Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial
BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.k5432 (Published 23 January 2019) Cite this as: BMJ 2019;364:k5432
All rapid responses
Dear Editors
I refer to Dr Timm’s rapid response, which seems to treat different terminologies as having the same meaning.
Please see these resources for the difference between non-inferiority vs equivalence vs superiority trials:
http://hjdbulletin.org/files/archive/pdfs/431.pdf
https://www.nps.org.au/australian-prescriber/articles/making-sense-of-eq...
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2024-2
https://www.certara.com/2011/01/01/trial-designs-non-inferiority-vs-supe...
https://rpsychologist.com/d3/equivalence/
It is important to understand different comparative goals lead to different needs in research setups.
As healthcare professionals in the age of Evidence Based Medicine, it is important that we all remain current in our understanding of similarities and differences in clinical research rather than simply relying on guidelines and recommendations to dictate our practice.
Revalidation and reaccreditation of healthcare professionals should involve adequate understanding of the science behind Evidence Based Medicine, to create the thinking clinician who is not just following governmental directions.
Competing interests: No competing interests
Not my area of expertise but, as I am moving into an age group where fractures are more likely, I read it with interest. I was, however, struck by the double negative used in the conclusion - "X .... was non-inferior to ...Y". This is really not clear English and not easy to read quickly. What is wrong with "X was ...... just as good as ....Y"? I don't blame the authors - their English is clearly superior to my Finnish, but I would expect the BMJ editors to pick up on this sort of thing.
Competing interests: No competing interests
Re: Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial
Dear Editor,
We have read and discussed the non-inferiority trial entitled "Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial" by Kortekangas et al published in the BMJ (2019;364:k5432) with great interest in our weekly Orthopaedic journal club. I want to congratulate the authors on a well written and concise clinical trial, and would like to make some contributions.
Out of the 560 unimalleolar Webber B fracture screened for inclusion, we note that more than 50% were excluded from the trial primarily because they were deemed to be unstable fractures (217). We wonder whether the authors also recorded what happened to these cases that were excluded as we feel this would be of interest to the wider Orthopaedic profession.
We look forward to hearing your response.
Kind regards
Dr Vincent Simpson
Competing interests: No competing interests