Who should play @Markku and @Hazel in the biopic if tinnitus is ever wiped away? (Because the Tinnitus Hub deserves some credit if that day ever arrives.) I'm thinking Rami Malek and Cate Blanchett respectively.
Thank you, PeterPan.
Yes, I guess this is possible. If you are experiencing less discomfort from hyperacusis then this may be reflected in the TFI score. It's hard to tell though. I recall that in the interviews with Neuromod, it was stated that patients experienced improvements in tinnitus, but not their hyperacusis. The good news is that if you suffer from hyperacusis, it seems you will more likely benefit from the treatment.
Does the 13.9% of THI also include the people Lenire didn't work for?
This is very encouraging news. Having someone on this forum who can report tinnitus/hyperacusis relief from a new development makes me feel like the medical community is beginning to understand this condition well enough to have medically-assisted success stories. I look forward to being able to have 1-3/10 days frequently myself.
There's no short answer to that, but:
People who filled in reports at 13 weeks averaged a 13.9 TFI reduction (29 people). Some people dropped out and were lost to the study, and some people dropped out because of adverse outcomes. These dropouts were not included as they didn't provide TFI data at 12 weeks.
Can it be assumed then that the additional dropouts due to adverse outcomes that are not included in the data would raise the chance of an adverse outcome to above 20% if they had provided data at 12 weeks?
I really don't understand why the fact that there are many different types of tinnitus and, hence, many different types of patient groups, is not paid attention to. Since we know for some decades that tinnitus may have a really large variety of causes, it should be very obvious that there is no single solution for all patients. If you have a success rate of, let's say, 60%, it is really huge in tinnitus.
By excluding Lenire users who dropped out or quit, you introduce a selection mechanism that is steered towards positive results in regards to the TFI score. This is, to put it mildly, misleading.
We started with 43 patients. 6 dropped out due to adverse outcomes (14%). 7 (or 16%) dropped out for various reasons (e.g. device broke, did not respond at various milestones and lost to study etc). The remaining 70% provided data.
Hi Mads, we did not in fact exclude the dropouts. We present both the results with that group and without that group. The infographic for instance clearly shows a representation of 100 people, where xx% is dropouts, including adverse events. However, when it comes to the TFI results, we can only present results for those who filled in the complete TFI surveys, which by definition does not include dropouts.
This is the part of statistics that really gets my goat!
We had no choice. They didn't provide data so we could only report they dropped out. We did, however, report on the number who dropped out and the reason for dropping out (e.g adverse outcome, lost to study etc). We also stated that the average TFI drop was the average for those providing TFI. If you have any ideas for improved reporting, suggestions are welcome.
Who should play @Markku and @Hazel in the biopic if tinnitus is ever wiped away? (Because the Tinnitus Hub deserves some credit if that day ever arrives.) I'm thinking Rami Malek and Cate Blanchett respectively.
In all seriousness, great job, Tinnitus Talk team! Once again, you've all done a tremendous service.
SO NICE!!!
That's how I interpret it...
All we can say is that for our sample of 43 patients, 14% reported they dropped out due to adverse events
I've skimmed trough one document, but the caveat regarding TFI sample didn't jump at me. But I'm sure you put it in. My point is that it is problematic measuring a treatment's efficacy solely via questionnaires of subjects' thoughts and feelings.
I don't want to manufacture drama over this but I would also consider those who dropped out due to adverse conditions to be totally worth including in crunching outcomes. The only rationale I can think of not to include them is the chance that if they stuck through it to the end that the disimprovement would have cleared. That's the matter of faith Neuromod expects from people but it seems to be too high of a burden.
I don't know how to explain this any better than I already did above, but we did NOT exclude dropouts from our analysis. If you look at the infographic, you'll see two types of analysis: one including dropouts (this one, incidentally, answers your question about success rate when including dropouts) and one excluding dropouts. The latter is a necessary evil because we cannot analyse and report TFI changes for those who dropped out and thus did not fill in TFI!
Earlier posts suggested an intentional positive bias but I didn't. I understand after such a long wait there will be some drama and arguing over this data but I'm over it already.
I hope you understand my explanation above though. We don't have any data on the dropouts, beyond the fact that they dropped out, so we cannot include them in any TFI based analysis. But we DID in fact report on the success rate including dropouts, which is 42%.
Understood. I'm happy with the work on the report but still underwhelmed with this figure either way--especially factoring in the risk of worsening. I know it's not your job to absorb negativity in lieu of Neuromod. You're just the messenger. Thanks.
It's an underwhelming figure for sure compared to what Neuromod reported. Of course, there are many caveats to our study, including small sample size, so I would be very careful with drawing strong conclusions. But I understand it's not what the community had hoped for. We hope at least to have provided a bit more insight to guide people in their decisions on whether to try Lenire or not; that was really our aim.
All our data gathering was done online, so COVID-19 would not obstruct us per se. But you might be right in the sense that fewer people will be trying Lenire now because of travel restrictions. Our biggest obstruction though is the huge time investment for this study; we probably would prefer focussing our energy on other projects.
Thanks. So actually the average TFI reduction is somewhat out of proportion as the people who worsened dropped out of the treatment?
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