Feasibility of randomized controlled trials in liver surgery using surgery-related mortality or morbidity as endpoint

2009 ◽  
Vol 96 (9) ◽  
pp. 1005-1014 ◽  
Author(s):  
M. A. J. van den Broek ◽  
R. M. van Dam ◽  
M. Malagó ◽  
C. H. C. Dejong ◽  
G. J. P. van Breukelen ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Liver Surgery ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Related Mortality

Infectious complications in lupus nephritis treatment: a systematic review and meta-analysis

Lupus ◽  
2019 ◽  
Vol 28 (3) ◽  
pp. 334-346 ◽  
Author(s):  
K M Thong ◽  
T M Chan
Keyword(s):  
Lupus Nephritis ◽  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Risk Ratio ◽  
Meta Analysis ◽  
Induction Treatment ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Serious Infections ◽  
Related Mortality

Objectives Infection is an important concern in lupus nephritis treatment, but few studies have focused on this complication. Available data suggest marked variation in occurrence and outcome. This meta-analysis and review aims to provide an overview of infective complications, focusing on the risk factors and outcomes. Methods Original articles on lupus nephritis Class III/IV/V published in the period January 1980 to December 2016 were identified from the Pubmed/Medline electronic database. Meta-analysis of randomized controlled trials was performed to investigate total and serious infections at different phases of treatment and their associated factors. A descriptive review that included all studies was also performed, providing details on the types of infection, infection-related mortality, and potential impact of different eras on infection rates. Results A total of 56 studies (32 randomized controlled trials) were included. The incidence rates of overall and serious infections were higher during the induction than maintenance phase of therapy, with serious infections occurring at 8.2–50 and 3.5 per 100 patient-years, respectively. Recent data, predominantly from Asia, suggested lower rates of overall infections with induction regimens that included tacrolimus compared with mycophenolate (risk ratio 0.50, 95% confidence interval 0.33–0.76, p = 0.001). Mycophenolate as induction treatment was associated with lower overall infection risks than cyclophosphamide in non-Asians (risk ratio 0.60, 95% confidence interval 0.48–0.75, p < 0.001). The rates of serious infections were 4.1–25% in Asian and 4.4–8.5% in non-Asian countries; with infection-related mortality rates of 0–6.7% in Asian, compared to 0–2.1% in non-Asian locations. Conclusions Infection remains a serious complication during treatment of lupus nephritis, but the reported rates and outcomes varied markedly. Mycophenolate was associated with lower infection risk than cyclophosphamide in non-Asians. Infection-related deaths appeared more common in Asian patients.

Development of a composite endpoint for randomized controlled trials in liver surgery

2011 ◽  
Vol 98 (8) ◽  
pp. 1138-1145 ◽  
Author(s):  
M. A. J. van den Broek ◽  
R. M. van Dam ◽  
G. J. P. van Breukelen ◽  
M. H. Bemelmans ◽  
E. Oussoultzoglou ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Liver Surgery ◽  
Composite Endpoint ◽  
Controlled Trials ◽  
Randomized Controlled

Colony-Stimulating Factors for Chemotherapy-Induced Febrile Neutropenia: A Meta-Analysis of Randomized Controlled Trials

2005 ◽  
Vol 23 (18) ◽  
pp. 4198-4214 ◽  
Author(s):  
Otavio A.C. Clark ◽  
Gary H. Lyman ◽  
Aldemar A. Castro ◽  
Luciana G.O. Clark ◽  
Benjamin Djulbegovic
Keyword(s):  
Febrile Neutropenia ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Recovery Period ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Colony Stimulating Factors ◽  
Neutrophil Recovery ◽  
Randomized Controlled ◽  
Related Mortality

Purpose Current treatment for febrile neutropenia (FN) includes hospitalization for evaluation, empiric broad-spectrum antibiotics, and other supportive care. Clinical trials have reported conflicting results when studying whether the colony-stimulating factors (CSFs) improve outcomes in patients with FN. This Cochrane Collaboration review was undertaken to further evaluate the safety and efficacy of the CSFs in patients with FN. Methods An exhaustive literature search was undertaken including major electronic databases (CANCERLIT, EMBASE, LILACS, MEDLINE, SCI, and the Cochrane Controlled Trials Register). All randomized controlled trials that compare CSFs plus antibiotics versus antibiotics alone for the treatment of established FN in adults and children were sought. A meta-analysis of the selected studies was performed. Results More than 8,000 references were screened, with 13 studies meeting eligibility criteria for inclusion. The overall mortality was not influenced significantly by the use of CSF (odds ratio [OR] = 0.68; 95% CI, 0.43 to 1.08; P = .1). A marginally significant result was obtained for the use of CSF in reducing infection-related mortality (OR = 0.51; 95% CI, 0.26 to 1.00; P = .05). Patients treated with CSFs had a shorter length of hospitalization (hazard ratio [HR] = 0.63; 95% CI, 0.49 to 0.82; P = .0006) and a shorter time to neutrophil recovery (HR = 0.32; 95% CI, 0.23 to 0.46; P < .00001). Conclusion The use of the CSFs in patients with established FN caused by cancer chemotherapy reduces the amount of time spent in hospital and the neutrophil recovery period. The possible influence of the CSFs on infection-related mortality requires further investigation.

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