scholarly journals Role of preoperative intravenous iron therapy to correct anemia before major surgery: a systematic review and meta-analysis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Abdelsalam M. Elhenawy ◽  
Steven R. Meyer ◽  
Sean M. Bagshaw ◽  
Roderick G. MacArthur ◽  
Linda J. Carroll
Keyword(s):  
Randomized Controlled Trials ◽  
Iron Supplementation ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Intravenous Iron ◽  
Major Surgery ◽  
Controlled Trials ◽  
Blood Transfusions ◽  
Randomized Controlled ◽  
Iv Iron

Abstract Background Preoperative anemia is a common comorbidity that often necessitates allogeneic blood transfusion (ABT). As there is a risk associated with blood transfusions, preoperative intravenous iron (IV) has been proposed to increase the hemoglobin to reduce perioperative transfusion; however, randomized controlled trials (RCT) investigating this efficacy for IV iron are small, limited, and inconclusive. Consequently, a meta-analysis that pools these studies may provide new and clinically useful information. Methods/design Databases of MEDLINE, EMBASE, EBM Reviews; Cochrane-controlled trial registry; Scopus; registries of health technology assessment and clinical trials; Web of Science; ProQuest Dissertations and Theses; Clinicaltrials.gov; and Conference Proceedings Citation Index-Science (CPCI-S) were searched. Also, we screened all the retrieved reference lists. Selection criteria Titles and abstracts were screened for relevance (i.e., relevant, irrelevant, or potentially relevant). Then, we screened full texts of those citations identified as potentially applicable. Results Our search found 3195 citations and ten RCTs (1039 participants) that met our inclusion criteria. Preoperative IV iron supplementation significantly decreases ABT by 16% (risk ratio (RR): 0.84, 95% confidence interval [CI]: 0.71, 0.99, p = 0.04). In addition, preoperatively, hemoglobin levels increased after receiving IV iron (mean difference [MD] between the study groups: 7.15 g/L, 95% CI: 2.26, 12.04 g/L, p = 0.004) and at follow-up >  4 weeks postoperatively (MD: 6.46 g/L, 95% CI: 3.10, 9.81, p = 0.0002). Iron injection was not associated with increased incidence of non-serious or serious adverse effects across groups (RR: 1.13, 95% CI: 0.78, 1.65, p = 0.52) and (RR: 0.96, 95% CI: 0.44, 2.10, p = 0.92) respectively. Conclusions With moderate certainty, due to the high risk of bias in some studies in one or two domains, we found intravenous iron supplementation is associated with a significant decrease in the blood transfusions rate, and modest hemoglobin concentrations rise when injected pre-surgery compared with placebo or oral iron supplementation. However, further full-scale randomized controlled trials with robust methodology are required. In particular, the safety, quality of life, and cost-effectiveness of different intravenous iron preparations require further evaluation.

scholarly journals Adjusting for bias in unblinded randomized controlled trials

2016 ◽  
Vol 27 (8) ◽  
pp. 2413-2427 ◽  
Author(s):  
AF Schmidt ◽  
RHH Groenwold
Keyword(s):  
Randomized Controlled Trials ◽  
Instrumental Variable ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Genetic Research ◽  
Risk Difference ◽  
Controlled Trials ◽  
Treatment Allocation ◽  
Randomized Controlled ◽  
Novel Method

It may not always be possible to blind participants of a randomized controlled trial for treatment allocation. As a result, estimators of the actual treatment effect may be biased. In this paper, we will extend a novel method, originally introduced in genetic research, for instrumental variable meta-analysis, adjusting for bias due to unblinding of trial participants. Using simulation studies, this novel method, “Egger Correction for non-Adherence”, is introduced and compared to the performance of the “intention-to-treat,” “as-treated,” and conventional “instrumental variable” estimators. Scenarios considered (time-varying) non-adherence, confounding, and between-study heterogeneity. The effect of treatment on a binary endpoint was quantified by means of a risk difference. In all scenarios with unblinded treatment allocation, the Egger Correction for non-Adherence method was the least biased estimator. However, unless the variation in adherence was relatively large, precision was lacking, and power did not surpass 0.50. As a comparison, in a meta-analysis of blinded randomized controlled trials, power of the conventional IV estimator was 1.00 versus at most 0.14 for the Egger Correction for non-Adherence estimator. Due to this lack of precision and power, we suggest to use this method mainly as a sensitivity analysis.

Effects of iron supplementation versus dietary iron on the nutritional iron status: Systematic review with meta-analysis of randomized controlled trials

2018 ◽  
Vol 59 (16) ◽  
pp. 2553-2561 ◽  
Author(s):  
Luiz Gonzaga Ribeiro Silva Neto ◽  
João Eudes dos Santos Neto ◽  
Nassib Bezerra Bueno ◽  
Suzana Lima de Oliveira ◽  
Terezinha da Rocha Ataide
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Iron Supplementation ◽  
Iron Status ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Dietary Iron ◽  
Randomized Controlled

scholarly journals A Systematic Review and Meta-Analysis of Immune-Related Adverse Events of Anti-PD-1 Drugs in Randomized Controlled Trials

2020 ◽  
Vol 19 ◽  
pp. 153303382096745
Author(s):  
Yukun Wang ◽  
Dejiu Kong ◽  
Chaokun Wang ◽  
Jing Chen ◽  
Jing Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Targeted Drugs ◽  
Randomized Controlled

Objective: We aimed to evaluate immune-related adverse events occurring in clinical trials of anti-programmed cell death 1 (PD-1) drugs, compared with control treatments, including chemotherapy, targeted drugs, or placebo. Further we compared the occurrence of immune -related events in patients treated with different anti-PD-1 drugs. Data Sources: Randomized controlled trial (RCT) data were sourced from PubMed, Embase, and the Cochrane Central Register of Controlled Trials combined with https://clinicaltrials.gov . Methods: Randomized controlled trial of anti-PD-1 drugs compared with control treatments published between January 1, 1970 and March 1,2019, were searched and data on trial patient characteristics, and adverse events extracted, reviewed, and subjected to meta-analysis. Results: Eighteen Randomized controlled trials were included in our study. The Randomized controlled trials compared nivolumab (n = 12), pembrolizumab (n = 6), with chemotherapy (n = 13), targeted drugs (n = 2), or placebo (n = 3). Compared with the control group, the risk of any immune-related adverse events in patients treated with anti-PD-1 drugs was increased (RR, 2.65; 95% confidence interval, 1.84–3.83; P < 0.00001). Of the immune-related adverse events, the risk rates of pneumonitis (risk ratio, 2.10; 95% CI, 0.85-5.18), colitis (2.96;1.62-5.38), hypophysitis(4.79;1.54-14.89), hypothyroidism(7.87;5.36-11.57), hyperthyroidism (7.03;4.35-11.34), rash (1.58;0.98-2.54), pruritus (2.28; 1.38-3.76), and hepatitis (9.31;2.18-39.85) were increased by anti-PD-1 drugs. Further, the risk of immune-related adverse events was similar for patients treated with pembrolizumab and nivolumab ( P = 0.14). Conclusions: In addition to previously reported organ-specific immune-related adverse events, we found that the risk of hyperthyroidism was also increased, in anit-PD-1-treated patients, relative to control treatments. The risk of total immune-related adverse events, was similar for pembrolizumab and nivolumab.

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