scholarly journals Efficacy and Moderators of Internet-Based Interventions in Adults with Subthreshold Depression: An Individual Participant Data Meta-Analysis of Randomized Controlled Trials

2020 ◽  
pp. 1-13 ◽  
Author(s):  
Jo Annika Reins ◽  
Claudia Buntrock ◽  
Johannes Zimmermann ◽  
Simon Grund ◽  
Mathias Harrer ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Subthreshold Depression ◽  
Individual Participant Data ◽  
Randomized Controlled ◽  
Individual Participant

scholarly journals Tolerability of duloxetine in the elderly and in adults: a protocol and preliminary results of a systematic review and individual participant data meta-analysis of randomized placebo-controlled trials

2020 ◽  
Author(s):  
Jean-Charles ROY ◽  
Chloé Rousseau ◽  
Alexis Jutel ◽  
Florian Naudet ◽  
Gabriel Robert
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Elderly Population ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Individual Participant Data ◽  
Younger Adults ◽  
Randomized Controlled ◽  
Individual Participant

Abstract Background. Duloxetine is an antidepressant which benefits from a wide range of approval in elderly population while its safety of use in elderly population, compared to younger adults, is not clearly assessed. A comparison of tolerability of duloxetine between elderly and younger adults would help to rule on this issue. Methods and Design. This protocol outlines a systematic review and meta-analysis of individual participant data (IPD) of all double-blind randomized controlled trials comparing the number of serious adverse events among individuals taking duloxetine in comparison to placebo between participants at least 65 years and younger adults in conditions approved by the European Medical Agency (EMA) and the Food Drug Administration (FDA). Secondarily, will be compared the number of any adverse events, clinical efficacy and quality of life between elderly and younger adults under duloxetine, in comparison to placebo. Relevant studies were selected on ClinicalTrials.gov, Clinicaltrialsregister.eu, data sharing platforms, FDA and EMA websites, and from systematic reviews and meta-analyses of duloxetine on PubMed, following Cochrane’s recommendations. Sponsors and authors from eligible studies were invited to share IPD on data sharing platform or directly with our research team. As data cannot be aggregate into a unique database, a two step-approach meta-analysis will be undertaken. Qualitative results from available data. 77 eligible randomized controlled trials were identified, representing 25303 participants. From online available data, 35 trials were assessed as being at an overall low risk of bias, 31 trials at an unclear risk of bias and 1 at high risk of bias. Evaluation of risk of bias was not feasible for 10 studies. Conclusion. This study would represent the first meta-analysis investigating the safety of duloxetine in elderly population across all conditions approved by European and American regulatory authorities with an overall low risk of bias. Registration. PROSPERO: 2019 CRD42019130488.

OP91 Individual Participant Data Meta-Analysis Of Exercise Rehabilitation In Heart Failure

2018 ◽  
Vol 34 (S1) ◽  
pp. 33-34
Author(s):  
Oriana Ciani ◽  
Sarah Walker ◽  
Fiona Warren ◽  
Neil Smart ◽  
Massimo Piepoli ◽  
...  
Keyword(s):  
Heart Failure ◽  
Systematic Review ◽  
Meta Analysis ◽  
Aggregate Data ◽  
Controlled Trials ◽  
Individual Participant Data ◽  
Exercise Rehabilitation ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Individual Participant

Introduction:Traditional meta-analyses synthesize aggregate data obtained from study publications or study authors, such as a treatment effect estimate and its associated uncertainty. An increasingly important approach is the meta-analysis of individual participant data (IPD) where the raw individual-level data are obtained for each study and used for synthesis. This study compares and discusses results from an IPD meta-analysis vs standard meta-analysis of randomized controlled trials of exercise cardiac rehabilitation in chronic heart failure (CHF).Methods:Based on a previous systematic review, the Exercise Training Meta-Analysis of Trials for Chronic Heart Failure (ExTraMATCH II) identified and collected IPD from randomized controlled trials (RCTs) that compared exercise rehabilitation with a non-exercise control with a minimum follow-up of six months. For this abstract, the outcome of interest was all-cause mortality. Original IPD were checked for consistency and compiled in a master dataset. Standard meta-analytic models were used for aggregate data whilst two-stage and one-stage approaches, accounting for the clustering of participants within studies, were planned for statistical analyses of IPD.Results:Overall thirty-three RCTs were included in the original systematic review, whereas within the ExTraMatch II project, IPD on all-cause mortality were obtained from seventeen RCTs of approximately 3,700 patients. From aggregate data there was no significant difference in pooled mortality (relative risk 0.92, 95% confidence interval 0.67 to 1.26). IPD analysis revealed 701 events across exercise and control groups. Our ongoing IPD analyses will allow us to examine how patients’ characteristics (e.g. age, New York Heart Association functional class, ejection fraction) modify treatment benefit.Conclusions:Given the limitations of current trial level meta-analysis evidence in CHF, access to individual data from several RCTs offers a timely and important opportunity to revisit the question of which CHF patient subgroups benefit most from exercise-based rehabilitation.

scholarly journals Pooling individual participant data from randomized controlled trials: Exploring potential loss of information

PLoS ONE ◽  
2020 ◽  
Vol 15 (5) ◽  
pp. e0232970
Author(s):  
Lennard L. van Wanrooij ◽  
Marieke P. Hoevenaar-Blom ◽  
Nicola Coley ◽  
Tiia Ngandu ◽  
Yannick Meiller ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Individual Participant Data ◽  
Loss Of Information ◽  
Randomized Controlled ◽  
Individual Participant ◽  
Potential Loss
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