Replies to post #254850 on Innovation Pharmaceuticals Inc (IPIX)

[DaubersUP]

In theory, B-OM study results would in essence be less than and not greater than regarding compliance.

Patients would more likely NOT swish for the recommended time rather than would swish longer and or not forget. Much more room for error making the results lesser than greater. IMO.

And with that said the results were very good for the cisplatin high dose group. My point, hopefully with more people it will be better

[loanranger]

Thanks. Still seems shaky to me.

"During the CRT treatment period, subjects will be assessed twice weekly for the
presence and severity of OM by trained evaluators using the WHO grading scale for
OM. Subjects will complete a daily study diary (including weekend days). The diary
contains Question 2 of the Oral Mucositis Daily Questionnaire (OMDQ), a record of
daily analgesic use for mouth and/or throat pain, a record of the study drug oral rinses
performed each day, and the subject’s assessment of mouth sensations. The diary will
be reviewed by a member of the study staff each day during the first week (at least 5
days) of study treatment to ensure that the subject is appropriately completing the
diary. If subject diary completion is satisfactory, then the diary will be reviewed at
least once weekly during the remainder of the study. At weekly intervals (on the same
day of each week), subjects will complete the FACT-H&N instrument to record
quality of life responses."


Once upon a time I filled out one of those diaries...not nearly as critical but still for a scientific purpose (okay, so it was a State survey of fishing results for a specific species). I experienced a few considerations that I don't think were unique to me.
1. At some point it became enough of a pain in the ass that I'd skip a few days (sometimes the diary and other times the details). I'd catch up with less than perfect entries.
2. There was a tendency to provide information that was likely to serve my own purposes (e.g. an enhanced stocking program).
3. There was also a tendency to provide information that reflected positively on ME.
4. And there was a desire to please the surveyor.

I regret the lack of diligence to this day. It was for the most part laziness based.
So some people can't be relied upon to provide data for a scientific survey without someone looking over their shoulder. Unless I'm the only one.