Indicators of questionable research practices were identified in 163,129 randomized controlled trials.

Objectives: To explore indicators of the following questionable research practices (QRPs) in randomized controlled trials (RCTs): (1) risk of bias in four domains (random sequence generation, allocation concealment, blinding of participants and personnel, and blinding of outcome assessment); (2) modifications in primary outcomes that were registered in trial registration records (proxy for selective reporting bias); (3) ratio of the achieved to planned sample sizes; and (4) statistical discrepancy.

Study Design And Setting: Full texts of all human RCTs published in PubMed in 1996-2017 were automatically identified and information was collected automatically. Potential indicators of QRPs included author-specific, publication-specific, and journal-specific characteristics.

Individualised prediction of drug resistance and seizure recurrence after medication withdrawal in people with juvenile myoclonic epilepsy: A systematic review and individual participant data meta-analysis.

Background: A third of people with juvenile myoclonic epilepsy (JME) are drug-resistant. Three-quarters have a seizure relapse when attempting to withdraw anti-seizure medication (ASM) after achieving seizure-freedom. It is currently impossible to predict who is likely to become drug-resistant and safely withdraw treatment.

Cumulative effects of antiseizure medication on intelligence in children with focal epilepsy.

Objective: Antiseizure medication may have long-term effects on the neurodevelopment of children. We aimed to investigate the association between cumulative antiseizure medication load and intelligence quotient (IQ) in relation to brain volume and cortical thickness.

Methods: A retrospective analysis of children with focal epilepsy who underwent neuropsychological assessment and MRI between the ages of 5-12 years in a tertiary epilepsy centre was performed.

Clinical Trial Registration Patterns and Changes in Primary Outcomes of Randomized Clinical Trials From 2002 to 2017.

This cross-sectional study evaluates the existence and timing of trial registration for randomized clinical trials (RCTs) published from 2002 to 2017 as well as substantive changes to the primary outcomes entered into registry information after those studies started.

The methodological quality of 176,620 randomized controlled trials published between 1966 and 2018 reveals a positive trend but also an urgent need for improvement.

Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices and implementation of reporting guidelines, but whether these efforts have improved the methodological quality of RCTs (e.g.

Seizure outcome and use of antiepileptic drugs after epilepsy surgery according to histopathological diagnosis: a retrospective multicentre cohort study.

Background: Surgery is a widely accepted treatment option for drug-resistant focal epilepsy. A detailed analysis of longitudinal postoperative seizure outcomes and use of antiepileptic drugs for different brain lesions causing epilepsy is not available. We aimed to analyse the association between histopathology and seizure outcome and drug freedom up to 5 years after epilepsy surgery, to improve presurgical decision making and counselling.

A Prediction Model to Determine Childhood Epilepsy After 1 or More Paroxysmal Events.

Objectives: The clinical profile of children who had possible seizures is heterogeneous, and accuracy of diagnostic testing is limited. We aimed to develop and validate a prediction model that determines the risk of childhood epilepsy by combining available information at first consultation.

Methods: We retrospectively collected data of 451 children who visited our outpatient department for diagnostic workup related to 1 or more paroxysmal event(s).

Why the TimeToStop trial failed to recruit: a survey on antiepileptic drug withdrawal after paediatric epilepsy surgery.

Following the results of the multicentre European retrospective "TimeToStop" cohort study, we initiated a randomised trial to determine cognitive benefits of early postoperative antiepileptic drug withdrawal. Unfortunately, the trial failed to recruit and was terminated, as almost all parents preferred early drug withdrawal. The objectives of the current survey were to obtain insight into current practices regarding drug withdrawal after paediatric epilepsy surgery among epileptologists, and better understand the reasons for difficulties in recruitment.

Statistical power of clinical trials increased while effect size remained stable: an empirical analysis of 136,212 clinical trials between 1975 and 2014.

Objectives: To study the statistical power of randomized clinical trials and examine developments over time.

Study Design And Setting: We analyzed the statistical power in 136,212 clinical trials between 1975 and 2014 extracted from meta-analyses from the Cochrane database of systematic reviews. We determined study power to detect standardized effect sizes, where power was based on the meta-analyzed effect size.

European trends in epilepsy surgery.

Objective: Resective surgery is effective in treating drug-resistant focal epilepsy, but it remains unclear whether improved diagnostics influence postsurgical outcomes. Here, we compared practice and outcomes over 2 periods 15 years apart.

Methods: Sixteen European centers retrospectively identified 2 cohorts of children and adults who underwent epilepsy surgery in the period of 1997 to 1998 (n = 562) or 2012 to 2013 (n = 736).

Adequate statistical power in clinical trials is associated with the combination of a male first author and a female last author.

Clinical trials have a vital role in ensuring the safety and efficacy of new treatments and interventions in medicine. A key characteristic of a clinical trial is its statistical power. Here we investigate whether the statistical power of a trial is related to the gender of first and last authors on the paper reporting the results of the trial.

Individualized prediction of seizure relapse and outcomes following antiepileptic drug withdrawal after pediatric epilepsy surgery.

The objective of this study was to create a clinically useful tool for individualized prediction of seizure outcomes following antiepileptic drug withdrawal after pediatric epilepsy surgery. We used data from the European retrospective TimeToStop study, which included 766 children from 15 centers, to perform a proportional hazard regression analysis. The 2 outcome measures were seizure recurrence and seizure freedom in the last year of follow-up.

Individualised prediction model of seizure recurrence and long-term outcomes after withdrawal of antiepileptic drugs in seizure-free patients: a systematic review and individual participant data meta-analysis.

Background: People with epilepsy who became seizure-free while taking antiepileptic drugs might consider discontinuing their medication, with the possibility of increased quality of life because of the elimination of adverse events. The risk with this action, however, is seizure recurrence. The objectives of our study were to identify predictors of seizure recurrence and long-term seizure outcomes and to produce nomograms for estimation of individualised outcomes.

Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial: study protocol for a randomized controlled trial.

Background: The goals of intentional curative pediatric epilepsy surgery are to achieve seizure-freedom and antiepileptic drug (AED) freedom. Retrospective cohort studies have indicated that early postoperative AED withdrawal unmasks incomplete surgical success and AED dependency sooner, but not at the cost of long-term seizure outcome. Moreover, AED withdrawal seemed to improve cognitive outcome.

Antiepileptic drug withdrawal in medically and surgically treated patients: a meta-analysis of seizure recurrence and systematic review of its predictors.

Aim: Many seizure-free patients consider withdrawal of antiepileptic drugs, both when seizure control is achieved by medication alone, or once they became seizure-free following epilepsy surgery. The risk of recurrence is consequently of very important prognostic value. However, estimations of recurrence risks are outdated for both populations.

Changing profiles of pediatric epilepsy surgery candidates over time: A nationwide single-center experience from 1990 to 2011.

Objective: Over the past decades, the number of epilepsy surgeries in children has increased and indications for surgery have broadened. We studied the changes in patient characteristics between 1990 and 2011 in a nationwide cohort and related these to seizure outcome and postoperative medication status. Second, we tried to identify predictors for seizure outcome after pediatric epilepsy surgery.