Seroprevalence of antibodies against SARS-CoV-2 in the Valencian Community (Spain) as of October 2022.

OBJECTIVE: To estimate the seroprevalence of SARS-CoV-2 antibodies in the Valencian Community (Spain) in October 2022, when BA.5 was the predominant variant. METHOD: Cross-sectional, region-wide, population-based serosurvey study in 88 randomly selected primary care centers of the Valencian Community. RESULTS: Seroprevalence of anti-nucleocapsid (indicative of past infection) and total receptor binding domain (indicative of past infection or vaccination) antibodies was 71.0% (confidence interval [CI]: 67.8-74.2) and 98.4% (CI: 97.5-99.3), respectively. 66.7% (CI: 63.4-70.0) of the population shows hybrid immunity, but only 43.2% in those 80 and over. CONCLUSIONS: The high proportion of hybrid immunity detected is relevant for public health strategies. A second vaccination booster was advisable in the elderly population.

Cumulative incidence of SARS-CoV-2 infection in the general population of the Valencian Community (Spain) after the surge of the Omicron BA.1 variant.

Studies investigating the cumulative incidence of and immune status against SARS-CoV-2 infection provide valuable information for shaping public health decision-making. A cross-sectional study on 935 participants, conducted in the Valencian Community (VC), measuring anti-SARS-CoV-2-receptor binding domain-RBD-total antibodies and anti-Nucleocapsid (N)-IgGs via electrochemiluminescence assays. Quantitation of neutralizing antibodies (NtAb) against ancestral and Omicron BA.1 and BA.2 variants and enumeration of SARS-CoV-2-S specific-IFNγ-producing CD4+ and CD8+ T cells was performed in 100 and 137 participants, respectively. The weighted cumulative incidence was 51.9% (95% confidence interval [CI]: 48.7-55.1) and was inversely related to age. Anti-RBD total antibodies were detected in 97% of participants; vaccinated and SARS-CoV-2-experienced (VAC-ex; n = 442) presented higher levels (p < 0.001) than vaccinated/naïve (VAC-n; n = 472) and nonvaccinated/experienced (UNVAC-ex; n = 63) subjects. Antibody levels correlated inversely with time elapsed since last vaccine dose in VAC-n (Rho, -0.52; p < 0.001) but not in VAC-ex (rho -0.02; p = 0.57). Heterologous booster shots resulted in increased anti-RBD antibody levels compared with homologous schedules in VAC-n, but not in VAC-ex. NtAbs against Omicron BA.1 were detected in 94%, 75%, and 50% of VAC-ex, VAC-n and UNVAC-ex groups, respectively. For Omicron BA.2, the figures were 97%, 84%, and 40%, respectively. SARS-CoV-2-S-reactive IFN-γ T cells were detected in 73%, 75%, and 64% of VAC-ex, VAC-n and UNVAC-ex, respectively. Median frequencies for both T-cell subsets were comparable across groups. In summary, by April 2022, around half of the VC population had been infected with SARS-CoV-2 and, due to extensive vaccination, displayed hybrid immunity.

Seroprevalence of antibodies against SARS-CoV-2 in the Valencian Community (Spain) as of October 2022 / Seroprevalencia de anticuerpos frente al SARS-CoV-2 en la Comunidad Valenciana (España) en octubre de 2022

Objective: To estimate the seroprevalence of SARS-CoV-2 antibodies in the Valencian Community (Spain) in October 2022, when BA.5 was the predominant variant. Method: Cross-sectional, region-wide, population-based serosurvey study in 88 randomly selected primary care centers of the Valencian Community. Results: Seroprevalence of anti-nucleocapsid (indicative of past infection) and total receptor binding domain (indicative of past infection or vaccination) antibodies was 71.0% (confidence interval [CI]: 67.8-74.2) and 98.4% (CI: 97.5-99.3), respectively. 66.7% (CI: 63.4-70.0) of the population shows hybrid immunity, but only 43.2% in those 80 and over. Conclusions: The high proportion of hybrid immunity detected is relevant for public health strategies. A second vaccination booster was advisable in the elderly population.(AU)

Objetivo: Estimar la seroprevalencia de anticuerpos frente al SARS-CoV-2 en la Comunidad Valenciana (España) en octubre de 2022, cuando BA.5 era la variante predominante. Método: Estudio transversal de base poblacional de ámbito autonómico en 88 centros de atención primaria de la Comunidad Valenciana seleccionados aleatoriamente. Resultados: La seroprevalencia de anticuerpos antinucleocápside (indicativos de infección previa) y frente al dominio de la unión al receptor (indicativos de infección o vacunación) fue del 71,0% (intervalo de confianza [IC]: 67,8-74,2) y del 98,4% (IC: 97,5-99,3), respectivamente. El 66,7% (IC: 63,4-70,0) de la población mostraba inmunidad híbrida, pero solo el 43,2% de los mayores de 80 años. Conclusiones: La alta proporción de inmunidad híbrida detectada era relevante para las estrategias de salud pública, pero era aconsejable un segundo refuerzo de vacunación en la población anciana.(AU)

Side effects during the week after first dose vaccination with four Covid-19 vaccines. Results of the ProVaVac Survey Study with 13,837 people in Spain.

BACKGROUND: In 2021, four vaccines against Covid-19 (BNT162b2, mRNA-1273, ChAdOx1nCoV-19, and JNJ-78436735) were employed in the region of Valencia, Spain. We conducted a survey to identify real-world, self-reported frequency and severity of side effects during the week after vaccination. METHODS: Survey data was obtained from April 19, 2021, to October 6, 2021, at three different moments in time: day one, day three and day seven after vaccination. Answers were linked to individual-level, personal and clinical information. Respondents were stratified by the vaccine they received and reported effects were presented over time and stratified by severity. We compared our results per vaccine with the frequencies stated in each Summary of Product Characteristics (SmPC). We used binomial logistic models to identify associations between respondent characteristics and side effects. RESULTS: No symptoms were reported by 1,986 respondents (14.35 %), 6,254 informed exclusively mild symptoms (45.20 %), 3,444 up to moderate symptoms (24.89 %), and 2,153 people (15.56 %) notified also severe symptoms. Among the latter, the more frequent were extreme tiredness (7.0 %), and nausea or vomiting (7.1 %). The reported frequency of facial paralysis (0.4 %) was much higher than reflected in SmPCs. Female sex, younger age, previous positive Active Infection Diagnostic Test, chronicity, and vaccination with other than the BNT162b2 vaccine were associated to an increased risk of side effects (p < 0.001). CONCLUSIONS: Side effects after vaccination are common in the real-world. However, they are principally mild, and their frequency declines after a few days. Providing patients with dependable, beforehand information about side effects may improve outcomes and reinforce vaccination programs.

SARS-CoV-2 Omicron BA.1 variant breakthrough infections in nursing home residents after an homologous third dose of the Comirnaty® COVID-19 vaccine: Looking for correlates of protection.

We investigated whether peripheral blood levels of SARS-CoV-2 Spike (S) receptor binding domain antibodies (anti-RBD), neutralizing antibodies (NtAb) targeting Omicron S, and S-reactive-interferon (IFN)-γ-producing CD4+ and CD8+ T cells measured after a homologous booster dose (3D) with the Comirnaty® vaccine was associated with the likelihood of subsequent breakthrough infections due to the Omicron variant. An observational study including 146 nursing home residents (median age, 80 years; range, 66-99; 109 female) evaluated for an immunological response after 3D (at a median of 16 days). Anti-RBD total antibodies were measured by chemiluminescent immunoassay. NtAb were quantified by an Omicron S pseudotyped virus neutralization assay. SARS-CoV-2-S specific-IFNγ-producing CD4+ and CD8+ T cells were enumerated by whole-blood flow cytometry for intracellular cytokine staining. In total, 33/146 participants contracted breakthrough Omicron infection (symptomatic in 30/33) within 4 months after 3D. Anti-RBD antibody levels were comparable in infected and uninfected participants (21 123 vs. 24 723 BAU/ml; p = 0.34). Likewise, NtAb titers (reciprocal IC50 titer, 157 vs. 95; p = 0.32) and frequency of virus-reactive CD4+ (p = 0.82) and CD8+ (p = 0.91) T cells were similar across participants in both groups. anti-RBD antibody levels and NtAb titers estimated at around the time of infection were also comparable (3445 vs. 4345 BAU/ml; p = 0.59 and 188.5 vs. 88.9; p = 0.70, respectively). Having detectable NtAb against Omicron or SARS-CoV-2-S-reactive-IFNγ-producing CD4+ or CD8+ T cells after 3D was not correlated with increased protection from breakthrough infection (OR, 1.50; p = 0.54; OR, 0.0; p = 0.99 and OR 3.70; p = 0.23, respectively). None of the immune parameters evaluated herein, including NtAb titers against the Omicron variant, may reliably predict at the individual level the risk of contracting COVID-19 due to the Omicron variant in nursing home residents.

SARS-CoV-2 Delta-variant breakthrough infections in nursing home residents at midterm after Comirnaty® COVID-19 vaccination.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta variant breakthrough infections in nursing home residents following vaccination with Comirnaty® COVID-19 vaccine were characterized. In total, 201 participants (median age, 87 years; range, 64-100; 133 female) from two nursing homes in the Valencian community (Spain) were included. SARS-CoV-2-Spike (S) antibody responses were determined by a lateral flow immunocromatography (LFIC) assay and by quantitative electrochemiluminescent assay in LFIC-negative participants. SARS-CoV-2-S-IFNγ T cells were enumerated by flow cytometry in 10 participants. Nasopharyngeal SARS-CoV-2 RNA loads were quantified by real-time polymerase chain reaction assays. Vaccine breakthrough COVID-19 due to the Delta variant occurred in 39 residents (median age, 87 years; range, 69-96; 31 female) at a median of 6.5 months after vaccination (nine requiring hospitalization). Breakthrough infections occurred at a higher rate (p < 0.0001) in residents who had not been previously infected with SARS-CoV-2 (naïve) (33/108; 18%) than in those with prior diagnosis of SARS-CoV-2 infection (experienced) (6/93; 6.4%), and were more likely (p < 0.0001) to develop in residents who tested negative by LFIC (20/49) at 3 months after vaccination as compared to their LFIC-positive counterparts (19/142). Among LFIC-negative residents, a trend towards lower plasma anti-RBD antibody levels was noticed in those developing breakthrough infection (p = 0.16). SARS-CoV-2 RNA loads in nasopharyngeal specimens were lower in SARS-CoV-2-experienced residents (p < 0.001) and in those testing positive by LFIC (p = 0.13). The frequency of SARS-CoV-2-S-reactive T cells at 3 months was similar in LFIC-negative residents with (n = 7) or without (n = 3) breakthrough infection. Prior history of SARS-CoV-2 infection and detection of S-reactive antibodies by LFIC at 3 months is associated with a lower risk of Delta-variant breakthrough infection in nursing home residents at midterm after Comirnaty® COVID-19 vaccination.

Severe Acute Respiratory Syndrome Coronavirus 2 Adaptive Immunity in Nursing Home Residents Following a Third Dose of the Comirnaty Coronavirus Disease 2019 Vaccine.

A third Comirnaty vaccine dose increased severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain antibody levels (median, 93-fold) and neutralizing antibody titers against Wuhan-Hu-1 (median, 57-fold), Beta (me 22-fold), Delta, (median, 43-fold), and Omicron (median, 8-fold) variants, but had less impact on S-reactive T-cell immunity in nursing home residents.

SARS-CoV-2 adaptive immunity in nursing home residents up to eight months after two doses of the Comirnaty® COVID-19 vaccine.

Burgos JS (General Directorate of Research and Healthcare Supervision, Department of Health, Valencia Government, Valencia, Spain); Meneu de Guillerna R (Vice-President Foundation Research Institute in Public Services, Valencia, Spain); Vanaclocha Luna H (General Directorate of Public Health, Department of Health, Valencia Government, Valencia, Spain); Burks DJ (The Prince Felipe Research Center-CIPF-, Valencia, Spain; Cervantes A (INCLIVA Health Research Institute, Valencia, Spain); Comas I (Biomedicine Institute of Valencia, Spanish Research Council (CSIC); Díez-Domingo J (Foundation for the promotion of health and biomedical research of the Valencian Community-FISABIO-, Valencia, Spain); Peiro S (Foundation for the promotion of health and biomedical research of the Valencian Community-FISABIO-, Valencia, Spain); González-Candelas F (CIBER in Epidemiology and Public Health, Spain; Joint Research Unit "Infection and Public Health" FISABIO-University of Valencia, Valencia, Spain; Institute for Integrative Systems Biology (I2SysBio), CSIC-University of Valencia, Valencia, Spain); Ferrer Albiach C (Fundación Hospital Provincial de Castelló); Hernández-Aguado I (University Miguel Hernández, Alicante, Spain); Oliver Ramírez N (DataPop Alliance); Sánchez-Payá J (Preventive Medicine Service, Alicante General and University Hospital, Alicante, Spain; Alicante Institute of Health and Biomedical Research (ISABIAL), Alicante, Spain; Vento Torres M (Instituto de Investigación Sanitaria La Fe); Zapater Latorre E (Fundación Hospital General Universitario de València); Navarro D (Microbiology Service, Clinic University Hospital, INCLIVA Health Research Institute, Valencia, Spain;Department of Microbiology, School of Medicine, University of Valencia, Valencia, Spain).

Immunological response against SARS-CoV-2 following full-dose administration of Comirnaty® COVID-19 vaccine in nursing home residents.

OBJECTIVES: The current study was aimed at examining SARS-CoV-2 immune responses following two doses of Comirnaty® COVID-19 vaccine among elderly people in nursing homes. METHODS: A prospective cohort study in a representative sample from nursing homes in Valencia (n = 881; males: 271, females 610; median age, 86 years) recruited residents using a random one-stage cluster sampling approach. A lateral flow immunochromatography device (LFIC) (OnSite COVID-19 IgG/IgM Rapid Test; CTK BIOTECH, Poway, CA, USA) was used as the front-line test for detecting SARS-CoV-2-Spike (S)-specific antibodies in whole blood obtained using a fingerstick. Residents returning negative LFIC results underwent venipuncture and testing for presence of SARS-CoV-2-S-reactive antibodies and T cells using the Roche Elecsys® Anti-SARS-CoV-2 S (Roche Diagnostics, Pleasanton, CA, USA), the LIAISON® SARS-CoV-2 TrimericS IgG assay (Diasorin S.p.A, Saluggia, Italy) and by flow cytometry, respectively. RESULTS: The SARS-CoV-2-S antibody detection rate in nursing home residents was 99.6% (283/284) and 98.3% (587/597) for SARS-CoV-2 recovered and naïve residents, respectively, within a median of 99 days (range 17-125 days) after full vaccination. Three out of five residents lacking SARS-CoV-2-S antibodies had detectable S-reactive CD8+ and/or CD4+ T cells. In addition, 50/50 and 40/50 participants with detectable SARS-CoV-2 antibodies also had SARS-CoV-2-S-reactive interferon-γ-producing CD4+ and CD8+ T cells, respectively. DISCUSSION: The Comirnaty® COVID-19 vaccine is highly immunogenic in nursing home residents.

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial.

BACKGROUND: Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients' associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). METHODS/DESIGN: Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients' associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. DISCUSSION: The first data gathered have allowed us to identify the characteristics of the study population and they support the appropriateness of the inclusion criteria.. When the study is complete, the results will enable us to establish whether this kind of intervention can be used as a self-regulation tool for increasing and maintaining walking as unsupervised physical exercise of low to moderate intensity in fibromyalgia patients. TRIAL REGISTRATION NUMBER: ISRCTN68584893.

A study of the prevalence of adverse events in primary healthcare in Spain.

BACKGROUND: Healthcare practices involve risks for patients, but there has been little research to date on the occurrence of adverse events (AE) in primary care (PC). The frequency of AE in PC in Spain, the factors that contribute to their occurrence, their severity and their preventability, were analysed. METHODS: Observational cross-sectional study was carried out in 48 PC centres in 16 regions of Spain. PC professionals were asked to assess whether the AE was caused by the healthcare or if it was an expectable consequence of the patient's underlying condition. A total of 452 healthcare professionals who attended 96 047 consultations were involved. RESULTS: A total of 773 AE were identified, so that the point prevalence of AE was 0.8% [95% confidence interval (CI) 0.76-0.85]. A majority of AE (64.3%) were considered preventable and only 5.9% were severe, usually related to medication [odds ratio (OR) = 4.6; 95% CI 2.1-10.3]. The most frequent causal factor of the AE was associated with medication (adverse drug reactions and medication errors), but problems in communication and management were at the root of many of the AE. Nurses reported more preventable AE (OR = 1.9; 95% CI 1.2-2.8). CONCLUSION: In spite of an AE being less damaging in PC, large numbers of patients and professionals suffer their consequences each year. An awareness of the magnitude and impact of AE is the first step on the road to the cultural change necessary for achieving safer healthcare.

[Adverse events in ambulatory surgical procedures]. / Efectos adversos en cirugía mayor ambulatoria.

OBJECTIVE: To assess the incidence of adverse events and patients with adverse events in ambulatory surgical procedures and to compare it with that of other studies. MATERIAL AND METHOD: Historical cohort study. The scope of the study was the ambulatory surgical procedures unit of a university hospital. All general surgery department patients seen in this unit during the year 2005 were included. RESULTS: The incidence of patients with adverse events directly related to hospital care was of 3% (95% CI, 0.9-5). Of the adverse events identified 5 were considered slight, 3 moderate and none were considered serious. All the moderate ones were considered unavoidable and of slight, only the one was avoidable. Six of the adverse events were associated to a procedure, one due to hospital infections and one with other causes. There was an increase in hospital stay due to 75% of the adverse events, and 25% of them affected admission. CONCLUSIONS: The incidence of adverse events related to medical care in the Spanish hospitals is similar to those found in the studies carried out in American and European countries using the same methodology. The surgical area is considered a high risk unit. However, ambulatory surgical procedures reduce these risks, in such a way that the incidence is far below that of surgery department. Therefore, besides improving the technical efficiency of the clinical services, it is safer for the patients.

Efectos adversos en cirugía mayor ambulatoria / Adverse events in ambulatory surgical procedures

Objetivo. Determinar la incidencia de efectos adversos y de pacientes con efectos adversos en cirugía mayor ambulatoria y compararla con la incidencia encontrada en los servicios de cirugía general incluidos en el estudio ENEAS. Material y método. Estudio de cohortes históricas. El ámbito del estudio fue la unidad de cirugía mayor ambulatoria de un hospital universitario. Se incluyó a todos los pacientes atendidos en el servicio de cirugía general durante el año 2005. Resultados. La incidencia de pacientes con efectos adversos relacionados directamente con la asistencia sanitaria fue del 3% (intervalo de confianza del95%, 0,9-5). De los 8 efectos adversos detectados, 5se consideraron leves, 3 moderados y ninguno grave. Todos los moderados se consideraron inevitables y de los leves tan sólo uno era evitable. Entre los efectos adversos, 6 tuvieron relación con un procedimiento, uno con infección nosocomial y otro con otras causas. Tres cuartas partes de los efectos adversos tuvieron como consecuencia un incremento de la estancia y en una cuarta parte el efecto adverso condicionó el ingreso. Conclusiones. La incidencia de efectos adversos relacionados con la asistencia sanitaria en los hospitales españoles es similar a la de los estudios realizados en países americanos y europeos con similar metodología. Se considera que el área quirúrgica es de alto riesgo para desencadenarlos; sin embargo, la cirugía mayor ambulatoria reduce su incidencia. Por lo tanto, además de mejorar la eficiencia técnica de los servicios clínicos, es más segura para los pacientes (AU)

Objective. To assess the incidence of adverse events and patients with adverse events in ambulatory surgical procedures and to compare it with that of other studies. Material and method. Historical cohort study. The scope of the study was the ambulatory surgical procedures unit of a university hospital. All general surgery department patients seen in this unit during the year 2005 were included. Results. The incidence of patients with adverse events directly related to hospital care was of 3% (95% CI, 0.9-5). Of the adverse events identified 5 were considered slight, 3 moderate and none were considered serious. All the moderate ones were considered unavoidable and of slight, only the one was avoidable. Six of the adverse events were associated to a procedure, one due to hospital infections an done with other causes. There was an increase in hospital stay due to 75% of the adverse events, and 25%of them affected admission. Conclusions. The incidence of adverse events related to medical care in the Spanish hospitals is similar to those found in the studies carried out in American and European countries using the same methodology. The surgical area is considered a high risk unit. However, ambulatory surgical procedures reduce these risks, in such a way that the incidence is far below that of surgery department. Therefore, besides improving the technical efficiency of the clinical services, itis safer for the patients (AU)

[Health assistance as a risk factor: side effects related to clinical practice]. / La asistencia sanitaria como factor de riesgo: los efectos adversos ligados a la práctica clínica.

The increasingly complex health care systems, together with more vulnerable, highly informed and demanding patients, conform a clinical environment in where adverse effects (AE) related to health care practice appear. The incidence of AE in hospitalized patients has been estimated between a 4 and a 17%. Twenty-five per cent of them were serious and half were considered avoidable. Seventy per cent of the AE are due to technical failures, faults in the decision making process, inappropriate performance based on the available information, problems in the anamnesis, and absent or inadequate health care provision. The explanatory model of the causal chain of an adverse effect supports that systems failures are more important than people failures. The IDEA Project seeks to study the incidence of AE related to health care for the first time in Spain. To facilitate the necessary change from a punitive culture to a proactive culture, a multidisciplinary approach of the problem taking into account the point of view of health professionals, patients, community leaders and courts is needed.

La asistencia sanitaria como factor de riesgo: los efectos adversos ligados a la práctica clínica / Health assistance as a risk factor: side effects related to clinical practice

Los sistemas sanitarios cada vez más complejos, junto con pacientes más vulnerables y a la vez más informados y demandantes, conforman un entorno clínico en el que aparecen los efectos adversos (EA) ligados a la asistencia sanitaria. La incidencia de EA en pacientes hospitalizados se ha estimado entre el 4 y el 17%. Una cuarta parte fueron graves y el 50% se consideró evitables. El 70% de los EA se deben a fallos técnicos, defectos en la toma de decisiones, no actuación de la manera más apropiada en función de la información disponible, problemas en la anamnesis, y ausencia o prestación inadecuada de cuidados necesarios. El modelo explicativo de la cadena causal de un efecto adverso mantiene que son más importantes los fallos de sistema que los fallos de las personas. Para facilitar el necesario cambio de la cultura punitiva a la cultura proactiva es necesario el enfoque multidisciplinario del problema teniendo en cuenta el punto de vista de los profesionales, los pacientes, los líderes sociales y la magistratura (AU)

The increasingly complex health care systems, together with more vulnerable, highly informed and demanding patients, conform a clinical environment in where adverse effects (AE) related to health care practice appear. The incidence of AE in hospitalized patients has been estimated between a 4 and a 17%. Twenty-five per cent of them were serious and half were considered avoidable. Seventy per cent of the AE are due to technical failures, faults in the decision making process, inappropriate performance based on the available information, problems in the anamnesis, and absent or inadequate health care provision. The explanatory model of the causal chain of an adverse effect supports that systems failures are more important than people failures. The IDEA Project seeks to study the incidence of AE related to health care for the first time in Spain. To facilitate the necessary change from a punitive culture to a proactive culture, a multidisciplinary approach of the problem taking into account the point of view of health professionals, patients, community leaders and courts is needed (AU)

Siguiendo la pista de los efectos adversos: cómo detectarlos / Monitoring adverse events: how to detect them

Objetivos: Comparar la efectividad, la validez y la aceptabilidad al estimar tasas de efectos adversos y su carácter evitable al utilizar 3 métodos diferentes: transversal, prospectivo y retrospectivo. Diseño: Valoración independiente de los métodos sobre una misma muestra. Participantes: Un total de 778 pacientes en 37 unidades clínicas en Francia. Medidas principales: Efectividad: proporción de casos identificados por cada método comparados con una lista de la referencia de casos confirmados por el personal del servicio y proporción de casos evitables. Otras medidas secundarias: fiabilidad en el cribado e identificación interobservador, carga de trabajo percibida y validez percibida de los resultados. Resultados: Los métodos prospectivo y retrospectivo identificaron un número similar de casos médicos y quirúrgicos (el 70 y el 66% del total, respectivamente), pero el prospectivo identificó más casos evitables (el 64 y el 40%, respectivamente). El método transversal mostró muchos falsos positivos y no identificó ninguno de los efectos adversos más graves. Ninguno de los métodos resultó apropiado para las unidades obstétricas. La carga de trabajo fue percibida como similar para los métodos prospectivo y transversal, y menor para el retrospectivo. Conclusión: En este estudio se han encontrado diferencias en la efectividad de identificación de estos métodos por tipo de servicio pero, globalmente, el método retrospectivo es igual de eficaz que el prospectivo para la identificación de efectos adversos. El papel que han de desempeñar los métodos epidemiológicos en el estudio de los efectos adversos podría resumirse en que el método transversal tiene un interesante coste de oportunidad en nuestro medio, el estudio de cohortes retrospectivo sigue siendo el método de referencia para evaluar la aparición de los efectos adversos; el prospectivo ha destacado por sus virtudes pedagógicas y comunicativas, y su buena apreciación de las cadenas de efectos y sus consecuencias y el estudio de casos y controles se podría utilizar para la evaluación del impacto de los efectos adversos

Objectives: To compare the effectiveness, reliability, and acceptability of estimating rates of adverse events and rates of preventable adverse events using three methods: cross sectional, prospective, and retrospective. Design: Independent assessment of three methods applied to the same sample. Participants: A total of 778 patients in 37 wards in France. Main outcome measures: Effectiveness: the proportion of cases identified by each method compared with a reference list of cases confirmed by ward staff and the proportion of preventable cases. Secondary outcome measures were inter-rater reliability in screening and identification, perceived workload, and the perceived validity of the results. Results: The prospective and retrospective methods identified similar numbers of medical and surgical cases (70% and 66% of the total, respectively), but the prospective method identified a greater number of preventable events (64% and 40%, respectively). The cross sectional method showed a large number of false positives and identified none of the most serious adverse events. None of the methods was appropriate for obstetrics. The workload for the prospective and cross sectional methods was perceived as similar and that for the retrospective method was perceived as lower. Conclusion: In this study, differences in the effectiveness of the three methods were found according to ward type; however, the overall effectiveness of the retrospective and prospective methods in identifying adverse events was similar. The role of epidemiological methods in the study of adverse events can be summarized as follows: the cross sectional method can be useful in certain circumstances; the retrospective cohort study continues to be the reference method to evaluate the incidence of adverse events; the prospective method has notable pedagogic and communicative properties and is effective in appraising chains of events and consequences, and the case-control study could be used to evaluate the impact of adverse events

Incidencia e impacto de los efectos adversos en dos hospitales / Incidence and impact of adverse events in two hospitals

Objetivos: Presentar los resultados preliminares del proyecto IDEA relativos a la incidencia e impacto de los efectos adversos (EA) en dos de los hospitales incluidos en el estudio. Material y método: Diseño: estudio de cohortes prospectivo realizado durante el primer trimestre de 2004 en dos servicios de dos hospitales de la Comunidad Valenciana. Muestreo consecutivo. Sujetos: pacientes de más de 14 años, ingresados más de 24 h en los servicios seleccionados, en total, 673 sujetos. Medidas principales: proporción de alerta de EA (formulario de cribado positivo) e incidencia acumulada de EA identificados (cuestionario modular para su confirmación y caracterización). Resultados: La incidencia de alertas fue de un 34,7% para el hospital A (servicio de cirugía general) y de un 31% en el hospital B (servicio de medicina interna). La incidencia de EA fue del 16,1 y el 5,6%, respectivamente. El 42,1% de los EA del hospital A y el 16,7% del hospital B fueron considerados evitables, independientemente de la gravedad de sus consecuencias. Conclusiones: Los sistemas de vigilancia de alerta de los EA se han mostrado muy diferentes en los servicios estudiados. La variabilidad en la práctica clínica condiciona la identificación de los EA al revisar las historias clínicas

Objectives: To present the preliminary results of the IDEA project relating to the effect and impact of adverse events in two of the hospitals included in the study. Material and method: Design: prospective cohort study carried out in the first quarter of 2004 in two wards of two hospitals of the Autonomous Community of Valencia (Spain). Sampling: consecutive. Subjects: patients more than 14 years old, hospitalized for more than 24 hours in the selected wards. The total number of subjects was 673. Main measurements: proportion of adverse event alerts (positive detection questionnaire) and the accumulated incidence of identified adverse events (modular questionnaire for confirmation of AE and their characterization). Results: The incidence of alerts was 34.7% in hospital A (general surgery ward) and 31% in hospital B (internal medicine ward). The incidence of adverse events was 16.1% and 5.6% respectively. A total of 42.1% of the adverse events in hospital A and 16.7% of those in hospital B were avoidable, independently of the seriousness of their consequences. Conclusions: The adverse event surveillance systems differed between the two wards studied. Variability in clinical practice affects identification of adverse events on reviewing medical records