Article type
Year
Abstract
Background: While updating a systematic review for the Cochrane Database for systematic reviews on the topic of ovulation induction, we observed unusual similarities in a number of randomised controlled trials (RCTs) published by two authors from the same institute in the same disease spectrum in a short period of time.
Objectives: We undertook a focused analysis of the data integrity of all RCTs published by the two authors.
Methods: We searched the PubMed database for authors ‘Badawy’ or ‘Abu Hashim’ using the affiliation ‘Mansoura’ restricting to RCTs. We made pairwise comparisons to find identical or similar values in baseline characteristics and outcome tables between trials. We also assessed whether baseline characteristics were compatible with chance, using Monte Carlo simulations and Kolmogorov-Smirnov test.
Results: For 35 trials published between September 2006 and January 2016, we found a large number of similarities in both the baseline characteristics and outcomes of 26. Analysis of the baseline characteristics of the trials indicated that their distribution was unlikely to be the result of proper randomisation.
Conclusions: Our analyses suggest serious data integrity issues in published RCTs from these authors. They have been cited 13 times in meta-analyses within Cochrane reviews. The procedures demonstrated in this paper may help to assess data integrity in future attempts to verify the authenticity of published RCTs.
Patient or healthcare consumer involvement: NA
Objectives: We undertook a focused analysis of the data integrity of all RCTs published by the two authors.
Methods: We searched the PubMed database for authors ‘Badawy’ or ‘Abu Hashim’ using the affiliation ‘Mansoura’ restricting to RCTs. We made pairwise comparisons to find identical or similar values in baseline characteristics and outcome tables between trials. We also assessed whether baseline characteristics were compatible with chance, using Monte Carlo simulations and Kolmogorov-Smirnov test.
Results: For 35 trials published between September 2006 and January 2016, we found a large number of similarities in both the baseline characteristics and outcomes of 26. Analysis of the baseline characteristics of the trials indicated that their distribution was unlikely to be the result of proper randomisation.
Conclusions: Our analyses suggest serious data integrity issues in published RCTs from these authors. They have been cited 13 times in meta-analyses within Cochrane reviews. The procedures demonstrated in this paper may help to assess data integrity in future attempts to verify the authenticity of published RCTs.
Patient or healthcare consumer involvement: NA