Tuesday, August 14, 2018

Overdiagnosis in lung cancer screening: don't tell, don't ask?

- Kenny Lin, MD, MPH

Although the U.S. Preventive Services Task Force recommended in 2013 that current and recent smokers 55 to 80 years of age with at least a 30 pack-year history receive annual low-dose CT screening for lung cancer, family physicians have been slow to implement this recommendation in their practices. Concerns about this screening test include the quality of the supporting evidence (which the American Academy of Family Physicians judged to be insufficient) and potential harms, including overdiagnosis and overtreatment of tumors that, left undetected, would never have caused symptoms during a patient's lifetime. An analysis of the National Lung Cancer Screening Trial (NLST) suggested that one in five lung cancers were overdiagnosed. In recognition of the balance of benefits and harms of lung cancer screening, the Centers for Medicare & Medicaid Services requires that eligible patients first have a "counseling and shared decision making visit" with a clinician that utilizes a patient decision aid prior to undergoing a scan.

A previous study of screening for other cancer types found that clinicians mentioned overdiagnosis as a potential harm less than 10 percent of the time. Are lung cancer screening discussions any different? In a study published this week in JAMA Internal Medicine, researchers evaluated shared decision making (SDM) using the validated Observing Patient Involvement in Decision Making (OPTION) scale in a sample of transcribed physician-patient conversations. Relative to the mean total visit length (just over 13 minutes), physicians spent a mean of 59 seconds discussing lung cancer screening. None of the conversations mentioned decision aids, and the mean total OPTION score was 6 out of 100 (where 0 indicates no evidence of SDM and 100 indicates SDM at the highest skill level), reflecting that physicians rarely informed patients about harms of low-dose CT scans or asked patients how they valued these harms.

This lack of attention to harms of lung cancer screening is concerning because the magnitude of overdiagnosis may be considerably higher than previous estimates. Researchers recently analyzed data from the Danish Lung Cancer Screening Trial, in which participants underwent 5 annual low-dose CT screenings (compared to 3 in the NLST) and concluded that two-thirds of lung cancers were likely overdiagnosed. In an accompanying commentary that compared the methods used to estimate overdiagnosis, AFP Deputy Editor Mark Ebell, MD, MS and I stressed the importance of communicating with patients about this "often underappreciated harm of screening":

Patients can make informed choices about low-dose CT only if practitioners fully disclose all the potential harms of screening, including the risk of overdiagnosis. It will be important to researchers to continue to refine estimates of lung cancer overdiagnosis, allowing physicians to provide more accurate information to our patients.

To best serve patients, primary care physicians and pulmonologists must do better than 59-second conversations about lung cancer screening that only mention potential benefits. We need to take the time to tell patients about harms such as overdiagnosis, and ask them how they value these harms relative to the benefits, before ordering the scan.

Monday, August 6, 2018

Overcoming rhinitis adherence challenges

- Jennifer Middleton, MD, MPH

The current issue of AFP includes an overview of "Chronic Nonallergic Rhinitis" (the newer term for "vasomotor rhinitis"). The article includes tips to distinguish allergic from nonallergic rhinitis along with treatment regimens. Many of the medications that are useful for allergic rhinitis are also useful for nonallergic rhinitis, including intranasal corticosteroids, intranasal antihistamines, oral decongestants - with the addition of intranasal ipratropium for nonallergic symptoms. Unfortunately, patient adherence to these intranasal medications tends to be low.

For many patients, rhinitis symptoms are inconsistent and episodic, waxing and waning with seasonal changes and exposure to triggers. While not taking intranasal medications when symptoms and triggers are absent may be reasonable, taking them only when symptoms are severe (and not more moderate) can result in decreased efficacy, increased physician visits, and increased healthcare costs. Many intranasal medications for rhinitis also have unpleasant tastes and smells that can affect adherence. Cost is another factor; some of these medications are not available in generic versions and can be expensive. Interestingly, personality type and gender may also correlate with intranasal medication adherence; in one study, men with higher "neuroticism" scores were less adherent to allergy medications, while men with higher "agreeableness" or "conscientiousness" scores were more adherent. Among women in this same study, however, personality traits did not correlate with adherence.

Knowing when patients are not using their intranasal medications is important to accurately assess treatment efficacy as well as the risk of worsening co-morbid conditions like asthma. The Allergic Rhinitis Treatment Satisfaction and Preference (ARTSP) scale provides information about a patient's preferences regarding intranasal treatment, which can guide physician and patient decision-making regarding specific medications. Prescribing an intranasal medication with characteristics that patients prefer (odor, taste, comfort, delivery device, cost) may increase adherence. Other solutions for increasing adherence include problem-solving solutions to identified barriers with patients and using text messaging to send patients daily reminders to use their intranasal medications.

You can read more about rhinitis treatment by using this AFP keyword search. There's also an AFP By Topic on Allergy and Anaphylaxis, which includes this reference on "Diagnosing Rhinitis: Allergic vs. Nonallergic" and an Allergic Rhinitis Treatment Guideline from 2015.

Tuesday, July 31, 2018

Help your patients achieve food security with SEARCH

- Kenny Lin, MD, MPH

As screening for social determinants of health in clinical settings "moves from the margins to the mainstream," research has focused on how to efficiently identify and address social needs in practice. An article in the May/June issue of FPM by Drs. David O'Gurek and Carla Henke provided a suite of practical approaches, including tools, workflow, and coding and payment considerations. Dr. Sebastian Tong and colleagues reported the experiences of primary care clinicians screening for social needs in 12 northern Virginia practices in the Journal of the American Board of Family Medicine. Knowledge of a social need changed care delivery in 23% of patients and improved communication in 53%, but clinicians often felt ill-equipped to help patients with identified needs or connect them to appropriate services.

Help is on the way. The American Academy of Family Physicians (AAFP) recently launched an interactive online tool, the Neighborhood Navigator, to make it easier for family physicians to connect patients with community organizations and social services. This tool complements other resources in the AAFP's EveryONE Project to support patients' health outside of the office that Dr. Jennifer Middleton discussed in a previous Community Blog post.

In the August 1 issue of American Family Physician, Dr. Shivajirao Prakash Patil and colleagues review the problem of food insecurity, defined as "limited availability of nutritionally adequate and safe food or the inability to acquire these foods in socially acceptable ways," which affected an estimated 12% of American households in 2016. According to the authors, food insecurity (FI) has a cyclical relationship with chronic disease, constraining dietary options in ways that increase the risk for development and progression of diseases in children and adults. They recommend that family medicine practices follow the SEARCH mnemonic and utilize food security resources and food assistance programs in appropriate patients:

S (Screen) - "An affirmative response to either of the following statements can identify FI with 97% sensitivity and 83% specificity: (1) Within the past 12 months we worried whether our food would run out before we got money to buy more, and (2) Within the past 12 months the food we bought just didn't last, and we didn't have money to get more."

E (Educate) - "Educate patients at risk of FI about appropriate coping strategies. Although some individuals with limited resources manage without major disruptions to food intake, many eat less or eat less healthy foods to get by."

A (Adjust) - "Adjust the patient's medication if it should be taken with food. Prescribe medications that minimize the likelihood of hypoglycemia for patients with FI who have diabetes."

R (Recognize) - "Recognize that FI is typically recurrent but is usually not chronic."

C (Connect) - "Connect patients with assistance programs and encourage patients with FI to use food banks."

H (Help) - "Help other health care professionals recognize that poor health and FI often exacerbate one another."

Family physicians can also choose to advocate to improve the quality and quantity of food resource programs available in their communities and across the nation.

Monday, July 23, 2018

Top Infectious Disease POEMS of 2017

- Jennifer Middleton, MD, MPH

The current issue of AFP includes the "Top POEMS of 2017 Consistent with the Choosing Wisely Guidelines," an annual round-up of practice-changing studies for family physicians from the last year. 14 POEMs are described in detail (along with 7 more in eTable A). 3 of these practice changers deal with common outpatient infections: oral corticosteroids don't help acute wheezing in adults without asthma, tympanostomy tubes don't improve hearing outcomes in children with recurrent acute otitis media (AOM) or chronic otitis media with effusion (OME), and adding trimethoprim/sulfamethoxale (TMP/SMX) to cephalexin doesn't improve outcomes for adolescents and adults with uncomplicated cellulitis.

The authors of the first study discuss the desirability of avoiding antibiotics for viral lower respiratory tract infections (LRTI), and having an alternative to offer patients may help decrease unnecessary antibiotic prescriptions. Unfortunately, 5 days of prednisolone did not improve the duration or severity of cough or wheezing compared to placebo in this multi-center, randomized controlled trial (RCT) of 401 adults without asthma in the United Kingdom. For now, conservative measures such as rest, fluids, honey (in children over 1 year of age), and antitussives (only in patients older than 6 years) will have to suffice for patients with LRTI as reviewed in this 2010 AFP article on "Diagnosis and Treatment of Acute Bronchitis."

A meta-analysis of 18 RCTs found no difference in hearing after tympanostomy tube placement in children with either recurrent AOM or chronic OME after 12-24 months with age-matched controls. Nearly 7% of US children have had tympanostomy tubes placed, making it the most common ambulatory surgery performed on children in the US at a mean cost of $769 per surgery. That's a lot of parental concern, patient discomfort, and expense for a procedure that's not improving outcomes. This AFP Clinical Evidence Handbook article reminds us that, without antibiotics, AOM symptoms resolve in 80% of children within 3 days. Searching AFP by the keyword "otitis" yields several other useful review articles.

An RCT of 496 patients aged 12 years and older across 5 US emergency departments found no difference in clinical cure rates between patients with uncomplicated cellulitis treated only with cephalexin and patients treated with both cephalexin and TMP/SMX. Dr. Lin discussed this study last year on the blog, reminding us that reducing unnecessary antibiotic prescriptions is an important step to reducing antibiotic resistance. (Patients with a skin abscess requiring incision and drainage, however, may benefit from either oral clindamycin or TMP/SMX.)

Changing established practice habits can be challenging; tools such as office QI projects and pre-visit planning may help, along with using motivational interviewing when patients request inappropriate treatments and using electronic health system reminders. This 2016 AFP editorial reviews "How to Prescribe Fewer Unnecessary Antibiotics: Talking Points that Work With Patients and Their Families." I've added that editorial and the Top POEMS of 2017 article to my AFP Favorites page for quick future reference.

Tuesday, July 17, 2018

Best practices for preventing gun violence in the clinic and the community

- Kenny Lin, MD, MPH

Family physicians have long recognized that gun violence is a national public health epidemic. In 2015, a coalition of nine medical, public health, and legal organizations, including the American Academy of Family Physicians and the American Bar Association, endorsed several specific recommendations for preventing firearm-related injury and death. These measures included universal criminal background checks for all firearm purchases; educating patients about gun safety and intervening in those at risk of self-harm or harm to others; improving access to mental health care; regulating civilian use of firearms with large capacity magazines; and supporting more research on evidence-based policies to prevent gun violence. A 2014 editorial in AFP also reviewed the role of primary care clinicians in counseling about gun safety based on the best available evidence.

After the February massacre of 17 people at Marjory Stoneman Douglas High School in Parkland, Florida by a 19 year-old former student wielding a legally purchased semiautomatic AR-15-style rifle, the medical editors of AFP felt that we needed to do more to empower clinicians. Surely, when the Founding Fathers endorsed the necessity of a "well-regulated Militia" in the Second Amendment to the U.S. Constitution, they did not envision mentally disturbed teenagers toting weapons with enough firepower to overwhelm entire regiments of Minutemen.

In a special editorial recently published online ahead of print, Dr. Sexton and the AFP medical editors argue that family medicine's emphasis on care of the whole person creates a duty to "confront the epidemic of violence by persons using guns." We review the evidence of the effects of firearm regulations, mental health counseling, and active shooter training on gun safety and violence. Unfortunately, evidence for many interventions remains limited:

A 2018 RAND review of U.S. studies on gun policy published since 2003 concluded that child-access prevention laws (e.g., safe gun storage) reduce self-inflicted and unintentional firearm deaths and nonfatal injuries among youth, and may reduce unintentional firearm injuries among adults. The review also found moderate evidence that laws requiring background checks and prohibiting firearm purchases by individuals with mental illness reduce violent crime and deaths. In contrast, state stand-your-ground laws are associated with increased homicide rates. There was insufficient evidence to determine whether any laws prevent mass shootings. 

Notably, almost two-thirds of the 36,000 firearm-related deaths in the U.S. each year are suicides, leading to our recommendation that "strategies to mitigate firearm suicides should include depression screening and nonjudgmentally asking anyone with depression whether they have a gun in the home." Useful clinical tools include the FIGHTS screening tool for adolescent firearm carrying, the SAD PERSONS suicide risk assessment scale, and the Violence Screening and Assessment of Needs tool for assessing risk of violence in military veterans.

Finally, we encourage family physicians to address the epidemic by making their voices heard in community meetings, online forums, and local publications and communicating with elected state and federal officials to advocate for funding research to study ways to reduce gun violence: "Whether it is speaking up in clinical settings, within our community, or with our elected officials, our voices can make a meaningful difference for our patients, our communities, and our nation."

Monday, July 9, 2018

Minimizing adverse effects from antibiotics: short duration + narrow spectrum

- Jennifer Middleton, MD, MPH

Adverse effects are not uncommon with antibiotics, and two recent POEMs (Patient Oriented Evidence that Matters) in AFP review strategies to minimize them. The first POEM found that shorter courses of antibiotics are equivalent to longer courses for several common outpatient infections. The 2nd POEM found that, for outpatient respiratory tract infections in children, narrow-spectrum antibiotics have a lower risk of adverse effects compared to broad-spectrum antibiotics with equivalent treatment efficacy.

The first POEM is a systematic overview of 9 systematic reviews comparing antibiotic treatment durations for urinary tract infection (UTI), acute pyelonephritis, sinusitis, and community-acquired pneumonia (CAP) in adults, and strep pharyngitis, CAP, UTI, and acute otitis media (AOM) in children. They found that:

AOM (children): 7 or less days =  more than 7 days
CAP (children): 3 days = 5 days
CAP (adults): 7 or less days = more than 7 days
Strep pharyngitis (children): 5-7 days = 10 days
Sinusitis (adults): 3-7 days = 6-10 days
UTI (children): 2-4 days =  7-14 days
UTI (non-pregnant, premenopausal women): 3 days = 5 or more days
UTI (older women): 3-6 days = 7-14 days
The authors found a reduced risk of adverse events for patients treated with shorter durations for AOM, sinusitis, and younger women with UTI; they found no difference among patients with pharyngitis, pyelonephritis, or older women with UTI. Adverse event data was not available for patients treated for CAP or children with UTI.

The 2nd POEM included both a large retrospective cohort arm (over 30,000 children) that reviewed outcomes of children with sinusitis, AOM, or strep pharyngitis diagnoses and a prospective cohort arm (almost 2500 children) examining the same conditions. The findings of the retrospective arm and the prospective arm concurred: broad-spectrum antibiotics (amoxicillin/clavulantate, cephalosporins, macrolides) offered no treatment benefit over narrow-spectrum antibiotics (penicillin, amoxicillin) but did increase the rate of reported adverse effects. The retrospective cohort only reported adverse event rates as documented in the medical record, but the prospective cohort included data gathering of adverse events from parents. The prospective cohort had a much higher rate (10.3 times higher) of adverse effects reported by parents, suggesting that many patients and/or their parents are not reporting these events to physicians.

It's possible that some of the patients who received antibiotics in these studies did not need them at all, thus explaining the lack of benefit in longer antibiotic treatment durations; for example, most cases of acute bacterial sinusitis will resolve without antibiotics (consider offering an intranasal corticosteroid instead), and deferring antibiotics for AOM in children over the age of 2 years with non-severe symptoms is a Choosing Wisely recommendation. Determining which patient needs an antibiotic is not always clear, either; Centor scoring can assist with pharyngitis, but, as Dr. Lin reviewed last week on the blog, procalcitonin levels may not distinguish CAP from lower respiratory tract infections that don't improve with antibiotics (such as bronchitis).

Limiting antibiotic overuse benefits patients and communitiesAFP's Choosing Wisely tool facilitates quick review of these recommendations, and there are also AFP By Topics on Pneumonia, Respiratory Tract Infections, and Urinary Tract Infections/Dysuria that include resources on diagnosis and treatment. 

Tuesday, July 3, 2018

Does procalcitonin make it easier to choose antibiotics wisely for respiratory infections?

- Kenny Lin, MD, MPH

American Family Physician has supported the Choosing Wisely campaign in several ways since it began in 2012, from maintaining a searchable database of primary care-relevant recommendations, to including tables of best practices in clinical review articles, to publishing an occasional editorial containing suggestions of how to implement it into practice. Although Choosing Wisely remains very much a work in progress, staff at the American Board of Internal Medicine Foundation recently identified a "Top 12" list of recommendations that are successfully reducing overuse in health systems across the United States. Leading the list is appropriate use of antibiotics for patients with upper respiratory tract infections, a topic that has been previously reviewed in this journal.

A more challenging task for family physicians may be deciding which patients with lower respiratory tract infections need antibiotics - distinguishing acute bronchitis from chronic obstructive pulmonary disease exacerbations or community-acquired pneumonia. Although clinical decision tools exist, their usefulness in outpatient settings is limited. A Cochrane for Clinicians in the July 1 issue reviewed the benefits and harms of procalcitonin-guided antibiotic therapy compared with routine care for acute respiratory infections on mortality, treatment failure, duration of antibiotic exposure, and antibiotic-related adverse effects. In a meta-analysis of 26 randomized, controlled trials (n = 6708), patients receiving procalcitonin-guided therapy had lower 30-day all-cause mortality (NNT=71) across all settings, but no difference in primary care settings. Rates of treatment failure were similar. Total duration of antibiotic exposure was 2.4 days lower in the procalcitonin group, corresponding to a lower percentage of patients in the procalcitonin group experiencing antibiotic-related adverse effects (16.3% vs. 22.1% in the control group).

Should this evidence lead clinicians to adopt procalcitonin-guided therapy algorithms to improve antibiotic stewardship for acute respiratory infections? Limitations of the Cochrane review are worth noting: the studies were relatively small (mean 258 participants); most were in Europe rather than in the U.S.; and most were in emergency department rather than primary care settings. After the review's publication, Dr. D.T. Huang and colleagues reported the results of a large (n=1656) RCT in 14 U.S. hospitals that compared procalcitonin-guided antibiotic therapy with usual care for patients with lower respiratory tract infections in the emergency department and on the inpatient service, if applicable (782 patients were subsequently hospitalized). In contrast to the Cochrane review, the investigators found no significant differences between the groups in duration of antibiotic exposure or adverse outcomes. They concluded that the addition of procalcitonin results did not significantly improve antibiotic decision-making or patient outcomes.

A take-home message from the Cochrane review and the recent U.S. trial is that the effects of procalcitonin measurement on diagnosis and management of acute respiratory infections depend on the clinical setting, patient characteristics, and preexisting adherence of clinicians to high-value care guidelines for antibiotic prescribing. This test may be helpful in certain cases, but probably should not be used routinely.

Monday, June 25, 2018

Which prescription medications are linked to depression?

- Jennifer Middleton, MD, MPH

Perhaps your patients have asked you if the medications they're taking are linked to an increased risk of depression as this study, "Prevalence of Prescription Medications with Depression as a Possible Adverse Effect Among Adults in the United States (US)," has been widely disseminated in the lay press over the last week.

The authors examined data from 2005-2014 from the National Health and Nutrition Examination Survey (NHANES), which included over 26,000 US adults. The NHANES data includes all medications that participants reported during these times, and the study authors identified medications that have depression as a listed potential side effect, which they termed "depression adverse effect medications." Overall, during this 10-year time period, 21% of surveyed adults took at least 1 of these medications, 8.7% took 2, and 7.5% took 3 or more. The prevalence of depression increased proportionally to the number of depression adverse effect medications adults were taking; adults taking none had a 4.7% prevalence of depression, adults taking 1 had a 6.9% prevalence of depression, adults taking 2 had a 9.5% prevalence of depression, and adults taking 3 or more had a 15.3% prevalence of depression. The most commonly prescribed depression adverse effect medications were metoprolol, atenolol, omeprazole, hydrocodone, gabapentin, and oral contraceptives. Use of multiple non-depression adverse effect medications was not associated with an increased prevalence of depression.

Observational studies can only prove correlation, not causation; the authors appropriately limited their conclusions to noting linkages between depression diagnoses and the use of depression adverse effect medications. The premise that we should consider how the medications we prescribe might contribute to mood diagnoses, however, is a reasonable one. The authors note that current screening instruments do not include review for possible depression adverse effect medications; it may be worth considering adding an assessment of current medications to whichever tool your practice uses.

The United States Preventive Services Task Force (USPSTF) recommends screening all adults for depression, and there is still plenty of room to improve mental health screening rates in the US. There's an AFP By Topic on Depression and Bipolar Disorder that includes this article on "Screening for Depression" that describes currently available instruments.

Will these results from the NHANES change how you prescribe medications that may contribute to depression?

Monday, June 18, 2018

Safe summer travel tips for you and your patients

- Kenny Lin, MD, MPH

As children finish school and the summer vacation season gets underway, readers of American Family Physician should know about all of the resources available in our archives for prevention and management of medical conditions in travelers, the best of which are included in our Travel Medicine collection. Family physicians can brush up on key components of the pretravel consultation for international travelers, including vaccination updates and malaria prophylaxis. Patients who plan to play in the water can be provided with recommendations for preventing recreational waterborne illnesses and tips for avoiding neurologic complications of scuba diving or surfing-related injuries.

Depending on the vacation destination, clinicians may need to counsel patients on risk factors and symptoms of altitude illness (which includes acute mountain sickness and less commonly, cerebral and pulmonary edema) or emerging vector-borne diseases such as West Nile virus, Dengue, Chikungunya, and, of course, Zika virus. A 2015 editorial reviewed advice for protection against mosquitoes and ticks that carry these and other diseases (such as Lyme disease, which doesn't always present with a classic "bull's eye" rash).

And whether your own summer plans include going on a medical humanitarian mission or just relaxing at your favorite fishing hole, AFP has you covered. Clinicians who plan to spend time near any body of water - including the backyard swimming pool - should consider familiarizing themselves with the essentials of prevention and treatment of drowning.

You can access patient education handouts on all of these activities and more from AFP and FamilyDoctor.org in your office and on the go.

Monday, June 11, 2018

Vitamin and mineral supplements don't improve mortality

- Jennifer Middleton, MD, MPH

A recent systematic review of "Supplemental Vitamins and Minerals for CVD Prevention and Treatment" has been making the rounds in the lay press for the last week; perhaps your patients have mentioned it to you as several of mine have. Sales of vitamin and mineral supplements have only increased since 2010 in the United States, with an estimated 36 billion dollars spent by consumers on these products in 2017. Perhaps this new systematic review will convince at least some of our patients to save their money, as most supplements were not found to improve CVD outcomes, and none improved overall mortality.

The authors included 179 randomized controlled trials in their final analysis; no vitamin or mineral supplement improved overall mortality. Folic acid use did correlate with decreased cardiovascular disease (CVD) risk, and folic acid and B-vitamin supplementation correlated with decreased stroke risk; the number needed to treat (NNT) for folic acid to prevent 1 CVD event was 167, the NNT for folic acid to prevent 1 stroke was 111, and the NNT for B-vitamin complex vitamins to prevent 1 stroke was 250. Use of multivitamins, vitamin C, vitamin D, beta-carotene, calcium, and selenium did not correlate with any change in mortality. Unfortunately, antioxidant products and niacin (when taken with a statin) did correlate with an increase in total mortality; the number needed to harm (NNH) for antioxidant supplements to cause 1 death was 250, and the NNH for slow-release niacin when taken with a statin was 200.

Dr. Lin wrote earlier this year for the blog, and in print for AFP, that vitamin D screening and supplementation is an ineffective use for finite healthcare dollars. Calcium supplements have not been found to improve outcomes related to osteoporosis, but they have been linked to an increase in CVD deaths. The Choosing Wisely campaign advocates against taking a "multivitamin, vitamin E, or beta-carotene to prevent cardiovascular disease or cancer."

Certainly, in specific situations, some vitamin and mineral supplements are useful. Iron and vitamin B12 deficiencies, when identified, are reasonable to treat. Calcium supplementation may improve premenstrual syndrome symptoms. Vitamin B6 is a safe and effective treatment for nausea and vomiting in pregnancy. In each of these scenarios, however, supplementation is only useful once a clinical problem has been identified. The systematic review mentioned above reinforces that empiric vitamin and/or mineral supplementation is unlikely to be beneficial for our patients - and may even be harmful.

Vitamin and mineral supplements can't take the place of consuming a healthy, nutrient-rich diet, and the United States Preventive Task Force (USPSTF) even has a B recommendation regarding the benefit of such counseling "to promote a healthful diet." There's an AFP By Topic on Nutrition if you'd like to read more, which includes several useful patient information resources.

Wednesday, May 30, 2018

Guest Post: Practicing what I preach about generic drugs

- Kathleen "Cook" Uhl, MD

In 2015, I was treated for stage 3 colorectal cancer. All of my cancer medications – from the chemotherapy right down to the anti-nausea medications – were generics.

Why did I take only generic medicines? Through my work at the U.S. Food and Drug Administration (FDA), I know that FDA-approved generic drugs meet the Agency’s high standards for safety, efficacy, and quality. So when my doctors at Walter Reed National Military Medical Center prescribed me generic cancer medications, I was confident that the generic prescriptions were as high-quality as brand-name medications, and could be substituted for the brand-name drug with no difference in safety or efficacy.

The generic drug approval process is supported by solid scientific research and review. Generic drug manufacturers must demonstrate their product is pharmaceutically equivalent and bioequivalent to the brand-name product before it can be approved. They also must demonstrate that the generic drug can be reliably and consistently manufactured in a way that maintains this equivalence and quality.

Pharmaceutical equivalence means that the generic has the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. Formulations may differ in inactive ingredients, provided that the generic drug manufacturer shows the inactive ingredients are safe and do not change the way the active ingredients are delivered to the body. Generic drugs may also have differences in characteristics such as size, shape, or color.

FDA standards of bioequivalence often require companies to conduct in vivo bioequivalence studies. Typically, volunteers take the brand-name and generic drug products to demonstrate that there is no significant difference between the rate and extent of absorption of the active ingredient. A bioequivalent drug will behave the same way in patients as its brand-name counterpart. FDA scientists compare data from these studies to ensure that a generic drug can be substituted for its brand-name counterpart and will behave the same way in patients.

Makers of generic drugs also submit data to FDA to show how the processes of combining the active and inactive ingredients to make the generic drug meet the same standards as the brand-name drug. It is only when a generic drug manufacturer has demonstrated that it can reliably make a high-quality, pharmaceutically equivalent and bioequivalent product that it can be made available to patients.

I am a cancer survivor. I am alive today because of the love and support of my family, friends, and co-workers. I am alive because of the incredible doctors and medical staff at Walter Reed. I am also alive because of generic drugs. Generic drugs saved my life.

**

Dr. Kathleen "Cook" Uhl is Director of the Office of Generic Drugs in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. Her editorial "How the FDA Ensures High-Quality Generic Drugs" appeared in the June 1 issue of AFP.

Monday, May 21, 2018

Tips for caring for persons with developmental disabilities

- Jennifer Middleton, MD, MPH

Two articles in the current issue of AFP, along with other recent primary care literature, contain a wealth of practical tips and techniques for successfully - and respectfully - caring for persons with developmental disabilities.

"Adults with Developmental Disabilities: A Comprehensive Approach to Medical Care" provides an overview of office accessibility pointers, communication techniques, approaches to preventive care and acute illnesses, and end-of-life planning. It also includes a discussion on the medical versus neurodiversity models of diversity, asserting that accepting patients as they are is preferable to trying to "normalize" them:
The goal of health care for patients with developmental disabilities is to improve their well-being, function, and participation in family and community. It is not always necessary or desirable to try to change a person's traits and characteristics to make them appear or behave more normally. 
Along those lines, the patient in this issue's Close-up, "Persons with Disabilities: I'm the Expert About the Body," says, "[T]here are many things they cannot know about me just by observing the way I look or the way I communicate." Avoiding the temptation to make assumptions can go a long way toward communicating respect. This website, quoted within the feature article, includes brief video examples of engaging with patients with no or limited speaking ability. An AFP Curbside Consultation from 2017 reinforces the importance of grounding medical decision making within the patient's definition of quality of life - which may not always align with physicians' assumptions.

Improving our ability to care for persons with developmental disabilities is critically important to reducing health care disparities between them and the non-disabled population. A 2017 statewide study across Ohio found that, compared with persons with no disability, persons with a disability (and/or their supporters) were more likely to report their health status as being "fair" or "poor," had more hospital and Emergency Department (ED) visits, and had more problems "getting needed care." Disabled persons reported more frequent "delayed treatment[s]," problem[s] getting care," and "problem[s] seeing a specialist." A study from the United Kingdom examining hospital admissions found similarly: hospitalizations were double that of non-disabled persons, even after controlling for "higher levels of comorbidity." The authors of both studies call for further studies to explore solutions to minimize these disparities; improving communication between persons with developmental disabilities and physicians, as detailed in the AFP articles above, may be an important first step.

These AFP articles also include a collection of online toolkits and resources on "Supported Decision Making." You can read more in the AFP By Topic on Care of Special Populations. Since family physicians often care for supporters, too, the CDC has tips for caregivers of persons with a disability, and so does FamilyDoctor.org.

Monday, May 14, 2018

Few family physicians are delivering babies, and few women are having VBACs. What's stopping them?

- Kenny Lin, MD, MPH

In 2017, fewer than one in five members of the American Academy of Family Physicians (AAFP) reported providing obstetric care. In a previous Graham Center Policy One-Pager in AFP, Dr. Tyler Barreto and colleagues reported that between 2009 and 2016, the percentage of family physicians practicing high-volume obstetrics (more than 50 deliveries per year) fell from 2.1% to 1.1%. A subsequent study in Family Medicine by Dr. Sebastian Tong and colleagues found that 51% of recent family medicine residency graduates intended to provide prenatal care, and 23% intended to deliver babies; however, less than 10% were delivering after 1 to 10 years in practice.

In a recent policy brief in the Journal of the American Board of Family Medicine, Dr. Barreto and colleagues analyzed data from the 2016 Family Medicine National Graduate Survey to identify barriers faced by residency graduates who stated interest in delivering babies but did not do so in practice. Almost 60% of respondents cited the lack of opportunity to do deliveries in the practice they joined and lifestyle considerations as the most important factors. Fewer than 10% felt that inadequate training or reimbursement were major issues.

Although these recent studies did not specifically focus on family physicians who perform surgical deliveries, prior research has established that Cesarean delivery outcomes are comparable whether performed by family physicians or obstetrician-gynecologists. To support women who choose to attempt labor and vaginal birth after Cesarean delivery (VBAC), the AAFP published a 2015 guideline that was largely based on an Agency for Healthcare Research and Quality review of the benefits and harms of VBAC versus elective repeat Cesarean. I summarized the key findings of this review in AFP's "Tips From Other Journals":

The risk of uterine rupture was statistically higher in women undergoing a trial of labor (0.47 percent) compared with women undergoing an elective repeat cesarean delivery (0.026 percent). Fourteen to 33 percent of women who experienced a uterine rupture underwent a hysterectomy. Maternal mortality was rare, but higher in women undergoing an elective repeat cesarean delivery (13.4 deaths per 100,000 deliveries) than in those undergoing a trial of labor (3.8 per 100,000). In contrast, trial of labor was associated with higher perinatal mortality (1.3 deaths per 1,000 deliveries) than elective repeat cesarean delivery (0.5 per 1,000). ... The evidence suggests that most of the differences in maternal and perinatal outcomes between these delivery options are statistically, but not clinically, significant.

As mentioned previously on the Community Blog, access to VBAC remains limited or nonexistent in many parts of the U.S., and debates continue about its safety for mothers and babies. This month in CMAJ, Dr. Carmen Young and colleagues analyzed a Canadian hospital database containing information on women with a single prior Cesarean between 2003 and 2015 and a second singleton birth at 37 to 43 weeks gestation. They found that rates of the composite outcomes "severe maternal morbidity and mortality" and "serious neonatal morbidity and mortality" were significantly higher after attempted VBAC compared to elective repeat Cesarean. However, absolute differences in these outcomes were low, with NNTs of 184 and 141, respectively.

This new study may give some hospitals and maternity care providers pause about continuing to support women who desire VBAC, and, together with the dwindling numbers of family physicians providing delivery services, could push the overall U.S. Cesarean rate of 32% higher in future years.

Monday, May 7, 2018

Supporting our patients' health outside of the office

- Jennifer Middleton, MD, MPH

Our patients' incomes, neighborhoods, and educational levels impact their health at least as much, if not more, than the interventions we discuss with them within our practice settings. Identifying patients who are struggling with housing, bills, child care, and/or safety might feel like a daunting task, though, and connecting them to helpful resources can feel overwhelming. A new toolkit released by the AAFP can make these tasks manageable; The EveryONE Project provides screening tools to help family physicians screen for social determinants of health (SDOH) and also connect patients to local resources.

The EveryONE Project website contains links to screen patients for SDOH challenges, a guide to patient resources, and planning tools for your office (or practice setting) to implement these changes. Each of these links provides more in-depth background material, a robust list of specific suggestions, and references to resources like Aunt Bertha, an online search engine that lists social services by zip code. These resources simplify connecting individual patients to local resources. (If you're interested in community planning tools, check out the CDC's Tools for Putting Social Determinants of Health into Action.)

A 2017 AFP editorial, "Acting on Social Determinants of Health: A Primer for Family Physicians," includes additional suggestions to implement SDOH interventions and also gives examples of how doing so can benefit patients:
Rather than simply recommending that a patient eat better and exercise more, care teams can connect patients to a local community garden, low-cost exercise resources (e.g., YMCA), or neighborhood walking groups. As another example, knowing that a patient lives in a neighborhood with old housing may prompt a physician to proactively screen for lead exposure based on elevated community risk. 
Perhaps a staff member in your office, or a visiting nursing or medical student, might compile a list of local resources where you practice, starting with tools like Aunt Bertha. Perhaps your practice might identify a champion to work through The EveryONE Project's assessment checklist. Or, perhaps your practice has a best practice to share with other Community Blog readers - please do so in the comment section below. The AFP By Topic on Health Maintenance and Counseling includes tools to deepen your understanding of your patients' unique situation via an in-depth family history and spiritual assessment as well.

If our goal is whole person health, then including SDOH assessment into our practices is essential. No advanced training in public health or social work is necessary to use these tools. As Sir Michael Marmot said, quoted in the The EveryONE Project Guide to Social Needs Screening Tool and Resources, "Why treat people and send them back to the conditions that made them sick in the first place?"

Monday, April 30, 2018

Top research studies of 2017 for primary care practice

- Kenny Lin, MD, MPH

In the most recent installment in an ongoing series in American Family Physician, Drs. Mark Ebell and Roland Grad summarized research studies of 2017 that were ranked highly for clinical relevance by members of the Canadian Medical Association who received daily summaries of studies that met POEMs (patient-oriented evidence that matters) criteria. This year's top 20 studies included potentially practice-changing research on cardiovascular disease and hypertension; infections; diabetes and thyroid disease; musculoskeletal conditions; screening; and practice guidelines from the American College of Physicians and the U.S. Preventive Services Task Force.

The April issue of Canadian Family Physician, the official journal of the College of Family Physicians of Canada, also featured an article on "Top studies relevant to primary care practice" authored by an independent group that selected and summarized 15 high-quality research studies published in 2017. Not surprisingly, some POEMs ended up on both lists:

1) Home glucose monitoring offers no benefit to patients not using insulin

2) Treatment of subclinical hypothyroidism ineffective in older adults

3) Pregabalin does not decrease the pain of sciatica

4) Steroid injections ineffective for knee osteoarthritis

The common theme running through these four studies is "less is more": commonly provided primary care interventions were found to have no net benefits when subjected to close scrutiny.

On the other hand, in a randomized trial that appeared on CFP's but not AFP 's list, adults and children with small, drained abscesses who received clindamycin or trimethoprim-sulfamethoxazole were more likely to achieve clinical cure at 10 days than those who received placebo, although the antibiotics also caused more adverse events, particularly diarrhea (number needed to harm = 9 to 11). As Dr. Jennifer Middleton explained on this blog last year, these findings challenge a previous Choosing Wisely recommendation from the American College of Emergency Physicians that states, "Avoid antibiotics and wound cultures in emergency department patients with uncomplicated skin and soft tissue abscesses after successful incision and drainage and with adequate medical follow-up." More can sometimes be, well, more.

Speaking of the Choosing Wisely campaign, Drs. Grad and Ebell will highlight more primary care-relevant research studies from 2017 consistent with the principles of the campaign in AFP later this year.

Monday, April 23, 2018

Caring for agitated patients...and ourselves

- Jennifer Middleton, MD, MPH

A patient of mine, who works in healthcare, was allegedly assaulted by a patient last week with injuries serious enough to warrant an Emergency Department visit. I suspect many healthcare workers can tell stories of times when they, or a colleague, felt unsafe with a patient. Nearly 70% of workplace assaults in the U.S. occur in healthcare or social services settings. A 2010 study of family physicians in Canada found that 39% reported at least one serious assault at some point during their career. Although thoughtful preparation can't provide a complete guarantee of safety, it can help to reduce the risk of serious injury at the hands of an agitated patient.

A recent AFP review of the American Psychiatric Association's (APA) Practice Guidelines on Psychiatric Evaluation in Adults includes taking a thorough mental health and social history, assessing for substance abuse, and assessing for risk of harm to self or others:
If the patient reports having aggressive ideas, the APA recommends that clinicians assess the patient's impulsivity, including anger management issues; determine the patient's access to firearms; identify specific persons toward whom homicidal or aggressive ideas or behaviors have been directed; and ask about the history of violent behaviors in the patient's biological relatives.
Patients can be agitated for reasons besides a mental health issue, according to a recent article in the Journal of Family Practice. Before determining whether a patient's agitation is due to a mental/behavioral health issue, metabolic/physiological cause, substance use, and/or perceptions of unfair treatment, though, we should employ the same de-escalation techniques: stay calm, be non-confrontational, assess the availability of help, and explore solutions. The article provides suggestions for maximizing safety with agitated patients in a variety of practice settings and also suggests the use of scales like the Agitated Behavior Scale to assess risk. It also includes a discussion on interventions to mitigate the development of post-traumatic stress disorder (PTSD) in healthcare workers including Critical Incident Stress Debriefing (CISD) and workplace support measures like Cleveland Clinic's "Code Lavender."

"What to Do When Emotions Run High" from the current issue of Family Practice Management centers on the importance of recognizing, and then addressing, patients' upset feelings before they escalate. The author encourages physicians to pay attention to nonverbal cues (such as "a blank stare or an angry tone") and respond to them by sharing your observation and making gentle inquiries ("'[I]t seems like something is really bothering you today,'" or "'I sense I may have done something to upset you, and if so I'd like for us to discuss it'"). Providing empathic statements can help to defuse tensions, and the author's advice to not "take it personally" reminds us that patients' upset feelings "are usually not about us."

Have you discussed workplace safety where you practice? What resources have you found helpful?

Monday, April 16, 2018

American Family Physician Podcast passes 1,000,000 downloads: why podcasts matter

- Steven R. Brown, MD, FAAFP

We released the first episode of the American Family Physician (AFP) Podcast in December 2015. AFP Podcast is a collaboration between American Family Physician, the most-read journal in primary care, and faculty and residents of the University of Arizona College of Medicine – Phoenix Family Medicine Residency.

Today the podcast passed a significant milestone: 1,000,000 episode downloads! We began counting downloads in May 2016, so this milestone was achieved in less than two years. The AFP Podcast audience continues to grow, and our listeners are now downloading episodes an average of over 45,000 times per month. A podcast with over 20,000 downloads per month, averaged over a year, is considered “high impact” for scholarly work. AFP Podcast is regularly a Top 10 medical podcast on iTunes, and has over 170 five star ratings on the platform. Listeners to the podcast are engaged. The credits at the end of each episode have been read by medical students, residents, and practicing physicians in 39 states and 4 countries. The @AFPPodcast Twitter account has over 1300 followers and an average of over 30,000 impressions per month.

Additionally, AFP Podcast has received a 2017 Gold EXCEL Award from Association Media & Publishing: Educational Podcast category.

Why podcasts matter

The role of podcasts in medical education is growing. With the emergence of new technology, changes in learning preferences, and resident work-hour restrictions, asynchronous methods of education are increasingly relevant. 89% of emergency medicine residents listen to podcasts regularly and 72% report podcasts change their clinical practice. 86% of these emergency residents report podcasts as their favorite form of medical education because of portability, ease of use, and ability to listen while doing sometime else.

We have received multiple comments from practicing family physicians that the AFP Podcast is useful as an American Board of Family Medicine preparation resource. Clerkship directors tell us they recommend AFP Podcast to students in required family medicine clerkships.

Podcasts are also a useful platform for exploring not just practice-changing clinical evidence, but the humanistic aspects of medical practice. The 2016 post “25 podcasts that every family physician should listen to” remains one of the most read articles on the AFP Community Blog. Recommendations from that post include podcasts related to public health, improving learning, patient stories, and medical economics.

The podcast Greyscale, produced by family physician Ben Davis, explores the physician – patient relationship and its impact on practice. Sawbones, hosted by family physician Sydnee McElroy and her husband Justin McElroy, discusses medical history and is regularly ranked as a Top 100 podcast in the iTunes “Comedy” category.

Podcasting quality

While many residents, medical students, and physicians are listening to medical podcasts, there is scant literature related to podcast quality. How do we know which podcasts should be recommended? How can the AFP Podcast be sure we are producing a quality product, worthy of family physicians and learners everywhere?

Two recent studies (published here and here) have examined medical education podcast quality. Both acknowledge that study of this topic is in its infancy. Key criteria for excellence include credibility (transparency, trustworthiness, avoidance of bias), content (professionalism, academic rigor), and design (aesthetics, interaction, functionality, ease of use).

Our editorial team will continue to strive to meet these metrics. Engagement from listeners is essential to these efforts. As we say on the credits at end of each episode: “Please send us your thoughts by emailing AFPPodcast@aafp.org or tweeting @AFPpodcast.” Engagement from listeners will help us improve AFP Podcast for the next million downloads and beyond.

**

Dr. Brown is an AFP Contributing Editor and Editor, AFP Podcast.

Monday, April 9, 2018

Increasing pneumococcal vaccination rates

- Jennifer Middleton, MD, MPH

A Medicine by the Numbers feature on Pneumococcal Vaccines in Chronic Obstructive Pulmonary Disease (COPD), in the current issue of AFP, gives pneumococcal vaccination in persons with COPD a "green" rating, indicating that the benefits outweigh potential harms. Despite these benefits, too few adults with COPD are receiving pneumococcal vaccination.

To clarify, adults with COPD aged less than 65 years should receive Pneumovax 23 (PPSV23); Prevnar 13 (PCV13) is only indicated for adults aged 18-64 with immunodeficiencies, certain hemoglobinopathies, and other specialized conditions (for a full list, check out this CDC Summary). All adults, regardless of co-morbid health conditions, should receive Prevnar 13 at age 65 followed by Pneumovax 23 at least one year later.

The article describes the evidence base demonstrating that, in persons with COPD, the number needed to treat (NNT) for pneumococcal vaccination is 21 to avoid an episode of community-acquired pneumonia and 8 to avoid an acute COPD exacerbation. (The authors reviewed studies that included adults both under and over age 65 to reach these conclusions.) While pneumococcal vaccination might not prevent mortality from COPD, patients are likely to be pleased with the benefit of avoiding pneumonia and/or exacerbations, especially given the lack of reported harms with this vaccine.

The CDC found that, in 2015, only 23% of adults eligible for pneumococcal vaccination had received one (the number eligible includes diagnoses other than COPD). Nonwhite adults and adults without health insurance reported lower vaccination rates. A study of vaccination attitudes and knowledge in Germany found that patient knowledge that pneumococcal vaccination was recommended correlated with increased rates of vaccination among eligible adults; interestingly, for influenza and tetanus vaccines, knowledge alone in this same study did not predict vaccination (though attitudes about each vaccine did).

Increasing awareness of the indications for pneumococcal vaccination is one step to increase vaccination rates; physician reminders, patient letters, and nurse-driven vaccination when used together were also effective at increasing rates in ambulatory specialty practices. In primary care practices, the 4 Pillars Toolkit has been effective; the 4 Pillars Toolkit includes online resources for increasing convenience, patient communication, systems of care, and practice motivation.

Pharmacist-driven interventions to increase influenza and pneumococcal vaccinations in patients with COPD have had mixed success. One study found pharmacist-initiated interventions did not increase pneumococcal vaccination rates for those with COPD or asthma in community settings. Inpatient pharmacist-led patient education, however, may increase pneumococcal vaccination. Employee health screenings that include a pharmacist review of vaccinations may also increase vaccination rates.

Ideal strategies are likely to differ by practice and locale; resources to guide your practice include the AFP By Topic on Immunizations (excluding Influenza) that includes this editorial on Navigating the Changes in Pneumococcal Vaccinations for Adults as well as this overview of the 2018 Advisory Committee on Immunization Practices (ACIP) Adult Immunization Recommendations. From Family Practice Management comes this article providing an overview of practice strategies to both increase vaccination rates and minimize lost costs from storing vaccines.

What strategies have worked to increase pneumococcal vaccination rates in your practice?

Tuesday, April 3, 2018

What's new in asthma treatment?

- Kenny Lin, MD, MPH

As part of the process of updating the 2007 National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 guidelines, the Agency for Healthcare Research and Quality (AHRQ) recently released two comparative effectiveness reviews. The first AHRQ review concluded that subcutaneous and sublingual immunotherapy for patients with environmental allergies both reduce the use of long-term controller medications for asthma, and that sublingual immunotherapy also improves asthma symptoms and quality of life. A previous article in American Family Physician discussed allergen immunotherapy for family physicians who wish to offer this treatment in their offices or to determine whether a patient would be a candidate for therapy for an allergist.

The second AHRQ review evaluated the effectiveness of inhaled corticosteroids, long-acting beta agonists (LABA), and long-acting muscarinic antagonists (LAMA) for asthma in different patient populations. In children younger than age five with recurrent wheezing, the authors found that intermittent inhaled corticosteroid use during upper respiratory tract infections decreases asthma exacerbations. Another section of the review, which was published as a research article in JAMA, found that in patients with uncontrolled, persistent asthma, adding LAMA to inhaled corticosteroids reduced exacerbations compared to adding placebo, but had similar benefits compared to adding LABA. Finally, a third section concluded that in patients age 12 years and older, the use of combined inhaled corticosteroids and LABA as controller and quick relief therapy was associated with a lower risk of asthma exacerbations than more traditional strategies involving a controller therapy plus a short-acting beta agonist as relief therapy.

It remains to be seen how this new evidence will be incorporated into the next version of the NAEPP guidelines, which have historically advocated a stepwise approach to management of persistent asthma until good control is achieved. A shortcoming of the AHRQ reviews is that they did not specifically examine harms of LABA, the subject of a Medicine By the Numbers in the March 1 issue of AFP. A Cochrane review examined 48 trials that compared step therapy with an inhaled LABA/steroid combination to a higher inhaled steroid dose in more than 33,000 patients with asthma. Although 1 in 73 patients in the LABA/steroid group avoided a mild asthma exacerbation, there was no benefit on hospitalizations, deaths, or severe exacerbations. Moreover, the authors concluded that 1 in 1,430 additional persons in the LABA/steroid group would experience an asthma-related death, leading them to conclude that combination LABA/steroid inhalers have no benefits. Given the close balance of benefits and harms and uncertainty surrounding these estimates, family physicians should practice shared decision-making with patients about the pros and cons of controller medication options.

Dr. Jennifer Middleton summarized some useful tools and apps for asthma management in a previous Community Blog post, and you can find more information on the diagnosis, prevention, and treatment of asthma in our AFP By Topic collection.

Monday, March 26, 2018

Which interventions benefit patients with dementia?

- Jennifer Middleton, MD, MPH

The prevalence of dementia continues to rise, and, according to "Evaluation of Suspected Dementia" in the latest issue of AFP, it's estimated that 14 million adults will be affected by 2050. This increasing prevalence brings increasing concern for many aging adults about developing dementia along with concern by families about how to support their loved ones. Several recent studies provide guidance; although information about diagnosing and caring for dementia patients is relatively robust, the evidence base is weaker regarding interventions that can slow cognitive decline.

Many patients and families worry about impending dementia when early signs of memory loss appear, but mild cognitive impairment (MCI) does not always lead to a dementia diagnosis. In a 2014 study, researchers followed 357 patients with MCI diagnoses over a 3 year period and found that only 22.4% of them progressed to a dementia diagnosis during this time. The majority of patients had stable symptoms that did not worsen.

For those patients who do receive dementia diagnoses, they and their caregivers may ask about interventions to decrease symptom progression. A recent series of systematic reviews explored several options. Despite earlier studies suggesting at least a small benefit from dementia medications, a 2018 systematic review examining the use of different medications (including dementia medications, antihypertensives, non-steroidal anti-inflammatory medications, aspirin, and statins) found that none delayed cognitive decline. Another systematic review examining the role of over-the-counter supplements found similarly; omega-3 fatty acids, various vitamins, soy, and gingko biloba all failed to demonstrate an effect. Turning to non-pharmacologic interventions, cognitive training increases cognitive abilities in normal adults, but studies have not, to date, supported a role in preventing or slowing dementia progression. Of all potential interventions, only physical activity has been found to slow cognitive decline, but the evidence behind this assertion is of low quality.

Although limited options are currently available to slow dementia's progress, several interventions do exist to help patients and families cope. Case managers can assist family physicians with meeting the most common needs of patients with dementia and their caregivers, early diagnosis and disease education, by providing education, connecting families to local resources, developing care plans, and coordinating social services. Caregivers who interacted with case managers reported increased confidence in caring for their family members. AAFP also has an online Cognitive Care Kit that includes cognitive evaluation tools, management resources, caregiver resources, and tools for discussing end of life planning. Shared group visits can offer patients and caregivers support and can increase practices' efficiency in caring for these often complex patients.

There's an AFP By Topic on Dementia if you'd like to read more; it includes these pro and con editorials regarding routine screening for cognitive impairment (about which the United States Preventive Services Task Force has issued an "I" statement). The AFP article on "Evaluation of Suspected Dementia" includes links to several assessment tools; I've added the Mini-Cog test and the Saint Louis University Mental Status Examination (SLUMS) to my AFP Favorites page for easy access at the point-of-care.

What resources and tools have you found useful in caring for patients with dementia?

Wednesday, March 21, 2018

For hypertension and diabetes, lower treatment targets not necessarily better

- Kenny Lin, MD, MPH

In a previous AFP Community Blog post, Dr. Jennifer Middleton analyzed the 2017 American College of Cardiology / American Heart Association clinical practice guideline on high blood pressure in adults, which proposed lowering the threshold for hypertension from 140/90 to 130/80 mm Hg. Later, the American Academy of Family Physicians and the American College of Physicians independently declined to endorse this guideline, citing concerns about its methodology (e.g., no quality assessment for included studies), management of intellectual conflicts of interest, and lack of information on harms of intensive drug therapy.

The March 15th issue of American Family Physician included a Practice Guideline summary and an editorial perspective on the ACC/AHA guideline by Dr. Michael LeFevre, a member of the panel that developed the JNC 8 guideline for hypertension in adults. In his editorial, Dr. LeFevre pointed out that the guideline's strengths include its emphasis on proper blood pressure measurement technique to avoid overtreating adults with normal out-of-office blood pressures. On the other hand, he argued that "it is an overreach" to classify everyone with a blood pressure above 130/80 as having uncontrolled hypertension. He predicted that since intensive behavioral counseling has only modest benefits in lowering blood pressure, many patients at low risk of cardiovascular disease will end up being treated with medication:

Much harm will come if this change [to the definition of hypertension] is widely accepted and implemented, particularly if quality measures that echo this definition are put into place. Harms from the consequences of poor measurement, overmedication, and arbitrary quality measures can easily offset the small reduction in CVD events found in trials of high-risk persons.

Blood pressure is not the only area of family medicine where there is ongoing debate about appropriate treatment thresholds. In a recent clinical guidance statement, the American College of Physicians recommended that clinicians "aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes," and "consider deintensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5%." This statement elicited a critical response from the American Diabetes Association and endocrinology groups, who argued that lower blood glucose targets are sometimes appropriate to reduce the risk of microvascular and perhaps cardiovacular complications.

This debate between lower and higher A1c targets has been ongoing for years, as illustrated by a pair of Pro and Con editorials on this topic that appeared in AFP in 2012. On the whole, however, more relaxed glucose control can have substantial benefits, especially for older persons with type 2 diabetes, as Dr. Allen Shaughnessy and colleagues argued in 2015:

A large part of the acceptance that “lower is better” hinges on a false belief that a pathophysiologic approach to decision making is always correct. It seems logical that reducing blood glucose levels to nondiabetic normal, no matter the risk or cost, should result in improved patient outcomes. But it doesn't. Today, an older patient with type 2 diabetes is more likely to be hospitalized for severe hypoglycemia than for hyperglycemia.

Underlining this point, a vignette-based study in the March/April issue of Journal of the American Board of Family Medicine found that primary care clinicians (particularly internists and nurse practitioners) would often chose to intensify glycemic control in an older adult with a HbA1c level of 7.5% and multiple life-limiting comorbidities. As family physicians look for opportunities to improve care for patients with hypertension and diabetes, we should not miss opportunities to avoid harm. 

Monday, March 12, 2018

Breastfeeding + pacifiers = no problem

- Jennifer Middleton, MD, MPH

In the designated "Baby-Friendly" hospital where I round, the use of pacifiers is discouraged in breastfeeding infants in the newborn nursery. Advising breastfeeding mothers about the risks of pacifier use contributing to early weaning is common practice, despite conflicting studies regarding the validity of this risk. A Cochrane meta-analysis, reviewed in the March 1 issue of AFP, may put the controversy to rest, as the reviewers found that pacifier use did not interfere with the establishment or duration of breastfeeding.

The Cochrane reviewers identified two randomized controlled trials (RCTs) for their meta-analysis, both of which divided breastfeeding mothers of newborn infants into two groups: one where pacifiers were prohibited, and one where pacifiers were permitted. Researchers in both RCTs found no difference in breastfeeding rates at 3-4 months of life between these two groups. Arguments against pacifier use have cited previous observational studies finding that pacifier use correlates with diminished establishment of maternal milk supply; the permissive pacifier groups in both of these RCTs, however, included pacifier use even in the immediate newborn period.

As these RCTs only included outcomes on breastfeeding rates in the first months of life, the AFP reviewers rightly encourage future research focusing on pacifiers' possible effect on additional outcomes including maternal confidence and total duration of breastfeeding. These more robust outcomes may dispel any lingering concerns about pacifier use. Adding pacifiers back to the tools available for comforting newborns certainly may benefit both babies and parents; since nonnutritive sucking is a natural self-soothing reflex in newborns, I suspect many parents would concur with my own experience regarding a pacifier's utility in calming a fussy baby.

If you'd like to read more, there are recent AFP articles on "Strategies for Breastfeeding Success" and "Risks and Benefits of Pacifiers," an editorial on "The Maternal Health Benefits of Breastfeeding," and a patient information page on "Helpful Tips for Breastfeeding." (Although these earlier articles do not reflect the findings of this new meta-analysis regarding pacifier use, they still contain a wealth of useful information for supporting breastfeeding in your practice.) The AAFP has a position paper on breastfeeding which encourages breastfeeding education in medical schools and residencies, breastfeeding-friendly office practices, and community advocacy to support breastfeeding mothers. This Society of Teachers of Family Medicine blog post from 2013 puts a compelling personal spin on the challenges of returning to work while breastfeeding, including suggestions on supporting breastfeeding within our own profession of working mothers.

Monday, March 5, 2018

Public health and advocacy resources in American Family Physician

- Kenny Lin, MD, MPH

Shaping local and national policies to improve patients' health outcomes is an appropriate and important role for family physicians. For the past several years, I have taught public health and advocacy skills to medical students, and last month, I attended Academy Health's National Health Policy conference in Washington, DC, for the first time. Although the majority of participants were researchers or policy analysts, family physicians were well-represented as medical directors, public health and insurance officials, and leaders of privately funded community health improvement projects.

In a previous blog post, I discussed the concept of assessing social determinants of health through "community vital signs," geocoded and individually linked data derived from public data sources. Although American Family Physician focuses on health interventions that clinicians provide in offices, emergency rooms, hospitals, and long-term care facilities, it also publishes resources to help family physicians improve social determinants outside of health care settings. For example, a 2014 editorial examined the role of the family physician in preventing and managing adverse childhood experiences, and a review article in the February 1 issue discussed implications for physicians of childhood bullying.

Previous editorials and articles have addressed environmental health hazards such as lead, radonair pollution and climate change, and a 2011 Letter to the Editor urged family physicians to take action to affect the built environment of American communities by "working to ensure that our patients have safe, convenient, and enjoyable places to walk, run, and bike." Other public health issues where physician advocacy can make a positive difference include food insecurity, homelessness, and firearm safety.

Family physicians are often first responders to natural and unnatural disasters in their communities. From influenza pandemics to bioterrorism, preparedness and early recognition is essential to protecting our patients. A 2015 editorial argued that the rapid spread of infectious diseases and migration and displacement of diverse populations have made global health knowledge essential for every family physician, regardless of location: "As the recent Ebola epidemic demonstrated, the world is not only smaller than ever, but it is also more intricately connected. Exotic diseases once confined to the third or developing world are now everyone's concern. Global has truly become local." For example, clinicians are likely to encounter victims of sex trafficking and labor trafficking in their practices.

AFP's sister publication, FPM, also provides resources for primary care clinicians with community and public health roles, from launching a community-wide flu vaccination plan, to following the Grand Junction, Colorado example of improving health system cost and quality outcomes, to working with community-based senior organizations. Finally, family medicine advocates can stay abreast of national initiatives that will shape the specialty's future, such as direct primary care, the patient-centered medical home, and the Medicare Access and CHIP Reauthorization Act (MACRA).