Table 1.
Themes about routine clinical use data and illustrative quotes
| Theme | Quotation (participant number) |
|---|---|
|
Perceptions of evidence from randomized controlled trials vs. routine clinical use data
Participants questioned the relevance of RCT evidence to them but also worried about the robustness of routine clinical use data |
I like to know efficacy percentages. It’s nice to have an idea of what you’re dealing with, where things can go. [] My [medical] team has been really good about keeping me informed, letting you know if there’s anything new, and how things are working, so I trust my team. But as I said it’s trust and verify. (Participant #13) |
| I would be looking at [] the difference between an observational study and a random, double-blind study [] the patients are much more closely selected for a random study. And so you have controls of other factors in the outcome, whereas an observational say, where you just look at insurance claims, and how many people had this, it doesn’t tell you anything about other aspects of their health, or medicines, or illnesses, or anything like that. [] If we had one or the other, I’d rather have the clinical trial than the observational. But when you put two of them together it looks pretty darn good. (#3) | |
| All of clinical trials, of course, have a time limit to them, and this [RWD] is showing how things work in the field, which is of notable interest to me and something I do ask doctors about it [] the experience in the broader population, it can theoretically be different than the clinical trials and errors and problems can come up. So this is actually quite supportive of the clinical trial and the calculation between Pradaxa and warfarin. (#6) | |
|
Evidence for decision-making: what does it mean for me?
Participants wanted to know how the data should be interpreted to apply to them as individuals |
Statistically there’s not much difference [] 1% is not a big number when you’re looking at [] the patient population this was done on. [] You don’t know if it’s classified by age group or severity of condition, things like that. But other than that it still goes back to [] it’s still your doctor, they’ve got to be like yeah, here’s my experience and here’s what I know about the data. And here’s what I still recommend for you, based on X. (#1) |
| The question is, what does that mean for me? And so, that would always be my question with my physician [] given my situation and given my [] specific biology, what is my risk over that specific risk pool. [] Let me put it this way: more information wouldn’t really help me, because I would need that in the context of a conversation with someone who is a physician or an expert. Otherwise, I feel like I’m following the Internet for facts and figures [] that might be legitimate but may not apply to me. Of course, it always comes down to what does it mean to me when we’re taking these drugs. (#14) | |
| It would just be one bit of data, if I looked at this, this wouldn’t—neither of these would make me choose. I’d really need to weigh this with my doctor and have my doctor’s opinion and really trust my doctor. And I do trust my doctors a lot. (#5) |
Quotes have been edited slightly for clarity.