The analysis of 168 randomised controlled trials to test data integrity

被引:166
作者
Carlisle, J. B. [1 ]
机构
[1] S Devon NHS Fdn Trust, Torbay Hosp, Torquay, Devon, England
关键词
D O I
10.1111/j.1365-2044.2012.07128.x
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
The purpose of this study was to use some statistical methods to assess if randomised controlled trials (RCTs) published by one particular author (Fujii) contained data of unusual consistency. I searched seven electronic databases, retrieving 168 RCTs published by this author between 1991 and July 2011. I extracted rates for categorical variables and means (SDs) for continuous variables, and compared these published distributions with distributions that would be expected by chance. The published distributions of 28/33 variables (85%) were inconsistent with the expected distributions, such that the likelihood of their occurring ranged from 1 in 25 to less than 1 in 1 000 000 000 000 000 000 000 000 000 000 000 (1 in 1033), equivalent to p values of 0.04 to < 1 x 10(-33), respectively. In 141 human studies, 13/13 published continuous variable distributions were inconsistent with expected, their likelihoods being: weight < 1 in 1033; age < 1 in 1033; height < 1 in 1033; last menstrual period 1 in 4.5 x 1015; baseline blood pressure 1 in 4.2 x 105; gestational age 1 in 28; operation time < 1 in 1033; anaesthetic time < 1 in 1033; fentanyl dose 1 in 6.3 x 108; operative blood loss 1 in 5.6 x 109; propofol dose 1 in 7.7 x 107; paracetamol dose 1 in 4.4 x 102; uterus extrusion time 1 in 33. The published distributions of 7/11 categorical variables in these 141 studies were inconsistent with the expected, their likelihoods being: previous postoperative nausea and vomiting 1 in 2.5 x 106; motion sickness 1 in 1.0 x 104; male or female 1 in 140; antihypertensive drug 1 in 25; postoperative headache 1 in 7.1 x 1010; postoperative dizziness 1 in 1.6 x 106; postoperative drowsiness 1 in 3.8 x 104. Distributions for individual RCTs were inconsistent with the expected in 96/134 human studies by Fujii et similar to al. that reported more than two continuous variables, their likelihood ranging from 1 in 22 to 1 in 140 000 000 000 (1 in 1.4 x 1011), compared with 12/139 RCTs by other authors. In 26 canine studies, the distributions of 8/9 continuous variables were inconsistent with the expected, their likelihoods being: right atrial pressure < 1 in 1033; diaphragmatic stimulation (100 Hz) < 1 in 1033; pulmonary artery occlusion pressure < 1 in 1033; diaphragmatic stimulation (20 Hz) < 1 in 1033; heart rate 1 in 6.3 x 1010; mean pulmonary artery pressure 1 in 2.2 x 1014; mean arterial pressure 1 in 6.3 x 107; cardiac output 1 in 110. Distributions were inconsistent with the expected in 21/24 individual canine studies that reported more than two continuous variables, their likelihood ranging from 1 in 345 to 1 in 51 000 000 000 000 (1 in 5.1 x 1013).
引用
收藏
页码:521 / 537
页数:17
相关论文
共 4 条
[1]  
Carlisle JB, 2006, COCHRANE DB SYST REV, V3
[2]   Reported data on granisetron and postoperative nausea and vomiting by Fujii et al. are incredibly nice! [J].
Kranke, P ;
Apfel, CC ;
Roewer, N .
ANESTHESIA AND ANALGESIA, 2000, 90 (04) :1004-1006
[3]   Fraud or flawed: adverse impact of fabricated or poor quality research [J].
Moore, R. A. ;
Derry, S. ;
McQuay, H. J. .
ANAESTHESIA, 2010, 65 (04) :327-330
[4]   Another kind of ethics: from corrections to retractions [J].
Yentis, S. M. .
ANAESTHESIA, 2010, 65 (12) :1163-1166