An appraisal of meta‐analysis guidelines: how do they relate to safety outcomes?

Bennetts, Meg; Whalen, Ed; Ahadieh, Sima; Cappelleri, Joseph C.

doi:10.1002/jrsm.1219

Cited by 10 publications

(12 citation statements)

References 44 publications

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“…Smaller number of events (9-97) could be included in the analysis of other outcomes (Table 1). Low event rates can have detrimental influence on the reliability of the results 168,169 . Based on the studies mentioned above, the results of all severity comparisons, mortality and recurrence rates in comparisons of AAP vs. BAP are strongly reliable.…”

Section: Discussionmentioning

confidence: 99%

Assessment of the course of acute pancreatitis in the light of aetiology: a systematic review and meta-analysis

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Kiss

et al. 2020

Sci Rep

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The main causes of acute pancreatitis (AP) are biliary disease, alcohol consumption, hypertriglyceridaemia (HTG) and endoscopic retrograde cholangiopancreatography (ERCP). The aim of this meta-analysis was to evaluate the effects of these aetiological factors on the severity and outcome of AP. Pubmed and Embase were searched between 01/01/2012 and 31/05/2020. Included articles involved adult alcoholic, biliary, HTG- or post-ERCP AP (PAP) patients. Primary outcome was severity, secondary outcomes were organ failures, intensive care unit admission, recurrence rate, pancreatic necrosis, mortality, length of hospital stay, pseudocyst, fluid collection and systematic inflammatory response syndrome. Data were analysed from 127 eligible studies. The risk for non-mild (moderately severe and severe) condition was the highest in HTG-induced AP (HTG-AP) followed by alcoholic AP (AAP), biliary AP (BAP) and PAP. Recurrence rate was significantly lower among BAP vs. HTG-AP or AAP patients (OR = 2.69 and 2.98, 95% CI 1.55–4.65 and 2.22–4.01, respectively). Mortality rate was significantly greater in HTG-AP vs. AAP or BAP (OR = 1.72 and 1.50, 95% CI 1.04–2.84 and 0.96–2.35, respectively), pancreatic necrosis occurred more frequently in AAP than BAP patients (OR = 1.58, 95% CI 1.08–2.30). Overall, there is a potential association between aetiology and the development and course of AP. HTG-AP is associated with the highest number of complications. Furthermore, AAP is likely to be more severe than BAP or PAP. Greater emphasis should be placed on determining aetiology on admission.

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Section: Discussionmentioning

confidence: 99%

Assessment of the course of acute pancreatitis in the light of aetiology: a systematic review and meta-analysis

Bálint

Für

Kiss

et al. 2020

Sci Rep

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“…different scales to assess functional outcome) along with an expected variability in follow-up time. As we only include randomised trials, rare or late important safety events might be underreported [ 101 , 102 ]. A final limitation is that we were aware of both previous reviews and also previous trials assessing the effects of prothrombin complex concentrate, which might result in data-driven methodology.…”

Section: Discussionmentioning

confidence: 99%

Prothrombin complex concentrate versus placebo, no intervention, or other interventions in critically bleeding patients associated with oral anticoagulant administration: a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

et al. 2018

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BackgroundAcute critical bleeding is one of the most feared complications during treatment with oral anticoagulating agents. As more patients undergo treatment with anticoagulating agents, critically bleeding episodes in patients with vitamin K antagonists, thrombin inhibitor, or factor Xa inhibitor-inducted coagulopathy will be encountered frequently by physicians. Hence, an effective treatment capable of reversing the iatrogenic coagulopathy in the acute setting is needed. In randomised clinical trials and observational studies, prothrombin complex concentrate has been reported to be superior to other acute interventions, and many guidelines recommend prothrombin complex concentrate in treatment of critically bleeding patients. The aim of this systematic review is to synthesise the evidence of the effects of prothrombin complex concentrate compared with placebo, no intervention, or other treatment options in critically bleeding patients treated with oral anticoagulants.Methods/designA comprehensive search for relevant published literature will be undertaken in Cochrane Central Register of Controlled Trials, MEDLINE, Embase, WHO International Clinical Trials Registry Platform, Science Citation Index, regulatory databases, and trial registers. We will include randomised clinical trials comparing prothrombin complex concentrate versus placebo, no intervention, or other interventions in critically bleeding patients with oral anticoagulant-induced coagulopathy. Data extraction and risk of bias assessment will be handled by two independent review authors. Meta-analysis will be performed as recommended by Cochrane Handbook for Systematic Reviews of Interventions, bias will be assessed with domains, and trial sequential analysis will be conducted to control random errors. Certainty will be assessed by GRADE.DiscussionAs critical bleeding in patients treated with oral anticoagulants is an increasing problem, an up-to-date systematic review evaluating the benefits and harms of prothrombin complex concentrate is urgently needed. It is the hope that this review will be able to guide best practice in treatment and clinical research of these critically bleeding patients.Systematic review registration PROSPERO CRD42018084371 Electronic supplementary materialThe online version of this article (10.1186/s13643-018-0838-y) contains supplementary material, which is available to authorized users.

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“…Although meta-analysis has advantages over analyzing a single clinical trial when estimating the rate of adverse events, there are some discussions that traditional meta-analysis methods may be ill-defined or have poor performance properties with rare events. 3–9 The main issues include (1) sparsity of data with many trials having no events (so-called zero-event trials), (2) insufficient statistical power to infer the effect heterogeneity across studies, and (3) the impact of trials with large sample sizes relative to smaller ones.…”

Section: Introductionmentioning

confidence: 99%

Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods

2020

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Background/aims: Regulatory approval of a drug or device involves an assessment of not only the benefits but also the risks of adverse events associated with the therapeutic agent. Although randomized controlled trials (RCTs) are the gold standard for evaluating effectiveness, the number of treated patients in a single RCT may not be enough to detect a rare but serious side effect of the treatment. Meta-analysis plays an important role in the evaluation of the safety of medical products and has advantage over analyzing a single RCT when estimating the rate of adverse events. Methods: In this article, we compare 15 widely used meta-analysis models under both Bayesian and frequentist frameworks when outcomes are extremely infrequent or rare. We present extensive simulation study results and then apply these methods to a real meta-analysis that considers RCTs investigating the effect of rosiglitazone on the risks of myocardial infarction and of death from cardiovascular causes. Results: Our simulation studies suggest that the beta hyperprior method modeling treatment group-specific parameters and accounting for heterogeneity performs the best. Most models ignoring between-study heterogeneity give poor coverage probability when such heterogeneity exists. In the data analysis, different methods provide a wide range of log odds ratio estimates between rosiglitazone and control treatments with a mixed conclusion on their statistical significance based on 95% confidence (or credible) intervals. Conclusion: In the rare event setting, treatment effect estimates obtained from traditional meta-analytic methods may be biased and provide poor coverage probability. This trend worsens when the data have large between-study heterogeneity. In general, we recommend methods that first estimate the summaries of treatment-specific risks across studies and then relative treatment effects based on the summaries when appropriate. Furthermore, we recommend fitting various methods, comparing the results and model performance, and investigating any significant discrepancies among them.

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An appraisal of meta‐analysis guidelines: how do they relate to safety outcomes?

Cited by 10 publications

References 44 publications

Assessment of the course of acute pancreatitis in the light of aetiology: a systematic review and meta-analysis

Assessment of the course of acute pancreatitis in the light of aetiology: a systematic review and meta-analysis

Prothrombin complex concentrate versus placebo, no intervention, or other interventions in critically bleeding patients associated with oral anticoagulant administration: a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods

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