John Mandrola
Cardiac electrophysiologist in Louisville, Kentucky. Co-writes the Sensible Medicine newsletter, where he reviews cardiology and other clinical trials, and blogs at drjohnm.org.
John Mandrola did not write this page.
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Their wordsYet there was no reduction in late-stage cancers, the primary endpoint.
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Their wordsBut it had a terrible sensitivity of only 30%, meaning it missed a lot of cancers.
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Their wordsA positive test leads to as many false positives as true positives, and a negative test is not at all reassuring.
- 7 days earlier
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Their wordsThe endpoint that drove the results were open to bias in this open label trial. In the win ratio, the HF hospitalization endpoint did the work: 9,280 vs 2,871 wins. Death rates were close (4,366 vs 3,166), and 74% of pairs were tied on death. Hospitalization, of course, is a clinician decision. Since everyone knows the treatment assignment, it's easy to give an increase in oral diuretics to a patient with a device while admitting a patient without one.
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Their wordsThe fourth issue was that the amount of TR reduction was modest. Only 70% of repair patients had moderate or less TR at 30 days, versus 30% of controls. That is less complete than reported in TRILUMINATE.
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Their wordsBefore embracing the tricuspid valve repair approach, I feel we need more compelling data.
- 7 days earlier
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Their wordsMy issue is the author's choice of primary and secondary endpoints. A rule of evidence is that you choose as the primary endpoint the most important outcome. Secondary outcomes are chosen to bolster or support the primary. POET II authors got this backward; but readers of the trial can still make conclusions from the evidence-it's just different from what the authors conclude.
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Their wordsWhen we treat infections, especially serious ones in the heart and bloodstream, there are a couple of important endpoints-and one is not days without antibiotics, but recurrence of infection or death.
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Our reading
The shorter antibiotic course in the POET II trial is a worse strategy than the standard course.
Their wordsThe bottom line is that you don't need to be an academic or infectious disease specialist to take from this trial data that the shorter course is clearly the worse strategy.
- 7 weeks earlier
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Their wordsWhile there were limitations of this data, including the lack of granular data on both patients and agencies, there was not any signal of benefit in the outcome of interest. Note here that the outcome of interest was not the quality of CPR, which may have been better, but survival and survival with neurologic recovery. Here, there was no signal of benefit.
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Their wordsA Cochrane Systematic review of 11 trials also found no evidence of benefit and a small signal of harm.
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Their wordsGiven the aggressiveness of these devices and their costs (approximately $20,000 plus disposables x many ambulances), I would think we would abandon them. That is, if the treatment of patients with out of hospital cardiac arrest is to remain an evidence-based intervention.
- 6 weeks earlier
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Our reading
A polypill may reduce the work of being a patient and may increase adherence to beneficial drugs.
Their wordsEnter the polypill: what if you could take one tablet that had multiple drugs in it? This reduces the work of being a patient and it may even increase adherence to beneficial drugs.
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Our reading
The Poly HF trial results may be limited by the highly selected nature of the patient group.
Their wordsThis, I think, is one of the major limitations of polypill data: namely, that you have to be highly selected to be eligible for a polypill.
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Their wordsWhat's more. the difference in EF in this trial was only 3%-a number that reached statistical significance, but it's not clinically significant.