Should a Trial with Lost Allocation Key be Incorporated in Meta-analysis?
Journal Title: Journal of Advances in Medicine and Medical Research - Year 2015, Vol 9, Issue 3
Abstract
Aims: On occasion randomized controlled studies may remain unpublished because the allocation key identifying which group received active treatment and which received placebo (or alternative treatment) has been lost. The purpose of this paper is to explore whether and under what circumstances an unpublished study like NCT00250237 whose allocation key has been irretrievably lost might be incorporated into a meta-analysis, allowing the information contained to contribute, however tentatively, to the evidence base around a clinical topic. Study Design: Review / meta-analysis Place and Duration of Study: Vancouver Coastal Health Research Institute and School of Population and Public Health, University of British Columbia and Department of Surgery, Rijnland Hospital, between 2009 and 2014. Methodology: For two published trials, we calculated separate effect measures for a simulated lost allocation key, under the alternative assumptions that Groups A or B received active treatment. These two effects were compared visually to the pooled effect from a meta-analysis of all other comparable studies. We present as well several quantitative methods for reconstituting a lost allocation code, involving frequentist meta-analysis, meta-regression, and Bayesian techniques. We apply these to an analysis of NCT00250237. Results: The simulated lost allocation keys of both trials were successfully identified through visual methods using meta-analysis. Reconstitution in this manner requires that the trial’s effect depart significantly from the null and that there exist a sufficient number of other high quality studies addressing the same clinical topic to allow unbiased calculation of a pooled summary effect. While direct reconstitution may sometimes be possible, our primary approaches are implicitly Bayesian and, as with NCT00250327, allow probabilities to be estimated for each allocation assignment. Conclusion: Under some circumstances studies with a lost allocation key may be incorporated cautiously into meta-analysis.
Authors and Affiliations
Bart G. Pijls, Boudewijn L. Borger-van der Burg, Larry E. Frisch, Anne J. Vochteloo, Rob G. H. H. Nelissen
Keywords
Related Articles
- EP ID EP347553
- DOI 10.9734/BJMMR/2015/17815
- Views 93
- Downloads 0
Vitamin D Deficiency is Associated with Nonspecific Low Back Pain in Young Women, a Case-Control Study
Background: Vitamin D deficiency is linked to several musculoskeletal conditions including nonspecific low back pain, autoimmune diseases. Data regarding to vitamin D deficiency and low back pain are not consistent acros...
Increases of Cardiometabolic Risk in Young Adults. Impact of Exercise Reductions during the College Years
Aims: The transition from school to university, traineeship or job especially along with moving away from home may lead to unhealthy lifestyle changes in young adults. Thus, we determined the effect of exercise changes d...
Factors Influencing A & E Attendance, Admissions and Waiting Times at Two London Hospitals
Aims: To inform wider debate regard attendance at the Accident & Emergency department via analysis of the complex factors regulating attendances at two London hospitals. Study Design: Analysis of 508,569 A&E attendances...
Broader Transparency on Risk-benefit Assessment of the Bial Trial in France
On 11 January 2016, a Phase I trial of an experimental fatty acid amide hydrolase inhibitor for pain developed by Bial-Portela was halted after six healthy volunteers were admitted to the University of Rennes Hospital in...
An Outpatient-based Survey on the Recognition of Locomotive Syndrome in Japan: The Results of three Years of Surveys
Background: In 2007, the Japanese Orthopaedic Association (JOA) proposed the term locomotive syndrome (LS) and the Japan Locomo Challenge Promotion Conference (JLCPC) began to carry out continuous campaigns to increase t...