Monday, June 14, 2021

Reexamining prenatal care and planned community birth

 - Kenny Lin, MD, MPH

The need to restrict in-person office visits in 2020 to slow the spread of the COVID-19 pandemic affected prenatal care, as some in-person visits were transitioned to virtual or visit intervals were extended. But how did the traditional U.S. prenatal visit schedule - monthly until 28 weeks, biweekly until 36 weeks, and weekly until delivery - become established in the first place? According to a recent review article in the American Journal of Obstetrics & Gynecology, the present-day schedule of 12-14 visits over the course of one's pregnancy was codified in 1930 in a booklet published by the Federal Children's Bureau, during an era when the majority of births occurred in the home. In the intervening century, the only major effort to change the frequency of prenatal appointments came in 1989, when an expert panel commissioned by the Department of Health and Human Services recommended a flexible, risk-based schedule:

Their proposed schedule included 7 visits for low-risk multiparous patients and 9 visits for low-risk nulliparous patients, with additional visits added as needed for high-risk patients based on medical and social risk factors. Interestingly, they suggested a phone visit for multiparous patients at 10 week's gestation, perhaps a first step toward what we now see as telemedicine for prenatal care.

The American College of Obstetricians and Gynecologists (ACOG) decided to reject the new schedule based on insufficient supporting evidence, even though "these recommendations implied maintaining an existing visit structure that was also not evidence-based." Then, as now, supporting evidence for prenatal interventions was limited. For example, though long endorsed by ACOG, counseling for healthy weight and weight gain in pregnancy was not officially recognized by the U.S. Preventive Services Task Force as a beneficial preventive service until last month.

A research study of the Google Trends database suggested that interest in planned community birth in the U.S. and the United Kingdom rose during the pandemic: the frequency of online search queries related to home birth increased by 239% and 53%, respectively, from March through November 2020 compared to the preceding year. According to an article by Dr. Gregory Lang and colleagues in the June 1 issue of American Family Physician, out-of-hospital births increased by 75% from 2004 to 2017, and in 2018 one out of every 61 newborns was delivered outside of a hospital. Planned community births are associated with a lower risk of obstetric interventions, including cesarean delivery, and, in "low-risk, vertex, singleton, term pregnancies in patients who have not had a previous cesarean delivery," neonatal outcomes may be similar to those in hospital settings.

In an accompanying editorial, Drs. Lawrence Leeman and Jessica Goldstein discussed ways to promote safety in community-based birth settings, including "adequate birth attendant training, access to emergency obstetric care, and careful risk assessment throughout the prenatal and intrapartum periods." The authors noted that regardless of whether they personally provide maternity care services, "family physicians play an important role in improving the safety of community birthing by offering counseling on the choice of birth setting, consultation, and collaboration during prenatal care, and by facilitating the process of maternal or newborn transfer [to the hospital] when necessary."

Monday, June 7, 2021

USPSTF updates colorectal cancer screening recommendations

 - Jennifer Middleton, MD, MPH

The United States Preventive Services Task Force (USPSTF) updated its recommendations for colorectal cancer (CRC) screening last month; it is now a B recommendation for adults aged 45-49 to be screened. (The previous A recommendation for adults aged 50-75 is unchanged.)  An increasing prevalence of CRC in younger adults, along with more outcome data from screening younger adults, led to the new recommendation for adults aged 45-49:

[T]he USPSTF determined that beginning screening at age 45 years and continuing to the age of 75 years, for the following screening strategies, yielded a reasonable balance of benefits (life-years gained) and burdens or harms (number of colonoscopies): annual FIT, sDNA-FIT every 1 to 3 years, CT colonography or flexible sigmoidoscopy every 5 years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years with annual FIT. 

The USPSTF's statement was supported by a systematic review and a modeling study. The systematic review sought to answer: 1) how effective is CRC screening to lower rates of CRC cancer and/or mortality, 2) how accurate are the available screening modalities, and 3) what are the harms of CRC screening. The researchers found that 1) screening via the modalities listed above* decreases cancer rates and improves mortality, 2) several modalities* have reasonable data to support their use, and 3) most harms are due to colonoscopy; since persons with a positive screening test then require colonoscopy, colonoscopy's harms were applied by researchers to the other testing modalities (the article's Table 4 reviews these in-depth). The modeling study used three sophisticated microsimulation models and found that "screening for colorectal cancer with stool tests, endoscopic tests, or computed tomography colonography starting at age 45 years provides an efficient balance of colonoscopy burden and life-years gained."

The studies cited by the systematic review did not separately analyze their data for adults aged 45-49, and the modeling study is limited by the assumptions entered into the model by researchers. Criticism of the new recommendation for adults aged 45-49 centers around the lack of randomized controlled trials specifically examining this population. The capacity to accommodate this additional population segment is also of concern: "[r]eliance on colonoscopy for screening among individuals aged 45 to 49 years might crowd out approximately one-third of individuals aged 50 to 75 years whose [colorectal cancer] screening is not up-to-date, given limited endoscopy capacity in some communities." The new recommendations are also not an endorsement to ignore patients with concerning symptoms under the age of 45, since "[n]early half of patients with early onset CRC are diagnosed before age 45 years...as was the case for the actor Chadwick Boseman, who died from CRC at age 43 years. Symptoms of CRC...should be evaluated promptly with appropriate diagnostic tests."

As family physicians, we should both discuss the new recommendation with patients and also provide guidance regarding the choice of screening modality when appropriate. Although these 2020 AFP Practice Guidelines from the BMJ and the ACP refer to the 2016 USPSTF recommendation statement, their overviews of CRC screening options remain relevant and useful. The USPSTF's website also has this table reviewing the evidence base behind each screening modality

If you'd like to read more, there's an AFP By Topic on Health Maintenance and Counseling and also this section on Colorectal Cancer Screening in the AFP By Topic on Cancer.

* recommended screening modalities are annual Fecal Immunochemical Test (FIT), stool DNA-Fecal Immunochemical Test (sDNA-FIT) every 1-3 years, CT colonography or flexible sigmoidoscopy every 5 years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years with annual FIT.

Tuesday, June 1, 2021

Guest Post: Patient-centered discussion of COVID-19 infection and mRNA vaccines

- Matthew R. Porter, MD, FAAFP, CAQHPM

Few patients understand what the SARS-CoV-2 virus does to the human body or how a COVID-19 messenger RNA (mRNA) vaccine works. The following patient-centered explanation utilizes readily understood metaphors and two clear, simple illustrations that you may use in your vaccine counseling visits. When patients understand how the virus infects cells and how an mRNA vaccine works, most anti-vaccine myths are neutralized and vaccine hesitancy decreases.

Here is a sample conversation I've used to help persuade vaccine-hesitant and vaccine-resistant patients of the safety of the COVID-19 mRNA vaccines:

"Ms. Smith, can I explain to you how the COVID virus infects our body?

Here is a picture of the virus. You can see the spike proteins on the outside. These are like suction cups. They help the virus attach to the cells in our lungs. Inside the virus is RNA, which functions like a DVD because it stores all the information needed to make another virus. For this reason I've made it look like a DVD.


After the virus attaches to a cell, it injects all of the RNA into the cell. The DVD goes to a photocopier in the cell and prints out all the information it has. This stack of pages I've drawn here represents all that information, like a stack of messages. Messenger RNA, mRNA for short, is just copies of all the messages.

The mRNA then goes to the part of the cell that makes proteins. But instead of making a single COVID virus, the mRNA tricks the cell into making thousands of copies of the virus. This overwhelms the cell, causing it to explode, releasing all of those viruses to attack other lung cells. This process occurs until our immune system gets the outbreak under control. By then, in some patients with risk factors, too much damage has been done to the lungs, causing respiratory failure.

Now let me compare this to how an mRNA vaccine works. Imagine this book is the entire COVID RNA. To make the vaccine, a single page of this book with instructions for how to make a spike protein was photocopied. That information is all that is in the vaccine. When it gets inside a cell, the body sees it and says "Hey, these are instructions for making a protein!" Then the spike protein is made. At this point, the cell looks at the spike protein and says "Hey, you don't have ID!" Antibodies are made that fit the shape of the spike protein. The protein is quickly destroyed, as was the single page of mRNA instructions. So all you have left at this point are the antibodies against the spike protein, ready to attack the actual COVID virus.


You can see from this explanation that all of the mRNA in the COVID vaccine is actually present in a COVID infection. But instead of making cells explode, it just prepares the body to fight off the infection. So it makes no sense to downplay the risk of a COVID infection and exaggerate the risk of the mRNA vaccine when the complete set of COVID RNA and mRNA enter your body when you get infected. Every other time in your life you had a viral infection, your body had no problem getting rid of virus proteins and virus mRNA. It is no different with the mRNA of the COVID vaccines."

**

Dr. Porter is a staff physician at Waco Family Medicine in Waco, Texas.

Monday, May 24, 2021

Ovarian cancer screening (still) doesn't save lives

 - Jennifer Middleton, MD, MPH

Five years ago, I wrote about the pitfalls of advertising ovarian cancer screening (specifically, the ROCA test) to post-menopausal persons given the dearth of evidence supporting a mortality or morbidity benefit. The primary study that I cited, the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), released preliminary data in 2016. While they offered the tantalizing suggestion that ovarian and tubal cancer screening may offer a small benefit, they also acknowledged that the mortality of its participant groups did not appear markedly different. Now, after following these 200,000+ participants for a median of 16.3 years, the UKCTOCS researchers are definitively reporting no difference in mortality rates among those who were screened for ovarian and tubal cancer compared to those who were not. 

The UKCTOCS enrolled participants who were post-menopausal from across the United Kingdom and randomized them into three groups: annual multimodal screening (MMS) using ROCA, annual transvaginal ultrasound screening (USS), or no screening. The completed study, published earlier this month, found that:

Compared with no screening, there was a 47·2% (95% CI 19·7 to 81·1) increase in stage I and 24·5% (−41·8 to –2·0) decrease in stage IV disease incidence in the MMS group. Overall the incidence of stage I or II disease was 39·2% (95% CI 16·1 to 66·9) higher in the MMS group than in the no screening group, whereas the incidence of stage III or IV disease was 10·2% (−21·3 to 2·4) lower. 1206 women died of the disease: 296 (0·6%) of 50 625 in the MMS group, 291 (0·6%) of 50 623 in the USS group, and 619 (0·6%) of 101 314 in the no screening group. No significant reduction in ovarian and tubal cancer deaths was observed in the MMS (p=0·58) or USS (p=0·36) groups compared with the no screening group.

Although the MMS identified more cancers at an earlier stage, this early identification did not translate into a mortality benefit. In 2016, the UKCTOCS researchers responsibly advised caution regarding the risk of lead time bias in judging MMS' early detection ability; their assertion then that "follow-up is needed to assess the extent of the mortality reduction before firm conclusions can be reached on the long-term efficacy...of ovarian cancer screening" presciently predicted their final findings.

The United States Preventive Services Task Force (USPSTF) continues to recommend against ovarian cancer screening, and their rationale includes the important caveat that "screening for ovarian cancer can result in...many false-positive results, which can lead to unnecessary surgical interventions in women who do not have cancer." The Choosing Wisely campaign similarly advises against ovarian cancer screening in average risk, asymptomatic persons. As I wrote in 2016we should continue to focus our preventive care on interventions that are proven to decrease mortalityThis AFP article on "Diagnosis and Management of Ovarian Cancer" includes links to editorials that provide additional context regarding screening if you'd like to read more. 

Thursday, May 20, 2021

Guest Post: Thinking about loss in medicine

 - Jason Kurland, MD

Seven years into my medical career and one year into COVID, I've been thinking a lot about loss. Thinking about the primary care patients I lost during COVID and those who died in years prior to the pandemic. I don't find myself missing every patient who has died months later, but I do think of the ones who saw me in clinic regularly every 3 months, then every 2, sometimes every 2 to 4 weeks when their health worsened. The ones I squeezed into an urgent care shift because they needed to be seen by someone familiar with their history. The ones I recognized immediately from my colleague's texts: "admitted your 67 y/o patient with CHF" or "recurrent GIB" or "decompensated cirrhosis." Since I practice full spectrum family medicine in a rural hospital, I may see some patients in clinic one week and in the Emergency Department (ED) or on the medical ward the next. On occasion, I might deliver their granddaughter’s child.

I recall the night over a year ago when we coded a 92 year-old woman, found down at home, only to hear a second ambulance arrive as I called the code. The new patient was her son, my primary care patient. I ended up diagnosing him with yet another myocardial infarction that night; he had five stents already. He survived another year and had many more clinic and virtual visits. Last spring, he was found pulseless on the bathroom floor at home. I walked past our single negative pressure ED room where my colleagues were struggling to restart his heart, unaware that it was him until a screener in the hall outside told me. I poked my masked and shielded head in the door to confirm his Do Not Resuscitate order, ending the code. I then broke the news by phone to his wife who was waiting outside the hospital, per our stringent pandemic visitor policies.

After all of those visits, the setbacks and the improbable upturns, my patient is gone. My role now is to comfort the family, help them process the loss. I feel a grim sense of pride in doing a good job of death care.

My patient no longer pops up reliably in my schedule. I have no reason to open the chart. The time I spent reading about one of their complications or discussing their care with a specialist who ultimately agrees "that's hard, there's no simple answer" no longer keeps me after clinic. I lose the pleasure of checking in with a patient whom I also happened to have liked as a person. I lose the moments when I tell a colleague who is taking care of my patient in our urgent care, "so, the history on that is...."

Of course it makes sense that patients who have an outsized presence in my professional life can, sometimes, have an outsized presence in my emotional life. On good days, it feels like what I do really matters. Even when I have nothing medical to offer, I sense my longtime patients appreciate a familiar voice. But my patients and I inevitably share an asymmetric intimacy. I learn secrets about them, and I am present at their moments of extreme vulnerability. I might share a fact about me or show them a picture of my daughter being goofy. I can drop a detail into our visit that humanizes me or connects with something in their life. But ultimately, I am there for them.

My profession doesn't have a custom or a process for my grieving. Twice in the last year, I had to stifle the impulse to ask a terminally ill patient I’ve known for years for a selfie with them. I recognized, even as the thought occurred, that the request was inappropriate, that it blurred a line. Reflecting since, I realize I just wanted something by which to remember them, to recall our connection, shared jokes and disappointments, our relationship.

**

Dr. Kurland is Director of the Emergency Department at Zuni Comprehensive Community Health Center in New Mexico.

Monday, May 17, 2021

AAFP updates recommendations on lung cancer screening

- Sarah Coles, MD and Alexis Vosooney, MD

Recently the U.S. Preventive Services Task Force (USPSTF) updated its recommendation statement on lung cancer screening, lowering the age to start screening and pack year eligibility. The USPSTF now recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 50 to 80 years who have at least a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should stop once a person has not smoked for 15 years or has health issues that limit life expectancy or the ability and desire to have curative lung surgery.

The American Academy of Family Physicians (AAFP) disagreed with the previous (2013) USPSTF recommendation, which was based predominantly on a single trial, the National Lung Screening Trial (NLST). At that time, the AAFP concluded there was insufficient evidence to recommend for or against LDCT lung cancer screening. The AAFP had concerns about the generalizability of the trial (conducted in a large, academic medical center with a population that was younger and more likely to be current smokers than in the general population), the uncertain magnitude of benefit and the potential for harm, overdiagnosis, and uncertainty about optimal screening intervals. Championing the science, the AAFP highlighted concerns about this recommendation and called for additional research, and that challenge was met.

The new evidence review commissioned by the USPSTF includes seven randomized clinical trials (RCTs) of lung cancer screening with LDCT. NLST and the NELSON trial were the largest and the only trials powered to detect lung cancer mortality benefits to screening. Screening resulted in a difference in lung cancer specific mortality of 0.46%. The relative risk reduction for lung cancer mortality is 16-20%. The NELSON trial demonstrated a number needed to screen (NNS) to prevent one lung cancer death of 130 over 10 years of follow up. These improvements in cancer specific mortality are comparable or greater than other recommended screening tests such as breast cancer screening. A modeling study was also performed comparing screening strategies with different starting and stopping ages, frequency, and eligibility criteria. This analysis suggested that the 2021 USPSTF recommendation would result in more benefit than the 2013 recommendation.

Among studies conducted in the US, rates of overdiagnosis and false positives varied widely, with false positives generally declining with each screening round. In NLST, false positives led to invasive procedures and complications were rare. Use of current nodule management strategies such as Lung-RADS can reduce false positive rates and decrease unnecessary invasive procedures and improve the balance of benefit and harms.

After a robust discussion that included the strength of evidence, the risk of harm, the likelihood and magnitude of benefit, and the impact on health equity, the AAFP’s Commission on Health of the Public and Science agreed that there was sufficient data from clinical trials and observational studies to recommend screening and supported the USPSTF recommendation.

Further research is needed into harms of screening, particularly rates and consequences of overdiagnosis, unnecessary procedures, and barriers to implementation in community settings. None of the included studies in the USPSTF systematic review provided estimates for the lifetime risk of radiation-induced cancers or fatal cancers from continuing annual screening up to age 80. The general population is less likely to benefit than the study participants in NSLT and NELSON trials because of higher risks of other causes of death, such as heart disease. These trials were mainly conducted at large, academic medical centers with access to case management, specialized radiologists, and surgical expertise. Community based practices may not have the same resources to navigate positive results and follow up needs. The studies had poor racial and gender diversity, and the impact of screening on health equity for communities of color is unknown.

As with all screening recommendations, family physicians should discuss the potential benefits and risks of harm with each patient when considering lung cancer screening. The National Cancer Institute has developed resources to help clinicians with these discussions. While lung cancer screening does appear to help, smoking cessation remains key to reducing lung cancer deaths.