Should we change how we treat mild asthma?

- Jennifer Middleton, MD, MPH

Inhaled corticosteroids are a mainstay for treating asthma; typically, they are prescribed on a scheduled basis, though many patients struggle with adherence. Two new studies may offer an alternative to scheduled inhaled corticosteroid dosing for patients with mild asthma.

As described in the "Top POEMS of 2018 Consistent with the Principles of the Choosing Wisely Campaign," these two randomized controlled trials compared the twice daily, scheduled use of budesonide (Pulmicort) to the as needed use of budesonide/formoterol (Symbicort) in patients with mild asthma. These researchers defined mild asthma as

asthma being uncontrolled while the patient was using short-acting bronchodilators as needed or as asthma that was well-controlled while the patient was using low-dose glucocorticoid or leukotriene-receptor antagonist maintenance therapy plus a SABA [short-acting beta agonist] as needed.

In the Symbicort Given as Needed in Mild Asthma (SYGMA) 1 trial, researchers randomized participants aged 12 years and older into three groups: twice daily placebo with an as needed terbutaline (a SABA) inhaler, twice daily placebo with as needed budesonide-formoterol, and twice daily budesonide with as needed terbutaline. Participants recorded daily peak expiratory flows, asthma symptoms, and nighttime awakenings using an electronic diary, and an electronic inhaler monitor recorded use of their as-needed inhaler. The researchers' primary outcome was "electronically recorded weeks of well-controlled asthma," a composite of all of these variables along with any documented additional prescribing of steroids (inhaled and/or oral). The as needed budesonide-formoterol group was superior to the as needed terbutaline group regarding mean percentage of weeks of well-controlled asthma (odds ratio 1.14, 95% confidence interval [CI] 1.00-1.30). The as needed budesonide-formoterol group was inferior to the maintenance budesonide group regarding weeks of well-controlled asthma (0.64, 95% CI 0.57-0.73), though there was no statistically significant difference regarding the secondary outcome of severe exacerbation occurrences in these two groups.

In the SYGMA 2 trial, the same group of researchers randomized participants aged 12 years and older into two groups to specifically focus on the outcome of severe exacerbations: as needed budesonide-formoterol versus maintenance budesonide. In contrast to the SYGMA 1 trial, where participants received daily reminders to use their inhalers, SYGMA 2 participants received no reminders. The researchers report that their preliminary results found a lower rate of exacerbations than anticipated (possibly because participants' inhaler adherence was also higher than anticipated), resulting in inadequate power with their sample size to demonstrate superiority of one group. They subsequently amended their study protocol to instead demonstrate noninferiority between the groups. The as needed budesonide-formoterol group had a 75% lower median dose of inhaled glucocorticoids than the maintenance budesonide group.

Both SYGMA trials offer the promise of less frequent inhaled steroid use for patients with mild asthma, though the results might not be convincing enough yet to change practice. Better powered studies would be useful to clarify 1) whether the trade-off of decreased steroid exposure is worth somewhat poorer weekly asthma control, and 2) whether there truly is any superiority between as needed budesonide-formoterol compared to maintenance budesonide regarding exacerbation rates. You can count on AFP to report the results of any future research and/or guideline changes; in the meantime, there's an AFP By Topic on Asthma if you'd like to read more (which includes this 2019 FPIN Clinical Inquiry on the use of intravenous magnesium to treat exacerbations in the emergency department).

Using life expectancy and prognosis to support shared decision-making

- Kenny Lin, MD, MPH

Due to competing causes of mortality, the benefits of most screening tests decline with increasing age; for example, screening for breast and colorectal cancers is not recommended in persons with a life expectancy of less than 10 years. However, estimating an individual patient's life expectancy and incorporating that estimate into shared decision-making with patients is challenging. A 2014 U.S. population-based survey found that 31% to 55% of participants with a greater than 75% risk of death in the next 9 years were still receiving breast, colorectal, or prostate cancer screenings.

There are multiple reasons why physicians provide so many unnecessary and potentially harmful screening tests to older persons with limited life expectancies. In an editorial in the September 1 issue of AFP, Dr. Emma Wallace and Norah Murphy observed that "barriers to discussing life expectancy include uncertainty in prognostic estimates, limited time to broach this sensitive topic, and concerns about upsetting the patient or getting negative reactions."

A systematic review of the prognostic value of the "Surprise Question" approach (which asks clinicians, "would you be surprised if this patient died in the next 12 months?") found that the answer has varying degrees of accuracy at identifying patients in their last year of life. The QMortality tool, in contrast, generates a more precise estimate of one-year mortality in persons age 65 to 99 years utilizing multiple clinical and demographic variables, and was found to have good predictive accuracy in 500,000 family practice patients in England.

Some patients may feel uncomfortable about stopping nonbeneficial screening tests even if they are objectively unlikely to benefit from them. In a mailed survey of patients age 50 years or older in the Veterans Affairs health system, nearly 30 percent reported being "not at all comfortable" with discontinuing screening colonoscopy in a hypothetical patient scenario where a colorectal cancer-specific risk calculator predicted a low likelihood of benefit. To help family physicians sensitively incorporate prognostic information into screening discussions, the University of California San Francisco's ePrognosis website provides risk calculators and video examples demonstrating key patient communication skills.

Guest post: AAFP Family Medicine Discovers!

Hello AAFP members!

Family Medicine Discovers seeks to enable practicing family physicians, with little or no research experience, to generate new evidence and innovative models for "what works" in real-world primary care settings. This program is designed for anyone who is curious about conducting research but hasn't had the support to try. Do you have a patient care-inspired question, clinical problem, or clinical conundrum you'd like to investigate? Apply to be an FMD RapSDI Scholar!

What is Family Medicine Discovers?

Family Medicine Discovers is a new scientific signature program offered by the AAFP Foundation in collaboration with the AAFP National Research Network (AAFP NRN). Formally titled, Family Medicine Discovers Rapid Cycle Scientific Discovery and Innovation initiative (FMD RapSDI), its vision is to cultivate scholarship and engagement among community family physicians who may not otherwise have the ability to ask and answer questions derived from their practice. 

Stakeholders from key family medicine organizations in the U.S. have developed a program that allows competitively selected AAFP members (FMD RapSDI Scholars) to research innovative, high impact project ideas that can be conducted in a short time-frame. This investment in the profession seeks to bring together mentors with mentees who will develop and implement research studies and participate in professional development activities related to practice-based research.

What does Family Medicine Discovers offer to scholars?

Selected scholars are awarded a monetary grant to cover costs associated with completing their research projects and/or to offset a portion of the scholar’s salary (up to 20% FTE) to develop and complete a project in 12-18 months. The AAFP NRN will provide scholars with research infrastructure and mentoring support to empower scholars to successfully develop and implement their research projects and to stimulate their professional development. FMD RapSDI Scholars will begin projects on June 1, 2020.

The application period for FMD RapSDI will open September 23, 2019 and run through October 31, 2019. During the open period, the application portal will be accessible here.

This investment in building a robust family medicine research infrastructure will advance knowledge and discovery in our specialty; it will also prepare our specialty for the transformation needed to deliver upon the Quadruple Aim. FMD RapSDI has exceptional potential to advance new evidence and knowledge while fostering a culture shift of what it means to participate in family medicine research.

Please spread the word about this program, and/or consider applying yourself!

For more information, please visit the FMD RapSDI website or contact us at nrn@aafp.org.

Best wishes,

Jen Carroll (Director AAFP NRN) and Christina Hester (Research Director AAFP NRN)

POEMs spotlight tests and interventions to consider avoiding in practice

- Kenny Lin, MD, MPH

In the fourth installment of this annual series, Drs. Roland Grad and Mark Ebell present the "Top POEMs of 2018 Consistent with the Principles of the Choosing Wisely Campaign" in the September 1 issue of American Family Physician. Unlike the official list of Choosing Wisely campaign recommendations produced by the American Academy of Family Physicians and many other medical organizations, these suggested clinical actions were generated from recent research studies whose findings were judged by members of the Canadian Medical Association to help reduce overdiagnosis and overtreatment in practice. Drs. Grad and Ebell reviewed 13 of these POEMs (patient-oriented evidence that matters) in a previous article on the top 20 research studies of 2018 for primary care physicians.

The current review article covers musculoskeletal conditions, respiratory disease, infections, cardiovascular disease, and miscellaneous topics. Here is a handy "cheat sheet":

1. Subacromial decompression surgery does not work.

2. Amitriptyline has no long-term benefits for chronic lower back pain.

3. In adults with mild asthma, as-needed budesonide/formoterol is as effective as a daily inhaled steroid.

4. In children with acute respiratory infections, broad-spectrum antibiotics are not more effective, but cause more adverse events, than narrow-spectrum antibiotics.

5. For chronic sinusitis, saline irrigation helps, and irrigation plus an intranasal steroid may help a little more.

6. A lower threshold for defining high blood pressure may harm patients at low risk for cardiovascular disease.

7. Don't order a high-sensitivity troponin level for a patient with a low pretest likelihood of myocardial infarction.

8. For women with symptomatic postmenopausal atrophic vaginitis, a nonprescription nonhormonal lubricant may be as effective as a vaginal estrogen tablet.

9. In adults with type 2 diabetes, NPH insulin is a cost-effective alternative to insulin analogues.

10. Ibuprofen is as effective as oral morphine for pain relief in children after minor outpatient orthopedic surgery, and has fewer side effects.

11. Skip the bath oil in children with atopic dermatitis.

Many of these overused tests and interventions are based on faulty pathophysiologic reasoning (e.g., if lowering blood pressure somewhat is good, then lowering blood pressure more should be even better). In a recent commentary on overuse in BMJ Evidence-Based Medicine, Drs. David Slawson and Allen Shaughnessy (both POEM authors) argued that "reducing overuse begins with the recognition and acceptance of the potential for unintended harm of our best intentions."

Drs. Slawson and Shaughnessy provided five examples of unintended harms of making medical decisions based on "what ought to work" rather than "what does work": activism gone awry (believing that no one is harmed by screening); innocent bystanders (traumatized loved ones of newborns with false positive screening results); the worried well we create (prediabetes); the butterfly effect (higher motor vehicle accident rates in patients with diabetes due to medication-induced hypoglycemia); and out of Oz and back to Kansas (over-extrapolating from research studies performed in ideal circumstances to real-world practice).