I've practiced family medicine long enough to remember when treatment of any patient with acute deep venous thrombosis (DVT) required hospitalization for several days administering intravenous unfractionated heparin and oral warfarin while waiting for the patient's international normalized ratio (INR) to reach a therapeutic level. Thanks to the development of low molecular-weight heparins and direct-acting oral anticoagulants (DOAC), outpatient treatment of uncomplicated DVT is now the norm. But patients with newly diagnosed pulmonary embolism (PE) are still typically hospitalized, since they often have hemodynamic instability or other potentially life-threatening conditions.
According to a 2017 article in American Family Physician, the American College of Chest Physicians suggests considering outpatient treatment of acute PE "if the risk of nonadherence is low and the patient is clinically stable; has no contraindications to anticoagulation, such as recent bleeding, severe renal or liver disease, or platelet count of less than 70; and feels capable of managing the disease at home." A recent Point-of-Care Guide reviewed clinical decision tools that predict mortality in patients with newly diagnosed PE. The simplified Pulmonary Embolism Severity Index (sPESI) stratifies patients into low and high risk categories. Low risk patients have a 30-day mortality rate of 1%, while high risk patients have a 9% mortality rate.
A prospective cohort study published in CHEST earlier this year enrolled 200 consecutive adults with newly diagnosed PE and a low risk of mortality using the related Pulmonary Embolism Severity Index (PESI). Participants were observed in the emergency department (ED) for 12 to 24 hours, then treated with anticoagulant medications in the outpatient setting (173 patients were treated with DOACs). After 90 days, no patients had died or suffered a recurrent venous thromboembolism (VTE). One patient had a major bleed after a traumatic thigh injury that required a blood transfusion and surgery.
A pragmatic controlled trial in Annals of Internal Medicine evaluated the effect of implementing an electronic clinical decision support system (CDSS) that included the PESI tool and an educational intervention on decision making for patients with acute PE in the 21 community EDs of Kaiser Permanente Northern California. 10 EDs received access to the CDSS and in-person education and feedback from an onsite emergency physician-researcher ("study champion"); the other 11 EDs served as control sites. The primary outcome was discharge to home from the ED or an ED-based outpatient observation unit. At the intervention sites, home discharge increased from 17.4% to 28%, while there were no changes in discharge practices at control sites. The intervention was not associated with increases in 30-day major adverse events (recurrent VTE, major hemorrhage, or all-cause mortality).
One day, one of my trainees will be able to write, "I've practiced family medicine long enough to remember when even low-risk patients with acute PE required hospitalization ..."
**
This post first appeared on the AFP Community Blog.
Monday, November 26, 2018
Tuesday, November 20, 2018
Delving deeper into the problem of overdiagnosis in medicine
Over the summer, two family physician colleagues and I published a commentary in Public Health Reviews on the implications of overscreening for carotid artery stenosis, prediabetes, and thyroid cancer. A theme connecting these three abnormalities (I won't call them "diseases," as evidence suggests that the most persons who receive these diagnoses through screening would be better off not knowing and being spared premature, costly, and/or invasive therapies) is that they are largely creations of modern medicine. A person can't feel a narrowing in a carotid artery, a slightly higher than normal blood sugar level, or a tiny thyroid nodule - instead, they learn about them after a doctor performs a test, either specifically to look for the abnormality or as an incidental finding. If the diagnosis leads to improved health outcomes, that's good news; if it only causes anxiety and unnecessary interventions, that's overdiagnosis.
2018 has seen the publication of several excellent reviews of the effects of overdiagnosis in primary care. In the Annals of Internal Medicine, Evidence-based Practice Center researchers affiliated with the U.S. Preventive Services Task Force (USPSTF) wrote about defining, estimating, and communicating overdiagnosis in cancer screening. They observed that several different study designs and approaches have been used to estimate the percentages of cancer cases that are overdiagnosed, all with limitations. (Sidebar: in a commentary in JAMA Internal Medicine, former USPSTF member Mark Ebell, MD, MS and I explored how these methods were used to produce varying estimates of overdiagnosis in randomized trials of lung cancer screening with low-dose CT scans.)
Members of the Canadian Task Force on Preventive Health Care (the evidence-based prevention panel after which the USPSTF was modeled) reviewed "causes and consequences" of overdiagnosis in primary care in a case-based discussion in Canadian Family Physician. Across the pond, the BMJ published a state-of-the-art review by two U.S. internists. Drs. Minal Kale and Deborah Korenstein pointed out that drivers of overdiagnosis include broadening disease definitions, advanced technology, public health screening programs, culture around medicine and health (e.g., "more screening is always better"), system factors (e.g., profit-driven testing, direct-to-consumer advertising, industry influence on guidelines and medical education), and limitations in evidence application. Finally, the World Organization of Family Doctors (WONCA) Europe released a position paper that defined overdiagnosis as "transforming people into patients unnecessarily" and urged family physicians, on behalf of their patients, to "demand balanced evidence informed and non emotional information material from providers and authorities in relation to cancer screening, health checks, etc."
Potential solutions to the problem of overdiagnosis should address each of the drivers, as outlined in a 2017 BMJ article by researchers at Bond University in Australia, which will co-host next year's international Preventing Overdiagnosis conference. One cancer-specific solution is to re-name low risk conditions currently labelled as cancer, such as small papillary thyroid cancers, ductal carcinoma in situ (DCIS), localized low-grade prostate cancer, melanoma in situ, and certain small lung and kidney cancers.
2018 has seen the publication of several excellent reviews of the effects of overdiagnosis in primary care. In the Annals of Internal Medicine, Evidence-based Practice Center researchers affiliated with the U.S. Preventive Services Task Force (USPSTF) wrote about defining, estimating, and communicating overdiagnosis in cancer screening. They observed that several different study designs and approaches have been used to estimate the percentages of cancer cases that are overdiagnosed, all with limitations. (Sidebar: in a commentary in JAMA Internal Medicine, former USPSTF member Mark Ebell, MD, MS and I explored how these methods were used to produce varying estimates of overdiagnosis in randomized trials of lung cancer screening with low-dose CT scans.)
Members of the Canadian Task Force on Preventive Health Care (the evidence-based prevention panel after which the USPSTF was modeled) reviewed "causes and consequences" of overdiagnosis in primary care in a case-based discussion in Canadian Family Physician. Across the pond, the BMJ published a state-of-the-art review by two U.S. internists. Drs. Minal Kale and Deborah Korenstein pointed out that drivers of overdiagnosis include broadening disease definitions, advanced technology, public health screening programs, culture around medicine and health (e.g., "more screening is always better"), system factors (e.g., profit-driven testing, direct-to-consumer advertising, industry influence on guidelines and medical education), and limitations in evidence application. Finally, the World Organization of Family Doctors (WONCA) Europe released a position paper that defined overdiagnosis as "transforming people into patients unnecessarily" and urged family physicians, on behalf of their patients, to "demand balanced evidence informed and non emotional information material from providers and authorities in relation to cancer screening, health checks, etc."
Potential solutions to the problem of overdiagnosis should address each of the drivers, as outlined in a 2017 BMJ article by researchers at Bond University in Australia, which will co-host next year's international Preventing Overdiagnosis conference. One cancer-specific solution is to re-name low risk conditions currently labelled as cancer, such as small papillary thyroid cancers, ductal carcinoma in situ (DCIS), localized low-grade prostate cancer, melanoma in situ, and certain small lung and kidney cancers.
Tuesday, November 13, 2018
For mild hypertension in low-risk adults, harms of drug therapy outweigh benefits
Prior to publication of the controversial 2017 ACC/AHA clinical practice guideline, stage 1 or "mild" hypertension was defined as a systolic blood pressure of 140-159 mm Hg and/or diastolic blood pressure of 90-99 mm Hg. Although guidelines have recommended that persons with mild hypertension receive anti-hypertensive drug therapy if lifestyle modification does not lower blood pressure below 140/90, a Cochrane review found that such therapy did not reduce cardiovascular disease (CVD) events, stroke, or mortality compared to placebo. A 2015 meta-analysis that included high-risk persons (patients with diabetes and/or who had received prior antihypertensive treatment) suggested that drug therapy for mild hypertension may prevent CVD events, but others have argued that this analysis mixed apples with oranges and did not establish benefits for adults at low CVD risk.
A retrospective cohort study recently published in JAMA Internal Medicine sought to clarify the benefits and harms of drug therapy in low-risk adults with mild hypertension using data from 40,000 patients in an electronic health records database in the United Kingdom. The authors compared the outcomes of persons aged 18 to 74 with mild hypertension who were prescribed anti-hypertensive medications within 12 months of diagnosis to those in similar untreated persons. Persons with a history of CVD, left ventricular hypertrophy, atrial fibrillation, diabetes, chronic kidney disease, or a family history of premature heart disease were excluded from the study.
After a median follow-up duration of 5.8 years, there were no differences between the groups in all-cause mortality, stroke, myocardial infarction, acute coronary syndrome, or heart failure. However, the treated group had an increased risk of hypotension (number needed to harm = 41 at 10 years), syncope (NNH = 35), electrolyte abnormalities (NNH = 111), and acute kidney injury (NNH = 91).
Although ideally the findings from this observational study should be confirmed in a randomized, controlled trial, it is unlikely that a trial will ever be performed due to the large number of participants that would be needed in order to provide enough statistical power to detect a difference in mortality or rare CVD events in this population. In the meantime, the best available evidence suggests that the harms of drug therapy outweigh benefits for low-risk adults with a systolic blood pressure of 140-159 mm Hg and/or diastolic blood pressure of 90-99 mm Hg (recently redefined by the ACC/AHA as stage 2 hypertension). In these patients, family physicians and other primary care clinicians should emphasize nonpharmacologic management strategies such as a diet with a high intake of vegetables, fruits, and whole grains; moderating excessive sodium intake and alcohol consumption; and at least 150 minutes per week of moderate-intensity aerobic physical activity, as recommended in the latest Physical Activity Guidelines for Americans.
**
A slightly different version of this post first appeared on the AFP Community Blog.
A retrospective cohort study recently published in JAMA Internal Medicine sought to clarify the benefits and harms of drug therapy in low-risk adults with mild hypertension using data from 40,000 patients in an electronic health records database in the United Kingdom. The authors compared the outcomes of persons aged 18 to 74 with mild hypertension who were prescribed anti-hypertensive medications within 12 months of diagnosis to those in similar untreated persons. Persons with a history of CVD, left ventricular hypertrophy, atrial fibrillation, diabetes, chronic kidney disease, or a family history of premature heart disease were excluded from the study.
After a median follow-up duration of 5.8 years, there were no differences between the groups in all-cause mortality, stroke, myocardial infarction, acute coronary syndrome, or heart failure. However, the treated group had an increased risk of hypotension (number needed to harm = 41 at 10 years), syncope (NNH = 35), electrolyte abnormalities (NNH = 111), and acute kidney injury (NNH = 91).
Although ideally the findings from this observational study should be confirmed in a randomized, controlled trial, it is unlikely that a trial will ever be performed due to the large number of participants that would be needed in order to provide enough statistical power to detect a difference in mortality or rare CVD events in this population. In the meantime, the best available evidence suggests that the harms of drug therapy outweigh benefits for low-risk adults with a systolic blood pressure of 140-159 mm Hg and/or diastolic blood pressure of 90-99 mm Hg (recently redefined by the ACC/AHA as stage 2 hypertension). In these patients, family physicians and other primary care clinicians should emphasize nonpharmacologic management strategies such as a diet with a high intake of vegetables, fruits, and whole grains; moderating excessive sodium intake and alcohol consumption; and at least 150 minutes per week of moderate-intensity aerobic physical activity, as recommended in the latest Physical Activity Guidelines for Americans.
**
A slightly different version of this post first appeared on the AFP Community Blog.
Monday, October 29, 2018
PSA screening: USPSTF recommendations changed, but the evidence did not
Comparing the 2018 U.S. Preventive Services Task Force (USPSTF) recommendation statement on prostate cancer screening in the October 15th issue of American Family Physician with its previous recommendation, the first question family physicians ought to ask is: what new evidence compelled the USPSTF to move from recommending against PSA screening in all men to determining that there was a small net benefit for screening in some men? Did another major randomized trial show a reduction in all-cause or prostate cancer-specific mortality in men invited to screening? Did other systematic reviewers re-analyze the evidence and find a mortality benefit where none previously existed? Have urologists or radiation oncologists developed new treatments for localized prostate cancer that no longer cause erectile dysfunction, urinary incontinence, or infections?
No, no, and no.
One of the Top 20 Research Studies of 2017 for Primary Care Physicians, the only U.S. trial of PSA-based screening for prostate cancer, reported that after a median followup of 15 years, there were still no differences in mortality between the two groups. In 2018, a large U.K. randomized trial of a single PSA screening also reported no effect on prostate cancer mortality after a median followup of 10 years. In both trials, more prostate cancers were diagnosed in the groups assigned to routine screening, but treating these cancers did not lead to improved health outcomes.
Last month, the authors of a 2010 Cochrane review of PSA screening (previously summarized in AFP's Cochrane for Clinicians) published an updated meta-analysis in the BMJ that incorporated the U.K. trial findings and extended followup of the U.S. and European screening trials and concluded that "at best, screening for prostate cancer leads to a small reduction in disease-specific mortality over 10 years but does not affect overall mortality." They also estimated that "for every 1000 men screened, approximately 1, 3, and 25 more men would be hospitalized for sepsis, require pads for urinary incontinence, and report erectile dysfunction, respectively." Another U.K. trial comparing active surveillance for localized prostate cancer with immediate surgery or radiation therapy found higher rates of clinical progression in the active surveillance group, but no differences in health-related quality of life or mortality.
No, no, and no.
One of the Top 20 Research Studies of 2017 for Primary Care Physicians, the only U.S. trial of PSA-based screening for prostate cancer, reported that after a median followup of 15 years, there were still no differences in mortality between the two groups. In 2018, a large U.K. randomized trial of a single PSA screening also reported no effect on prostate cancer mortality after a median followup of 10 years. In both trials, more prostate cancers were diagnosed in the groups assigned to routine screening, but treating these cancers did not lead to improved health outcomes.
Last month, the authors of a 2010 Cochrane review of PSA screening (previously summarized in AFP's Cochrane for Clinicians) published an updated meta-analysis in the BMJ that incorporated the U.K. trial findings and extended followup of the U.S. and European screening trials and concluded that "at best, screening for prostate cancer leads to a small reduction in disease-specific mortality over 10 years but does not affect overall mortality." They also estimated that "for every 1000 men screened, approximately 1, 3, and 25 more men would be hospitalized for sepsis, require pads for urinary incontinence, and report erectile dysfunction, respectively." Another U.K. trial comparing active surveillance for localized prostate cancer with immediate surgery or radiation therapy found higher rates of clinical progression in the active surveillance group, but no differences in health-related quality of life or mortality.
Representing the views of American Academy of Family Physicians (AAFP), Drs. James Stevermer and Kenneth Fink explained in an editorial why "the AAFP believes that the net benefit [of PSA screening] does not justify routine screening or routinely offering shared decision making." The AAFP took the unusual step of declining to endorse the USPSTF recommendation statement and instead writing its own clinical preventive services recommendation that emphasizes the harms of routine screening. Men who bring up the topic of PSA screening should engage in shared decision-making with their physicians about the benefits and harms of screening and express a clear preference to be screened before undergoing the test.
**
This post first appeared on the AFP Community Blog.
**
This post first appeared on the AFP Community Blog.
Monday, October 15, 2018
We should be alarmed that congenital syphilis is on the rise
The Tuskegee Syphilis Study will always be a black mark on American medicine. Designed to record the natural history of untreated syphilis in a population of illiterate African American men in rural Alabama, it continued for 25 years after penicillin became widely available and an accepted cure for the disease. Participants were deceived into believing that they were receiving effective treatment and never informed that they had the option of leaving the study. Although the ethics of these practices were occasionally questioned, the study did not end until it had received widespread negative publicity and Congressional hearings had been called.
In 1972, the last year of the Tuskegee study, I hadn't been born yet. But when I was a medical student doing my Internal Medicine clerkship in early 2000, an older African American man was admitted to our hospital service with memory loss, confusion and difficulty walking and was eventually diagnosed with tertiary neurosyphilis. Based on what he told me about his sexual history and prior symptoms (genital ulcers, rashes, muscle and joint pains), he had likely been infected decades before. Though he was a U.S. citizen by birth, he did not have a family physician and had rarely received health care due to not having insurance or the ability to pay. I don't remember what happened after we started penicillin, but much of the damage already done to his nervous system was irreversible. This patient's illness wasn't quite as outrageous as doctors knowingly withholding antibiotics for decades, but I have little doubt that it could have turned out differently if he had had access to primary care earlier in his life.
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.
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 repeating 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.
It is alarming that nearly a thousand American babies born last year were afflicted with congenital syphilis. Medically speaking, preventing this condition through detection and treatment of syphilis is straightforward. This is a population health failure, resulting from an underfunded public health infrastructure and a fragmented health system that makes it hard for women at high risk to access timely prenatal and primary care. Our country can do much better.
**
Parts of this post first appeared on the AFP Community Blog.
In 1972, the last year of the Tuskegee study, I hadn't been born yet. But when I was a medical student doing my Internal Medicine clerkship in early 2000, an older African American man was admitted to our hospital service with memory loss, confusion and difficulty walking and was eventually diagnosed with tertiary neurosyphilis. Based on what he told me about his sexual history and prior symptoms (genital ulcers, rashes, muscle and joint pains), he had likely been infected decades before. Though he was a U.S. citizen by birth, he did not have a family physician and had rarely received health care due to not having insurance or the ability to pay. I don't remember what happened after we started penicillin, but much of the damage already done to his nervous system was irreversible. This patient's illness wasn't quite as outrageous as doctors knowingly withholding antibiotics for decades, but I have little doubt that it could have turned out differently if he had had access to primary care earlier in his life.
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.
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 repeating 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.
It is alarming that nearly a thousand American babies born last year were afflicted with congenital syphilis. Medically speaking, preventing this condition through detection and treatment of syphilis is straightforward. This is a population health failure, resulting from an underfunded public health infrastructure and a fragmented health system that makes it hard for women at high risk to access timely prenatal and primary care. Our country can do much better.
**
Parts of this post first appeared on the AFP Community Blog.
Saturday, October 6, 2018
What works and what doesn't for chronic sleeplessness
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 American Family Physician, 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 antipsychotic medications 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.
**
This post first appeared on the AFP Community Blog.
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 antipsychotic medications 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.
**
This post first appeared on the AFP Community Blog.
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