Rather curiously, as I was going to give a Work-in-Progress presentation on a Systematic Review and Meta-Analysis of prognosis studies in epilepsy, I looked at this week’s edition of the BMJ, a regular weekly practice, and in it were three articles discussing the quality of prognosis studies, with broader implications for observational research generally. The first, Ten steps towards improving prognosis research (free full text) by seasoned researchers of prognosis – Harry Hemingway, Richard Riley and Doug Altman – does just what its title says in what Richard Lehman described on his blog as “rather angry in tone, but not angry enough for my taste.”
In a linked editorial, Sørensen and Rothman in their interestingly titled The prognosis for research disagree with Hemingway et al on their suggestion that there should be a register for prognosis studies, and observational research generally as it is presently required by law for clinical trials:
We suspect that historians and philosophers of science would recoil at the notion that advance registration of all scientific studies in a publicly accessible database would produce better science. How much room would this policy leave for exploration, serendipity, or pursuit of unpopular theories?
If the rules precluded easy registration, that might create an undesirable drag on the end of the research spectrum that constitutes the quirky, brilliant work that is not enterprise driven. Moreover, registration would not prevent publication bias among the many studies conducted with secondary data, because researchers could still selectively register study ideas after the data have been explored.
They also disagree with Hemingway et al on their suggestion of developing guidelines for reporting prognosis research:
Reporting guidelines do have advantages, but the disadvantages are generally overlooked. On the positive side, guidelines increase uniformity and can improve the average quality of reporting. But guidelines also promote rigidity and can enshrine misconceptions, because they are merely compiled from the consensus of a few opinion leaders and form a common denominator of current beliefs. If all science throughout human history had been filtered through reporting guidelines, we suspect we would live in a very different world, one in which the science had lagged far behind what actually has been achieved.
They end their article by placing the responsibility and the blame for the quality of prognosis research at the feet of journal editors:
Consider the crucial role of the gatekeepers of published research. Any published research, including the low quality work … has survived the scrutiny of peer reviewers and of the ultimate gatekeepers, journal editors. Perhaps the priority should be continuing education efforts focused on journal editors.
Then comes the third article this week on the same topic as BMJ editors Elizabeth Loder, Trish Groves, and Domhnall MacAuley respond to Sørensen and Rothman in another editorial, Registration of observational studies. They defend the need for protocol driven observational studies:
At present, consumers of observational research cannot easily distinguish hypothesis driven studies from exploratory, post hoc data analyses. Researchers do not routinely disclose the number of additional analyses performed. Nor is there any satisfactory way to know whether the research questions or methods of statistical analysis diverged from those initially planned.
We agree that exploratory observational research is important. Many new ideas arise from unexpected findings in observational research, and many researchers learn their skills from examining available datasets. However, that is not the sort of research the BMJ usually aims to publish…
I thought that was a rather weak argument though, and while they are quiet about the need to train journal editors, they go ahead to state a series of not necessarily insurmountable hurdles to get your observational study published in the BMJ:
We will now ask authors of papers reporting observational studies submitted to the BMJ to tell us more about the origins, motivations, and data interrogation methods of that work.
We will be asking authors to report in their papers a clear statement of whether the study hypothesis arose before or after inspection of the data…
We will ask to see study protocols if they exist; and we will add to the papers’ abstracts their registration details, if they have been registered…
The Systematic Review and Meta-Analysis I’m presently conducting though shows that apart from the thorny issue of inconsistent definitions of disease state and classification, and the conceptualisation of outcome measures – which none of these hurdles addresses or could possibly address – there seems to be relatively better quality of prognosis research at least in epilepsy than these articles generally suggest, which may at least partly be due to the fact that clinical trials in epilepsy are rather tricky.
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