Good or best practice statements: proposal for the operationalisation and implementation of GRADE guidance.

An evidence-based approach is considered the gold standard for health decision-making. Sometimes, a guideline panel might judge the certainty that the desirable effects of an intervention clearly outweigh its undesirable effects as high, but the body of supportive evidence is indirect. In such cases, the application of the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach for grading the strength of recommendations is inappropriate. Instead, the GRADE Working Group has recommended developing ungraded best or good practice statement (GPS) and developed guidance under which circumsances they would be appropriate.Through an evaluation of COVID-1- related recommendations on the eCOVID Recommendation Map (COVID-19.recmap.org), we found that recommendations qualifying a GPS were widespread. However, guideline developers failed to label them as GPS or transparently report justifications for their development. We identified ways to improve and facilitate the operationalisation and implementation of the GRADE guidance for GPS.Herein, we propose a structured process for the development of GPSs that includes applying a sequential order for the GRADE guidance for developing GPS. This operationalisation considers relevant evidence-to-decision criteria when assessing the net consequences of implementing the statement, and reporting information supporting judgments for each criterion. We also propose a standardised table to facilitate the identification of GPS and reporting of their development. This operationalised guidance, if endorsed by guideline developers, may palliate some of the shortcomings identified. Our proposal may also inform future updates of the GRADE guidance for GPS.

Clinical-epidemiological characteristics and maternal-foetal outcomes in pregnant women hospitalised with COVID-19 in Venezuela: a retrospective study.

BACKGROUND: In low- and middle-income countries, pregnant women and newborns are more vulnerable to adverse outcomes from coronavirus disease 2019 (COVID-19). However, in Venezuela, there are no integrated data in a national surveillance system to identify the clinical-epidemiological characteristics and maternal-foetal outcomes of pregnant women hospitalised with COVID-19. METHODS: A retrospective study was conducted among Venezuelan pregnant women hospitalised with COVID-19 seen at the "Ruiz y Páez" University Hospital Complex and the San Cristobal Central Hospital between June 2020 and September 2021. Information was obtained from physical and digitised clinical records using a purpose-designed proforma to collect epidemiological, clinical, paraclinical, treatment, obstetric and perinatal complications, and maternal-foetal outcomes data. RESULTS: A total of 80 pregnant women with confirmed severe acute respiratory syndrome coronavirus 2 infection were seen within the study period, 59 (73.8%) survived and 21 (26.2%) died. The median (interquartile range) age was 29 (23-33) years, the majority being in the third trimester of pregnancy (81.2%; n = 65). Interestingly, four (5%) pregnant women were co-infected with malaria by Plasmodium vivax and three (3.8%) with syphilis. The most frequent symptoms were fever (75%; n = 60), dry cough (68.8%; n = 55), dyspnoea (55%; n = 44), and headache (53.8%; n = 43). The most frequent maternal complications were anaemia (51.5%; n = 66) and hypertensive disorders of pregnancy (17.5%; n = 14). The most frequent perinatal complications were preterm delivery (39.2%; n = 20/51) and oligohydramnios (31.3%; n = 25). A total of 29 (36.3%) adverse foetal outcomes were documented, 21 stillbirth and eight abortions. CONCLUSION: This is the first study to describe the clinical-epidemiological behaviour of COVID-19 in hospitalised Venezuelan pregnant women. Anaemia, hypertensive disorders of pregnancy, oligohydramnios, and low birth weight were the most frequent maternal-foetal complications in this population of pregnant women.

Impact of the social determinants of health on the rate of infections by COVID-19 / Impacto de los determinantes sociales de la salud sobre la tasa de contagios por COVID-19

RESUMEN Objetivo Analizar el impacto entre los determinantes sociales en salud en México y la tasa de contagios por COVID-19. Método Estudio ecológico cuantitativo a nivel nacional y municipal. Las principales variables fueron tasa de contagios por COVID-19, población total no hablante de español, ingreso per cápita, pobreza e índice de desarrollo humano (IDH). La tasa media nacional de contagios fue de 2 880/100 000 habitantes. Se aplicó la prueba T-test y, para determinar la fuerza de asociación entre la tasa de contagios y las variables, se aplicó la prueba de correlación de Pearson. Resultados Las entidades con menos tasa de población no hablante de español tuvo la menor tasa de contagios por COVID-19. El análisis de correlación mostró que los estados con tasas de contagio por COVID-19 por arriba de la media nacional tienen mejores condiciones de desarrollo. Discusión En nuestros resultados se revela una correlación negativa entre las tasas contagios por COVID-19 y la variable pertenecer a población indígena. Es necesario analizar desde la perspectiva de las comunidades las necesidades para afrontar escenarios de pandemia.

ABSTRACT Objective To analyze the impact between the social determinants in health and the rate of COVID-19 infection. Methods Quantitative ecological study at national and municipal levels. The main variables were COVID-19 infection rate, total non-Spanish-speaking population, per capita income, poverty, and human development index (HDI). The average national infection rate was 2 880/100 000 inhabitants. The T-test was applied, and Pearson's correlation test was performed to determine the strength of the association between the infection rate and the variables. Results Entities with the lowest rate of non-Spanish-speaking population had the lowest rate of COVID-19 infections. The correlation analysis showed that states with COVID-19 infection rates above the national average have better development conditions. Discussion Our results reveal a negative correlation between COVID-19 infection rates and the variable belonging to an indigenous population. It is necessary to analyze from the perspective of the communities the needs to face pandemic scenarios.

The Analytical Framework of Governance in Health Policies in the Face of Health Emergencies: A Systematic Review.

The Governance Analytical Framework (MAG) defines governance as a social fact, endowed with analyzable and interpretable characteristics, through what it calls observable constitutive elements of governance: the problem, the actors, the social norms, the process of decision-making and scope or nodal points; in the sense that each society develops its modes of governance, its decision-making or conflict resolution systems among its members, its norms, and institutions. In this perspective, the purpose of this article was to carry out a systematic review of the scientific literature to understand the role of governance in health policies in health emergencies, such as that caused by the SARS-CoV-2. The systematic review was designed based on the methodology proposed in the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) Declaration. The literature search was carried out in six databases: Psychology and Behavioral Sciences, APA-PsycInfo, MEDLINE, eBook Collection (EBSCOhost), PubMED, and MedicLatina, published in the last 5 years. Fifteen articles that met quality and evidence criteria were analyzed. The governance approach alluding to the health emergency problem in health policies was the most addressed by the authors (80%), followed by a description of the actors (40%), the process of decision-making spaces (33%), and ultimately, social norms or rules with 13%. Formulating a coherent set of global health policies within a large-scale global governance framework is mostly absent. Although the countries adopt international approaches, it is a process differentiated by the social, economic, and political contexts between countries, affecting heterogeneous health outcomes over the pandemic.

A multistakeholder development process to prioritize and translate COVID-19 health recommendations for patients, caregivers and the public. A case study of the COVID-19 recommendation map.

BACKGROUND AND OBJECTIVES: To develop a digital communication tool to improve the implementation of up-to-date COVID-19 recommendations. Specifically, to improve patient, caregiver and public understanding of healthcare recommendations on prevention, diagnoses and treatment. METHODS: Multi-stakeholder engagement design. In conjunction with the COVID-19 Recommendations and Gateway to Contextualization RecMap, we co-developed a stakeholder prioritization, drafting and editing process to enhance guideline communication and understanding. RESULTS: This paper presents the multi-stakeholder development process with three distinct plain language recommendation formats: formal recommendation, good practice statement, and additional guidance. Our case study of COVID-19 plain language recommendations PLRs addresses both public health interventions (e.g., vaccination, face masks) and clinical interventions (e.g., home pulse oximetry). CONCLUSION: This paper presents a novel approach to engaging stakeholders in improving the communication and understanding of published guidelines during the COVID-19 pandemic.

Which actionable statements qualify as good practice statements In Covid-19 guidelines? A systematic appraisal.

OBJECTIVES: To evaluate the development and quality of actionable statements that qualify as good practice statements (GPS) reported in COVID-19 guidelines. DESIGN AND SETTING: Systematic review . We searched MEDLINE, MedSci, China National Knowledge Infrastructure (CNKI), databases of Grading of Recommendations Assessment, Development and Evaluation (GRADE) Guidelines, NICE, WHO and Guidelines International Network (GIN) from March 2020 to September 2021. We included original or adapted recommendations addressing any COVID-19 topic. MAIN OUTCOME MEASURES: We used GRADE Working Group criteria for assessing the appropriateness of issuing a GPS: (1) clear and actionable; (2) rationale necessitating the message for healthcare practice; (3) practicality of systematically searching for evidence; (4) likely net positive consequences from implementing the GPS and (5) clear link to the indirect evidence. We assessed guideline quality using the Appraisal of Guidelines for Research and Evaluation II tool. RESULTS: 253 guidelines from 44 professional societies issued 3726 actionable statements. We classified 2375 (64%) as GPS; of which 27 (1%) were labelled as GPS by guideline developers. 5 (19%) were labelled as GPS by their authors but did not meet GPS criteria. Of the 2375 GPS, 85% were clear and actionable; 59% provided a rationale necessitating the message for healthcare practice, 24% reported the net positive consequences from implementing the GPS. Systematic collection of evidence was deemed impractical for 13% of the GPS, and 39% explained the chain of indirect evidence supporting GPS development. 173/2375 (7.3%) statements explicitly satisfied all five criteria. The guidelines' overall quality was poor regardless of the appropriateness of GPS development and labelling. CONCLUSIONS: Statements that qualify as GPS are common in COVID-19 guidelines but are characterised by unclear designation and development processes, and methodological weaknesses.

Chronic Thromboembolic Pulmonary Hypertension (CTEPH): A Review of Another Sequel of Severe Post-Covid-19 Pneumonia.

The spectrum of pulmonary parenchymal and vascular pathologies related to the COVID-19 have emerged. There is evidence of a specific susceptibility related to thrombotic microangiopathy in situ and a complex immune-inflammatory cascade, especially in the pulmonary vascular bed. The potential to lead to transient or self-correcting sequelae of pulmonary vascular injury will only become apparent with longer-term follow-up. In this review, we aimed to present the findings in a group of patients with severe pneumonia due to covid-19 complicated by acute pe documented by chest angiography, who during a follow-up of more than 3 months with oral anticoagulant met clinical, hemodynamic, and imaging criteria of chronic thromboembolic pulmonary hypertension. We present a brief review of the epidemiology, pathophysiology, clinical findings, comorbidities, treatment, and imaging findings of chronic thromboembolic pulmonary hypertension as a sequel of severe post-covid-19 pneumonia; and compared and discussed these findings with similar reports from the medical literature.

HIPERAMONEMIA EN PACIENTE COVID 19 POSITIVO. UNA RARA CAUSA DE ALTERACIÓN DEL ESTADO DE CONCIENCIA EN PACIENTES SIN FALLA HEPÁTICA. REPORTE DE CASO HYPERAMMONAEMIA IN A POSITIVE COVID 19 PATIENT. A RARE CAUSE OF ALTERED CONSCIOUSNESS IN PATIENTS WITHOUT LIVER FAILURE. A CASE REPORT

Reporte de un caso de infección por COVID 19, en un paciente que se presenta con síntomas gastrointestinales y respiratorios altos y bajos, terminando en falla respiratoria y necesidad de ventilación mecánica invasiva, presentando mejoría de su cuadro respiratorio y gastrointestinal, pero con limitaciones para la extubación por alteración del estado de conciencia a pesar del destete de sedo analgesia por más de 72 horas, en quien se encontró niveles elevados de amonio sin signos de falla hepática. La diarrea y el compromiso hepático son manifestaciones frecuentes en pacientes con COVID 19, que pueden llevar posiblemente a una disminución de los niveles de carnitina e hiperamonemia secundaria, convirtiéndose en un verdadero desafío para los clínicos.

Presence of SARS-CoV-2 RNA on Surfaces of Public Places and a Transportation System Located in a Densely Populated Urban Area in South America.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly transmissible RNA virus that causes COVID-19. Being aware of the presence of the virus on different types of surfaces and in different environments, and having a protocol for its detection, is important to understand the dynamics of the virus and its shedding patterns. In Ecuador, the detection of viral RNA in urban environmental samples has not been a priority. The present study analyzed samples from two densely populated neighborhoods and one public transportation system in Quito, Ecuador. Viral RNA presence was assessed using RT-LAMP. Twenty-eight out of 300 surfaces tested positive for SARS-CoV-2 RNA (9.33%). Frequently touched surfaces, especially in indoor spaces and on public transportation, were most likely to be positive for viral RNA. Positivity rate association for the two neighborhoods and for the surface type was not found. This study found viral RNA presence on urban surfaces; this information provides an insight into viral dissemination dynamics. Monitoring environmental SARS-CoV-2 could support the public health prevention strategies in Quito, Ecuador.

HIPERAMONEMIA EN PACIENTE COVID 19 POSITIVO. UNA RARA CAUSA DE ALTERACIÓN DEL ESTADO DE CONCIENCIA EN PACIENTES SIN FALLA HEPÁTICA. REPORTE DE CASO

Resumen Reporte de un caso de infección por COVID 19, en un paciente que se presenta con síntomas gastrointestinales y respiratorios altos y bajos, terminando en falla respiratoria y necesidad de ventilación mecánica invasiva, presentando mejoría de su cuadro respiratorio y gastrointestinal, pero con limitaciones para la extubación por alteración del estado de conciencia a pesar del destete de sedo analgesia por más de 72 horas, en quien se encontró niveles elevados de amonio sin signos de falla hepática. La diarrea y el compromiso hepático son manifestaciones frecuentes en pacientes con COVID 19, que pueden llevar posiblemente a una disminución de los niveles de carnitina e hiperamonemia secundaria, convirtiéndose en un verdadero desafío para los clínicos. A case report of COVID 19 infection in a patient presenting with upper and lower gastrointestinal and respiratory symptoms, ending in respiratory failure and the need for invasive mechanical ventilation, presenting with improvement in his respiratory and gastrointestinal symptoms, but with limitations for extubation due to altered state of consciousness despite weaning from analgesia for more than 72 hours, in whom elevated levels of ammonia were found without signs of liver failure. Diarrhoea and liver involvement are frequent manifestations in patients with COVID 19, which can possibly lead to a decrease in carnitine levels and secondary hyperammonaemia, becoming a challenge for clinicians.

Gobernanza en el sistema de salud ante la pandemia por Covid-19 en México.

Objetivo. Analizar la gobernanza en el sistema de salud en México, en las políticas frente a la pandemia por Covid-19. Material y métodos. Estudio cualitativo, analítico, realizado entre junio y noviembre de 2020. Se analizaron 41 entrevistas semiestructuradas que se aplicaron a acto-res clave del sistema de salud y que se organizaron en el software ATLAS.ti 9. El análisis se adhirió a los principios teórico-metodológicos del Marco Analítico de Gobernanza. Resultados. El problema: la formulación de políticas fue centralizada; los actores: sólo los altos mandos participan en las decisiones; las normas: los valores sociales y el liderazgo determinan su nivel de responsabilidad; toma de decisio-nes: los altos mandos reconocieron poder para proponer modificaciones al Marco Normativo; los nodos: las políticas federales fueron adaptadas a nivel estatal de manera diferen-ciada. Conclusiones. La gobernanza centralizada, los niveles diferenciados de convocatoria de los actores, su poder de decisión, acuerdos, responsabilidad y liderazgo, definieron el alcance de la gobernanza y, a su vez, el nivel de respuesta ante la pandemia por Covid-19.

A taxonomy and framework for identifying and developing actionable statements in guidelines suggests avoiding informal recommendations.

OBJECTIVE: To propose a taxonomy and framework that identifies and presents actionable statements in guidelines. STUDY DESIGN AND SETTING: We took an iterative approach reviewing case studies of guidelines produced by the World Health Organization and the American Society of Hematology to develop an initial conceptual framework. We then tested it using randomly selected recommendations from published guidelines addressing COVID-19 from different organizations, evaluated its results, and refined it before retesting. The urgency and availability of evidence for development of these recommendations varied. We consulted with experts in research methodology and guideline developers to improve the final framework. RESULTS: The resulting taxonomy and framework distinguishes five types of actional statements: formal recommendations; research recommendations; good practice statements; implementation considerations, tools and tips; and informal recommendations. These statements should respond to a priori established criteria and require a clear structure and recognizable presentation in a guideline. Most importantly, this framework identifies informal recommendations that differ from formal recommendations by how they consider evidence and in their development process. CONCLUSION: The identification, standardization and explicit labelling of actionable statements according to the framework may support guideline developers to create actionable statements with clear intent, avoid informal recommendations and improve their understanding and implementation by users.

COVID-19 Screening by Anti-SARS-CoV-2 Antibody Seropositivity: Clinical and Epidemiological Characteristics, Comorbidities, and Food Intake Quality.

Developing countries have reported lower molecular diagnostic testing levels due to a lack of resources. Therefore, antibody tests represent an alternative to detect exposure to SARS-CoV-2 and analyze possible risk factors. We aimed to describe and compare the clinical-epidemiological characteristics and the quality of food intake in Mexican individuals with a positive or negative test to antibodies against SARS-CoV-2. We carried out antibody tests and applied a survey to 1799 individuals; 42% were positive, and diabetes was more prevalent in these cases (p < 0.01). No differences were identified in the blood type nor influenza vaccination between groups. Coughing, respiratory distress, muscle pain, joint pain, and anosmia were the most prevalent symptoms among seropositive cases (p < 0.0001). Food intake quality was similar in both groups, except for the most consumed type of fat (p = 0.006). In conclusion, this study supports the association of diabetes as a principal risk factor for SARS-CoV-2 infection in the Mexican population. The results do not support previous associations between blood group or influenza vaccination as protective factors against SARS-CoV-2 infection. However, frequent consumption of polyunsaturated fats is highlighted as a new possible associated factor with COVID-19, which more studies should corroborate as with all novel findings.

Knowledge, Attitudes, and Practices Regarding COVID-19 Among Healthcare Workers in Venezuela: An Online Cross-Sectional Survey.

Background: The deterioration of Venezuela's health system in recent years undoubtedly contributes to an increased impact of the COVID-19 pandemic. Understanding healthcare workers' (HCWs) knowledge, attitudes, and practices (KAPs) toward COVID-19 in the early stages of the pandemic could inform their medical training and improve their preparedness. Methods: A online national cross-sectional survey was conducted between May 26th and May 30th, 2020, to assess KAPs among HCWs in Venezuela. Results: A total of 1,441 HCWs from all 24 regions of the country responded to the survey. The mean age of the HCWs was 44 (SD [standard deviation] 14) years; most were women (66.4%). Most HCWs were specialized doctors (48%), followed by nurses (13%) and resident doctors (12.3%). The majority of HCWs had good knowledge (76.3%), obtained information mainly from scientific literature (85.4%); had negative attitudes (53.6%), felt uncomfortable with their work during the current pandemic (59.8%); and reported appropriate practices (76.9%). However, participation in COVID-19 related training was absent in more than half of the HCWs. Positive attitudes were significantly more frequent in frontline workers than in non-frontline workers (p = 0.001). Bioanalysts, students, and doctors were more likely to have good knowledge; participating in training was a predictor for positive attitudes and older age was an appropriate practice predictor. Conclusions: HCWs, knowledge in Venezuela could be improved by strengthening education and training programs. Strategies should focus on reducing fear and improving attitudes toward the care of COVID-19 patients, as well as the promotion of preventive practices.

Frequency and phenotype of headache in covid-19: a study of 2194 patients.

To estimate the frequency of headache in patients with confirmed COVID-19 and characterize the phenotype of headache attributed to COVID-19, comparing patients depending on the need of hospitalization and sex, an observational study was done. We systematically screened all eligible patients from a reference population of 261,431 between March 8 (first case) and April 11, 2020. A physician administered a survey assessing demographic and clinical data and the phenotype of the headache. During the study period, 2194 patients out of the population at risk were diagnosed with COVID-19. Headache was described by 514/2194 patients (23.4%, 95% CI 21.7-25.3%), including 383/1614 (23.7%) outpatients and 131/580 (22.6%) inpatients. The headache phenotype was studied in detail in 458 patients (mean age, 51 years; 72% female; prior history of headache, 49%). Headache was the most frequent first symptom of COVID-19. Median headache onset was within 24 h, median duration was 7 days and persisted after 1 month in 13% of patients. Pain was bilateral (80%), predominantly frontal (71%), with pressing quality (75%), of severe intensity. Systemic symptoms were present in 98% of patients. Headache frequency and phenotype was similar in patients with and without need for hospitalization and when comparing male and female patients, being more intense in females.Trial registration: This study was supported by the Institute of Health Carlos III (ISCIII), code 07.04.467804.74011 and Regional Health Administration, Gerencia Regional de Salud, Castilla y Leon (GRS: 2289/A/2020).

Swabbing the Urban Environment - A Pipeline for Sampling and Detection of SARS-CoV-2 From Environmental Reservoirs.

To control community transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the 2020 global pandemic, most countries implemented strategies based on direct human testing, face covering, and surface disinfection. Under the assumption that the main route of transmission includes aerosols and respiratory droplets, efforts to detect SARS-CoV-2 in fomites have focused on locations suspected of high prevalence (e.g., hospital wards, cruise ships, and mass transportation systems). To investigate the presence of SARS-CoV-2 on surfaces in the urban environment that are rarely cleaned and seldomly disinfected, 350 citizens were enlisted from the greater San Diego County. In total, these citizen scientists collected 4,080 samples. An online platform was developed to monitor sampling kit delivery and pickup, as well as to collect sample data. The sampling kits were mostly built from supplies available in pandemic-stressed stores. Samples were processed using reagents that were easy to access despite the recurrent supply shortage. The methods used were highly sensitive and resistant to inhibitors that are commonly present in environmental samples. The proposed experimental design and processing methods were successful at engaging numerous citizen scientists who effectively gathered samples from diverse surface areas. The workflow and methods described here are relevant to survey the urban environment for other viruses, which are of public health concern and pose a threat for future pandemics.

The "false-positive" conundrum: IgA reference level overestimates the seroprevalence of antibodies to SARS-CoV-2.

BACKGROUND: On 12 June 2020, Brazil reached the second position worldwide in the number of COVID-19 cases. Authorities increased the number of tests performed, including the identification of antibodies to SARS-CoV-2 (IgG, IgA, and IgM). There was an overflooding of the market with several tests, and the presence of possible false-positive results became a challenge. The purpose of this study was to describe the seroprevalence and immunoglobulin blood levels in a group of asymptomatic individuals using the reference levels provided by the manufacturer. METHODS: Levels of IgG and IgA antibodies to SARS-CoV-2 were determined in blood serum by the same ELISA (enzyme-linked immunoassay) test. Patients must be free of symptoms. RESULTS: From 20 to 22 May 2020, 938 individuals were tested. There were 441 (47%) men, age 53 years (interquartile range (IQR) = 39-63.2). The sample included 335 (35.7%) subjects aged ≥60 years old. Subjects with a positive test were 54 (5.8%) for IgG and 96 (10.2%) for IgA and 42 (4.5%) for both IgG and IgA. The prevalence of IgG and IgA positive test was not different in men and women and not different in individuals under 60 and over 60 years of age. Conversely, analysing only individuals with positive tests, the levels of IgG in positive subjects were significantly higher than those with an IgA positive test, 3.00 (IQR = 1.68-5.65), and 1.95 (IQR = 1.40-3.38), respectively; P = 0.017. Additionally, individuals with isolated IgA positive tests had significantly lower levels of IgA than those with both IgA and IgG positive tests: 1.95 (IQR = 1.60-2.40) and 3.15 (IQR = 2.20-3.90), respectively, P = 0.005. These latter data suggest that IgA shows a deviation of the distribution to the left in comparison to IgG distribution data. Indeed, many subjects reported as IgA positive had immunoglobulin levels slightly elevated. CONCLUSIONS: In conclusion, we strongly suggest caution in the interpretation of IgA test results. This recommendation is more important for those with positive IgA just above the reference level.