Improvement in Quality of Life With the Use of a Technological System Among Patients With Chronic Disease Followed Up in Primary Care (TeNDER Project): Protocol for a Randomized Controlled Trial.

BACKGROUND: Among chronic diseases, cognitive, neurological, and cardiovascular impairments are becoming increasingly prevalent, generating a shift in health and social needs. Technology can create an ecosystem of care integrated with microtools based on biosensors for motion, location, voice, and expression detection that can help people with chronic diseases. A technological system capable of identifying symptoms, signs, or behavioral patterns could provide notification of the development of complications of disease. This would help the self-care of patients with chronic disease and save health care costs, promoting the autonomy and empowerment of patients and their caregivers, improving their quality of life (QoL), and providing health professionals with monitoring tools. OBJECTIVE: The main objective of this study is to evaluate the effectiveness of a technological system (the TeNDER system) to improve quality of life in patients with chronic diseases: Alzheimer disease, Parkinson disease, and cardiovascular disease. METHODS: A multicenter, randomized, parallel-group clinical trial will be conducted with a follow-up of 2 months. The scope of the study will be the primary care health centers of the Community of Madrid belonging to the Spanish public health system. The study population will be patients diagnosed with Parkinson disease, Alzheimer disease, and cardiovascular disease; their caregivers; and health professionals. The sample size will be 534 patients (380 in the intervention group). The intervention will consist of the use of the TeNDER system. The system will monitor the patients by means of biosensors, and their data will be integrated into the TeNDER app. With the information provided, the TeNDER system will generate health reports that can be consulted by patients, caregivers, and health professionals. Sociodemographic variables and technological affinity will be measured, as will views on the usability of and satisfaction with the TeNDER system. The dependent variable will be the mean difference in QoL score between the intervention and control groups at 2 months. To study the effectiveness of the TeNDER system in improving QoL in patients, an explanatory linear regression model will be constructed. All analyses will be performed with the 95% CI and robust estimators. RESULTS: Ethics approval for this project was received on September 11, 2019. The trial was registered on August 14, 2020. Recruitment commenced in April 2021, and the expected results will be available during 2023 or 2024. CONCLUSIONS: This clinical trial among patients with highly prevalent chronic illnesses and the people most involved in their care will provide a more realistic view of the situation experienced by people with long-term illness and their support networks. The TeNDER system is in continuous development based on a study of the needs of the target population and on feedback during its use from the users: patients, caregivers, and primary care health professionals. TRIAL REGISTRATION: ClinicalTrials.gov NCT05681065; https://clinicaltrials.gov/ct2/show/NCT05681065. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47331.

Effectiveness of a game-based educational strategy e-EDUCAGUIA for implementing antimicrobial clinical practice guidelines in family medicine residents in Spain: a randomized clinical trial by cluster.

BACKGROUND: Clinical practice guidelines (CPGs) have teaching potential for health professionals in training clinical reasoning and decision-making, although their use is limited. The objective was to evaluate the effectiveness of a game-based educational strategy e-EDUCAGUIA using simulated clinical scenarios to implement an antimicrobial therapy GPC compared to the usual dissemination strategies to improve the knowledge and skills on decision-making of family medicine residents. Additionally, adherence to e-EDUCAGUIA strategy was assessed. METHODS: A multicentre pragmatic cluster-randomized clinical trial was conducted involving seven Teaching Units (TUs) of family medicine in Spain. TUs were randomly allocated to implement an antimicrobial therapy guideline with e-EDUCAGUIA strategy ( intervention) or passive dissemination of the guideline (control). The primary outcome was the differences in means between groups in the score test evaluated knowledge and skills on decision-making at 1 month post intervention. Analysis was made by intention-to-treat and per-protocol analysis. Secondary outcomes were the differences in mean change intrasubject (from the baseline to the 1-month) in the test score, and educational game adherence and usability. Factors associated were analysed using general linear models. Standard errors were constructed using robust methods. RESULTS: Two hundred two family medicine residents participated (104 intervention group vs 98 control group). 100 medicine residents performed the post-test at 1 month (45 intervention group vs 55 control group), The between-group difference for the mean test score at 1 month was 11 ( 8.67 to 13.32) and between change intrasubject was 11,9 ( 95% CI 5,9 to 17,9). The effect sizes were 0.88 and 0.75 respectively. In multivariate analysis, for each additional evidence-based medicine training hour there was an increase of 0.28 points (95% CI 0.15-0.42) in primary outcome and in the change intrasubject each year of increase in age was associated with an improvement of 0.37 points and being a woman was associated with a 6.10-point reduction. 48 of the 104 subjects in the intervention group (46.2%, 95% CI: 36.5-55.8%) used the games during the month of the study. Only a greater number of evidence-based medicine training hours was associated with greater adherence to the educational game ( OR 1.11; CI 95% 1.02-1.21). CONCLUSIONS: The game-based educational strategy e-EDUCAGUIA shows positive effects on the knowledge and skills on decision making about antimicrobial therapy for clinical decision-making in family medicin residents in the short term, but the dropout was high and results should be interpreted with caution. Adherence to educational games in the absence of specific incentives is moderate. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02210442 . Registered 6 August 2014.

Cardiovascular risk in subjects over 55 years of age and cognitive performance after five years. NEDICES2-RISK study. Study protocol.

BACKGROUND: Cognitive impairment and dementia have a high prevalence among the elderly and cause significant socio-economic impact. Any progress in their prevention can benefit millions of people. Current data indicate that cardiovascular risk (CVR) factors increase the risk of developing cognitive impairment and dementia. Using models to calculate CVR specific for the Spanish population can be useful for estimating the risk of cognitive deterioration since research on this topic is limited and predicting this risk is mainly based on outcomes in the Anglo-Saxon population. The aim of this study is to assess the relationship between CVR in the Spanish population, as calculated using the FRESCO (Función de Riesgo Española de acontecimientos Coronarios y Otros) and REGICOR (Registre Gironí del Cor) CVR tables, and the change in cognitive performance at a 5-year follow-up. METHODS: Design: Observational, analytic, prospective cohort study, with a 5-year follow-up. Ambit: Population. Population: Subjects 55 to 74 years of age, included in the NEDICES2 (2014-2017) cohort, who did not present dementia and had undergone the neuropsychological evaluation (N = 962). Variables: Exposure factors (CVR factors and estimated risk according to the CVR predictors by REGICOR and FRESCO), dependent variables (change in the score of the brief neuropsychological test in the study NEDICES2 five years after the first evaluation), and clinical and socio-demographic variables. Statistical analysis: Analysis of data quality. Descriptive analysis: socio-demographic and clinical variables of subjects. Bivariate analysis: relationship between basal CVR and change in neuropsychological tests. Multivariate analysis: relationship between basal CVR and change in neuropsychological tests adjusted by co-variables. Analysis and comparison of the reliable change in independent samples. DISCUSSION: The Spanish population can benefit from determining if individuals with high CVR, which is commonly detected in usual clinical practice, will present decreased cognitive performance compared to subjects with lower CVR. This study can affect how to address CVR factors and the design of effective prevention strategies for cognitive deterioration. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03925844.

How to Improve Healthcare for Patients with Multimorbidity and Polypharmacy in Primary Care: A Pragmatic Cluster-Randomized Clinical Trial of the MULTIPAP Intervention.

(1) Purpose: To investigate a complex MULTIPAP intervention that implements the Ariadne principles in a primary care population of young-elderly patients with multimorbidity and polypharmacy and to evaluate its effectiveness for improving the appropriateness of prescriptions. (2) Methods: A pragmatic cluster-randomized clinical trial was conducted involving 38 family practices in Spain. Patients aged 65-74 years with multimorbidity and polypharmacy were recruited. Family physicians (FPs) were randomly allocated to continue usual care or to provide the MULTIPAP intervention based on the Ariadne principles with two components: FP training (eMULTIPAP) and FP patient interviews. The primary outcome was the appropriateness of prescribing, measured as the between-group difference in the mean Medication Appropriateness Index (MAI) score change from the baseline to the 6-month follow-up. The secondary outcomes were quality of life (EQ-5D-5 L), patient perceptions of shared decision making (collaboRATE), use of health services, treatment adherence, and incidence of drug adverse events (all at 1 year), using multi-level regression models, with FP as a random effect. (3) Results: We recruited 117 FPs and 593 of their patients. In the intention-to-treat analysis, the between-group difference for the mean MAI score change after a 6-month follow-up was -2.42 (95% CI from -4.27 to -0.59) and, between baseline and a 12-month follow-up was -3.40 (95% CI from -5.45 to -1.34). There were no significant differences in any other secondary outcomes. (4) Conclusions: The MULTIPAP intervention improved medication appropriateness sustainably over the follow-up time. The small magnitude of the effect, however, advises caution in the interpretation of the results given the paucity of evidence for the clinical benefit of the observed change in the MAI. Trial registration: Clinicaltrials.gov NCT02866799.

Multimorbidity clusters among long-term breast cancer survivors in Spain: Results of the SURBCAN study.

The disease management of long-term breast cancer survivors (BCS) is hampered by the scarce knowledge of multimorbidity patterns. The aim of our study was to identify multimorbidity clusters among long-term BCS and assess their impact on mortality and health services use. We conducted a retrospective study using electronic health records of 6512 BCS from Spain surviving at least 5 years. Hierarchical cluster analysis was used to identify groups of similar patients based on their chronic diagnoses, which were assessed using the Clinical Classifications Software. As a result, multimorbidity clusters were obtained, clinically defined and named according to the comorbidities with higher observed/expected prevalence ratios. Multivariable Cox and negative binomial regression models were fitted to estimate overall mortality risk and probability of contacting health services according to the clusters identified. 83.7% of BCS presented multimorbidity, essential hypertension (34.5%) and obesity and other metabolic disorders (27.4%) being the most prevalent chronic diseases at the beginning of follow-up. Five multimorbidity clusters were identified: C1-unspecific (29.9%), C2-metabolic and neurodegenerative (28.3%), C3-anxiety and fractures (9.7%), C4-musculoskeletal and cardiovascular (9.6%) and C5-thyroid disorders (5.3%). All clusters except C5-thyroid disorders were associated with higher mortality compared to BCS without comorbidities. The risk of mortality in C4 was increased by 64% (adjusted hazard ratio 1.64, 95% confidence interval 1.52-2.07). Stratified analysis showed an increased risk of death among BCS with 5 to 10 years of survival in all clusters. These results help to identify subgroups of long-term BCS with specific needs and mortality risks and to guide BCS clinical practice regarding multimorbidity.

Effectiveness of a home-based nursing support and cognitive restructuring intervention on the quality of life of family caregivers in primary care: A pragmatic cluster-randomized controlled trial.

BACKGROUND: Caregivers of patients with chronic conditions or disability experience fatigue, burden and poor health-related quality of life. There is evidence of the effectiveness of support interventions for decreasing this impact. However, little is known about the benefits of home-based nursing intervention in primary health care. OBJECTIVES: To evaluate the effectiveness of a home-based, nurse-led-intervention (CuidaCare) on the quality of life of caregivers of individuals with disabilities or chronic conditions living in the community, measured at 12-month follow-up. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial with a 1-year follow-up period was performed between June 2013 and December 2015. Consecutive caregivers aged 65 years or older, all of whom assumed the primary responsibility of caring for people with disabling conditions for at least 6 months a year, were recruited from 22 primary health care centers. Subsequently, 11 centers were randomly assigned to usual care group, and 11 were assigned to the intervention group. The caregivers in the intervention group received the usual care and additional support (cognitive restructuring, health education and emotional support). The primary outcome was quality of life, assessed with the EQ-5D instrument (visual analog scale and utility index score); the secondary outcome variables were perception of burden, anxiety, and depression. Data were collected at baseline, at the end of the intervention, and at the 6- and 12-month follow-up visits. We analyzed the primary outcome as intention-to-treat, and missing data were added using the conditional mean single imputation method. RESULTS: A total of 224 caregivers were included in the study (102 in the intervention group and 122 in the usual care group). Generalized Estimating Equation models showed that the CuidaCare intervention was associated with a 5.46 point (95% CI: 2.57; 8.35) change in the quality of life, as measured with the visual analog scale adjusted for the rest of the variables at 12 months. It also produced an increase of 0.04 point (95% CI: 0.01; 0.07) in the utilities. No statistically significant differences were found between the two groups at 12 months with respect to the secondary outcomes. CONCLUSIONS: The findings suggest that incorporating a home-based, nurse-led-intervention for caregivers into primary care can improve the health-related quality of life of caregivers of patients with chronic or disabling conditions.

Correction: Use of an Electronic Clinical Decision Support System in Primary Care to Assess Inappropriate Polypharmacy in Young Seniors With Multimorbidity: Observational, Descriptive, Cross-Sectional Study.

[This corrects the article DOI: 10.2196/14130.].

Use of real-world data to study health services utilisation and comorbidities in long-term breast cancer survivors (the SURBCAN study): study protocol for a longitudinal population-based cohort study.

INTRODUCTION: Breast cancer has become a chronic disease due to survival improvement and the need to monitor the side effects of treatment and the disease itself. The aim of the SURBCAN study is to describe comorbidity, healthcare services use and adherence to preventive recommendations in long-term breast cancer survivors and to compare them with those in women without this diagnosis in order to improve and adapt the care response to this group of survivors. METHODS AND ANALYSIS: Population-based retrospective cohort study using real-world data from cancer registries and linked electronic medical records in five Spanish regions. Long-term breast cancer survivors diagnosed between 2000 and 2006 will be identified and matched by age and administrative health area with women without this diagnosis. Sociodemographic and clinical variables including comorbidities and variables on the use of health services between 2012 and 2016 will be obtained from databases in primary and hospital care. Health services use will be assessed through the annual number of visits to primary care professionals and to specialists and through annual imaging and laboratory tests. Factors associated with healthcare utilisation and comorbidities will be analysed using multilevel logistic regression models. Recruitment started in December 2018. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Parc de Salut Mar. The results of the study will be published in a peer-reviewed journal and will be presented at national and international scientific conferences and at patient associations. TRIAL REGISTRATION NUMBER: This protocol is registered in Clinical Trials.gov (identifier: NCT03846999).

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).

OBJECTIVES: To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. DESIGN: Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain). PARTICIPANTS: 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm. INTERVENTIONS: The IM arm received 1 mg VB12 on alternate days in weeks 1-2, 1 mg/week in weeks 3-8 and 1 mg/month in weeks 9-52. The oral arm received 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. MAIN OUTCOMES: Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction. RESULTS: The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were -0.7% (133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were -6.3% (103 out of 112 vs 115 out of 117; 95% CI: -11.9 to -0.1; p=0.025) and -6.8% (103 out of 140 vs 115 out of 143; 95% CI: -16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>-10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route. CONCLUSIONS: Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low. TRIAL REGISTRATION NUMBERS: NCT01476007; EUDRACT (2010-024129-20).

Use of an Electronic Clinical Decision Support System in Primary Care to Assess Inappropriate Polypharmacy in Young Seniors With Multimorbidity: Observational, Descriptive, Cross-Sectional Study.

BACKGROUND: Multimorbidity is a global health problem that is usually associated with polypharmacy, which increases the risk of potentially inappropriate prescribing (PIP). PIP entails higher hospitalization rates and mortality and increased usage of services provided by the health system. Tools exist to improve prescription practices and decrease PIP, including screening tools and explicit criteria that can be applied in an automated manner. OBJECTIVE: This study aimed to describe the prevalence of PIP in primary care consultations among patients aged 65-75 years with multimorbidity and polypharmacy, detected by an electronic clinical decision support system (ECDSS) following the 2015 American Geriatrics Society Beers Criteria, the European Screening Tool of Older Person's Prescription (STOPP), and the Screening Tool to Alert doctors to Right Treatment (START). METHODS: This was an observational, descriptive, cross-sectional study. The sample included 593 community-dwelling adults aged 65-75 years (henceforth called young seniors), with multimorbidity (≥3 diseases) and polypharmacy (≥5 medications), who had visited their primary care doctor at least once over the last year at 1 of the 38 health care centers participating in the Multimorbidity and Polypharmacy in Primary Care (Multi-PAP) trial. Sociodemographic data, clinical and pharmacological treatment variables, and PIP, as detected by 1 ECDSS, were recorded. A multivariate logistic regression model with robust estimators was built to assess the factors affecting PIP according to the STOPP criteria. RESULTS: PIP was detected in 57.0% (338/593; 95% CI 53-61) and 72.8% (432/593; 95% CI 69.3-76.4) of the patients according to the STOPP criteria and the Beers Criteria, respectively, whereas 42.8% (254/593; 95% CI 38.9-46.8) of the patients partially met the START criteria. The most frequently detected PIPs were benzodiazepines (BZD) intake for more than 4 weeks (217/593, 36.6%) using the STOPP version 2 and the prolonged use of proton pump inhibitors (269/593, 45.4%) using the 2015 Beers Criteria. Being a woman (odds ratio [OR] 1.43, 95% CI 1.01-2.01; P=.04), taking a greater number of medicines (OR 1.25, 95% CI 1.14-1.37; P<.04), working in the primary sector (OR 1.91, 95% CI 1.25-2.93; P=.003), and being prescribed drugs for the central nervous system (OR 3.75, 95% CI 2.45-5.76; P<.001) were related to a higher frequency of PIP. CONCLUSIONS: There is a high prevalence of PIP in primary care as detected by an ECDSS in community-dwelling young seniors with comorbidity and polypharmacy. The specific PIP criteria defined by this study are consistent with the current literature. This ECDSS can be useful for supervising prescriptions in primary health care consultations.

Use of an Electronic Clinical Decision Support System in Primary Care to Assess Inappropriate Polypharmacy in Young Seniors With Multimorbidity: Observational, Descriptive, Cross-sectional Study.

BACKGROUND: Multimorbidity is a global health problem that is usually associated with polypharmacy, which increases the risk of potentially inappropriate prescribing (PIP). PIP entails higher hospitalization rates and mortality and increased usage of services provided by the health system. Tools exist to improve prescription practices and decrease PIP, including screening tools and explicit criteria that can be applied in an automated manner. OBJECTIVE: This study aimed to describe the prevalence of PIP in primary care consultations among patients aged 65-75 years with multimorbidity and polypharmacy, detected by an electronic clinical decision support system (ECDSS) following the 2015 American Geriatrics Society Beers Criteria, the European Screening Tool of Older Person's Prescription (STOPP), and the Screening Tool to Alert doctors to Right Treatment (START). METHODS: This was an observational, descriptive, cross-sectional study. The sample included 593 community-dwelling adults aged 65-75 years (henceforth called young seniors), with multimorbidity (≥3 diseases) and polypharmacy (≥5 medications), who had visited their primary care doctor at least once over the last year at 1 of the 38 health care centers participating in the Multimorbidity and Polypharmacy in Primary Care (Multi-PAP) trial. Sociodemographic data, clinical and pharmacological treatment variables, and PIP, as detected by 1 ECDSS, were recorded. A multivariate logistic regression model with robust estimators was built to assess the factors affecting PIP according to the STOPP criteria. RESULTS: PIP was detected in 57.0% (338/593; 95% CI 53-61) and 72.8% (432/593; 95% CI 69.3-76.4) of the patients according to the STOPP criteria and the Beers Criteria, respectively, whereas 42.8% (254/593; 95% CI 38.9-46.8) of the patients partially met the START criteria. The most frequently detected PIPs were benzodiazepines (BZD) intake for more than 4 weeks (217/593, 36.6%) using the STOPP version 2 and the prolonged use of proton pump inhibitors (269/593, 45.4%) using the 2015 Beers Criteria. Being a woman (odds ratio [OR] 1.43, 95% CI 1.01-2.01; P=.04), taking a greater number of medicines (OR 1.25, 95% CI 1.14-1.37; P<.001), working in the primary sector (OR 1.91, 95% CI 1.25-2.93; P=.003), and being prescribed drugs for the central nervous system (OR 3.75, 95% CI 2.45-5.76; P<.001) were related to a higher frequency of PIP. CONCLUSIONS: There is a high prevalence of PIP in primary care as detected by an ECDSS in community-dwelling young seniors with comorbidity and polypharmacy. The specific PIP criteria defined by this study are consistent with the current literature. This ECDSS can be useful for supervising prescriptions in primary health care consultations.

A primary healthcare information intervention for communicating cardiovascular risk to patients with poorly controlled hypertension: The Education and Coronary Risk Evaluation (Educore) study-A pragmatic, cluster-randomized trial.

PURPOSE: Uncertainty exists regarding the best way to communicate cardiovascular risk (CVR) to patients, and it is unclear whether the comprehension and perception of CVR varies according to the format used. The aim of the present work was to determine whether a strategy designed for communicating CVR information to patients with poorly controlled high blood pressure (HBP), but with no background of cardiovascular disease, was more effective than usual care in the control of blood pressure (BP) over the course of a year. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial was performed. Consecutive patients aged 40-65 years, all diagnosed with HBP in the last 12 months, and all of whom showed poor control of their condition (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg), were recruited at 22 primary healthcare centres. Eleven centres were randomly assigned to the usual care arm, and 11 to the informative intervention arm (Educore arm). At the start of the study, the Educore arm subjects were shown the "low risk SCORE table", along with impacting images and information pamphlets encouraging the maintenance of good cardiovascular health. The main outcome variable measured was the control of HBP; the secondary outcome variables were SCORE table score, total plasma cholesterol concentration, use of tobacco, adherence to prescribed treatment, and quality of life. RESULTS: The study participants were 411 patients (185 in the Educore arm and 226 in the usual care arm). Multilevel logistic regression showed that, at 12 months, the Educore intervention achieved better control of HBP (OR = 1.57; 1.02 to 2.41). No statistically significant differences were seen between the two arms at 12 months with respect to the secondary outcomes. CONCLUSIONS: Compared to usual care, the Educore intervention was associated with better control of HBP after adjusting for age, baseline SBP and plasma cholesterol, at 12 months.

[To promote knowledge on patient safety: the case of the Biblioteca Breve de Seguridad del Paciente (Brief Patient Safety Library)]. / Para avanzar en el conocimiento de la seguridad del paciente: a propósito de la biblioteca breve de seguridad del paciente.

OBJECTIVE: Within the framework of the Patient Safety Strategy 2015-2020, the Regional Ministry of Health of the Community of Madrid developed two lines of action to consolidate the Patient Safety Culture through the dissemination of scientific knowledge in Patient Safety. The main objective was to identify, disseminate and improve access to relevant information on patient safety for patient-citizens, professionals and the organization itself through a pool of resources accessible on the Internet and intranet. METHODS: After an analysis of the tools and communication channels available to disseminate knowledge in patient safety, the references of interest were selected by a group of experts, a consultation tool was developed in a navigable format on the internet and various dissemination actions were carried out to make it known. RESULTS: The Biblioteca Breve de Seguridad del Paciente (Brief Patient Safety Library) was developed, accessible for navigation on the web of the Community of Madrid and as a download document, with 154 references, structured in 4 areas: General resources (74 references), Resources by thematic area (51 references), Videos and multimedia (12 references) and Organizations and websites of interest (17 references). CONCLUSIONS: The Biblioteca Breve de Seguridad del Paciente (Brief Patient Safety Library) can help to promote the safety culture in health centers and to achieve greater citizen involvement in their safety, by providing reliable information on this crosscutting dimension of clinical practice.

OBJETIVO: En el marco de la Estrategia de Seguridad del Paciente 2015-2020 la Consejería de Sanidad de la Comunidad de Madrid desarrolló dos líneas de actuación para consolidar la cultura de seguridad a través de la difusión del conocimiento científico en Seguridad del Paciente. El objetivo principal fue identificar, difundir y mejorar el acceso a la información relevante en seguridad del paciente a pacientes-ciudadanos, profesionales y a la propia organización mediante un catálogo de recursos accesible en internet e intranet. METODOS: Tras un análisis de las herramientas y canales de comunicación disponibles para difundir el conocimiento en seguridad del paciente, se seleccionaron las referencias de interés por un grupo de expertos, se desarrolló una herramienta de consulta en un formato navegable en internet y se realizaron distintas acciones de difusión para darla a conocer. RESULTADOS: Se desarrolló la Biblioteca Breve de Seguridad del Paciente, accesible en la web de la Comunidad de Madrid para navegación y como documento para descargar, con 154 referencias, estructuradas en 4 áreas: Recursos generales (74 referencias), Recursos por Área temática (51 referencias), Videos y multimedia (12 referencias) y Organismos y sitios web de interés (17 referencias). CONCLUSIONES: La Biblioteca Breve de Seguridad del Paciente puede contribuir a impulsar la cultura de seguridad en los centros sanitarios y a lograr mayor implicación de los ciudadanos en su seguridad, al poner a su disposición información fiable sobre esta dimensión transversal de la práctica clínica.

MULTICAGE CAD-4: Psychometric characteristics for the screening of addictive behaviors / MULTICAGE CAD-4 para la detección de adicciones conductuales: validez estructural después de la inclusión de una escala en el abuso de teléfonos inteligentes

Addictive behaviors are not limited to drugs use, but also include certain daily behaviors that can cause gratification. Their progression to more severe pathological patterns entails grave consequences for the individual, including multiple psychopathological manifestations. The early detection of this type of behavior is of concern to primary health care. Therefore, in order to detect risk at early stages, reliable and valid tools for daily practice are essential. The MULTICAGE CAD-4 questionnaire is a screening tool for simultaneously detecting addictive behaviors. This study includes a new scale for the detection of smartphone abuse. The objective is to evaluate the adequacy of its psychometric properties. A sample of 2,074 subjects that were recruited from primary care centers ofMadrid(Spain) completed the MULTICAGE CAD-4 questionnaire. A confirmatory factor analysis, using unweighted least squares method, was performed. The test showed good internal consistency both at item and scale levels. The questionnaire structure was consistent with theoretical expectations. The MULTICAGE CAD-4, including the new smartphone scale, is a robust, reliable tool with a valid structure for assessing the presence of dysfunctional or potentially addictive behaviors, and especially useful in primary health care services

Los comportamientos adictivos no se limitan al uso de drogas, sino que también incluyen ciertos comportamientos diarios que pueden causar gratificación. Su progresión a patrones patológicos más severos conlleva graves consecuencias para el individuo, incluidas múltiples manifestaciones psicopatológicas. La detección temprana de este tipo de comportamiento es de interés para la atención primaria de salud. Por lo tanto, para detectar riesgos en etapas tempranas, las herramientas confiables y válidas para la práctica diaria son esenciales. El cuestionario MULTICAGE CAD-4 es una herramienta de detección para detectar simultáneamente conductas adictivas. Este estudio incluye una nueva escala para la detección del abuso de teléfonos inteligentes. El objetivo es evaluar la adecuación de sus propiedades psicométricas. Una muestra de 2.074 sujetos reclutados en centros de atención primaria de Madrid (España) completó el cuestionario MULTICAGE CAD-4. Se realizó un análisis factorial confirmatorio, utilizando el método de mínimos cuadrados no ponderados. La prueba mostró una buena consistencia interna tanto a nivel del ítem como de las escalas. La estructura del cuestionario fue consistente con las expectativas teóricas. El MULTICAGE CAD-4, incluida la nueva escala para teléfonos inteligentes, es una herramienta robusta y confiable con una estructura válida para evaluar la presencia de comportamientos disfuncionales o potencialmente adictivos, y especialmente útil en servicios de atención primaria de salud

Explaining differences in perceived health-related quality of life: a study within the Spanish population / Explicar las diferencias en cuanto a la calidad de vida percibida relacionada con la salud: estudio realizado en la población española

Objective: To assess the burden of several determinants on health-related quality of life (HRQOL) and to study its heterogeneity among the different Spanish regions. Method: Cross-sectional study. Data were obtained from the Spanish National Health Survey (2012), and HRQOL was measured using the EQ-5D-5L questionnaire (utility and visual analogue scale -VAS- scores). Demographic variables, physical health condition, social variables, mental health status, and lifestyle were also analysed. Tobit regression models were employed to study the relationships between expressed HRQOL and personal characteristics. Results: A total of 20,979 surveys were obtained. Of them, 62.4% expressed a utility score of 1, corresponding to perfect health (95%CI: 61.8%-63.2%), and 54.2% showed VAS scores ≥80 (95%CI: 53.5%-54.9%). HRQOL was mainly described as a function of age, chronic limitation in daily activities, and mental health status. Belonging to a higher-class strata and physical activity were related to better self-perceived HRQOL. Ageing worsened perceived HRQOL, but did not influence its determinants, and differences in HRQOL by regions were also not significant after model adjustment. Conclusion: HRQOL perception in the Spanish population varied slightly depending on the measure used (utilities index or VAS). Age, chronic limitations in daily life, and mental health status best explained the variability in perception, and no meaningful differences in HRQOL perception among regions were found after adjustment

Objetivo: Evaluar la carga de ciertos determinantes de la calidad de vida relacionada con la salud (CVRS) y su heterogeneidad entre diferentes regiones españolas. Métodos: Estudio transversal. Utilizando datos de la Encuesta Nacional de Salud (2012), se midió la CVRS con el cuestionario EQ5D-5L (utilidad y escala visual analógica [EVA]). Se analizaron variables demográficas, estado de salud, variables sociales, salud mental y estilos de vida, utilizando modelos Tobit. Resultados: Se incluyeron 20.979 encuestas. El 62,4% de los sujetos expresó una utilidad de 1, perfecta salud (intervalo de confianza del 95% [IC95%]: 61,8% -63,2%), y el 54,2% mostró puntuaciones en la EVA ≥80 (IC95%: 53,5%-54,9%). La CVRS se vio modificada fundamentalmente por la edad, la limitación crónica en las actividades diarias y el estado de salud mental. La clase social alta y la actividad física aparecían relacionadas con una mejor CVRS. La edad empeoró la percepción de la CVRS, pero no se asoció con un cambio en la influencia de sus determinantes. Después de ajustar los modelos, no había diferencias en la CVRS en las diferentes regiones. Conclusión: La percepción de la CVRS en la población española varió dependiendo de la medida utilizada (utilidades o EVA). La edad, las limitaciones crónicas en la vida diaria y el estado de salud mental explicaban fundamentalmente las diferencias en la CVRS, y las diferencias entre regiones se explicaron principalmente por diferentes características poblacionales

Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study.

BACKGROUND: The World Health Organization leads a global strategy to promote the initiation and maintenance of breast-feeding. Existing literature shows that education and supportive interventions, both for breast-feeding mothers as well as for healthcare professionals, can increase the proportion of women that use exclusive breast-feeding, however, more evidence is needed on the effectiveness of group interventions. METHODS: This study involves a community-based cluster randomised trial conducted at Primary Healthcare Centres in the Community of Madrid (Spain). The project aims to evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice. The number of patients required will be 432 (216 in each arm). All mother-infant pairs using exclusive breastfeeding that seek care or information at healthcare centres will be included, as long as the infant is not older than four weeks, and the mother has used exclusive breastfeeding in the last 24 h and who gives consent to participate. The main response variable is mother-infant pairs using exclusive breast-feeding at six months. Main effectiveness will be analysed by comparing the proportion of mother-infant pairs using exclusive breast-feeding at six months between the intervention group and the control group. All statistical tests will be performed with intention-to-treat. The estimation will be adjusted using an explanatory logistic regression model. A survival analysis will be used to compare the two groups using the log-rank test to assess the effect of the intervention on the duration of breastfeeding. The control of potential confounding variables will be performed through the construction of Cox regression models. DISCUSSION: We must implement strategies with scientific evidence to improve the percentage of exclusive breast-feeding at six months in our environment as established by the WHO. Group education is an instrument used by professionals in Primary Care that favours the acquisition of skills and modification of already-acquired behaviour, all making it a potential method of choice to improve rates of exclusive breast-feeding in this period. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (Date of registration: June 3, 2013).

Explaining differences in perceived health-related quality of life: a study within the Spanish population.

OBJECTIVE: To assess the burden of several determinants on health-related quality of life (HRQOL) and to study its heterogeneity among the different Spanish regions. METHOD: Cross-sectional study. Data were obtained from the Spanish National Health Survey (2012), and HRQOL was measured using the EQ-5D-5L questionnaire (utility and visual analogue scale -VAS- scores). Demographic variables, physical health condition, social variables, mental health status, and lifestyle were also analysed. Tobit regression models were employed to study the relationships between expressed HRQOL and personal characteristics. RESULTS: A total of 20,979 surveys were obtained. Of them, 62.4% expressed a utility score of 1, corresponding to perfect health (95%CI: 61.8%-63.2%), and 54.2% showed VAS scores ≥80 (95%CI: 53.5%-54.9%). HRQOL was mainly described as a function of age, chronic limitation in daily activities, and mental health status. Belonging to a higher-class strata and physical activity were related to better self-perceived HRQOL. Ageing worsened perceived HRQOL, but did not influence its determinants, and differences in HRQOL by regions were also not significant after model adjustment. CONCLUSION: HRQOL perception in the Spanish population varied slightly depending on the measure used (utilities index or VAS). Age, chronic limitations in daily life, and mental health status best explained the variability in perception, and no meaningful differences in HRQOL perception among regions were found after adjustment.

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

BACKGROUND: Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12 months, as compared with usual care. METHODS/DESIGN: Design: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient. SCOPE: PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain). POPULATION: patients aged 65-74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months). SAMPLE SIZE: n = 400 (200 per study arm). INTERVENTION: complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview. OUTCOMES: MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables. STATISTICAL ANALYSIS: primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle. DISCUSSION: It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02866799.

Effectiveness of a strategy that uses educational games to implement clinical practice guidelines among Spanish residents of family and community medicine (e-EDUCAGUIA project): a clinical trial by clusters.

BACKGROUND: Clinical practice guidelines (CPGs) have been developed with the aim of helping health professionals, patients, and caregivers make decisions about their health care, using the best available evidence. In many cases, incorporation of these recommendations into clinical practice also implies a need for changes in routine clinical practice. Using educational games as a strategy for implementing recommendations among health professionals has been demonstrated to be effective in some studies; however, evidence is still scarce. The primary objective of this study is to assess the effectiveness of a teaching strategy for the implementation of CPGs using educational games (e-learning EDUCAGUIA) to improve knowledge and skills related to clinical decision-making by residents in family medicine. The primary objective will be evaluated at 1 and 6 months after the intervention. The secondary objectives are to identify barriers and facilitators for the use of guidelines by residents of family medicine and to describe the educational strategies used by Spanish teaching units of family and community medicine to encourage implementation of CPGs. METHODS/DESIGN: We propose a multicenter clinical trial with randomized allocation by clusters of family and community medicine teaching units in Spain. The sample size will be 394 residents (197 in each group), with the teaching units as the randomization unit and the residents comprising the analysis unit. For the intervention, both groups will receive an initial 1-h session on clinical practice guideline use and the usual dissemination strategy by e-mail. The intervention group (e-learning EDUCAGUIA) strategy will consist of educational games with hypothetical clinical scenarios in a virtual environment. The primary outcome will be the score obtained by the residents on evaluation questionnaires for each clinical practice guideline. Other included variables will be the sociodemographic and training variables of the residents and the teaching unit characteristics. The statistical analysis will consist of a descriptive analysis of variables and a baseline comparison of both groups. For the primary outcome analysis, an average score comparison of hypothetical scenario questionnaires between the EDUCAGUIA intervention group and the control group will be performed at 1 and 6 months post-intervention, using 95 % confidence intervals. A linear multilevel regression will be used to adjust the model. DISCUSSION: The identification of effective teaching strategies will facilitate the incorporation of available knowledge into clinical practice that could eventually improve patient outcomes. The inclusion of information technologies as teaching tools permits greater learning autonomy and allows deeper instructor participation in the monitoring and supervision of residents. The long-term impact of this strategy is unknown; however, because it is aimed at professionals undergoing training and it addresses prevalent health problems, a small effect can be of great relevance. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02210442 .

CuidaCare: effectiveness of a nursing intervention on the quality of life's caregiver: cluster-randomized clinical trial.

BACKGROUND: In Spain, family is the main source of care for dependent people. Numerous studies suggest that providing informal (unpaid) care during a prolonged period of time results in a morbidity-generating burden. Caregivers constitute a high-risk group that experiences elevated stress levels, which reduce their quality of life.Different strategies have been proposed to improve management of this phenomenon in order to minimize its impact, but definitive conclusions regarding their effectiveness are lacking. METHODS/DESIGN: A community clinical trial is proposed, with a 1-year follow-up period, that is multicentric, controlled, parallel, and with randomized allocation of clusters in 20 health care centers within the Community of Madrid. The study's objective is to evaluate the effectiveness of a standard care intervention in primary health care (intervention CuidaCare) to improve the quality of life of the caregivers, measured at 0, 6, and 12 months after the intervention.One hundred and forty two subjects (71 from each group) ≥65 years, identified by the nurse as the main caregivers, and who provide consent to participate in the study will be included.The main outcome variable will be perceived quality of life as measured by the Visual Analogue Scale (VAS) of EuroQol-5D (EQ-5D). The secondary outcome variables will be EQ-5D Dimensions, EQ-5D Index, nursing diagnosis, and Zarit's test. Prognostic variables will be recorded for the dependent patient and the caregiver.The principle analysis will be done by comparing the average change in EQ-5D VAS value before and after intervention between the two groups. All statistical tests will be performed as intention-to-treat. Prognostic factors' estimates will be adjusted by mixed-effects regression models. Possible confounding or effect-modifying factors will be taken into account. DISCUSSION: Assistance for the caregiver should be integrated into primary care services. In order to do so, incorporating standard, effective interventions with relevant outcome variables such as quality of life is necessary. Community care nurses are at a privileged position to develop interventions like the proposed one. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov under code number NCT 01478295.