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Journalology

Using the SPIRIT statement to improve trial protocols

18 Jan, 13 | by Richard Sands, Managing Editor


We have updated our instructions for authors to show that we now encourage the use of the SPIRIT statement.

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is ‘an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol’. Its creation was funded by four Canadian health research institutions.

The full statement has been published in the Annals of Internal Medicine, and the explanation and elaboration in the BMJ. BMJ Open’s editor-in-chief, Dr Trish Groves, is a member of the SPIRIT group.

BMJ Open published 17 protocols in 2011 and 79 in 2012, though not all were for interventional trials. We require ethics approval and registration in an ICMJE-approved registry for trial protocols, and encourage registration of systematic review protocols in PROSPERO, led by BMJ Open editorial board member Prof Lesley Stewart.

Publishing protocols provides a valuable service by allowing researchers to publicise ongoing work and hopefully facilitating cooperation and reducing duplicated efforts. By making the intended methods fully available the chances of a study’s replication may be enhanced. Protocol publication should also ensure that any changes to methods adopted during a trial are reported as such in results papers.

As the SPIRIT authors write, ‘High quality protocols facilitate proper conduct, reporting, and external review of clinical trials.’ We will be encouraging authors to use SPIRIT to help meet these goals.

Open roads and closed sessions

10 May, 11 | by Richard Sands, Managing Editor

 

A recent report on the next steps for increasing open access to UK research concluded that Green OA infrastructure (i.e. repositories) should be encouraged while an economically sustainable transition to Gold OA is worked through. 

‘Heading for the open road: costs and benefits of transitions in scholarly communications’ by CEPA and Mark Ware Consulting, was commissioned by the Research Information Network, the Wellcome Trust and others, and was released a few weeks ago.

The report assesses various ways to increase access to scholarly communications (i.e. journal articles) emanating from researchers based at UK institutions.

The authors produce a benefit—cost ratio for each scenario and discuss the relative risks, including risks to the publishing industry’s business models, acknowledging the value that the industry brings over and above the administration of peer review.

The report concludes that the most cost-effective scenario is the ‘delayed’ scenario, where articles are made freely available after an embargo period. As publishers retain control of this embargo period, subscription cancellations are thought to be less likely, and the set-up costs for such a transition are seen to be low. The embargo periods would quite probably be longer than preferred by funders, though, meaning that the idea is unlikely to gain traction. Another premise is that the preferred scenario should be one open to influence by public and funders’ policies, and the current run of mandates for repository deposition casts further doubt on this model’s success.

So the report concludes as follows.

‘[O]ur view is that the prudent stance for policy-makers seeking to promote access in the current environment is likely to be as follows:

to encourage the use of existing Green infrastructure [i.e. repositories] (whose costs are largely sunk);

but to be cautious about pushing for reductions in embargo periods to the point where the sustainability of the underlying publishing model is put at risk;
in parallel, to work to facilitate a transition to Gold OA (in specific disciplines first) provided that (i) the average level of APCs [article-processing charges] remain at or below £1,995; (ii) the proportion of articles funded through APCs moves broadly in line with global rates; and (iii) mechanisms are in place to ensure that total payments from UK universities and their funders do not rise as a consequence of this transition.’

In a reply posted in various parts of the blogosphere Green OA advocate Stevan Harnad has branded the second part of the report’s conclusions short-sighted, premature and mistaken. You can download the report, read his views and the response from RIN’s Michael Jubb, here.

In his response to Harnad, Jubb argues that ‘it is perverse not to recognise that the stakes are high for individual publishers and perhaps for the industry as a whole’. What is at stake was under discussion at the PA–ALPSP journal publishers’ forum on ‘Open access: the next 10 years’. The event was held under the Chatham House rule so comments can’t be attributed. There was a cautious approach, reflected in the session’s premises (‘Has the time come to turn the threat into an opportunity?’). There was a focus on: getting to grips with the current trajectory of public sector and funding bodies’ open access policies, rather than crystal-ball gazing to predict the state of play in a decade’s time; the rise of Green OA mandates; and the perceived need for a ‘compelling, coherent and above all positive story’ to tell about the value the scholarly publishing industry brings.

A more formal output is promised.