With thanks to The Annals of Surgery 12 February 2013 doi: 10.1097/SLA.0b013e3182864fa3
Comparison of Registered and Published Primary Outcomes in Randomized Clinical Trials of Surgical Interventions
Hannink, Gerjon PhD; Gooszen, Hein G. MD, PhD; Rovers, Maroeska M. PhD
Objective: To assess the proportion of registered surgical trials with results published in journals with high-impact factors; compare the primary outcomes specified in trial registries with those reported in the published papers; and determine whether primary outcome-reporting bias favored significant outcomes.
Background: Outcome-reporting bias, that is, the selective reporting of a subset of the original registered outcome measures based on their results, has not yet been studied specifically for surgical trials.
Methods: We searched PubMed for reports of surgical randomized controlled trials (RCTs) indexed between 2007 and 2012 in 10 general medical journals and 10 surgical journals with the highest impact factors. For each article included, we obtained the trial registration information using a standardized data extraction form.
Results: Of the 327 evaluated surgical trials, registration was lacking for 109 (33%) published papers. Two (2%) of these papers were published in general medical journals and 107 (98%) in surgical journals. Twelve (6%) of the trials were still recruiting patients, and 48 (22%) were registered after completion of the study. A total of 152 trials were registered before the end of the trial with the primary outcome clearly specified. Among these papers, 49% (75 of 152) showed some evidence of discrepancies between outcomes registered and the outcomes published, most often related to omitting or introducing a primary outcome. These discrepancies favored statistically significant results in 28% of the papers.
Conclusions: The quality of registration of surgical trials published in surgical journals was inferior to those published in general medical journals. Comparison of the primary outcomes of surgical RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent and appears to be higher than in general medical trials.
See http://www.iscc.cnrs.fr/spip.php?article1666 Why Most Biomedical Findings Echoed by Newspapers Turn out to be False: the Case of Attention Deficit Hyperactivity Disorder. François Gonon, Jan-Pieter Konsman, David Cohen and Thomas Boraud, Plos One, 2012. ‘… ”Because newspapers failed to inform the lay public that most initial scientific claims were later refuted or strongly attenuated, they did not reflect the evolution of scientific knowledge,” which “might have detrimental consequences on the management and prevention of ADHD,” Dr. Gonon and colleagues write…’
See Why Most Published Research Findings Are False Ioannidis JPA (2005) Why Most Published Research Findings Are False. PLoS Med 2(8): e124. doi:10.1371/journal.pmed.0020124 ‘… There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research…’
See A key player in stoking this Swine Flu hysteria was Dr Iain Stephenson, a Consultant at University Hospital of Leicester NHS Trust who has been found guilty of vaccine research fraud on a grand scale by the General Medical Council (GMC).
See Thirteen per cent of scientists or doctors have said they know of colleagues who have fabricated data in order to get research published. More than one in ten (13%) scientists or doctors have witnessed colleagues intentionally altering or fabricating data to get published or during their research, a poll suggests. The survey of almost 2,800 experts in the UK also found 6% knew of possible research misconduct at their institution that has not been properly investigated. The poll, for the British Medical Journal (BMJ), is being presented at a meeting aimed at tackling research misconduct in the UK. 13 January 2012
See Mental scores decline precipitously at 30 months after anthrax vaccine, but CDC spins study to say vaccine safe Thursday, January 12, 2012
See http://www.theoneclickgroup.co.uk/news.php?id=6732#newspost Patient No. 28665 was helping a Chesterfield company test a drug dubbed the “female Viagra” but stopped showing up for exams in December 2007. That didn’t stop a staffer of the company, PPS Clinical Research STL, from claiming that six months later the patient came in for an exam, was diagnosed with medical conditions, had undergone tests and even had given a urine sample. That admission was made in the company’s guilty plea to a federal felony charge of obstructing a proceeding of a federal agency. The drug the company helped test, aimed at women who suffered from an unexplained lack of sexual desire, never made it to market. As part of the plea, PPS admitted that it “corruptly influenced, obstructed, and impeded” an inspection by the Food and Drug Administration by providing false patient records in May 2010. During the trials, the drug’s manufacturer faulted PPS for failing to have a trained investigator conduct some exams, for back dating records and for failing to properly oversee one patient’s selection for the study, according to prosecutors. Boehringer did not respond to emails seeking comment.
See http://www.theoneclickgroup.co.uk/news.php?id=6610#newspost A well-known psychologist in the Netherlands whose work has been published widely in professional journals falsified data and made up entire experiments, an investigating committee has found. Experts say the case exposes deep flaws in the way science is done in a field, psychology, that has only recently earned a fragile respectability.
See Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments. Michelle Roseman, BA; Katherine Milette, BSc; Lisa A. Bero, PhD; James C. Coyne, PhD; Joel Lexchin, MD; Erick H. Turner, MD; Brett D. Thombs, PhD. JAMA. 2011;305(10):1008-1017. doi: 10.1001/jama.2011.257