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BACKGROUND: Patients should be closely monitored during procedures under sedation outside the operating room, but it is unclear which type of monitoring is best. We investigated the efficacy and safety of BIS monitoring vs conventional monitoring for sedation during colonoscopy. METHODS: We performed a double-blind clinical trial in 180 patients undergoing elective colonoscopy. Patients were randomized to 1) the BIS group or 2) a control group, in which sedation was monitored with a BIS monitor or the Ramsay Sedation Score, respectively. The primary outcome was the rate of sedation-induced adverse events in both groups. Secondary outcomes were the characteristics of patients who developed adverse events, and time during colonoscopy when these events occurred, propofol and remifentanil dosage, and patient satisfaction. RESULTS: Univariate analysis showed fewer cardiopulmonary complications in the BIS group (41.11% vs 57.78% in controls; p = 0.02). Multivariate analysis found a significantly higher risk of adverse events in older patients (95% CI, 1.013-1.091; p = 0.0087) and in men (95% CI, 1.129-7.668; p = 0.0272). These events were observed at the hepatic flexure. No significant differences between propofol or remifentanil dosage, use of rescue medication, and patient satisfaction were observed between groups. CONCLUSIONS: Our data suggest that BIS monitoring during sedation in scheduled colonoscopies reduces adverse respiratory events. Although its routine use in sedation does not appear to be warranted, clinicians should take steps to identify patients with a higher risk of complications who might benefit from this type of monitoring.

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Objectives: Hypoalbuminemia is a negative acute phase reactant which has been associated with inflammatory response and poor outcome in infectious diseases. The aim of this study was to analyze the value of hypoalbuminemia on admission as a predictor of mortality and adverse events in COVID-19 patients.MethodsWe analyzed retrospective data from a cohort of 609 consecutive patients, with confirmed diagnosis of COVID-19, discharged from hospital (deceased or alive). Demographic characteristics, previous comorbidities, symptoms and laboratory findings on admission were collected. Comorbidities were assessed by Charlson-Age Comorbidity Index.ResultsHypoalbuminemia on admission (<34g/L) was more frequent in nonsurvivors than survivors (65.6% vs. 38%, p<0.001) and was significantly associated with the development of sepsis, macrophage activation syndrome, acute heart failure, acute respiratory distress syndrome and acute kidney injury, regardless of Charlson-Age Comorbidity Index. Hypoalbuminemia was a predictor of mortality in multivariable Cox regression analysis (HR 1.537, 95% CI 1.050–2.250, p=0.027), independently of Charlson-Age Index, gender, lymphocyte count <800/μL, creatinine, high-sensitivity C- reactive protein >8mg/L, lactate dehydrogenase >250U/L, bilateral infiltration on chest X-ray and q-SOFA ≥2.ConclusionsHypoalbuminemia was an early predictor of in-hospital mortality in COVID-19, regardless of age, comorbidity and inflammatory markers. It also had significant association with severe adverse events, independently of Charlson-Age Comorbidity Index. Our results suggest that serum albumin determination on admission may help to identify patients with SARS-CoV-2 infection at high risk of developing potential life-threatening conditions and death. (AU)

Objetivos: La hipoalbuminemia es un reactante de fase aguda negativo que ha sido asociado a la respuesta inflamatoria y mal resultado en enfermedades infecciosas. El objetivo de este estudio fue analizar el valor de la hipoalbuminemia en el momento del ingreso, como factor predictivo de mortalidad y episodios adversos en los pacientes de COVID-19.MétodosAnalizamos los datos retrospectivos de una cohorte de 609 pacientes consecutivos, con diagnóstico confirmado de COVID-19, que abandonaron el hospital (fallecidos o vivos). Se recopilaron las características demográficas, comorbilidades previas, síntomas y hallazgos de laboratorio en el momento del ingreso. Las comorbilidades se asociaron al índice de comorbilidad de Charlson-Age.ResultadosLa hipoalbuminemia en el momento del ingreso (<34g/l) fue más frecuente en los no supervivientes que en los supervivientes (65,6 vs. 38%; p<0,001) y estuvo significativamente asociada a desarrollo de sepsis, síndrome de activación macrofágica, insuficiencia cardiaca aguda, síndrome de distrés respiratorio agudo e insuficiencia renal aguda, independientemente del índice de comorbilidad de Charlson-Age. La hipoalbuminemia fue un factor predictivo de la mortalidad en el análisis multivariable de regresión de Cox (HR: 1,537; IC 95%: 1,050-2,250; p=0,027), independientemente del índice de Charlson-Age, sexo, recuento linfocítico <800/μl, creatinina, proteína C reactiva de alta sensibilidad >8mg/l, lactato deshidrogenasa >250U/l, infiltración bilateral en la placa de tórax y q-SOFA ≥2. (AU)

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Objetivo: Caracterizar los episodios adversos relacionados con la asistencia sanitaria en pacientes infectados por SARS-CoV-2 fallecidos en un hospital de tercer nivel.MétodosEstudio observacional retrospectivo en el que se incluyeron los pacientes fallecidos en el centro entre el 16 de marzo y el 10 de abril de 2020. La información fue extraída desde la historia clínica electrónica.ResultadosLa mediana de edad de los 164 pacientes analizados fue de 77,5 años. Más de 9 de cada 10 pacientes fallecidos presentaban al menos una comorbilidad. El 40,2% de los pacientes presentó al menos un episodio adverso (EA) asociado a la atención sanitaria. Un 23,8% de los pacientes presentó alguna reacción adversa a medicamentos, constituyendo la primera causa de EA entre los pacientes fallecidos. Entre los pacientes que fallecieron en unidades de cuidados intensivos, los problemas relacionados con la ventilación mecánica han aparecido con una frecuencia del 8,8%.ConclusionesA pesar de que la letalidad asociada a los EA detectados fue muy reducida, es fundamental establecer una vigilancia estrecha de los posibles EA asociados a la asistencia sanitaria, especialmente los farmacológicos, dado que se trata de una enfermedad con un tratamiento terapéutico incierto. (AU)

Objective: To characterize health care-related adverse events in patients with SARS-CoV-2 infection who died in a tertiary hospital.MethodsThis is a retrospective, observational study, that included patients who died at HUGTiP hospital between 16 March and 10 April 2020. Data was extracted from the electronic medical record.ResultsThe median age of the 164 SARS-CoV-2 infected patients who died in the center in the study period was 77.5 years and> 90% of patients had ≥ 1 comorbidity. Forty point two percent of patients had at least ≥ 1 health care-related adverse event. Twenty three point eight of patients had an adverse drug reaction, the leading cause of adverse events in patients who died. Of patients who died in intensive care units, the frequency of problems related to mechanical ventilation was 8.8%.ConclusionsAlthough the case fatality rate associated with the adverse events detected was very low, close monitoring of potential health care-related adverse events, especially drug reactions, as the therapeutic management of the disease remains unclear. (AU)

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OBJECTIVES: Hypoalbuminemia is a negative acute phase reactant which has been associated with inflammatory response and poor outcome in infectious diseases. The aim of this study was to analyze the value of hypoalbuminemia on admission as a predictor of mortality and adverse events in COVID-19 patients. METHODS: We analyzed retrospective data from a cohort of 609 consecutive patients, with confirmed diagnosis of COVID-19, discharged from hospital (deceased or alive). Demographic characteristics, previous comorbidities, symptoms and laboratory findings on admission were collected. Comorbidities were assessed by Charlson-Age Comorbidity Index. RESULTS: Hypoalbuminemia on admission (<34g/L) was more frequent in nonsurvivors than survivors (65.6% vs. 38%, p<0.001) and was significantly associated with the development of sepsis, macrophage activation syndrome, acute heart failure, acute respiratory distress syndrome and acute kidney injury, regardless of Charlson-Age Comorbidity Index. Hypoalbuminemia was a predictor of mortality in multivariable Cox regression analysis (HR 1.537, 95% CI 1.050-2.250, p=0.027), independently of Charlson-Age Index, gender, lymphocyte count <800/µL, creatinine, high-sensitivity C- reactive protein >8mg/L, lactate dehydrogenase >250U/L, bilateral infiltration on chest X-ray and q-SOFA ≥2. CONCLUSIONS: Hypoalbuminemia was an early predictor of in-hospital mortality in COVID-19, regardless of age, comorbidity and inflammatory markers. It also had significant association with severe adverse events, independently of Charlson-Age Comorbidity Index. Our results suggest that serum albumin determination on admission may help to identify patients with SARS-CoV-2 infection at high risk of developing potential life-threatening conditions and death.

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OBJECTIVE: To assess the additional value in the evaluation of incidents and adverse events by adding the IHI Skilled Nursing Facility Trigger Tool (SNFTT) to the Institute for Healthcare Improvement's Global Trigger Tool (GTT) in an acute geriatric hospital. MATERIAL AND METHODS: A one-year retrospective study reviewing 240 electronic clinical records using the general GTT, either alone or combined with SNFTT. MAIN OUTCOME MEASURES: Number of triggers and identified adverse events (AEs), categories of severity and preventability of AEs, GTT incidence rates, and the number needed to alert (NNA). RESULTS: One hundred and thirty-seven AEs were identified in 107 patients (57.1 AEs per 100 admissions). Of these, 127 (92.7%) occurred 3 or more days after admissions; 49.6% of the harm events were preventable. The NNA for GTT plus SNFTT was 8.6. No significant difference was found using the general GTT alone versus the general GTT plus SNFTT in terms of the main outcome measures. Eleven categories of triggers were better identified when using GTT plus SNFTT because with GTT alone they were allocated to a category of "Other": 9 from the care module (C15) and 2 from the medication module (M13). CONCLUSIONS: The study demonstrates that adding the SNFTT to the GTT did not increase its effectiveness as regards the evaluation of AEs. However, some triggers are better described in SNFTT and now have now been added into the general GTT method in our hospital.

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OBJECTIVE: To characterize health care-related adverse events in patients with SARS-CoV-2 infection who died in a tertiary hospital. METHODS: This is a retrospective, observational study, that included patients who died at HUGTiP hospital between 16 March and 10 April 2020. Data was extracted from the electronic medical record. RESULTS: The median age of the 164 SARS-CoV-2 infected patients who died in the center in the study period was 77.5 years and> 90% of patients had ≥ 1 comorbidity. Forty point two percent of patients had at least ≥ 1 health care-related adverse event. Twenty three point eight of patients had an adverse drug reaction, the leading cause of adverse events in patients who died. Of patients who died in intensive care units, the frequency of problems related to mechanical ventilation was 8.8%. CONCLUSIONS: Although the case fatality rate associated with the adverse events detected was very low, close monitoring of potential health care-related adverse events, especially drug reactions, as the therapeutic management of the disease remains unclear.

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INTRODUCTION: To assess the efficacy and safety of gastric peroral endoscopic myotomy for the treatment of gastroparesis. METHODS: PubMed, Embase, Cochrane Library and Web of Science databases were searched from their earliest records to May 2018. The evaluation of clinical efficacy and safety was based on gastric emptying scintigraphy normalization, the improvement in clinical symptoms and adverse event rate. R 3.5.0 software was used to calculate the pooled estimate rates by meta-analysis. The improvement rate of the Gastroparesis Cardinal Symptom Index score was analyzed at different follow-up times. RESULTS: Fourteen studies with a total of 276 patients were included in this systematic review. The pooled gastric emptying scintigraphy normalization rate was 61.3% (95% CI, 51.5-70.8%) and clinical symptom improvement rate was 88.2% (95% CI, 83.6-93.1%). Intra-operative complications were found in about 3.2% (95% CI, 0.1-4.2%) of all included patients, and postoperative adverse events in 2.1% (95% CI, 0.3-4.8%). The mean Gastroparesis Cardinal Symptom Index score improvement rate was about 90.2% at one month follow-up, 83.3% at three months, 70.3% at six months, 52.4% at twelve months and 57.1% at eighteen months. DISCUSSION: Our systematic review demonstrates that gastric peroral endoscopic myotomy is a safe and effective treatment for gastroparesis. Though the short-term outcomes are promising, prospective, randomized, controlled studies with large sample size and long-term follow-up are required to further confirm these results.

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OBJECTIVES: To investigate the prevalence of physicians and nurses involved in an adverse event within mental health. MATERIALS AND METHODS: A quantitative, cross-sectional study was performed. Six Flemish psychiatric hospitals (Belgium) participated in this exploratory cross-sectional study. All psychiatrists and nurses working in these hospitals were invited to complete an online questionnaire in March 2013. RESULTS: 28 psychiatrists and 252 nurses completed the survey. 205 (73%) of the 280 respondents were personally involved at least once in an adverse event within their entire career. Respondents reported that the adverse event with the greatest impact was related to suicide in almost 64% of the cases. About one in eight respondents considered quitting their job because of it. Almost 18% declared that due to the impact of the event, they believed that the quality of the administered care was affected for longer than one month. Respondents stated that they received much support of colleagues (95%), the chief nurse (86%) and the partner (71%). Colleagues seemed to be most supportive in the recovery process. CONCLUSIONS: Physicians and nurses working in inpatient mental health care may be at high risk to being confronted with an adverse event at some point in their career. The influence on health professionals involved in an adverse event on their work is particularly important in the first 4-24h. Professionals at those moments had higher likelihood to be involved in another adverse event. Institutions should seriously consider giving support almost at that time.

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