Monday, May 4, 2015

PSA screening by the numbers: no benefits, many harms

- Kenny Lin, MD, MPH

Previous studies found that two-thirds of men who receive prostate-specific antigen (PSA) screening for prostate cancer didn't have shared decision making with their physicians. If shared decision making occurred at all, patients were more likely to remember hearing about the advantages than the disadvantages of PSA screening, and many older men with a high probability of death within the next 9 years were screened nonetheless.

These findings, along with a Cochrane review and another systematic review (that I co-authored) which both found no pooled mortality benefits in several randomized controlled trials, led the U.S. Preventive Services Task Force to recommend against PSA-based screening for prostate cancer in 2012. Since then, the American Academy of Family Physicians and the American College of Preventive Medicine have added this service to their Choosing Wisely lists of tests and procedures that patients and physicians should question.

The Medicine By the Numbers published in the May 1st issue of American Family Physician clearly illustrates that the harms of PSA screening exceed the benefits. 1 in 5 men who received PSA screening ended up undergoing a biopsy for a false-positive test; 1 in 34 and 1 in 56 screened men, respectively, suffered erectile dysfunction or urinary incontinence as a result of prostate cancer treatment. In contrast, PSA screening prevented zero deaths from prostate cancer or all causes. In other words, no benefits.

This review begs the question of why clinicians should bother with shared decision making in most average-risk men, rather than simply telling them that this test is a bad deal.

Monday, April 20, 2015

Does every discharged patient need close outpatient follow-up?

- Jennifer Middleton, MD, MPH

Reducing unnecessary readmissions has been of increasing interest to hospitals and health systems, but, until recently, no evidence base supported the current Medicare strategy of incentivizing outpatient follow-up within 30 days of discharge. Theoretically, this close follow-up allows the patient's outpatient physician to proactively address issues that, left unaddressed, could result in the patient being readmitted. Jackson et al in this month's Annals of Family Medicine showed that this strategy is beneficial, but only for patients with multiple chronic conditions.

The authors examined a year's worth of North Carolina Medicaid claims data to identify which patients had follow-up after hospital discharge and when after discharge they had it. They also stratified patients into risk categories for readmission in 30 days; to determine this risk, they looked at patients with similar diagnoses in the previous 5 years of claims data and identified readmission trends. They found that patients with 0 or 1 chronic medical conditions didn't benefit from close follow-up, as their baseline readmission rate was already quite low. For patients with multiple chronic medical conditions, though, close follow-up significantly reduced readmissions:
For those whose readmission risk exceeds 20%, our analysis suggests that 1 readmission may be prevented for every 5 patients who receive outpatient follow-up within 14 days. These patients are characterized by having 3 or more chronic conditions, often including advanced coronary artery disease, chronic obstructive pulmonary disease, chronic renal failure, congestive heart failure, diabetes, ischemic vascular disease, or a history of organ transplant, dialysis, or total parenteral nutrition. 
The challenge, conclude the authors, is that risk stratification for readmission is not common practice at the time of discharge.

The authors used claims data to identify regional "bounce back" trends, but validated tools like LACE might be easier for busier family physicians (Length of stay, Acute admission, Charlson comorbidity index tool, and number of Emergency Department visits in the last 6 months). The tricky part may be incorporating a tool like LACE into a busy outpatient-only family physicians' office. If the hospital discharging a patient doesn't calculate a LACE score, should the physicians' office prior to scheduling a follow-up appointment? It may be easier to just keep scheduling all discharged patients a follow-up appointment within 14 days, but how patient-centered is it to do so for the patients who may not benefit? How much responsibility for ensuring timely post-discharge follow-up should fall on the hospital, and how much on the outpatient family physician?

The question left unanswered by this study is what other benefits patients get from close follow-up besides lowered readmission rates. Are they more confident managing their medical conditions? Do those low-risk patients still find value in close follow-up? Hopefully researchers are focusing on other elements of post-hospital care besides readmissions to answer these patient-oriented questions.

In the meantime, the Family Practice Management website includes this article on using the Medicare transitional care management codes along with blog posts answering common questions about the codes and this list of additional resources.

Wednesday, April 15, 2015

The SGR is history, but will its replacement improve care?

- Kenny Lin, MD, MPH

Last night, the U.S. Senate overwhelmingly passed the Medicare Access and CHIP Reauthorization Act of 2015, which, among other things, repealed Medicare's sustainable growth rate (SGR) formula that for the past 12 years had threatened to slash physician payments in order to meet targets for overall program spending. The American Academy of Family Physicians was one of many medical groups that declared victory. Instead of cuts, physicians will now receive annual 0.5% increases to payment schedules through 2019, after which payments will be designed to reward quality over quantity of care.

As many have pointed out, though, the devil of quality measurement is in the details. In family medicine, "high quality" care has often boiled down to how often physicians provide a service to eligible patients: what percentage had smoking cessation counseling, had tests for blood glucose control, or underwent appropriate screenings. Despite the existence of the Choosing Wisely campaign, physicians are rarely, if ever, rewarded financially for forming therapeutic relationships with patients and collaboratively deciding not to provide a service. That's a big problem, since the original intent of the SGR wasn't to improve quality, but to reduce costs (or at least slow the rate of cost growth) of care. Although Medicare officials are hopeful that accountable care organizations will save money in the long run by coordinating care and reducing redundant services, it's not at all certain that this will happen.

Screening mammography is a good example of how current quality measurement approaches could end up increasing costs of care. Fee-for-service Medicare spends about $1 billion each year on mammography; across all payers, about 70% of U.S. women age 40 to 85 years are screened annually at a cost of just under $8 billion. A provision of the Affordable Care Act mandated that women over 40 receive screening mammograms at no cost, and it's easy to measure if women are screened or not. So am I a necessarily a better doctor who deserves higher pay because more of my patients get mammograms? Medicare officials would say yes, but I'd argue that they're wrong. Screening mammography's benefits and harms are closely balanced, and as Drs. Russell Harris and Linda Kinsinger observed in a previous issue of American Family Physician, some women might reasonably make an informed decision to decline this test:

Over the years we have learned more about the limited benefits of screening mammography, and also more about the potential harms, including anxiety over false-positive results and overdiagnosis and overtreatment of disease that would not have caused health problems. More and more, the goal for breast cancer screening is not to maximize the number of women who have mammography, but to help women make informed decisions about screening, even if that means that some women decide not to be screened.

A recent study estimated that patients and insurers in the U.S. spend an additional $4 billion annually on working up false-positive mammogram results or treating women with breast cancer overdiagnoses. That's an extraordinary amount to spend for no health benefit, and it could be substantially less if physicians had the time and resources to explain difficult concepts such as overdiagnosis. But that doesn't appear to be where we're headed.

Don't get me wrong: I'm happy that the SGR is history. There's a lot more work to do, though, to prevent it from being replaced down the line with crude measures of physician quality that will end up costing even more money and make few patients happier or healthier.

Monday, April 6, 2015

Acetaminophen ineffective for chronic low back pain - now what?

- Jennifer Middleton, MD, MPH

Acetaminophen has been a mainstay of treatment for chronic low back pain (LBP) for years, but a recent study turns that conventional wisdom on its head.

In a meta-analysis that was published in the BMJ last month, Machado et al searched multiple medical literature databases looking for randomized controlled trials (RCTs) evaluating acetaminophen against placebo in patients with chronic "non-specific" low back pain, hip osteoarthritis (OA), or knee OA. They ended up with 13 RCTs of fair to high quality: 10 RCTs for hip and/or knee OA, and 3 RCTs for chronic LBP. All of the studies for chronic LBP were from 2014.

For chronic LBP, the authors found a non-significant difference for both pain and measures of disability for acetaminophen compared to placebo. For hip and/or knee OA, the difference was statistically significant but likely not clinically significant (only a 4 point difference on a 100-point scale).

Intuitively, acetaminophen seems like a reasonable choice for treating chronic LBP. It's inexpensive and relatively safe when used at recommended doses. A 2009 AFP article on treating chronic LBP advises a trial of acetaminophen prior to trying other medications; that recommendation was based on the best evidence available at the time. This 2015 meta-analysis, that includes newer studies, overturns that recommendation and should prompt a change in the clinical guidelines.

This study raises significant questions about appropriate treatments for this common condition. Opiates can cause dependence and addiction, and long-term NSAID use is also of questionable safety as discussed here in 2013. A 2011 AFP article describes non-pharmaceutical treatments for chronic LBP with some evidence of efficacy; back exercises, acupuncture, massage, spinal manipulation, behavioral therapy, and intensive multidisciplinary treatments programs are all reasonable treatments to offer patients. Perhaps chronic LBP treatment should focus more on these physical modalities and less on medications, though for some patients physical therapies alone may not be enough. Hopefully, we will see future studies addressing the care of patients with this common condition, because right now our medication treatment options feel limited with acetaminophen and NSAIDs both potentially off the table.

Keeping up with changes in the primary care evidence base can feel like a daunting task, even more so, perhaps, when new studies challenge assumptions that once seemed immutable. Chances are, your favorite journals have Twitter and Facebook accounts (AFP does!), and the print version of AFP also includes a round-up of recent evidence-base game changers in its "Cochrane for Clinicans" and "AFP Journal Club" sections.

How do you care for patients with chronic LBP? Will this meta-analysis change your practice?

Tuesday, March 31, 2015

Palliative care at the end and the beginning of life

- Kenny Lin, MD, MPH

A troubling study published earlier this year in the Annals of Internal Medicine reported that patients and their caregivers were more likely to report pain, depression, and periodic confusion during the last year of life in 2010 than in 1998. This worsening trend occurred despite increasingly frequent calls to improve end-of-life care communication and the interim publication of practice guidelines on palliative care for adults from the National Consensus Project for Quality Palliative Care and the American College of Physicians. Although the reasons for underutilization of palliative care are not entirely clear, persistent misconceptions about these services being the equivalent of "giving up" on patients or hastening their death likely play a role.

On the other end of the age spectrum, a Close-ups in the April 1st issue of American Family Physician highlighted the benefits of providing palliative care at the beginning of life: in this case, to a baby with trisomy 13 diagnosed by prenatal genetic testing. The devastated parents testified to the importance of their family physician providing support and guidance throughout the pregnancy and after their child's birth:

She helped us understand the decisions we had to make and helped us express our goals for the care of our unborn daughter. We wanted our daughter to have a comfortable life - for however long she lived - and a natural death. At the same time, we wanted as few medical interventions as possible to avoid unnecessarily prolonging her death or suffering.

Although less well-studied than palliative care in adults, critically ill neonates and infants who received palliative care consultations spent fewer days in intensive care units, received fewer blood draws and invasive interventions, and received more referrals to chaplains and social services than comparable patients with life-limiting diagnoses. Perinatal hospice programs take perinatal palliative care one step further and provide compassionate, multidisciplinary support for parents from the time of prenatal diagnosis through the remainder of pregnancy and their child's birth and death. Clinicians who provide maternity and/or newborn care and would like to learn more about perinatal hospice can consult the website, which lists contact information for more than 200 programs across the United States and internationally.

Monday, March 23, 2015

Stop beta-blockers 30 days after acute MI?

- Jennifer Middleton, MD, MPH

Although prescribing a beta-blocker for patients with acute myocardial infarction (AMI) has been dogma for decades, a recent meta-analysis raises serious questions about the benefit - and harms - of continued use afterwards. The March 15 AFP reviews this study that found the benefits of beta-blockade may be limited to 30 days after AMI, and the harms may be greater than previously realized.

The authors of this large meta-analysis identified 60 studies that met their inclusion criteria (randomized controlled trials examining beta-blocker use in patients with AMI); they divided studies into pre-reperfusion-era ("early," before stents, thrombolytics, etc) and reperfusion-era ("modern era"). They found that, while in the early studies, beta-blockers conferred significant survival benefit (incident rate ratio [IRR] 0.86; 95% confidence interval [CI], 0.79-0.94), in the modern era they did not (IRR 0.98; 95% CI, 0.92-1.05). In the modern era, beta-blockers did reduce angina and reinfarction rates, but only in the first 30 days, and they increased the rates of heart failure and cardiogenic shock. The authors hypothesized that reperfusion technologies are so effective nowadays that any added benefit from beta-blockers is minimal.

COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) was by far the largest study in the modern era group; published in 2005, it had 45,000+ participants and found that metoprolol did not reduce the risk of death, reinfarction, or cardiac arrest even in the first few days after AMI. The COMMIT authors did not seem to seek to change practice widely, however, stating only that "it might generally be prudent to consider starting β-blocker therapy in hospital only when the haemodynamic condition after MI has stabilised."

Beta-blocker use following AMI is a Joint Commission Core Measure, and hospitals receive performance incentives for demonstrating that patients admitted with AMI are discharged with a beta-blocker. The American College of Cardiology and the American Heart Association's (ACC/AHA) 2013 Guideline for the Management of ST-Elevation Myocardial Infarction also recommends beta-blocker use after AMI. (The AFP By Topic on Coronary Artery Disease/Coronary Heart Disease includes many additional resources if you'd like to read more.)

The COMMIT trial sought to explore appropriate beta-blocker use immediately after AMI; the Joint Commission and ACC/AHA, similarly, describe recommended practice immediately after AMI. While this new meta-analysis potentially raises questions about beta-blocker use immediately after AMI, the bigger issue is what happens 30 days after AMI, when the risk of harm and lack of benefit are clear. The greatest challenge for family physicians managing patients following up after an AMI admission may be the decision to stop a beta-blocker. Discontinuing therapies may be difficult for physicians; many physicians continue clopidogrel (Plavix) past its recommended 12 months following drug-eluting stent placement, and many patients with asthma remain on controller treatment regimens past the 3 month time when physicians and patients should investigate stepping down that regimen. Inertia can be difficult to overcome, especially when other colleagues and specialities follow other practices. 

Will this meta-analysis change how you care for patients when they follow-up after AMI?