Monday, June 27, 2016

Is the best colorectal cancer screening test the one that gets done?

- Kenny Lin, MD, MPH

In 2008, the U.S. Preventive Services Task Force recommended routinely screening adults aged 50 to 75 years for colorectal cancer using fecal immunochemical testing (FIT), flexible sigmoidoscopy, or colonoscopy. At that time, it did not endorse two newer strategies, computed tomographic (CT) colonography and fecal DNA testing. But data from the National Health Interview Survey indicated that in 2013, only 60 percent of non-Hispanic white adults in the target age group was up-to-date on one of the three recommended colorectal cancer screening tests, with lower percentages for ethnic and racial minorities. Proponents of CT colonography and fecal DNA testing argued that more widespread insurance coverage of these "noninvasive" tests could potentially increase screening rates.

Earlier this month, JAMA published a USPSTF-commissioned systematic review of more recent studies and an analytic modeling study that compared the effects of different screening tests and strategies. The Task Force's updated recommendation statement said to screen adults aged 50 to 75 years, but expressed no clear preference about the "best" test or tests. A Figure that accompanied the statement showed that assuming perfect adherence, each screening strategy produces a similar number of life-years gained, with a colonoscopy-first strategy predictably leading to more total colonoscopies and procedure-related harms. Rather than recommending that eligible patients undergo a specific test, the USPSTF advised:

Given the lack of evidence from head-to-head comparative trials that any of the screening strategies have a greater net benefit than the others, clinicians should consider engaging patients in informed decision making about the screening strategy that would most likely result in completion, with high adherence over time, taking into consideration both the patient’s preferences and local availability.

Shared decision making is all well and good, but I am concerned about the communication challenges of expanding my standard discussion of colorectal cancer screening options from FIT versus colonoscopy (since physicians in my area no longer perform flexible sigmoidoscopy for colorectal cancer screening) to choosing between FIT, fecal DNA, CT colonography, and colonoscopy. I wish that the Task Force had provided more practical guidance about how primary care physicians can help individual patients select the "best" test for them.

Surprisingly for a group that typically has required the highest degree of evidence to justify an "A" rating, the USPSTF did not emphasize stool guaiac testing and flexible sigmoidoscopy, the only screening strategies that have reduced colorectal cancer deaths in randomized controlled trials. Earlier this year, the Canadian Task Force on Preventive Health Care did not recommend screening colonoscopy because it had not met that standard. (As Dr. Rita Redberg wrote in an editorial published simultaneously in JAMA Internal Medicine, "It would be interesting to know how many patients would undergo colonoscopy if they knew that there were no data to suggest that this procedure results in longer life.")

Finally, although the USPSTF reiterated that it "does not recommend routine screening for colorectal cancer in adults age 86 years and older," it omitted its previous "D" (don't do) recommendation against this unnecessary and potentially harmful practice. I think that this was a mistake. Plenty of octo- and nonagenarians still receive colorectal cancer screening tests; in a 2015 editorialAFP editor Jay Siwek related his 90 year-old father-in-law's complications from a "routine" colonoscopy as an example of the harms caused by overscreening. The best test isn't only the one that gets done, but gets done in a patient who has a chance of benefiting from that test.

Monday, June 20, 2016

Chronic opioid therapy - who, when, how?

- Jennifer Middleton, MD, MPH

A significant portion of the June 15 issue of AFP is devoted to chronic opioid use in patients with non-malignant pain. The issue provides an overview of Weighing the Risks and Benefits of Chronic Opioid Therapy along with reviewing the Centers for Disease Control's (CDC) new guideline for opioid prescribing with accompanying editorials from the CDC and the American Medical Association (AMA). The messages from these sources are consistent: the evidence base supporting the efficacy of chronic opioid use is limited but certainly some patients benefit, other modalities should be our first choice when possible, and monitoring for misuse or addiction is of critical importance. None of these recommendations are likely to come as a surprise to family physicians, but the challenges with identifying the right patients to treat, being aware of alternative modalities to offer, and providing effective monitoring may still remain for many practices.

The Risks and Benefits article provides guidance regarding the initiation, maintenance, and discontinuation of chronic opioid therapy. Assessing for risk of overdose and counseling patients regarding risks of opioid use are reviewed in Tables 3 and 4. Patients at lower risk of overdose, who have failed alternative treatments, and are willing to comply with ongoing monitoring are more ideal candidates for chronic opioid therapy.

Alternatives to using opioids for treating chronic pain have been studied with various degrees of rigor depending on the underlying source or cause. For chronic low back pain, several non-pharmacologic methods have evidence of at least short-term efficacy, but, unfortunately, acetaminophen does not  help in the short- or long-term, and NSAIDs should be used with caution.

Physical therapy and tai chi help knee osteoarthritis (OA) pain as does general exercise and weight loss; corticosteroid injections may help, though hyaluronic acid injections and glucosamine/chondroitin supplements don't. For upper body OA sites, splinting reduces hand pain, and corticosteroid injections and manipulation can help shoulder pain.

Exercise reduces fibromyalgia symptoms, and aquatic therapy helps stiffness and quality of life but doesn't necessarily reduce pain. Counseling, especially cognitive behavioral therapy, can be quite beneficial for patients with fibromyalgia, and several non-opioid medications can also provide some relief. The data to date for opioids in treating the chronic pain of fibromyalgia does not show any benefit.

A Family Practice Management (FPM) article from 2014 reviews helpful office protocols for monitoring patients on chronic opioids. The authors share their office policies for prescribing controlled substances, including opioids, and also discuss the use of patient pain questionnaires, risk assessment tools such as SOAPP, controlled substance agreements, urine drug screening, and prescription drug monitoring programs. Each office will want to tailor its plan to best meet its population's needs, but there are a lot of useful resources in this article to help you do so.

Identifying the most appropriate patients for chronic opioid therapy, trying alternative treatments, and monitoring patients can be challenging and time-intensive and, ideally, engages your entire office team. For more resources, there's an AFP By Topic on Pain:Chronic that includes the above referenced AFP and FPM articles and also includes information about neuropathic pain, more office-based tools, relevant Curbside Consultation features, and patient education materials.

Monday, June 13, 2016

Steroids for severe community-acquired pneumonia: ready for prime time?

- Kenny Lin, MD, MPH

A generation ago, one of the major controversies in infectious disease was whether or not to prescribe early adjunctive corticosteroids in addition to antibiotics for AIDS patients with presumed pneumocystis pneumonia. Advocates of steroids argued that they would improve outcomes by reducing the body's damaging inflammatory response, but opponents expressed concerns that further suppressing an already impaired immune system could increase the risk for other opportunistic infections. The advocates turned out to be right, as summarized in a 1990 National Institutes of Health consensus statement and this more recent FPIN Clinical Inquiry based on a Cochrane review of six randomized controlled trials that showed decreased mortality in patients receiving steroids.

The debate occurring today is whether steroids benefit patients with severe community-acquired pneumonia (CAP) from other causes. Commenting on a 2015 meta-analysis of 12 trials published in the Annals of Internal Medicine, Dr. Marcos Restrepo and colleagues asserted that it was "time to change clinical practice" and routinely use steroids in patients with severe CAP, with the major research question being how to identify these patients accurately and efficiently. On the other hand, the authors of the Medicine By The Numbers on this topic in the June 1st issue of AFP felt that the supporting evidence was less definitive:

No large, multicenter, methodologically rigorous trials on this topic have been published, making results inconclusive. Small trials like the ones included [in the
Annals review] have significant potential to exaggerate effects, suggesting that large, well-designed trials have the potential to override the findings.

In exchange for 1 in 29 patients developing transient hyperglycemia due to steroids, 1 in 20 avoided mechanical ventilation, 1 in 16 avoided acute respiratory distress syndrome, and there was a nonsignficant trend toward mortality reduction. Drs. Jonathan Fu and Gary Green concluded that "improvements in two patient-oriented outcomes, and no major patient-oriented harms established thus far suggest it may be reasonable to use corticosteroids in patients with CAP while awaiting further data."

Monday, June 6, 2016

Have your female patients asked you about ROCA?

- Jennifer Middleton, MD, MPH

Smiling pictures of women greet visitors to the ROCA website along with infographics about ovarian cancer and a brief video describing the utility of ROCA in detecting ovarian cancer. The website describes that ROCA is intended as a "routine test" for post-menopausal women and extols that it is "the only test proven to detect ovarian cancer at an early stage." A "purchase the test" button figures prominently at the top corner of the home page, and it's not hard to imagine that many of our female patients might be tempted to do so. Unfortunately, rigorous study cannot yet validate these claims, and pitching this test directly to consumers sets a worrisome precedent.

The current issue of AFP covers the topic of ovarian cancer in detail, including an article on the Diagnosis and Management of Ovarian Cancer along with two editorials on ovarian cancer screening, one by representatives of the Ovarian Cancer Research Fund Alliance and one by AFP editor Dr. Jay Siwek. The first editorial describes the study that investigated the ROCA screening algorithm, and while there were many strengths to the study, Dr. Siwek in the second editorial rightly points out several concerns.

The Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) trial enrolled over 200,000 women in the United Kingdom and followed them for a median of 11 years. Participating women were randomized to one of three groups: annual multimodal screening (MMS) using ROCA, annual transvaginal ultrasound screening, or no screening. Although the authors found that the MMS group had a morality reduction compared to the other two groups after at least 7 years of annual screening, overall mortality among the three groups across the entire time period of the trial did not differ significantly. The authors themselves concluded that:

Further follow-up is needed to assess the extent of the mortality reduction before firm conclusions can be reached on the long-term efficacy and cost-effectiveness of ovarian cancer screening.

This conclusion is responsibly consistent with the published trial data, yet ROCA is still being sold to women with the promises described above. Offering a screening test directly to consumers prior to establishing its clinical utility is presumptuous at best and exploitative at worst; hopefully our patients will discuss ROCA with us prior to spending $295 on it. It will be up to us to discuss the shortcomings of this test, and ovarian cancer screening in general, with our patients.

Ovarian cancer remains the deadliest gynecologic cancer, largely because screening tests have been ineffective to date. The UKCTOCS trial is unlikely to change the current United States Preventive Services Task Force (USPSTF) D recommendation for ovarian cancer; to date, no screen has convincingly demonstrated decreased mortality, and screening can cause serious harm due to unnecessary surgical interventions for patients with false positive results. While the promise of ROCA holds understandable appeal, Dr. Siwek wisely advises us to "avoid the pitfalls of overscreening and wait for results that promise more hope than hype."

There's an AFP By Topic on Health Maintenance and Counseling if you'd like to read more on preventive care measures that are effective, and AFP's Choosing Wisely tool provides a useful review of the evidence base against ineffective screenings (such as those for ovarian cancer). As family physicians, we should continue to focus our preventive care on interventions that are proven to decrease mortality.