Monday, August 8, 2022

Gestational diabetes is an increasingly common pregnancy complication

 - Kenny Lin, MD, MPH

A recent report from the Centers for Disease Control and Prevention documented a precipitous rise in the rate of gestational diabetes in the U.S. from 2016 to 2020, based on data collected from birth certificates. In 2020, gestational diabetes affected 7.8% of all pregnancies, reflecting a 13% increase since 2019 and a 30% increase since 2016. Prevalence increased with increasing age (2.5% in patients younger than 20 years and 15.3% in those aged 40 or older) and increasing pre-pregnancy body mass index (BMI). Both factors are likely driving the overall rise in gestational diabetes; the median age at which U.S. women gave birth reached an all-time high of 30 years in 2019 and only 2 in 5 women with a live birth in 2020 had a normal BMI prior to pregnancy.

The U.S. Preventive Services Task Force (USPSTF) recommends screening for gestational diabetes in asymptomatic pregnant patients at or after 24 weeks of gestation. Although the USPSTF did not identify a preferred test, a previously discussed study suggested that the two-step approach (a non-fasting 50 gram oral glucose challenge test followed by a fasting 100 gram glucose tolerance test if the first test is positive) "produces equivalent benefits, and fewer harms, than the one-step approach."

Adverse outcomes associated with gestational diabetes include gestational hypertension, preeclampsia, shoulder dystocia, macrosomia, and Cesarean delivery. Gestational diabetes also confers a 7-fold greater maternal risk of developing type 2 diabetes later in life and 1.5 times greater risk of the child being overweight in childhood or adolescence. Management of gestational diabetes begins with glucose self-monitoring and lifestyle modifications, followed by oral medication or insulin if target blood glucose levels are not achieved.

Prevention of gestational diabetes includes counseling on appropriate weight gain goals based on pre-pregnancy BMI, which can generally be achieved by averaging "350 to 450 calories per day above the previous intake (e.g., two slices of bread with half an avocado, ¾ cup of Greek yogurt or 1 cup of blueberries with two hard-boiled eggs)." Additionally, "patients should be encouraged to engage in moderate aerobic activity most days of the week for at least 20 to 30 minutes at a time, for a total of at least 150 minutes per week." In a previous AFP Community Blog post, Dr. Erin Fredrickson discussed strategies for facilitating exercise in pregnant patients. The USPSTF recommends offering behavioral counseling interventions for healthy weight and weight gain in pregnancy; effective interventions generally started at the end of the first trimester and varied in duration and intensity (from 15 to 120 minutes and from 1 to more than 12 total contacts).

Monday, August 1, 2022

Will vaccine hesitant US adults accept a more traditional COVID-19 vaccine?

 - Jennifer Middleton, MD, MPH

Earlier this month, the United States (US) Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Novavax for adults aged 18 and older:

The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual.

This technology is similar to more traditional vaccines, such as the influenza vaccine, and differs from the available mRNA COVID-19 vaccines from Pfizer and Moderna. It's currently authorized as a 2 shot series, with doses given 3 weeks apart. In the clinical trial data of 25,500 participants submitted to the FDA, Novavax reported that 2 doses of their vaccine were, overall, "90.4% effective in preventing mild, moderate or severe COVID-19....in the subset of participants 65 years of age and older, the vaccine was 78.6% effective." Several countries worldwide who have previously authorized the Novavax vaccine offer a booster 5 months after the 2nd shot, and Novavax is reportedly pursuing authorization in the US for both that booster as well as administration to adolescents aged 12-17. They are also testing boosters with protection against the omicron strain. Although Novavax was part of the US government's Operation Warp Speed in 2020, the company suffered "developing and manufacturing setbacks" as a smaller start-up which put it behind Pfizer and Modera in the race to an EUA. 

The speed of the mRNA vaccines' development, along with the newness of their technology, led some people to question their short- and long-term safety. Given this reluctance regarding mRNA vaccines, Novavax, which "has no genetic material, only proteins," may be a more comfortable option for some patients. Approximately 10% of the adult population in the US has yet to receive a first dose of any of the COVID-19 vaccines, and increasing vaccine uptake may help slow the development of new variants

As noted on the blog last year, helpful resources to discuss vaccine hesitancy with patients include these resources and talking points from the US Centers for Disease Control and Prevention (CDC) along with this article on "Helping Patients Make Healthy Decisions on COVID-19" found in the AFP By Topic on Coronavirus Disease 2019 (COVID-19).

Monday, July 25, 2022

What to tell patients about exercise in pregnancy

- Erin Fredrickson, DO, MPH

If we had a magic pill to reduce rates of pregnancy complications and improve the health of pregnant patients, we would prescribe it faster than Allyson Felix can sprint 400 meters. Exercise during pregnancy isn’t a magic pill, but the potential benefits of engaging in purposeful physical activity during all stages of the reproductive journey far outweigh the perceived risks. Family physicians have a unique opportunity to assess health behaviors of patients before, during, and after pregnancy and provide guidance around lifestyle changes in the context of families and communities.

Before discussing the benefits and considerations for leisure-time physical activity in pregnancy, it is important to note that not every pregnant patient has the privileges of time or safety required to include exercise in their daily routine. The burden of societal inequity, systemic racism, misogyny, and climate change falls hardest on Black, brown, Indigenous, and people of color, especially during pregnancy. Acknowledging these barriers, we can encourage patients through individual relationships while advocating for policy changes to support our communities.

All adults, including pregnant patients without contraindications, are recommended to engage in 150 minutes per week of moderate intensity physical activity for optimal health. Exercise in pregnancy is associated with lower rates of prenatal complications, better fetal outcomes, and gentler labor experiences and postpartum recovery. Studies have found lower rates of gestational diabetes and large for gestational age infants, gestational hypertension, and preterm delivery among exercising pregnant patients compared to those who did not exercise. One study found that people with higher physical activity levels during pregnancy had a shorter duration of active labor. Another systematic review and meta-analysis of 17 trials found a reduction in cesarean birth rate of 16% in the exercise group. Exercise is well-known to improve mood regulation and is associated with fewer symptoms of postpartum depression. Considering the biomechanical changes of pregnancy, at least 60% of pregnant patients experience musculoskeletal pain, but greater self-reported overall fitness is associated with lower levels of bodily pain, lumbar/sciatic pain, and reduced pain disability in the second and third trimester.

How should we talk to patients about exercise during pregnancy? Previously inactive patients can begin exercising with gradual increases in frequency and duration over time. Anyone physically active prior to pregnancy can continue throughout pregnancy, but will likely need to modify activities to adapt to physiologic and biomechanical changes over time. With the right support in place, elite athletes can partner with their care teams and coaches to prioritize a healthy pregnancy and athletic longevity. Almost all types of aerobic exercise are safe (walking, jogging, swimming, cycling), but pregnant patients should avoid activities with higher risk of blunt abdominal trauma. Patients should be counseled to take breaks when needed, get enough to eat and drink, avoid extreme heat, and stop exercise immediately if vaginal bleeding or contractions occur. Most people should aim for intensity <80% of their maximum heart rate (or <15 “hard” on the rating of perceived exertion scale).

People with certain obstetric and medical conditions, particularly cardiovascular/respiratory complications, should be more cautious with exercise during pregnancy and the primary obstetric care team should have a low threshold to consult with maternal-fetal medicine.

AFP has been discussing exercise in pregnancy before it was cool (1998), and the American College of Obstetricians and Gynecologists updated their clinical guidance in 2020 with helpful tables for counseling. Our July issue includes a FPIN Clinical Inquiry on reducing risk of hypertensive disorders of pregnancy with exercise and an article on care of the active female with recommendations for exercise in pregnancy and the postpartum period in this Table (subscription required). Encouraging and facilitating exercise during pregnancy, particularly for those with societally imposed barriers, is an important component of working toward health equity for pregnant patients.

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Dr. Fredrickson is a third-year resident at the University of Washington Family Medicine Residency Program, Seattle and one of AFP's 2022 Resident Representatives.

Monday, July 18, 2022

Pharmacists can now prescribe Paxlovid

 - Jennifer Middleton, MD, MPH

The United States (US) Food and Drug Administration (FDA) recently modified its Emergency Use Authorization (EUA) for nirmatrelvir/ritonavir (Paxlovid) to "authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing." Although some physician organizations have previously expressed concern with expanding pharmacists' scope of practice, others argue that increased access to Paxlovid is necessary

Nirmatrelvir/ritonavir must be started within 5 days of symptom onset, and its EUA applies to outpatient adults at high risk for severe COVID-19 illness. It is effective at reducing the risk of hospitalization or death, with a number needed to treat (NNT) of 18 in unvaccinated persons, with early non-peer-reviewed data demonstrating efficacy in vaccinated persons as well. When first approved, supplies and access were limited, but now plenty of nirmatrelvir/ritonavir is available to meet demand, which has been increasing in the US as COVID-19 surges again. The challenge for many patients is access to a prescription within the short 5 day window; COVID-19 tests, especially home test kits, may not be positive on the first day or two of symptoms, and prescribing requires time to review medical records for underlying liver and kidney disease as well as medication lists for nirmatrelvir/ritonavir's many drug-drug interactions.

The FDA encourages patients seeking nirmatrelvir/ritonavir after a positive COVID-19 test to first "consider seeking care from their regular health provider" or look for a Test-to-Treat location nearby. If seeking nirmatrelvir/ritonavir from a state-licensed pharmacist, patients should bring records of liver and kidney labwork that are less than 1 year old along with a comprehensive list of their medications and supplements.

Pharmacists' expertise can benefit patients and physicians. This 2021 FPM article reviews how in-office pharmacists can help with medication safety reviews, assist with tobacco cessation, and improve diabetes and hypertension control. "Interventions that involve pharmacists" increase medication adherence in patients with multiple chronic health conditions. Compared to physicians, pharmacists' management of warfarin results in improved INR readings and safety outcomes, and pharmacists can safely manage uncomplicated urinary tract infections (UTIs). The Choosing Wisely campaign urges us to "[not] continue medications at transitions of care without a pharmacist...performing a comprehensive medication review."

The AAFP recognizes these benefits of collaborative agreements with pharmacists, but it also warns about fragmentation of care when pharmacist prescribing is decoupled from a patient's primary care physician. Ensuring adequate communication with primary care offices when a pharmacist prescribes nirmatrelvir/ritonavir will be necessary to minimize the risk of this fragmentation. Looking beyond the COVID-19 pandemic, family physicians should think creatively about how to maximize collaboration opportunities with pharmacists, especially since, on average, patients access their community pharmacists much more frequently than their primary care physician. 

Monday, July 11, 2022

Advances in peanut allergy prevention and treatment

 - Kenny Lin, MD, MPH

People with severe peanut allergy are at risk of life-threatening anaphylaxis from unintentional ingestion of small amounts of peanuts. A recent new drug review in AFP discussed oral immunotherapy with peanut allergen powder, which increases tolerance for ingesting the amount of peanut protein in a single peanut by 63% but has important downsides: 1 in 10 patients need to use epinephrine after administration (compared to 1 in 20 in a placebo group); common short-term adverse effects include abdominal pain, throat irritation, and oral pruritus; and a price of approximately $3000 annually.

Although it was once believed that children should not consume peanuts early in life, a United Kingdom randomized trial in infants 4 to 11 months of age at high risk of developing peanut allergies (described in this Practice Guidelines summary) found that early consumption of peanuts reduced the risk of developing peanut allergy by age 5 years by 80% (absolute risk reduction=14%, NNT=7). This finding led the National Institute of Allergy and Infectious Diseases to recommend in 2017 that peanut-containing foods be introduced into the diet of infants with severe eczema, egg allergy, or both at 4 to 6 months of age. In 2021, a consensus document on the primary prevention of food allergy from three North American professional allergy societies recommended introducing peanut-containing products to all infants around 6 months of age, regardless of their risk of developing peanut allergy.

A similar change to infant feeding guidelines in Australia occurred in 2016, recommending that all infants be introduced to peanuts before age 12 months. A study in JAMA last week evaluated changes in feeding practices and the prevalence of peanut allergy across two population-based cross-sectional samples recruited in 2007-2011 and 2018-2019. Although infants in the later sample were much more likely to have consumed peanuts before 12 months than infants in the earlier sample (86% vs. 22%), overall there was no statistical difference in peanut allergy prevalence. Noting that East Asian ancestry is considered a risk factor for peanut allergy, the authors hypothesized that the increased representation of infants with parents from East Asia in the later sample may have contributed to finding no effect. Another possible explanation is that early introduction of peanut-containing foods does not significantly modify peanut allergy development in infants not at high risk.

In a previous paper on identifying and using clinical practice guidelines, Dr. David Slawson and I observed: "The ultimate test of a good guideline is whether or not it has been prospectively validated; that is, has its adoption been shown to improve patient-oriented outcomes in real-world settings?" Based on the JAMA study, infant feeding recommendations to prevent peanut allergies have not yet passed this test. On the other hand, an accompanying editorial argued that "given the potential for benefit and the low risk of harm, the [study results] should not dissuade clinicians from following current consensus guidance that recommends early peanut introduction for infants." The challenge of identifying children at increased risk for peanut allergy (as noted in the consensus document, definitions have varied across studies and guidelines) and the inherently artificial nature of previous guidance restricting what an infant would otherwise naturally eat make this a reasonable course of action in the face of imperfect evidence.

Monday, July 4, 2022

Contraception resources for physicians & patients

 - Jennifer Middleton, MD, MPH

Patients may be more interested in methods to prevent pregnancy after the United States (US) Supreme Court's recent decision to allow state legislatures to determine whether, and to what degree, to permit abortion. Nearly half of US states are banning, or plan to ban, most or all abortion services. Patients may also present with questions about accessing contraception, including emergency contraception, after some US retaliers instituted purchasing limits on over the counter (OTC) emergency contraception, fearing consumer stockpiling after the Supreme Court's decision. Contraception remains legal in the US, and family physicians have a range of options and resources to share with patients who desire pregnancy prevention.

This 2021 AFP article on "Initiating Hormonal Contraception" provides an overview of contraceptive pills, patches, injections, implants, and intrauterine devices (IUDs). Patients may initiate contraception at any point in their menstral cycle, and this Choosing Wisely recommendation reminds us that a pelvic examination is not necessary to prescribe contraceptive pills. The article also provides several useful algorithms for the "quick start" of pills, patches, injections, implants, and IUDs. Another AFP article, "Evidence-Based Contraception: Common Questions and Answers," was recently published online ahead of print and provides guidance on emergency contraception, fertility awareness methods, safety precautions in persons with migraine with aura, duration of long-acting reversible contraception (LARC), subcutaneous depot medroxyprogesterone acetate, and considerations for transgender and gender-diverse people. There's an AFP By Topic on Family Planning and Contraception with additional content including patient education handouts. 

Family physicians can also discuss contraception for families in between pregnancies to optimize outcomes for parents and infants. Breastfeeding (lactational amenorrhea method or "LAM") can prevent pregnancy, but only with "exclusive, frequent" breastfeeding in the first 6 months after birth. Persons desiring to prevent pregnancy after birth who are not breastfeeding frequently or exclusively, or who desire additional contraception in addition to LAM, have several safe options to choose from. Increasing intrapartum intervals to a minimum of 18 months is one of the aims of the March of Dimes' IMPLICIT project to reduce the prevalence of low birth weight infants. 

The US Centers for Disease Control and Prevention (CDC) has a "Contraceptive Guidance for Health Care Providers" website that includes a link to their US Medical Eligibility Criteria for Contraceptive Use (US MER) and US Selected Practice Recommendations for Contraceptive Use (US SPR) app. The app allows for convenient access to recommendations related to underlying medical conditions as well as "selected practice recommendations" regarding use and management of contraceptive methods.

For persons desiring irreversible contraception, family physicians can provide counseling regarding vasectomy and tubal ligationVasectomies are performed far less frequently than tubal ligations in the US despite the procedure's relative simplicity, safety, and inexpensive cost. The American Urological Association's Vasectomy Guideline (2015) describes optimal patient selection and post-procedure counseling, including recommended timing of postvasectomy semen analyses. Approximately 13% of vasectomies in the US are performed by family physicians, and the procedure can be learned in residency or following residency with a local mentor or skills course.

Lastly, the American Journal of Public Health just released a supplement to their June 2022 issue on "Reshaping Contraceptive Access Efforts By Centering Equity, Justice, and Autonomy." The issue "focuses on how contraceptive access policy is shaped, how policy is translated into practice, and how a focus on equity, justice, and autonomy has reshaped the field's approach to contraceptive access efforts." It's a resource to consider sharing with leaders in your healthcare system, state medical societies, and local and state government. The supplement includes descriptions of initiatives that successfully decreased adolescent pregnancy rates, used telehealth to "bridge gaps in contraceptive care deepened by COVID-19," and can promote health equity by "scaling up evidence-based practices in contraceptive access initiatives."