Concerns about Data Integrity of 22 Randomized Controlled Trials in Women's Health

Abstract

Objective During a review on postpartum hemorrhage, we identified randomized controlled trials (RCTs) of one author conducted at the same time and place for the same condition, with large differences in baseline characteristics. We assessed the data integrity of the RCTs of this author.

Study Design We undertook a focused analysis of the data integrity of all RCTs published by Dr. Ahmed M. Maged. We examined the studies for clinical logic and made pairwise comparisons of baseline characteristics and outcomes between trials. We used mathematical methods to assess whether the distribution of baseline characteristics was compatible with chance.

Results Between March 2015 and December 2019, Dr. Maged published 22 RCTs (n = 3,722). The median number of participants randomized per center per month was 32 (range = 1–89). Fifteen studies were either not or retrospectively registered, with one study registered 1 year after publication. One study was submitted for publication prior to the completion of the described study period. There were many unusual findings in the studies, including biologically implausible occurrences such as the absence of an association between gestational age and birthweight in seven studies and very different body mass index between three trials, which ran at the same time in the same hospital on the same topic as well as unlikely occurrences such as limited participant drop outs. One paper contained considerable text duplication and identical data to that in a paper published by a different author group from a different hospital, with both papers submitted at the same time. Mathematical analysis of the baseline characteristics of all 22 trials indicated that at least some of the reported baseline characteristics were unlikely to be the result of proper randomization.

Conclusion Our analyses of the 22 RCTs of Dr. Maged suggest potential data integrity issues in at least some of them. We suggest that journals investigate according to the Committee on Publication Ethics guidelines. The procedures demonstrated in this paper may help to assess data integrity in future attempts to verify the authenticity of published RCTs.

Key Points

• We identified a number of findings biologically implausible in RCTs by Maged.

• Monte Carlo simulation found pooled data of Maged RCTs were unlikely result of proper randomization.

• Textual overlap and almost identical data were found between a Maged paper and another paper.

• The methods we described may be useful for future efforts in validating scientific data integrity.

Keywords

data integrity - research integrity - Monte Carlo simulation - randomized control trials

Publikationsverlauf

Eingereicht: 10. September 2020

Angenommen: 02. März 2021

Artikel online veröffentlicht:
18. Mai 2021

• References

• 1 Gallos ID, Papadopoulou A, Man R. et al. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev 2018; 12
• 2 Bordewijk EM, Wang R, Askie LM. et al. Data integrity of 35 randomised controlled trials in women' health. Eur J Obstet Gynecol Reprod Biol 2020; 249: 72-83
• 3 Carlisle JB. The analysis of 168 randomised controlled trials to test data integrity. Anaesthesia 2012; 67 (05) 521-537
• 4 Li W, Suke S, Wertaschnigg D. et al. Randomised controlled trials evaluating endometrial scratching: assessment of methodological issues. Hum Reprod 2019; 34 (12) 2372-2380
• 5 Carlisle JB, Dexter F, Pandit JJ, Shafer SL, Yentis SM. Calculating the probability of random sampling for continuous variables in submitted or published randomized controlled trials. Anaesthesia 2015; 70 (07) 848-858
• 6 Saleh WF, Ragab WS, Aboulgheit SS. Audit of maternal mortality ratio and causes of maternal deaths in the largest maternity hospital in Cairo, Egypt (Kasr Al Aini) in 2008 and 2009: lessons learned. Afr J Reprod Health 2013; 17 (03) 105-109
• 7 Shehata NAA. RETRACTED: Calcium versus oral contraceptive pills containing drospirenone for the treatment of mild to moderate premenstrual syndrome: a double blind randomized placebo controlled trial. Eur J Obstet Gynecol Reprod Biol 2016; 198: 100-104
• 8 Alalfy M, Elgazzar A, Fares T. et al. Effect of subcutaneous tissue closure technique in cesarean section on postoperative wound complications in obese Egyptian women. J Matern Fetal Neonatal Med 2019; 32 (15) 2452-2459
• 9 Hartgerink C. Research practices and assessment of research misconduct. ScienceOpen Res 2016
• 10 Carlisle JB. False individual patient data and zombie randomized controlled trials submitted to Anesthesia. Anesthesia 2020
• 11 Shoab AY, Maged AM, Ramadan W. et al. The value of endocervical and endometrial lidocaine flushing before office hysteroscopy: A randomized controlled trial. Int J Gynaecol Obstet 2020; 148 (01) 113-117
• 12 Maged AM, Mosaad M, AbdelHak AM. et al. The effect of hyoscine butylbromide on the duration and progress of labor in primigravidae: a randomized controlled trial. J Matern Fetal Neonatal Med 2018; 31 (22) 2959-2964