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Chronic obstructive pulmonary disease (COPD) imposes a substantial burden on individuals with the disease, which can include a range of symptoms (breathlessness, cough, sputum production, wheeze, chest tightness) of varying severities. We present an overview of the biomedical literature describing reported relationships between COPD symptoms and disease burden in terms of quality of life, health status, daily activities, physical activity, sleep, comorbid anxiety, and depression, as well as risk of exacerbations and disease prognosis. In addition, the substantial variability of COPD symptoms encountered (morning, daytime, and nighttime) is addressed and their implications for disease burden considered. The findings from this narrative review, which mainly focuses on real-world and observational studies, demonstrate the impact of COPD symptoms on the burden of disease and that improved recognition and understanding of their impact is central to alleviating this burden.

Although composite endpoints (CE) are common in clinical trials, the impact of the relationship between the components of a binary CE on the sample size requirement (SSR) has not been addressed. We performed a computational study considering 2 treatments and a CE with 2 components: the relevant endpoint (RE) and the additional endpoint (AE). We assessed the strength of the components' interrelation by the degree of relative overlap between them, which was stratified into 5 groups. Within each stratum, SSR was computed for multiple scenarios by varying the events proportion and the effect of the therapy. A lower SSR using CE was defined as the best scenario for using the CE. In 25 of 66 scenarios the degree of relative overlap determined the benefit of using CE instead of the RE. Adding an AE with greater effect than the RE leads to lower SSR using the CE regardless of the AE proportion and the relative overlap. The influence of overlapping decreases when the effect on RE increases. Adding an AE with lower effect than the RE constitutes the most uncertain situation. In summary, the interrelationship between CE components, assessed by the relative overlap, can help to define the SSR in specific situations and it should be considered for SSR computation.

We studied the ABO haemolytic disease of the newborn in our neonatal unit to consider their serological aspects and clinical importance. 21% of all pregnancies were ABO incompatibles. The direct antiglobulin test was positive in 46 (11.3%) of them. The Elution was positive in all the newborns with direct antiglobulin test positive (Cd+). The anti-A o anti-B antibodies concentration in mothers was higher than 1/128 in 38 (84%). The C3d complement fraction was activated in two newborns. The infants Cd+ were born to group O mothers in all cases, and nobody was premature. Twelve (26%) of Cd+ presented jaundice which need phototherapy, and one moreover exchange transfusion. The direct antiglobulin test is very useful for detect the liable newborns of serious jaundice; therefore, we thing that is suitable to make this test in infants born to group O mothers. The newborns Cd+ did not have significant anemia at first three months of life.