BioMed Central Blog

Authenticity of some published trials in question

More than 90% of a sample of randomised controlled trials (RCTs) published in Chinese journals between 1994 and 2005 did not adhere to recognised methodology for randomisation, according to a study published yesterday in Trials, casting doubt on the reliability of research that has the potential to influence medical decision-makers.

Wu and colleagues (Chinese Cochrane Centre at Sichuan University, China and Ottawa Hospital Research Institute) searched the China National Knowledge Infrastructure electronic database for reports published in the Chinese literature between January 1994 and June 2005, that were described by the authors as RCTs or claimed to have used random sequence generation or allocation concealment.

Telephone interviews with the first or co-authors of 2235 reports about randomisation methods and quality-control features of the trial indicated that only 6.8% of the studies be considered “authentic” RCTs. Although only 51.6% of trials supported by government or other official organizations were found to be authentic, all trials of pre-market drugs were identified as such. Wu et al. report that of the first-authors erroneously identifying their studies as RCTs, 85.6% did not fully understand the principles of randomisation, whilst 5.1% mislabelled their trials despite an understanding of the relevant methodology.

Methodology    
Randomized trials published in some Chinese journals: how many are randomized?
Taixiang Wu, Youping Li, Zhaoxiang Bian, Guanjian Liu, David Moher
Trials 2009, 10:46 (2 July 2009)
[Abstract] [Provisional PDF]

The misleading reporting of RCTs is likely a worldwide problem, but the investigators suggest a link between their results and the high proportion of positive trial results published in Chinese journals, noting that inadequate randomisation has been previously shown to result in more favourable estimates of treatment effects. They also highlight the potential for falsely reported RCTs to mislead healthcare providers and policy makers, and impact upon the findings of systematic reviews.

Wu et al. advocate improvements to the education of researchers in the principles of randomisation methodology and scientific reporting. In addition, they suggest that the development of peer review guidelines is needed to help identify poorly randomised studies before publication.

Victoria Thompson
Assistant Journal Development Editor - Trials

Posted by Iain Hrynaszkiewicz at 17:16    Comments (0)

 

Reporting of treatment heterogeneity proves challenging

A review of randomised controlled trials (RCTs) that had been published in five prominent medical journals has revealed that heterogeneity of treatment effects (HTE) is frequently ignored or incorrectly analysed. The results of this study were published last week in Trials.

Some patients will experience more or less benefit from treatment than the averages reported from clinical trials; the magnitude of such variation in therapeutic outcome across a population is termed HTE. Highly variable treatment response rates are known to exist for many common conditions, including ischemic stroke and diabetes. Identifying HTE is therefore necessary to individualise treatment.

Gabler et al., conducted a review of the prevalence of HTE analyses in 319 RCTs published in Annals of Internal Medicine, BMJ, Journal of the American Medical Association, The Lancet, and New England Journal of Medicine. They found that just 29% of studies reported HTE analysis and were only marginally better in 2004 than in 1994. Another 28% reported subgroup-only analyses, without the formal statistical tests of heterogeneity that are recommended by the CONSORT guidelines.  

The authors conclude that HTE reporting in the general medical literature is neither rigorous nor routine and suggest it may be time to develop new standards for reporting.

Dealing with heterogeneity of treatment effects: is the literature up to the challenge?
Nicole B Gabler, Naihua Duan, Diana Liao, Joann G Elmore, Theodore G Ganiats, Richard L Kravitz

These results follow those of a another study published last year in Trials, which revealed that only 31% of RCTs published in the same leading medical journals reliably accounted for missing data when analysing quality of life outcomes.

In addition to original research relating to RCTs, Trials also encourages the publication of study protocols, recognizing that this reduces risk of non-publication of trial results and facilitates methodological discussion. Such published study protocols, while important to the scientific record, are unlikely to be heavily cited. It is therefore all the more impressive that Trials has increased its Impact Factor in the latest 2008 Journal Citation Reports to 1.74 (up from 1.44 last year). For the first time the journal is ranked above competitors such as the official journal of the Society for Clinical Trials, Clinical Trials (2008 Impact Factor 1.69)  and the Elsevier title Contemporary Clinical Trials (2008 Impact Factor 1.42).

For more information about the journal Trials, please contact the editorial office.

Abigail Jones
Senior Assistant Editor – Trials

Posted by Iain Hrynaszkiewicz at 17:15    Comments (0)

 

BioPsychoSocial Medicine announces the Winner of the 2008 Ikemi Award

Psychological and weight-related characteristics of patients with anorexia nervosa-restricting type who later develop bulimia nervosa
Nishimura H, Komaki G, Ando T, Nakahara T, Oka T, Kawai K, Nagata T, Nishizono A, Okamoto Y, Okabe K, Koide M, Yamaguchi C, Saito S, Ohkuma K, Nagata K, Naruo T, Takii M, Kiriike N, Ishikawa T, Japanese Genetic Research Group for Eating Disorders
BioPsychoSocial Medicine 2008, 2:5 (12 February 2008)

The 2008 Ikemi Award was presented to Mr Nishimura at the 50th Annual Meeting of the Japanese Society of Psychosomatic Medicine.

The Ikemi Award is presented to the first author of the best article (as decided by the selection committee) published in BioPsychoSocial Medicine during the previous year. To be considered for the 2009 Ikemi Award, submit your next manuscript to BioPsychoSocial Medicine. Please see the Award page of the journal website for further details.

BioPsychoSocial Medicine is the official journal of the Japanese Society of Psychosomatic Medicine and publishes research on psychosomatic disorders and diseases. For more information, please see the ‘About’ page or contact the Editorial office.

Posted by Genevieve Horne at 09:50    Comments (0)