Our local Guru of EBM, Brian Doyle, hosts a monthly Journal Club for the locals. In the spirit of consolidating knowledge and sharing this with the world, with permission, here is a re-post of one of the articles discussed.
For more juicy journals served on a platter, head over to Brian's JC blog: EmergencyMedJc
Do PE patients discharged from the ED on rivaroxaban have a shorter length stay than those admitted to hospital?
Yes, you read the question correctly…
This was essentially the aim of a recent study published in Academic Emergency Medicine.
This RCT conducted at 35 hospitals (yes 35… but they planned on 57!) enrolled 114 subjectsrandomised to early discharge on rivaroxaban vs. “standard of care” (generally admission to hospital). Primary outcome was length of stay.
It turns out the early discharge had a much shorter length of stay at 4.8 hours vs 33 hours for standard care.
Why would anyone conduct an RCT to answer such an obvious research question (Notwithstanding, it is considered unethical to conduct an RCT without clinical equipoise… oh well…)
All 11 of the authors disclosed conflict of interest in taking money from Janssen. Guess what drug they make…
Two of the authors were employed by the drug company and declared that they were involved in the study concept, design, analysis, interpretation and revision of the manuscript.
One other important aspect may have slipped your attention.
Was this a “seeding trial?”
As per Sax HC & Rennie D, Seeding Trials: Just Say “No” (Ann Intern Med. 2008;149:279-280)
Why would a drug company go to the expense and bother of conducting a trial involving hundreds of practitioners- each recruiting a few patients- when a study based at a few large medical centres could accomplish the same scientific purposes much more efficiently? The main point of a seeding trial is not to get high-quality scientific information: It is to change the prescribing habits of large numbers of physicians. A secondary purpose is to transform physicians into advocates for the sponsor’s drug. The company flatters a physician by selecting him because he is “an opinion leader” and incorporates him in the research team with the title of “investigator.” Then, it pays him good money: a consulting fee to advise the company of the drug’s use and another fee for each patient he enrols. The physician becomes invested in the drug’s future and praises its good features to patients and colleagues. Unwittingly, the physician joins the sponsor’s marketing team. Why do companies pursue this expensive tactic? Because it works.
Without internal company documents, we’ll never know the true reason for this study. But I highly doubt it was to advance great research.
Dr Brian Doyle is an emergency physician originally from the United States but now very much calls Tasmania his home. Unfortunately, it will now be a bit more difficult to deport him from the country as he passed his Australian citizenship test a few years ago. (He was able to answer that Phar Lap won the Melbourne rather than the Davis Cup). His main interests are mostly the clinical aspects of emergency medicine but also in education, ultrasound and critical appraisal of the literature. He spends much of his time annoying people to help out with conferences.