Monday, October 15, 2018

Influenza vaccine in pregnancy decreases hospitalizations

- Jennifer Middleton, MD, MPH

According to the Centers for Disease Control and Prevention (CDC), pregnant women with influenza infection are more likely to be hospitalized than non-pregnant women of the same age. It seems intuitive that influenza vaccination would help reduce these hospitalizations, but data demonstrating as such has only been published in the last week. A large multi-center retrospective study found that influenza vaccination reduces influenza-related hospitalizations among pregnant women by 40%.

Organizations from several countries, including the CDC, comprise the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), who conducted this retrospective study that reviewed over 19,000 hospitalization records from Australia, Canada, Israel, and the western United States (US). A significant limitation to the study is that, overall, only 6% of pregnant women admitted for flu-like illness had documented influenza virus testing; among these women, 13% with confirmed influenza had been vaccinated, compared with 22% with confirmed influenza who had not been vaccinated. The authors note that vaccine uptake was low across all studied countries, with the US having the highest vaccination rates at just 50%. (The authors' findings correlate with CDC data from the 2016-17 influenza season, when 53.6% of pregnant US women were vaccinated.)

Given the many documented benefits of influenza vaccine in pregnancy, we need to improve vaccination rates. Safety concerns, especially in pregnancy, continue to be a major barrier to vaccination. The CDC has a website devoted to allaying these safety concerns that cites multiple studies demonstrating the vaccine's safety and efficacy in pregnancy. The American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Family Physicians (AAFP) both also strongly recommend influenza vaccination in pregnancy; ACOG has an online fact sheet for patients as does AAFP's familydoctor.org.

Studies also cite low rates of physician recommendation as a factor in suboptimal influenza vaccination rates in pregnant women, even though physician recommendation to vaccinate correlates with higher vaccination rates. Even though many family physicians do not provide direct obstetric care, we can still work with our pregnant patients to encourage influenza vaccination. FPM has a resource describing "How to Talk to Reluctant Patients About the Flu Shot," and the latest issue of AFP includes the CDC's Advisory Committee on Immunization Practices (ACIP) update for 2018-2019. There's also an AFP By Topic on Influenza with more references and patient handouts.

Monday, October 8, 2018

Rise in congenital syphilis highlights pregnancy screening gaps

- Kenny Lin, MD, MPH

Last month, the Centers for Disease Control and Prevention (CDC) announced that the number of reported cases of congenital syphilis in the U.S. rose from 362 in 2013 to 918 in 2017, paralleling increases in syphilis infections in reproductive-age women during this time period. From 2016 to 2017, congenital syphilis cases rose from 16 to 23 per 100,000 live births. Although two-thirds of affected infants have no symptoms at birth, congenital syphilis is associated with increased neonatal mortality and a variety of early (through 48 months of age) and late complications, detailed in a previous AFP article.

The first line of prevention against congenital syphilis is screening for syphilis in all pregnant women at the first prenatal visit, a well-established standard of care that the U.S. Preventive Services Task Force (USPSTF) recently reaffirmed. Although some cases occur in infants whose mothers receive no prenatal care, about one-third of women who delivered a baby with congenital syphilis in 2016 were screened during their pregnancies.

The CDC, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists all recommend repeat syphilis screening in women at high risk for syphilis at around 28 weeks of gestation and at time of delivery. Women at high risk include those living in higher-prevalence communities or geographic areas; those living with HIV infection; those with a history of incarceration or commercial sex work; and those exposed to a sexual partner with confirmed syphilis infection. Early penicillin treatment of infected pregnant women reduces the risk of congenital syphilis.

The USPSTF has also previously recommended screening nonpregnant adults and adolescents at increased risk for syphilis infection. Higher risk groups in nonpregnant adults are similar to those in pregnant women, but also include men who have sex with men (MSM), particularly men aged 20 to 29 years, whose prevalence of primary or secondary syphilis is nearly 3 times higher than that of the general U.S. male population. Finally, the USPSTF recommends intensive behavioral counseling for all sexually active adolescents and for adults at increased risk for sexually transmitted infections.

Monday, October 1, 2018

Exercise for chronic back pain: tips for success

- Jennifer Middleton, MD, MPH

The article on "Mechanical Low Back Pain" in the current issue of AFP provides an overview of diagnosis and treatment for the 1 in 5 adults who suffer from low back pain. The article reminds us that NSAIDs alone work just as well as opioids, muscle relaxers, and/or oral corticosteroids. Non-pharmacologic pain relief is emphasized, with some evidence of benefit found with physical therapy, osteopathic manipulative treatment, and exercise. Patients want more than just exercise advice, though; they also want to have their experiences with both pain and exercise considered to develop personalized recommendations.

Patients want physicians to listen to their prior experiences with back pain and exercise, taking their perceived fitness ability into account when recommending exercise. They prefer plans that consider their exercise likes and dislikes. Patients also want an exercise plan that they feel they can be successful with, partially because they fear judgment from their physician if they don't improve. Validating patients' experiences with their pain, eliciting their exercise preferences, and having resources to discuss with patients may increase the likelihood of their success with a new exercise regimen.

Engaging regularly in exercise is challenging for many people, let alone someone with chronic low back pain. Simply counseling patients regarding physical activity is a critical first step, one that many patients don't ever recall hearing from their physician. Working with patients to create a tailored exercise prescription may help. Several fitness apps, as recently reviewed in FPM, also provide a wide range of motivational methods, from raising money for charity to running from simulated zombie chases.

AFP has additional resources you may find useful, including the AFP By Topic on Health Maintenance and Counseling along with patient education at familydoctor.org, where "sports and exercise at every age" is the site's current monthly focus.

Monday, September 24, 2018

Chronic insomnia: therapies to start, therapies to stop

- Kenny Lin, MD, MPH

Can't sleep? Then spend your extra awake time reading the latest installment of Implementing AHRQ Effective Care Reviews in the September 1 issue of AFP, on management of insomnia disorder in adults. This evidence review, which supported an American College of Physicians practice guideline, examined the effectiveness of behavioral therapies and medications for adults with insomnia disorder, defined as "poor sleep quality or quantity that causes distress or dysfunction and lasts for longer than three months."

The most beneficial sleep intervention overall is cognitive behavior therapy for insomnia (CBT-I), which produced sustained improvements for at least 6 months. CBT-I consists of cognitive therapy, sleep restriction and stimulus control, and sleep hygiene education. Medications that have sufficient evidence demonstrating improvement in short-term (3 months or less) sleep outcomes include eszopiclone, zolpidem, and suvorexant; there was insufficient data to evaluate benzodiazepines or over-the-counter sleep aids (diphenhydramine, doxylamine, or melatonin). For most patients, medications should not be prescribed for longer than five weeks.

Physicians commonly prescribe antipsychotics off-label to treat insomnia in older persons. The Practice Guidelines in the September 15 issue summarized a Canadian guideline for deprescribing antipsychotics for behavioral and psychological symptoms of dementia and insomnia, produced by the Deprescribing Guidelines in the Elderly Project. Due to the potential harms of these medications and the lack of evidence of benefits (a single randomized trial with 13 participants found nonsignificant differences in sleep latency in patients taking quetiapine), the guideline recommends that antipsychotics prescribed for primary or secondary insomnia in which comorbidities are under control be discontinued without tapering, regardless of treatment duration.

AFP's sister journal, FPM, recently published an article on deprescribing unnecessary medications that featured a four-step process (review current medications; identify inappropriate, unnecessary, or harmful medications; plan deprescribing with the patient; and regularly re-review medications) and links to additional resources on medication reconciliation and deprescribing. You can find more information on sleep disorders in adults in our AFP By Topic collection.

Monday, September 17, 2018

Cervical cancer screening in the age of HPV vaccination

- Jennifer Middleton, MD, MPH

A POEM (Patient-Oriented Evidence that Matters) in the current edition of AFP suggests the potential for change in cervical cancer screening practices; screening younger women only with human papillomavirus (HPV) testing, and not cytology, resulted in better identification of high grade pre-cancerous disease in individuals who have received the HPV vaccine.

This study from Australia enrolled nearly 5,000 women aged 25-64 presenting for cervical cancer screening to one of three groups: liquid-based cytology screening followed by HPV testing if abnormal, HPV screening followed by liquid-based cytology as indicated, or HPV screening followed by dual-stained cytology (staining for high-risk HPV markers) as indicated. At the time of the study, women 33 years old or younger had been eligible to receive the HPV vaccine when it was first available in Australia; in these women, both of the HPV screening groups had a higher rate of pre-cancerous disease detection than the cytology-based screening group.

The United States Preventive Services Task Force (USPSTF) currently recommends HPV screening every 5 years as an option only for women aged 30 and older along with screening every 3 years with cytology alone or screening every 5 years with cytology and HPV co-testing; they recommend discussing risks (HPV screening alone and HPV/cytology co-testing both have an increased rate of false positive screening results, while cytology alone may miss some true positives) of each method with individuals to personalize screening decisions. For women aged 21-29, the USPSTF only recommends cervical cancer screening with cytology alone every 3 years. The American College of Gynecology and Obstetrics does not allow for the option of HPV testing alone for women of any age, but otherwise their recommendations align with the USPSTF.

HPV vaccine acceptance and uptake has been quite high in Australia, with the study authors citing that 70-78% of women aged 12-17 years were fully vaccinated in 2013. In the United States, HPV vaccine uptake has been less successful; the Centers for Disease Control (CDC) estimates that half of US teens have not completed the HPV series (you can find specific data for your state using this interactive map). It's possible that this POEM's findings may not be generalizable to the US given this difference in vaccination rates, but studies have also supported the sole use of HPV screening in women who were beyond vaccination age when HPV vaccine was introduced in the US.

Regardless, HPV vaccination rates have plenty of room for improvement in the US. Barriers to increasing HPV vaccination in the US, as outlined in this 2016 AFP Community Blog post by Dr. Lin, include safety concerns and parental worry about the vaccine encouraging earlier initiation of sexual activity (it doesn't). Physicians, too, are sometimes reluctant to discuss or recommend the vaccine. Strategies to overcome these barriers include reviewing vaccinations at every visit (not just well visits) as recommended by the authors of this 2015 AFP editorial on "HPV Vaccination: Overcoming Parental and Physician Impediments." The CDC also advises physicians to recommend HPV vaccine "the same way, the same day as other vaccines." Identifying office workflow barriers, implementing previsit planning, and permitting walk-in vaccinations can help increase vaccine uptake as well. There's an AFP by Topic on Immunizations (excluding Influenza) with several other resources on discussing vaccine hesitancy and increasing vaccination rates if you'd like to read more.

Monday, September 10, 2018

Continue to Choose Wisely: updates to the AAFP Choosing Wisely recommendations

- Sarah Coles, MD and James Stevermer, MD

Providing high value, safe, and cost-effective care is the cornerstone of family medicine. However, there remains significant overutilization of low-value or even harmful care in the U.S. health care system. The American Academy of Family Physicians (AAFP) partnered with the Choosing Wisely Campaign to identify care that may be overused or misused and tackle this pressing issue. Founded in 2012 as an initiative of the American Board of Internal Medicine Foundation, the Choosing Wisely campaign collates lists of procedures and tests that add little or no value to medical care. The AAFP was one of the first organizations to participate, submitting 5 initial recommendations and a total of 15 recommendations by 2013.

Once again, the AAFP has added 5 new recommendations to the Choosing Wisely campaign. Developed by the AAFP's Commission on Health of the Public and Science, these evidence-based recommendations are based on sources such as the Cochrane Collaboration and the Agency for Healthcare Research and Quality systematic reviews. Each recommendation focuses on a practice that is either harmful or has very little supporting evidence of benefit.

Here are the new recommendations:

Don’t perform pelvic exams on asymptomatic nonpregnant women, unless necessary for guideline-appropriate screening for cervical cancer.

Screening pelvic examinations, except for the purpose of performing cervical cancer screening at recommended intervals, have not led to reduction in mortality or morbidity. Additionally, they increase costs and expose asymptomatic women to unnecessary invasive testing.

Don’t routinely recommend daily home glucose monitoring for patients who have Type 2 diabetes mellitus and are not using insulin.

Self-monitoring of blood glucose (SMBG) has no demonstrated benefit in patients with type 2 diabetes mellitus who are not on insulin or medications associated with hypoglycemia. SMBG should be reserved for patients during the titration of their medication doses or during periods of changes in patients’ diet and exercise routines.

Don’t screen for genital herpes simplex virus infection (HSV) in asymptomatic adults, including pregnant women.

Serologic testing for HSV infection has low specificity and a high false-positive rate. No confirmatory test is currently available and the serologic tests cannot determine the site of infection. Given the prevalence of the infection in the United States, the positive predictive value of the test is estimated at about 50%. A positive test can cause considerable anxiety and disruption of personal relationships.

Don’t screen for testicular cancer in asymptomatic adolescent and adult males.

There is no benefit to screening for testicular cancer due to the low incidence of disease and high cure rates of treatment, even in patients who have advanced disease. Potential harms include false-positive results, anxiety, and harms from diagnostic tests or procedures.

Don’t transfuse more than the minimum of red blood cell (RBC) units necessary to relieve symptoms of anemia or to return a patient to a safe hemoglobin range (7 to 8 g/dL in stable patients).

Unnecessary transfusion exposes patients to potential adverse effects without any likelihood of benefit and generates additional costs.

Using tools like Choosing Wisely, family physicians can lead change and reduce unnecessary care in the US to cut costs, improve health outcomes, and limit harms. To help you put Choosing Wisely into practice, you can find the lists from the AAFP and over 80 other specialty organizations at choosingwisely.org and a search tool for primary care-relevant recommendations on the AFP website.

**

Drs. Coles and Stevermer are members of the AAFP's Commission on Health of the Public and Science. Dr. Coles is also an AFP Contributing Editor and Assistant Editor, AFP Podcast.

Tuesday, September 4, 2018

Is aspirin effective primary prevention for CVD?

- Jennifer Middleton, MD, MPH

Two recent studies challenge the premise that adults at increased risk of cardiovascular disease (CVD) should take a daily aspirin. More specifically, the United States Preventive Services Task Force (USPSTF) currently recommends that adults aged 50-59 with a 10-year risk of CVD of at least 10% take a daily low-dose aspirin. One of the studies published earlier this week, however, found no benefit to daily aspirin use regarding primary prevention of CVD but did find an increased risk of gastrointestinal (GI) bleeding; the other study found that aspirin did decrease the risk of initial CVD events in its participants with diabetes but it also, again, increased the risk of GI bleeding.

The first study, the ARRIVE study, enrolled over 12,000 participants across several countries (most participants came from the United Kingdom, Germany, and Poland) deemed to be at "moderate" risk of CVD based on a lengthy list of criteria that resulted in a mean ASCVD risk score for participants of approximately 17%. Participants were randomized into either the aspirin (100 mg of enteric-coated aspirin a day) group or the placebo group and were followed for an average of 5 years. The researchers' primary outcome was a composite of first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischemic attack. There was no difference in the rate of these events between the aspirin and the placebo groups (hazard ratio 0.96; 95% confidence interval [0.81-1.13]), but the aspirin group had a higher rate of GI bleeding events (hazard ratio 2.11; 95% confidence interval [1.36-3.28]).

Interestingly, though the mean ASCVD risk score for enrolled participants was 17.3-17.4%, the rate of CVD events that actually occurred among participants was much lower; only 4.29-4.48% of participants had a CVD event during this study. The researchers attribute this difference to good management of non-acute CVD symptoms and note this trial was intentionally "pragmatic" in this regard, though they do also concede that "risk calculators developed with older data might overestimate risk in current practice." Concerns about the ASCVD risk score's propensity to inflate CVD risk are not new and have even been acknowledged within the cardiology community. Unfortunately, as the USPSTF notes in their statement, "although concerns have been raised about the equations’ potential to overpredict risk and their moderate discrimination, they are the only U.S.-based, externally validated equations that report risk as a combination of cerebrovascular and CHD events."

The second study, the ASCEND study, enrolled over 15,000 participants across the United Kingdom with diabetes but without known CVD and randomized them into daily aspirin (100 mg of aspirin a day) or placebo groups. Participants were followed for an average of 7.4 years. Unlike the ARRIVE study, the ASCEND researchers found that CVD events were decreased in the aspirin group (relative risk 0.88; 95% confidence interval [0.79-0.97]), but, similar to ARRIVE, GI events were increased in the aspirin group (relative risk 1.29; 95% confidence interval [1.09-1.52]). The researchers concluded that "[t]he absolute benefits were largely counterbalanced by the bleeding hazard." Additionally, "91 patients would need to be treated to avoid a serious vascular event over a period of 7.4 years, and 112 to cause a major bleeding event."

Both of these studies looked at relatively high risk populations for CVD and had a large number of participants. The ARRIVE study's participants did not have diabetes, while the ASCEND study's participants did. Both groups of researchers, however, came to the same conclusion: the risks of taking daily aspirin for primary prevention of CVD outweigh any possible benefit.

Dr. Lin and I have both previously written about aspirin as primary prevention on the blog, and you can count on AFP to continue bringing you the latest evidence to inform your practice. Will these new studies change your recommendations about aspirin for primary prevention of CVD?

Monday, August 27, 2018

Fracture prevention in older adults: what does the evidence say?

- Kenny Lin, MD, MPH

Hip fractures are a significant preventable cause of morbidity and mortality in older adults. Strategies to reduce hip fracture rates include preventing falls, screening for osteoporosis and prescribing bisphosphonate drugs to increase low bone density, and vitamin D supplementation. Recent studies and guidelines have clarified some of the evidence surrounding hip fracture prevention.

In a Putting Prevention Into Practice case study in the August 15 issue of American Family Physician, Drs. Tina Fan and Elizabeth Erickson discussed two updated U.S. Preventive Services Task Force (USPSTF) recommendations on interventions to prevent falls and supplements for primary prevention of fractures. Although the USPSTF continues to recommend exercise interventions to prevent falls in community-dwelling adults 65 years or older at increased risk of falls, it no longer recommends vitamin D supplements to prevent falls, due to evidence of no benefit and potential harms (increased falls and kidney stones). The Task Force found insufficient evidence to assess the balance of benefits and harms of vitamin D and calcium supplements at daily doses greater than 400 IU of vitamin D and 1,000 mg of calcium (lower doses are not effective) in postmenopausal women without a history of osteoporosis, which may come as a surprise, given how many are taking such supplements.

The USPSTF also recently reaffirmed its previous recommendation to screen for osteoporosis with bone measurement testing in women 65 years and older. Earlier this year, The Lancet published the first randomized controlled trial of osteoporosis screening with fracture outcomes. Although screening did not affect the primary outcome of all osteoporosis-related fractures over 5 years (HR 0.94, 95% CI 0.85-1.03), it reduced the incidence of hip fractures (HR 0.72, 95% CI 0.59-0.89). More controversial was the Task Force's recommendation to screen postmenopausal women younger than 65 years at increased risk for osteoporosis. In a JAMA editorial, Dr. Margaret Gourlay (a family physician and former AFP editor), argued that the 2-step screening strategy advised by the USPSTF - clinical risk assessment tool followed by bone density testing if indicated - may not produce a net benefit to patients. Although screening women younger than age 65 has potential benefits, it is unclear if these benefits outweigh the opportunity costs:

If complicated risk tools perform no better than age alone to identify screening candidates, women younger than 65 years may be subjected to inefficient screening procedures. … The clinician could spend half of a 15-minute clinical visit accessing a risk tool and asking the patient about unfamiliar risk factors (eg, secondary causes of osteoporosis) to make 1 decision out of the dozen or more compressed into an annual physical examination. … Given the myriad responsibilities of primary care practices caring for patients with high-acuity conditions, implementation of screening programs that are needlessly complex is burdensome and distracts from high-value medical care.

Finally, for patients with osteoporosis who are eligible for treatment, given concerns about long-term adverse effects of bisphosphonates, including rare osteonecrosis of the jaw, for how long should these drugs be prescribed? A FPIN Help Desk Answer found low-quality evidence that for most women, bisphosphonate therapy beyond 5 years does not further reduce clinical vertebral fractures, nonvertebral fractures, or mortality. However, women with persistent femoral neck T-scores lower than -2.5 may benefit from longer treatment durations.

Monday, August 20, 2018

Are mental health apps helpful?

- Jennifer Middleton, MD, MPH

A wide variety of mental health apps are currently available. Two recent studies describe the appeal of these apps yet also advise caution with their use, as some of them may reinforce harmful messages and/or are not based on evidence-based practice. Helping our patients identify reputable apps is becoming an important element of mental health management.

The first study, from the current issue of the Annals of Family Medicine, evaluated the content of 61 mental health apps. The researchers found that many of these apps framed mental health problems as "exist[ing] for everybody" and claimed "their product could help quickly and easy." 49% of the apps provided disclaimers, "thus, app consumers were assigned responsibility not only for using an app, but also for knowing whether it was appropriate for them." Visual images in the apps were predominantly of white individuals, and comments in many apps suggested that app users were expected to be employed and/or have families, which the authors criticized as being non-inclusive. While 61% of apps included claims that their methods were scientifically-based, none cited studies or evidence to support these claims. Although the researchers identified a few reasonably reputable apps, they advise physicians to ask patients with mental health diagnoses about app use and review the above limitations with them.

The second study from June of this year aimed to formally analyze apps which claimed to be following cognitive behavioral therapy (CBT) tenets. They reviewed 31 apps which advertised CBT for depressive symptoms and found that, while user ratings of these apps tended to be quite high, only some of their features were based on CBT. 12 apps only provided 1 feature consistent with CBT; another 9 apps only included 2. They found that CBT features tended to be limited to mood tracking, recording thoughts, and dealing with negative thoughts, and they expressed concern that other CBT elements, such as addressing core beliefs, were absent. "Even though all of their descriptions mentioned CBT, only half of all features provided by apps reflected core competencies of CBT." The authors also analyzed the rating comments of these apps and found that many users appreciated their relative affordability compared to traditional therapy. Some raters describing themselves as therapists stated that they appreciated the use of these apps as adjuncts to their meetings with patients.

Many patients like using apps; many physicians and counselors like being able to recommend useful tools to patients. The challenge for patients and physicians alike is to identify apps that incorporate the best evidence-based practice into their design. Thankfully, FPM has its regular feature "SPPACES: Medical App Reviews" to help guide our decisions. (SPPACES = Source or developer, Platforms available, Pertinence to primary care, Authoritativeness/accuracy, Cost, Ease of use, and Sponsor.) Earlier this year, a SPPACES article identified "Five Mobile Apps to Help Patients with Anxiety and Depression." All five of these apps were developed by reputable experts, and a couple of them were even mentioned in the above studies as being exemplars of evidence-based practice (MoodTools and What's Up-Mental Health App).

Discussing app use with patients and guiding patients to reputable apps is, of course, only one part of good mental health care. You can read more in the AFP By Topic on Depression and Bipolar Disorder and in the AFP By Topic on Anxiety Disorders.

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?