Do we as sites, site managers, site business owners need the voice of the patient? Does it matter as a site?
Hello, I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. Today we’re going to talk about the site perspective on the voice of the patient. We all hear Sponsors saying that they want the voice of the patient, especially in protocol design and development. But I would argue that sites need to become much, much better at getting the voice of the patient. Our job is simply to put patients in trials, cross T’s, dot I’s, correct? I think sites can dramatically improve performance from multiple different perspectives if sites got better at accessing the voice of the patient.
Accessing the voice of the patient is not simply saying hi to your patient when they walk in the front door and how are you? Those are pleasantries and you’re not actually going to get asked underlying issues. Let me give you a quick example. We, as an industry, have an unacceptable loss-to-follow-up ratio. The loss-to-follow-up ratio is the percent of patients who simply drop out of a trial and disappear. They don’t come in and do an end-of-treatment visit; they don’t have an early termination visit; they simply stop coming, stop answering the phone. And from a statistical standpoint, that’s a nightmare for the quality of the data in the trial because you have to treat that patient’s data in the worst possible way. Well, what happened with that patient? Did they just disappear? Were they kidnapped? Unlikely. It’s likely that if you had the voice of that patient, you would have had red flags long in advance. It’s likely that something happened either in their personal life or in their relationship with you and your team. Something happened that was a precursor to them dropping out of the trial and disappearing.
I go see patients and I’ll sit next to them in the patient chairs and it’s astounding what you see when you’re looking from the perspective of the patient. I saw a patient last week and my exam table was to my right and the top of the exam table was tipped up, which is more comfortable for a lot of patients. Well, underneath the up-tipped exam table was some previous patients chewed on straw and some tissues and I could never see that. From my perspective in the room where I typically stand, or sit on a stool, the top of the table would block that from my view. The same would be true of my research coordinators – they would never be able to see it. But if you’re a patient sitting in that chair, it’s readily obvious. And if I were a patient, I would question the quality of the research site if they can’t even keep their exam rooms clean. The voice of the patient matters.
Ask Questions – Frequently
So what do you do to gather the voice of the patient? Ask open ended questions and ask frequently. If you only ask the patient how their experience was at the end of therapy visit, you’re only going to get the voice of the patients who lasted to the end of therapy visit. The patients that dropped out? You’re not going to capture the reasons that they dropped out – the ups and downs of a research trial. You’re not going not going to capture those nuances. So I would suggest that you ask your patients maybe at the randomization visit, mid point of the trial, and at the end of a therapy visit (multiple other times when there seems to be an issue). If there’s an unhappy patient, it is a perfect opportunity to ask them some questions. I would argue that getting the voice of the patient as a research site will reduce your loss-to-follow-up rate because you’ll know when a patient is having difficulties and you’ll be able to intervene faster. It will improve the quality of your operations at your office and your patients will feel far more respected because you’re taking the time to find out in detail how they’re doing.
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