Thursday, August 27, 2015

First experiences with end-of-life "care"

As a medical student, my first experiences with end-of-life care occurred in Bellevue Hospital in New York City, a 150 year-old institution famous for caring for the city's poor and providing a rite-of-passage learning experience for generations of medical students. I inserted my first chest tube into a man from Thailand who spoke no English and was dying painfully from incurable rectal cancer. After we ran out of sites to place intravenous lines to deliver his medication and fluids, a first year surgical resident inserted a central line for access directly into his neck veins, but accidentally nicked the top of his right lung in the process (a common complication of this procedure). In order to re-inflate his collapsed lung, I used what was essentially a large pair of sterilized pliers to punch through his chest wall and force in a large plastic tube connected to suction. None of these procedures, incidentally, would have been necessary had this man chosen hospice care, but no one had ever found a translator to talk to him about it. So he lived the last few days of his life, as it turns out, alone and with a tube in his chest.

My second encounter with death was no better. For several weeks during my 4th year sub-internship, I cared for an elderly woman who was dying slowly from metastatic colorectal cancer. Surgeons had taken out most of her large intestine, but were unable to completely remove the cancer that had spread to her liver and bones. (This type of cancer, by the way, is almost completely preventable with colorectal cancer screening, but only 6 in 10 eligible adults receive such screening.) After the surgery, her kidneys failed, and her wound healing was so poor that they were unable to close the surgical incision. Day after day I took a scalpel to the outer edges of the incision, carving away blackened, dead tissue; day after day I searched in vain for more sites to draw blood from her battered, bruised veins; and finally resorted to painful arterial punctures to get the laboratory tests that I was told we needed. Unlike my earlier patient, she and her family spoke perfect English; but she was essentially comatose and her family (who filled the sterile hospital room with flowers, balloons, and photos) was rarely around when we were at the bedside.

On my last night on call, the inevitable happened - my patient stopped breathing, her heart stopped beating, and having received no orders to the contrary, we attempted to revive her. As I performed CPR for the first time on a real patient, I remember thinking how brittle her bones had become from the cancer, and how easily her rib cage shattered under the weight of my chest compressions. The "Code Blue" team, knowing nothing at all about the patient, swarmed into the room, donning gowns and gloves inserting lines into every orifice. As we worked futilely to revive this dying woman, her bowels reflexively emptied one last time, soiling the sterile towels. We worked on her for twenty minutes, and when it was over, the room reeked of blood and urine and feces.

As the only person who knew the patient, I dutifully made the middle-of-the-night call to give the news to her sons and daughters. They sounded surprised, which shook me, since I understood metastatic cancer to be a death sentence (but no one had explained this to them, they said). Sad to say, these events repeat themselves on a daily basis at hospitals all over America, where end-of-life discussions are pushed aside by misrepresentations, false hopes, and a technologically-driven, unrealistic, never-give-up mindset that pervades our broken health care system. How many medical students and doctors in training are, right now, learning about death this way? Will these be the medical professionals who attend to your loved ones when they reach the ends of their lives? Is this the kind of care you would wish for them?

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An earlier version of this post appeared on Common Sense Family Doctor on August 16, 2009.

Monday, August 24, 2015

Announcing the #AFPTop20 Tweet Chat on August 26th

For each of the past four years, American Family Physician has published a summary review of the top 20 clinically relevant research articles of the preceding year, as selected by a survey of Canadian Medical Association members using a validated tool. Each of these summary articles draws on material from POEMs (patient-oriented evidence that matters) written by experts in primary care and evidence appraisal at Essential Evidence Plus. This year's compilation, authored by AFP deputy medical editor Mark Ebell and McGill University family physician Roland Grad, features the top 20 research studies published in 2014 judged to be most likely to change primary care practice.

This Wednesday, August 26th at 4 PM Eastern, @AFPJournal will hold its first #AFPTop20 Tweet Chat to take a deeper dive into the findings of some of these POEMs and their ramifications for family physicians. Contributing medical editor Jennifer Middleton (@singingpendrjen) and I (@kennylinafp) will serve as moderators, and we will be joined by Dr. Ebell (@markebell). To focus the discussion, we have selected three studies that we found to be the most challenging and/or potentially controversial. If you want to read the POEMs ahead of time (helpful, but definitely not essential), they are available at the links below:

Opioids for Chronic Back Pain: Short-Term Effectiveness, Long-Term Uncertain

Low-Carb Diet Better Than Low-Fat Diet to Reduce CV Risk Factors and Cause Weight Loss (or, listen to the podcast)

New Anticoagulants vs Warfarin in A Fib: No Clear Winner

For those who can't tune in to #AFPTop20 live, we plan to make the highlights available on Storify. Either way, please follow us at @AFPJournal and re-tweet this announcement (with the #AFPTop20 hashtag) far and wide!

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This post originally appeared on the AFP Community Blog.

Wednesday, August 19, 2015

Do restrictions on sofosbuvir for HCV harm or protect the vulnerable?

Accusing Anthem Blue Cross of denying them access to a "cure," plaintiffs with hepatitis C infection have filed a class action lawsuit against the health insurer for restricting coverage of sofosbuvir (Sovaldi), an antiviral drug that costs $84,000 in the U.S. for a single 12-week course of treatment. Although the medical criteria that Anthem uses to determine if patients are eligible to receive sofosbuvir are complicated, they basically boil down to limiting access to patients with proven liver damage, demonstrated by advanced fibrosis or cirrhosis. Most HCV-infected patients, who have no or minimal liver damage, do not meet these criteria but understandably want to receive "lifesaving" treatment too.

Public insurance programs have also been struggling to prevent sofosbuvir from busting their limited budgets. In June, a Health Affairs blog post discussed the potential consequences to Medicare Part D spending if even a fraction of the estimated 350,000 Medicare beneficiaries with HCV receive sofosbuvir. And this month, an analysis and related CDC review published in the Annals of Internal Medicine found that three-quarters of state Medicaid programs, like Anthem, pay for the drug only for HCV patients with advanced fibrosis. More than half restrict sofosbuvir prescribing to liver specialists and/or require a 1 to 12 month period of abstinence from illicit drug or alcohol use prior to treatment. Arguing that these restrictions may violate federal Medicaid law, the authors conclude:

None of the restrictions on sofosbuvir coverage detailed here seem to meet the criteria for permissible restrictions. Although the price of new therapies creates financial challenges for federal and state Medicaid budgets, decisions for prioritizing patients for more immediate therapy should be based on clinical criteria and medical evidence. It is recommended that the restrictions be removed; apart from potentially being a human rights violation, they do not make (economic) sense in terms of clinical, public, and long-term health.

But are restrictions on sofosbuvir coverage purely about health equity and human rights, as the Annals pieces assert, or are other ethical issues in play? First, is sofosbuvir really a cure? Unlike a vaccination, it does not prevent HCV re-infection, which occurs in a non-insignificant proportion of patients who continue intravenous drug use after successful treatment. Second, sofosbuvir is only proven to produce undetectable HCV viral loads after 12 weeks, and it is a huge leap of faith to assume that this surrogate marker of "cure" will definitely translate to less liver faillure or improved mortality. Finally, only 10 to 20 percent of persons with HCV will develop cirrhosis or hepatocellular cancer up to 30 years after becoming infected. For the 80 to 90 percent who don't, sofosbuvir can only cause harm: inconvenience and financial harm, to be sure, plus the potential for rare but serious adverse events.

Advocates of widespread sofosbuvir use have portrayed the coverage debate as one about rationing based on cost. But I don't think I would favor treating most healthy persons with HCV if the drug cost a dollar a dose, rather than $1000. A patient with fibrosis has headed far enough down the path to poor health outcomes that I am willing to overlook the gaps in the evidence on sofosbuvir's benefits, since it's unlikely that treatment would be worse than the alternative. It's not nearly as easy to disregard the uncertainties about benefits and harms for someone who is not ill from HCV and may never be. By accounting for a patient's current clinical status, limits on sofosbuvir prescribing are as likely to protect vulnerable patients as to harm them. On the contrary, insurers that have not put such restrictions in place may be encouraging potentially unethical prescribing.

Monday, August 10, 2015

Primary care training: follow the money

Training any kind of doctor is time-consuming and expensive, but the way teaching hospitals are financed often means that it is more profitable to open a subspecialist residency program than one in primary care. In a previous post, I reviewed a Robert Graham Center study that concluded: "Medicare pays a disproportionate amount of its nearly $10 billion per year in subsidies to institutions that produce mostly subspecialists, even in specialties where supplies are plentiful, at the expense of training sorely needed family physicians and other generalists." I elaborated on the imperative to align public graduate medical education spending with population health outcomes in a recent Medscape video commentary. Here are some excerpts:

Researchers have estimated that in order to meet the projected US population need for primary care physicians in 2035, residency production will need to increase by 21%. For the past 5 years, a small grant program from the Health Resources and Services Administration (HRSA) has supported training about 900 additional residents in family medicine, internal medicine, and pediatrics. Of these, historical trends predict that about 600 will practice primary care. Although this is only a drop in the bucket compared with what is needed, the funding for these positions unfortunately will expire this year. Two surveys of program directors whose programs received one of these time-limited grants found that only 1 in 5 has secured funding to continue to support the expanded positions after 2017. ...

Last year, the Institute of Medicine published a report that called for reforming the allocation of taxpayer-supported residency funding to make teaching institutions accountable for producing a physician workforce that "can provide better individual care, better population health, and lower cost." My interpretation of this statement is: Provide financial incentives to train more family physicians! ...


The bottom line is that primary care physicians and our professional organizations need to push not only for reforms in how we are paid for patient care, but also reforms in how residency programs are funded in order to increase our numbers and produce a balanced workforce that meets the health needs of our nation.

Thursday, August 6, 2015

Improving one's chances for a successful vaginal delivery

Two of the most important questions that pregnant women have are: 1) How can I improve my chances of having a normal (vaginal) delivery? and 2) Does where I plan to have my baby make a difference in birth outcomes? In the August 1st issue of American Family Physician, Drs. Lee Dresang and Nicole Yonke reviewed the management of spontaneous vaginal delivery by family physicians. The authors noted that the following practices are associated with positive maternal and neonatal birth outcomes:

1) Encouraging patients to walk and stay in upright positions
2) Waiting until at least 6 cm cervical dilation to diagnose active stage arrest
3) Providing continuous labor support (e.g., doulas)
4) Using intermittent auscultation in low-risk deliveries
5) Group B streptococcus prophylaxis
6) Active management of the third stage of labor

Guidelines from the American Academy of Family Physicians and American College of Obstetricians and Gynecologists encourage women with a previous low transverse uterine incision to consider a trial of labor after cesarean delivery, as most will be able to deliver vaginally.

Although obstetricians and family physicians remain the most common birth attendants in the U.S., pregnant women at low risk of complications have been increasingly turning to midwives practicing in birth centers or other out-of-hospital settings. A United Kingdom prospective cohort study that examined perinatal and maternal outcomes by planned place of birth in 64,000 healthy women with low-risk pregnancies found no differences in the odds of a composite outcome of perinatal mortality and intrapartum neonatal morbidities in freestanding midwifery centers compared to obstetric hospital units. Planned home births were associated with worse neonatal outcomes for women delivering for the first time, but not for women in subsequent pregnancies. As one might expect, labor interventions occurred most frequently in hospital settings.

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This post first appeared on the AFP Community Blog. I've also written other posts about the decline of vaginal birth after Cesarean and studies comparing the risks of planned home to planned hospital births.

Friday, July 31, 2015

The paradox of health and screening for prediabetes

In a classic article from the 1980s, Harvard psychiatrist Arthur Barsky described what he termed the "paradox of health": despite great improvements in many objective measures of health in America, people were actually becoming less satisfied with their personal health. Dr. Barsky suggested several explanations for this paradox, including "greater self-scrutiny and an amplified awareness of bodily symptoms and feelings of illness"; "a climate of apprehension, insecurity, and alarm about disease"; and "the progressive medicalization of daily life." He was especially critical of what he saw as the increasing commercialization of health services:

Each producer tries to convince the public that something is dangerously wrong, or about to go wrong, and that immediate steps must be taken to remedy the situation. An indifferent public is first galvanized into becoming a market of alarmed consumers by constant reminders of myriad threats to health, and then convinced of the need for more and more products and services to protect them. In the process, deep-seated fears about disease are mobilized, and insecurities about health and longevity are intensified. As a result, many come to feel less secure about their health, more worried about the possibility of disease, more absorbed in trivial symptoms.

Fast forward to this year, when a blog post from the U.S. Department of Health and Human Services advised, "It's never too early to prevent type 2 diabetes." Noting that women with high blood sugar levels in pregnancy (gestational diabetes) are more likely to develop type 2 diabetes later in life, this post suggested that mothers be tested for diabetes 6 to 12 weeks after the birth, then tested again periodically, with more frequent testing if their results showed prediabetes.

When medical and public health professionals talk about diabetes prevention, they are generally referring to helping people with prediabetes (high blood sugar levels that aren't high enough to meet diagnostic criteria for diabetes) improve their diets, become more physically active, and (if overweight) lose extra weight. In March, the Centers for Disease Control and Prevention and the American Medical Association announced the Prevent Diabetes: STAT campaign, with STAT standing for Screen, Test, Act-Today. Since few persons with prediabetes have recognizable symptoms, the reasoning goes, physicians need to find them by screening. But what is the evidence that screening for prediabetes makes a difference in long-term health outcomes?

Let's start with screening for diabetes. In 2008, the U.S. Preventive Services Task Force recommended that adults with blood pressures over 135/80 be screened for diabetes, not from direct evidence that screening was beneficial, but because at that time blood pressure goals were lower for diabetic patients. However, the 2014 JNC-8 hypertension guideline set the same goal blood pressure of 140/90 for adults younger than 60 years regardless of diabetes status, removing this rationale for screening.

So when the USPSTF updated their 2008 recommendations, they would need to find proof that earlier treatment of screen-detected diabetes (as opposed to clinically detected) prevented or delayed patients from going blind, losing limbs, requiring dialysis, having heart attacks, or dying as a result of their disease. The Task Force completed its review last November. The review found no evidence that screening for diabetes, even in high-risk persons, prevented or delayed any of the those outcomes. In fact, two randomized trials of screening for diabetes found no differences in mortality rates after 10 years of follow-up. These findings would typically have resulted in a "I" (insufficient evidence) statement or "D" (don't do) recommendation. Instead, the USPSTF provisionally recommended screening a much larger group of adults than before, reasoning that in the process of screening for diabetes, physicians would find lots of people with prediabetes and hopefully be able to prevent them from developing diabetes.

Huh?

Both the USPSTF review and a more recent review commissioned by the Community Preventive Services Task Force clearly showed that combined diet and physical activity promotion programs can slow (or sometimes stop) the progression from prediabetes to diabetes. No argument there. What we don't know is if finding more adults with prediabetes (and, since so many are thought to be undiagnosed, creating an epidemic of prediabetes) will help them live longer or better. Most persons with prediabetes are overweight, sedentary, and/or consume an unhealthy diet. Family physicians already provide lifestyle counseling to these patients. And if (like a few of my own patients with prediabetes) they happen to be normal-weight long-distance runners who haven't touched junk food in years, I just tell them to keep doing what they're doing.

Two editorials that accompanied publication of the USPSTF and Community Task Force reviews in Annals of Internal Medicine essentially argued that we don't need any more evidence to go out and screen everybody for prediabetes. Drs. K.M. Venkat Narayan and Mary Beth Weber wrote, "Much of the debate around screening for prediabetes and diabetes focuses on the lack of direct evidence from randomized, controlled trials comparing screened with unscreened persons on a hard outcome, such as CVD or mortality. However, such a definitive trial of hyperglycemia screening is infeasible, unrealistic, and arguably unethical ..."

Tell that to the authors of exactly this type of randomized trial which has been going on for more than a decade! Similarly, Dr. Ronald Ackermann argued, "As a society, we should no longer hold for ransom the potential to reduce the burden of diabetes by continuing to await further evidence that interventions will be cost-saving or prevent myocardial infarctions or deaths."

Well, while we're talking about hostage-taking, consider that being told that he or she has diabetes or prediabetes makes a patient immediately feel worse (or as Dr. Barsky would have put it, feel less secure about their health, more worried about the possibility of disease, [and] more absorbed in trivial symptoms). In my view, widespread screening for prediabetes will only become ethically justifiable when we have proof that it will lead to people living longer or better.