As the editor of a major medical journal, you are the gatekeeper between the questionable submissions you receive from the research community and the high-quality, practice-changing studies you actually want to publish.
Clinicians look to your publications for guidance on how to treat their patients. It’s an immense responsibility.
There are clear guidelines in place for pharmaceutical and medical trials, but surgical trials have always been a challenge.
How do you encourage methodologically sound, practical results from appropriate study designs, and how do you choose what to publish?
- For you, IDEAL is a set of standards for reporting surgical research.
- Readers include clinical surgeons who, by definition, tend to be focused on operating and may be far-removed from academia. As such, many of them cannot assess whether methodology is sound or whether a certain study design is appropriate.
- Editors are vital in promoting the idea that the randomised controlled trial, while an effective gold standard for pharmaceutical and medical research, is not always the best format for developing evidence in surgery, for reasons with which most surgeons are familiar. A placebo control (sham surgery) is almost never feasible. Even randomisation is not always possible.
- Researchers, clinicians, and manufacturers do not have the power to initiate this paradigm shift. It is up to editors, whose publications are already the trusted source for evidence.
- For example, Lilford et al  have proposed tracker trials as a study design as a solution to the problem of rapidly-changing innovation for which RCTs would not be appropriate.
- IDEAL can offer specifics for editors in eliciting submissions. In top journals, the vast majority of abstracts are rejected after a call for papers, perhaps partly due to the wide variety of submissions received. Assessing each submission for publication is a tedious process. Asking for specific prospective study designs in accordance with IDEAL methodology will cut down on sub-par submissions.
What IDEAL doesn’t mean for editors
- It does not mean setting standards so high that articles with good evidence are rejected, but it provides guidelines so we can point out shortcomings. As the late Dr William A Silverman stated in Where’s the Evidence? Debates in Modern Medicine, “In medicine we can never be certain about the consequences of our interventions, we can only narrow the area of uncertainty.” The aim is to be transparent, not perfect.
- IDEAL proposes that registries of surgical protocols and of early reports, as well as prospective research databases, be established, but doesn’t necessarily require editors to establish them – rather, they should encourage researchers to use them, and as a result, will receive better quality submissions.
- Who should establish them? This is not yet agreed upon, and we acknowledge that because IDEAL is only in its beginning stages, there is still much work to be done. To again draw from non-surgical evidence: the U.S. Food and Drug Administration has made it compulsory for pharmaceutical trials to be registered before they be carried out. Accordingly, methodology and reporting for new drugs is now clearly standardised. Perhaps a similar regulatory body will be used for IDEAL.
- Methodologists will need to further describe and protocolise new study designs, but once established, it will be up to editors to promote these by calling for them and publishing the best of these studies.
- Lilford, R. J., D. A. Braunholtz, et al. (2000). “Trials and fast changing technologies: the case for tracker studies.” BMJ 320(7226): 43-46.