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)

 

Robotic lower limb exoskeletons – a new thematic series published in Journal of NeuroEngineering and Rehabilitation

Recent advances in materials and technology mean that the field of robotic exoskeletons is full of new and exciting potential. The purposes of and uses for exoskeletons are continually expanding, as is demonstrated in the series Robotic lower limb exoskeletons, edited by Dr Daniel Ferris and published in Journal of NeuroEngineering and Rehabilitation.
 
Introduced by Dr Ferris’ commentary ‘The exoskeletons are here’, the nine articles in this series cover diverse topics ranging from robotic movement training after neurological injury,  gait training after stroke, and energy harvesting exoskeletons that function by converting mechanical work at the knee into electrical energy.

Journal of NeuroEngineering and Rehabilitation is overseen by Editor-in-Chief Paolo Bonato and a prestigious Editorial Board. For more information, please see the journals ‘About’ page.
 

Posted by Genevieve Horne at 17:08    Comments (0)

 

Richard Hays joins Asia Pacific Family Medicine as co-Editor-in-Chief

Richard Hays has recently joined Tai Pong Lam and Zorayda Leopando as co-Editor-in-Chief of Asia Pacific Family Medicine. We are pleased to welcome Richard, the Head of the School of Medicine at Keele University, onboard the journal. We would also like to extend our gratitude to Lyn Clearihan for her hard work and dedication as she retires as co-Editor.

Asia Pacific Family Medicine is currently inviting contributions to a thematic series entitled ‘The expanding role of family medicine in medical education’.  Authors are invited to submit their latest research on this topic for publication in a article series highlighting the important role of GPs in medical education, review and commentary articles will also be considered.  Anyone wishing to contribute to this thematic series should submit their work by the end of December 2009, or contact the Editorial Office to discuss further.

Asia Pacific Family Medicine, the official journal for the Asia Pacific Region of WONCA, aims to provide a forum for the dissemination of high quality regional research and to enhance the standards of family medicine by focusing on best practice.

Posted by Charlotte Hubbard at 10:54    Comments (0)

 

Stem Cell Research & Therapy: now accepting submissions

A new BioMed Central journal, Stem Cell Research & Therapy, is now accepting submissions.

Stem Cell Research & Therapy aims to be the major forum for translational research into stem cell therapies. An international peer-reviewed journal, it will publish open access research articles of outstanding quality. The journal will have a special emphasis on translational, laboratory, and clinical research into stem cells. It will include animal trials, pre-clinical and clinical trials. We will consider adult, embryonic, and induced pluripotent stem cell research, especially with a focus on cell-based transplantation, drug discovery and testing, cell-mediated tissue response and biological effects stimulated by endogenous cells. We will have a unique focus on drug discovery and testing, stem cell manufacture, engineering, and biomaterials.

The journal is edited by Dr Rocky Tuan (National Institutes of Health, USA) and Prof Timothy O'Brien (National University of Ireland, Galway), and is supported by an international Editorial Board.

Stem Cell Research & Therapy joins BioMed Central’s growing portfolio of journals that uniquely focus on publishing translational research of exceptional interest, as well as authoritative reviews and commentaries. Other titles in this series include the well-established Arthritis Research & Therapy, and Alzheimer’s Research & Therapy, which is due to publish its first issue in July 2009.

For more information on Stem Cell Research & Therapy please visit the journal’s information page or contact the editorial office. To keep up to date with the latest developments and to receive a copy of the inaugural issue, please register your email address on the website.

Submit your next outstanding piece of research to Stem Cell Research & Therapy to benefit from the rapid peer review, high visibility, and immediate and free access to all research papers.

Surayya Johar
In-house Editor
Stem Cell Research & Therapy

Posted by Iain Hrynaszkiewicz at 10:07    Comments (0)

 

BMC Medical Genomics publishes over 100 articles

Since launching in January last year, BMC Medical Genomics has published over 100 articles. The latest original research paper, on growth factor signalling in drug-insensitive breast cancers has recently been press-released. This is a fantastic start for a new publication, and in just over a year the journal has published a diverse range of research covering our wide scope.

Recent research highlights include exciting work by Hai Yan’s group at Duke University and the Vogelstein, Kinzler and Velculescu labs at Johns Hopkins Medical Institutions using Digital Karyotyping Microbe Identification to determine the presence of microbial DNA in human tumor samples, and the discovery by Olli Kallioniemi’s group in Turku University of a putative breast cancer tumor-suppressor by a novel combination of array-CGH with non-sense mediated mRNA decay and gene expression data. As well as original research, the journal has also published commentaries and reviews, the latest by Edward Ramos and Charles Rotimi on the positive contribution that medical genomics can have on improving the health of minority groups. Douglas Kell’s overarching systems medicine review of the otherwise highly disparate literature linking inappropriate iron chelation and human disease published at the start of the year is already our most highly-accessed article, with over 5000 accesses in just 5 months.

BMC Medical Genomics, along with BMC Systems Biology, was one of the first journals in the BMC-series to embrace the involvement of Associate Editors in the peer review process. We would like to thank all of our Associate Editors as well as members of our Advisory Board for their help and support since the launch of the journal. Submit your next paper to BMC Medical Genomics to take part in the future success of the journal!

Scott Edmunds PhD
In-house Editor, BMC Medical Genomics

Posted by Scott Edmunds at 16:55    Comments (0)

 

Copy number variation: larger clues to cancer?

‘Copy number variations and cancer’, a Review article published in Genome Medicine,  describes the emerging importance of the role of genetic structural variation and diversity in cancer.

Copy number variations (CNV) are large, structurally variant regions of DNA that contribute substantially to genetic diversity. Until recently, the majority of genomic studies in cancer have focused on the single-nucleotide polymorphisms associated with different forms of the disease. Technological progress in the form of high-resolution SNP arrays, however, has allowed the identification of increasing numbers of CNVs and the association of these components of genetic variation with different forms of cancer has become apparent.

As Dr Adam Shlien and Dr David Malkin discuss in this Review, the importance of understanding the complex structural dynamics of CNVs, both in constitutional and somatic mutations, and their association with cancer, is evident. The authors analyze the research in this field to date, and highlight the possibility of exciting developments for the future.

Genome Medicine, BioMed Central’s premier medical journal, stands at the forefront of research and clinical practice in the post-genomic era. The journal is led by six Section Editors and is supported by a world renowned Editorial Board.

We welcome cutting-edge genomic and post-genomic research reporting findings that significantly advance our understanding and management of human health and disease.

Keep abreast of recent developments in these exciting times: register for article updates and submit your next manuscript of outstanding research to Genome Medicine.

Jasmine Farsarakis
Commissioning/Development Editor, Genome Medicine

Posted by Jasmine Farsarakis at 11:26    Comments (0)

 

Swine flu and the modeling of pandemics – A new review in BMC Medicine

Influenza A (H1N1), more commonly known as swine flu,  has recently received a great deal of media attention, much of it focused on the measures that governments and organisations are taking to contain this infectious disease from spreading.

A new review published this week in BMC Medicine by Editorial Board member Sally Blower and her colleagues at the Semel Institute Centre for Biomedical modeling, UCLA considers how mathematical modeling of influenza pandemic outbreaks can inform pandemic preparedness planning, using swine flu as the focus.

Review    
Modeling influenza epidemics and pandemics: insights into the future of swine flu (H1N1)
Brian J Coburn, Bradley G Wagner, Sally Blower
BMC Medicine 2009, 7:30 (22 June 2009)
[Abstract] [Provisional PDF]

If you are interested in the recent swine flu outbreak, visit the BioMed Central Influenza Gateway for more information.  This portal includes the latest news about Influenza A (H1N1), as well as the latest research about influenza published across all of the BioMed Central journals.

BMC Medicine publishes original research articles, commentaries and reviews in all areas of medical science and clinical practice. To be appropriate for BMC Medicine, articles need to be of outstanding quality, broad interest and special importance. Why not sign up for our article alerts to keep abreast of notable research in medicine, and submit your outstanding research articles?

Posted by Robin Cassady-Cain at 09:38    Comments (0)

 

Solving the genetic puzzle of atrial fibrillation

‘Molecular genetics of atrial fibrillation’, a Review article recently published in Genome Medicine, highlights recent groundbreaking work in atrial fibrillation genetics that has provided researchers with an increased understanding of the genetic origin of this disease.

Historically, many studies have successfully identified the  familial predisposition for atrial fibrillation, a common type of cardiac dysrhythmia and a known risk factor for stroke; however, up to 30% of patients are affected without any known familial association and the absence of any identifiable risk factors, such as hypertension or diabetes.

Many studies have identified mutations associated with the disease, but it was not until recent work using high-throughput sequencing technology, that the 4q25 locus was identified as a susceptibility factor for atrial fibrillation. The gene PITX2, which is known to have a role in embryonic cardiac development, has also been identified as the causal variant within the 4q25 susceptibility locus.

As Dr Samir B Damani and Dr Eric J Topol discuss in this Review, the advances in genomic research of atrial fibrillation represent more than just increased understanding of the disease; translation of these findings will lead to improved screening, prognosis, and treatment, as well as the future possibility of a personalized approach for treatment for atrial fibrillation.

Genome Medicine welcomes genomic and post-genomic research reporting findings that significantly advance our understanding and management of human health and disease. The journal also regularly publishes Review, Minireview and Commentary articles that appraise progress in any area of medicine studied from a genomic or post-genomic perspective.

We invite you to submit your next manuscript of outstanding research to Genome Medicine. You can also keep abreast of recent developments by registering online for our article updates.

Jasmine Farsarakis
Commissioning/Development Editor, Genome Medicine

Posted by Jasmine Farsarakis at 16:42    Comments (0)

 

John Hardy elected to Royal Society

John Hardy, Editorial Board member of the soon-to-be launched Alzheimer’s Research & Therapy, has been elected to the Fellowship of the Royal Society for his exceptional contribution to science.  Professor Hardy, UCL Institute of Neurology, is one of the most highly cited authors in Alzheimer’s disease research, with more than 23,000 citations between January 1985 to April 2008.

His research interests are in the genetic analysis of disease, specifically Alzheimer’s disease and other dementias. He has had a focus on investigating tau proteins, which accumulate in abnormal folds in patients with Alzheimer's.

Professor Hardy is a founding member of the Alzheimer’s Research & Therapy Editorial Board.  The journal aims to be the major forum for translational research into Alzheimer’s disease. An international open access journal, Alzheimer’s Research & Therapy will publish basic research with a translational focus, as well as clinical trials, research into drug discovery and development, and epidemiologic studies. Although the journal’s primary focus is Alzheimer’s dementia, the scope will encompass other neurodegenerative disease.

Congratulations to Professor Hardy from all at BioMed Central.

Frances Mulvany
In-house Editor, Alzheimer's Research & Therapy

Posted by Iain Hrynaszkiewicz at 13:31    Comments (0)

 

A long and winding road for genomic disorders

In a recent article published in Genome Medicine, Section Editor James R Lupski reports on the progress in our understanding of genomic disorders over the past 10 years.

The article ‘Genomic disorders ten years on’ chronicles the discovery of structural variation in the human genome and the great progress that the last decade has seen in terms of our understanding of such structural variation and its role in genomic disorders.

Author Dr Lupski, who is based at the Baylor College of Medicine, discusses how the field has overcome many challenges on both a technological and a conceptual level, and highlights how the advances in our understanding of the factors underlying such structural changes are paralleled only by the improvements in the technology used to identify, or rather discover, structural modification.

The journey in genomic disorder research is only just beginning though, as investigators are now able to use identified mechanisms, including those of rearrangement or break-induced replication, to further elucidate the effects of genomic rearrangements and structural variation in a clinical context. Overall, Dr Lupski stresses the importance of appreciating the role of copy number variation in the human genome, and comments on directions for future research.

Genome Medicine, BioMed Central’s premier medical journal, stands at the forefront of research and clinical practice in the post-genomic era. The journal is led by six Section Editors and is supported by a world renowned Editorial Board.

We welcome cutting-edge genomic and post-genomic research reporting findings that significantly advance our understanding and management of human health and disease.

Keep abreast of recent developments in these exciting times: register for article updates and submit your next manuscript of outstanding research to Genome Medicine.


Jasmine Farsarakis
Commissioning and Development Editor, Genome Medicine

Posted by Nicole Nogoy at 16:48    Comments (0)

 

Noninvasive Brain stimulation a thematic series from Journal of Neuroengineering and Rehabilitation

With a predicted rise in neurological disorders in the coming years, the new thematic series published in Journal of NeuroEngineering and Rehabilitation entitled ‘'Noninvasive Brain stimulation'’ (NBS) gives an important evaluation of the emergent technologies of non-invasive brain stimulation.

The series of 6 articles brings together leaders in the fields of robotics, NBS, plasticity and motor learning, to provide an up-to-date overview for researchers and clinicians interested in physical neurorehabilitation, including their effectiveness and their possible future role in physical rehabilitation therapies.

For further information on the series please read the commentary written by the guest Editor for the series, Dr Edwards.

To keep up-to-date with articles published in Journal of NeuroEngineering and Rehabilitation you can register to receive regular email article alerts. The journal is overseen by the Editor-in-Chief, Paolo Bonato.

Posted by Tim Allen at 12:07    Comments (0)

 

Can we establish best practice for publishing raw clinical trial data?

Assessment of the reliability of published articles is seriously impeded by incomplete reporting. Many research funding agencies now require open access to the results of research they have funded, and some also require that researchers make available the raw data generated from that research, in recognition of the numerous benefits associated with this level of transparency.

As previously reported, Trials and BMC Research Notes are working with the scientific community to encourage complete and transparent reporting of scientific research. A recent Genome Medicine editorial also highlighted the data-sharing debate in genomics.

Common issues encountered when considering raw clinical data for publication include patient privacy – unless explicit consent for publication is obtained – and ownership, but agreed policies on tackling these concerns do not appear to be addressed in the guidance or mandates currently established.

An editorial just published in Trials sets out the challenges and opportunities presented by publishing raw clinical trial data sets in journals. The authors encourage further debate in the community and propose next steps for journal editors and publishers, ethics committees, research-funding agencies and trialists for establishing best practice for publishing trial data.

Editorial    
Towards agreement on best practice for publishing raw clinical trial data
Iain Hrynaszkiewicz, Douglas G Altman
Trials 2009, 10:17 (18 March 2009)
[Abstract] [Provisional PDF]

Following a meeting of relevant members of the scientific community, which included representation from the BMJ, The Lancet, Wellcome Trust and National Research Ethics Service, it was agreed that an important step forwards would be widely agreeable guidance on preparing raw data for publication in journals. This is a challenge currently being undertaken by the Trials Editors.

As stated in the editorial, any members of the clinical trials community interested in participating in this journal’s initiative to establish best publication practice for trial data and/or would be interested in reviewing draft guidance, are encouraged to leave their comments or contact the editorial office.

Posted by Iain Hrynaszkiewicz at 14:02    Comments (0)

 

New thematic series from Molecular Neurodegeneration that asks ‘What kills neurons in neurodegenerative disease?’

To refresh efforts to answer the question 'What kills neurons in neurodegenerative disease?', Molecular Neurodegeneration have commenced publication of a new thematic series with this title.

In the last few decades experiments have been conducted, which have determined the triggers of most neurodegenerative disease. However the pathological processes, the precise pathways that lead to neuronal cell death in each disease, remain largely unknown. In many cases therapy targeting a trigger is limited in its effect because the disease process is significantly progressed before the effects are observed. Therefore a detailed understanding of the precise steps that lead to neuronal cell death may be invaluable for providing new therapies in patients who have a progressed form of a neurodegenerative disease.

The review series consists of 20 articles, which will be published over the coming months. The articles will cover a broad range of neurodegenerative diseases, with both disease specific reviews as well as more general reviews on possible pathways leading to neurodegeneration, with an emphasis on future work required in the area.

The first articles published focus on the therapeutic importance of understanding mechanisms of neuronal cell death in neurodegenerative disease and α-synuclein toxicity in Parkinson disease.

For a more detailed overview of the series please read the commentary by guest Editors Todd Golde and Leonard Petrucelli.

To keep up-to-date with all the latest articles published in Molecular Neurodegeneration please register to receive email article alerts.

Posted by Tim Allen at 15:09    Comments (0)