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.

Factors associated with Allergic Rhinitis in Colombian subpopulations aged 1 to 17 and 18 to 59.

BACKGROUND: Several studies have shown variations in the prevalence of allergic rhinitis (AR) around the world, and different potential predisposing factors. More studies are needed on risk factors, specifically in developing countries. This study explored the association of several factors and AR among urban residents in six cities of Colombia. METHODOLOGY: A cross-sectional study and a nested case-control study were carried out between 2009 and 2010 involving two Colombian subpopulations: children/adolescents and adults. Cases were affirmative respondents to "In the past 12 months, have you (or your child) had a problem with sneezing or a running or blocked nose, when you (or your child) did not have a cold or the flu?" "Controls" were subjects who never had been diagnosed with asthma, AR or atopic eczema by a physician, and whom did not report any symptoms in the past twelve months. Weighted logistic regression was used to assess the association of different factors with case/control status. RESULTS: Factors associated with AR in children/adolescents were family history of AR, acetaminophen consumption and high socioeconomic status. Among adults, family history of asthma, AR and atopic eczema, and cetaminophen consumption were associated with AR. Consumption of cereals among children/adolescents and eating eggs among adults showed protective associations. CONCLUSIONS: Our findings suggest the presence of previously unknown cultural, environmental and family factors associated with the presence of AR in Colombia.

Prophylactic probiotics to prevent death and nosocomial infection in preterm infants.

BACKGROUND AND OBJECTIVE: It has been suggested that probiotics may decrease infant mortality and nosocomial infections because of their ability to suppress colonization and translocation of bacterial pathogens in the gastrointestinal tract. We designed a large double-blinded placebo-controlled trial using Lactobacillus reuteri to test this hypothesis in preterm infants. METHODS: Eligible infants were randomly assigned during the first 48 hours of life to either daily probiotic administration or placebo. Infants in the intervention group were administered enterally 5 drops of a probiotic preparation containing 10(8) colony-forming units of L reuteri DSM 17938 until death or discharge from the NICU. RESULTS: A total of 750 infants ≤ 2000 g were enrolled. The frequency of the primary outcome, death, or nosocomial infection, was similar in the probiotic and placebo groups (relative risk 0.87; 95% confidence interval: 0.63-1.19; P = .376). There was a trend toward a lower rate of nosocomial pneumonia in the probiotic group (2.4% vs 5.0%; P = .06) and a nonsignificant 40% decrease in necrotizing enterocolitis (2.4% vs 4.0%; P = .23). Episodes of feeding intolerance and duration of hospitalization were lower in infants ≤ 1500 g (9.6% vs 16.8% [P = .04]; 32.5 days vs 37 days [P = .03]). CONCLUSIONS: Although L reuteri did not appear to decrease the rate of the composite outcome, the trends suggest a protective role consistent with what has been observed in the literature. Feeding intolerance and duration of hospitalization were decreased in premature infants ≤ 1500 g.

Prevalence of asthma and other allergic conditions in Colombia 2009-2010: a cross-sectional study.

BACKGROUND: While it is suggested that the prevalence of asthma in developed countries may have stabilized, this is not clear in currently developing countries. Current available information for both adults and children simultaneously on the burden and impact of allergic conditions in Colombia and in many Latin American countries is limited. The objectives of this study were to estimate the prevalence for asthma, allergic rhinitis (AR), atopic eczema (AE), and atopy in six colombian cities; to quantify costs to the patient and her/his family; and to determine levels of Immunoglobulin E (IgE) in asthmatic and healthy subjects. METHODS: We conducted a cross-sectional, population-based study in six cities during the academic year 2009-2010. We used a school-based design for subjects between 5-17 years old. We carried out a community-based strategy for subjects between 1-4 years old and adults between 18-59 years old. Serum samples for total and antigen-specific (IgE) levels were collected using a population-based, nested, case-control design. RESULTS: We obtained information on 5978 subjects. The largest sample of subjects was collected in Bogotá (2392). The current prevalence of asthma symptoms was 12% (95% CI, 10.5-13.7), with 43% (95% CI, 36.3-49.2) reporting having required an emergency department visit or hospitalization in the past 12 months. Physician diagnosed asthma was 7% (95% CI, 6.1-8.0). The current prevalence of AR symptoms was 32% (95% CI, 29.5-33.9), and of AE symptoms was 14% (95% CI, 12.5-15.3). We collected blood samples from 855 subjects; 60.2% of asthmatics and 40.6% of controls could be classified as atopic. CONCLUSIONS: In Colombia, symptom prevalence for asthma, AR and AE, as well as levels of atopy, are substantial. Specifically for asthma, symptom severity and absence from work or study due to symptoms are important. These primary care sensitive conditions remain an unmet public health burden in developing countries such as Colombia.

Comparación de la función pulmonar de pacientes con diabetes mellitus tipo 2 sometidos a tratamiento de insulina inyectada versus tratamiento con hipoglucemiantes orales / Comparison of the pulmonary function of patients with type 2 diabetes mellitus treated with insulin injections versus that of patients treated with oral hypoglucemic agents

Introducción: la potencial asociación entre el tipo de tratamiento de la diabetes mellitus tipo 2 (DM2) y alteración de la función pulmonar es algo poco estudiado hasta ahora. Objetivos: comparar la función pulmonar de pacientes con DM2 que reciben tratamiento con insulina inyectable versus hipoglicemiantes orceles (HO). Determinar si niveles de marcadores de inflamación en pacientes con tratamiento basado en insulina son diferentes a los de los tratados con HO. Métodos: estudio observacional analítico de corte transversal a partir de una muestra de conveniencia de 369 pacientes con diagnóstico de DM2, y tratamiento con insulina o HO. Se realizaron espirometrías, y se obtuvieron valores residuales promedios para VEF1, CVF y relación VEF1/CVF. Mediante regresión lineal múltiple, se ajustó por diferencias en determinantes conocidos de la función pulmonar, así como por control de la diabetes y tiempo desde el diagnóstico. Adicionalmente, se midieron niveles de marcadores inflamatorios sanguíneos para cada grupo de tratamiento. Resultados: 63 pacientes (17%) recibían tratamiento con insulina y 306 (83%) con HO. La diferencia en residuales favoreció a los tratados con HO. Para VEF1, CVF y VEF1/CVF la diferencia fue 57.6 mL (IC95% 32.45-82.74; P 0.0047), 45.6 mL (IC95% 20.84-70.39; P 0.0231) y 0.017, (IC95% 0.01- 0.02, P<0.0001), respectivamente. No hubo cambios estadísticamente significativos en marcadores de inflamación. Conclusiones: los pacientes en tratamiento con HO presentaron mejor función pulmonar que los tratados con insulina. Este hallazgo de diferencias en función pulmonar pudiera tener implicación clínica en el manejo de los pacientes diabéticos, pero debe confirmarse en estudios prospectivos (Acta Med Colom; 2010: 35: 113-118).

Introduction: the potential association between the type of treatment of type 2 diabetes mellitus (DM2) and impaired lung function is something rarely studied so far. Objectives: to compare the lung function of patients with DM2 who are treated with injectable insulin versus HO. To determine whether levels of inflammatory markers in patients with insulin-based treatment are different from those treated with HO. Methods: an observational, analytical, cross-sectional study from a convenience sample of 369 patients diagnosed with DM2 and treated with insulin or HO. Spirometry was performed, and residual values were averaged for FEV1, FVC and FEV1/FVC ratios. Multiple linear regression results were adjusted by differences in known determinants of lung function, as well as control of diabetes and time since diagnosis. Additionally, we measured blood levels of inflammatory markers for each treatment group. Results: 63 patients (17%) were treated with insulin and 306 (83%) with OH. The difference in residual favored those treated with HO. For FEV1, FVC and FEV1/FVC the difference was 57.6 mL (95% CI 32.45 to 82.74, P 0.0047), 45.6 mL (95% CI 20.84 to 70.39, P 0.0231) and 0.017 (95% CI 0.01 to 0.02, P <0.0001), respectively. There were no statistically significant changes in inflammation markers. Conclusions: patients treated with HO showed better lung function than those treated with insulin. This finding of differences in lung function may have clinical implications in the management of diabetic patients, but needs to be confirmed in prospective studies (Acta Med Colom; 2010: 35: 113-118).

Inadequate glucose control in type 2 diabetes is associated with impaired lung function and systemic inflammation: a cross-sectional study.

BACKGROUND: Inadequate glucose control may be simultaneously associated with inflammation and decreased lung function in type 2 diabetes. We evaluated if lung function is worse in patients with inadequate glucose control, and if inflammatory markers are simultaneously increased in these subjects. METHODS: Subjects were selected at the Colombian Diabetes Association Center in Bogotá. Pulmonary function tests were performed and mean residual values were obtained for forced expiratory volume (FEV1), forced vital capacity (FVC) and FEV1/FVC, with predicted values based on those derived by Hankinson et al. for Mexican-Americans. Multiple least-squares regression was used to adjust for differences in known determinants of lung function. We measured blood levels of glycosylated hemoglobin (HBA1c), interleukin 6 (IL-6), tumor necrosis factor (TNF-alpha), fibrinogen, ferritin, and C-reactive protein (C-RP). RESULTS: 495 diabetic patients were studied, out of which 352 had inadequate control (HBA1c > 7%). After adjusting for known determinants of lung function, those with inadequate control had lower FEV1 (-75.4 mL, IC95%: -92, -59; P < 0.0001) and FVC (-121 mL, IC95%: -134, -108; P < 0,0001) mean residuals, and higher FEV1/FVC (0.013%, IC95%: 0.009, 0.018, P < 0.0001) residuals than those with adequate control, as well as increased levels of all inflammatory markers (P < 0.05), with the exception of IL-6. CONCLUSIONS: Subjects with type 2 diabetes and inadequate control had lower FVC and FEV1 than predicted and than those of subjects with adequate control. It is postulated that poorer pulmonary function may be associated with increased levels of inflammatory mediators.

Randomized, multicenter trial of conventional ventilation versus high-frequency oscillatory ventilation for the early management of respiratory failure in term or near-term infants in Colombia.

OBJECTIVE: To determine the efficacy and safety of high-frequency oscillatory ventilation (HFOV) compared to conventional ventilation (CV) for the treatment of respiratory failure in term and near-term infants in Colombia. STUDY DESIGN: Eligible infants with moderate to severe respiratory failure were randomized to early treatment with CV or HFOV. Ventilator management and general patient care were standardized. The main outcome was neonatal death or pulmonary air leak. RESULTS: A total of 119 infants were enrolled (55 in the HFOV group; 64 in the CV group) during the study period. Six infants in the HFOV group (11%) and two infants in the CV group (3%) developed the primary outcome (RR: 3.6, 95% CI: 0.8-16.9). Five infants in the HFOV group (9%) and one infant in the CV (2%) died before 28 days of life (RR: 5.9 CI: 0.7-48.2). Secondary outcomes were similar between groups. CONCLUSION: HFOV may not be superior to CV as an early treatment for respiratory failure in this age group. Standardization of ventilator management and general patient care may have a greater impact on the outcome in Colombia than mode of ventilation.

Risk factors for nosocomial infections in selected neonatal intensive care units in Colombia, South America.

OBJECTIVE: This study was designed to identify risk factors for nosocomial infections among infants admitted into eight neonatal intensive care units in Colombia. Knowledge of modifiable risk factors could be used to guide the design of interventions to prevent the problem. STUDY DESIGN: Data were collected prospectively from eight neonatal units. Nosocomial infection was defined as culture-proven infection diagnosed after 72 hours of hospitalization, resulting in treatment with antibiotics for >3 days. Associations were expressed as odds ratios. Logistic regression was used to adjust for potential confounders. RESULTS: From a total of 1504 eligible infants, 80 were treated for 127 episodes of nosocomial infection. Logistic regression analysis identified the combined exposure to postnatal steroids and H2-blockers, and use of oral gastric tubes for enteral nutrition as risk factors significantly associated with nosocomial infection. CONCLUSION: Nosocomial infections in Colombian neonatal intensive care units were associated with modifiable risk factors including use of postnatal steroids and H2-blockers.

Epidemiology of nosocomial infections in selected neonatal intensive care units in Colombia, South America.

OBJECTIVE: The epidemiology of nosocomial infections (NI) in neonatal intensive care units in developing countries has been poorly studied. We conducted a prospective study in selected neonatal units in Colombia, SA, to describe the incidence rate, causative organisms, and interinstitutional differences. STUDY DESIGN: Data were collected prospectively from February 20 to August 30, 2001 from eight neonatal units. NI was defined as culture-proven infection diagnosed after 72 h of hospitalization, resulting in treatment with antibiotics for >3 days. Linear regression models were used to describe associations between institutional variables and NI rates. RESULTS: A total of 1504 infants were hospitalized for more than 72 h, and therefore, at risk for NI. Of all, 127 infections were reported among 80 patients (5.3%). The incidence density rate was 6.2 per 1000 patient-days. Bloodstream infections accounted for 78% of NIs. Gram-negative organisms predominated over gram-positive organisms (55 vs 38%) and were prevalent in infants < or =2000 g (54%). The most common pathogens were Staphylococcus epidermidis (26%) and Klebsiella pneumonia (12%). CONCLUSION: Gram-negative organisms predominate in Colombia among infants <2000 g. The emergence of gram-negative organisms and their associated risk factors requires further study.

Asthma and other allergic conditions in Colombia: a study in 6 cities.

BACKGROUND: No detailed information is available on the burden and impact of allergic diseases simultaneously for adults and children in Colombia and most Latin American countries. OBJECTIVES: To investigate the prevalence of asthma, allergic rhinitis, and atopic dermatitis symptoms in 6 cities in Colombia; to measure patient expenses and school days and workdays lost; to describe disease severity; and to determine levels of total and specific IgE in asthmatic subjects. METHODS: A multistage stratified random sample selection of schools with subjects aged 5 to 18 years in each city was used. Guardian subjects selected were contacted, and home visits were arranged. Subjects aged 1 to 4 years and older than 19 years were also selected randomly by systematic sampling based on the addresses of the subjects aged 5 to 18 years. Subjects with asthma symptoms were invited to provide a blood sample. RESULTS: Information was obtained from 6,507 subjects. The prevalence of asthma, rhinitis, and atopic dermatitis symptoms in the past 12 months was 10.4% (95% confidence interval [CI], 9.7%-11.1%), 22.6% (95% CI, 21.6%-23.6%), and 3.9% (95% CI, 3.4%-4.4%), respectively. Thirty-eight percent of asthmatic subjects had visited the emergency department or have been hospitalized, and 50% reported lost school days and workdays. Seventy-six percent of sampled asthmatic patients were considered to be atopic. CONCLUSIONS: The burden of disease and societal consequences of allergic entities in urban settings in countries such as Colombia are of concern but are largely ignored, perhaps because of the misconception that these diseases are of public health importance only in industrialized nations.