Gray whale (Eschrichtius robustus) post-mortem findings from December 2018 through 2021 during the Unusual Mortality Event in the Eastern North Pacific.

Beginning in December 2018, increased numbers of gray whale (Eschrichtius robustus) strandings were reported along the west coast of Mexico, the United States, and Canada, prompting declaration of a gray whale Unusual Mortality Event (UME) by the United States National Marine Fisheries Service. Although strandings declined in 2020 and 2021 from a peak in 2019, the UME is still ongoing as of fall 2023. Between 17 December 2018 and 31 December 2021, 503 animals stranded along the west coast of North America, with 226 strandings in Mexico, 71 in California, 12 in Oregon, 56 in Washington, 21 in British Columbia, and 117 in Alaska. These included 187 males, 167 females, and 149 whales of undetermined sex; and 193 adults, 194 subadults, 40 calves, 1 fetus, and 75 whales of undetermined age class. We report on 61 of the 503 carcasses (12%) that had external and internal gross necropsy and/or histopathology data: of these 61 whales, findings that contributed to death were identified in 33 (54%) whales. Sixteen of the 61 (26%) were severely emaciated. Gross lesions of blunt force trauma consistent with vessel strike were identified in 11 of the 61 animals (18%), only two of which were emaciated. Two whales (3%) were entangled at time of death, and one died from entrapment. Signs of killer whale (Orcinus orca) interaction were documented in 19 of the 61 animals; five were deemed from recent interactions and three (5%) likely contributed to mortality. A specific cause of death could not be identified in 28 of 61 whales (46%). Additionally, logistical challenges and the advanced state of decomposition of most examined carcasses precluded detection of potential infectious or toxic causes of morbidity or mortality. Up to 2016, the eastern North Pacific population of gray whale population had generally been increasing since the cessation of historic whaling and a prior UME in 1999-2000. However, recent abundance and calf production estimates have declined, a trend that overlaps the current UME. The relative contributions of carrying capacity, environmental change, prey shifts, and infectious, toxic, and other processes to the increased gray whale mortalities have not yet been resolved. Nevertheless, the marked temporal increase in strandings, including findings of malnutrition in some of the whales, along with low calf production, likely represent consequences of complex and dynamic ecological interactions in the ocean impacting the population.

Características de los ensayos clínicos activos desarrollados en la Seguridad Social de Salud del Perú / Characteristics of the active clinical trials developed in the Social Health Security of Peru

Objetivo: Describir las características de los ensayos clínicos activos (EC) desarrollados en la Seguridad Social de Salud del Perú. Material y métodos: Estudio observacional y descriptivo de los EC activos entre el 24 mayo al 8 julio del 2021, inscritos en el Registro Peruano de Ensayos Clínicos durante el periodo 2007-2020. Se analizó la distribución de las diferentes variables tales como N° de EC, fase, redes de EsSalud, regiones en el Perú, patrocinador, fuentes de financiamiento, especialidad, número de centros de investigación (CI) de EsSalud por EC, CIEI que aprobó los ECs por CI, y el cálculo de frecuencias relativas y absolutas. Resultados: Se identificaron 97 EC, ejecutados 144 veces en 23 diferentes CI pertenecientes a EsSalud. El 94,9% de los EC activos fue patrocinado por la industria farmacéutica y el 36% pertenecen a la especialidad de oncología. El 80,42% son de fase III y el 70,8% fue aprobado por un CIEI de EsSalud. Conclusiones: Los EC activos en EsSalud se desarrollan mayormente en Lima, son financiados por la industria farmacéutica y se aprobaron en su mayoría en los CIEIs de EsSalud.

Objetive: To describe the characteristics of active clinical trials (CTs) developed in the Social Health Security of Peru. Material and methods: Observational and descriptive study of active CTs between May 24 to July 8, 2021, registered in the Peruvian Registry of Clinical Trials during the period 2007-2020. The distribution of the different variable was analyzed, such as the number of CTs, phase, EsSalud networks, sponsor, funding sources, specialty, number of EsSalud research centers per CT, CIEI that approved CT by research center, and the calculation of relative and absolute frequencies. Results: 97 active CTs were identified, executed 144 times in 23 different research centers that belong to EsSalud. 94.9% of the active CTs were sponsored by pharmaceutical industries and 36% belong to the specialty of oncology. 80.42% are phase III and 70.8% were approved by an EsSalud CIEI. Conclusions: The active CTs in EsSalud are developed mostly in Lima, are financed by the pharmaceutical industry and are mostly approved in the CIEI of EsSalud.

Diagnóstico situacional de los Comités Institucionales de Ética en Investigación de la Seguridad Social en Perú / Situational diagnosis of the Institutional Research Ethics Committees in Social Security in Peru

Introducción: Aunque el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) ha impulsado la conformación de Comités Institucionales de Ética en Investigación (CIEI) en la Seguridad Social de Salud del Perú (EsSalud), pueden existir aspectos perfectibles. Se describen las características de los CIEI de EsSalud y sus miembros durante el 2021. Material y Métodos: Se realizó un estudio descriptivo y observacional que empleó una base de datos secundaria. Se encuestó a los miembros de los CIEI de EsSalud mediante un formulario virtual confeccionado por IETSI. Resultados: Se incluyó a 114 miembros pertenecientes a 18 redes prestacionales de EsSalud. El 52,6% de los participantes era de sexo masculino, la media de edad fue de 50,6 ± 11,9 años y el 42,1% tenía función científica. El 38,8% de los CIEI evaluó más de cinco ensayos clínicos en los últimos dos años y el 72,2% más de cinco estudios observacionales en el mismo periodo de tiempo. Los miembros refirieron limitaciones para la realización de reuniones o supervisiones virtuales, falta de tiempo para la realización de sus labores debido a la alta carga laboral y necesidad de capacitaciones sobre metodología de la investigación y bioestadística. Conclusión: Es necesario mejorar el soporte administrativo y el plan de capacitaciones a los miembros de los CIEI de EsSalud, para el logro de competencias metodológicas, éticas y regulatorias que aseguren una mejora en los procesos de evaluación y monitoreo ético de las investigaciones con seres humanos a su cargo.

Background:Although the Instituto de Evaluación de Tecnologías e Investigaciones en Salud (IETSI) has promoted the formation of Institutional Research Ethics Committees (IRECs) in the social security of Peru (EsSalud), there may be perfectible aspects. The characteristics of the IREC of EsSalud and its members during 2021 are described. : Adescriptive and observational study was Material and Methodscarried out using a secondary database. IREC members were surveyed using a virtual form created by IETSI. 114 members belonging to 18 EsSalud networks were included. Results:52.6% of the participants were male, the mean age was 50.6 ± 11.9 years, and 42.1% had a scientific role. In 38.8% of the IREC were evaluated more than five clinical trials in the last two years and 72.2% more than five observational studies in the same period. The members reported limitations for holding virtual meetings or supervisions, lack of time to carry out their tasks due to the high workload and the need for training on research methodology and biostatistics. it is Conclusion:necessary to improve the administrative support and the training plan for the members of the IREC of EsSalud, to achieve methodological, ethical, and regulatory competencies that ensure an improvement in the processes of evaluation and ethical monitoring of human research.

Recomendaciones clínicas para la evaluación y manejo de riesgo de COVID-19 en personal de salud del Seguro Social del Perú (EsSalud) / Clinical recommendations for evaluation and risk management of COVID-19 in healthcare personnel in the Peruvian social insurance (EsSalud)

RESUMEN Actualmente estamos viviendo una pandemia de enfermedad causada por coronavirus (COVID-19). Un grupo vulnerable de ser infectado por este agente patógeno es el personal de salud. Por ello, el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) del Seguro Social del Perú (EsSalud) ha emitido recomendaciones clínicas sobre la Evaluación de riesgo y manejo de personal de salud en el contexto de la pandemia de COVID-19, que resumiremos en el presente artículo. Se incluye un flujograma de evaluación y manejo, así como una tabla para determinar el riesgo de presentar infección por COVID-19.

ABSTRACT We are currently experiencing a coronavirus disease (COVID-19) pandemic. A vulnerable group of being infected by this pathogenic agent is health personnel. For this reason, the Health Technology Assessment and Research Institute (IETSI in Spanish) of the Peruvian social insurance (EsSalud) has issued clinical recommendations on risk assessment and management of health care personnel in the context of the COVID-19 pandemic, which we will summarize in this paper. An evaluation and management flow chart are included, as well as a table to determine the risk of developing COVID-19 infection.

Enfermedad periodontal como factor de riesgo en enfermedad cardiovascular y parto pretérmino / Periodontal disease as risk factor in cardiovascular disease and preterm birth

La "Medicina Periodontal" estudia la contribución de la enfermedad periodontal a enfermedades sistémicas como la enfermedad cardiovascular y parto pretérmino. Este estudio se realizó en el Instituto Especializado Materno Perinatal (IEMP) en Lima-Perú, el cual registra anualmente entre 15,000 a 20,000 nacidos vivos, donde se concentra gran número de pacientes de alto riesgo obstétrico. Este estudio de casos y controles tiene como propósito determinar si la enfermedad periodontal puede incrementar el riesgo de tener enfermedad cardiovascular y parto pretérmino. Fue realizado desde Setiembre del 2004 a Febrero del 2005, se incluyeron un total 45 puérperas voluntarias. Los casos, conformados por 15 puérperas, se caracterizaron por tener diagnóstico de enfermedad cardiovascular con parto pretérmino con edad gestacional, entre 20 y 36 semanas o parto a término con edad gestacional mayor o igual a 37 semanas. Los controles, conformados por las 30 puérperas restantes, tenían diagnóstico de enfermedad cardiovascular, con parto pretérmino con edad gestacional entre 20 y 36 semanas o parto a término con edad gestacional mayor o igual a 37 semanas. Las variables de este estudio fueron factores de riesgo conocidos como: obstétricos, conductuales, cuidados prenatales, tipo de parto y peso del recién nacido. El diagnóstico periodontal se basó en los siguientes criterios: 1. Gingivitis, donde el valor del índice de 2 ó 3 indica presencia de enfermedad; 2. Pérdida de adherencia clínica (CAL), donde más del 50 por ciento de las superficies examinadas mayor o igual a 3 mm indica enfermedad y; 3. Profundidad de bolsa (PD), donde más del 50 por ciento de los dientes examinados mayor o igual a 3 mm de bolsa indicaba enfermedad. Los modelos de regresión logística multivariado, que controlan las otras potenciales variables confusoras, demostraron que la enfermedad periodontal fue estadísticamente significativa como factor de riesgo para la enfermedad cardiovascular...

The Periodontal Medicine studies the contribution of the periodontal disease to systemic diseases like cardiovascular disease and preterm birth. This research was conducted at the Instituto Especializado Materno Perinatal (IEMP) in Lima, Peru. This center registers between 15,000 and 20,000 successful birth per year where a lot of high risk patients are attended. This case-control study has as aim to determine if the periodontal cardiovascular disease and preterm birth. It was conducted since September 2004 until February 2005, including the participation of 45 pregnant voluntaries. The cases, conformed by 15 voluntaries, had a cardiovascular disease diagnosis, preterm birth with gestational age between 20 and 36 weeks or a term birth with gestational age of 37 weeks or more. Otherwise, the controls, conformed by 30 voluntaries, did not have cardiovascular disease diagnosis, preterm birth with gestational age between 20 and 36 weeks or a term birth with gestational age of 37 weeks or more. The variables of this research were risk factors like: obstetric, behavioral, pregnant care, type of birth and new born weight. The periodontal diagnosis was based on the following criteria: 1. Gingivitis, where the index value 2 – 3 indicates presence of disease; 2. Clinical attachment loss (CAL), where more than 50% of the examined surfaces more or equal than 3mm. indicate disease; and 3. Probing depth (PD) where more than 50% of examined teeth more or equal than 3mm of probing indicated disease. Multivariate models of logistic regression, that controls the order potential confusing variables, demonstrated that the periodontal disease was statistically significant as a risk factor for the cardiovascular disease and for the preterm birth. The OR was 4.8 IC 95% (1.04 – 21.99). The final results have evidences that the periodontal disease is a risk factor for the cardiovascular disease and preterm birth.