Dataset Information

Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer.

ABSTRACT:

Background

Randomized controlled trials (RCTs) that are inappropriately designed or executed may provide biased findings and mislead clinical practice. In view of recent interest in the treatment and prevention of thrombotic complications in cancer patients we evaluated the characteristics, risk of bias and their time trends in RCTs of anticoagulation in patients with cancer.

Methods

We conducted a comprehensive search, including a search of four electronic databases (MEDLINE, EMBASE, ISI the Web of Science, and CENTRAL) up to February 2010. We included RCTs in which the intervention and/or comparison consisted of: vitamin K antagonists, unfractionated heparin (UFH), low molecular weight heparin (LMWH), direct thrombin inhibitors or fondaparinux. We performed descriptive analyses and assessed the association between the variables of interest and the year of publication.

Results

We included 67 RCTs with 24,071 participants. In twenty one trials (31%) DVT diagnosis was triggered by clinical suspicion; the remaining trials either screened for DVT or were unclear about their approach. 41 (61%), 22 (33%), and 11 (16%) trials respectively reported on major bleeding, minor bleeding, and thrombocytopenia. The percentages of trials satisfying risk of bias criteria were: adequate sequence generation (85%), adequate allocation concealment (61%), participants' blinding (39%), data collectors' blinding (44%), providers' blinding (41%), outcome assessors' blinding (75%), data analysts' blinding (15%), intention to treat analysis (57%), no selective outcome reporting (12%), no stopping early for benefit (97%). The mean follow-up rate was 96%. Adequate allocation concealment and the reporting of intention to treat analysis were the only two quality criteria that improved over time.

Conclusions

Many RCTs of anticoagulation in patients with cancer appear to use insufficiently rigorous outcome assessment methods and to have deficiencies in key methodological features. It is not clear whether this reflects a problem in the design, conduct or the reporting of these trials, or both. Future trials should avoid the shortcomings described in this article.

SUBMITTER: Rada G

PROVIDER: S-EPMC3579688 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Publications

Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer.

Rada Gabriel G Schünemann Holger J HJ Labedi Nawman N El-Hachem Pierre P Kairouz Victor F VF Akl Elie A EA

BMC cancer 20130214

<h4>Background</h4>Randomized controlled trials (RCTs) that are inappropriately designed or executed may provide biased findings and mislead clinical practice. In view of recent interest in the treatment and prevention of thrombotic complications in cancer patients we evaluated the characteristics, risk of bias and their time trends in RCTs of anticoagulation in patients with cancer.<h4>Methods</h4>We conducted a comprehensive search, including a search of four electronic databases (MEDLINE, EMB ...[more]

PMID: 23406262

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Project description:Objective: The optimal management for cervical artery dissection (CAD) is uncertain. This study aimed to summarize the current randomized controlled trials (RCTs) to compare the efficacy and safety of antiplatelet and anticoagulation therapies for CAD. Methods: A literature search was conducted in the major databases, such as MEDLINE, Embase, and the Cochrane Library. Only the RCTs comparing the antiplatelet and anticoagulation therapies for the patients with CAD were included. Combined estimates of the relative risk (RR) of antiplatelet vs. anticoagulation were analyzed. Heterogeneity was measured using the I 2 statistical analysis. The analyses were performed in the intention-to-treat (ITT) and per-protocol (PP) population, respectively. Results: Two RCTs involving 444 patients in the ITT population and 370 patients in the PP population were included. The quality of studies was high overall. In the ITT population, compared with the patients in the anticoagulation group, the patients in the antiplatelet group showed a higher rate of ischemic stroke within 3 months (RR = 6.73 [95% CI, 1.22-37.15], I 2 = 0%, P = 0.029). No difference between these two treatment groups was found for the outcomes of transient ischemic attack (RR = 0.37 [95% CI, 0.09-1.58], I 2 = 0%, P = 0.181), intracranial hemorrhage (RR = 0.33 [95% CI, 0.01-7.98], I 2 = 0%, P = 0.494), major extracranial bleeding (RR = 0.31 [95% CI, 0.01-7.60], I 2 = 0%, P = 0.476), or the composite of these outcomes within 3 months. For the PP population, the results of the meta-analysis of outcomes between the antiplatelet and anticoagulation groups were consistent with the ITT population. Conclusions: Compared with the antiplatelet group, the anticoagulation group has a lower risk of ischemic stroke without increasing bleeding risk when treating CAD. Anticoagulation seems to be superior over the antiplatelet in treating CAD but needs to be further tested by specifying several issues, such as location, initial symptom types, and treatment protocols.

Project description:BackgroundContinuous renal replacement therapy (CRRT) is a widely used standard therapy for critically ill patients with acute kidney injury (AKI). Despite its effectiveness, treatment is often interrupted due to clot formation in the extracorporeal circuits. Anticoagulation is a crucial strategy for preventing extracorporeal circuit clotting during CRRT. While various anticoagulation options are available, there were still no studies synthetically comparing the efficacy and safety of these anticoagulation options.MethodsElectronic databases (PubMed, Embase, Web of Science, and the Cochrane database) were searched from inception to October 31, 2022. All randomized controlled trials (RCTs) that examined the following outcomes were included: filter lifespan, all-cause mortality, length of stay, duration of CRRT, recovery of kidney function, adverse events and costs.ResultsThirty-seven RCTs from 38 articles, comprising 2648 participants with 14 comparisons, were included in this network meta-analysis (NMA). Unfractionated heparin (UFH) and regional citrate anticoagulation (RCA) are the most frequently used anticoagulants. Compared to UFH, RCA was found to be more effective in prolonging filter lifespan (MD 12.0, 95% CI 3.8 to 20.2) and reducing the risk of bleeding. Regional-UFH plus Prostaglandin I2 (Regional-UFH + PGI2) appeared to outperform RCA (MD 37.0, 95% CI 12.0 to 62.0), LMWH (MD 41.3, 95% CI 15.6 to 67.0), and other evaluated anticoagulation options in prolonging filter lifespan. However, only a single included RCT with 46 participants had evaluated Regional-UFH + PGI2. No statistically significant difference was observed in terms of length of ICU stay, all-cause mortality, duration of CRRT, recovery of kidney function, and adverse events among most evaluated anticoagulation options.ConclusionsCompared to UFH, RCA is the preferred anticoagulant for critically ill patients requiring CRRT. The SUCRA analysis and forest plot of Regional-UFH + PGI2 are limited, as only a single study was included. Additional high-quality studies are necessary before any recommendation of Regional-UFH + PGI2. Further larger high-quality RCTs are desirable to strengthen the evidence on the best choice of anticoagulation options to reduce all-cause mortality and adverse events and promote the recovery of kidney function. Trial registration The protocol of this network meta-analysis was registered on PROSPERO ( CRD42022360263 ). Registered 26 September 2022.

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Project description:BackgroundThe therapeutic evidence collected from well-designed studies is needed to help manage the global pandemic of the coronavirus disease 2019 (COVID-19). Evaluating the quality of therapeutic data collected during this most recent pandemic is important for improving future clinical research under similar circumstances.ObjectiveTo assess the methodological quality and variability in implementation of randomized controlled trials (RCTs) for treating COVID-19, and to analyze the support that should be provided to improve data collected during an urgent pandemic situation.Search strategyPubMed, Excerpta Medica Database, China National Knowledge Infrastructure, Wanfang, and Chongqing VIP, and the preprint repositories including Social Science Research Network and MedRxiv were systematically searched, up to September 30, 2020, using the keywords "coronavirus disease 2019 (COVID-19)," "2019 novel coronavirus (2019-nCoV)," "severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2)," "novel coronavirus pneumonia (NCP)," "randomized controlled trial (RCT)" and "random."Inclusion criteriaRCTs studying the treatment of COVID-19 were eligible for inclusion.Data extraction and analysisScreening of published RCTs for inclusion and data extraction were each conducted by two researchers. Analysis of general information on COVID-19 RCTs was done using descriptive statistics. Methodological quality was assessed using the risk-of-bias tools in the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). Variability in implementation was assessed by comparing consistency between RCT reports and registration information.ResultsA total of 5886 COVID-19 RCTs were identified. Eighty-one RCTs were finally included, of which, 45 had registration information. Methodological quality of the RTCs was not optimal due to deficiencies in five main domains: allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting. Comparisons of consistency between published protocols and registration information showed that the 45 RCTs with registration information had common deviations in seven items: inclusion and exclusion criteria, sample size, outcomes, research sites of recruitment, interventions, and blinding.ConclusionThe methodological quality of COVID-19 RCTs conducted in early to mid 2020 was consistently low and variability in implementation was common. More support for implementing high-quality methodology is needed to obtain the quality of therapeutic evidence needed to provide positive guidance for clinical care. We make an urgent appeal for accelerating the construction of a collaborative sharing platform and preparing multidisciplinary talent and professional teams to conduct excellent clinical research when faced with epidemic diseases of the future. Further, variability in RCT implementation should be clearly reported and interpreted to improve the utility of data resulting from those trials.

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Dataset Information

Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer.

Background

Methods

Results

Conclusions

Publications

Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer.

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