Thursday, September 21, 2017

Blood pressure goals in patients with kidney disease: how low should we go?

In 2013, the Eighth Joint National Committee (JNC 8) recommended that adults with hypertension and chronic kidney disease (CKD) be treated to a blood pressure (BP) goal of lower than 140/90, after finding no evidence that treating to lower BP goals showed the progression of CKD. At the same time, the American College of Physicians published a guideline on screening, monitoring, and treatment of Stage 1 to 3 CKD that suggested pharmacologic therapy with an ACE inhibitor or angiotensin II receptor blocker, but noted "no difference in end-stage renal disease or mortality between strict blood pressure control (128 to 133/75 to 81 mm Hg) and standard control (134 to 141/81 to 87 mm Hg)."

Less than two years later, however, findings from the Systolic Blood Pressure Intervention Trial (SPRINT) suggested that some older adults at high risk of heart disease and stroke, including those with CKD, may experience additional benefits if treated to a systolic BP goal of 120. After reviewing SPRINT and other recent studies, the American Academy of Family Physicians and the American College of Physicians decided in a new guideline for adults aged 60 years or older to stick with a systolic BP goal of 140 for adults at high cardiovascular risk.

Two systematic reviews and meta-analyses published recently in JAMA Internal Medicine ensure that debate about BP goals for adults with CKD will continue. The first study, by Dr. Wan-Chuan Tsai and colleagues, identified 9 randomized trials (n=8127) that compared intensive BP control (less than 130/80 mm Hg) with standard BP control (less than 140/90 mm Hg) in nondiabetic patients with chronic kidney disease. They found no significant differences between the groups in annual rate of change in glomerular filtration rate (GFR), doubling of serum creatinine level, a composite renal outcome, or all-cause mortality over a median follow-up of 3.3 years.

The second study, by Dr. Rakesh Malhotra and colleagues, reviewed data from 18 randomized trials that included 15,924 participants with CKD to determine if more intensive (mean systolic BP 132 mm Hg) compared with less intensive (mean systolic BP 140 mm Hg) control reduced mortality risk in persons with CKD stages 3 to 5. The authors found that more intensive BP control was associated with a statistically significant 14% lower relative risk of all-cause mortality.

An accompanying editorial by Dr. Csaba Kovesdy did a good job of putting these findings into perspective. Dr. Kovesdy pointed out that the benefits of a systolic BP goal of 120 for persons with CKD remain uncertain, and that the meta-analysis could have low external validity because trials had much lower death rates than those in observational cohorts of adults with CKD. Finally, he observed that any incremental mortality benefit from intensive BP control is small in comparison to that already achieved by standard BP control:

We must remember that the highest risks of hypertension occur in those with extremely elevated BP levels, and the benefits accrued with treating systolic BP to levels below about 140 mm Hg are much smaller. ... More intensive vs less intensive BP lowering resulted in a [number needed to treat] to prevent 1 death of 167 based on the absolute risk reduction estimated in the meta-analysis by Malhotra et al and an NNT to prevent 1 composite renal failure event of 250 based on the results of another meta-analysis. These diminishing absolute benefits have to be weighed against the increased likelihood of adverse effects and the higher costs associated with more intensive BP lowering.

Bottom line: if family physicians choose to devote more resources to patients with CKD or other cardiovascular risk factors who might benefit from lower-than-usual BP goals, they should not lose focus on improving care for the 46% of U.S. adults with hypertension whose BP numbers are not adequately controlled by any standard.

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This post first appeared on the AFP Community Blog.

Monday, September 18, 2017

Ambition, rejection and leadership

Most readers are aware that it was my work as a medical officer in the U.S. Preventive Services Task Force program at the Agency for Healthcare Research and Quality that catapulted me from a little-known junior faculty member to a recognized authority on preventive medicine and guidelines. What you probably didn't know is that AHRQ turned me down the first time I applied for the job, fresh out of my medical editing fellowship at Georgetown. In retrospect, they absolutely made the right decision. Not only was the physician they selected considerably more qualified, she is still working there, while I left four years after being hired (2006-2010). But that initial rejection, painful as it was, put me in excellent position to seize the next opportunity to join the program one year later.

I've been reflecting on this and other early-career disappointments to put my more recent leadership setbacks into perspective. Even though I won't take the helm at American Family Physician (the medical journal with the third highest print circulation in the world, behind the New England Journal of Medicine and JAMA), I will continue to contribute behind the scenes and support the new Editor in a variety of ways. And although I won't have the opportunity to Chair the AAFP's Commission on the Health of the Public and Science (and my 4-year term as a member ends in December), I will continue to work on evidence-based clinical practice guidelines and other projects in family medicine, such as this position paper on incarceration and health and last week's presentation at FMX on the challenges of providing preventive services to adolescents and young adults. Finally, I remain a go-to source for reporters looking for a skeptical perspective on overused screening tests, especially the prostate-specific antigen test; I was recently quoted in the New York Times and STAT about a modeling study that in my estimation didn't live up to the hype surrounding its conclusion that PSA screening "saves lives."

In short, I'm down but certainly not out. Although I have again fallen slightly short of my high ambitions, I will find other avenues to demonstrate leadership in medical publishing, evidence-based medicine, and population health. At least one silver lining is that I should have more time to devote to blogging about subjects that need the context that a Common Sense Family Doctor can bring.

Monday, September 11, 2017

Too much medicine disrupts end-of-life care

During one of the plenary sessions at the Lown Institute's Road to Right Care conference in 2015, a speaker recounted how overdiagnosis and overtreatment ruined her father's last year of life. Diagnosed with symptomatic multi-vessel coronary artery disease but otherwise in good health and independent at age 85, her father underwent successful coronary artery bypass surgery. His postoperative course was happily uneventful, except for a single stool sample that was positive for blood.

Why her father's stool was tested at all was unclear, since his blood counts were normal during his hospitalization. But his heart surgeon nonetheless strongly recommended that he see a gastroenterologist and undergo a colonoscopy. She tried to dissuade her father from doing this, since at his age even an advanced colorectal cancer would be unlikely to progress enough to cause symptoms before he died a natural death, most likely of heart disease. But her father was accustomed to following doctors' orders, so he dutifully underwent the colonoscopy, which showed a single precancerous lesion.

That should have been the end of the story, but since the gastroenterologist was unable to completely remove the lesion, he recommended consulting a surgeon to operate and take out the entire affected section of large intestine. Her father was barely four weeks out from heart surgery, and she again advised him to disregard this spectacularly ill-advised plan. But he wanted to get everything taken care of, to get this all behind him, so he consented to going under the knife again. This time, the postoperative course did not go well. He developed profuse and unremitting diarrhea, most likely from an antibiotic given prior to the surgery. His doctor pronounced the surgery a success - the cancer was cut out, after all - and expressed little interest in dealing with diarrhea. Her father was then transferred to a nursing home, where his diarrhea continued to resist all treatment, and where he died, miserable beyond all imagining, 6 months later.

Lown Institute senior vice president Shannon Brownlee told another sad end-of-life story about her own father in the Washington Monthly. The article's subtitle said it all: "How Medicare and other federal subsidies rope the elderly into painful, futile, and costly end-of-life care." Despite her father's expressed wish to never go to "the big hospital in Portland" again, he not only ended up there anyway, but underwent a totally unnecessary nuclear stress test and was hooked up to intravenous nutrition before his hospitalist could be persuaded to call in the palliative care team. Brownlee minced no words in describing the deficiences of what passes for end-of-life care in America:

When a frail, elderly person gets sick, takes a fall, or has trouble breathing, it’s as if they have stepped onto a slippery chute leading straight into the hospital, no matter how fervently they and their families might wish to avoid invasive treatment as they age and approach death. That’s because hospital services are what our medical industrial complex has been built to offer, and delivering invasive end-of-life care is the job for which we have trained our doctors and nurses. ... What we don’t do is train clinicians to talk to patients, and what we don’t have is the community-based infrastructure for delivering “high touch” care to people where they live.


I've written before about my belief that the future of medicine is low-tech and high-touch, and I agree with Brownlee that changing Medicare regulations that value ineffective "technology-rich, hospital-centric" interventions rather than house calls and social services to help elderly persons age in place are a necessary first step in fixing the way we provide care near the end of life. It's equally critical that we change the mindsets of physicians who see their roles as sustaining life at all costs ("doing everything," in classic medical parlance) even when they are only prolonging death. Hospitalist Aaron Stupple made a highly sensible proposal in an editorial in BMJ: pair advanced cardiovascular life support (ACLS) training with communication training about palliative care:

Coupling ACLS with communication training has several advantages. Firstly, it legitimizes the skill set as an important and valid component of today’s medical practice. ... Secondly, affixing communication training to mandatory ACLS training binds this material to an established curriculum with a good track record of reliability and measurability. ... Thirdly, all clinical disciplines receive ACLS training, so it could be used to teach a common message and an essential skill set.

Alas, Dr. Stupple's proposal makes so much sense that I fear it may be ignored. How long have we been trying to change the health care system to protect older patients from harmful interventions near the end of life? I remember reading the late surgeon Sherwin Nuland's How We Die in college and being shocked that most of us will die in hospitals, receiving "heroic" interventions that we don't want and won't do us a bit of good anyway. That was more than twenty years ago, and very little has changed. Let's spread the word about the Right Care Movement and dedicate ourselves to making sure I won't be able to write that again twenty years from now.

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This post first appeared on Common Sense Family Doctor on April 2, 2015.

Monday, September 4, 2017

Taking stock of a new guideline for high blood pressure in children

Last month, the American Academy of Pediatrics (AAP) published a new practice guideline on screening, evaluation and management of high blood pressure in children and adolescents, updating a 2004 guideline from the National Heart, Lung, and Blood Institute. The new guideline includes 30 evidence-informed "key action statements" and 27 other recommendations based on consensus opinion. The AAP recommends that blood pressure be measured annually in every child starting at 3 years of age, and at every health care encounter in children with obesity, renal disease, diabetes, aortic arch obstruction or coarctation, or who are taking medications known to increase blood pressure. Notably, the guideline's blood pressure tables lower previous thresholds for abnormal blood pressure in children by several mmHg because they are based on normal weight children only.

The American Academy of Family Physicians (AAFP) currently supports the U.S. Preventive Services Task Force's (USPSTF) 2013 statement that "current evidence is insufficient to assess the balance of benefits and harms of screening for primary hypertension in asymptomatic children and adolescents to prevent subsequent cardiovascular disease in childhood or adulthood." According to the USPSTF, the accuracy and reliability of blood pressure screening protocols in children has not been well studied; a sizable percentage of persons with high blood pressure in childhood will have normal blood pressure as adults; and there is inadequate evidence that lifestyle modification or pharmacotherapy results in sustained blood pressure decreases in children or prevents cardiovascular events. Also, abnormal blood pressure thresholds in the AAP guideline are based on a normal population distribution (with 3 different readings greater than the 95th percentile defined as hypertensive) rather than on patient-oriented evidence of improved outcomes, as in the JNC-8 guidelines for hypertension management in adults.

How can family physicians know if a new guideline is trustworthy and applicable to their patients? In a 2009 article, Dr. David Slawson and I proposed several attributes of good practice guidelines:
  • Comprehensive, systematic evidence search with end date noted
  • Evidence linked directly to recommendations via strength of recommendation grading system
  • Recommendations based on patient-oriented rather than disease-oriented outcomes
  • Transparent guideline development process
  • Potential conflicts of interest identified and addressed
  • Prospectively validated (i.e., guideline use has been shown to improve patient-oriented outcomes)
  • Recommendations offer flexibility in various clinical situations
Subsequently, the Institute of Medicine (IOM; now the National Academy of Medicine) published a report, "Clinical Practice Guidelines We Can Trust," that recommended many similar criteria. The IOM report informed the American Academy of Family Physicians' current processes for developing and endorsing clinical practice guidelines from other organizations. The AAP guideline will undergo a structured quality assessment by AAFP staff and members of the Commission on the Health of the Public and Science (including me), who will recommend to the Board of Directors if the guideline should be fully endorsed, receive an Affirmation of Value, or not endorsed. So stay tuned for more analysis of this guideline in the coming months.

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This post first appeared on the AFP Community Blog.

Monday, August 28, 2017

In health care and disasters, details make all the difference

In October 2012, when I heard that Superstorm Sandy was projected to make landfall somewhere in the vicinity of DC and Maryland, I prepared for the worst. I stocked up on non-perishable goods and evacuated to higher ground. (The rest of my family was already coincidentally out of town and harm's way.) I put fresh batteries into two flashlights and installed a flashlight app on my smartphone for good measure. Although I didn't give it much thought at the time, I assumed that hospitals in Sandy's path were taking similar precautions - stocking medical supplies, testing backup generators and so forth. So when a power failure at NYU Langone Medical Center (one of the teaching hospitals for NYU School of Medicine, where I received my medical degree) forced an evacuation of the entire hospital, with heart-stopping scenes of neonatal ICU nurses cradling respirator-dependent newborns down several flights of stairs to safety, I couldn't understand what had happened. How had they not been better prepared? Had NYU administrators been the equivalent of residents of low-lying coastal areas who ignored repeated warnings and defied evacuation orders?

As it turned out, NYU did a lot of things right before the storm. According to an article in ProPublica, after the scare of last year's Hurricane Irene, the hospital moved its emergency generators from street level to the rooftop and thoroughly waterproofed the generators' fuel pumps. Unfortunately, they neglected to relocate or protect the electricity distribution circuits, which remained in the basement and were quickly disabled by the flooding. As in many areas of health care, doing everything "almost right" wasn't good enough.

All people are fallible, and health professionals no less so than others. But medicine is usually less forgiving of simple mistakes. A technically perfect surgery is a disaster because it was performed on the wrong body part. A patient develops a life-threatening infection because a doctor forgot to wash his hands. A child dies three days after being discharged from an emergency room because his parents were not notified of critical lab values that came back hours after they left.

People are fallible, but health systems need not be. Despite the staggering complexity involved in flying passenger jets and constructing skyscrapers, commercial airline accidents are rare and building collapses even rarer. Atul Gawande argued in The Checklist Manifesto that checklists are the best way to make sure that small but critical details of health care are addressed systematically, so that every member of a care team feels empowered to preempt potential disasters. I believe that checklists and decision support tools are applicable not only to surgery or intensive care settings, but to primary care as well.

Fortunately, the emergency evacuation of NYU Langone Medical Center went off smoothly. But today, as the news of Hurricane Harvey's devastating impact on Houston's hospitals and nursing homes is just coming into focus, I hope that the good outcome of NYU's near-miss did not make any hospital or public health system complacent about addressing the little details and vulnerabilities that can make all the difference.

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An earlier version of this post was publised on Common Sense Family Doctor on December 4, 2012.

Monday, August 21, 2017

Procedures and prevention: the challenges of Choosing Wisely

A 55 year-old woman with chronic low back pain and symptomatic knee osteoarthritis asks her family physician's opinion about lumbar fusion surgery and some arthritis walking shoes she saw advertised on television. She is prescribed long-acting oxycodone and physical therapy for back pain, and her orthopedist recently began a series of hyaluronic acid injections for her knees. She is up-to-date on cervical and breast cancer screening, but also desires screening for ovarian cancer.

The next patient is her husband, a 60 year-old man with stable coronary artery disease. He was recently hospitalized for an episode of chest pain, and although tests did not show a myocardial infarction, a cardiac catheterization found an 80% stenosis in the left anterior descending artery. He already takes a baby aspirin daily, but his cardiologist has advised adding clopidogrel and having a coronary stent placed. Last year, he quit smoking after going through a pack of cigarettes a day for 40 years, and he is interested in screening for lung cancer. Also, since his brother was diagnosed with colorectal cancer at age 50, he has undergone screening colonoscopies at ages 40, 45, 50, and 55. These have all been normal, and he wonders if it is necessary for him to continue having them every 5 years.

Although both of these patients are fictitious, they represent common clinical scenarios in family medicine that contain enormous potential for overdiagnosis and overtreatment. In the August 15 issue of American Family Physician, Drs. Roland Grad and Mark Ebell presented this year's edition of the "Top POEMs Consistent with the Principles of the Choosing Wisely Campaign," which included the following suggested clinical actions:
As with last year's Top POEMs list, questioning unnecessary procedures or non-beneficial treatments is an effective way to protect patients from harm. But it's important to take a critical approach to preventive care as well to avoid overscreening. For example, as Dr. Jennifer Middleton noted in a previous blog post, one high-profile screening test for ovarian cancer still has big gaps in the evidence regarding its effect on mortality. Drs. Grad and Ebell advised not screening for ovarian cancer and carefully weighing the risks and benefits of lung and colorectal cancer screening:
It is challenging, and sometimes uncomfortable, to question long-accepted practices that feel like "old friends," AFP assistant medical editor Allen Shaughnessy wrote in a 2016 editorial. He suggested that clinicians keep in mind that the purpose of these evidence-based recommendations, and all of those from the Choosing Wisely campaign, is to improve care and reduce harm:

Every aspect of patient care—every word we say, every test or exam we perform, every treatment or procedure we employ—carries with it the possibility of harm as well as the opportunity for benefit. Although eliminating overuse is often perceived as a way of cutting medical costs, it is really about decreasing wasteful, unnecessary testing and treatment that offer only the potential of harm without the corresponding possibility of benefit. Sometimes, we need to leave our old friends behind.

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This post first appeared on the AFP Community Blog.