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    ABSTRACT: To develop prognostic models for time to 12-month remission and time to treatment failure after initiating antiepileptic drug monotherapy for generalised and unclassified epilepsy. We analysed data from the Standard and New Antiepileptic Drug (arm B) study, a randomised trial that compared initiating treatment with lamotrigine, topiramate and valproate in patients diagnosed with generalised or unclassified epilepsy. Multivariable regression modelling was used to investigate how clinical factors affect the probability of achieving 12-month remission and treatment failure. Significant factors in the multivariable model for time to 12-month remission were having a relative with epilepsy, neurological insult, total number of tonic-clonic seizures before randomisation, seizure type and treatment. Significant factors in the multivariable model for time to treatment failure were treatment history (antiepileptic drug treatment prior to randomisation), EEG result, seizure type and treatment. The models described within this paper can be used to identify patients most likely to achieve 12-month remission and most likely to have treatment failure, aiding individual patient risk stratification and the design and analysis of future epilepsy trials.
    Full-text · Article · Nov 2013 · Journal of neurology, neurosurgery, and psychiatry
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    ABSTRACT: Outcome data from dental caries clinical trials have a naturally hierarchical structure, with surfaces clustered within teeth, clustered within individuals. Data are often aggregated into the DMF index for each individual, losing tooth- and surface-specific information. If these data are to be analysed by tooth or surface, allowing exploration of effects of interventions on different teeth and surfaces, appropriate methods must be used to adjust for the clustered nature of the data. Multilevel modelling allows analysis of clustered data using individual observations without aggregating data, and has been little used in the field of dental caries. A simulation study was conducted to investigate the performance of multilevel modelling methods and standard caries increment analysis. Data sets were simulated from a three-level binomial distribution based on analysis of a caries clinical trial in Scottish adolescents, with varying sample sizes, treatment effects and random tooth level effects based on trials reported in Cochrane reviews of topical fluoride, and analysed to compare the power of multilevel models and traditional analysis. 40,500 data sets were simulated. Analysis showed that estimated power for the traditional caries increment method was similar to that for multilevel modelling, with more variation in smaller data sets. Multilevel modelling may not allow significant reductions in the number of participants required in a caries clinical trial, compared to the use of traditional analyses, but investigators interested in exploring the effect of their intervention in more detail may wish to consider the application of multilevel modelling to their clinical trial data. © 2013 S. Karger AG, Basel.
    No preview · Article · Nov 2013 · Caries Research
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    ABSTRACT: To determine the standard of reporting of harms-related data, in randomised controlled trials (RCTs) according to the Consolidated Standards of Reporting Trials (CONSORT) statement extension for harms. Systematic review. The Cochrane library, Ovid MEDLINE, Scopus and ISI Web of Knowledge were searched for relevant literature. We included publications of studies that used the CONSORT harms extension to assess the reporting of harms in RCTs. We identified 7 studies which included between 10 and 205 RCTs. The clinical areas of the 7 studies were: hypertension (1), urology (1), epilepsy (1), complimentary medicine (2) and two not restricted to a clinical topic. Quality of the 7 studies was assessed by a risk of bias tool and was found to be variable. Adherence to the CONSORT harms criteria reported in the 7 studies was inadequate and variable across the items in the checklist. Adverse events are poorly defined, with 6 studies failing to exceed 50% adherence to the items in the checklist. Readers of RCT publications need to be able to balance the trade-offs between benefits and harms of interventions. This systematic review suggests that this is compromised due to poor reporting of harms which is evident across a range of clinical areas. Improvements in quality could be achieved by wider adoption of the CONSORT harms criteria by journals reporting RCTs.
    Full-text · Article · Sep 2013 · BMJ Open
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