Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru.

OBJECTIVE: This study aimed to describe the results of inspection of clinical trials (CTs) and the feasibility of conducting inspections virtually in Peruvian Social Security hospitals during the pandemic of COVID-19. METHODS: This study described 25 CTs that were inspected during August 2021-November 2021. The data for the variables were obtained from the CT inspection database of the Social Security Sub-directorate of Regulation and Management of Health Research which includes minutes and inspection reports. We describe the characteristics of the CT included and findings during the inspections using relative and absolute frequencies. Likewise, we evaluated the feasibility of virtual inspection through a self-administered questionnaire. RESULTS: According to the findings of the inspection, 60% of CTs were on biological products, and 60% were focused on infectiology. Additionally, 64% of CTs were implemented in Lima, 52% were conducted in level IV health facilities, and 72% were funded by the pharmaceutical sector. The lack of submission of requested documents (16/25) and inadequate access to the internet (9/15) and source documents (4/15) were the primary observations during the inspection. Regarding the feasibility of virtual supervisions, most interviewees rated their understanding of instruction form as "normal" and its content as "adequate." Similarly, in the virtual self-assessment matrix, a large proportion of interviewees rated comprehension as "normal" (7/15) and its content as "adequate" (13/15). The quality of the virtual supervision process was 8.6 ± 1.1 on a scale of 1-10. CONCLUSION: Discrepancies in records and failure to submit requested documents were the main observations. Most interviewees considered the material to be adequate and gave an overall good rating to the virtual inspection process.

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.

[Factors associated with dropout in outpatient clinic in a Peruvian Social Security hospital]. / Factores asociados a deserción en consulta externa en hospital del Seguro Social del Perú.

BACKGROUND: dropout is considered a problem because attention is interrupted, causing in many cases, complications and important sequelae. The prevalence and factors associated with outpatient referral (DECE) in a national hospital in Peru, 2014-2015, were evaluated. METHODS: analytical cross-sectional design. The DECE is that medical appointment by external office that was not specified. Demographic factors related to the medical appointment were collected. To assess the factors associated with DECE, a generalized linear model of the Poisson family with robust standard errors (crude and adjusted) was used. RESULTS: Of 592160 medical appointments granted, the prevalence of DECE was 20.2%. The average age was 51.10 ± 23.23 years and 59.6% were women. The factors associated with a greater probability of DECE were: being a woman, being under 18 years of age or adult, programming schedule, type of patient of the service and the hospital; and have more than 15 days of deferral in the appointment. CONCLUSIONS: Conclusions: One out of every five patients did not make an appointment in the outpatient clinic. There were demographic and health system factors associated with a higher prevalence of DECE, which could be considered to propose strategies to reduce it.

INTRODUCCIÓN: se considera la deserción un problema debido a que interrumpe la atención, ocasionando, en muchos casos, complicaciones y secuelas importantes. Se planteó valorar la prevalencia y los factores asociados a la deserción en consulta externa (DECE) en un hospital nacional de Perú, 2014-2015. MÉTODOS: diseño transversal analítico. La DECE es aquella cita médica por consultorio externo que no fue concretada. Se recolectaron factores demográficos y relacionados a la cita médica. Para valorar los factores asociados a la DECE se utilizó un modelo lineal generalizado de la familia Poisson con errores estándares robustos (crudo y ajustado). Se reporta como medida de asociación a la razón de prevalencias (RP) con sus IC95%. RESULTADOS: de 592 160 citas médicas otorgadas, la prevalencia de DECE fue de 20.2%. La edad promedio fue 51.1 ± 23.2 años, y el 59.6% fueron mujeres. Los factores asociados a una mayor probabilidad de DECE fueron: ser mujer, ser menor de 18 años de edad, horario de programación (tarde), tipo de paciente (continuador y de reingreso) del servicio y del hospital y tener más de 15 días de diferimiento en la cita. En contraste, los factores que disminuyeron la probabilidad de DECE fueron: tener cita adicional, horario de programación (noche) y si fueron horas extras u horas de régimen de prestaciones complementarias de trabajo. CONCLUSIONES: uno de cada cinco pacientes no concretó su cita en consulta externa. Se evidenciaron factores demográficos y del sistema de salud asociados a una mayor prevalencia de DECE que podrían ser tomados en cuenta para plantear estrategias para disminuirla.

Geographic differences in overweight and obesity prevalence in Peruvian children, 2010-2015.

BACKGROUND: Childhood obesity is emerging as a major public health problem worldwide. To date, most studies of obesity and overweight in Peru are focused on adults, with few of them involving children, a population at a critical stage of development. The trend in overweight and obesity prevalence in Peruvian children under the age of five has not yet been determined. Thus, the objective of the present study is to evaluate the prevalence rates of overweight and obesity between 2010 and 2015 in children under the age of five, stratified by geographical areas in Peru. METHODS: Data were obtained from the Nutritional Status Information System of Peru. The total number of children evaluated was 14,155,914. For the Geographic Information Systems (GIS), the program Geo Da 1.8® was used to ascertain the spatial distribution of prevalence rates and was mapped for children under five. To assess the degree of spatial dependence, exploratory spatial data analysis was performed using the Moran's I statistic and was assessed with the Local Indicators of Spatial Association (LISA) analysis to identify geographic concentrations of high and low of obesity and overweight levels. RESULTS: Between 2010 and 2015, the national prevalence of childhood overweight and obesity ranged from 6.2%- 6.8% and 1.5%-2.7%, respectively. The highest prevalence of childhood overweight and obesity was found in 2014 and 2013, respectively. During these years, we observed that obesity decreased, but overweight remained stable. The highest prevalence of overweight and obesity was found in the departments located on the coast. Significant positive spatial autocorrelation was found for both overweight and obesity. The departments with the highest prevalence of overweight and obesity were concentrated in Lima, Callao, Ica, Moquegua and Tacna. The lowest were found in Loreto, Cusco and San Martin. CONCLUSION: The decrease in obesity and the stabilisation of overweight are positive results for the Peruvian childhood. However, in comparison with other Latin American countries, Peru still lags in obesity prevention.

[Associated Factors to non-use of Formal Health Services in the Peruvian Population: Analysis of the National Household Survey (ENAHO) 2015]. / Factores asociados a la no utilización de los servicios formales de prestación en salud en la población peruana: análisis de la encuesta nacional de hogares (ENAHO) 2015.

The aim of the study was to estimate the prevalence of non-use of health services (NUHS) and its associated factors using the National Household Survey (ENAHO 2015). The participants were defined as NUHS if they have presented any symptoms, discomfort, illness, relapse of chronic illness or accident during the last month and did not go to the health services. 35036 participants were analyzed; the prevalence of NUHS was 53,9%. NUHS was higher in the coastal region (adjusted Prevalence Ratio [aPR]=1.24;95%CI:1.17-1.31), highlands (aPR=1.38; 95%CI: 1.31-1.46) and jungle (aPR=1.25,95%CI:1.18-1.33) compared to Lima. Likewise, there were a higher prevalence of NUHS in participants without health insurance (aPR=1.59;95%CI:1.52-1.66) and those affiliated to Ministry of Health insurance (aPR=1.16;95%CI:1.11-1.22) compared to those affiliated to Social Security. More than half of the participants suffered from NUHS, which was associated with geographical and health system conditions. It is required evidenced-informed public policies to improve this situation.

El objetivo del estudio fue estimar la prevalencia de la no utilización de los servicios formales de prestación de salud (NUSFPS) y sus factores asociados en Perú. Se realizó un análisis secundario de datos de la Encuesta Nacional de Hogares (ENAHO) del año 2015. Se definió como NUSFPS a aquellos participantes que, pese a haber presentado algún síntoma, malestar, enfermedad, recaída de enfermedad crónica o accidente durante el último mes, no acudieron a los servicios de salud. Se analizaron 35 036 participantes; la prevalencia de NUSFPS fue de 53,9% (IC95%:52,9-54,8). La NUSFPS fue superior en la costa (razón de prevalencia ajustada [RPa] = 1,24;IC95%:1,17-1,31), sierra (RPa =1,38;IC95%:1,31-1,46) y selva (RP = 1,25;IC95%:1,181,33) en comparación a Lima Metropolitana. Hubo mayor prevalencia de NUSFPS en los participantes sinseguro (RPa = 1,59; IC95%: 1,52-1,66) y afiliados al seguro integral de salud (RPa = 1,16; IC95%: 1,11-1,22) comparados con los afiliados a la Seguridad Social. En conclusión, más de la mitad de los participantes padecieron NUSFPS, lo cual se asoció con condiciones geográficas y de aseguramiento. Se sugieren políticas públicas informadas en la evidencia para mejorar esta situación.

Factores asociados a la no utilización de los servicios formales de prestación en salud en la población peruana: análisis de la encuesta nacional de hogares (ENAHO) 2015 / Associated Factors to non-use of Formal Health Services in the Peruvian Population: Analysis of the National Household Survey (ENAHO) 2015

RESUMEN El objetivo del estudio fue estimar la prevalencia de la no utilización de los servicios formales de prestación de salud (NUSFPS) y sus factores asociados en Perú. Se realizó un análisis secundario de datos de la Encuesta Nacional de Hogares (ENAHO) del año 2015. Se definió como NUSFPS a aquellos participantes que, pese a haber presentado algún síntoma, malestar, enfermedad, recaída de enfermedad crónica o accidente durante el último mes, no acudieron a los servicios de salud. Se analizaron 35 036 participantes; la prevalencia de NUSFPS fue de 53,9% (IC95%:52,9-54,8). La NUSFPS fue superior en la costa (razón de prevalencia ajustada [RPa] = 1,24;IC95%:1,17-1,31), sierra (RPa =1,38;IC95%:1,31-1,46) y selva (RP = 1,25;IC95%:1,181,33) en comparación a Lima Metropolitana. Hubo mayor prevalencia de NUSFPS en los participantes sinseguro (RPa = 1,59; IC95%: 1,52-1,66) y afiliados al seguro integral de salud (RPa = 1,16; IC95%: 1,11-1,22) comparados con los afiliados a la Seguridad Social. En conclusión, más de la mitad de los participantes padecieron NUSFPS, lo cual se asoció con condiciones geográficas y de aseguramiento. Se sugieren políticas públicas informadas en la evidencia para mejorar esta situación.

ABSTRACT The aim of the study was to estimate the prevalence of non-use of health services (NUHS) and its associated factors using the National Household Survey (ENAHO 2015). The participants were defined as NUHS if they have presented any symptoms, discomfort, illness, relapse of chronic illness or accident during the last month and did not go to the health services. 35036 participants were analyzed; the prevalence of NUHS was 53,9%. NUHS was higher in the coastal region (adjusted Prevalence Ratio [aPR]=1.24;95%CI:1.17-1.31), highlands (aPR=1.38; 95%CI: 1.31-1.46) and jungle (aPR=1.25,95%CI:1.18-1.33) compared to Lima. Likewise, there were a higher prevalence of NUHS in participants without health insurance (aPR=1.59;95%CI:1.52-1.66) and those affiliated to Ministry of Health insurance (aPR=1.16;95%CI:1.11-1.22) compared to those affiliated to Social Security. More than half of the participants suffered from NUHS, which was associated with geographical and health system conditions. It is required evidenced-informed public policies to improve this situation.