Conservative, Liberal, or Relevant Blood Pressure? We need studies that are really relevant...

The following is a guest post from Robert Bowman, MD

One set of guidelines says to loosen up blood pressure control to prevent consequences such as falls. Almost in reaction there appears a new study that indicates a need to, perhaps, tighten up control to reduce the potential for stroke or heart disease. When British GPs were paid more to address BP there did not seem to be gains, other than better pay for participating GPs. Time after time we seem to have cutting edge studies that are pro-intervention. They remain until longer and bigger studies come out years later indicating problems or limitations involving the once “cutting edge” pro-intervention studies.

The lives of millions of people can be impacted by hypertension guidelines. How can we best deal with blood pressure issues?

The answer is not likely to be found in guidelines, quality measures, reports, or the latest studies.

The answer is more about process and less about print.

The problem with guidelines that are too liberal or too conservative is the same – they are too distant from the real world. The real problem remains the failure to include many of those most important to the process.

The real world in health care is what is happening at home. What is the real world for elderly patients? What happens when you get up at night to go to the bathroom? Do you get up at night more because of your medications or because of how you take them? Do your physicians coordinate the addition and subtraction of medications – including drugs that impact blood pressure or fluid volumes? With more and more medications there are more potential interactions. What happens when you get up from a chair or sofa? When you lose 10 or 15 pounds, do your medications drop your blood pressure to dangerous levels? Do you even have contact with a health care professional to help look out for the problem of weight loss and medications that are suddenly too effective?

We know about the benefits of blood pressure control, but do we know about the consequences of too much control?

Sadly we know less about the risk of blood pressure that is kept too low, the risk that a fall that may belife or lifestyle ending will occur.For example, should our blood pressure goals be more aggressive in men or in those with proven bone stability while being less aggressive with those likely to suffer greater consequences becaue they have osteopenia, osteoporosis, or other conditions? We often assume linear increase in risk, but this may not be the case.

What Is Missing from “Guidelines?”

With control of BP or coagulation or other treatments that defeat how the body adjusts to change, the patient and family must have the best understanding regarding what the drugs do and how the drugs impact their particular body and situations.

Large scale studies can be helpful, but the studies need to be relevant. Studies should reflect the real world. After three hundred recent home visits, observations indicated a few with perhaps lax control that may, just may have problems in 1, 5, or 10 years. There are also a different few of the 300 who are having falls or symptoms that suggest the potential for falls - with the potential of immediate consequences. Many large studies examine only the outcome of interest to the researchers – such as the rate of strokes in people with uncontrolled blood pressure – rather than the overall rate of harm or death to the people involved. In addition, many studies exclude from participation people who have the risk factors most likely to cause them harm. Studies that do examine all outcomes (“all-cause morbidity and mortality”) are of more value, and we need to be sure that the people we are treating in the “real world” are similar to those studied.

And then there is the problem of getting reliable BP measurements at the office or at home. How many people do we overtreat based on office-only measurements when lower home BP measurements are more relevant? How do we best use ambulatory measurements? Are these accessed and priced in ways that can make a difference?

A final reflection may be more relevant. In the 5 or 6 minutes of face-to-face time that is often all that exists, given current payment design, how do we get to know our patients well enough in our office environment to optimize BP control while minimizing the consequences to them as they live in their world? How do we teach them enough to loosen up medication when necessary to help prevent falls?

Addressing Problems and Solutions

One thing is certain. As long as research is distant and irrelevant, guidelines will contribute to too much negative consequence and not enough gain.

Practice-based research could contribute. But the real potential involves home-based research. The irrelevance of the academic setting and even the office was suggested by the founders of family medicine. What matters most is far away from university hospitals and NIH researchers. Lest we forget, the home – and the community -- is where it all happens.

Follow up to come:

Why the Home is the Best Unit of Analysis for Research

Research on disparities/inequities, in practices and communities needs much greater funding

This is my first attempt at a blog in several weeks; indeed only one in the last month. I took (and time will tell if I passed) the Family Medicine recertification exam, so I am now able to raise my head above water.

Research is the way we gain new knowledge. It is how we discover if the things that we are doing are the right things to do, or if they are of little or no value, or perhaps even of harm. In the decades after World War II, when the country was optimistic and growing and seeking new frontiers, science was a major area for investment by our government. Things were getting better, returned GIs found a plethora of well-paying jobs, were able to buy houses and cars and plan to send their children to college. American industry did extremely well, if not solely because of great planning and management here, because there was no competition from the rest of the world which had been devastated by the war.

Things were not all good, especially on the political front; there was the cold war, and the associated fanatic fear of Communists epitomized by Senator McCarthy, and there was a legitimate fear of nuclear. But, on the economic front, things were going well for the US. The growth benefited many more people, and the gap between the income of the average worker was large but not unconscionable. Not like today, where as demonstrated by much research, and the title of this HuffPost article, “CEO Pay Grew 127 Times Faster Than Worker Pay Over Last 30 Years”, (“It’s good to be a CEO!”), or in this graphic from Prof. GW Domhoff of UC-SC.

The most dramatic expenditures on science were on space travel; after the Soviet Union launched Sputnik, the first artificial satellite, in 1957 and the space race was on. With the election of John Kennedy in 1960, space exploration moved front and center. All of us who were schoolchildren, in addition to hiding under our desks to protect us from nuclear weapons, were much more productively engaging in a new-found, broad-based physical fitness program encouraged by the President. While Harry Truman was unsuccessful in passing a national health insurance plan, thanks to both the reactionary opposition of the AMA, and the fact that labor unions chose to demonstrate their effectiveness by negotiating health coverage rather than seeking political change as the Labour Party successfully did in Britain, in other areas of science, health moved to the forefront.

The National Institute of Health (NIH) became the major government institution funding medical research and saw enormous growth in the ensuing decades, including a doubling of the budget from about $15B to about $30B in the decade surrounding the last millennium. This fueled the development of an enormous expansion of medical research in laboratories, primarily in universities and medical schools. In addition, corporate support, mainly from pharmaceutical research companies, further enhanced the growth of these laboratories. There were many successes, of which the most famous is the sequencing of the human genome, but our understanding of human biology and how it might contribute to human health and diseases has been remarkably enhanced. Some of this research has led to true medical breakthroughs, with the creation of new drugs and treatment modalities that have sometimes been of great help to large numbers of people with common diseases, and sometimes of enormous help to a few with uncommon ones.

However (and you knew that there was going to be a “however”), the focus on laboratory research and new discoveries at the molecular, protein and genetic levels left unfunded areas of research at least as critical, but not seen as “hard science”, and thus not generally funded by NIH and drug companies. This is a problem. Yes, there are “clinical” research studies, but these are mostly trials of drugs and interventions in populations. The number of studies based in communities, looking at health disparities, and trying to discover how most effectively to have a positive influence on the health of people, populations, rather than occasional individuals, remains small.

 

Certainly, it has grown. As demonstrated in the graph, after the NIH budget doubled, it leveled off, “stagnated” given inflation, until the one-time infusions of American Recovery and Reinvestment Act (ARRA) funds in 2009. Funding for health disparities research has increased, both from NIH and from other federal agencies such as the Centers for Disease Control (CDC) and the Agency for Healthcare Quality and Research (AHRQ), which has but a tiny fraction of the funding that NIH does. NIH created Clinical Translational Science Awards (CTSAs) which funded centers at many medical schools to look at moving research into the community, but much more from the basic science laboratory to first-in-humans trials (or even from one basic science laboratory to another). A major new initiative of the Affordable Care Act (ACA) is the creation of the Patient-Centered Outcomes Research Institute (PCORI), designed to evaluate not just new treatments but how they affect people. However, even the community-based research has focused largely on the recruitment of research subjects to studies designed by academic researchers, rather than on directly studying issues that would improve the health of the people in those communities.

Part of the problem is that it is difficult to get community members to think about what would be in the best interests of their health and that of their communities. They are, after all, not trained in such assessment. In addition, particularly in the communities that are the most vulnerable, that have to greatest health inequities, people are just focused on getting by, paying the rent, buying food, working multiple low-wage jobs. However, another part of the problem is that research at this level is seen as less important and significant, particularly by those who have always focused on new discoveries in the lab and who control most of the agencies such as NIH.

But it is not true. No matter how wonderful the discoveries in the lab, no matter how much they might lead to new understanding, new drugs, new treatments, these are only of value if people benefit from them. So this requires clinical research in the real world, with actual people. But beyond this, if they are to benefit not just a chosen few, the interventions have to be studied among diverse populations, including people facing economic, social, psychological and environmental challenges. In addition, the delivery of these treatments is sporadic. It is clearly demonstrated that administration of aspirin is of benefit to people who have had heart attacks. So it should be used. Why, then, are half the Americans who should be on aspirin not? I don’t know. It probably isn’t cost. It requires research to find out why and to change it. Saying (as is often done) that “new medical knowledge takes 10-20 years to penetrate into practice” is not adequate. Finding out how to get this effective treatment to the people who need it is as important as discovering the treatment. This is known as “fidelity” research.

Finally, effective research on improving people’s health needs to involve medical practices, where the people are being seen. There are many Practice-Based research networks (PBRNs) around the nation, but they are all challenged by how busy the providers are seeing patients; this is at least as true in practices such as Federally-Qualified Health Centers (FQHCs) that care for poorer populations. And yet, without involving them in research, how can we know what is effective in delivering the “best quality” care, and how can practices at the point of care be changed?

This is not to say that we should not fund basic biomedical research or early clinical trials. Nor is it to say that the current programs from NIH and PCORI and others to fund work in health disparities and inequities, and in population and community health are not good. But they are too little. People working in basic laboratory research, early clinical research, practice-based research, and community health should not be competing with each other. There should be more money for all of it, but especially a lot more for fidelity research, community-based participatory research, and practice based research.

Where will the money come from? From policies that are used in every other successful country, and every time the US has been successful, progressive tax policies that take some of our wealth out of the control of private corporations, who use it only to sock away more money, and into the public sector where it can be used to benefit us all.