Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants.

BACKGROUND: Intestinal dysbiosis may contribute to the pathogenesis of necrotising enterocolitis (NEC) in very preterm or very low birth weight (VLBW) infants. Dietary supplementation with probiotics to modulate the intestinal microbiome has been proposed as a strategy to reduce the risk of NEC and associated mortality and morbidity in very preterm or VLBW infants. OBJECTIVES: To determine the effect of supplemental probiotics on the risk of NEC and associated mortality and morbidity in very preterm or very low birth weight infants. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, the Maternity and Infant Care database, and CINAHL from inception to July 2022. We searched clinical trials databases and conference proceedings, and examined the reference lists of retrieved articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs comparing probiotics with placebo or no probiotics in very preterm infants (born before 32 weeks' gestation) and VLBW infants (weighing less than 1500 g at birth). DATA COLLECTION AND ANALYSIS: Two review authors independently evaluated risk of bias of the trials, extracted data, and synthesised effect estimates using risk ratios (RRs), risk differences (RDs), and mean differences (MDs), with associated 95% confidence intervals (CIs). The primary outcomes were NEC and all-cause mortality; secondary outcome measures were late-onset invasive infection (more than 48 hours after birth), duration of hospitalisation from birth, and neurodevelopmental impairment. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included 60 trials with 11,156 infants. Most trials were small (median sample size 145 infants). The main potential sources of bias were unclear reporting of methods for concealing allocation and masking caregivers or investigators in about half of the trials. The formulation of the probiotics varied across trials. The most common preparations contained Bifidobacterium spp., Lactobacillus spp., Saccharomyces spp., andStreptococcus spp., alone or in combination. Very preterm or very low birth weight infants Probiotics may reduce the risk of NEC (RR 0.54, 95% CI 0.46 to 0.65; I² = 17%; 57 trials, 10,918 infants; low certainty). The number needed to treat for an additional beneficial outcome (NNTB) was 33 (95% CI 25 to 50). Probiotics probably reduce mortality slightly (RR 0.77, 95% CI 0.66 to 0.90; I² = 0%; 54 trials, 10,484 infants; moderate certainty); the NNTB was 50 (95% CI 50 to 100). Probiotics probably have little or no effect on the risk of late-onset invasive infection (RR 0.89, 95% CI 0.82 to 0.97; I² = 22%; 49 trials, 9876 infants; moderate certainty). Probiotics may have little or no effect on neurodevelopmental impairment (RR 1.03, 95% CI 0.84 to 1.26; I² = 0%; 5 trials, 1518 infants; low certainty). Extremely preterm or extremely low birth weight infants Few data were available for extremely preterm or extremely low birth weight (ELBW) infants. In this population, probiotics may have little or no effect on NEC (RR 0.92, 95% CI 0.69 to 1.22, I² = 0%; 10 trials, 1836 infants; low certainty), all-cause mortality (RR 0.92, 95% CI 0.72 to 1.18; I² = 0%; 7 trials, 1723 infants; low certainty), or late-onset invasive infection (RR 0.93, 95% CI 0.78 to 1.09; I² = 0%; 7 trials, 1533 infants; low certainty). No trials provided data for measures of neurodevelopmental impairment in extremely preterm or ELBW infants. AUTHORS' CONCLUSIONS: Given the low to moderate certainty of evidence for the effects of probiotic supplements on the risk of NEC and associated morbidity and mortality for very preterm or VLBW infants, and particularly for extremely preterm or ELBW infants, there is a need for further large, high-quality trials to provide evidence of sufficient validity and applicability to inform policy and practice.

Cost-utility analysis of genomic profiling in early breast cancer in Colombia.

BACKGROUND: In Colombia, the best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) remains unknown. This study aimed to identify the cost-utility of Oncotype DX™ (ODX) or Mammaprint™ (MMP) tests to establish the necessity of adjuvant chemotherapy. METHODS: This study used an adapted decision-analytic model to compare cost and outcomes of care between ODX or MMP tests and routine care without ODX or MMP tests (adjuvant chemotherapy for all patients) over a 5-year time horizon from the perspective of the Colombian National Health System (NHS; payer). Inputs were obtained from national unit cost tariffs, published literature, and clinical trial database. The study population comprised women with hormone-receptor-positive (HR +), HER2-negative, lymph-node-negative (LN0) EBC with high-risk clinical criteria for recurrence. The outcome measures were discounted incremental cost-utility ratio (ICUR; 2021 United States dollar per quality-adjusted life-year [QALY] gained) and net monetary benefit (NMB). Probabilistic (PSA) and deterministic sensitivity analysis (DSA) were performed. RESULTS: ODX increases QALYs by 0.05 and MMP by 0.03 with savings of $2374 and $554 compared with the standard strategy, respectively, and were cost-saving in cost-utility plane. NMB for ODX was $2203 and for MMP was $416. Both tests dominate the standard strategy. Sensitivity analysis revealed that with a threshold of 1 gross domestic product per capita, ODX will be cost-effective in 95.5% of the cases compared with 70.2% cases involving MMP.DSA showed that the variable with significant influence was the monthly cost of adjuvant chemotherapy. PSA revealed that ODX was a consistently superior strategy. CONCLUSIONS: Genomic profiling using ODX or MMP tests to define the need of adjuvant chemotherapy treatment in patients with HR + and HER2 -EBC is a cost-effective strategy that allows Colombian NHS to maintain budget.

A Framework for the Development of Living Practice Guidelines in Health Care.

BACKGROUND: Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence. OBJECTIVE: To develop a framework that characterizes the processes of development of living practice guidelines in health care. DESIGN: First, 3 background reviews were conducted: a scoping review of methods papers, a review of handbooks of guideline-producing organizations, and an analytic review of selected living practice guidelines. Second, the core team drafted the first version of the framework. Finally, the core team refined the framework through an online survey and online discussions with a multidisciplinary international group of stakeholders. SETTING: International. PARTICIPANTS: Multidisciplinary group of 51 persons who have experience with guidelines. MEASUREMENTS: Not applicable. RESULTS: A major principle of the framework is that the unit of update in a living guideline is the individual recommendation. In addition to providing definitions, the framework addresses several processes. The planning process should address the organization's adoption of the living methodology as well as each specific guideline project. The production process consists of initiation, maintenance, and retirement phases. The reporting should cover the evidence surveillance time stamp, the outcome of reassessment of the body of evidence (when applicable), and the outcome of revisiting a recommendation (when applicable). The dissemination process may necessitate the use of different venues, including one for formal publication. LIMITATION: This study does not provide detailed or practical guidance for how the described concepts would be best implemented. CONCLUSION: The framework will help guideline developers in planning, producing, reporting, and disseminating living guideline projects. It will also help research methodologists study the processes of living guidelines. PRIMARY FUNDING SOURCE: None.

Calidad de vida relacionada con salud en la población Colombiana: ¿cómo valoran los colombianos su estado de salud? / Quality of life related to health in the Colombian population: how do Colombians perceive their health condition?

RESUMEN Objetivo Determinar la percepción sobre la calidad de vida relacionada con salud (CVrS) que tiene la población adulta en Colombia. Métodos Encuesta poblacional en una muestra representativa de la población rural y urbana, de 18 y más años. Se midió la CVrS con el instrumento EQ5D-3L y la escala visual análoga, como parte de la cuarta Encuesta Nacional de Salud Mental. Las estimaciones fueron ajustadas por el diseño de muestreo y se acompañan de intervalos de confianza al 95 %. Resultados 1 0867 personas completaron la medición; 69,7 % (IC95 % 66,9 a 68,9) de la población reporto estar en "salud completa"; la mayor proporción de personas valoraron su salud por encima de 80 puntos. La presencia de "moderado dolor o malestar", seguida de estar "moderadamente angustiado o deprimido" fueron las alteraciones más frecuentes. Los adultos jóvenes tienden a valorar mejor su salud que los adultos mayores. No hay diferencias en la percepción de la salud entre regiones del país. Conclusiones La calidad de vida relacionada con salud en la población colombiana es mayor de 80 puntos en una escala de 1 a 100. Las alteraciones como angustia y depresión y la percepción del dolor, fueron las más comúnmente reportadas por los colombianos. La situación de pobreza y el bajo nivel educacional son determinantes de la valoración que hacen los colombianos de su CVrS.(AU)

ABSTRACT Objective To determine the perception about quality of life related to health in the adult population of Colombia. Methods Population-based survey applied on a representative sample of the Colombian rural and urban population, aged 18 years or more. Quality of life related to health was measured using the generic EQ5D instrument and the analogue visual scale as part of the fourth National Mental Health Survey. Estimates were accompanied by 95 % confidence intervals and were adjusted by the sampling design. Results 10 867 people aged 18 years or older completed the measurement. 69.7 % (CI95 %; 66.9-68.9) of the population reported being "completely healthy". Most of the population rated their health condition above 80 points. The presence of "moderate pain or discomfort", followed by being "moderately distressed or depressed" were the most frequent alterations. Young adults tend to perceive their health better than older adults. There is no difference in the perception of health between regions of the country. Conclusions Quality of life related to health in the Colombian population is greater than 80 points on a scale of 1 to 100. Alterations such as angst and depression and the perception of pain were the most frequently reported by Colombians. Poverty and a low level of education are determinants of the perception of Colombians regarding their quality of life related to health.(AU)

[Quality of life related to health in the Colombian population: how do Colombians perceive their health condition?] / Calidad de vida relacionada con salud en la población Colombiana: ¿cómo valoran los colombianos su estado de salud?

OBJECTIVE: To determine the perception about quality of life related to health in the adult population of Colombia. METHODS: Population-based survey applied on a representative sample of the Colombian rural and urban population, aged 18 years or more. Quality of life related to health was measured using the generic EQ5D instrument and the analogue visual scale as part of the fourth National Mental Health Survey. Estimates were accompanied by 95 % confidence intervals and were adjusted by the sampling design. RESULTS: 10 867 people aged 18 years or older completed the measurement. 69.7 % (CI95 %; 66.9-68.9) of the population reported being "completely healthy". Most of the population rated their health condition above 80 points. The presence of "moderate pain or discomfort", followed by being "moderately distressed or depressed" were the most frequent alterations. Young adults tend to perceive their health better than older adults. There is no difference in the perception of health between regions of the country. CONCLUSIONS: Quality of life related to health in the Colombian population is greater than 80 points on a scale of 1 to 100. Alterations such as angst and depression and the perception of pain were the most frequently reported by Colombians. Poverty and a low level of education are determinants of the perception of Colombians regarding their quality of life related to health.

OBJETIVO: Determinar la percepción sobre la calidad de vida relacionada con salud (CVrS) que tiene la población adulta en Colombia. MÉTODOS: Encuesta poblacional en una muestra representativa de la población rural y urbana, de 18 y más años. Se midió la CVrS con el instrumento EQ5D-3L y la escala visual análoga, como parte de la cuarta Encuesta Nacional de Salud Mental. Las estimaciones fueron ajustadas por el diseño de muestreo y se acompañan de intervalos de confianza al 95 %. RESULTADOS: 1 0867 personas completaron la medición; 69,7 % (IC95 % 66,9 a 68,9) de la población reporto estar en "salud completa"; la mayor proporción de personas valoraron su salud por encima de 80 puntos. La presencia de "moderado dolor o malestar", seguida de estar "moderadamente angustiado o deprimido" fueron las alteraciones más frecuentes. Los adultos jóvenes tienden a valorar mejor su salud que los adultos mayores. No hay diferencias en la percepción de la salud entre regiones del país. CONCLUSIONES: La calidad de vida relacionada con salud en la población colombiana es mayor de 80 puntos en una escala de 1 a 100. Las alteraciones como angustia y depresión y la percepción del dolor, fueron las más comúnmente reportadas por los colombianos. La situación de pobreza y el bajo nivel educacional son determinantes de la valoración que hacen los colombianos de su CVrS.