Proportion Of Patients In Category Research Articles

A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia.

BACKGROUNDPassive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19. Evidence from controlled clinical trials is inconclusive.METHODSWe conducted a randomized, open-label, controlled clinical trial at 27 hospitals in Spain. Patients had to be admitted for COVID-19 pneumonia within 7 days from symptom onset and not on mechanical ventilation or high-flow oxygen devices. Patients were randomized 1:1 to treatment with CP in addition to standard of care (SOC) or to the control arm receiving only SOC. The primary endpoint was the proportion of patients in categories 5 (noninvasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), or 7 (death) at 14 days. Primary analysis was performed in the intention-to-treat population.RESULTSBetween April 4, 2020, and February 5, 2021, 350 patients were randomly assigned to either CP (n = 179) or SOC (n = 171). At 14 days, proportion of patients in categories 5, 6, or 7 was 11.7% in the CP group versus 16.4% in the control group (P = 0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in the CP group versus 17.0% in the control group (P = 0.021). The difference in overall survival did not reach statistical significance (HR 0.46, 95% CI 0.19-1.14, log-rank P = 0.087).CONCLUSIONCP showed a significant benefit in preventing progression to noninvasive ventilation or high-flow oxygen, invasive mechanical ventilation or ECMO, or death at 28 days. The effect on the predefined primary endpoint at 14 days and the effect on overall survival were not statistically significant.TRIAL REGISTRATIONClinicaltrials.gov, NCT04345523.FUNDINGGovernment of Spain, Instituto de Salud Carlos III.

Poor Performance Status Is Associated With Increased Mortality in Patients With Cirrhosis.

Functional status (a patient's ability to perform activities that meet basic needs, fulfill usual roles, and maintain health and well-being) has been linked to outcomes in patients with cirrhosis and can be measured by the Karnofsky performance status (KPS) scale. We investigated the association between KPS score and mortality in patients with cirrhosis. We used the United Network for Organ Sharing database to perform a retrospective cohort study of patients listed for liver transplantation in the United States between 2005 and 2015. We used Cox proportional hazards and competing risk regression analyses to examine the association between KPS and mortality and transplantation. Of 79,092 patients, 44% were in KPS category A (KPS, 80%-100%), 43% were in category B (KPS, 50%-70%), and 13% were in category C (KPS, 10%-40%). Between 2005 and 2015, the proportion of patients in category A decreased from 53% to 35%, whereas the proportions in categories B and C increased from 36% to 49% and from 11% to 16%, respectively. KPS was associated with mortality: compared with patients in KPS category A, the KPS B adjusted hazard ratio (HR) was 1.14 (95% confidence interval [CI], 1.11-1.18) and the KPS C adjusted HR was 1.63 (95% CI, 1.55-1.72). KPS was also associated with liver transplantation; compared with patients in KPS category A, the KPS B adjusted HR was 1.08 (95% CI, 1.06-1.11) and the KPS C adjusted HR was 1.35 (95% CI, 1.30-1.40). In competing risk analysis, only the relationship between KPS and mortality maintained significance and directionality. These relationships were most pronounced in patients without hepatocellular carcinoma. Among patients with cirrhosis listed for liver transplantation, poor performance status, based on the KPS scale, is associated with increased mortality. In this population, performance status has decreased over time.

P185 Quantification and Treatment Patterns of Real-World Patients Classified by the GOLD 2011 Strategy

ObjectivesThe Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 Strategy classifies COPD patients into 4 categories (A: low risk, less symptoms; B: low risk, more symptoms; C: high risk,...

Changing trends in the surgical treatment of duodenal ulcer

On the basis of fully or partly controlled clinical trials the long term results of several standard operations for duodenal ulcer have been compared--subtotal gastrectomy, truncal vagotomy and antrectomy, truncal vagotomy and gastro-enterostomy, truncal vagotomy and pyloroplasty, selective vagotomy and pyloroplasty and proximal gastric vagotomy without drainage. Few statistically significant differences emerge but the following observations seems to be justified: (a) Subtotal gastrectomy and vagotomy and antrectomy probably offer better protection against recurrent ulceration than any of the other operations examined, but the greater intrinsic operative risks of these two resection procedures is emphasized. (b) Disturbances of alimentary function occur to a variable extent after all operations but appear to be least troublesome after proximal gastric vagotomy without drainage. In particular this operation is followed by a negligible incidence of diarrhoea compared with truncal vagotomy procedures. (c) On overall (Visick) grading the two resection operations and proximal gastric vagotomy without drainage do better than truncal vagotomy with drainage, proximal gastric vagotomy being specially notable for the relatively small proportion of patients in category 3 after its use. Surgical strategy in the choice of elevtive operation for duodenal ulcer is discussed.