Re: Applications for participation in Dr. K's POIS study

[mellivora]

Hi,
I?m a patient chap but, grateful as I am to have him on our side, I am a little disappointed with the lack of communication coming from Dr Komisaruk. I appreciate that his work involves more than just our POIS research and that there are many careful steps that need to be taken without giving anyone say false hope of inclusion in the study or too much detailed information that might affect participants? results amongst other things.

I sent my application for participation on 1st October. I imagine like most/all people here, I still have no idea if my application was received or when participants will be required to attend. Assuming all is well with Dr Komisaruk, I am certain he must have some idea when he might commence with the experiments. Many of us gave substantial funds toward the research and some of us will be participating. I?m sure there is no need to keep us all in the dark and for any air of mystery. It would be a simple courtesy to  inform us that our questionnaires have been received and when a ballpark start date for those chosen would be (in the knowledge that this date might change). A little information along these lines would immediately eliminate the uncertainty I?m guessing many of us are feeling as to what is happening and it would  be reassuring. So far, I have read a few assurances on the forum that things are progressing but these have been vague and  I do think its about time we heard something a little more helpful.

As POIS sufferers we are used to non-responses from the medical world but I?d hoped our chosen team of researchers would be a bit more communicative.  I?m certain Dr Komisaruk isn?t setting out to be cryptic and to seem unreachable and incommunicative but sadly that is how things are coming across to  me at the moment. If we could be given a better idea of timescale and some acknowledgment that would be great. I wonder if this message can be communicated to Dr Komisaruk in a tactful fashion. We should be grateful that the research is taking place but as funders of the research (not to mention participants in it) I believe we should be given more regular and concrete updates than we have been receiving thus far.
Thanks,
Mel

[Alex]

Keep Mellivora . Demo, you do have a relationship with the doctor? Maybe you could politely learn at least some approximate dates for the research? That is, it will be until June or noticed it 2 years. We are of course in no case do not hurry doctor Komissaruk, we just would have been much easier to live, if we knew how much we have to wait some information about our disease.
We would be very grateful to you

[Stef]

Alex, one of the forms says that it "expires" in June of 2015, but I am not sure what that is referring to. Maybe the document itself? Maybe when people can officially apply? It might be that the whole study must be completed in a year, but that seems really fast. I don't really know, maybe another member knows.

Where are you from, Alex?

I know this is a somewhat difficult question to answer, but does anyone know how long it's going to take to actually get results from this study? I know it won't happen tomorrow, but I'm just looking for a general timetable, if anyone has any knowledge or experience with this sort of thing.y

Dean93,

I'm sorry for the delay in answering your question about that June 2015 expiration date.

I haven't looked back at the forms in a while, but I believe it was the IRB approval that contains the expiration date. The consent form may also have that expiration date. FYI, the IRB committee gives its approval for both the study and the consent form on the same date.

IRB approvals are "good" for one year. But researchers often aren't able to complete a one-year study in exactly one year, so they then obtain an extension of the IRB approval. It's standard practice, and the study does not get interrupted because of it.

When that June 2015 expiration date comes up, Dr. Komisaruk will obtain the needed extension.

I hope this answered the question.


Best wishes to all,
Stef

[Alex]

dean93, Thanks for the reply. From Russia, St. Petersburg. I have applied to participate, but it seems only need 12 participants, and my English is average. Therefore, participants will be better than these other people. I can only help financially if suddenly once again be a fundraiser or something else. There is also a huge amount of analysis of surveys in hospitals, but they are all in Russian.

[Stef]

Mel --

We heard from Dr. Komisaruk three weeks ago (November 26th). He was replying to my earlier email, in which I asked for confirmation that he was still accepting applications. His reply could not have been kinder. They were still accepting applications, and he also advised that "all was in order" (I hadn't asked him about that). He stated that they would be going forward with the study participation "soon."

I hear your frustration about the lack of communication from him. We've experienced it also!  This is really a mystery to us, as he's expressed such sensitivity to the plight of POIS sufferers.  And -- he really is an outstanding scientist.

Ultimately, he always answers our questions...but it takes some effort to get the answers. I don't know why this is the case.

I'll definitely write to him tomorrow morning, Mel. You've expressed your concerns very well...making it easy to convey them to him (on behalf of everyone).

Stef

[demografx]

Mel --

We heard from Dr. Komisaruk three weeks ago (November 26th). He was replying to my earlier email, in which I asked for confirmation that he was still accepting applications. His reply could not have been kinder. They were still accepting applications, and he also advised that "all was in order" (I hadn't asked him about that). He stated that they would be going forward with the study participation "soon."

I hear your frustration about the lack of communication from him. We've experienced it also!  This is really a mystery to us, as he's expressed such sensitivity to the plight of POIS sufferers.  And -- he really is an outstanding scientist.

Ultimately, he always answers our questions...but it takes some effort to get the answers. I don't know why this is the case.

I'll definitely write to him tomorrow morning, Mel. You've expressed your concerns very well...making it easy to convey them to him (on behalf of everyone).

Stef

Stef:

[Stef]

Hi Mel and Everyone,

Dr. Komisaruk replied right away to the email I sent him earlier today. I had clearly explained to him the need for communication from him. I also mentioned that some, if not all applicants had not received an acknowledgement that their applications had been received.

Here's his reply:

"We have selected two applicants to start piloting the research; they are geographically close to us here, so it would be relatively easy for them to come and go repeatedly, if necessary.  We intend to start the research when convenient for them. We will be proceeding more rapidly as soon as we establish the optimal procedures with those two participants.  Please feel free to post this information for the others."

FYI, I do recall that when Demo met with him last summer, he'd advised that he might choose the first few participants based on their proximity to Rutgers. This was because he wanted to be able "to establish the optimal procedures," -- exactly as he just wrote in his reply above.

Also, as I've mentioned previously, it's my guess that he's requested that ALL participants not disclose ANYTHING about the study experience -- so as not to influence other participants' reactions.

So -- the study is on!

I hope this helps.  I was very glad to hear this news!

Stef

 

 

[demografx]

Thank

           you,


                  S T E F !!!!!!!!

[mellivora]

Stef,
Thanks for taking time to follow this up. It really does help to be updated and I think, as you have done, some updates can be given without compromising the study. I hope communications will be better from now on. I see Dr Komisaruk has written that the pilot will be started when its convenient for the chosen participants. It would be nice to have another update from him with a rough expected time of completion of the pilot study when the participants' availability has been more firmly established and things are well underway. Mainly its about avoiding prolonged periods of silence (say more than 7weeks or so??) and having a better idea of timescale.

Thanks again for helping us and please thank Dr Komisaruk for his quick response on this occasion (I'm sure you have already!)
Best,
Mel

[demografx]

It would be nice to have another update from him with a rough expected time of completion of the pilot study when the participants' availability has been more firmly established and things are well underway. Mainly its about avoiding prolonged periods of silence (say more than 7weeks or so??) and having a better idea of timescale.

Excellent suggestions, Mel!!!

[demografx]

Hang in there, we are just about ready to get down to the [POIS Research] nitty gritty,

[Stef]

Stef,
Thanks for taking time to follow this up. It really does help to be updated and I think, as you have done, some updates can be given without compromising the study. I hope communications will be better from now on. I see Dr Komisaruk has written that the pilot will be started when its convenient for the chosen participants. It would be nice to have another update from him with a rough expected time of completion of the pilot study when the participants' availability has been more firmly established and things are well underway. Mainly its about avoiding prolonged periods of silence (say more than 7weeks or so??) and having a better idea of timescale.

Thanks again for helping us and please thank Dr Komisaruk for his quick response on this occasion (I'm sure you have already!)
Best,
Mel

Mel,

The waiting for news about the study is very, very difficult -- I know it is. It gets to me also.

This is directed to everyone (not directed specifically at you, Mel)...just some thoughts that I wanted to share here...

My sense is that Dr. Komisaruk is tredding very cautiously with everyone's safety -- and is assuming nothing. He doesn't/can't know at this point if or how men will respond to the Cerbomed device, and he also doesn't know how most men, in the midst of full-blown POIS, will cope far away from home in Newark, NJ. I have no "insider" information -- but I'm betting that this will be a slow-moving study -- for the safety of the participants and for the strength of this research.

I, for one, am absolutely grateful about this, no matter how frustrating the waiting for updates has been.   

I've never met personally with Dr. K. or spoken directly with him, but I have exchanged a few emails with him -- literally, only a few emails. He is, without any doubt, a humanitarian and is no stranger to suffering. (You'll each have to read about him online -- his path to vagus nerve research and orgasm is nothing like you might have imagined and had nothing to do with sex.)

Re: those of you who may need to travel long distances to participate -- I have not one single concern about him understanding the difficulty and expense, the need for planning, etc., and am certain that he's already figured out how to best accomplish this.

He has your backs. You can trust him.

As time passes, I'll be in touch with him again if necessary. But I do think things will go slowly, at least with the first two participants.

Best wishes to all,
Stef

[Colm]

Thanks Stef, Mel and Demo :-)

Wishing everyone here well over the holidays, that is for those who take time out at the year end.

[Stef]

Hi, Everyone --

I've  some good news about the study that I wanted to share ASAP.

Dr. Komisaruk has just brought a Clinical Study Coordinator on board for the POIS study. I heard from her yesterday. She'll be reaching out to all applicants via email. First and foremost, she'll be individually acknowledging receipt of each of your applications:

Nan Wise, PhD
Assistant Research Professor, Psychology, Rutgers-Newark
Fellow, The American Psychotherapy Association
Fellow, The National Board for Clinical Hypnotherapists
Board Certified Diplomate, The American Board of Examiners in Social Work
Certified Sex Therapist, AASECT

Dr. Wise is an associate of Dr. Komisaruk at Rutgers, and is an experienced clinician and researcher in her own right. Her doctorate is in neuroscience, and she has been directly involved in Dr. K's studies related to fMRIs.  She's co-authored at least one paper with him.

From the three brief emails we've exchanged, it's obvious that she's aware of and sensitive to the issues and miseries that can accompany a condition like POIS. You'll find her to be approachable and very kind (and knowledgeable!). Additionally, Dr. Wise is aware of the frustration that applicants have expressed on the forum due to the lack of communications, and intends to remedy this.

So -- you should be hearing from her VERY soon.

Best wishes,

Stef

[demografx]

Thank

           you

                again,


                  S T E F !!!!!!!!

[demografx]

Thanks Daveman, Stef, Mel and Demo :-)




Wishing everyone

here well over the

holidays



that is, for those who take time out at the year end.

THANKS, COLM!!!

[mellivora]

Hi, Everyone --

I've  some good news about the study that I wanted to share ASAP.

Dr. Komisaruk has just brought a Clinical Study Coordinator on board for the POIS study. I heard from her yesterday. She'll be reaching out to all applicants via email. First and foremost, she'll be individually acknowledging receipt of each of your applications:

Hi Stef,
This is good news. Thank you for once again being a terrific Babel fish and much valued supporter of us POIS folk.
Best,
Mel

[Stef]

Hi Mel,

You're welcome and thanks for the kind words

Research really does have it's own strange language. I remember when it was all new to me, thinking, "Huh?"

You're all pretty fluent at this point. :-)

Stef

[demografx]

You're all pretty fluent at this point. :-)

Stef

Does that mean "POIS Research" can be added to this shirt?

[demografx]

Hi Stef,
This is good news. Thank you for once again being a terrific Babel fish and much valued supporter of us POIS folk.
Best,
Mel