Monday, August 19, 2019

E-cigarettes and health: some answers, more questions

- Kenny Lin, MD, MPH

As the Centers for Disease Control and Prevention is actively investigating a cluster of severe lung illnesses in 14 states that may be linked to e-cigarette use among adolescents and young adults, an article in the August 15 issue of AFP discusses common questions and answers about vaping and health. Since Dr. Middleton's 2016 blog post on the promise and perils of e-cigarettes, more data has accumulated about the potential harms and benefits of this increasingly common activity. In 2017, one in five high school students reported e-cigarette use in the previous year, leading U.S. Surgeon General Jerome Adams to issue an advisory last year that labeled e-cigarette use in youth a "public health epidemic." More recent data from the Monitoring the Future survey suggested that this epidemic shows no signs of slowing:

Put in historical context, the absolute increases in the prevalence of nicotine vaping among 12th-graders and 10th-graders are the largest ever recorded by Monitoring the Future in the 44 years that it has continuously tracked dozens of substances. These results indicate that the policies in place as of the 2017–2018 school year were not sufficient to stop the spread of nicotine vaping among adolescents.

Although a nationally representative survey of parents of middle and high school students found that nearly all are aware of e-cigarettes, only 44% accurately identified an image of the "pod mod" device Juul; less than one-third reported concerns about their own child's use of e-cigarettes; and nearly three-quarters had received no communication from their child's school regarding the dangers of e-cigarettes. To help family physicians counsel parents and adolescents about vaping and Juuls, a patient education handout accompanying the AFP article highlights important discussion points.

It remains unclear whether e-cigarettes can help adults who are trying to quit smoking. E-cigarettes are not approved by the U.S. Food and Drug Administration as smoking cessation devices; however, a recent randomized trial in the U.K. National Health Service found that in smokers receiving weekly behavioral support, the 1-year abstinence rate in the e-cigarette group was superior to that of smokers using traditional nicotine replacement products. Notably, 80 percent of the e-cigarette group was still vaping after 1 year, compared with only 9 percent of the nicotine-replacement group - a troubling secondary finding given the unknown long-term health consequences of e-cigarette use.

In addition, the AFP article cautions that "unlike nicotine replacement therapy, the advertised nicotine dose on the labeling of e-cigarettes is not always consistent with laboratory analysis of the e-cigarette liquid, and the device and user behavior may affect the dose of nicotine received." Consequently, the authors recommend that clinicians first counsel patients to quit using evidence-based smoking cessation guidelines such as those from the U.S. Preventive Services Task Force, and only discuss using e-cigarettes if these methods are ineffective.

Monday, August 12, 2019

Is "prediabetes" a useful term?

- Jennifer Middleton, MD, MPH

The ADA's goal in defining prediabetes,"blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes," is to identify those persons who would benefit from interventions to reduce their risk of developing type 2 diabetes. While reducing the incidence of type 2 diabetes is a laudable goal, the term "prediabetes" may be problematic; a 2017 meta-analysis found that "[a]s screening is inaccurate, many people will [receive] an incorrect diagnosis and be referred on for interventions while others will be falsely reassured and not offered the intervention." The imprecise label of "prediabetes" may be hampering efforts to identify effective interventions to delay or prevent the onset of type 2 diabetes.

A pair of editorials in the current issue of AFP explore the controversy surrounding metformin prescribing in persons determined to have prediabetes. Dr. Lin reviews these editorials and their evidence base in a recent tweetorial; in summary, asserting that metformin is beneficial in prediabetes, Dr. Tannaz Moin cites the Diabetes Prevention Program (DPP) which found that, in obese persons with prediabetes, metformin delayed onset of type 2 diabetes over three years (number needed to treat = 14). Dr. Moin advocates, however, for considering more than just a prediabetes test result when considering metformin treatment: "higher A1C (i.e., 6.0% to 6.4%), but also other important risk factors, such as family history of diabetes, higher fasting plasma glucose levels, and higher triglyceride levels, may predict greater risk of progression to diabetes." 

Arguing against the use of metformin is Dr. Steven Brown, who describes his concern with using prediabetes as an impetus to prescribe medication. He cites the above-mentioned 2017 meta-analysis' findings that, "[c]ompared with the reference standard of an oral glucose tolerance test, a single A1C measurement is 49% sensitive and 79% specific for prediabetes." He interprets the DPP findings differently:
 At four years, the average A1C was 5.9% in the metformin or lifestyle groups and 6.1% in the placebo group. Although these surrogate outcome differences are statistically significant, they are not clinically meaningful. Treating borderline glucose values does not improve quality of life, mortality, or any other patient-oriented outcomes.
It's quite possible that the DPP's findings were less significant because of the inherent imprecision in the "prediabetes" label. As Dr. Lin wrote in an earlier post on the Community Blog, "the term prediabetes is misleading: many of these patients will not develop diabetes." A more precise risk elucidation may be found in that same 2017 meta-analysis, where "those most at risk of developing diabetes had both impaired fasting glucose and impaired glucose tolerance." 

A reasonable middle ground may be to consider glucose readings between the ranges of normal and diabetic as just one risk factor among many for developing type 2 diabetes. There's an AFP By Topic on Diabetes: Type 2 if you'd like to read more about diabetes screening and diagnosis, and there's an AFP Department Collection with more Controversies in Family Medicine with more pro/con editorial pairs, too.

Monday, August 5, 2019

The continuing plague of gun violence: what family physicians can do

- 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 2018 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 published online ahead of print, Dr. Sexton and the AFP medical editors argued 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 reviewed the evidence of the effects of firearm regulations, mental health counseling, and active shooter training on gun safety and violence:

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 encouraged 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."

**

This post first appeared on the AFP Community Blog on July 17, 2018. Since then, approximately 40,000 more Americans have died from firearm suicide or homicide, including 31 in two separate terrorist attacks in Dayton and El Paso within a 24-hour period this past weekend.

Monday, July 29, 2019

Curbing the use of nonprescription antibiotics

- Jennifer Middleton, MD, MPH

A just-published review found that antibiotics remain readily available in the United States without a prescription. The authors found that between 1-66% of studied populations reported possession and/or planned use of antibiotics obtained from sources other than a prescriber's order. With implications for both personal side effects and population-wide antibiotic resistance, examining the factors contributing to nonprescription antibiotic use may lead to some solutions.

The authors performed a scoping review with the goal of answering these two questions: "What are the prevalence, sources, and characteristics of nonprescription antibiotic use in the US, and what are the factors influencing it?" They identified 31 articles that met their inclusion criteria:
Several studies focused on the availability of antibiotics without a prescription from flea markets, pet stores, botanical or health food stores, or online. Others explored nonprescription use from a range of sources, including leftover prescribed courses, markets or stores, family or friends, and antibiotics obtained without a prescription from other countries. In 1 study, patients in an STI clinic and a county jail were interviewed about self-treatment with antibiotics. All studies of injection drug users examined self-treatment of abscesses and injection-related wounds with antibiotics obtained on the street.
In reviewing these studies, the authors identified several factors that influenced nonprescription use of antibiotics; wait times to see a physician, cost of the physician visit, and lack of transportation were prominent as might be expected, but concerns about judgment by healthcare staff when seeking care for sexually transmitted infections and injection-drug-use-related infections were also noted. Of course, the ready availability of antibiotics from a multitude of sources enabled nonprescription use, too.

According to the basic tenets of health behavior theory, most adults make decisions about their health that they deem rational in the context of their knowledge, environment, and social norms. It makes sense, for example, that persons with ready access to antibiotics who are concerned about the cost and/or stigma of seeking medical care would choose the easier route of bypassing the physician's office. Tackling the problem of antibiotic resistance may need to include efforts to reduce barriers and stigma around receiving treatment for more potentially sensitive conditions.

The AAFP's Everyone Project toolkit contains a wealth of resources to help your patients who have barriers to accessing healthcare. The Canadian Public Health Association has a toolkit to help practices identify and decrease stigmatizing language and behaviors. Limiting inappropriate antibiotic prescribing remains important, too, as Dr. Lin and I discussed on an AFP tweet chat back in 2017; here are the AFP references we used, which contain pragmatic, evidence-based strategies for reducing antibiotic overuse.

Antibiotic overuse remains a complex challenge, and hopefully we'll see future studies continuing to address not only its multifaceted causes but also successful strategies to combat them.

Monday, July 22, 2019

Deliberate clinical inertia: protecting patients from low value care

- Kenny Lin, MD, MPH

Clinical inertia is usually considered to be a negative term, used to refer to situations in which clinicians do not appropriately initiate or intensify therapy for uncontrolled chronic conditions. For example, a recent study in JAMA Internal Medicine found that less than one-quarter of patients with chronic hypercalcemia in the Veterans Affairs health system received parathyroid hormone level testing, and only about 13 percent of patients who met diagnostic criteria for primary hyperparathyroidism underwent parathyroidectomy.

However, clinical inertia has also been described as a "clinical safeguard" against aggressive consensus guideline prescriptions that do not account for patient preferences and/or potential harms of intensifying treatment. For example, an analysis of the incremental benefits of and harms of the 2017 American College of Cardiology / American Heart Association guideline that redefined hypertension as a sustained blood pressure of >= 130/80 mm Hg concluded:

For most adults newly classified as having high blood pressure under the ACC/AHA guideline (the 80% of those newly diagnosed who have <10% 10-year risk), there is no incremental benefit in CVD risk reduction, but potential incremental harms from disease labeling, and, for those who meet the threshold for drug treatment, from adverse drug effects.

In this instance, a large number of patients with systolic blood pressures between 130 and 140 mm Hg could potentially benefit from clinical inertia by avoiding a hypertension diagnosis, additional testing, or prescription medications.

In a 2011 JAMA commentary, Drs. Dario Giugliano and Katherine Esposito observed that clinical inertia "also may apply to the failure of physicians to stop or reduce therapy no longer needed," but that "this neglected side of clinical inertia does not seem to generate as much concern among physicians or scientific associations." A review of polypharmacy in the July 1 issue of AFP noted that regular use of at least five medications is associated with decreased quality of life, increased mobility problems and falls, greater health system use, and increased long-term care placement. As discussed in a previous AFP Community Blog post, judicious deprescribing can help reduce polypharmacy and improve patient outcomes.

Another (sometimes better) strategy is not starting nonbeneficial medications for unclear reasons in the first place. In a 2018 article in Emergency Medicine Australasia, Dr. Gerben Keijzers and colleagues defined "deliberate clinical inertia" as "the art of doing nothing as a positive response." Arguing that doctors generally have a bias to intervene with diagnostic tests, drugs, or procedures, they suggested reframing the typical decision-making approach:

In clinical practice, 'risk versus benefit' is usually considered in terms of missing a diagnosis rather than potential risks of treatment, so a better approach to care may be to ask, 'Is this intervention more likely to cause harm than the underlying condition with its possible harm or risk?' There are many reasons why 'doing nothing' is difficult, but doing what we can to provide excellent care while preventing medical harm from unnecessary interventions must become one of the pillars of modern holistic healthcare.

Family physicians may readily grasp the rationales behind campaigns to avoid harms and costs of low value care such as Choosing Wisely and Right Care, but our patients often need convincing. Dr. Keijzers and colleagues suggested several ways to support deliberate clinical inertia in practice: empathy and acknowledgment; symptom management; clinical observation; explanation of the natural course of the condition; managing expectations; and shared decision-making ("communicating rather than doing").

Monday, July 15, 2019

Updates in CVD diagnosis, treatment, and prevention

- Jennifer Middleton, MD, MPH

Updates on diagnosis, treatment, and prevention of cardiovascular disease (CVD) abounded in the medical literature over the last month. While these studies' findings were largely non-significant or limited, they still provide clarity regarding current best practices while paving the way for future research.

First, the search for a clinical decision rule to stratify patients presenting to primary care with chest pain regarding risk of acute coronary syndrome (ACS) will have to continue, as the results of a "flash mob" study, published this month in the Annals of Family Medicine, failed to validate the Marburg Heart Score for use in primary care. The investigators recruited nearly 20% of the family physicians in the Netherlands to gather data on patients with suspected ACS during a 2 week time period. The family physicians sent information back to the investigators using a brief case report form, filed either electronically or on paper. Although the study results were disappointing, the feasibility of this novel research method was more promising. Perhaps we'll see more "flash mob" studies in the near future.

In an AFP Medicine By the Numbers summary out today, a Cochrane review of early reperfusion therapy in patients with STEMI received a "no benefits" rating by the thennt.com. The meta-analysis examined data from 8 randomized controlled trials including a total of over 8900 participants, all with chest pain at rest and either EKG changes consistent with STEMI (ST-segment myocardial infarction), NSTEMI (non-ST-segment myocardial infarction), or a previously established diagnosis of coronary artery disease. Participants were randomized to either receive reperfusion immediately or to receive medical therapy first with reperfusion only if symptoms persisted. There was no mortality benefit to early reperfusion, and participants who underwent early reperfusion were also more likely to have a periprocedural myocardial infarction (MI) or a major bleeding event. The risk of these adverse events was deemed to outweigh the found benefits of increased relief from refractory chest pain, decreased repeat hospitalization, and decreased risk of a susbsequent MI in the next year with early reperfusion.

Finally, an umbrella review (a systematic review of prior meta-analyses) sought to identify the best current evidence regarding diet changes and supplements on improving CVD outcomes. These investigators found moderate quality evidence to support reduced salt intake (lower all-cause mortality in individuals without hypertension, and lower cardiovascular mortality in individuals with hypertension). Lower quality evidence correlated omega-3-fatty-acid intake with lower risks for MI and CAD. Folic acid intake correlated with lower stroke risk, though the authors caution that this finding was largely driven by a study based in China, where fewer foods are fortified with folate than in the United States. Interestingly, calcium and vitamin D intake correlated with a higher stroke risk. "Other nutritional supplements, such as vitamin B6, vitamin A, multivitamins, antioxidants, and iron and dietary inter- ventions, such as reduced fat intake, had no significant effect on mortality or cardiovascular disease outcomes (very low– to moderate-certainty evidence)." Given the relative low quality of many studies, the authors' call for further, more rigorous research is understandable.


Studies finding a lack of benefit (the Marburg score "flash mob" and the early reperfusion meta-analysis) are still useful to help family physicians avoid harm and to spur the search for better alternatives. Hopefully, more rigorous research will come to verify the findings of the nutrition and supplement umbrella review. We'll look forward to reporting on these hoped-for follow-up studies; in the meantime, what research would you like see to regarding CVD in primary care?