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.

Tuesday, May 31, 2016

Realistic expectations for prostate cancer treatment

- Kenny Lin, MD, MPH

For patients to make informed decisions about treatment for localized prostate cancer, they must receive accurate information about the effects of various therapies and guidance from clinicians who understand their preferences and values. Unfortunately, a study in the May/June issue of Annals of Family Medicine suggested that one or both of these is lacking for many men. Dr. Jinping Xu and colleagues surveyed a population-based sample of 260 men in the metropolitan Detroit area who were newly diagnosed with localized prostate cancer between 2009 and 2010. The survey asked them to estimate how many years they would live without any treatment and with their chosen treatment.

Men greatly underestimated their life expectancy without treatment and overestimated the gain in life expectancy with surgery or radiation. Although 98% of patients with localized prostate cancer who choose active surveillance will not have died from prostate cancer 10 years after diagnosis, only 25% of study participants thought that they would live at least 10 years without treatment. And although the only U.S. study to compare radical prostatectomy to watchful waiting for localized prostate cancer showed no overall or prostate cancer-specific mortality benefit, men in this study who underwent surgery expected to live an average of 12 years longer than if they did not choose surgery. The authors suggested that the typically short time frame for urologists or radiation oncologists to establish patient relationships between diagnosis and treatment discussions may contribute to misconceptions about treatment prognoses. In contrast, they argue that

Primary care physicians, who care for patients over long periods, have the advantage of intimate knowledge of their patients’ approach to clinical decision making and disease management in the course of their prior illnesses. If primary care physicians are included in the decision process following diagnosis, they could begin to focus on helping patients with localized prostate cancer develop realistic expectations and make choices that support their treatment goals.

Whether or not more of these "primary care consultations" have occurred in recent years is unclear, but last week a New York Times story highlighted the increasing number of men with low-risk prostate cancer choosing active surveillance rather than surgery or radiation, from 10-15 percent five years ago to nearly half of men today. Delaying or avoiding the adverse effects of traditional therapies should ultimately reduce the burden of urinary incontinence and sexual dysfunction in many prostate cancer survivors. An article in the May 1st issue of AFP reviewed key American Cancer Society recommendations for primary care of the prostate cancer survivor, including monitoring for common physical and psychosocial issues and encouraging healthy lifestyle choices.

Monday, May 23, 2016

Preventing cancer with lifestyle counseling

- Jennifer Middleton, MD, MPH

You may have heard about a study examining the correlation among lifestyle habits and cancer that has been making headlines in both the medical and lay press this past week; the researchers found that individuals who met their criteria of a "healthy lifestyle pattern" had significantly lower risk of developing multiple types of cancers. This finding should further bolster our efforts to provide lifestyle counseling to our patients.

The study researchers examined data from the Nurses' Health Study (NHS) and the Health Professionals Follow-up Study (HPFS), both large U.S. population cohorts. The NHS has been following female nurses since 1976, and the HPFS has been following male health professionals since 1986. Both cohorts are composed of entirely white individuals. The researchers divided each cohort into two groups: those enrollees who met 4 criteria for a "healthy lifestyle pattern" (never smoked or less than 5 pack-years of smoking, no or moderate alcohol intake, BMI between 18 and 27.5, and at least 75 minutes of vigorous aerobic activity a week and/or 150 minutes of moderate physical activity a week) and everyone else, that is, those who did not meet all 4 criteria and therefore fell into the "high risk group." Since they assumed that even the high risk group might still follow healthier behaviors compared to the general population, given that the cohort enrollees all worked in the health professions, they also compared their findings against the U.S. white population as a whole.

The researchers included most cancers in their analyses but excluded skin, brain, lymphatic, and hematopoietic cancers ("because these cancers likely have other strong environmental causes"), along with non-fatal prostate cancers ("given the concern for prostate-specific antigen screening"). 18.5% of the women fell into the healthy lifestyle group, compared to 25.3% for men. 4.6% of the women in the healthy lifestyle group developed cancer compared to 6.2% of women in the high risk group and 7.9% of women in the general US white population; 2.8% of the men in the healthy lifestyle group developed cancer compared to 4.3% in the high risk group and 7.6% in the general US white population. The risk of mortality from cancer follows a similar trend for both genders. The numbers that have been widely quoted in the media in the last week, the population attributable risk, suggests a 20-40% lower cancer incidence and an approximately 50% lower cancer mortality rate among the healthy lifestyle groups compared to the high risk groups. It's not necessarily unreasonable to extrapolate these results to non-white populations, but hopefully future studies will include a more diverse population.

It's important to remember that cohort studies can demonstrate an association or correlation between risk factors and disease, but they cannot definitively prove causation in and of themselves. Regardless of this caveat, the media coverage of this study (which rarely seems to include this point) may still spur more patients to discuss lifestyle counseling with us. The current issue of AFP reviews the recent United States Preventive Services Task Force (USPSTF) recommendations regarding tobacco smoking cessation, which serves as a good reminder that even brief behavioral interventions can help our patients quit smoking. Physicians and their staff can maximize the efficacy of behavioral interventions by providing them repeatedly, since the intensity of counseling does correlate with quit rates. Providing nicotine replacement therapy is also an effective option for helping patients quit.

Many patients may already connect tobacco use with an increased risk for cancers, but I suspect few relate excessive alcohol use, obesity, and/or lack of exercise to an increased cancer risk. Discussing this study's findings with patients may help encourage lifestyle changes, since fear of developing cancer generally ranks quite high among our patients' health concerns. Here are some recent AFP articles that provide additional information regarding counseling for excessive alcohol use, obesity, and exercise. For more in-depth reading, check out the AFP By Topics on Alcohol Abuse and DependenceObesity, and Health Maintenance and Counseling.