Dosis de refuerzo con la vacuna BNT162b2 en población que recibió el esquema de vacunación completa para COVID-19 en Perú: Un análisis crítico de la evidencia actual

Background: In Peru, the current immunization schedule for COVID-19 includes BBIBP-CorV, BNT162B2 and ChAdOx1 nCoV-19 vaccines. Although the full immunization schedule is two doses, some countries have recently included a booster dose to their schedule. Methods: We conducted a search for scientific evidence on the efficacy and safety of booster vaccination with BNT162b2 vaccine in a population with a complete vaccination schedule for COVID-19 in Peru. Evidence: Four evidence-based recommendation documents, one observational study and three ongoing phase III clinical trials were included for analysis. Conclusion: To date, there is insufficient evidence on the efficacy of adding a booster dose to the immunization schedule for COVID-19. The available evidence does not justify the use of a booster dose of BNT162B2 vaccine in a population that has previously received two doses of the aforementioned vaccines.Introducción: En el Perú, el programa actual de inmunización para COVID-19 comprende las vacunas BBIBP-CorV, BNT162B2 y ChAdOx1 nCoV-19. Si bien el esquema de inmunización es de dos dosis, algunos países han incluido recientemente una dosis de refuerzo a su esquema. Métodos: Se realizó una búsqueda de evidencia científica sobre la eficacia y seguridad de la vacunación de refuerzo con la vacuna BNT162b2 en población con esquema de vacunación completa para COVID-19 en Perú. Evidencia incluida: Se consideraron cuatro documentos de recomendación basados en evidencia, un estudio observacional y tres ensayos clínicos fase III en curso. Conclusión: A la fecha, no existe evidencia suficiente sobre la eficacia de agregar una dosis de refuerzo al esquema de inmunización para COVID-19. La evidencia disponible no permite justificar el uso de una dosis de refuerzo con la vacuna BNT162B2 en población que recibió previamente dos dosis de las vacunas anteriormente mencionadas

Características metodológicas de las evaluaciones de tecnologías sanitarias elaboradas en Perú, 2019-2021

Background: Limitations have been reported to comply with good methodological practices in the development of health technology assessments (HTA). Therefore, the objective of the present study was to describe the methodological characteristics of the HTAs carried out in Peru, between 2019-2021. Methods: Descriptive study. We are looking for Peruvian institutions that prepare HTAs whose reports are accessible to the public. We collected the total number of HTAs produced by these institutions per year, and we collected the characteristics of the HTAs produced during the 2019-2021 period. Results: Three Peruvian institutions developed at least three public HTAs between 2019-2021: The Institute for the Evaluation of Technologies in Health and Research (IETSI) (n=142), the Unit for the Analysis and Generation of Evidence in Public Health (UNAGESP) (n=60), and the National Institute of Neoplastic Diseases (INEN) (n=40). The HTAs of UNAGESP did not reach a decision, while 35.9% of those of IETSI and 70.0% of those of INEN concluded in favor of the evaluated technology. All STDs explained the methodology used and performed systematic searches. However, few presented the risk of bias assessment of the included studies (17.4%), the certainty of the evidence (4.6%), or the benefits and harms per outcome (14.4%). None of the HTAs carried out cost studies or made explicit the methodology used to reach the decision. Conclusions: The HTAs evaluated presented favorable methodological aspects and certain shortcomings (in topics such as the report in the evaluation of risk of bias and certainty of the evidence, presentation of benefits and harms by outcome, and explanation of the methodology used to make decisions).Introducción: Se han reportado limitaciones para cumplir con buenas prácticas metodológicas en el desarrollo de evaluaciones de tecnologías sanitarias (ETS). Por ello, el objetivo del presente estudio fue describir las características metodológicas de las ETS elaboradas en Perú, entre 2019-2021. Métodos: Estudio descriptivo. Buscamos las instituciones peruanas que elaboren ETS cuyos informes sean accesibles al público. Recolectamos el número total de ETS que elaboraron estas instituciones por año, y recolectamos las características de las ETS elaboradas durante el periodo 2019-2021. Resultados: Tres instituciones peruanas elaboraron al menos tres ETS públicas entre 2019-2021: El Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) (n=142), la Unidad de Análisis y Generación de Evidencias en Salud Pública (UNAGESP) (n=60), y el Instituto Nacional de Enfermedades Neoplásicas (INEN) (n=40). Las ETS de UNAGESP no brindaron una decisión, mientras que 35,9% de las de IETSI y 70,0% de las de INEN concluyeron a favor de la tecnología evaluada. Todas las ETS explicaron la metodología usada y realizaron búsquedas sistemáticas. Sin embargo, pocas presentaron la evaluación de riesgo de sesgo de los estudios incluidos (17,4%), la certeza de la evidencia (4,6%), o los beneficios y daños por desenlace (14,4%). Ninguna ETS realizó estudios de costos ni explicitó la metodología usada para llegar a la decisión. Conclusiones: Las ETS evaluadas presentaron aspectos metodológicos favorables y ciertas falencias (en temas como el reporte en la evaluación de riesgo de sesgo y certeza de la evidencia, presentación de beneficios y daños por desenlace, y explicitación de la metodología usada para tomar decisiones)

Factors Associated with Mortality in Patients with COVID-19 from a Hospital in Northern Peru

We aimed to identify the factors associated with mortality in patients with COVID-19 from the hospitalization service of the Cayetano Heredia Hospital, Piura, Peru, from May to June 2020. A prospective study was conducted in hospitalized patients with a confirmed diagnosis of COVID-19 through serological and/or molecular reactive testing. The dependent variable was death due to COVID-19, and the independent variables were the epidemiological, clinical and laboratory characteristics of the patient. The chi-square test and the non-parametric Mann–Whitney U test were used, with a significance level of 5%. Of 301 patients with COVID-19, the majority of them were male (66.1%), and the mean age was 58.63 years. Of the patients analyzed, 41.3% of them died, 40.2% of them were obese and 59.8% of them had hepatic steatosis. The three most frequent signs/symptoms were dyspnea (90.03%), fatigue (90.03%) and a cough (84.72%). Being an older adult (p = 0.011), being hospitalized in the ICU (p = 0.001), overweight (p = 0.016), obese (p = 0.021) and having compromised consciousness (p = 0.039) and thrombocytopenia (p = 0.024) were associated with mortality due to COVID-19. Overall, the mortality rate due to COVID-19 was 41.3%. Having an older age, being hospitalized in the ICU, overweight, obese and having compromised consciousness and thrombocytopenia were positively associated with mortality in patients with COVID-19. These findings highlight the need to establish an adequate system of surveillance and epidemiological education in hospitals and communities in the event of new outbreaks, especially in rural and northern Peru

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

[Factores asociados a la mortalidad en pacientes cirróticos]

Introducción: La cirrosis hepática representa en Perú el 9,1 % de las causas de mortalidad. Existe poca evidencia sobre la influencia de variables epidemiológicas y clínicas en la mortalidad de pacientes con cirrosis hepática en Latinoamérica, en especial en países en vías de desarrollo, como Perú. Objetivo: Identificar los factores asociados a la mortalidad en pacientes cirróticos. Métodos: Estudio trasversal en pacientes cirróticos atendidos en el Hospital “Cayetano Heredia”, de Piura, Perú, en el año 2017. La variable dependiente fue la mortalidad hospitalaria y las variables independientes fueron las características epidemiológicas, clínicas y de laboratorio. Se utilizó la prueba exacta de Fisher y la prueba de t para estimar los factores asociados a la mortalidad. Resultados: De 52 pacientes, la frecuencia de mortalidad debido a cirrosis fue de 35,4 %. Tener ascitis moderada (p = 0,004), grado de encefalopatía (p = 0,001), leucocitosis (p = 0,004), enfermedad descompensada según índice de Child Pugh (p = 0,023), índice de Meld entre 30-39 puntos (p < 0,001) y niveles de creatinina (p = 0,009) resultaron asociados a una mayor frecuencia de mortalidad. Conclusión: La presencia de ascitis moderada, grado de encefalopatía, leucocitosis, enfermedad descompensada según índice de Child Pugh, índice de Meld entre 30-39 y los niveles de creatinina, están asociados a la mortalidad en pacientes cirróticos

Factors Associated with Nutritional Deficiency Biomarkers in Candidates for Bariatric Surgery: A Cross-Sectional Study in a Peruvian High-Resolution Clinic

Previous studies have described multiple nutritional deficiencies after bariatric surgery (BS). However, few studies have evaluated these deficiencies prior to BS, specifically in Latin America. This study aimed to determine the factors associated with nutritional deficiency biomarkers in candidates for BS in Peru. We included adults of both sexes, aged 18 to 59 years, admitted to a Peruvian clinic with a body mass index (BMI) &ge;30 kg/m2; they were candidates for BS from 2017 to 2020. We considered the serum levels of hemoglobin and albumin (in tertiles) as the nutritional deficiency biomarkers. In order to assess the associated factors, we calculated crude (cPR) and adjusted prevalence ratios (aPR) with their respective 95% confidence intervals (95%CI). We analyzed 255 patients: 63.1% were males, with a mean age of 37.1 &plusmn; 10.3 years and mean hemoglobin and albumin values of 14.0 &plusmn; 1.5 g/dL and 4.6 &plusmn; 0.4 g/dL, respectively. We found that males (aPR = 1.86; 95%CI: 1.26&ndash;2.73; p = 0.002), participants between 30 and 49 (aPR = 2.02; 95%CI: 1.24&ndash;3.28; p = 0.004) or 50 years or more (aPR = 2.42; 95%CI: 1.35&ndash;4.35; p = 0.003), participants with a BMI &ge;40 kg/m2 (aPR = 1.68; 95%CI: 1.09&ndash;2.60; p = 0.018), participants with impaired high-density lipoprotein levels (aPR = 1.43; 95%CI: 1.01&ndash;2.05; p = 0.049) and individuals in the high tertile of C-reactive protein (aPR = 6.94; 95%CI: 3.37&ndash;14.32; p &lt; 0.003) had a higher probability of being in the lower tertile of albumin. In addition, we found that the male sex (aPR = 6.94; 95%CI: 3.37&ndash;14.32; p &lt; 0.001) and elevated cholesterol levels (aPR = 0.71; 95%CI: 0.52&ndash;0.97; p = 0.034) were associated with the lowest hemoglobin tertile. In our setting, nutritional deficiency biomarkers were associated with sociodemographic, anthropometric and laboratory markers. The pre-bariatric surgery correction of nutritional deficiencies is essential, and can prevent major complications after surgery

Asociación entre tipo de terapia y erradicación de Helicobacter pylori en pacientes del Hospital Cayetano Heredia, Piura, Perú

Introducción: Estudios recientes han identificado reducción de eficacia de terapia triple para la erradicación del H. pylori. En Perú, no existe suficiente evidencia sobre la eficacia de este tipo de terapia. El objetivo fue identificar la asociación entre tipo de terapia y erradicación de H. pylori. Materiales y métodos: Estudio retrospectivo analítico en un hospital privado de Piura, Perú 2017. Se recolectó información de historias clínicas de pacientes con biopsia positiva para H. pylori. Se evaluó la asociación entre tipo de terapia recibida (triple estándar, MOCA y BOTF) y la erradicación de infección por H. pylori. También, se exploró la presencia de comorbilidad, diagnóstico endoscópico antes y después de la terapia recibida,presencia de metaplasia y displasia. Se utilizó la prueba exacta de Fisher y un nivel de significancia al 5 %. Resultados: De 80 pacientes, la mayoría era mujer (65 %) y la media de edad fue 52,4 años. El 76,3 % recibió terapia triple estándar y la mayoría obtuvo erradicación de H. pylori (75 %). Se observa que los pacientes que recibieron terapia triple tenían 62 % y 17,7 % mayor frecuencia de erradicación de H. pylori, en comparación con quienes recibieron terapia BOTF y MOCA, respectivamente (82 % vs 20 % vs 64,3 %). Se observó asociación entre presencia de metaplasia y erradicación de H. pylori (89,3 % vs. 67,3 %). Conclusión: La mayoría de los pacientes erradicaron el H. pylori, particularmente con el uso de terapia triple estándar. El tipo de terapia implementada y la presencia de metaplasia resultaron asociados a la erradicación de la bacteria

Guía de práctica clínica para el tamizaje y manejo del episodio depresivo leve en el primer nivel de atención del Seguro Social del Perú (EsSalud)

ABSTRACT This paper summarizes the clinical practice guide (CPG) for the screening and management of mild depressive episode at the first level of care in the Social Security of Peru (EsSalud). A guideline development group (GDG) was established for develop this CPG, which included clinical and methodology specialists, who formulated 06 clinical questions. Systematic searches were conducted in Pubmed and GPC repositories to answer each question, and relevant evidence was selected. The certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. In periodic work meetings, the GDG used the GRADE methodology for reviewing the evidence and for developing recommendations. At the end, this CPG formulated 07 recommendations (03 strong and 04 conditional), 28 points of good clinical practice, and 02 flow charts were formulated.RESUMEN El presente artículo resume la guía de práctica clínica (GPC) para el tamizaje y el manejo del episodio depresivo leve en el primer nivel de atención en el Seguro Social del Perú (EsSalud). Para el desarrollo de esta GPC, se conformó un grupo elaborador de la guía (GEG) que incluyó especialistas clínicos y metodólogos, el cual formuló 06 preguntas clínicas. Para responder cada pregunta se realizó búsquedas sistemáticas en PubMed y en repositorios de GPC, y se seleccionó la evidencia pertinente. La certeza de la evidencia fue evaluada usando la metodología Grading of Recommendations Assessment, Development, and Evaluation (GRADE). En reuniones periódicas, el GEG usó la metodología GRADE para revisar la evidencia y emitir las recomendaciones. Se emitieron siete recomendaciones (tres fuertes y cuatro condicionales), 28 puntos de buena práctica clínica, y dos flujogramas

Initial invasive or conservative strategy for stable coronary disease

BACKGROUND Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, 121.8 percentage points; 95% CI, 124.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used