No-Care Equals Bad Care

A Talk With Sam Bozzette

April 2003

This article is part of The Body PRO's archive. Because it contains information that may no longer be accurate, this article should only be considered a historical document.

Much of your research has focused on the systems through which people receive medical care and how those systems affect the actual outcomes of care in terms of, say, fewer hospital days or improved quality of life. In a broad sense, this kind of research is part of a trend to patient-centered care, in which those being treated are considered an integral part of the health care system. Where does this interest come from, why is it especially significant for HIV, and where does it lead?

I am an admirer of the patient-centered care movement and its ethical roots in the principle of respect for autonomy; respect for the person. In a way it's similar to the principle of patient satisfaction. Not satisfaction with the amenities of the care, but whether people receiving care felt they were being treated with the respect they deserved; that people felt providers were putting their interests ahead of, say, business considerations; and that people felt they were being given enough information to participate in decisions regarding their care in an appropriate fashion. These all flow from the principle of respect for the person.

Another thread woven into patient-oriented care is the idea of the activated patient, which came out of work that had been done around the role of the patient in the so-called chronic disease model. At some point someone realized that people with chronic diseases spend only a small slice of their lives in contact with the health care system. The rest of the time they're managing themselves. Of course the fifteen minutes or half-hour spent with the provider each month is a very powerful and important vignette, but it's still only a vignette. The rest of the time they may be very much on their own. You see this in diseases like diabetes where people have relatively unstable blood sugars and are continually reacting to the measurements they take. Imagine if HIV replication were that dynamic and you had a viral load test that you could do at home. HIV is very dynamic but it doesn't respond to eating an ice cream cone. Or as another example, if people with high blood pressure decide to stop their drugs or go off their diet, they may have heart failure. But they're tasked with the day-by-day managing of their disease. So this idea of the activated patient is another thread in the patient-centered care movement.

My interest in the broader outcomes of care initially came out of a desire to rationalize medical decision-making. In the early days of HIV care before we had effective drugs, we didn't have a lot going for us. Those were truly the bad old days. But in a perverse way, because we didn't have anything, we didn't have the burden of history to hamper us. We didn't have to worry about what our teacher's teachers had said about HIV -- they'd never heard of it. And since there was no constraining tradition, we were able to ask, "How are we going to make rational decisions with this disease?" You see, when you make a rational decision you're trying to optimize something. In those days we knew we certainly weren't going to fix anybody -- we didn't even expect to get somebody to retirement age. So, what was there to optimize? We wanted to help people get as much as they could out of what they had in the time they had left. It seemed to us that we needed to start looking at a broader range of outcomes and considerations -- including the drawbacks of taking medications, such as what side effects were happening and how the side effects made people feel.

In the 1980s, when we were doing the early AIDS clinical trials, we were using toxicity grading scales from oncology research. I'd look at these things and see that Grade 4 organ toxicity was defined perhaps as some enzymatic test ten times the upper limit of normal. Then I'd look at Grade 2 nausea and see something like: "Requires frequent powerful antiemetics." So I'd think, okay, one of these is a serious reportable reaction and the other is not considered serious or reportable. But if I had a relatively limited time on this earth, which would I rather have? Grade 3 diarrhea was defined as something like: "Persistent despite continuous medication." This was Grade 3 -- how could Grade 4 be any worse? So that made many of us think that maybe we should be incorporating some of these broader outcome measures that took a person's quality of life, ability to function, and the efficiency of care into account. This kind of thing had mostly been used in population-based research, although people were starting to use them in clinical trials for heart disease, some cancers, and a few other diseases, and we began talking about using them in HIV.

Obviously, a lot has changed since then, and even though we're doing a whole lot better in keeping people alive, there's still no magic bullet and people are still struggling with tradeoffs. But I believe we're all thinking about the tradeoffs much more clearly these days. If you look at the federal HHS Treatment Guidelines, the sections about when to start treatment and what to use are impressively sophisticated with respect to the notion of tradeoffs. And when you look at the innovation that's come from our major clinics -- the antiretroviral adherence programs, directly observed therapy, the beepers, and so on -- it's very impressive. I also think that community-based and provider-based efforts at educating people living with HIV, whether on therapy or simply being monitored prior to taking therapy, have been impressive. A remarkable number of people with this disease in this country are incredibly well-informed. Every survey shows that information levels are very high -- and it's not like that for every disease by any means. If you look at the accuracy of information that people have about HIV, particularly people who are managing their own HIV, it's very impressive. These are all real advances.

So where is all this going in the future? I think there are two large challenges looming. I think the focus on activating, educating and involving patients needs to continue, because getting patients involved in decision-making, on their own and as a community, has paid tremendous returns. It's given us great gains over the past ten years, and it needs to continue, but that's not where the biggest gains up ahead are going to come from. I think there are two other fronts where we have much more to accomplish and a great deal to gain. First, I think it's a given that we need more antiretroviral agents and hopefully a vaccine. So, assuming an atmosphere of continued investment in developing therapeutic and prophylactic technologies, it seems to me that some kind of assistance with physician decision-making will inevitably be needed. I think the amount and complexity of information that clinicians will have to process is going to start running ahead of anyone's ability to grasp. I worry about this because we know that physician experience and training are linked to good outcomes. Here in this hospital we have Doug Richman, one of the world's experts in virology. If you've got a patient with this or that mixture of resistance, you can go ask Doug what to do. But not everybody has that resource, so when the time comes that there are twenty to thirty drugs to choose from, how will providers decide what to do? I believe assisting physician decision-making is going to be a big challenge and addressing it will produce important gains in the quality of care people receive in the future.

But the biggest challenge is going to be getting more people into care. Data seems to show that people are coming into care too late, and that many of the people who die from HIV do so either without benefit of treatment or very shortly after their initial diagnosis. With all of these new technologies you'd think that we would be preventing AIDS. Why are people being reported with HIV and then turning up with AIDS six months later? Why are people still dying so soon after being discovered to be positive? It's because they're not in care. Too many people in this country are not in care, and, if you think about it, not having care means poor quality care. Even someone who is found to be infected but doesn't have indications for treatment still deserves knowledge, deserves monitoring, and has a right to care. The lack of care is bad care.

To me the biggest unaddressed concern for patient-centered care is the no-care patient. A substantial number of people who are getting no care -- it's not clear how many this is -- are actually people who know of their infection. I think I've seen estimates that roughly half of people with HIV who are not in care actually know their status. And those people fall into two groups: first, the people who find out their status and then flee, because they're scared or in denial. And the other group are people who have bad access for some reason. Maybe they enter a system and they have a bad experience. Perhaps they're plugged into some health care system that's not particularly sophisticated about HIV; they're not handled appropriately, they feel shunned or they feel disrespected or discriminated against, and they just don't go back. Or maybe they're in a traditionally underserved population and have poor access to begin with. They might get emergent care for some reason and are tested, but there is no provision for ongoing care. They're told that they're HIV positive and they're told that they should be in regular care, but there's no system to deliver them the care.

So, we've got to do something. We've got to encourage people to come forward. We have to do this in ways that respect privacy and respect autonomy and are not coercive. Reporting or testing programs alone aren't the answer. That's just surveillance -- which is useful -- but it's not the same thing as care. People can find ways to know their status, but you still need to let them know that it's good for them to be in care, even if being in care simply means being checked out now and then. Hook them up. I'm not talking about drugs or chemotherapy for everybody; I'm just talking about some system where they can get monitoring and get good information. And when they're ready for treatment, they can get that too.

So I think that getting people with HIV involved and optimizing their care was a huge victory. Making sure that the choices don't run ahead of patients' and providers' abilities to make good therapeutic choices is becoming an increasingly urgent priority. But I firmly believe that the biggest priority, in terms of unmet need, is taking care of people who have no care. I'd like to see the community -- everybody -- take up that challenge.

Samuel A. Bozzette, M.D., Ph.D. is affiliated with the UCSD School of Medicine, the Veteran Affairs San Diego Healthcare System and the RAND Institute.

The Long-Term Safety Problem: Seeking an Answer in Large Database Studies

Large administrative database studies have a great potential for detecting the rare drug-related adverse event. These are things that aren't going to pop up in relatively small, relatively short-term clinical trials, which is the way HIV drugs are typically approved. Approval based on short-term data has worked to our benefit, I think. Yet, as more drugs become available, a return to risk aversion may be on the horizon. I hear people in Europe saying that maybe 48-week drug trials are not long enough; that maybe we should be talking about two-year or three-year phase III trials. Nevertheless, many people believe that somehow, some other kind of study has to start looking for the kind of things we all agree we would care about if we knew were drug-related adverse effects.

So, can we do that without subjecting a drug to the very long trial that it would take to pick up that rare effect in a traditional clinical trial? There are going to be rare adverse events occurring in real-world usage that would take a really long, really huge Phase III clinical trial to pick up -- if it ever did. Subjecting new drugs to such long studies would profoundly decrease our ability to get new drugs into the clinic. And it would have the more subtle effect of discouraging investment. The worst thing anybody could do would be to make pharmaceutical executives think that investing in HIV is a bad idea. And if it looks like concerns about toxicity are going to push people do longer or bigger trials, it's going to make drug companies believe that it's going to be tougher to get these drugs approved.

Potentially, a system where large living databases like the VA's supplements data from traditional trials could help reassure people about safety without putting pressure on pivotal clinical trials to be longer and bigger than they need to be to prove effectiveness and reasonable safety. -- SB

This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.


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