Use and evaluation of a line probe assay in patients with tuberculosis in Peru: 2011-2013.

Objective To determine the use and performance of a line probe assay (LPA) compared with conventional culture and drug sensitivity testing (CDST) in patients registered with tuberculosis (TB) under routine program conditions in Peru in 2011-2013. Methods This was a descriptive, operational research, cross-sectional study of sputum specimens from patients with smear-positive pulmonary TB and mycobacterial cultures from patients with smear-negative or positive TB. Drug resistance to rifampicin and/or isoniazid detected by LPA was compared to CDST. Sensitivity, specificity, and predictive values were calculated and reliability for detecting drug resistance was assessed through kappa coefficient, with values 0.61-0.80 showing substantial correlation, and 0.81 or above showing almost-perfect correlation. Results In 2011-2013, there were 16 169 LPA tests performed, with the proportion of TB patients receiving the test increasing from 3.2% to 30.2%. In all, 2 905 LPA test results were compared to CDST. For LPA in sputum specimens, sensitivity for rifampicin was 92%; isoniazid, 94%; and MDR-TB, 88%; while specificity for rifampicin was 92%; isoniazid, 92%; and MDR-TB, 95%. For LPA in mycobacterial cultures, sensitivity for rifampicin was 95%; isoniazid, 96%; and MDR-TB, 90%; while specificity for rifampicin was 85%; isoniazid, 91%; and MDR-TB, 94%. Kappa coefficients were at 0.81 or above for all comparisons of LPA with CDST using sputum specimens and cultures, except for isoniazid in cultures, which was at 0.79. Conclusions This study suggests that LPA is a reliable and rapid screening test for drug-resistant TB and should be considered suitable for routine use and scale up in Peru.

Multidrug-resistant Acinetobacter baumannii Harboring OXA-24 carbapenemase, Spain.

In February 2006, a patient colonized with a multidrug-resistant sequence type 56 Acinetobacter baumannii strain was admitted to a hospital in Madrid, Spain. This strain spread rapidly and caused a large outbreak in the hospital. Clinicians should be alert for this strain because its spread would have serious health consequences.

Household transmission of SARS-CoV-2 (COVID-19) in Lima, Peru. / Transmisión intra-hogar en personas infectadas por SARS-CoV-2 (COVID-19) en Lima, Perú.

The study aimed to describe the characteristics of SARS-CoV-2 transmission among members of households with a confirmed primary case of COVID-19 in districts with low burden of cases in Lima, Peru, compared to a district with high burden. This was a retrospective study with a secondary database review. Information was collected from an epidemiological surveillance activity in close contacts (household members) in 52 households in Lima, with a single member with COVID-19. Reevaluation was conducted in 10 households. The study evaluated epidemiological and clinical variables and their association with the result of the rapid serological test (presence of IgG, IgM, or both). Secondary cases were found in 40 households, representing mean identification of 49.9% per household. Secondary attack rate in household members was 53% (125 cases), and symptomatic individuals accounted for 77.6% of cases (symptomatic/asymptomatic ratio: 3.5). Presence of fever and/or chills was found in 40% of persons with positive test results, followed by sore throat with 39.2%. Ageusia and anosmia were present in 22.4% and 20.8% of cases, respectively. When there was a primary case of COVID-19 in the household, the secondary attack rate was 53%; however, in an important proportion of households there were no positive cases other than the primary case. The epidemiological and clinical findings were consistent with reports from other international series.

El objetivo fue describir las características de la infección por SARS-CoV-2 entre miembros de hogares, con un caso confirmado primario de COVID-19, en distritos de baja carga de casos en Lima, Perú, en comparación con un distrito de alta carga. Estudio retrospectivo de revisión de base de datos secundaria. Se recolectó información proveniente de una actividad de vigilancia epidemiológica en contactos cercanos (cohabitantes), en 52 hogares de Lima, con un solo miembro con COVID-19. En 10 hogares se realizó una reevaluación. Se evaluaron variables epidemiológicas y clínicas; y su asociación con el resultado a la prueba serológica rápida (presencia de IgG, IgM o ambas). En 40 hogares se encontraron casos secundarios, lo que representa un 49,9% de identificación en promedio por hogar. Se encontró una tasa de ataque secundaria entre cohabitantes de 53% (125 casos), siendo sintomáticos un 77,6% de casos (razón sintomáticos/asintomáticos: 3,5). La presencia de fiebre y/o escalofríos se encontró en el 40% de las personas con resultado positivo, seguido del dolor de garganta en el 39,2%. La ageusia y anosmia estuvieron presentes en el 22,4% y 20,8% de los casos, respectivamente. Al tener un caso primario de COVID-19 en el hogar, la tasa de ataque secundaria de esta infección es de 53%; sin embargo, en una proporción importante de hogares evaluados no hubo un caso positivo, más allá del caso primario. Las características epidemiológicas y clínicas encontradas en este caso estuvieron acorde a lo ya reportado en otras series internacionales.

O objetivo foi descrever as características da infecção por SARS-CoV-2 entre os membros de domicílios, com um caso primário confirmado de COVID-19, em distritos com baixa carga de casos em Lima, Peru, em comparação com um distrito com alta carga. Estudo retrospectivo de revisão de banco de dados secundário. As informações foram coletadas em uma atividade de vigilância epidemiológica em contatos próximos (coabitantes), em 52 domicílios em Lima, com um único membro com COVID-19. Foi realizada uma reavaliação em 10 domicílios. Variáveis ​​epidemiológicas e clínicas foram avaliadas; e sua associação com o resultado do teste sorológico rápido (presença de IgG, IgM ou ambos). Os casos secundários foram encontrados em 40 domicílios, representando uma taxa média de identificação de 49,9% por domicílio. Foi encontrada uma taxa de ataque secundário entre coabitantes de 53% (125 casos), com 77,6% dos casos sendo sintomáticos (relação sintomático/assintomático: 3,5). A presença de febre e/ou calafrios foi encontrada em 40% das pessoas com resultado positivo, seguida de dor de garganta em 39,2%. Ageusia e anosmia estiveram presentes em 22,4% e 20,8% dos casos, respectivamente. Quando há um caso primário de COVID-19 em casa, a taxa de ataque secundário para essa infecção é de 53%; No entanto, em uma proporção significativa dos domicílios avaliados não houve caso positivo, além do caso primário. As características epidemiológicas e clínicas encontradas neste caso foram consistentes com o que já foi relatado em outras séries internacionais.

OXA-24 carbapenemase gene flanked by XerC/XerD-like recombination sites in different plasmids from different Acinetobacter species isolated during a nosocomial outbreak.

A clinical strain of Acinetobacter calcoaceticus resistant to carbapenems was isolated from a blood culture sample from an inpatient in a hospital in Madrid (Spain) during a large outbreak of infection (affecting more than 300 inpatients), caused by a multidrug-resistant Acinetobacter baumannii clone. The carbapenem resistance in both the A. calcoaceticus and A. baumannii clones was due to a bla(OXA-24) gene harbored in different plasmids. The plasmids were fully sequenced, revealing the presence of site-specific recombination binding sites putatively involved in mobilization of the bla(OXA-24) gene. Comparison of plasmids contained in the two strains revealed possible horizontal transmission of resistance genes between the Acinetobacter species.

Clinical and molecular characteristics of infections with CO2-dependent small-colony variants of Staphylococcus aureus.

Most Staphylococcus aureus small-colony variants (SCVs) are auxotrophs for menadione, hemin, or thymidine but rarely for CO(2). We conducted a prospective investigation of all clinical cases of CO(2)-dependent S. aureus during a 3-year period. We found 14 CO(2)-dependent isolates of S. aureus from 14 patients that fulfilled all requirements to be considered SCVs, 9 of which were methicillin resistant. The clinical presentations included four cases of catheter-related bacteremia, one complicated by endocarditis; two deep infections (mediastinitis and spondylodiscitis); four wound infections; two respiratory infections; and two cases of nasal colonization. Pulsed-field gel electrophoresis typing showed that the 14 isolates were distributed into 4 types corresponding to sequence types ST125-agr group II (agrII), ST30-agrIII, ST34-agrIII, and ST45-agrI. An array hybridization technique performed on the 14 CO(2)-dependent isolates and 20 S. aureus isolates with normal phenotype and representing the same sequence types showed that all possessed the enterotoxin gene cluster egc, as well as the genes for alpha-hemolysin and delta-hemolysin; biofilm genes icaA, icaC, and icaD; several microbial surface components recognizing adhesive matrix molecules (MSCRAMM) genes (clfA, clfB, ebh, eno, fib, ebpS, sdrC, and vw); and the isaB gene. Our study confirms the importance of CO(2)-dependent SCVs of S. aureus as significant pathogens. Clinical microbiologists should be aware of this kind of auxotrophy because recovery and identification are challenging and not routine. Further studies are necessary to determine the incidence of CO(2) auxotrophs of S. aureus, the factors that select these strains in the host, and the genetic basis of this type of auxotrophy.

[Rapid influenza diagnostic tests for detection of novel influenza A (H1N1) virus in children]. / Utilidad de las pruebas rápidas de detección antigénica en el diagnóstico de la nueva gripe A (H1N1) en niños.

INTRODUCTION: Accuracy of rapid BD Directigen(®) EZ Flu A+B diagnostic test against Influenza A (H1N1) Virus in children. METHODS: A descriptive retrospective study was performed. One hundred and forty children underwent the rapid influenza test and the RT-PCR against Influenza A (H1N1) Virus. RESULTS: The sensitivity was 70.4% (95% CI: 58.9-79.7), specificity 100 % (95% CI: 94.7-100), NPV 76.6% (95% CI: 66.9-84,2) and PPV 100% (95% CI: 92.8-100). CONCLUSION: This test showed high sensitivity and specificity, very similar to the seasonal influenza, in children.

Interpretation systems, therapeutic itineraries and repertoires of leprosy patients in a low prevalence country. / Sistemas de interpretación, itinerarios y repertorios terapéuticos de pacientes con lepra en un país con baja prevalencia.

OBJECTIVES: In Peru, despite the small number of cases, there is evidence of late diagnosis and hidden prevalence of leprosy. In this context the objective of the study was to know the interpretation systems on leprosy, itineraries and therapeutic repertoires of patients diagnosed with leprosy who are in treatment or who have finished treatment. MATERIALS AND METHODS: A qualitative study was carried out, applying se mi-structured interviews to patients diagnosed with leprosy from the Loreto and Ucayali regions. RESULTS: 30 patients were interviewed. Most did not know the mechanism of leprosy transmission. In relation to therapeutic itineraries, patients generally went to health facilities on the recommendation of third parties who knew the disease. In some cases, health personnel made a bad diagnosis. The importance of the treatment indicated by the "Ministerio de Salud" (Ministry of Health) is recognized; however, economic factors and the distance to health facilities negatively affect adherence to treatment. In addition, it was evidenced that stigma persists towards the disease. CONCLUSIONS: Patients recognize the importance of treatment; however, they express misconceptions about the pathogenesis of leprosy, and weaknesses in the health system are also identified. These problems would lead to delay in diagnosis and treatment. It is recommended to strengthen control strategies and decentralize the care of leprosy with the participa tion of the community, patients, health personnel and healers, considering the identified barriers and a probable underdiagnosis in women.

OBJETIVOS: En Perú, a pesar del escaso número de casos, existe evidencia de un diagnóstico tardío y prevalencia oculta de la lepra. En este contexto el objetivo del estudio fue conocer los sistemas de inter pretación sobre la lepra, itinerarios y repertorios terapéuticos de pacientes con diagnóstico de lepra que se encuentren en tratamiento o con tratamiento culminado. MATERIALES Y MÉTODOS: Se realizó un estudio cualitativo, aplicando entrevistas semiestructuradas a pacientes con diagnóstico de lepra de las regiones de Loreto y Ucayali. RESULTADOS: Se entrevistaron a 30 pacientes. La mayoría no conocía el mecanismo de transmisión de la lepra. En relación con los itinerarios terapéuticos, los pacientes generalmente acudie ron a los establecimientos de salud por recomendación de terceros que conocían la enfermedad. En al gunos casos, el personal de salud realizó un mal diagnóstico. Se reconoce la importancia del tratamiento indicado por el Ministerio de Salud; sin embargo, factores económicos y la distancia a los establecimien tos de salud afectan de forma negativa la adherencia al tratamiento. Además, se evidenció que persiste el estigma de la enfermedad. CONCLUSIONES: Los pacientes reconocen la importancia del tratamiento, sin embargo, manifiestan ideas equivocadas sobre la patogenia de la lepra, además se identifican debilidades en el sistema de salud. Estos problemas conllevarían al retraso en el diagnóstico y tratamiento. Se reco mienda fortalecer las estrategias de control y descentralizar la atención de la lepra con la participación de la comunidad, pacientes, personal de salud y curanderos, considerando las barreras identificadas y un probable infradiagnóstico en la mujer.

Nosocomial spread of colistin-only-sensitive sequence type 235 Pseudomonas aeruginosa isolates producing the extended-spectrum beta-lactamases GES-1 and GES-5 in Spain.

The mechanisms responsible for the increasing prevalence of colistin-only-sensitive (COS) Pseudomonas aeruginosa isolates in a Spanish hospital were investigated. Pulsed-field gel electrophoresis revealed that 24 (50%) of the studied isolates belonged to the same clone, identified as the internationally spread sequence type 235 (ST235) through multilocus sequence typing. In addition to several mutational resistance mechanisms, an integron containing seven resistance determinants was detected. Remarkably, the extended-spectrum beta-lactamase GES-1 and its Gly170Ser carbapenem-hydrolyzing derivative GES-5 were first documented to be encoded in a single integron. This work is the first to describe GES enzymes in Spain and adds them to the growing list of beta-lactamases of concern (PER, VIM, and OXA) detected in ST235 clone isolates.

[Supervision of clinical trials in Social Health Insurance at Peruvian Hospitals: administrative and regulatory approach]. / Supervisión de ensayos clínicos en hospitales del Seguro Social de Salud del Perú: enfoque administrativo y regulatorio.

The objective of the study was to describe the characteristics of the Clinical Trials (CT) supervised by the Institute of Health Technology Assessment and Research carried out in EsSalud between 2015 and 2018 and the main observations of the supervisions completed. A descriptive study of 82 supervised clinical trials was conducted between 2015 and 2018. Most of the clinical trials were phase III studies (81.7%); the most frequent route of administration of the study products was oral (47.6%), and most were sponsored by the pharmaceutical industry (96.3%). The most frequent observations were those related to the study contract (83.8%), overhead payment (57.3%), and the lack of regulatory documents (47.6%). These findings allow the identification of opportunities for improvement in research regulation and management.

El objetivo del estudio fue describir las características de los ensayos clínicos (EC) supervisados por el Instituto de Evaluación de Tecnologías en Salud e Investigación en EsSalud entre el 2015 y 2018 y las principales observaciones de las supervisiones realizadas. Se realizó un estudio descriptivo de 82 ensayos clínicos supervisados entre 2015 y 2018. La mayoría de los ensayos clínicos fueron estudios de fase III (81,7%), la vía de administración más frecuente de los productos de estudio fue oral (47,6%) y la mayoría fueron patrocinados por la industria farmacéutica (96,3%). Las observaciones más frecuentes fueron las relacionadas al contrato de estudio (83,8%), al pago por concepto de overhead (57,3%) y a la falta de documentos regulatorios (47,6%). Estos hallazgos permiten la identificación de oportunidades de mejora en la regulación y gestión de la investigación.

Prevalencia de bacterias multidrogoresistentes en un hospital público ubicado en la sierra del Perú

Introducción. La resistencia antibiótica es una de las mayores amenazas para la salud global. Una de las estrategias para su control, es la vigilancia microbiológica. Objetivo. Describir la variación de la prevalencia de cepas multidrogoresistentes (MDR) de las bacterias más frecuentemente aisladas en muestras clínicas de pacientes atendidos en un hospital de tercer nivel de una ciudad de altura en el Perú, y determinar los factores asociados a su aislamiento. Además, evaluar la prevalencia de otros fenotipos de resistencia. Métodos. Se realizó un estudio observacional transversal a partir de una cohorte histórica de aislamientos entre los años 2012 y 2019. Resultados. La prevalencia general de cepas MDR fue 74,1%, observándose una tendencia a la disminución de la prevalencia anual de cepas de MDR en cinco de las nueve bacterias analizadas. Los factores asociados a cepas MDR se correspondían con los descritos previamente: sexo masculino, edad mayor a 75 años y hospitalización en servicios de cuidados intensivos. Además, se observó un incremento en la prevalencia de otros fenotipos de resistencia. Conclusión. Se encontró una alta prevalencia de cepas MDR en todas las bacterias evaluadas, asociadas a factores previamente descritos.

Introduction. Antibiotic resistance is one of the greatest threats to global health. One of the strategies for its control is microbiological surveillance. Objective. To describe the variation of the prevalence of multidrug resistant strains (MDR) of the most frequently isolated bacteria in clinical samples of patients treated at a tertiary care hospital in a high-altitude city in Perú and the factors associated with its isolation. Also, to assess the prevalence of other resistance phenotypes. Results. The general prevalence of MDR strains was 74,1%, observing a downward trend in the annual prevalence of MDR strains in five of the nine bacteria included. The factors associated with MDR strains corresponded to those previously described: male sex, age over 75 years, and hospitalization in intensive care services. In addition, an increase in the annual prevalence of other resistance mechanisms was evidenced. Conclusions. A high prevalence of MDR strains was found in all the bacteria evaluated, associated with previously described factors.

Transmisión intra-hogar en personas infectadas por SARS-CoV-2 (COVID-19) en Lima, Perú / Transmissão intradomiciliar em pessoas infectadas por SARS-CoV-2 (COVID-19) em Lima, Peru / Household transmission of SARS-CoV-2 (COVID-19) in Lima, Peru

El objetivo fue describir las características de la infección por SARS-CoV-2 entre miembros de hogares, con un caso confirmado primario de COVID-19, en distritos de baja carga de casos en Lima, Perú, en comparación con un distrito de alta carga. Estudio retrospectivo de revisión de base de datos secundaria. Se recolectó información proveniente de una actividad de vigilancia epidemiológica en contactos cercanos (cohabitantes), en 52 hogares de Lima, con un solo miembro con COVID-19. En 10 hogares se realizó una reevaluación. Se evaluaron variables epidemiológicas y clínicas; y su asociación con el resultado a la prueba serológica rápida (presencia de IgG, IgM o ambas). En 40 hogares se encontraron casos secundarios, lo que representa un 49,9% de identificación en promedio por hogar. Se encontró una tasa de ataque secundaria entre cohabitantes de 53% (125 casos), siendo sintomáticos un 77,6% de casos (razón sintomáticos/asintomáticos: 3,5). La presencia de fiebre y/o escalofríos se encontró en el 40% de las personas con resultado positivo, seguido del dolor de garganta en el 39,2%. La ageusia y anosmia estuvieron presentes en el 22,4% y 20,8% de los casos, respectivamente. Al tener un caso primario de COVID-19 en el hogar, la tasa de ataque secundaria de esta infección es de 53%; sin embargo, en una proporción importante de hogares evaluados no hubo un caso positivo, más allá del caso primario. Las características epidemiológicas y clínicas encontradas en este caso estuvieron acorde a lo ya reportado en otras series internacionales.

O objetivo foi descrever as características da infecção por SARS-CoV-2 entre os membros de domicílios, com um caso primário confirmado de COVID-19, em distritos com baixa carga de casos em Lima, Peru, em comparação com um distrito com alta carga. Estudo retrospectivo de revisão de banco de dados secundário. As informações foram coletadas em uma atividade de vigilância epidemiológica em contatos próximos (coabitantes), em 52 domicílios em Lima, com um único membro com COVID-19. Foi realizada uma reavaliação em 10 domicílios. Variáveis ​​epidemiológicas e clínicas foram avaliadas; e sua associação com o resultado do teste sorológico rápido (presença de IgG, IgM ou ambos). Os casos secundários foram encontrados em 40 domicílios, representando uma taxa média de identificação de 49,9% por domicílio. Foi encontrada uma taxa de ataque secundário entre coabitantes de 53% (125 casos), com 77,6% dos casos sendo sintomáticos (relação sintomático/assintomático: 3,5). A presença de febre e/ou calafrios foi encontrada em 40% das pessoas com resultado positivo, seguida de dor de garganta em 39,2%. Ageusia e anosmia estiveram presentes em 22,4% e 20,8% dos casos, respectivamente. Quando há um caso primário de COVID-19 em casa, a taxa de ataque secundário para essa infecção é de 53%; No entanto, em uma proporção significativa dos domicílios avaliados não houve caso positivo, além do caso primário. As características epidemiológicas e clínicas encontradas neste caso foram consistentes com o que já foi relatado em outras séries internacionais.

The study aimed to describe the characteristics of SARS-CoV-2 transmission among members of households with a confirmed primary case of COVID-19 in districts with low burden of cases in Lima, Peru, compared to a district with high burden. This was a retrospective study with a secondary database review. Information was collected from an epidemiological surveillance activity in close contacts (household members) in 52 households in Lima, with a single member with COVID-19. Reevaluation was conducted in 10 households. The study evaluated epidemiological and clinical variables and their association with the result of the rapid serological test (presence of IgG, IgM, or both). Secondary cases were found in 40 households, representing mean identification of 49.9% per household. Secondary attack rate in household members was 53% (125 cases), and symptomatic individuals accounted for 77.6% of cases (symptomatic/asymptomatic ratio: 3.5). Presence of fever and/or chills was found in 40% of persons with positive test results, followed by sore throat with 39.2%. Ageusia and anosmia were present in 22.4% and 20.8% of cases, respectively. When there was a primary case of COVID-19 in the household, the secondary attack rate was 53%; however, in an important proportion of households there were no positive cases other than the primary case. The epidemiological and clinical findings were consistent with reports from other international series.

Sistemas de interpretación, itinerarios y repertorios terapéuticos de pacientes con lepra en un país con baja prevalencia / Interpretation systems, therapeutic itineraries and repertoires of leprosy patients in a low prevalence country

RESUMEN Objetivos: En Perú, a pesar del escaso número de casos, existe evidencia de un diagnóstico tardío y prevalencia oculta de la lepra. En este contexto el objetivo del estudio fue conocer los sistemas de inter pretación sobre la lepra, itinerarios y repertorios terapéuticos de pacientes con diagnóstico de lepra que se encuentren en tratamiento o con tratamiento culminado. Materiales y métodos: Se realizó un estudio cualitativo, aplicando entrevistas semiestructuradas a pacientes con diagnóstico de lepra de las regiones de Loreto y Ucayali. Resultados: Se entrevistaron a 30 pacientes. La mayoría no conocía el mecanismo de transmisión de la lepra. En relación con los itinerarios terapéuticos, los pacientes generalmente acudie ron a los establecimientos de salud por recomendación de terceros que conocían la enfermedad. En al gunos casos, el personal de salud realizó un mal diagnóstico. Se reconoce la importancia del tratamiento indicado por el Ministerio de Salud; sin embargo, factores económicos y la distancia a los establecimien tos de salud afectan de forma negativa la adherencia al tratamiento. Además, se evidenció que persiste el estigma de la enfermedad. Conclusiones: Los pacientes reconocen la importancia del tratamiento, sin embargo, manifiestan ideas equivocadas sobre la patogenia de la lepra, además se identifican debilidades en el sistema de salud. Estos problemas conllevarían al retraso en el diagnóstico y tratamiento. Se reco mienda fortalecer las estrategias de control y descentralizar la atención de la lepra con la participación de la comunidad, pacientes, personal de salud y curanderos, considerando las barreras identificadas y un probable infradiagnóstico en la mujer.

ABSTRACT Objectives: In Peru, despite the small number of cases, there is evidence of late diagnosis and hidden prevalence of leprosy. In this context the objective of the study was to know the interpretation systems on leprosy, itineraries and therapeutic repertoires of patients diagnosed with leprosy who are in treatment or who have finished treatment. Materials and methods: A qualitative study was carried out, applying se mi-structured interviews to patients diagnosed with leprosy from the Loreto and Ucayali regions. Results: 30 patients were interviewed. Most did not know the mechanism of leprosy transmission. In relation to therapeutic itineraries, patients generally went to health facilities on the recommendation of third parties who knew the disease. In some cases, health personnel made a bad diagnosis. The importance of the treatment indicated by the "Ministerio de Salud" (Ministry of Health) is recognized; however, economic factors and the distance to health facilities negatively affect adherence to treatment. In addition, it was evidenced that stigma persists towards the disease. Conclusions: Patients recognize the importance of treatment; however, they express misconceptions about the pathogenesis of leprosy, and weaknesses in the health system are also identified. These problems would lead to delay in diagnosis and treatment. It is recommended to strengthen control strategies and decentralize the care of leprosy with the participa tion of the community, patients, health personnel and healers, considering the identified barriers and a probable underdiagnosis in women.

Supervisión de ensayos clínicos en hospitales del Seguro Social de Salud del Perú: enfoque administrativo y regulatorio / Supervision of clinical trials in Social Health Insurance at Peruvian Hospitals: administrative and regulatory approach

RESUMEN El objetivo del estudio fue describir las características de los ensayos clínicos (EC) supervisados por el Instituto de Evaluación de Tecnologías en Salud e Investigación en EsSalud entre el 2015 y 2018 y las principales observaciones de las supervisiones realizadas. Se realizó un estudio descriptivo de 82 ensayos clínicos supervisados entre 2015 y 2018. La mayoría de los ensayos clínicos fueron estudios de fase III (81,7%), la vía de administración más frecuente de los productos de estudio fue oral (47,6%) y la mayoría fueron patrocinados por la industria farmacéutica (96,3%). Las observaciones más frecuentes fueron las relacionadas al contrato de estudio (83,8%), al pago por concepto de overhead (57,3%) y a la falta de documentos regulatorios (47,6%). Estos hallazgos permiten la identificación de oportunidades de mejora en la regulación y gestión de la investigación.

ABSTRACT The objective of the study was to describe the characteristics of the Clinical Trials (CT) supervised by the Institute of Health Technology Assessment and Research carried out in EsSalud between 2015 and 2018 and the main observations of the supervisions completed. A descriptive study of 82 supervised clinical trials was conducted between 2015 and 2018. Most of the clinical trials were phase III studies (81.7%); the most frequent route of administration of the study products was oral (47.6%), and most were sponsored by the pharmaceutical industry (96.3%). The most frequent observations were those related to the study contract (83.8%), overhead payment (57.3%), and the lack of regulatory documents (47.6%). These findings allow the identification of opportunities for improvement in research regulation and management.

Use and evaluation of a line probe assay in patients with tuberculosis in Peru: 2011 and 2013 / Utilización y evaluación de un ensayo con sondas en línea en los pacientes con diagnóstico de tuberculosis en el Perú del 2011 al 2013

ABSTRACT Objective To determine the use and performance of a line probe assay (LPA) compared with conventional culture and drug sensitivity testing (CDST) in patients registered with tuberculosis (TB) under routine program conditions in Peru in 2011–2013. Methods This was a descriptive, operational research, cross-sectional study of sputum specimens from patients with smear-positive pulmonary TB and mycobacterial cultures from patients with smear-negative or positive TB. Drug resistance to rifampicin and/or isoniazid detected by LPA was compared to CDST. Sensitivity, specificity, and predictive values were calculated and reliability for detecting drug resistance was assessed through kappa coefficient, with values 0.61–0.80 showing substantial correlation, and 0.81 or above showing almost-perfect correlation. Results In 2011–2013, there were 16 169 LPA tests performed, with the proportion of TB patients receiving the test increasing from 3.2% to 30.2%. In all, 2 905 LPA test results were compared to CDST. For LPA in sputum specimens, sensitivity for rifampicin was 92%; isoniazid, 94%; and MDR-TB, 88%; while specificity for rifampicin was 92%; isoniazid, 92%; and MDR-TB, 95%. For LPA in mycobacterial cultures, sensitivity for rifampicin was 95%; isoniazid, 96%; and MDR-TB, 90%; while specificity for rifampicin was 85%; isoniazid, 91%; and MDR-TB, 94%. Kappa coefficients were at 0.81 or above for all comparisons of LPA with CDST using sputum specimens and cultures, except for isoniazid in cultures, which was at 0.79. Conclusions This study suggests that LPA is a reliable and rapid screening test for drug-resistant TB and should be considered suitable for routine use and scale up in Peru.

RESUMEN Objetivo Definir la utilización de un ensayo con sondas en línea y evaluar su desempeño, en comparación con el método convencional de cultivo y antibiograma, en los pacientes registrados con tuberculosis en condiciones programáticas en el Perú del 2011 al 2013. Métodos Investigación operativa descriptiva con un estudio transversal de las muestras de esputo de los pacientes con diagnóstico de tuberculosis pulmonar y baciloscopia positiva y de los cultivos de micobacterias de los pacientes con tuberculosis y baciloscopia positiva o negativa. La farmacorresistencia a la rifampicina, la isoniacida o a ambas, detectada mediante el ensayo con sondas en línea, se comparó con los resultados obtenidos por el método de cultivo y antibiograma. Se calculó la sensibilidad, la especificidad y los valores predictivos del ensayo con sondas en línea y se evaluó su fiabilidad en la detección de la farmacorresistencia mediante el coeficiente k, cuyos valores de 0,61 a 0,80 correspondían a una fuerte correlación y los valores de 0,81 o superiores reflejaban una correlación casi perfecta. Resultados Del 2011 al 2013 se practicaron 16 169 ensayos con sondas en línea, y la proporción de pacientes con diagnóstico de tuberculosis en quienes se practicaba aumentó de 3,2% a 30,2%. En total, se compararon 2 905 resultados del ensayo molecular con el método convencional. En las muestras de esputo, el ensayo molecular ofreció una sensibilidad de 92% para la resistencia a la rifampicina, 94% a la isoniacida y 88% para la tuberculosis multirresistente; su especificidad fue 92% con respecto a la rifampicina, 92% a la isoniacida y 95% a la tuberculosis multirresistente. En los cultivos de micobacterias, el ensayo con sondas en línea mostró una sensibilidad de 95% para la resistencia a la rifampicina, 96% a la isoniacida y 90% para la tuberculosis multirresistente; la especificidad fue 85% para la rifampicina, 91% para la isoniacida y 94% para la tuberculosis multirresistente. El coeficiente k fue 0,81 o superior en todas las comparaciones del ensayo molecular con el método tradicional cuando se usaron muestras de esputo y cultivo, excepto con la isoniacida en cultivo, cuyo coeficiente fue 0,79. Conclusiones Los resultados del presente estudio indican que el ensayo con sondas en línea constituye una prueba de detección fiable y rápida para la tuberculosis multirresistente, y se debe considerar apropiada su utilización en la práctica de rutina y la ampliación de su empleo en el Perú.

Depresión y síntomas depresivos en pacientes que acuden al consultorio de dermatología de un hospital general de Lima / Depression and depressive symptoms in outpatients of a dermatology´s service in a general hospital of Lima

Objetivos: Determinar la prevalencia de depresión y síntomas depresivos entre pacientes nuevos que acuden al consultorio de Dermatología del Hospital Nacional Cayetano Heredia (HNCH), así como la posible asociación entre las variables demográficas o las características de la patología dermatológica y la presencia de depresión y síntomas depresivos. Métodos: Se realizó un estudio descriptivo, transversal entre 287 pacientes nuevos que acudieron al consultorio de dermatología del HNCH. Se registraron los datos demográficos, los de la enfermedad dermatológica, y los antecedentes personales y familiares. Se aplicó el Inventario de depresión de Beck (IDB) y la Entrevista Clínica Estructurada para Trastornos del DSM-IV (SCID), apartado de depresión mayor, entre enero y agosto del año 2003. Resultados: La prevalencia de depresión fue de 20,6% y la de síntomas depresivos, de 44,9% (puntuación en el IDB de 11 ó más). Se encontró asociación estadísticamente significativa entre la ocupación del paciente y depresión (p=0,042); así como entre género (p=0,039), grado de instrucción (p=0,002) y estado civil (p=0,026), y la presencia de síntomas depresivos. Los diagnósticos dermatológicos más frecuentes entre los pacientes con depresión fueron dermatitis (11,86%), acné (8,47%), melasma (8,47%) y vitíligo (6,77%). Conclusiones: La prevalencia de depresión y síntomas depresivos fue similar a la reportada en estudios similares, siendo mayor a la reportada en la población general, confirmando la importancia del tratamiento conjunto, tanto dermatológico como psiquiátrico, para brindar mejor calidad de vida a los pacientes.

Objective: To determine the prevalence of depression and depressive symptoms among new patients attending to the outpatients Dermatology service in the Hospital Nacional Cayetano Heredia (HNCH), and to determine the posible association between demographic variables or the features of the dermatological disease and the presence of depression or depressive symptoms. Methods: A cross sectional study of 287 new patients attending to the dermatology outpatients consultation in the HNCH. We recorded demographic data, skin disease data, and personal and family history. We applied the Beck Depression Inventory (BDI) and the Structured Clinical Interview for DSM-IV (SCID), Major Depression Module, between January and August 2003. Results: The prevalence of depression was 20.6% and that of depressive symptoms 44.9% (BDI score 11 or more). There was a statistically significant association between occupation of the patient and depression (p=0.042), and between gender (p=0.039), education level (p=0.002) and marital status (p=0.026), and depressive symptoms. The most common dermatologic diagnoses among patients with depression were dermatitis (11.86%), acne (8.47%), melasma (8.47%) and vitiligo (6.77%). Conclusions: The prevalence of major depression and depressive symptoms is similar to that reported in similar studies, being greater than that founded in general population. This confirms the importance of treatment collaboration between dermatologists and psychiatrists, to provide better quality of life to patients.

Utilidad de las pruebas rápidas de detección antigénica en el diagnóstico de la nueva gripe A (H1N1) en niños / Rapid influenza diagnostic tests for detection of novel influenza A (H1N1) virus in children

Introducción Utilidad de la prueba rápida BD Directigen® EZ Flu A+B frente a gripe A (H1N1) en niños. Metódos Estudio descriptivo retrospectivo con 140 niños a los que se realizó la prueba rápida y la reacción en cadena de la polimerasa en tiempo real frente a gripe A (H1N1).Resultados Sensibilidad del 70,4% (IC: 58,9–79,7), especificidad de 100% (IC: 94,7–100), valor predictivo negativo del 76,6% (IC: 66,9–84,2) y valor predictivo positivo del 100% (IC: 92,8–100).Conclusión La prueba presenta buena sensibilidad y buena especificidad en niños, siendo similares a los de la gripe estacional (AU)

Introduction Accuracy of rapid BD Directigen® EZ Flu A+B diagnostic test against Influenza A (H1N1) Virus in children. Methods A descriptive retrospective study was performed. One hundred and forty children underwent the rapid influenza test and the RT-PCR against Influenza A (H1N1) Virus. Results The sensitivity was 70.4% (95% CI: 58.9–79.7), specificity 100 % (95% CI: 94.7–100), NPV 76.6% (95% CI: 66.9–84,2) and PPV 100% (95% CI: 92.8–100).Conclusion This test showed high sensitivity and specificity, very similar to the seasonal influenza, in children (AU)

Actualización en terapia con oxígeno hiperbárico / Actualization in therapy with hiperbaric oxygen

Se presenta una revisión actualizada de los últimos datos en la literatura médica sobre la Terapia con Oxígeno Hiperbárico, indicando el mecanismo de acción, los efectos colaterales, la disponibilidad, la forma de administración, asi como sus indicaciones terapéuticas. Se hará hincapié en las indicaciones relacionadas a patología infecciosa y dermatológica y en el desarrollo de este tipo de terapia en el Perú.