Difficult patients in health care research

  Bj Kirschner      2 December 2017     Team Insight, Industry Analysis

Health care research depends on the participation of disease sufferers so it’s essential to respect their needs throughout the research process.

Difficult patients in health care research

Many years ago, I was doing a study with stage IV cancer patients in central location. A patient pulled me aside after her interview and said, word-for-word, “I have been told by my doctor that I may have a year left to live. In this interview they showed me four ads for my cancer drug and all we talked about for the first 30 minutes were the colors. Why do I care what color the ads are? I may not be around when the ad ends up in magazines and I’m already taking it anyway.”

You don’t forget a quote like that and it really forces you to reconsider an approach to qualitative health care research with patients. Not just patients, “difficult patients.” 

Each time a new audience is sought in the world of qualitative health care market research, the audience gets the label of “difficult.” There used to be “easy” physicians, such as cardiologists and primary care physicians, and “difficult” physicians, such as surgeons and oncologists. Hospital purchasing managers? No way! Now they are all routine.

The same thing is happening with patients. I say “happening” because there are still a bevy of thorny issues facing us when it comes to patient research. But, just as with HCPs, each time we do the unthinkable, we find the confidence, and tools, to tackle someone even more “difficult.” 

Discussions of how to recruit difficult patients are common but less investigated is what happens after the patients are recruited. How do we design and implement research studies aimed at harnessing the bounty of information from such small and unique populations while maintaining their comfort and accessibility? Since qualitative research is about personal stories and not box-checking, my aim here is to use such stories to launch this discussion. I have picked just a few topics for consideration, some of the more high-level considerations, so this is by no means exhaustive! 

Not a numbers game

According to the American Cancer Society, based on data collected between 2011 and 2013, 12.9 percent of Americans are “likely” to be diagnosed with prostate cancer, 12.4 percent with breast cancer and 6.5 percent with lung cancer. However, the “probability of dying” from lung cancer is 5.4 percent, double that of either prostate cancer or breast cancer, so when you look at the numbers, it seems the harder to interview – wait a minute, why are we looking at numbers? 

Qualitative research is not a numbers game. The quotas can often be counted on fingers and toes. Incidence rates among country populations are nice to know but they don’t really have anything to do with the people themselves. The universe in a qualitative study is the number of patients that can be reached, are qualified and are available. In quantitative terminology, an IR of under 1 percent. 

What each person specifically has to say is most important, not an aggregate of what everyone says, not what 100 people say, not what yesterday’s respondents said. Each one is sui generis. Difficult patients are people with rare conditions and everything they have to say on the topic is pure expertise, whether or not it matches data or expectations. Names help make it real. Look at a daily schedule of cystic fibrosis patients and parents and say, “Today we have patient John B. at 11 a.m., patient Dave F. at 1:30 p.m. and caregiver Louise W. at 5:30 p.m. and Louise told the recruiters she may be five minutes late because she’s picking her son up from the doctor” as opposed to “Today we have two patients and a caregiver.”

Takeaway: Look at your difficult patients as unique individuals and they will respond in kind.

Have to work harder

Who are the most important people in any market research study? The respondents, of course. But, as qualitative researchers, we often forget to remind them of this fact. When dealing difficult patients, we as an industry have to work harder to make the process smooth for them. We should do that for all respondents – none of us would have careers without them – but just like moderators once learned to start days in central location at 7:00 a.m. and end at 10:00 p.m. so they could get surgeons before and after long days of surgery, we have to adapt to the needs of our difficult patients. The benefits of it are incalculable. 

I have long moved on from my days as a recruiter but there are certain times I jump back to it. Case in point: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. I do a lot of research with these patients and my connection with them is tight. I’m in their phones as a contact. I know their answers to basic screening questions like age and when they were diagnosed, so even just a feasibility request can be impressive to a client. On top of helping the clients, possibly learning something new and of course making a little extra money, they are willing to help because they trust me and because I act as an advocate for them during the study if they have issues or questions. I have come to understand the challenges of their conditions and help my clients adapt to those challenges.

Takeaway: If difficult patients know how much you appreciate their commitment, they become your friends, always willing to help out, participate, refer, etc. 

Terrible mix

The pharma and device companies usually want their participation to be blinded to avoid bias but we often over-obscure everything to make sure that happens. One of the best uses of mobile phone-based research I have seen, and this is going back to the infancy of mobile research, was with arthritis patients, specifically those with arthritis in their hands. What a terrible mix of methodology and audience, asking people who often cannot grip a toothbrush to do exercises on a tiny phone, right? That was actually the reason for the research. The app being designed was targeted at people who have manual dexterity issues as a way to track how they could input information comfortably. However, the respondents were not told this up front and the recruiting refusals piled up faster than the grumpy respondents who did agree and barely did the required activities. When it was decided to tell potential respondents the point of the study, which meant literally the addition of a single sentence explanation about design something specifically for people like them, respondents started over-participating. We only needed an hour of time across a few days and people were doubling and tripling that. The study was a success because of the way it was presented. 

Takeaway: Treat your respondents like partners and their dedication soars. 

Not easy to pick the right methodology

When it comes to methodologies, I could spend 10 pages on that topic alone! It is not easy to pick the right methodology when your sample size is very small. Flying from city to city is often expensive. Doing phone interviews can lack personality. Some studies have to balance difficult patients with physicians, nurses and other stakeholders. When you are doing device-testing and the respondents have to hold a mock device, the only methodologies available are in-person. And on and on and on…

A favorite qual methodology is in-home interviews. Over the course of a few hours, we can see how a respondent lives, reacts to surroundings and so much more. You may even get others in the household to participate and make a new friend with a lively puppy. Most importantly, you see a person in his or her natural environment. By “you,” I’m referring to a moderator. Not a collective “you” consisting of the moderator, a videographer and a few clients. That is a lot of people to bring into someone’s home and suddenly it’s not a comfortable chat anymore. Kind of like it’s not as comfortable when a male moderator is doing an ovarian cancer study or a female moderator researching prostate cancer. It is one thing to have an opposite gender doctor talking to you but quite another when it’s a market research moderator.

Another thing to keep in mind are laws and customs. We all have to be compliant, no matter the country or the condition. Some methodologies are simply not possible in some countries. In the U.S., HIPAA does not allow for a patient to be connected to his or her doctor without permission. Even if both signed off on allowing it, it’s not very likely any patient will allow a client to tag along to an office visit. Even in countries where legal hurdles are fewer, in part of Asia for example, it’s not often any patient agrees to this methodology because it’s culturally unthinkable. With difficult patients, any visit to the physician can be a minefield of unexpected news or test results. It’s not quite the same as having someone tag along while you get a flu shot.

What methodology is ideal? Which is best for the budget? Which will make the end client happiest? There is not just one – that’s the point – but think of it this way: If you were the patient with this condition being asked to do a study in this way, would you say yes? Start from there and the rest comes into focus naturally.

Takeaway: What works best is what works best for the patients. 

Not a perfect fit

Most research companies have specific methodologies they prefer to use based on experience and client needs. They become the hallmarks of that company, which is wonderful. Not every study is a perfect fit for your company’s offering but don’t despair, with a bit of finesse and experience, square pegs and round holes can fit together. 

Technology is amazing. Technology is why difficult patients are possible. Without the Internet, we wouldn’t find many of them and without communication devices we wouldn’t be able to talk to them. Think of companies who do just online communities – their whole business model is based on technology. 

Technology is only scary until that fear is overcome by experience. Potential respondents hear, “You will need to go on for an hour a day for two weeks and do a bunch of exercises.” That sounds like a drain on their time but once they get through an activity or two, watch them blossom, it never fails. They have unlimited time and space to provide feedback and some people really need that outlet. By the end of the study, they have become converts to the idea and all future studies are measured against this one. If a recruiter tells you something will be tough, don’t panic – they aren’t telling you it’s impossible. We want to make respondents comfortable but that does not mean we cannot push a bit to achieve study goals the way we anticipated.

There are, however, times where patterns are too confining. Forms of telephone interviewing have become the preferred methodologies because they allow for people all over the place to participate without travel time and expense; documents are easily shared; clients can listen in remotely; Webcams make it as close to sitting in a room with someone as possible. However, not every respondent wants to use a Webcam. I find this most often with late-stage cancer patients. Inevitably, a few on every study will stop the interview before it even gets started because they are not feeling their best that day. That puts the moderator in a tight spot – should he or she continue or not? Does the success of the interview depend on seeing the respondents’ faces? What about a bit of negotiating? Offer five minutes. If the patient says yes and you can make a connection in those five minutes, most likely the Webcams will stay on the whole time. Or, how about a reschedule? The patients agreed to the Webcam methodology and it’s only because they are truly feeling awful that day that they have reconsidered. Reschedules are no fun but if that is what will make the patient most comfortable, the appreciation for your accommodation will produce a great result when you do connect for the interview.

Takeaway: Patterns are great, especially flexible ones, but it never hurts to take a step out of the market research zone and really consider what is required and what the challenges may be.

Elephant in front of the mirror 

When we are dealing with difficult patients, fatality is often the elephant in front of the one-way mirror. We do not typically discuss it as a main focus of any research project but it’s there. 

Our firm ran a study in South America with parents of children with an extremely rare condition, one that is usually fatal in early infancy. During screening, the parents were quite emotional. One of the country reps came to me and said they wanted to use a different moderator than the one approved and trained because they felt this new moderator would be able to connect better to emotional respondents. To me, that was the key moment of the study because although it could potentially throw that country’s timeline into disarray for me, my clients and the end clients, it was best for the respondents. 

Takeaway: That was the absolute acme of understanding qualitative research with difficult patients: keeping the focus on the respondents.

All over the place

When doing studies on Alzheimer’s disease, there are often requests for mild patients because the medical definition of mild includes people who can function on their own, at least part of the time. However, mild patients are all over the place in terms of how much they are affected on a daily basis and that can make them less-than-ideal respondents. A mild patient makes medical sense but what about market research sense? What is the focus of the research? Let’s say it is side effects. Who will know the side effects best? Caregivers. There is no one more reliable and you will get more information, and more detailed information, from a caregiver. 

Or consider Parkinson’s disease. Of all difficult patient populations where telephone interviews are used, Parkinson’s disease patients are among the most skittish. Why? Because their motor and communication skills are tough to control and voice-to-voice communication even with the best of today’s equipment can be garbled and filled with dropped words. The patients will feel they cannot be understood and clam up when really the issue is a bad phone connection.

Many marketing research studies now focus on method of delivery, even old-fashioned and/or relatively non-invasive delivery like swallowing pills or applying a patch. Studies want to see respondents doing these very normal acts. “Let’s have them hold off on taking their medication until the time of the interview,” is a common request. Many difficult patients will have no problem with that. But some will because some are very precise and take a pill every day at 9:00 a.m. on the dot, for example. If the interview time is earlier or later, they may not agree. But what is the intention here? It’s usually not the actual chemical interaction as it enters the body. It may be patch placement or the measuring out of a liquid. If so, can that be done with non-medicated patches or water? 

For many years, it was trendy to attempt to visit schizophrenia patients in-home. Of course the screening required the patients to be on their medication and the hope was that they were well-controlled. Finding experienced moderators willing to go alone to a schizophrenia patient’s home was a tough sell. Why? We were telling the patients we wanted to see them in their most natural surroundings and they took that to mean seeing them at their worst, so they stopped taking their medication. They were not asked to do so but that’s how they interpreted the request.

In these three unique situations, we learned by experience, seemingly negative, that we had to consider every possible scenario when designing a study. But we did and now this type of problem-solving is becoming second nature to everyone.

I often get asked, “Isn’t all of this common sense?” No. What may now seem like common sense is actually individual experience becoming general knowledge. Or, “Aren’t these issues for the recruiters to point out to us?” Sure, the recruiters are the first contacts of our difficult patients but they do not have detailed medical knowledge and often they are not consulted until after a study is designed, when all they can do is promise “best effort” because it’s too late to make large-scale changes. 

Overwhelmingly positive 

Here is the really good news: Feedback from difficult patients is overwhelmingly positive. They enjoy the block of time given to just them and their experiences; they teach and they learn. The most common negative feedback is that was not properly attuned the condition or that the research was not personally useful. Those issues can be solved because they all stem from the same basic principle: Think of the patients and their difficulties first and work from there. We have done it before with great success and will continue to do so.

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