Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: An empirical assessment

Hammad, Tarek A.; Neyarapally, George A.; Pinheiro, Simone P.; Iyasu, Solomon; Rochester, G. D.; Pan, Gerald J. Dal

doi:10.1177/1740774513479467

Cited by 18 publications

(13 citation statements)

References 48 publications

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“…Due to the sparse nature of serious AEs, meta-analyses of safety data collected from RCTs can contribute to better delineate the risk/benefit ratio of pharmacological treatments (Hammad et al, 2013). The main goal of the present systematic review is to determine the association between the use of Cetuximab or Panitumumab in addition to other therapeutic regimens with risk of severe diarrhoea or mucositis in colorectal cancer patients.…”

Section: Introductionmentioning

confidence: 98%

Risk of grade 3-4 diarrhea and mucositis in colorectal cancer patients receiving anti-EGFR monoclonal antibodies regimens: A meta-analysis of 18 randomized controlled clinical trials

Miroddi

Sterrantino

Simonelli

et al. 2015

Critical Reviews in Oncology/Hematology

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Section: Introductionmentioning

confidence: 98%

Risk of grade 3-4 diarrhea and mucositis in colorectal cancer patients receiving anti-EGFR monoclonal antibodies regimens: A meta-analysis of 18 randomized controlled clinical trials

Miroddi

Sterrantino

Simonelli

et al. 2015

Critical Reviews in Oncology/Hematology

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“…Studies might also give different answers because of flaws in the design or conduct, such as excessive loss to follow-up. 2 Modeling to understand heterogeneity can be helpful. However, relationships that would allow drawing conclusions about effects in different populations, or effects for an ideal study, do not always emerge from the analyses of heterogeneity.…”

mentioning

confidence: 99%

Meta-analysis as Evidence

Berlin

Golub²

2014

JAMA

137

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In following the practice of evidence-based medicine, when faced with a question about prevention or treatment the clinician should seek out the best evidence that addresses the question. If quality of evidence is considered a pyramid, what category should be placed at the peak? One dogma argues that it is the best-conducted randomized clinical trial (RCT) comprising patients similar to those seen by the clinician, reasoning that a well-done RCT mimics pure experimental conditions better than any other study design, hence minimizing the likelihood of confounding. A counterargument is that the best evidence is a systematic review with meta-analysis, because this approach can integrate all of the relevant evidence and provide a more reliable answer than a single study, however well conducted.The notion that a synthesis that includes mathematically combining a complete body of evidence provides the highest level of evidence is attractive. However, as with most of evidencebased medicine, the principles are rational, consistent, and appealing, but in practice are fraught with practical challenges, ambiguities, and nuances. Moreover, a busy clinician faces tension between searching for and assessing the best-quality primary evidence vs accepting the efficiency of using easily obtained but potentially inferior information as a shortcut to an answer.As a general principle, generating, summarizing, and understanding the best available evidence are essential for establishing the benefits and safety of interventions. Metaanalysis has become a valuable tool toward these ends. There has been a proliferation of guidelines by professional societies and others, aimed at ensuring that the best preventive interventions or treatment options are provided to the appropriate patients at the appropriate time; these guidelines often incorporate meta-analyses as a key evidence support for their recommendations.However, limitations of meta-analysis as a study design preclude consistently placing this evidence at the top of the pyramid, and a number of issues need to be resolved before that can happen. These are the problems that researchers, guideline developers, journal editors, and critical readers of the literature struggle with, and understanding the limitations of metaanalytic evidence is crucial for each of these stakeholders. 1 One useful way to view these challenges is to divide them into 2 categories: heterogeneity and methodological dilemmas.Heterogeneity (variation in true effect sizes and in factors that might influence those effect sizes) is inherent in metaanalysis, not a problem to be solved. It includes clinical com-

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“…Hammad et al [36] have developed a set of criteria, not yet included in the PRISMA statement, for the detection of unintended consequences of treatment in single-indication meta-analyses but do not mention multiple-indication reviews. However, we have encountered resistance to use of this method in the assessment of effectiveness.…”

Section: Resultsmentioning

confidence: 99%

Scientific hypotheses can be tested by comparing the effects of one treatment over many diseases in a systematic review

Chen

Hemming

Chilton

et al. 2014

Journal of Clinical Epidemiology

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Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: An empirical assessment

Cited by 18 publications

References 48 publications

Risk of grade 3-4 diarrhea and mucositis in colorectal cancer patients receiving anti-EGFR monoclonal antibodies regimens: A meta-analysis of 18 randomized controlled clinical trials

Risk of grade 3-4 diarrhea and mucositis in colorectal cancer patients receiving anti-EGFR monoclonal antibodies regimens: A meta-analysis of 18 randomized controlled clinical trials

Meta-analysis as Evidence

Scientific hypotheses can be tested by comparing the effects of one treatment over many diseases in a systematic review

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