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• W3115809527 abstract "Lau JYW, Yu Y, Tang RSY, et al. Timing of endoscopy for acute upper gastrointestinal bleeding. N Engl J Med. 2020;382:1299-1308. In patients with overt signs of an upper gastrointestinal bleeding event, does urgent endoscopy provide a mortality benefit compared with early endoscopy? Design: Open-label, randomized, interventional trial. Setting: The emergency department (ED) and medical ward of a quaternary hospital in Hong Kong. Population: A total of 516 adult patients with overt signs of an upper gastrointestinal bleeding event (hematemesis, melena, or both), who were predicted to be at high risk for further bleeding or death according to a Glasgow-Blatchford score. Intervention: Urgent endoscopy (within 6 hours) versus early endoscopy (within 24 hours). Primary and Secondary Outcomes: Death from any cause within 30 days, with secondary endpoints including receipt of endoscopic therapy, further bleeding, and transfusion requirements. Sponsors: Health and Medical Fund of the Food and Health Bureau, Government of Hong Kong Special Administrative Region. ClinicalTrials.gov NCT01675856. Of the 516 patients enrolled in the trial, no difference in 30-day mortality was observed between those randomized to urgent endoscopy versus early endoscopy, at 8.9% versus 6.6%, respectively. An intervention at endoscopy was performed for 60.1% of patients in the urgent group compared with 48.4% in the early group. No differences were observed in hospital length of stay, rebleeding events, or RBC transfusion requirements. Emergency endoscopy was performed in 20 patients in the early endoscopy group owing to acute clinical deterioration. The authors concluded that urgent endoscopy in stable patients with upper gastrointestinal bleeding does not reduce mortality. These authors were not able to demonstrate added value to early endoscopy even for quite ill patients with upper gastrointestinal bleeding, as long as they otherwise exhibited clinical stability. These findings have implications regarding the need for specialist coverage, particularly in regard to off-hours resource use. Most patients in the group randomized to early endoscopy were able to be monitored as appropriate for their clinical status while awaiting a nonurgent procedure. Generalizability to the acutely ill patient with an upper gastrointestinal bleeding event requiring resuscitation is, however, limited. 1.These authors reported 30-day all-cause mortality as their primary outcome. It could be argued a more relevant outcome might be early death owing to bleeding. What considerations might inform these outcome choices? The proposed alternative primary outcome is an example of a disease-specific outcome. At face value, it would seem appropriate to match an intervention for bleeding with an outcome directly measuring the consequences of bleeding. Advantages to disease-specific outcomes include considerations for sample size. All-cause mortality comparisons inevitably converge with time, increasing the likelihood of type II error. Greater, and likely more costly, trial enrollment is then necessary to detect the defined minimally clinical important difference. Other work has proposed valid disease-specific measures while measuring quality-of-life outcomes.1Ware J.E. Gandek B. Guyer R. et al.Standardizing disease-specific quality of life measures across multiple chronic conditions: development and initial evaluation of the QOL Disease Impact Scale (QDIS®).Health Qual Life Outcomes. 2016; 14: 84Crossref PubMed Scopus (31) Google Scholar However, disease-specific outcomes, particularly mortality, do not always exhibit patient-oriented features. With respect to mortality, as in this trial, a patient is less likely concerned regarding the specific cause and timing of death and more likely concerned regarding their overall mortality status. Disease-specific mortality is therefore a surrogate for overall mortality and must be judged on how well the 2 outcomes align. Additional challenges with disease-specific outcomes involve reliable attribution of outcomes to the disease. Outcomes may be confounded by multiple clinical variables, reducing the accuracy of ascertainment. Clinicians and research staff may be asked to weigh the relative influence of several competing factors with respect to an outcome, and misclassification may significantly bias trial results. Disease-specific measures may fail to account for procedure- or treatment-related harms, in which narrowly defined measures may have positive results despite overall negative effects of treatment.2.Examining enrollment criteria and procedures is critical to evaluating generalizability. What examples from this trial are instructive in terms of translating findings to ED practice? To apply the findings of any trial, an assessment must be made regarding the similarity of an individual patient to those represented in a trial population. This trial sought to include patients with upper gastrointestinal bleeding event and Blatchford-Glasgow scores of 12 or higher. Greater than two thirds of the patients had Blatchford-Glasgow scores between 12 and 14, which the authors justified by stating a score of 12 or higher was predictive of need of an endoscopic intervention. Although a large portion of both groups ultimately required endoscopic control for their upper gastrointestinal bleeding, it is unclear how time sensitive these procedures were. In fact, the patients ultimately enrolled may best reflect a population in which emergency endoscopy is likely not required. In this trial, 598 patients had Glasgow-Blatchford scores of 12 or higher. However, only 512 were ultimately randomized. Patients who did not receive randomization included 50 who declined to participate or otherwise were unable to consent, as well as 32 who underwent immediate endoscopy. Then, in those allocated to the early endoscopy arm, 4 patients died before their scheduled endoscopy, whereas 20 became too ill and required emergency intervention. In addition, specialty consultation for endoscopy was not obtained for approximately 7 or 8 hours after ED presentation. Therefore, to be randomized, patients would have received substantial resuscitation and exhibited ongoing clinical stability. Essentially, despite enrolling what at first glance appeared to be a moderately sick cohort, the trial’s exclusion criteria and crossover in any clinically decompensating patient led to selection of a cohort for whom it would be unlikely to measure any benefit to emergency endoscopy." @default.
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• W3115809527 doi "https://doi.org/10.1016/j.annemergmed.2020.11.015" @default.
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