We will be updating the blog with news about the journal, highly accessed papers, press coverage, events and matters of interest in the open access and publishing world, and anything else that catches our eye.
NHS Health Checks, the risks of bereavement by suicide, and public involvement in medical research
The Top 10 Most Read list for January is almost completely comprised of new entries, with the exception of the ever popular review by Kristensen et al on the effects of statins. In the top spot this month is an evaluation of the first four years of the NHS Health Check in England, by Robson et al. At number two we have a cross-sectional study seeking to test the hypothesis that young adults bereaved by suicide have an increased risk of suicidal ideation and suicide attempt compared to their peers bereaved by other sudden deaths. Parsons et al enter the list at number five with a paper asking what pharmaceutical industry professionals believe about public involvement in medicines research and development, and Joost et al enter at number eight with a paper on persistent spatial clusters of high body mass index.
Most read figures are based on pdf downloads and full text views. Abstract views are excluded.
19 Jan, 16 | by Fay Pearson
We have recently made some changes to our submission system. If we receive a clinical trial, we will now ask that authors include the original trial protocol. Editor-in-chief, Dr Trish Groves, explains why:
Transparent reporting of research has always been at the heart of BMJ Open. From the very start the journal has published all research with open access, open peer review, and sometimes – when authors opt for sharing via the Dryad repository – open data.
Openness is specially important for clinical trials, and that’s why we are now requiring that trialists submit the study protocol to BMJ Open along with their paper:
- This should be the version of the protocol that gained ethics approval and was used to run the trial
- If the protocol was amended between getting ethics approval and starting the trial, the authors must say why in their cover letter
- The submitted protocol should be labelled with a version number and should include a history of substantive amendments, giving the dates when amended
- If the trial protocol has been published in an open access journal, and if that published version includes all the information and dates as listed above, then authors can simply provide BMJ Open with the reference and link to the published protocol
- If BMJ Open publishes the submitted trial, the protocol will be posted alongside as part of the pre-publication history
Why is BMJ Open now requiring protocols? For clinical trials (and protocols for clinical trials) BMJ Open has always required prospective registration, and we ask authors to give the trial’s registration ID in the paper’s abstract. This allows editors, peer reviewers, and ultimately readers to see a summary of the planned design of the trial and to compare it with the paper that reports the trial’s results. And dates in the registration record allow us to check that the trial was, indeed, registered prospectively – before any patients were enrolled. Isn’t this enough? Not quite. Trial registration provides a lot of useful information about a planned study, but registries have space only for a minimum of key information.
You can’t interpret the results of a clinical trial without fully understanding how the study was planned, designed, and conducted. Yet it’s all too common for methods to be reported selectively, partly, or not at all. And it has become clear that registration does not always prevent this, particularly when it comes to outcome switching. Too often, prespecified outcomes are not reported, and others are added and reported in analyses that may not be valid. By making trial protocols available when trial results are reported in BMJ Open, we can all help to optimise the evidence base for treatments and other interventions.
10 Jan, 16 | by ed_sucksmith
This week we have been looking at some of our staff editors’ favourite articles from 2015. These papers have covered a variety of important issues in medical research, from the transparency of clinical trials to the publication of negative findings. Our final editors’ pick takes us to Ireland, where Professor Tom Fahey and colleagues from the Royal College of Surgeons in Dublin looked at pharmacy claims data to investigate long-term trends in prescribing of medicines between 1997 and 2012. Their findings included the positive news that prescribing quality had improved across the time period. However, there was a substantial increase in the number of people taking multiple regular medicines (known as ‘polypharmacy’), and this significantly predicted potentially inappropriate prescription of medicines. The authors suggested that patients should be made more aware of the trade-off between taking more medicines to prevent disease and the potential for harm from potentially inappropriate prescribing of drugs, which is associated with taking more medicines.
9 Jan, 16 | by ed_sucksmith
In December we surveyed our staff editors to tell us about their favourite articles from 2015. Our penultimate editors’ pick investigates the relationship between autism risk and a putative marker of testosterone exposure: the 2D: 4D digit ratio.
In spite of large investments in autism research, the underlying causes of autism diagnoses remain largely unknown, although twin and family studies suggest that autism is highly heritable. Perplexingly, autism is more frequently diagnosed in males, with male-to-female ratio estimates ranging from 2:1 to 9:1. A popular theory put forward to explain the sex differences behind autism diagnoses is the ‘Extreme Male Brain theory’, which proposes that people with autism are exhibiting an exaggerated profile of the male cognitive profile. A proposed physiological mechanism underlying this theory is the effect of prenatal sex steroids (such as testosterone) on the developing brain. The index to ring finger ratio (2D:4D digit ratio) is believed to be a proxy for fetal testosterone exposure; males have a lower 2D:4D digit ratio on average than females.
In this study by Anna Guyatt and colleagues, the 2D:4D digit ratio was examined in 6015 children from a British birth cohort known as The Avon Longitudinal Study of Parents and Children. The 2D:4D digit ratio was then tested for association with autistic traits in the general population and with autism diagnoses. Analysis of the data did not indicate a significant association between 2D:4D digit ratio and autism diagnoses or high autistic traits in the general population for either sex. Thus, the data did not support the extreme male brain theory of autism.
The study is just one of many published in BMJ Open in 2015 reporting negative findings. We believe that a study should be published irrespective of the direction of the findings providing that the study meets our publication criteria. Publishing negative findings has the added benefit of combating the damaging effects of dissemination bias in medical research (see Editors’ Picks 2015: Part Three)
8 Jan, 16 | by ed_sucksmith
In December we surveyed our staff editors to tell us about their favourite articles from 2015. Part 5 focuses on another important editorial issue: the quality of reporting in systematic reviews.
Clinicians and healthcare professionals often rely on systematic reviews and meta-analyses for information on how effective interventions are, as they do not have the time to read through the literature on each individual trial that is published. But how useful are systematic reviews for clinicians and are the interventions reported in sufficient detail for clinicians to implement them in clinical practice? Interventions should also be reported in sufficient detail so that other researchers could independently replicate the interventions in future studies.
In our fifth editors’ pick, Tammy Hoffman and colleagues selected a random sample of systematic reviews of non-pharmacological interventions for stroke, and examined the completeness of reporting of the interventions in the reviews. Using an established reporting instrument called the Template for Intervention Description and Replication (TIDieR) checklist, the authors found that a number of checklist items were incompletely reported in the reviews, including: (1) modifications to the intervention; (2) a description of intervention adherence/ fidelity; (3) a description of the materials used in the intervention; (4) a description of the procedures used in the intervention and; (5) if there was a plan for the intervention to be personalised or adapted during the study. The incomplete descriptions of the intervention materials and procedures were highlighted as crucial missing elements that have previously been reported as most frequently missing in publications of individual randomized trials.
The authors concluded that better reporting of interventions were needed in systematic reviews if they were going to be effectively used and interpreted by readers. Recommendations are provided for authors of systematic reviews to use the TIDieR checklist as a guide for reporting interventions, and to provide an ‘intervention options table’ that summarises the pros and cons of all usable and feasible interventions reported in the review.
7 Jan, 16 | by ed_sucksmith
Each day this week we’ve been looking at a published paper from 2015 that sparked the interest of one of our staff editors. Our fourth pick is a study protocol for a randomised controlled trial of exercise training in an elderly population.
BMJ Open supports the publication of study protocols to improve transparency in the ‘research to publication’ process and to protect the wider community against numerous damaging research practices, such as publication bias and HARKing.
In this study protocol, Dorthe Stensvold and colleagues from Norway, Australia and the USA aim to evaluate the effects of 5 years of exercise training on mortality in an elderly population. Whilst previous epidemiological studies have indicated that physical activity is associated with reduced risk of premature death and that changes in fitness predict mortality, it is unclear whether the level of physical activity is the direct cause of favourable health effects rather than other factors associated with a person’s state of health.
The proposed study in just under 1600 participants is considered to be the first randomised controlled trial to assess the effect of exercise training on mortality and morbidity in an elderly population. The protocol currently has 6 citations in Google Scholar, suggesting that the article has been a useful addition to the scholarly literature since it was published in February 2015.
If you are interested in learning more about study protocols then check out BMJ’s recently launched e-learning programme: Research to Publication. The programme includes a free taster module on how to write and publish a study protocol. If you successfully complete the module, then you will receive formal recognition with a certificate from The BMJ’s Editor-in-Chief and UCSF’s associate dean. If you provide this certificate when you submit your study protocol to BMJ Open, then you will receive a 75% reduction on the open access publication fee if your article is accepted.
Antidepressants, medically unexplained symptoms, and alcohol consumption in Alzheimer’s patients
December saw a lot of new papers entering the Top 10 Most Read, with half of them being from the current issue. Patel et al‘s research paper, complete with video abstract and press release, questions whether antidepressants increase the risk of mania and bipolar disorder in people with depression in the top spot this month. Miller et al and Kristensen et al maintain their places at numbers two and three, with papers on clinical trial registration and the effect of statins on survival. Our fourth most read article examines junior doctors’ knowledge and experiences of managing patients with medically unexplained symptoms via a qualitative study using in-depth interviews. Berntsen et al enter the list at number seven, with a prospective cohort study investigating the association between alcohol consumption and mortality in patients with Alzheimer’s disease, and Jonas et al write about surgery and the placebo response.
Most read figures are based on pdf downloads and full text views. Abstract views are excluded.
6 Jan, 16 | by ed_sucksmith
Tip of the iceberg: Dissemination bias includes publication bias, where published papers that are exposed to readers are biased in favour of particular characteristics (e.g. positive findings). Papers with other characteristics (e.g. negative findings) are not published and, as a result, remain out of view from readers.
This week we have been highlighting some of our favourite articles from 2015, which were selected by our staff editors in December. Today’s pick looks at what can be done to combat dissemination bias in clinical research.
Dissemination bias is a problem that extends beyond clinical trials to include all clinical research. It is estimated that 50% of research findings are not published at all or only present partial information, which means healthcare professionals and other stakeholders can’t make informed decisions. The focus of our third editors’ pick, by Joerg Meerpohl and colleagues from the OPEN project consortium, was to address how this problem could be resolved. The research group drafted a comprehensive set of evidence-informed recommendations for combating dissemination bias that was discussed by a variety of external experts and stakeholders. These recommendations included the need to raise awareness among stakeholders, e.g., patients participating in clinical trials who may need to be informed that their participation only contributes to scientific knowledge and progress if the results are published or at least publicly available. Other important recommendations included the need to promote trial registration and posting of results and to support initiatives that help trials to be easily searched and identified across registries.
A large number of more specific recommendations were proposed that targeted particular stakeholder groups. For journal editors/ publishers, these included (1) the consideration of research papers for publication regardless of the direction of the findings; (2) making trial registration a compulsory pre-requisite for publication; (3) checking manuscripts next to study protocols to identify selective reporting and; (4) checking for redundant publication of results.
Combating dissemination bias in medical research is an important issue for BMJ Open and its editors. We welcome these proposals and further studies addressing this vital issue.
5 Jan, 16 | by ed_sucksmith
In December we surveyed our staff editors, who oversee and manage the peer review process, to tell us about their favourite articles from 2015. Part 2 looks at clinical trial transparency for new drugs.
The ability of medical and healthcare professionals to select the most effective and appropriate treatments for patients depends on an unbiased and scientifically sound evidence base. Clinical trials, particularly randomized controlled trials, are the most rigorous methods for investigating the effectiveness of drugs and other treatments. If clinical trials are not registered or only selectively disseminated then the medical evidence is distorted and clinicians are unable to make informed decisions about which treatments are best for patients. As a result patients may be harmed by taking inferior treatments and participants in clinical trials are not sufficiently protected because they may be unknowingly recruited into a failed experiment that has already been conducted previously but has not been publicly disseminated.
In our second editors’ pick, Jennifer Miller and colleagues examined the levels of clinical trial registration, reporting and publication rates for new drugs approved by the Food and Drug Administration (FDA) in 2012. Out of a total of 318 clinical trials reviewed, 57% were registered per drug on average. 56% of trials were published whilst 65% of trials were either published or had reported results. The authors concluded that disclosures for new drugs frequently fell below the legal requirements and did not meet the ethical standard that results of clinical research should be publicly accessible.
Along these lines, BMJ Open supports editorial policies and procedures that improve clinical trial transparency. These include: (1) our commitment to making all papers accessible to the public; (2) compulsory prospective registration of all clinical trials submitted to the journal in a WHO or ICJME approved registry; (3) the publication of clinical trial protocols and; (4) the publication of negative findings. BMJ is also a founding member of the AllTrials campaign, an initiative specifically set up to improve clinical trial transparency by calling for all past and present clinical trials to be registered and their results reported.
4 Jan, 16 | by ed_sucksmith
2015 was another exciting year for BMJ Open, with over 1500 articles published. Since launching in 2011, we have published over 4000 articles, and we look forward to February, when the journal will celebrate its fifth anniversary.
In December we surveyed our staff editors, who oversee and manage the peer review process, to tell us about their favourite articles from 2015. We managed to narrow the list down to seven editors’ picks, and we will be presenting the results over the next few days.
Whilst peer review is entrenched as the ‘gold standard’ used by medical journals to assess the quality and validity of submitted research, many different models of peer review are used and surprisingly little research has been carried out to examine just how effective these models are. In a study by Maria Kowalczuk and colleagues from the Open Access Publisher BioMed Central, the quality of reviewer reports were analysed and compared between two journals that had different peer review models, namely ‘open’ peer review and ‘single-blind’ peer review. They also compared the quality of reviewer reports within a single journal that had switched from open to single-blind peer review. The authors found that the quality of reviewer reports were 5% higher on average in the open peer review journal compared to the single-blind review journal, a difference that was statistically significant. However, no differences in report quality were found in the journal that had operated under both peer review models. The findings suggest that open peer review may lead to higher quality reviewer reports on average, or at the very least does not lead to a decline in report quality as some people have feared it would. The authors also found differences in the recommendations of author-suggested and non-author-suggested reviewers, with author-suggested reviewers recommending acceptance significantly more frequently than non-author-suggested reviewers. This suggests that caution should be taken by editors when making decisions based on author-suggested reviews alone.
BMJ Open operates a fully open peer review process where authors and reviewers are made aware of each other’s identity. We also publish the reviewer reports and authors’ responses along with the accepted manuscript. By prioritising transparency in the process, we believe our model opens up the ‘black box’ of peer review. It also gives authors greater incentive to produce high quality reports and makes reviewers more accountable.