Monthly Archives: December 2015

Recommended: Points to consider on switching between superiority and non-inferiority

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One of the most confusing aspects of medical research is the difference between non-inferiority and superiority trials. This article explains in simple terms what the two type of trials are. Then it covers the desire of many researchers to switch from a non-inferiority trail to a superiority trial or vice versa. In general, if you would like to make the claim of superiority if the data justifies it, or to fall back on a claim of non-inferiority if you must, you are best off designing a high quality non-inferiority trial. The extra methodological rigor and the typically larger sample sizes that come with a non-inferiority trial make the transition from a non-inferiority hypothesis to a superiority hypothesis much smoother than the reverse. A high quality non-inferiority trial includes pre-specifying the margin of non-inferiority, demonstrating adequate power for the non-inferiority hypothesis, and justifying that the control group has demonstrated efficacy in previous trials. You need to show sufficient methodological rigor in your research design to establish that a non-inferiority finding is not just caused by an insensitive research design. Finally, you need to consider a “per protocol” analysis for the non-inferiority hypothesis, but switch to an “intention to treat” analysis for the superiority hypothesis. Continue reading

Recommended: Differences between information in registries and articles did not influence publication acceptance

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Here’s a research article tackling the same problem of changing outcome measures after the data is collected. Apparently, this occurs in 66 of the 226 papers reviewed here or almost 30% of the time. The interesting thing is that whether this occurred or not was independent of whether paper was accepted. So journal editors are missing an opportunity here to improve the quality of the published literature by demanding that researchers abide by the choices that they made during trial registration. Continue reading

Recommended: The COMPare Project

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One of the many problems with medical publications is that researchers will choose which outcomes to report based on their statistical significance rather than their clinical importance. This can seriously bias your results. You can easily avoid this potential bias by specifying your primary and secondary outcome measures prior to data collection. Apparently, though, some researchers will change their minds after designating these outcome variables and fail to report on some of the outcomes and/or add new outcomes that were not specified prior to data analysis. How often does this occur? A group of scientists at the Centre for Evidence-Based Medicine at the University of Oxford are trying to find out. Continue reading

PMean: A book review of my first book

I wrote a book about nine years ago and interest in it has largely died down. Perhaps I should write a second edition. Anyway, I ran across a book review that I had not seen before. It was published in 2006, but I never noticed it until now. Sarah Boslaugh wrote the review and it got published in MAA Reviews (MAA stands for Mathematical Association of America). It says some nice things like my approach was “fresh.” Dr. Bosluagh also likes my web site, according to the review. Continue reading