Data integrity of 35 randomised controlled trials in women’ health

Esmée M. Bordewijk; Rui Wang; Lisa M. Askie; Lyle C. Gurrin; Jim G. Thornton; Madelon van Wely; Wentao Li; Ben W. Mol

doi:10.1016/j.ejogrb.2020.04.016

Data integrity of 35 randomised controlled trials in women’ health

Esmée M. Bordewijk^*, Rui Wang, Lisa M. Askie, Lyle C. Gurrin, Jim G. Thornton, Madelon van Wely, Wentao Li, Ben W. Mol

^*Corresponding author for this work

Research output: Contribution to journal › Editorial › peer-review

37 Citations (Scopus)

Abstract

While updating a systematic review on the topic of ovulation of 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. We therefore undertook a focused analysis of the data integrity of all RCTs published by the two authors. 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. 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. The procedures demonstrated in this paper may help to assess data integrity in future attempts to verify the authenticity of published RCTs.

Original language	English
Pages (from-to)	72-83
Number of pages	12
Journal	European Journal of Obstetrics and Gynecology and Reproductive Biology
Volume	249
Early online date	11 Apr 2020
DOIs	https://doi.org/10.1016/j.ejogrb.2020.04.016
Publication status	Published - Jun 2020

Bibliographical note

LMA is a co-convener of the Cochrane Prospective Meta-analysis Methods Group and manager of the Australian New Zealand Clinical Trials Registry. MvW is co-oordinating editor of the Netherlands Satellite of the Cochrane Gynaecology and Fertiliy Group. BWM reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. All other authors have no conflicts of interest.

Keywords

Data integrity
Fabricated data
Ovulation induction
Randomization
Research integrity
POLYCYSTIC-OVARY-SYNDROME
COMBINED METFORMIN
OVULATION INDUCTION
HORMONE AGONISTS
CLOMIPHENE-RESISTANT WOMEN
N-ACETYL CYSTEINE
CITRATE
UNEXPLAINED INFERTILITY
AROMATASE INHIBITORS
INTRAUTERINE INSEMINATION

Access to Document

10.1016/j.ejogrb.2020.04.016Licence: Unspecified

Cite this

@article{979eaf72fffa448f919fc98acc3ce18c,

title = "Data integrity of 35 randomised controlled trials in women{\textquoteright} health",

abstract = "While updating a systematic review on the topic of ovulation of 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. We therefore undertook a focused analysis of the data integrity of all RCTs published by the two authors. 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. 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. The procedures demonstrated in this paper may help to assess data integrity in future attempts to verify the authenticity of published RCTs.",

keywords = "Data integrity, Fabricated data, Ovulation induction, Randomization, Research integrity, POLYCYSTIC-OVARY-SYNDROME, COMBINED METFORMIN, OVULATION INDUCTION, HORMONE AGONISTS, CLOMIPHENE-RESISTANT WOMEN, N-ACETYL CYSTEINE, CITRATE, UNEXPLAINED INFERTILITY, AROMATASE INHIBITORS, INTRAUTERINE INSEMINATION",

author = "Bordewijk, {Esm{\'e}e M.} and Rui Wang and Askie, {Lisa M.} and Gurrin, {Lyle C.} and Thornton, {Jim G.} and {van Wely}, Madelon and Wentao Li and Mol, {Ben W.}",

note = "LMA is a co-convener of the Cochrane Prospective Meta-analysis Methods Group and manager of the Australian New Zealand Clinical Trials Registry. MvW is co-oordinating editor of the Netherlands Satellite of the Cochrane Gynaecology and Fertiliy Group. BWM reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. All other authors have no conflicts of interest. ",

year = "2020",

month = jun,

doi = "10.1016/j.ejogrb.2020.04.016",

language = "English",

volume = "249",

pages = "72--83",

journal = "European Journal of Obstetrics and Gynecology and Reproductive Biology",

issn = "0301-2115",

publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - Data integrity of 35 randomised controlled trials in women’ health

AU - Bordewijk, Esmée M.

AU - Wang, Rui

AU - Askie, Lisa M.

AU - Gurrin, Lyle C.

AU - Thornton, Jim G.

AU - van Wely, Madelon

AU - Li, Wentao

AU - Mol, Ben W.

N1 - LMA is a co-convener of the Cochrane Prospective Meta-analysis Methods Group and manager of the Australian New Zealand Clinical Trials Registry. MvW is co-oordinating editor of the Netherlands Satellite of the Cochrane Gynaecology and Fertiliy Group. BWM reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. All other authors have no conflicts of interest.

PY - 2020/6

Y1 - 2020/6

N2 - While updating a systematic review on the topic of ovulation of 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. We therefore undertook a focused analysis of the data integrity of all RCTs published by the two authors. 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. 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. The procedures demonstrated in this paper may help to assess data integrity in future attempts to verify the authenticity of published RCTs.

AB - While updating a systematic review on the topic of ovulation of 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. We therefore undertook a focused analysis of the data integrity of all RCTs published by the two authors. 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. 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. The procedures demonstrated in this paper may help to assess data integrity in future attempts to verify the authenticity of published RCTs.

KW - Data integrity

KW - Fabricated data

KW - Ovulation induction

KW - Randomization

KW - Research integrity

KW - POLYCYSTIC-OVARY-SYNDROME

KW - COMBINED METFORMIN

KW - OVULATION INDUCTION

KW - HORMONE AGONISTS

KW - CLOMIPHENE-RESISTANT WOMEN

KW - N-ACETYL CYSTEINE

KW - CITRATE

KW - UNEXPLAINED INFERTILITY

KW - AROMATASE INHIBITORS

KW - INTRAUTERINE INSEMINATION

UR - http://www.scopus.com/inward/record.url?scp=85084227779&partnerID=8YFLogxK

U2 - 10.1016/j.ejogrb.2020.04.016

DO - 10.1016/j.ejogrb.2020.04.016

M3 - Editorial

AN - SCOPUS:85084227779

SN - 0301-2115

VL - 249

SP - 72

EP - 83

JO - European Journal of Obstetrics and Gynecology and Reproductive Biology

JF - European Journal of Obstetrics and Gynecology and Reproductive Biology

ER -

Data integrity of 35 randomised controlled trials in women’ health

Abstract

Bibliographical note

Keywords

Access to Document

Other files and links

Fingerprint

Cite this