TRIUMPH-1 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Clinical Trials
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SUSTAIN-6 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The advice is mostly reasonable. The certainty is not earned.
The gap between a defensible recommendation and a confident one is where most of the harm in this subject lives.
Grams per kilogram of what? The denominator problem in protein guidance
A survey of what the meta-analyses support, with the populations named.
SURMOUNT-3 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The out-of-range flag is a statistical convention with a printer attached
A flag is a probability statement about a population. It is not a statement about the person holding the printout.
STEP 1 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Percentage of loss, absolute kilograms, and the sleight of hand between them
What was pre-specified, what was exploratory, and what was calculated afterwards by people who did not run the trial.
SURMOUNT-4 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Every fortnight, every third week, seasonally: an unstudied practice
An absence of evidence is not evidence of harm. It is also not a licence.
SURPASS-4 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
A reference interval is not a target, and a result outside one is not a diagnosis
Almost every misreading of a laboratory panel is a misunderstanding of what a reference interval is and how much a result has to move before the movement means anything.
STEP 4 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
SURMOUNT-OSA misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
What the older diet-and-exercise trials found in the hip
A plausible mechanism, a measurable change, and no outcome data. This is what an open question looks like.
LEADER misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
SURMOUNT-2 was built to answer the stopping question, and it did
Three randomised withdrawal designs have tested what happens when treatment stops. Their results are consistent and they are consistently misreported.
STEP 8 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The three-times-upper-limit convention, and where it came from
What the renal and hepatic outcome programmes actually measured, and over what duration.
What the protein literature actually shows, and in whom it was shown
Where the familiar figures come from, what populations they were measured in, and how far the extrapolation reaches.