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Anti-epileptic drug harms: issues for meta-analysis

Springer (Biomed Central Ltd.)
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DOI: 10.1186/1745-6215-12-s1-a11
  • Oral Presentation


Anti-epileptic drug harms: issues for meta-analysis ORAL PRESENTATION Open Access Anti-epileptic drug harms: issues for meta-analysis Catrin Tudur Smith1*, Arif Shukralla2, Sarah Donegan1, Karla Hemming3, Graham A Powell2, Paula Williamson1, Anthony Marson2 From Clinical Trials Methodology Conference 2011 Bristol, UK. 4-5 October 2011 Objectives Decisions regarding choice and dose of anti-epileptic drug (AED) are driven by considering the potential ben- efits of reducing seizure frequency against the potential harms of alternative AEDs. Such decisions should be made using the best available evidence, which often requires a quantitative synthesis of data from multiple randomised controlled trials (RCT). However, the sys- tematic review and meta-analysis of harms data is hin- dered by problems such as inadequate reporting, heterogeneity of harms definitions, and selective report- ing bias. Here we will evaluate the quality of reporting of harms data in epilepsy trials, and assess the potential added value of incorporating harms data beyond the clinical indication of epilepsy. Methods To evaluate the quality of reporting of harms data in RCTs of AEDs in patients with epilepsy we have under- taken a systematic review [1]. We searched MEDLINE, the Cochrane Library and the Epilepsy Group register for published trials comparing AEDs in patients with epilepsy. Each trial was assessed according to a 23 item checklist developed from the CONSORT statement for the reporting of harms in clinical trials [2]. In a separate analysis, Bayesian panoramic meta-analysis models [3] were used to pool estimates of harm across studies and across indications of epilepsy, neuropathy and headache, allowing for variation between both study and indication. Results For the reporting quality review we identified 152 RCTs that met the eligibility criteria. None of the trials satis- fied all criteria. The mean number of criteria per trial was 11.3 (standard deviation 4.3, range 0 to 21). No improvement cou

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