ABSTRACT
Resumen Introducción : Existe poca información sobre la pre sencia de COVID-19 en participantes de ensayos clínicos. El objetivo del estudio fue evaluar la tasa de infección acumulada por SARS-CoV-2 en esta población. Además, investigamos el riesgo, letalidad y mortalidad por CO VID-19. Métodos : Diseño observacional retrospectivo que incluyó adultos participantes en ensayos clínicos de intervención aprobados por nuestro comité de ética du rante los dos primeros años de la pandemia (31/3/2020 a 31/3/2022). Se excluyeron protocolos pediátricos, obser vacionales, de corta duración y con sujetos internados. Resultados : Se incluyeron 513 sujetos adultos que participaron en ensayos clínicos durante ese período de la pandemia por COVID-19. Los pacientes con CO VID-19 se caracterizaron por tener una edad de 59.7 ± 13.7 años (50% sexo femenino) y el 92% presentó riesgo incrementado de letalidad por COVID-19. La tasa acu mulada de COVID-19 fue de 9.74% (IC 95%: 7.32-12.64%) que se situó por debajo del 17% de la población de 60 a 69 años de la Argentina (p<0.0001). La tasa de letalidad por COVID-19 fue de 14% (IC 95%: 5.8-26.7), que se situó por encima del 2.45% de la población de 50 a 69 años de la Argentina (p<0.0001). Conclusión : La tasa de COVID-19 en los sujetos adultos participantes de ensayos clínicos estuvo por debajo de las cifras de la población argentina de simi lar edad. La tasa de letalidad estuvo por encima de las cifras poblacionales y se explica por el alto riesgo de esa población.
Abstract Introduction : There is little information on the pres ence of COVID-19 in clinical trial participants. The objec tive of the study was to evaluate the cumulative infec tion rate for SARS-CoV-2 in this population. Additionally, we investigated the risk, lethality, and mortality from COVID-19. Methods : The design was observational retrospective that included adult subjects participating in clinical intervention trials approved by our ethics committee during the first two years of the pandemic (March 31, 2020 to March 31, 2022). Pediatric, observational, short-term, and inpatient protocols were excluded. Results : We included 513 adult subjects who par ticipated in clinical trials during the first two years of the COVID-19 pandemic. Patients with COVID-19 were characterized as being 59.7 ± 13.7 years old (50% fe male), and 92% had an increased risk of fatality from COVID-19. The cumulative rate of COVID-19 was 9.74% (95% CI: 7.32-12.64%) and its confidence intervals were below 17% of the population aged 60 to 69 in Argentina (p<0.0001). The case fatality rate for COVID-19 was 14% (95% CI: 5.8%-26.7%) and its confidence intervals were above 2.45% of the population aged 50 to 69 in Argentina (p< 0.0001). Conclusion : The rate of COVID-19 in adult subjects participating in clinical trials was below the figures for the Argentine population of similar age. The fatality rate was above the population figures, and it is explained by the high risk of the population.
ABSTRACT
Resumen El grado de comprensión de la información brindada en el proceso de consentimiento informado permite tomar una decisión libre y voluntaria. La comprensión y satisfacción de los participantes impactan sobre la adherencia a los ensayos clínicos. El objetivo de este estudio observacional fue analizar el grado de satisfacción de los sujetos con el proceso de consentimiento informado y con la participación en un ensayo clínico. Se incluyeron 3115 de 3404 encuestas recibidas, de 362 protocolos (y similar cantidad de in vestigadores) realizados en diversas provincias de la Argentina. El 91% de las personas clasificó la información recibida como muy buena o excelente y el 95% contestó que todas sus dudas fueron aclaradas. El 97% expresó su voluntad de volver a participar en estudios futuros y el 98% recomendaría a otras personas participar en ensayos clínicos. El puntaje de satisfacción con la participación en el estudio se asoció, en forma independiente de la edad y del nivel socioeconómico, con el deseo de volver a participar en un ensayo clínico (OR 13.6: IC95%: 4.7-39.1, p < 0.001) y con la recomendación a un tercero para que también participe (OR 16.7: IC95%: 4.4-63.4, p < 0.001). En esta muestra de la Argentina existe alto grado de satisfacción tanto con el proceso de toma de consentimiento informado como con la participación en los ensayos clínicos, en forma independiente de la edad y del nivel socioeconómico.
Abstract The level of comprehension on the information provided in the process of the informed consent can provide a free and voluntary decision. The comprehension and satisfaction of the participants affect their adherence to clinical trials. The objective of the study was to analyze the level of satisfaction of the subjects with the informed consent process as well as with their participation in clinical trials. A total of 3115 out of 3404 surveys received were included, from 362 protocols (with a similar number of investigators), conducted in different Argentinian provinces. Overall, 91% of the people classified the received information as rather good or excellent, and 95% replied that all of their doubts were cleared up. In the sur veys, 97% expressed their willingness to participate in future studies, and 98% would recommend participating in clinical trials to others. The satisfaction score with participation in the study was associated, independently of age and socioeconomic level, with the desire to participate in a clinical trial again (OR 13.6: 95% CI: 4.7- 39.1, p < 0.001) and with the recommendation to participate given to others (OR 16.7: 95% CI: 4.4-63.4, p < 0.001). In this sample from Argentina, there was a high degree of satisfaction both with the process of obtaining informed consent and with participation in clinical trials, regardless of age and socioeconomic status.
ABSTRACT
To evaluate the risk factors involved in antituberculosis treatment-induced hepatotoxicity. In a retrospective study we analyzed the rate of drug-induced hepatotoxicity in a sample of 456 patients. Patients received a combination of drugs including isoniazid, rifampin, pirazinamide and streptomycinor or ethambutol. The association among hepatotoxicity and several risk factors (age, sex, alcoholism and HIV infection) was studied by univariate methods, stratified analysis and the multiple logistic regression model. Signs of liver injury were found in 9.86 percent of the treated patients. In the logistic model, the adjusted odds ratios (OR) and significance were found as follows: a) for alcoholism, OR=17.31 (95 percent CI:6.35-47.16), p<0.001; b) for HIV infection, OR=3.23 (95 percent CI:1.47-7.11), p=0.003 and c) for female Sex, OR=2.44 (95 percent CI:1.22-4.86), p=0.011. Age was not significantly associated with hepatotoxicity. Alcoholism, HIV infection and female sex were associated with an increased risk of hepatotoxicity in this study.