Adverse events in anesthesia: Analysis of claims against anesthesiologists affiliated to an insurance fund in Colombia. Cross-sectional study / Eventos adversos en anestesia: Análisis de las reclamaciones contra anestesiólogos afiliados a un fondo de aseguramiento en Colombia. Estudio de corte transversal

Abstract Introduction: Prevention, identification, analysis and reduction of adverse events (AEs) are all activities designed to increase safety of care in the clinical setting. Closed claims reviews are a strategy that allows to identify patient safety issues. This study analyzes adverse events resulting in malpractice lawsuits against anesthesiologists affiliated to an insurance fund in Colombia between 2013-2019. Objective: To analyze adverse events in closed medicolegal lawsuits against anesthesiologists affiliated to an insurance fund between 2013-2019. Methods: Cross-sectional observational study. Convenience sampling was used, including all closed claims in which anesthesiologists affiliated to an insurance fund in Colombia were sued during the observation period. Variables associated with the occurrence of AEs were analyzed. Results: Overall, 71 claims were analyzed, of which 33.5% were due to anesthesia-related AEs. Adverse events were found more frequently among ASA I-II patients (78.9%), and in surgical procedures (95.8%). The highest number of adverse events occurred in plastic surgery (29.6%); the event with the highest proportion was patient death (43.7%). Flaws in clinical records and failure to comply with the standards were found in a substantial number of cases. Conclusions: When compared with a previously published study in the same population, an increase in ethical, disciplinary and administrative claims was found, driven by events not directly related to anesthesia. Most of the anesthesia-related events occurred in the operating room during surgical procedures in patients and procedures categorized as low risk, and most of them were preventable.

Resumen Introducción: La prevención, identificación, análisis y reducción de los eventos adversos (EA), son actividades direccionadas a incrementar la seguridad de la atención en el entorno clínico. El estudio de los casos cerrados es una estrategia que permite identificar problemas relacionados con la seguridad del paciente. En este estudio se analizan eventos adversos conducentes a procesos medicolegales cerrados contra anestesiólogos afiliados a un fondo de aseguramiento en Colombia entre 2013-2019. Objetivo: Analizar los eventos adversos en procesos medicolegales cerrados de anestesiólogos afiliados a un fondo de aseguramiento entre 2013-2019. Métodos: Estudio observacional de corte transversal. Se analizó una muestra a conveniencia en la que se incluyeron todos los casos cerrados en los que anestesiólogos afiliados a un fondo de aseguramiento en Colombia fueron objeto de reclamaciones en el período de observación. Se analizaron variables relacionadas con la presentación del EA. Resultados: Se analizaron 71 reclamaciones, de las cuales el 33,5 % fueron por EA relacionado con anestesia. Los eventos adversos se encontraron con mayor frecuencia en pacientes ASA I-II (78,9 %), y en procedimientos quirúrgicos (95,8 %). El mayor número de eventos adversos se presentó en cirugía plástica (29,6 %); el evento de mayor proporción fue el fallecimiento del paciente (43,7 %). En un importante número de casos se demostró fallos en el registro de la historia clínica e incumplimiento de normas. Conclusiones: En relación con un estudio publicado previamente en la misma población, se encuentra un incremento en los procesos éticos, disciplinarios y administrativos, motivados por eventos sin una relación directa con el acto anestésico. La mayoría de eventos adversos relacionados con anestesia se presentan en procedimientos quirúrgicos, en salas de cirugía, en pacientes y procedimientos catalogados como de bajo riesgo, y son en su mayoría prevenibles.

In loco nursing practice inspection costs in a Brazilian setting / Costes de la inspección in loco de la supervisión de la práctica profesional de enfermería en una realidad brasileña / Custos da inspeção in loco da fiscalização do exercício profissional de Enfermagem em uma realidade brasileira

Abstract Objective: To identify the average direct cost related to the direct labor of the inspectors involved in the "in loco inspection" step of the inspection process carried out at the Headquarters of the Regional Nursing Council of São Paulo. Method: Quantitative, exploratory-descriptive research, in the form of a single case study. The non-probabilistic convenience sample consisted of records of initial and return "in loco inspections", carried out by inspectors working at the Headquarters of The Regional Nursing Council of São Paulo, from January 13, 2020 to March 13, 2020. Results: The average direct cost of initial in loco inspection (N = 182) corresponded to BRL 331.67 (SD = 140.32), ranging from BRL 115.80 to BRL 1071.15, and that of return in loco inspection (N = 98) to BRL 256.16 (SD = 130.90), ranging from BRL 77.20 to BRL 694.80. Time and cost variables analysis of initial and return in loco inspections showed an alpha significance level of 0.05, and it was possible to statistically state that the time (p ≤ 0.001) and the cost of initial in loco inspection (p ≤ 0.001) are higher than those for return in loco inspection. Conclusion: the cost of the step of "in loco inspection" will support the Nursing Council in the decision-making process aiming at allocating efficiency of human resources required in the inspection process.

RESUMEN Objetivo: Identificar el coste medio directo relacionado con la labor directa de los inspectores involucrados en la etapa de "inspección in loco" del proceso de inspección realizado en la Unidad Sede del Consejo Regional de Enfermería de São Paulo. Método: Investigación cuantitativa, exploratoria-descriptiva, en forma de estudio de caso único. La muestra de conveniencia no probabilística consistió en registros de "inspecciones in loco", iniciales y de retorno, realizadas por inspectores que trabajan en la Sede, desde el 13/01/2020 al 13/03/2020. Resultados: El coste medio directo de la inspección inicial (N = 182) correspondió a R$ 331,67 (DP = 140,32), con un rango de R$ 115,80 a R$ 1071,15, y el de la inspección de retorno (N = 98) a R$ 256,16 (DP = 130,90), oscilando entre R$ 77,20 y R$ 694,80. El análisis de las variables tiempo y coste de las inspecciones inicial y de retorno indicó un nivel de significancia alfa de 0.05, y fue posible afirmar estadísticamente que el tiempo (p ≤ 0.001) y el costo de la inspección inicial (p ≤ 0,001) son mayores que los de la inspección de retorno. Conclusión: el costo de la etapa de "inspección in loco" subsidiará el Consejo en el proceso de toma de decisiones buscando la eficiencia en la asignación de los recursos humanos requeridos en el proceso de inspección.

RESUMO Objetivo: Identificar o custo direto médio relativo à mão de obra direta dos fiscais envolvidos na etapa "inspeção in loco" do processo de fiscalização realizado na Unidade Sede do Conselho Regional de Enfermagem de São Paulo. Método: Pesquisa quantitativa, exploratório-descritiva, na modalidade de estudo de caso único. A amostra de conveniência, não probabilística, foi constituída por registros de "inspeções in loco", iniciais e de retorno, realizadas por fiscais atuantes na Unidade Sede, no período de 13/01/2020 a 13/03/2020. Resultados: O custo direto médio da inspeção in loco inicial (N = 182) correspondeu a R$ 331,67 (DP = 140,32), variando de R$ 115,80 a R$ 1071,15, e da inspeção in loco de retorno (N = 98) a R$ 256,16 (DP = 130,90), variando entre R$77,20 e R$ 694,80. A análise das variáveis tempo e custo das inspeções in loco iniciais e de retorno evidenciou nível de significância alfa de 0,05, sendo possível afirmar estatisticamente que o tempo (p ≤ 0,001) e o custo da inspeção in loco inicial (p ≤ 0,001) são maiores do que os da inspeção in loco de retorno. Conclusão: o custeio da etapa "inspeção in loco" subsidiará o Conselho no processo decisório visando à eficiência alocativa dos recursos humanos requeridos no processo de fiscalização.

Anesthesia-related care dissatisfaction: a cohort historical study to reveal related risks.

BACKGROUND: Most previous reports have used questionnaires to investigate patient satisfaction regarding anesthesia-related care. We retrospectively investigated the dissatisfaction rate for anesthesia and the contributing factors for it using a questionnaire including anesthesia-related adverse events and a simplified patient satisfaction scale. METHODS: This is a retrospective review of an institutional registry containing 21,606 anesthesia cases. We conducted multivariate logistic analysis in 9,429 patients using the incidence of dissatisfaction as a dependent variable and other covariates, including items of anesthesia registry and a postoperative questionnaire, as independent variables to investigate factors significantly associated with the risk of dissatisfaction with anesthesia. RESULTS: In the study population, 549 patients rated the anesthesia service as dissatisfactory. Multivariate analysis identified the preoperative presence of coexisting disease [odds ratio (OR), 1.29; 95% confidence interval (CI), 1.05-1.59], combination of regional anesthesia (OR, 1.44; 95% CI, 1.10-1.88), self-reported awareness (OR, 1.99; 95% CI, 1.29-3.06), postoperative nausea and vomiting (PONV) (OR, 1.54; 95% CI, 1.25-1.90), occurrence of nightmares (OR, 1.96; 95% CI, 1.52-2.53), and the number of days taken to visit a postoperative anesthesia consultation clinic (OR, 1.01; 95% CI, 1.00-1.02) to be independently associated with dissatisfaction with anesthesia service. CONCLUSIONS: Patients with coexisting disease, undergoing a combination of regional anesthesia, with self-reported awareness, experiencing PONV, suffering from nightmares, and who took longer to visit a postoperative anesthesia consultation clinic tended to rate our anesthesia service as dissatisfactory. Although the exact reasons for the factors contributing to dissatisfaction are unknown, this study suggests that there is room to improve our service.

Caracterización de los procesos de responsabilidad médica contra obstetras afiliados al Fepasde en Colombia, en el periodo 1999-2014. Cohorte Histórica / Characterization of medical malpractice claims against obstetricians affiliated to FEPASDE in Colombia 1999-2014: historic cohort

Abstract Introduction: Medical malpractice claims have been increasing at a constant rate worldwide, resulting in a burden for practitioners as well as for the health system. In obstetrics, the problem is even greater considering that it is one of the medical specialties with the largest number of medical malpractice suits. Objective: To characterize medical malpractice claims in the area of obstetrics in Colombia from the perspectives of the physician, the patient, the institution, the medical care provided, and the legal proceeding. Materials and methods: Historical descriptive cohort of closed medical malpractice cases between 1999 and 2014 filed against obstetricians affiliated to a special solidarity fund for support in lawsuit cases. Simple random sampling (n = 279) in a universe of 982 proceedings. Variables related to the proceeding, the obstetrician, the institution, medical care, and the patient were measured. Results: The most frequent lawsuits were related to ethics (44.4%). The proportion of unfavorable rulings was 7.7%, more frequently in civil cases (31.8%). The prevalence of lawsuits was higher in private institutions (60%). The majority of the cases were related to patients in the second half of the gestation period (86%). In 74.7% of the cases, legal action was initiated as a result of events occurring during childbirth. The most frequent cause was neonatal compromise (38.9%), followed by fetal compromise (24.7%). Conclusion: Care during childbirth, fetal, and neonatal demise are critical sources of medical malpractice claims.

Resumen Introducción: Los procesos de responsabilidad médica han tenido un aumento sostenido en el mundo, representando una carga para el profesional y el sistema de salud. En obstetricia el problema es aún mayor dada que es una de las especialidades con más acciones médico legales. Objetivo: Caracterizar los procesos de responsabilidad médica en obstetricia en Colombia, desde las dimensiones del médico, la paciente, la institución, la atención médica provista y el proceso legal. Materiales y métodos: Cohorte histórica descriptiva de procesos médico legales cerrados entre 1999 y 2014 contra obstetras asociados a un fondo solidario especial para auxilio en caso de demandas. Muestreo aleatorio simple (n = 279) de un universo de 982 procesos. Se midieron variables del proceso, obstetra, la institución, la atención médica y la paciente. Resultados: Los procesos más frecuentes fueron éticos (44,4%). La proporción de procesos desfavorables fue del 7.7%, con mayor frecuencia en procesos civiles (31,8%). Hubo mayor prevalencia de procesos en instituciones privadas (60%). La mayoría de los procesos ocurrió en pacientes en la segunda mitad de la gestación (86%). La acción judicial estuvo relacionada a hechos acaecidos durante la atención del parto en un 74,7% de las pacientes. La causa más frecuente de la acción legal, fue el compromiso del recién nacido (38,9%) seguido por el compromiso del feto (24,7%). Conclusiones: La atención del parto, la mortalidad fetal y del recién nacido son áreas críticas en la generación de procesos médico legales.

Costs of Drug Therapy in Patients with Ankylosing Spondylitis in Brazil.

INTRODUCTION: The Brazilian Public Health System offers free-of-charge drug treatment for ankylosing spondylitis (AS) to all Brazilian citizens. We report here the first population-based cohort study on patients with AS in Brazil. The aim of this study was to evaluate the costs of the tumour necrosis factor (anti-TNF) blockers and disease-modifying antirheumatic drugs (DMARDs) that were used in the treatments of patients with AS in Brazil between March 2010 and September 2013. METHODS: A retrospective cohort study was performed using administrative databases. All patients with a diagnosis of AS who were aged 18 years or older and had been dispensed anti-TNF or DMARDs were included in the analysis. The cost analysis was carried out from the health system perspective, and the results were described as median monthly cost per capita and the annual cost over the study period. RESULTS: A search of the databases identified 1251 patients with AS who were treated during the study period, of whom 63.3% were male; the median age was 41 years. During the study period, 78.0% of patients initiated treatment with anti-TNF drugs and 22.0% with DMARDs. The median monthly cost per capita was US$ 1650 for anti-TNF therapy and US$ 25 for treatment with DMARDs. Among the anti-TNF drugs, therapy with etanercept was associated with the lowest cost per patient, followed by adalimumab and infliximab. No difference in monthly cost was observed in relation to gender and age. CONCLUSION: The cost per patient of treating AS in this study cohort was lower with etanercept than with adalimumab and infliximab. These results highlights the economic burden of treating patients with AS.

The High Direct Medical Costs of Prader-Willi Syndrome.

OBJECTIVE: To assess medical resource utilization associated with Prader-Willi syndrome (PWS) in the US, hypothesized to be greater relative to a matched control group without PWS. STUDY DESIGN: We used a retrospective case-matched control design and longitudinal US administrative claims data (MarketScan) during a 5-year enrollment period (2009-2014). Patients with PWS were identified by Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code 759.81. Controls were matched on age, sex, and payer type. Outcomes included total, outpatient, inpatient and prescription costs. RESULTS: After matching and application of inclusion/exclusion criteria, we identified 2030 patients with PWS (1161 commercial, 38 Medicare supplemental, and 831 Medicaid). Commercially insured patients with PWS (median age 10 years) had 8.8-times greater total annual direct medical costs than their counterparts without PWS (median age 10 years: median costs $14 907 vs $819; P < .0001; mean costs: $28 712 vs $3246). Outpatient care comprised the largest portion of medical resource utilization for enrollees with and without PWS (median $5605 vs $675; P < .0001; mean $11 032 vs $1804), followed by mean annual inpatient and medication costs, which were $10 879 vs $1015 (P < .001) and $6801 vs $428 (P < .001), respectively. Total annual direct medical costs were ∼42% greater for Medicaid-insured patients with PWS than their commercially insured counterparts, an increase partly explained by claims for Medicaid Waiver day and residential habilitation. CONCLUSION: Direct medical resource utilization was considerably greater among patients with PWS than members without the condition. This study provides a first step toward quantifying the financial burden of PWS posed to individuals, families, and society.