoid arthritis/ankylosing spondylitis), work status (yes or no for the variables housewife, at least 3 episodes of sick leave, patients who abandoned their work, and patients with permanent work disability). A content analysis based on the Grounded Theory was done to detect and explore emerging categories. RESULTS: The emerging dimensions were: alterations in daily life activities, need for caregiver support, physical and psychological impact on the caregiver, characteristics of the patient, and several aspects of care. Relevant experiences mentioned were: the diagnosis of a MSD changes the patient and their family members' life affecting work, financial, social, psychological and physical spheres, making it necessary help for basic activities of daily living. Early age at onset or severe MSDs require dedication and effort on the part of caregivers which increases with time. This leads to a great emotional overload on the caregivers, which may be modulated by the support they receive when providing care. CONCLUSION: The primary consequences for caregivers are loss of purchasing power, work problems, social isolation and emotional stress. Programs for effective at-home support need to be developed with streamlined administrative processes to quickly classify the level of disability and provide official assistance.

Knowledge on musculoskeletal diseases by the Spanish population.

OBJECTIVE: To explore knowledge on musculoskeletal-diseases (MSDs) by the Spanish population. METHODS: This was a cross-sectional study of the general population (> 18 years) using a telephone survey of 1,009 subjects stratified by habitat size, age, sex, and geographic area. A structured questionnaire was used to collect information on the subjects, their general knowledge of MSDs (GK), their specific knowledge of particular MSDs (SK), and their knowledge of their social impact (KSI). Synthetic indicators of the level of knowledge were used to analyze, using univariate and multivariate models, variables associated to the level of knowledge. RESULTS: The KSI level ranges from medium-high (mean: 0.62 ± 0.16 out of 1), suggesting that most subjects recognize MSDs as disabling conditions which affect the ability to work and have a high personal and social cost. The GK level is intermediate (mean: 0.50 ± 0.17); 60% of subjects know something about MSDs, but 54% state that their information is poor/very poor. The SK level is low (mean: 0.18 ± 0.10), and there are some MSDs that are little known (lupus, spondylitis). Being male or retired or having a MSD is associated to a greater knowledge of MSDs. CONCLUSION: The Spanish population has a medium level of knowledge of the frequency and extent to which MSDs affect performance of activities by those who suffer them. They identify them adequately and have a GK of their symptoms, but have little information about them. The level of knowledge varies depending on social and demographic factors and on whether or not the subject has direct or indirect experience of what a MSD means.

Desarrollo de estándares de calidad para la enfermedad inflamatoria intestinal y diseño de un instrumento de evaluación de los cuidados de enfermería / Development of quality standards in inflammatory bowel disease management and design of an evaluation tool of nursing care

Introducción y objetivos: el manejo de la enfermedad inflamatoria intestinal (EII) por enfermería es muy relevante, sin embargo, existe una gran variabilidad en su práctica clínica. El objetivo de esta investigación es desarrollar estándares de calidad asistencial del manejo de la EII por enfermería, para elaborar un “Instrumento de Evalua - ción de la Calidad Asistencial de la EII por Enfermería” (IEC-EII). Métodos: tras una búsqueda bibliográfica del manejo de la EII por enfermería se elaboró un cuestionario de 178 ítems de calidad asistencial. Con este cuestionario, se realizaron dos estudios Delphi a dos rondas: Delphi A dirigido a 27 profesionales sanitarios en EII y Delphi B a 12 pacientes. Con los ítems de ambos estudios Delphi, se elaboró una lista que, junto con la opinión experta del Comité Científico, contribuyó a desarrollar el IEC-EII. Resultados: el IEC-EII se compone de 90 ítems, subdivididos en 13 dimensiones que miden aspectos del manejo de la EII por enfermería como: infraestructura, servicios, recursos humanos, tipo de organización, competencias asumidas por enfermería, información de enfermería al paciente, formación de enfermería, revisiones anuales de la actividad de enfermería e investigación de enfermería de EII. La evaluación de estos aspectos mediante el IEC-EII permite clasificar la calidad asistencial en EII por enfermería en 4 categorías de la A a la D. Siendo A el nivel de calidad superior y D el inferior. Conclusiones: el IEC-EII puede contribuir a aumentar la calidad asistencial de enfermería en EII y reducir su variabilidad, puesto que la evaluación ayudará a detectar sus deficiencias mejorables (AU)

Background and aims: nursing management of inflammatory bowel disease (IBD) is highly relevant for patient care and outcomes. However, there is evidence of substantial variability in clinical practices. The objectives of this study were to develop standards of healthcare quality for nursing management of IBD and elaborate the evaluation tool “Nursing Care Quality in IBD Assessment” (NCQ-IBD) based on these standards. Methods: a 178-item healthcare quality questionnaire was developed based on a systematic review of IBD nursing management literature. The questionnaire was used to perform two 2-round Delphi studies: Delphi A included 27 IBD healthcare professionals and Delphi B involved 12 patients. The NCQ-IBD was developed from the list of items resulting from both Delphi studies combined with the Scientific Committee’s expert opinion. Results: the final NCQ-IBD consists of 90 items, organized in 13 sections measuring the following aspects of nursing management of IBD: infrastructure, services, human resources, type of organization, nursing responsibilities, nurse-provided information to the patient, nurses training, annual audits of nursing activities, and nursing research in IBD. Using the NCQ-IBD to evaluate these components allows the rating of healthcare quality for nursing management of IBD into 4 categories: A (highest quality) through D (lowest quality). Conclusions: the use of the NCQ-IBD tool to evaluate nursing management quality of IBD identifies areas in need of improvement and thus contribute to an enhancement of care quality and reduction in clinical practice variations (AU)

Nursing resources and responsibilities according to hospital organizational model for management of inflammatory bowel disease in Spain.

BACKGROUND: Nurses play an important role in the multidisciplinary management of inflammatory bowel disease (IBD), but little is known about this role and the associated resources. OBJECTIVE: To improve knowledge of resource availability for health care activities and the different organizational models in managing IBD in Spain. METHODS: Cross-sectional study with data obtained by questionnaire directed at Spanish Gastroenterology Services (GS). Five GS models were identified according to whether they have: no specific service for IBD management (Model A); IBD outpatient office for physician consultations (Model B); general outpatient office for nurse consultations (Model C); both, Model B and Model C (Model D); and IBD Unit (Model E) when the hospital has a Comprehensive Care Unit for IBD with telephone helpline, computer, including a Model B. Available resources and activities performed were compared according to GS model (chi-square test and test for linear trend). RESULTS: Responses were received from 107 GS: 33 Model A (31%), 38 Model B (36%), 4 Model C (4%), 16 Model D (15%) and 16 Model E (15%). The model in which nurses have the most resources and responsibilities is the Model E. The more complete the organizational model, the more frequent the availability of nursing resources (educational material, databases, office, and specialized software) and responsibilities (management of walk-in appointments, provision of emotional support, health education, follow-up of drug treatment and treatment adherence) (p<0.05). CONCLUSIONS: Nurses have more resources and responsibilities the more complete is the organizational model for IBD management. Development of these areas may improve patient outcomes.