Would You Retain or Dismiss This Participant?

[dale.gribble]

I'm really struggling with whether or not to keep this participant in my study, and would really love some objective POVs.

Short summary of the study: The appts are in a strategic order such that the first, much cheaper, appt is the one that filters most of the people who would ever end up getting filtered out, out. The patient group is those with SZ or similar sxs, 25% of which need to be unmedicated (stably so). The control group is pretty broad outside of matching demographics--i.e., no one special. No surprise--as we go one, getting the types of pts we need is becoming exponentially more difficult.

I was super excited when I got a call from a pt, so we scheduled them. Two reschedulings resultant of bogus excuses later, they finally come in for the clinical, which took 2 full appts (normally takes 1, if that) because of their constantly interrupting the session for unrelated matters (may or may not be symptomatic/controllable; I lean towards the latter).

So, my basic question is whether or not you would schedule them for subsequent appointments. They've already been an inordinate opportunity cost and has wasted a lot of our time, and that is exponentially worse for the rest of the study. My gut feeling is that they wouldn't finish the study.

That being said, dismissing them would mean kicking out a type of participant it's really hard to get.

What would you do?

[Edited to restore anonymity.]

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[OneNeuroDoctor]

Probably need to retain since she meets a specific category you are having trouble finding and give her more chances to make the other two meetings. Does she get bonus points or extra credit in her classes?

Sometimes it is difficult during summer to get students to show up. I had my data collection set up during the summer and ran into same problems you are having. We had to extend to the fall semester and new students in intro psych classes for me to have enough subjects to complete the study.


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[CheetahGirl]

What does your IRB-approved methods say? It sounds like basic study attrition, but you can't save your opportunity costs based on premonition (stemming from past behavior). If this were my study, I would be the one to contact the participant after the next 'no show' to inquire about his/her willingness to continue (opposed to your supervisee). Also, document everything for your IRB renewal report in case you have to renew the project.

 

[dale.gribble]

Yeah, we have a statement in the consent that failure to appear (I can't recall offhand how that's defined) constitutes their withdrawal from the study unless accompanied by a follow-up call or something. But that's hardly anything, if not nothing, in the way of a backbone IRB standard to utilized. And the follow-up calls are generally "I just didn't want to come today." I'm thinking, to that end, I need to speak with them and lay down the law.

And, yes, this isn't a student study for class points; it's community-based. And there is a bonus of an extra $20 for finishing the study, and we don't pay until the end of their association with the study (for whatever reason) to try and weed out those that are only motivated to come to the 1st appt..

I suppose this is rooted in my personal fear of the participants' failure to show being misconstrued as my not doing my job, which I know is not the case (as does the PI), but there's been conversations with the Co-PI (my boss--who is quite literally unreachable [somewhere in Asia] for the entire summer, up to the day before fall semester starts) in the past where he seems to assume I'm just not trying hard enough. But that's irrelevant to this pt. and my own issue. But has anyone run into a similar issue and/or does anyone have any suggestions for combating this? Thus far I've just kept a typical recruitment method-and-yield log, along with detailed info about each participants' outcome. (Sidenote: has anyone used FB advertising, and how did that work for you?)

ANYWAY, I suppose I need to contact them and be a bit more direct about the importance of showing up on time. Any other suggestions are very much welcome.

 

[futureapppsy2]

Thanks for reading these long posts and providing suggestions--having no supervision time to flesh these sorts of things out all summer engenders a lot of sustained uncertainty!

Maybe it's just me, but I find this kind of surprising. Although I've had plenty of very hands of faculty PIs, it seems odd for one to be hands off regarding participant recruitment/retention issues, especially with vulnerable populations in multi-session, procedural studies. This is the type of thing where everyone has to be really careful to toe the IRB-approved line. If someone makes a mistake, even a completely well-meaning unintentional one, with that type of stuff, it really has the potential to come back and hurt the study and the PI.

 

[LM02]

I agree with the other responses re: sticking closely to the IRB protocol and to trying to get ahold of your supervisor/PI. I will add that, as someone who has done research with SMI populations for over 15 years, if we were to exclude those folks who frequently canceled, no-showed, and/or had to reschedule repeatedly, we'd never be able to recruit the samples we need. It is completely par for the course when conducting research with populations who have SMI, and not at all a reflection on you.Unmedicated patients with schizophrenia or other psychotic-spectrum disorders are going to be hard to find and, as frustrating as it is, are likely to be harder to retain. Unless you have a ton of people knocking on your door, and can afford to lose participants at the point of the first no-show, persistence (yours, not the participants') will be key.

At the same time, there should be a point when you know that it's time to call it quits (e.g., after 3 cancellations/no-shows or whatever) - and that is what should be specified in your protocol.

(I'll also add that sending taxis for people isn't a bad idea, either! Good luck.)

 

[dale.gribble]

Maybe it's just me, but I find this kind of surprising. Although I've had plenty of very hands of faculty PIs, it seems odd for one to be hands off regarding participant recruitment/retention issues, especially with vulnerable populations in multi-session, procedural studies. This is the type of thing where everyone has to be really careful to toe the IRB-approved line. If someone makes a mistake, even a completely well-meaning unintentional one, with that type of stuff, it really has the potential to come back and hurt the study and the PI.

Yeah...the PI is out of the country until (literally) the day before fall semester starts.

I've always been one to work in such a way that makes the IRB happy, to the extent that I've been told I'm letting ethical concerns/IRB rules obscure my thinking. Whether or not that's accurate, for this study I'm working under a PI who's never interacted with a human-subjects IRB. So it's interesting to try and bridge the gap between the demands of said IRB when the PI is not used to working with their associated degrees of restrictions.

 

[chman]

I think you need to retain for a couple reasons. Has she signed the consent? If so, while she is, of course, free to discontinue any time, it probably gives you less leeway when it comes to not having her participate. If you tell her she can't participate strictly on a feeling (whether based in reality or not) that she may not complete, that looks a bit sketchy.

Secondly, you should retain strictly on the hopes that she will complete the study since she is in a targeted demographic for you. This depends on how hard up you are I guess, but there are some people that I would retain in certain demographics for the study I work on on even a 20% chance they would complete.

I run in to this issue a lot recruiting. We have people that come in a meet the criteria for a study I'm doing that is VERY costly to run and I have had people not show up, give me the run around, etc., countless times. There are also times when I get a gut feeling that someone isn't "right" or reliable, but it is too late and they have already signed the consent and are scheduled. At that point it just needs to play out.

Did your PI give you a go between to ask questions while he/she is out of town? That would be a good step. Maybe asking someone in another research team that you know is experienced. This really is a common problem though, and I'm sure your PI knows, as you stated, that %100 retention is just unrealistic.

 

[00851341032]

Ok first. be careful about how much detail you are putting here. This is a lot of detail about a single participant. While you may be ok technically in terms of not using names, my guess is that if somehow this person saw this post (remember this is a public forum) they could identify themselves. Risk is low but something to be mindful of. This question could be asked with much less detail about this specific person and the specific research protocol.

For the 2 more expensive visits, is there also an issue of sharing space? In other words besides being costly if the appointment is missed can in be hard to book a new time for access? If so it might be reasonable to let the participant know when scheduling that the equipment you need to use for those visits is shared and therefore is an appointment is missed it may be difficult to have flexibility with rescheduling. Of course only say that if true. But emphasizing how those appointments are different for scheduling may help. If you honestly for example can't book on less than a week notice (just an example) it might help to be upfront about some of those limitations. If this person has been canceling and getting quickly rescheduled appointments for the 1st visit it might be important to give a heads up. Not only for your costs issue but also for if they no show and become upset about difficulty finding a new time.

Other than that, for this population (and really any population) some missed visits are to be expected. Ideally your lab has planned for this inevitable fact and can handle this type of cost happening from time to time. I wouldn't want to exclude just on this since this disorganization may be a severity index and you don't want to lose that variability.

 

[WisNeuro]

I don't think he's sharing any more information than will be reported in the "participants" section of a publication.

 

[00851341032]

I don't think he's sharing any more information than will be reported in the "participants" section of a publication.

Technically OP is probably in the clear, but I think given that the thread is expressing a lot of frustration with this person it does not hurt to be cautious especially when some of the info included here did not need to be shared to ask the question. I very easily found a what the name of the study is from a quick google search. I doubt OP would get in trouble over this post, but I think a reminder to be careful is not unreasonable.

 

[psychRA]

I agree with the other responses re: sticking closely to the IRB protocol and to trying to get ahold of your supervisor/PI. I will add that, as someone who has done research with SMI populations for over 15 years, if we were to exclude those folks who frequently canceled, no-showed, and/or had to reschedule repeatedly, we'd never be able to recruit the samples we need.

So true. Depending on the populations that you research, frequent cancellations and no shows are a dreaded, but inevitable, part of the process. In grad school, our lab shared a building with two other labs. One lab happened to be conducting several studies with undergrads, and their attendance rate seemed pretty awesome - after all, their samples generally lived within walking distance of the lab, were already on campus most days, and were eager for extra credit or extra cash. The other lab was running a study that (for several reasons) ended up recruiting mostly higher-SES children, so they were dealing with high-functioning parents who were really good about either keeping their appointments, or calling to reschedule if something came up.

And then there was our lab. Our community samples were generally living very choatic lives, and they incredibly difficult to recruit: they were hard to contact (addresses changed frequently, phones were disconnected due to nonpayment, etc.), it was rough to find appointment times that fit for them, and they frequently cancelled or no-showed several times before we could actually get them in the door. Some weeks, we had maybe a 50% cancel/noshow rate. It just came with the territory. We did have a policy that after a certain number of cancellations or noshows, we would no longer actively reach out to the participant to reschedule, but if they contacted us, we would reschedule. That helped a bit.

We also found that for some participants, being less flexible with the schedule actually helped. Some people really did have incredibly crazy schedules, and for those people, we were willing to reschedule several times until they could finally make it. For others, though, it seemed like they would cancel or noshow just because something better came along, or they didn't feel like coming in. I'd say that for those folks, our willingness to bend over backwards to see them whenever they wanted to come in backfired: it gave the impression that we were always sitting around the lab waiting for them, so cancelling wasn't a big deal. Instead, we tried offering them a few appointments to choose from in a given week, and stating that if they needed to cancel, the next available appointments were a week later. When appointments became a scarce commodity, those particular participants seemed to prioritize them more.