Often, new treatments are no better than old ones

- Kenny Lin, MD

A recent systematic review and meta-analysis from the Cochrane Collaboration broke new ground in evaluating not one intervention or group of interventions for a single health condition, but the more general question of whether new treatments are more effective than established ones. The authors analyzed data from four cohorts of publicly funded trials of cancer treatments, treatments for neurological problems, and treatments for mixed diseases. In this sample, they found that slightly more than half of new treatments turned out to be better than old ones, but not by much: primary outcomes were just 9 percent better with the new treatments, and mortality fell by only 5 percent.

To make it easier for family physicians to compare new treatments to old ones, AFP publishes the STEPS (Safety, Tolerability, Effectiveness, Price, and Simplicity) series of new drug reviews. The October 15th issue includes a STEPS review of rivaroxaban (Xarelto), a new oral anticoagulant that is indicated to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation. Under Effectiveness, the review notes: "Rivaroxaban was as effective as warfarin at preventing stroke and systemic embolism, and reduced annual stroke rates to 2.1 percent, compared with 2.4 percent for warfarin. No trials have compared rivaroxaban with dabigatran (Pradaxa), a direct thrombin inhibitor, or with fondaparinux (Arixtra), an injectable factor Xa inhibitor." Rivaroxaban does not require laboratory INR monitoring like warfarin, but costs more than 40 times as much. Family physicians and patients will need to decide whether this relatively small benefit is worth the increased cost of this new drug compared to the old.

Why don't comparative effectiveness studies change clinical practice?

- Kenny Lin, MD

The October 1st issue features the third article in AFP's new series "Implementing Effective Health Care Reviews," a summary of the Agency for Healthcare Research and Quality's comparative effectiveness report on treatments for gastroesophageal reflux disease. Notably, the report found no differences in efficacy between proton pump inhibitors; better symptom relief from continuous daily compared with on-demand dosing; and limited data on endoscopic treatments. What are the chances that results from this and other high-quality comparative effectiveness studies will quickly change your practice? Not very good, unfortunately. As I wrote in an editorial that introduced the series:

To date, the track record of translating comparative effectiveness research findings into clinical practice has been mixed, at best. For example, several years after a landmark randomized controlled trial demonstrated the superiority of thiazide diuretics compared with other first-line medications for hypertension, prescribing of thiazide diuretics had increased only modestly. An evaluation of diabetes practice guidelines produced after the publication of an Effective Health Care review of oral treatments found numerous inconsistencies between guideline recommendations and evidence-based conclusions. Despite extensive evidence that initial coronary stenting provides no advantages over optimal medical therapy for stable coronary artery disease, more than one-half of patients who undergo stenting in the United States have not had a prior trial of medical therapy.

In the October issue of Health Affairs, Justin Timbie and colleagues propose five reasons that scientific evidence is slow to change how physicians practice:

1) Misalignment of financial incentives - e.g., fee-for-service payment systems tend to reward invasive therapies, such as surgery for back pain, that may be no better than conservative management.

2) Ambiguity of results - "Without consensus on evidentiary standards prior to the release of comparative effectiveness results, ambiguous results become fuel for competing interpretations, making it difficult for providers, insurers, and policy makers to act on the evidence."

3) Cognitive biases in interpreting new information - e.g., a tendency to reject evidence that contradicts previous strongly held beliefs, such as the superiority of atypical to conventional antipsychotics.

4) Failure to address the needs of end users - e.g., designing a study to compare the benefits of two therapeutic strategies, but not the harms.

5) Limited use of decision support - e.g., poorly designed electronic or paper patient decision aids that do not fit into the workflow of primary care practices.

Do these reasons sound about right to you? How do you think these obstacles could be overcome in order for front-line family physicians to rapidly incorporate the best scientific evidence into their practices?

Who should receive medications for influenza?

- Kenny Lin, MD

Flu season is coming soon, and in addition to familiarizing themselves with the Advisory Committee on Immunization Practices vaccination guidelines for the 2012-13 season (offer influenza vaccine to everyone 6 months of age or older), physicians should consider how they plan to diagnose patients with suspected influenza. Despite the availability of multiple antiviral medications for influenza, whom to treat remains a challenging question.

In a 2010 Cochrane for Clinicians commentary, Dr. William E. Cayley observed that the neuraminidase inhibitors oseltamivir and zanamivir provided limited benefits for prevention and treatment of otherwise healthy persons with influenza. However, this conclusion was based on incomplete data - that is, results from published trials only. Subsequently, the Cochrane review authors were able to access several unpublished "clinical study reports" from the manufacturers and modified the review to reflect these additional data. In an updated Cochrane for Clinicians, published in the October 1st issue of AFP, Dr. Cayley finds that the evidence no longer supports using neuraminidase inhibitors to prevent influenza transmission:

The authors found that, based on clinical study reports, treatment with oseltamivir reduced the likelihood of an antibody response to influenza, the diagnostic marker that is typically used to determine the effectiveness of prophylaxis. In the absence of another way to measure the effectiveness of oseltamivir prophylaxis, it is uncertain whether the medication reduces the risk of influenza transmission.

Even for treatment of persons with influenza, the benefits of antivirals are modest: oseltamivir reduced the duration of symptoms by less than one day and had no effect on hospitalizations. Since these medications have side effects, physicians may reserve their use for persons at higher risk of complications, such as those with asthma or other chronic respiratory problems. As Dr. Cayley notes, existing guidelines are only as good as the evidence that supports them - and in the case of influenza treatments, not very good at all:

The contrast between the limited positive findings of this review and the strong support for treatment with neuraminidase inhibitors in public health guidelines (such as those from the CDC) highlights the importance of ongoing assessment of such recommendations and related educational materials, especially when evidence to support widespread implementation of an expensive intervention is lacking.

The spiritual assessment in family medicine: unnecessary or essential?

- Kenny Lin, MD

Since it became possible to post online comments on AFP content earlier this year, no single article has prompted as many comments as "The Spiritual Assessment," published in the September 15th issue. The range of comments thus far reflects family physicians' diversity of views on this topic. For example, while one reader opined that spiritual concerns have "little to do with improving the health of our patients," another countered, "I do not think this article goes far enough in promoting this type of spiritual health assessment." Another reader argued that the spiritual assessment should "not be elevated to the status of another vital sign we must always take." Some readers expressed concerns that physicians might seek to impose their religious beliefs on vulnerable patients, while another suggested that "many physicians seem to have more fear of [discussing] spiritual issues than the patients do."

In the article, Drs. Aaron Saguil and Karen Phelps suggest assessing older patients, hospitalized patients, and patients with worsening or terminal illness, who are more likely to be interested in sharing their spiritual or religious beliefs. Other patients may bring up their faith or spiritual practices without prompting in the course of a normal conversation. Since 80 percent of patients and family physicians perceive religion to be important, according to the authors, acknowledging and supporting spiritual beliefs is a key component of holistic, patient-centered care:

The spiritual assessment allows physicians to support patients by stressing empathetic listening, documenting spiritual preferences for future visits, incorporating the precepts of patients' faith traditions into treatment plans, and encouraging patients to use the resources of their spiritual traditions and communities for overall wellness. Conducting the spiritual assessment also may help strengthen the physician-patient relationship and offer physicians opportunities for personal renewal, resiliency, and growth.

We invite other readers to share their perspectives on the role of the spiritual assessment in family medicine by posting a comment on the article, posting a comment to this blog, or sending an e-mail to afpcomment@aafp.org.

What works for patients with irritable bowel syndrome?

- Kenny Lin, MD

A lot of treatments do, according to a review article by Thad Wilkins, MD and colleagues in the Sept. 1 issue of American Family Physician. Most effective appear to be regular exercise, antibiotics, antispasmodics, peppermint oil, and probiotics. Less effective (increase stool frequency but not pain) are over-the-counter antidiarrheals and laxatives. Fiber is no more effective than placebo. Other treatments that can provide some benefit include antidepressants, psychological therapies, and lubiprostone. With this many options to choose from, the challenge for physicians is selecting treatments that are most likely to benefit individual patients. The authors suggest classifying irritable bowel syndrome as diarrhea-predominant, constipation-predominant, or mixed presentation to guide initial and subsequent choices. Forming a therapeutic alliance with patients is critical, since IBS symptoms often recur despite treatment, and "a positive patient-physician interaction is associated with fewer return visits for IBS and is a key component in the treatment of these patients." A freely accessible handout for patients summarizes the most common treatments and provides additional informational resources.

Screening for chronic kidney disease

- Kenny Lin, MD

In patients without diabetes or hypertension, there is not enough evidence to assess benefits and harms of screening for chronic kidney disease with a serum creatinine level or urine albumin testing, the U.S. Preventive Services Task Force reported yesterday. A 2011 AFP article on chronic kidney disease detection and evaluation noted that multiple organizations recommend screening in patients with cardiovascular disease or diabetes, and a systematic review performed to support the USPSTF recommendation found that angiotensin-converting enzyme inhibitors slowed progression to end-stage renal disease and decreased mortality if prescribed in the early stages of this condition. However, few studies included patients without diabetes or hypertension.

For family physicians, the bottom line from this recommendation is that there is no clinical indication for ordering a basic metabolic profile or urinalysis in an asymptomatic patient as part of a preventive health evaluation. Ordering such unnecessary tests frequently does more harm than good, and has been discouraged by the AAFP-supported Choosing Wisely initiative and a previous AFP editorial.

Prescribing opioids for chronic pain: avoiding pitfalls

- Kenny Lin, MD

For years, family physicians who treat patients with chronic nonterminal pain have been caught between a rock and a hard place: national surveys show that chronic pain is undertreated, but opioids often have serious adverse effects and can lead to dependence, addiction, and abuse. A recent AFP review article advised comprehensive assessments for patients with chronic pain, careful patient selection using an opioid risk tool, and use of written agreements that "outline appropriate intervals for follow-up, refill policies, participation in any indicated multimodal management plan (e.g., physical therapy, psychological treatment), use of only one prescriber and one pharmacy for all controlled medications, and prohibition of illicit substance use or prescription diversion." In July, the U.S. Food and Drug Administration, in consultation with the AAFP, required that manufacturers of prescription opioids pay to support new voluntary educational programs for clinicians and patient education materials designed to reduce opioid misuse and its consequences.

An editorial in this week's Archives of Internal Medicine questioned whether there is a true difference between opioid "dependence" and "addiction," noting that a Washington state law that limited the amount of opioid that can be prescribed for chronic pain led to many patients experiencing persistent withdrawal effects after being tapered to lower doses. The authors concluded: "Dependence on opioid pain treatment is not, as we once believed, easily reversible; it is a complex physical and psychological state that may require therapy similar to addiction treatment, consisting of structure, monitoring, and counseling, and possibly continued prescription of opioid agonists." What has been your experience in prescribing opioids for patients with chronic nonterminal pain?