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Manni Mohyuddin: We analyze use of terms that minimize toxicity in myeloma trials
Nov 14, 2023, 04:36

Manni Mohyuddin: We analyze use of terms that minimize toxicity in myeloma trials

Manni Mohyuddin, Assistant Professor, Huntsman Cancer Institute, University of Utah, shared a post on X/Twitter:

“Just out in JAMA Network Open, we analyze use of terms that minimize toxicity in myeloma trials. Thanks to a stellar team led by Mimi Najjar, with Raj Chakraborty, Eddie Cliff, David Steensma, Aaron Goodman, Samer Al Hadidi and Kate.

Previous work by Bishal Gyawali has highlighted the use of ‘minimizing terms’. These are terms like ‘tolerable’, ‘manageable’, ‘safe’, and ‘well-tolerated’ that minimize the actual harms treatments inflict on patients, and are inherently subjective. https://t.co/uJ6S2Gn3ws

In this study, we aimed to systematically evaluate the use of these terms in a cohort of myeloma randomized trials, identified through a systematic review of the literature. We also aimed to statistically explore whether the use of terms (or not) had any bearing with actual tox

What did we find? Of the 65 RCTs included, 86% used minimizing terms when describing treatment toxicities. The most frequently used minimizing terms were well-tolerated or tolerable in 29 trials (45%), manageable in 18 (28%), and acceptable in 16 (25%) .

Was the use of these terms associated with actual toxicities? Sadly, No. A univariate regression analysis demonstrated no association between the use of minimizing terms and the rates of grade 3 or 4 toxicities. Even studies with Grade 5 toxicities (death!) used these terms!

We found that industry studies were more likely to use these terms 🙁 And we found that most of the times when these terms were used, patient reported outcomes were not reported in the manuscript.

The lack of patient reported outcomes makes this all the more troubling- as only patients should decide what is tolerable and acceptable. We recommend that instead of using these terms- event rates and PROs should be reported so we can assess toxicities for ourselves.

We only studied randomized trials- although we studied all published myeloma randomized trials- and did not limit to top journals. However, this phenomena may be even more prevalent in abstract presentations at meetings.

Thank you so much for reading this thread. So proud of Mimi Najjar for doing this, and so thankful to all my other co-authors for their stellar input. And always thankful to Myeloma Amateur for her patient advocate perspective

For the article click here.
Source: Manni Mohyuddin/Twitter