[Patient safety incidents reported before and after the start of the COVID-19 pandemic in Primary Care in Tarragona]. / Incidentes de seguridad del paciente notificados antes y después del inicio de la pandemia de COVID-19 en atención primaria en Tarragona.

OBJECTIVE: To analyse and compare the epidemiology of patient safety incidents reported in Primary Health Care, before and after the start of the COVID-19 pandemic. DESIGN AND SETTING: Analytical descriptive study comparing reported incidents from March 1st 2019 to February 28th 2020, and from March 1st 2020 to February 28th 2021, notified through the TPSC Cloud™ platform accessible from the Intranet corporative in 25 Primary Health Care centres from Tarragona district, in Catalonia (Spain). MEASUREMENTS: Data obtained from voluntary notifications, through electronic, standardized and anonymized forms. VARIABLES: Centre, professional, incident type, risk matrix, causal factors and contributing factors, and avoidability. STATISTICAL ANALYSIS: Every notification was included in descriptive analysis, and another one specifically for adverse events, comparing both periods. RESULTS: 2231 incidents were reported. Comparing both periods, during the pandemic a reduction in the number of reported incidents was observed (only represented 20% of the total). However, the percentage of reported notifications from health care professionals and adverse events that required observation were increased. Causal factors related to attendance and diagnosis were incremented whereas the causal factors related to medication were decreased. In addition, an increase in contributing factors related to the professional was observed. Avoidability was high (>95%) in both periods. CONCLUSIONS: During the pandemic, fewer patient safety incidents have been reported, but proportionally more adverse events, most of which are preventable. The professional himself becomes the main contributing factor.

Effectiveness of New Tools to Define an Up-to-Date Patient Safety Risk Map: A Primary Care Study Protocol.

BACKGROUND: Reducing incidents related to health care interventions to improve patient safety is a health policy priority. To strengthen a culture of safety, reporting incidents is essential. This study aims to define a patient safety risk map using the description and analysis of incidents within a primary care region with a prior patient safety improvement strategy organisationally developed and promoted. METHODS: The study will be conducted in two phases: (1) a cross-sectional descriptive observational study to describe reported incidents; and (2) a quasi-experimental study to compare reported incidents. The study will take place in the Camp de Tarragona Primary Care Management (Catalan Institute of Health). In Phase 1, all reactive notifications collected within one year (2018) will be analysed; during Phase 2, all proactive notifications of the second and third weeks of June 2019 will be analysed. Adverse events will also be assessed. Phases 1 and 2 will use a digital platform and the proactive tool proSP to notify and analyse incidents related to patient safety. EXPECTED RESULTS: To obtain an up-to-date, primary care patient safety risk map to prioritise strategies that result in safer practices.

[Population-based incidence of hospitalised pneumococcal pneumonia in adults with distinct baseline risk strata in Catalonia throughout 2015, the EPIVAC study.] / Incidencia poblacional de neumonía neumocócica hospitalizada en adultos con distintos niveles de riesgo en cataluña durante 2015, estudio EPIVAC.

OBJECTIVE: Pneumococcal pneumonia is a major public health problem, especially in high risk population and older adults. This study assessed the epidemiology of pneumococcal pneumonia requiring hospitalisation among adults in Catalonia. METHODS: This is a population-based cohort study, including all individual ≥50 years-old assigned to the Institut Catala de la Salut (Catalonia, Spain), who were prospectively followed from 01/01/2015 to 31/12/2015. The Catalonian information system for the development of research in primary care (SIDIAP) was used to establish baseline characteristics and risk-strata of cohort members at study start: low-risk (immunocompetent persons without risk conditions), intermediate-risk (immunocompetent persons with at-risk condition) and high-risk (immunocompromising conditions). All hospitalisations from pneumococcal pneumonia occurred among cohort members within 2015 were collected from CMBD discharge data of 64 reference Catalonian hospitals. RESULTS: Among the 2.025.730 cohort members the global incidence of hospitalised pneumococcal pneumonia was 82.8 cases per 100,000 population-year (9.8 for bacteremic and 72.9 for non- bacteremic cases). Incidence substantially increased by age (34.9 in 50-64 years vs 88.7 in 65-79 years vs 231.5 in >80 years; p<0.001) and baseline-risk stratum (30.1, 119.1 and 240.7 in low-, intermediate- and high-risk stratum, respectively; p<0.001). Overall case-fatality was 4.9% (7.7% in bacteremic vs 4.5% in non- bacteremic; p=0.059). In multivariable models, high-risk stratum and oldest age were the strongest predictors for invasive and non-invasive cases, respectively. CONCLUSIONS: The burden of pneumococcal pneumonia among adults is intermediate-low in Catalonia, but large incidences emerge among oldest persons and immunocompromised subjects.

OBJETIVO: La neumonía neumocócica (NN) es un importante problema de salud, especialmente entre personas de edad avanzada y/o con condiciones de riesgo. Este trabajo analizó la incidencia de neumonía neumocócica (NN) hospitalizada en adultos de Cataluña. METODOS: Estudio de cohortes de base poblacional que incluyó todas las personas ≥50 años asignadas al Institut Català de la Salut, con seguimiento prospectivo entre 01/01/2015-31/12/2015. El Sistema de Información para el Desarrollo de la Investigación en Atención Primaria (SIDIAP) de Cataluña fue usado para establecer las características basales de los miembros de la cohorte, clasificados en tres estratos de riesgo: bajo (inmunocompetentes sin condiciones de riesgo), medio (inmunocompetentes con alguna condición de riesgo) y alto (inmunocompromiso/asplenia). La ocurrencia de NN entre los miembros de la cohorte fue identificada mediante CMBD de los 64 hospitales catalanes de referencia. RESULTADOS: Entre los 2.025.730 miembros de la cohorte la incidencia global de NN fue de 82,8 casos por 100.000 personas/año (9,8 bacteriémicas y 72,9 no bacteriémicas), aumentando sustancialmente según edad (34,9 en 50-64 años, 88,7 en 65-79 años, 231,5 en >80 años; p<0.001) y estrato de riesgo basal (30,1; 119,1 y 240,7 en bajo, medio y alto riesgo, respectivamente; p<0.001). La letalidad global fue de 4,9% (7,7% en casos bacteriémicos vs 4,5% en no bacteriémicos; p=0.059). En modelos multivariantes, estrato de riesgo alto y edad avanzada (>80 años) fueron los más fuertes predictores para padecer episodios bacteriémicos y no bacteriémicos, respectivamente. CONCLUSIONES: La incidencia global de NN en adultos de Cataluña es intermedia-baja, aunque incidencias considerablemente altas emergen en inmunocomprometidos y/o edad avanzada.

Incidencia poblacional de neumonía neumocócica hospitalizada en adultos con distintos niveles de riesgo en cataluña durante 2015, estudio EPIVAC / Population-based incidence of hospitalised pneumococcal pneumonia in adults with distinct baseline risk strata in Catalonia throughout 2015, the EPIVAC study

OBJETIVO: La neumonía neumocócica (NN) es un importante problema de salud, especialmente entre personas de edad avanzada y/o con condiciones de riesgo. Este trabajo analizó la incidencia de neumonía neumocócica (NN) hospitalizada en adultos de Cataluña. MÉTODOS: Estudio de cohortes de base poblacional que incluyó todas las personas ≥50 años asignadas al Institut Català de la Salut, con seguimiento prospectivo entre 01/01/2015-31/12/2015. El Sistema de Información para el Desarrollo de la Investigación en Atención Primaria (SIDIAP) de Cataluña fue usado para establecer las características basales de los miembros de la cohorte, clasificados en tres estratos de riesgo: bajo (inmunocompetentes sin condiciones de riesgo), medio (inmunocompetentes con alguna condición de riesgo) y alto (inmunocompromiso/asplenia). La ocurrencia de NN entre los miembros de la cohorte fue identificada mediante CMBD de los 64 hospitales catalanes de referencia. RESULTADOS: Entre los 2.025.730 miembros de la cohorte la incidencia global de NN fue de 82,8 casos por 100.000 personas/año (9,8 bacteriémicas y 72,9 no bacteriémicas), aumentando sustancialmente según edad (34,9 en 50-64 años, 88,7 en 65-79 años, 231,5 en >80 años; p<0.001) y estrato de riesgo basal (30,1; 119,1 y 240,7 en bajo, medio y alto riesgo, respectivamente; p<0.001). La letalidad global fue de 4,9% (7,7% en casos bacteriémicos vs 4,5% en no bacteriémicos; p=0.059). En modelos multivariantes, estrato de riesgo alto y edad avanzada (>80 años) fueron los más fuertes predictores para padecer episodios bacteriémicos y no bacteriémicos, respectivamente. CONCLUSIONES: La incidencia global de NN en adultos de Cataluña es intermedia-baja, aunque incidencias considerablemente altas emergen en inmunocomprometidos y/o edad avanzada

OBJECTIVE: Pneumococcal pneumonia is a major public health problem, especially in high risk population and older adults. This study assessed the epidemiology of pneumococcal pneumonia requiring hospitalisation among adults in Catalonia. METHODS: This is a population-based cohort study, including all individual ≥50 years-old assigned to the Institut Catala de la Salut (Catalonia, Spain), who were prospectively followed from 01/01/2015 to 31/12/2015. The Catalonian information system for the development of research in primary care (SIDIAP) was used to establish baseline characteristics and risk-strata of cohort members at study start: low-risk (immunocompetent persons without risk conditions), intermediate-risk (immunocompetent persons with at-risk condition) and high-risk (immunocompromising conditions). All hospitalisations from pneumococcal pneumonia occurred among cohort members within 2015 were collected from CMBD discharge data of 64 reference Catalonian hospitals. RESULTS: Among the 2.025.730 cohort members the global incidence of hospitalised pneumococcal pneumonia was 82.8 cases per 100,000 population-year (9.8 for bacteremic and 72.9 for non- bacteremic cases). Incidence substantially increased by age (34.9 in 50-64 years vs 88.7 in 65-79 years vs 231.5 in >80 years; p<0.001) and baseline-risk stratum (30.1, 119.1 and 240.7 in low-, intermediate- and high-risk stratum, respectively; p<0.001). Overall case-fatality was 4.9% (7.7% in bacteremic vs 4.5% in non- bacteremic; p=0.059). In multivariable models, high-risk stratum and oldest age were the strongest predictors for invasive and non-invasive cases, respectively. CONCLUSIONS: The burden of pneumococcal pneumonia among adults is intermediate-low in Catalonia, but large incidences emerge among oldest persons and immunocompromised subjects

Utilidad de la escala de severidad modificada CRB75 en el manejo del paciente anciano con neumonía adquirida en la comunidad / Ability of the modified CRB75 severity scale in assessing elderly patients with community acquired pneumonia

Objetivo: Comparar la utilidad de la escala CRB65, acrónimo inglés de confusión, taquipnea, hipotensión, edad ≥ 65 años, versus la escala modificada CRB75 para determinar el grado de severidad en pacientes mayores de 65 años con neumonía adquirida en la comunidad (NAC). Diseño: Estudio de cohortes prospectivo. Emplazamiento: Región Sanitaria de Tarragona. Participantes: Se incluyeron 350 pacientes ≥ 65 años con NAC radiográficamente confirmada (ambulatoria u hospitalizada) diagnosticada durante 2008-2010. Mediciones principales: La escala CRB65 considera confusión mental de nueva aparición; frecuencia respiratoria ≥ 30resp./min; presión arterial sistólica<90mmHg o diastólica ≤ 60mmHg y edad ≥ 65 años. La escala modificada CRB75 usa criterios similares pero edad ≥ 75 años. Ambas fueron calculadas al diagnóstico, y la mortalidad a los 30 días fue considerada como variable dependiente. Resultados: La mortalidad global fue del 13,1% (4% en NAC ambulatorias y 15% en NAC hospitalizadas). La mortalidad fue 7,7% para CRB65=1, 22,5% en CRB65=2 y 50% en CRB65=3. La mortalidad en CRB75=0 fue 3,2%, en CRB75=1 fue 9,7%, en CRB75=2 fue 30% y en CRB75=3 del 45,5%. La capacidad discriminativa de ambas escalas para clasificar el riesgo de mortalidad a los 30 días fue aceptable, siendo el área bajo la curva ROC significativamente mejor en el CRB75 que en el CRB65 (0,735 vs 0,681; p<0,01). Conclusión: Ambas escalas son una herramienta aceptable para clasificar el riesgo de mortalidad a corto plazo en los pacientes con NAC. La escala CRB75 puede ser de mayor utilidad en pacientes mayores de 65 años(AU)

Objective: To compare the ability of the classic CRB65 (confusion, respiratory rate, blood pressure and age ≥65 years) vs the modified CRB-75 for the severity assessment of patients 65 years or older with community acquired pneumonia (CAP). Design: Prospective cohort study. Setting: Tarragona Health Region. Participants: A total of 350 patients ≥65 years with a radiographically confirmed CAP (hospitalized or outpatient) during 2008-2010. Main outcome measures: The CRB-65 score (confusion; respiratory rate ≥30; systolic blood pressure<90mmHg or diastolic ≤ 60mmHg; age ≥65 years) and the modified CRB-75 (similar criteria but age ≥75 years) were calculated at the time of diagnosis, and 30-day mortality was considered as the main dependent variable. Results: The overall 30-day mortality rate was 13.1% (4% in outpatient CAP and 15% in hospitalized CAP). According to CRB-65, mortality was 7,7% with a score of 1, 22.5% with a score of 2, and 50% with a score of 3 (no cases with a score of 4). Mortality also directly increased according to CRB-75, being 3,2% with a score of 0, 9,7% with a score of 1, 30.0% with a score of 2, and 45.5% with a score of 3. The discriminative value of both CRB65 and CRB75 rules to classify risk of short-term mortality among our study population was acceptable, with a better area under receive operating characteristic curve (ROC) for CRB75 than for CRB-65 (0,735 vs 0,681; P<0.01). Conclusion: Both CRB-65 and CRB-75 scales are an acceptable tool to classify mortality risk among elderly patients with CAP. However, CRB-75 can be more useful for evaluating patients over 65 years with CAP(AU)

[Ability of the modified CRB75 severity scale in assessing elderly patients with community acquired pneumonia]. / Utilidad de la escala de severidad modificada CRB75 en el manejo del paciente anciano con neumonía adquirida en la comunidad.

OBJECTIVE: To compare the ability of the classic CRB65 (confusion, respiratory rate, blood pressure and age ≥65 years) vs the modified CRB-75 for the severity assessment of patients 65 years or older with community acquired pneumonia (CAP). DESIGN: Prospective cohort study. SETTING: Tarragona Health Region. PARTICIPANTS: A total of 350 patients ≥65 years with a radiographically confirmed CAP (hospitalized or outpatient) during 2008-2010. MAIN OUTCOME MEASURES: The CRB-65 score (confusion; respiratory rate ≥30; systolic blood pressure <90 mmHg or diastolic ≤ 60 mmHg; age ≥65 years) and the modified CRB-75 (similar criteria but age ≥75 years) were calculated at the time of diagnosis, and 30-day mortality was considered as the main dependent variable. RESULTS: The overall 30-day mortality rate was 13.1% (4% in outpatient CAP and 15% in hospitalized CAP). According to CRB-65, mortality was 7,7% with a score of 1, 22.5% with a score of 2, and 50% with a score of 3 (no cases with a score of 4). Mortality also directly increased according to CRB-75, being 3,2% with a score of 0, 9,7% with a score of 1, 30.0% with a score of 2, and 45.5% with a score of 3. The discriminative value of both CRB65 and CRB75 rules to classify risk of short-term mortality among our study population was acceptable, with a better area under receive operating characteristic curve (ROC) for CRB75 than for CRB-65 (0,735 vs 0,681; P<.01). CONCLUSION: Both CRB-65 and CRB-75 scales are an acceptable tool to classify mortality risk among elderly patients with CAP. However, CRB-75 can be more useful for evaluating patients over 65 years with CAP.

Rationale and design of the CAPAMIS study: effectiveness of pneumococcal vaccination against community-acquired pneumonia, acute myocardial infarction and stroke.

BACKGROUND: The 23-valent polysaccharide pneumococcal vaccine (PPV-23) is recommended for elderly and high-risk people, although its effectiveness is controversial. Some studies have reported an increasing risk of acute vascular events among patients with pneumonia, and a recent case-control study has reported a reduction in the risk of myocardial infarction among patients vaccinated with PPV-23. Given that animal experiments have shown that pneumococcal vaccination reduces the extent of atherosclerotic lesions, it has been hypothesized that PPV-23 could protect against acute vascular events by an indirect effect preventing pneumonia or by a direct effect on oxidized low-density lipoproteins. The main objective of this study is to evaluate the clinical effectiveness of PPV-23 in reducing the risk of pneumonia and acute vascular events (related or nonrelated with prior pneumonia) in the general population over 60 years. METHODS/DESIGN: Cohort study including 27,000 individuals 60 years or older assigned to nine Primary Care Centers in the region of Tarragona, Spain. According to the reception of PPV-23 before the start of the study, the study population will be divided into vaccinated and nonvaccinated groups, which will be followed during a consecutive 30-month period. Primary Care and Hospitals discharge databases will initially be used to identify study events (community-acquired pneumonia, hospitalisation for acute myocardial infarction and stroke), but all cases will be further validated by checking clinical records. Multivariable Cox regression analyses estimating hazard ratios (adjusted for age, sex and comorbidities) will be used to estimate vaccine effectiveness. DISCUSSION: The results of the study will contribute to clarify the controversial effect of the PPV-23 in preventing community-acquired pneumonia and they will be critical in determining the possible role of pneumococcal vaccination in cardiovascular prevention.

[EVAN-50 study: Effectiveness of polysaccharide pneumococcus vaccine in preventing pneumococcal infections in the over-50 population]. / Estudio EVAN-50: efectividad de la vacuna antineumocócica polisacárida en la prevención de infecciones neumocócicas en población mayor de 50 años.

OBJECTIVE: To assess the effectiveness of 23-valent polysaccharide vaccine in preventing severe pneumococcal infections in adults over 50 years old. DESIGN: Case-control study. SETTING: Primary Health Care Service, Tarragona, Spain. PATIENTS: A total of 270 patients >50 with severe pneumococcal disease (invasive pneumococcal disease and non-bacteraemic pneumococcal pneumonia) and 540 control patients randomized from the primary care Centres of the case patients. Case and control patients will be matched for age, sex, family physician, and level of risk for pneumonia. MAIN MEASUREMENTS: Odds ratio (OR) will be used to measure the vaccine effect. Multivariate logistical regression, adjusted for age, sex, and comorbidity, will be conducted. Vaccine effectiveness (VE) will be calculated by the formula, VE = 1-OR. Vaccine effectiveness will be distinguished for the various age groups and at each risk stratum. It will also be estimated by means of indirect cohort analysis, taking as cases the infection caused by vaccine serotypes and as controls infection caused by non-vaccine serotype. DISCUSSION: The study will give an answer in terms of effectiveness of the vaccine for several age and risk strata. It will contribute to taking a decision regarding the controversial question of the systematic indication, or otherwise, of this vaccine for the elderly.

Estudio EVAN-50: efectividad de la vacuna antineumocócica polisacárida en la prevención de infecciones neumocócicas en población mayor de 50 años / EVAN-50 Study: effectiveness of polysaccharide pneumococcus vaccine in preventing pneumococcal infections in the over-50 population

Objetivo. Evaluar la efectividad de la vacunación antineumocócica 23-valente en la prevención de infecciones neumocócicas graves en población mayor de 50 años. Diseño. Estudio de casos y controles. Emplazamiento. Atención primaria de salud (Región Sanitaria de Tarragona). Participantes. Un total de 270 pacientes >50 años con una enfermedad neumocócica grave (incluidas la enfermedad invasiva y las neumonías neumocócicas no bacteriémicas) y un total de 540 controles seleccionados aleatoriamente en los registros de usuarios de los centros de salud de referencia de los casos (tras aparejamiento por edad, sexo, médico de cabecera y estrato de riesgo para neumonía). Mediciones principales. Como medida del efecto se usará la odds ratio (OR), realizándose un análisis multivariante de regresión logística para el control de los posibles factores de confusión, estimándose unas OR ajustadas y calculándose la efectividad vacunal (EV) mediante la fórmula: EV = 1 ­ OR. Se discriminará la efectividad de la vacuna para los diferentes grupos de edad y en cada uno de los estratos de riesgo. Finalmente, se evaluará también la efectividad vacunal mediante un análisis de cohortes indirectas, considerando como casos los episodios causados por serotipos vacunales y como controles los episodios causados por serotipos no incluidos en la vacuna. Discusión. El estudio podrá dar una respuesta en términos de efectividad de la vacuna para diferentes estratos etarios y de riesgo, y contribuirá a una toma de decisiones respecto al controvertido tema de la indicación sistemática o no de esta vacuna en las personas mayores

Objective. To assess the effectiveness of 23-valent polysaccharide vaccine in preventing severe pneumococcal infections in adults over 50 years old. Design. Case-control study. Setting. Primary Health Care Service, Tarragona, Spain. Patients. A total of 270 patients >50 with severe pneumococcal disease (invasive pneumococcal disease and non-bacteraemic pneumococcal pneumonia) and 540 control patients randomized from the primary care Centres of the case patients. Case and control patients will be matched for age, sex, family physician, and level of risk for pneumonia. Main measurements. Odds ratio (OR) will be used to measure the vaccine effect. Multivariate logistical regression, adjusted for age, sex, and comorbidity, will be conducted. Vaccine effectiveness (VE) will be calculated by the formula, VE=1-OR. Vaccine effectiveness will be distinguished for the various age groups and at each risk stratum. It will also be estimated by means of indirect cohort analysis, taking as cases the infection caused by vaccine serotypes and as controls infection caused by non-vaccine serotype. Discussion. The study will give an answer in terms of effectiveness of the vaccine for several age and risk strata. It will contribute to taking a decision regarding the controversial question of the systematic indication, or otherwise, of this vaccine for the elderly