Table 2 Study recruiter responses to queries about the use of elements of shared decision making during interviews (n = 9). Responses organized by element, response, and frequency
SDM question | N | Representative quote |
|---|---|---|
Can an informed consent interaction be successful if it does not result in enrollment? | 9 - Yes | “Oh yes, absolutely. There has been many times where we have gone through lots of information and the patient does not end up going into the study, but during that time I’ve been able to answer a lot of questions about possibly the disease or about the drug.” |
“…yeah the patient probably leaves with a little bit more information about their diagnosis. They, they often ask me maybe questions that they forgot to ask the doctor and then I can bring those up with the doctor before they go home…So yeah as far as the patient yeah there is some, there is success for them, not for me for enrolling…” | ||
Would you describe your style in informed consent interactions as more directive or non-directive? | 5 - Non-directive | “I would say non-directive I would say more help them with the decision on whether or not they, you know, will participate. So it’s just to inform them as much as possible about, about the study…” |
3 - Directive | “I’m probably more directive. I spend a lot of time highlighting potential benefits to the patient. Never, you know, giving false promises or anything like that but as we mentioned with me having drank the Kool-Aid I have that approach when I talk to the patient… So I take that more kind of that approach versus just being totally impartial. There is some definite biases into the project but never in a coercive way.” | |
1 - Both | “I’d say it’s a combination to be honest with you… I would say at the beginning it’s kind of directive when I first start talking to the patient. You know maybe my wording will be more directive… so you more use like salesman words… but then I do not want to pressure the patient so I’m, I’m pretty, indirect.” | |
How often would your interactions with patients involve these activities: | ||
Assessing the decision making needs of the patient? | 8 - Always/usually 1 - Sometimes 0 - Rarely/never | “I would say pretty much every time; because I mean I’m asking them if they have questions and encouraging it and, you know, asking them to speak either with their family doctor or their family or to do their own Googling themselves to see, you know, what other literature exists out there.” |
Verifying understanding? | 6 - Always/usually 3 - Sometimes 0 - Rarely/never | “Yeah like we ask them questions like if they for example if they know the signs and symptoms of clots and ask them to relay that back to us...” |
Providing information on their options, benefits, and harms (e.g., verbally or with additional patient education resources)? | 9 - Always/usually 0 - Sometimes 0 - Rarely/never | “So every time in addition to it being incorporated into the pitch that I have for the study it’s also all laid out in the consent form. There’s the section for side effects, risks and benefits… what would happen if they did not participate. So they are getting, you know, something written down but then it’s also mentioned to them as part of the pitch.” |
Clarifying their values and their attitude/tolerance towards risks? | 4 - Always/usually 3 - Sometimes 1 - Rarely/never 1 – No response | “…I think I do that every time like because I do talk about the risks and ... Here’s the risk of bleeding if you stay on. Here’s the percentage of people that get blood clots. Here’s the percentage, right, so which risk factor are you more happy to, you know, can you live with the risk factor of a blood clot versus can you or would you rather stay on the drug and have this risk factor of a major bleed?” |
“So if I’m understanding it correctly, I would say sometimes. So if they focus on a specific side effect maybe that’s listed. I try to quantify it for them a little bit because we have to list every possible side effect that’s ever been experienced, you know, like let them know that that’s the case that it does not mean that that’s actually gonna happen to you. And if it does happen to you here’s the plan we have in place and how we’ll deal with it. And, you know, maybe give them kind of information on the percentage of patients that could actually experience that side effect.” | ||
Building their skills in deliberating, communicating, and assessing support? | 1 - Always/usually 1 - Sometimes 7 - Rarely/never | “It’s not our job to build those kinds of skills with patients…” |
Facilitating progress towards decision-making? | 7 - Always/usually 1 - Sometimes 1 - Rarely/never | “Oh I’d say usually then I guess … it does not mean I’m like pushing them to say a certain answer it just means I’m helping them make their answer.” |
Discussing their ability/self-efficacy? | 5 - Always/usually 1 - Sometimes 3 - Rarely/never | “Mm hmm well yeah and we do. And one of the things that we specifically talk about when we talk about coming into the research study is that this is 100% voluntary. That, you know, by signing consent you are not locked into anything, right.” |
“No I, I do not discuss that stuff specifically because I worry about it maybe in potentially being like condescending or something.” | ||
Defining/explaining the decision? | 8 - Always/usually 0 - Sometimes 0 - Rarely/never 1 - no response | “… we go through all the information and sometimes they’ll say, can I think about it overnight or, you know, I want to talk to my wife about it. And what I would say to them, you know, unfortunately for this type of study we have to do it today. So if you are not comfortable and I do tell people if you are coming in a research study I want you 100% into the study. I want you to, to be coming into the study, you know, that you are fully confident coming in, right. If you are thinking if you have any doubts do not go in the study and I tell them that.” |