Federal Practitioner

Primary care providers can confidently pick any of three cervical cancer screening strategies recommended by the American Cancer Society and the United States Preventive Services Task Force, experts said.

Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.

“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.

To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.

First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.

“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”

Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.

In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.

“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.

Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
 

Primary HPV vs. cytology testing

Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.

Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.

Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.

“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
 

Self-swabbing could improve screening in certain groups

To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.

Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.

“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”

Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.

“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”

Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.

“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”

Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.

Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.

“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”

“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.

Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.

Primary care providers can confidently pick any of three cervical cancer screening strategies recommended by the American Cancer Society and the United States Preventive Services Task Force, experts said.

Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.

“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.

To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.

First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.

“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”

Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.

In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.

“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.

Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
 

Primary HPV vs. cytology testing

Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.

Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.

Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.

“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
 

Self-swabbing could improve screening in certain groups

To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.

Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.

“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”

Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.

“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”

Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.

“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”

Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.

Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.

“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”

“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.

Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.

Primary care providers can confidently pick any of three cervical cancer screening strategies recommended by the American Cancer Society and the United States Preventive Services Task Force, experts said.

Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.

“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.

To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.

First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.

“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”

Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.

In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.

“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.

Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
 

Primary HPV vs. cytology testing

Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.

Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.

Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.

“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
 

Self-swabbing could improve screening in certain groups

To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.

Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.

“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”

Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.

“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”

Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.

“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”

Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.

Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.

“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”

“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.

Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.

Clinicians should consider the use of medication for adults with untreated stage 1 hypertension (130-139/80-89 mm Hg) whose 10-year risk for atherosclerotic cardiovascular disease is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy, the American Heart Association (AHA) advises in new scientific statement.

The statement was published online April 29 in Hypertension.

The recommendation complements the 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines, which do not fully address how to manage untreated stage 1 hypertension, the AHA says.

“There are no treatment recommendations in current guidelines for patients who are at relatively low short-term risk of heart disease when blood pressure does not drop below 130 mm Hg after six months of recommended lifestyle changes. This statement fills that gap,” Daniel W. Jones, MD, chair of the statement writing group and a past president of the AHA, said in a news release.

If after 6 months with lifestyle changes, blood pressure does not improve, lifestyle therapy should be continued and “clinicians should consider adding medications to control blood pressure,” said Dr. Jones, professor and dean emeritus, University of Mississippi, Jackson.

Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, and following the Dietary Approaches to Stop Hypertension (DASH) diet, which is plentiful in fruits and vegetables with low-fat dairy products and reduced saturated fat and total fat. In addition, patients should be advised to limit alcohol intake and to not smoke.

The writing group acknowledges that these goals can be hard to achieve and maintain over time.

“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Dr. Jones said.

“We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life,” said Dr. Jones.

The AHA statement also addresses cases in which adults were found to have hypertension during adolescence or childhood and were prescribed antihypertensive drug therapy.

In this patient population, clinicians should consider the original indications for starting antihypertensive drug treatment and the need to continue the medication and lifestyle therapy as young adults, the AHA advises.

“In young adults with stage 1 hypertension who are not controlled with lifestyle therapy, special consideration should be given to use of antihypertensive medication in individuals with a family history of premature CVD, a history of hypertension during pregnancy, or a personal history of premature birth,” the AHA states.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Hypertension; the Council on the Kidney in Cardiovascular Disease; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular Radiology and Intervention; the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and the Stroke Council.

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clinicians should consider the use of medication for adults with untreated stage 1 hypertension (130-139/80-89 mm Hg) whose 10-year risk for atherosclerotic cardiovascular disease is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy, the American Heart Association (AHA) advises in new scientific statement.

The statement was published online April 29 in Hypertension.

The recommendation complements the 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines, which do not fully address how to manage untreated stage 1 hypertension, the AHA says.

“There are no treatment recommendations in current guidelines for patients who are at relatively low short-term risk of heart disease when blood pressure does not drop below 130 mm Hg after six months of recommended lifestyle changes. This statement fills that gap,” Daniel W. Jones, MD, chair of the statement writing group and a past president of the AHA, said in a news release.

If after 6 months with lifestyle changes, blood pressure does not improve, lifestyle therapy should be continued and “clinicians should consider adding medications to control blood pressure,” said Dr. Jones, professor and dean emeritus, University of Mississippi, Jackson.

Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, and following the Dietary Approaches to Stop Hypertension (DASH) diet, which is plentiful in fruits and vegetables with low-fat dairy products and reduced saturated fat and total fat. In addition, patients should be advised to limit alcohol intake and to not smoke.

The writing group acknowledges that these goals can be hard to achieve and maintain over time.

“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Dr. Jones said.

“We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life,” said Dr. Jones.

The AHA statement also addresses cases in which adults were found to have hypertension during adolescence or childhood and were prescribed antihypertensive drug therapy.

In this patient population, clinicians should consider the original indications for starting antihypertensive drug treatment and the need to continue the medication and lifestyle therapy as young adults, the AHA advises.

“In young adults with stage 1 hypertension who are not controlled with lifestyle therapy, special consideration should be given to use of antihypertensive medication in individuals with a family history of premature CVD, a history of hypertension during pregnancy, or a personal history of premature birth,” the AHA states.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Hypertension; the Council on the Kidney in Cardiovascular Disease; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular Radiology and Intervention; the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and the Stroke Council.

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clinicians should consider the use of medication for adults with untreated stage 1 hypertension (130-139/80-89 mm Hg) whose 10-year risk for atherosclerotic cardiovascular disease is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy, the American Heart Association (AHA) advises in new scientific statement.

The statement was published online April 29 in Hypertension.

The recommendation complements the 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines, which do not fully address how to manage untreated stage 1 hypertension, the AHA says.

“There are no treatment recommendations in current guidelines for patients who are at relatively low short-term risk of heart disease when blood pressure does not drop below 130 mm Hg after six months of recommended lifestyle changes. This statement fills that gap,” Daniel W. Jones, MD, chair of the statement writing group and a past president of the AHA, said in a news release.

If after 6 months with lifestyle changes, blood pressure does not improve, lifestyle therapy should be continued and “clinicians should consider adding medications to control blood pressure,” said Dr. Jones, professor and dean emeritus, University of Mississippi, Jackson.

Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, and following the Dietary Approaches to Stop Hypertension (DASH) diet, which is plentiful in fruits and vegetables with low-fat dairy products and reduced saturated fat and total fat. In addition, patients should be advised to limit alcohol intake and to not smoke.

The writing group acknowledges that these goals can be hard to achieve and maintain over time.

“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Dr. Jones said.

“We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life,” said Dr. Jones.

The AHA statement also addresses cases in which adults were found to have hypertension during adolescence or childhood and were prescribed antihypertensive drug therapy.

In this patient population, clinicians should consider the original indications for starting antihypertensive drug treatment and the need to continue the medication and lifestyle therapy as young adults, the AHA advises.

“In young adults with stage 1 hypertension who are not controlled with lifestyle therapy, special consideration should be given to use of antihypertensive medication in individuals with a family history of premature CVD, a history of hypertension during pregnancy, or a personal history of premature birth,” the AHA states.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Hypertension; the Council on the Kidney in Cardiovascular Disease; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular Radiology and Intervention; the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and the Stroke Council.

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Although the healing properties of cannabis have been touted for millennia, research into its potential neuropsychiatric applications truly began to take off in the 1990s following the discovery of the cannabinoid system in the brain. This led to speculation that cannabis could play a therapeutic role in regulating dopamine, serotonin, and other neurotransmitters and offer a new means of treating various ailments.

LPETTET/Getty Images

At the same time, efforts to liberalize marijuana laws have successfully played out in several nations, including the United States, where, as of April 29, 36 states provide some access to cannabis. These dual tracks – medical and political – have made cannabis an increasingly accepted part of the cultural fabric.

Yet with this development has come a new quandary for clinicians. Medical cannabis has been made widely available to patients and has largely outpaced the clinical evidence, leaving it unclear how and for which indications it should be used.
 

The many forms of medical cannabis

Cannabis is a genus of plants that includes marijuana (Cannabis sativa) and hemp. These plants contain over 100 compounds, including terpenes, flavonoids, and – most importantly for medicinal applications – cannabinoids.

The most abundant cannabinoid in marijuana is the psychotropic delta-9-tetrahydrocannabinol (THC), which imparts the “high” sensation. The next most abundant cannabinoid is cannabidiol (CBD), which is the nonpsychotropic. THC and CBD are the most extensively studied cannabinoids, together and in isolation. Evidence suggests that other cannabinoids and terpenoids may also hold medical promise and that cannabis’ various compounds can work synergistically to produce a so-called entourage effect.

Patients walking into a typical medical cannabis dispensary will be faced with several plant-derived and synthetic options, which can differ considerably in terms of the ratios and amounts of THC and CBD they contain, as well in how they are consumed (i.e., via smoke, vapor, ingestion, topical administration, or oromucosal spray), all of which can alter their effects. Further complicating matters is the varying level of oversight each state and country has in how and whether they test for and accurately label products’ potency, cannabinoid content, and possible impurities.

Medically authorized, prescription cannabis products go through an official regulatory review process, and indications/contraindications have been established for them. To date, the Food and Drug Administration has approved one cannabis-derived drug product – Epidiolex (purified CBD) – for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years and older. The FDA has also approved three synthetic cannabis-related drug products – Marinol, Syndros (or dronabinol, created from synthetic THC), and Cesamet (or nabilone, a synthetic cannabinoid similar to THC) – all of which are indicated for treatment-related nausea and anorexia associated with weight loss in AIDS patients.

Surveys of medical cannabis consumers indicate that most people cannot distinguish between THC and CBD, so the first role that physicians find themselves in when recommending this treatment may be in helping patients navigate the volume of options.
 

Promising treatment for pain

Chronic pain is the leading reason patients seek out medical cannabis. It is also the indication that most researchers agree has the strongest evidence to support its use.

“In my mind, the most promising immediate use for medical cannabis is with THC for pain,” Diana M. Martinez, MD, a professor of psychiatry at Columbia University, New York, who specializes in addiction research, said in a recent MDedge podcast. “THC could be added to the armamentarium of pain medications that we use today.”

In a 2015 systematic literature review, researchers assessed 28 randomized, controlled trials (RCTs) of the use of cannabinoids for chronic pain. They reported that a variety of formulations resulted in at least a 30% reduction in the odds of pain, compared with placebo. A meta-analysis of five RCTs involving patients with neuropathic pain found a 30% reduction in pain over placebo with inhaled, vaporized cannabis. Varying results have been reported in additional studies for this indication. The National Academies of Sciences, Engineering, and Medicine concluded that there was a substantial body of evidence that cannabis is an effective treatment for chronic pain in adults.

The ongoing opioid epidemic has lent these results additional relevance. Data indicate that patients with chronic pain who undergo treatment with medical cannabis can reduce their intake of opioids by more than 60%.

Seeing this firsthand has caused Mark Steven Wallace, MD, a pain management specialist and chair of the division of pain medicine at the University of California San Diego Health, to reconsider offering cannabis to his patients.

“I think it’s probably more efficacious, just from my personal experience, and it’s a much lower risk of abuse and dependence than the opioids,” he said.

Dr. Wallace advised that clinicians who treat pain consider the ratios of cannabinoids.

“This is anecdotal, but we do find that with the combination of the two, CBD reduces the psychoactive effects of the THC. The ratios we use during the daytime range around 20 mg of CBD to 1 mg of THC,” he said.

In a recent secondary analysis of an RCT involving patients with painful diabetic peripheral neuropathy, Dr. Wallace and colleagues showed that THC’s effects appear to reverse themselves at a certain level.

“As the THC level goes up, the pain reduces until you reach about 16 ng/mL; then it starts going in the opposite direction, and pain will start to increase,” he said. “Even recreational cannabis users have reported that they avoid high doses because it’s very aversive. Using cannabis is all about, start low and go slow.”
 

A mixed bag for neurologic indications

There are relatively limited data on the use of medical cannabis for other neurologic conditions, and results have varied. For uses other than pain management, the evidence that does exist is strongest regarding epilepsy, said Daniel Freedman, DO, assistant professor of neurology at the University of Texas at Austin. He noted “multiple high-quality RCTs showing that pharmaceutical-grade CBD can reduce seizures associated with two particular epilepsy syndromes: Dravet Syndrome and Lennox Gastaut.”

These findings led to the FDA’s 2018 approval of Epidiolex for these syndromes. In earlier years, interest in CBD for pediatric seizures was largely driven by anecdotal parental reports of its benefits. NASEM’s 2017 overview on medical cannabis found evidence from subsequent RCTs in this indication to be insufficient. Clinicians who prescribe CBD for this indication must be vigilant because it can interact with several commonly used antiepileptic drugs.

Cannabinoid treatments have also shown success in alleviating muscle spasticity resulting from multiple sclerosis, most prominently in the form of nabiximols (Sativex), a standardized oralmucosal spray containing approximately equal quantities of THC and CBD. Nabiximols is approved in Europe but not in the United States. Moderate evidence supports the efficacy of these and other treatments over placebo in reducing muscle spasticity. Patient ratings of its effects tend to be higher than clinician assessment.

Parkinson’s disease has not yet been approved as an indication for treatment with cannabis or cannabinoids, yet a growing body of preclinical data suggests these could influence the dopaminergic system, said Carsten Buhmann, MD, from the department of neurology at the University Medical Center Hamburg-Eppendorf (Germany).

“In general, cannabinoids modulate basal-ganglia function on two levels which are especially relevant in Parkinson’s disease, i.e., the glutamatergic/dopaminergic synaptic neurotransmission and the corticostriatal plasticity,” he said. “Furthermore, activation of the endocannabinoid system might induce neuroprotective effects related to direct receptor-independent mechanisms, activation of anti-inflammatory cascades in glial cells via the cannabinoid receptor type 2, and antiglutamatergic antiexcitotoxic properties.”

Dr. Buhmann said that currently, clinical evidence is scarce, consisting of only four double-blind, placebo-controlled RCTs involving 49 patients. Various cannabinoids and methods of administering treatment were employed. Improvement was only observed in one of these RCTs, which found that the cannabinoid receptor agonist nabilone significantly reduced levodopa-induced dyskinesia for patients with Parkinson’s disease. Subjective data support a beneficial effect. In a nationwide survey of 1,348 respondents conducted by Dr. Buhmann and colleagues, the majority of medical cannabis users reported that it improved their symptoms (54% with oral CBD and 68% with inhaled THC-containing cannabis).

NASEM concluded that there was insufficient evidence to support the efficacy of medical cannabis for other neurologic conditions, including Tourette syndrome, amyotrophic lateral sclerosis, Huntington disease, dystonia, or dementia. A 2020 position statement from the American Academy of Neurology cited the lack of sufficient peer-reviewed research as the reason it could not currently support the use of cannabis for neurologic disorders.

Yet, according to Dr. Freedman, who served as a coauthor of the AAN position statement, this hasn’t stymied research interest in the topic. He’s seen a substantial uptick in studies of CBD over the past 2 years. “The body of evidence grows, but I still see many claims being made without evidence. And no one seems to care about all the negative trials.”
 

Cannabis as a treatment for, and cause of, psychiatric disorders

Mental health problems – such as anxiety, depression, and PTSD – are among the most common reasons patients seek out medical cannabis. There is an understandable interest in using cannabis and cannabinoids to treat psychiatric disorders. Preclinical studies suggest that the endocannabinoid system plays a prominent role in modulating feelings of anxiety, mood, and fear. As with opioids and chronic pain management, there is hope that medical cannabis may provide a means of reducing prescription anxiolytics and their associated risks.

The authors of the first systematic review (BMC Psychiatry. 2020 Jan 16;20[1]:24) of the use of medical cannabis for major psychiatric disorders noted that the current evidence was “encouraging, albeit embryonic.”

Meta-analyses have indicated a small but positive association between cannabis use and anxiety, although this may reflect the fact that patients with anxiety sought out this treatment. Given the risks for substance use disorders among patients with anxiety, CBD may present a more viable option. Positive results have been shown as treatment for generalized social anxiety disorder.

Limited but encouraging results have also been reported regarding the alleviation of PTSD symptoms with both cannabis and CBD, although the body of high-quality evidence hasn’t notably progressed since 2017, when NASEM declared that the evidence was insufficient. Supportive evidence is similarly lacking regarding the treatment of depression. Longitudinal studies suggest that cannabis use, particularly heavy use, may increase the risk of developing this disorder. Because THC is psychoactive, it is advised that it be avoided by patients at risk for psychotic disorders. However, CBD has yielded limited benefits for patients with treatment-resistant schizophrenia and for young people at risk for psychosis.

The use of medical cannabis for psychiatric conditions requires a complex balancing act, inasmuch as these treatments may exacerbate the very problems they are intended to alleviate.

Marta Di Forti, MD, PhD, professor of psychiatric research at Kings College London, has been at the forefront of determining the mental health risks of continued cannabis use. In 2019, Dr. Di Forti developed the first and only Cannabis Clinic for Patients With Psychosis in London where she and her colleagues have continued to elucidate this connection.

Dr. Di Forti and colleagues have linked daily cannabis use to an increase in the risk of experiencing psychotic disorder, compared with never using it. That risk was further increased among users of high-potency cannabis (≥10% THC). The latter finding has troubling implications, because concentrations of THC have steadily risen since 1970. By contrast, CBD concentrations have remained generally stable. High-potency cannabis products are common in both recreational and medicinal settings.

“For somebody prescribing medicinal cannabis that has a ≥10% concentration of THC, I’d be particularly wary of the risk of psychosis,” said Dr. Di Forti. “If you’re expecting people to use a high content of THC daily to medicate pain or a chronic condition, you even more so need to be aware that this is a potential side effect.”

Dr. Di Forti noted that her findings come from a cohort of recreational users, most of whom were aged 18-35 years.

“There have actually not been studies developed from collecting data in this area from groups specifically using cannabis for medicinal rather than recreational purposes,” she said.

She added that she personally has no concerns about the use of medical cannabis but wants clinicians to be aware of the risk for psychosis, to structure their patient conversations to identify risk factors or family histories of psychosis, and to become knowledgeable in detecting the often subtle signs of its initial onset.

When cannabis-associated psychosis occurs, Dr. Di Forti said it is primarily treated with conventional means, such as antipsychotics and therapeutic interventions and by refraining from using cannabis. Achieving the latter goal can be a challenge for patients who are daily users of high-potency cannabis. Currently, there are no treatment options such as those offered to patients withdrawing from the use of alcohol or opioids. Dr. Di Forti and colleagues are currently researching a solution to that problem through the use of another medical cannabis, the oromucosal spray Sativex, which has been approved in the European Union.
 

The regulatory obstacles to clarifying cannabis’ role in medicine

That currently there is limited or no evidence to support the use of medical cannabis for the treatment of neuropsychiatric conditions points to the inherent difficulties in conducting high-level research in this area.

“There’s a tremendous shortage of reliable data, largely due to regulatory barriers,” said Dr. Martinez.

Since 1970, cannabis has been listed as a Schedule I drug that is illegal to prescribe (the Agriculture Improvement Act of 2018 removed hemp from such restrictions). The FDA has issued guidance for researchers who wish to investigate treatments using Cannabis sativa or its derivatives in which the THC content is greater than 0.3%. Such research requires regular interactions with several federal agencies, including the Drug Enforcement Administration.

“It’s impossible to do multicenter RCTs with large numbers of patients, because you can’t transport cannabis across state lines,” said Dr. Wallace.

Regulatory restrictions regarding medical cannabis vary considerably throughout the world (the European Monitoring Center for Drugs and Drug Addiction provides a useful breakdown of this on their website). The lack of consistency in regulatory oversight acts as an impediment for conducting large-scale international multicenter studies on the topic.

Dr. Buhmann noted that, in Germany, cannabis has been broadly approved for treatment-resistant conditions with severe symptoms that impair quality of life. In addition, it is easy to be reimbursed for the use of cannabis as a medical treatment. These factors serve as disincentives for the funding of high-quality studies.

“It’s likely that no pharmaceutical company will do an expensive RCT to get an approval for Parkinson’s disease because it is already possible to prescribe medical cannabis of any type of THC-containing cannabinoid, dose, or route of application,” Dr. Buhmann said.

In the face of such restrictions and barriers, researchers are turning to ambitious real-world data projects to better understand medical cannabis’ efficacy and safety. A notable example is ProjectTwenty21, which is supported by the Royal College of Psychiatrists. The project is collecting outcomes of the use of medical cannabis among 20,000 U.K. patients whose conventional treatments of chronic pain, anxiety disorder, epilepsy, multiple sclerosis, PTSD, substance use disorder, and Tourette syndrome failed.

Dr. Freedman noted that the continued lack of high-quality data creates a void that commercial interests fill with unfounded claims.

“The danger is that patients might abandon a medication or intervention backed by robust science in favor of something without any science or evidence behind it,” he said. “There is no reason not to expect the same level of data for claims about cannabis products as we would expect from pharmaceutical products.”

Getting to that point, however, will require that the authorities governing clinical trials begin to view cannabis as the research community does, as a possible treatment with potential value, rather than as an illicit drug that needs to be tamped down.

A version of this article first appeared on Medscape.com.

Although the healing properties of cannabis have been touted for millennia, research into its potential neuropsychiatric applications truly began to take off in the 1990s following the discovery of the cannabinoid system in the brain. This led to speculation that cannabis could play a therapeutic role in regulating dopamine, serotonin, and other neurotransmitters and offer a new means of treating various ailments.

LPETTET/Getty Images

At the same time, efforts to liberalize marijuana laws have successfully played out in several nations, including the United States, where, as of April 29, 36 states provide some access to cannabis. These dual tracks – medical and political – have made cannabis an increasingly accepted part of the cultural fabric.

Yet with this development has come a new quandary for clinicians. Medical cannabis has been made widely available to patients and has largely outpaced the clinical evidence, leaving it unclear how and for which indications it should be used.
 

The many forms of medical cannabis

Cannabis is a genus of plants that includes marijuana (Cannabis sativa) and hemp. These plants contain over 100 compounds, including terpenes, flavonoids, and – most importantly for medicinal applications – cannabinoids.

The most abundant cannabinoid in marijuana is the psychotropic delta-9-tetrahydrocannabinol (THC), which imparts the “high” sensation. The next most abundant cannabinoid is cannabidiol (CBD), which is the nonpsychotropic. THC and CBD are the most extensively studied cannabinoids, together and in isolation. Evidence suggests that other cannabinoids and terpenoids may also hold medical promise and that cannabis’ various compounds can work synergistically to produce a so-called entourage effect.

Patients walking into a typical medical cannabis dispensary will be faced with several plant-derived and synthetic options, which can differ considerably in terms of the ratios and amounts of THC and CBD they contain, as well in how they are consumed (i.e., via smoke, vapor, ingestion, topical administration, or oromucosal spray), all of which can alter their effects. Further complicating matters is the varying level of oversight each state and country has in how and whether they test for and accurately label products’ potency, cannabinoid content, and possible impurities.

Medically authorized, prescription cannabis products go through an official regulatory review process, and indications/contraindications have been established for them. To date, the Food and Drug Administration has approved one cannabis-derived drug product – Epidiolex (purified CBD) – for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years and older. The FDA has also approved three synthetic cannabis-related drug products – Marinol, Syndros (or dronabinol, created from synthetic THC), and Cesamet (or nabilone, a synthetic cannabinoid similar to THC) – all of which are indicated for treatment-related nausea and anorexia associated with weight loss in AIDS patients.

Surveys of medical cannabis consumers indicate that most people cannot distinguish between THC and CBD, so the first role that physicians find themselves in when recommending this treatment may be in helping patients navigate the volume of options.
 

Promising treatment for pain

Chronic pain is the leading reason patients seek out medical cannabis. It is also the indication that most researchers agree has the strongest evidence to support its use.

“In my mind, the most promising immediate use for medical cannabis is with THC for pain,” Diana M. Martinez, MD, a professor of psychiatry at Columbia University, New York, who specializes in addiction research, said in a recent MDedge podcast. “THC could be added to the armamentarium of pain medications that we use today.”

In a 2015 systematic literature review, researchers assessed 28 randomized, controlled trials (RCTs) of the use of cannabinoids for chronic pain. They reported that a variety of formulations resulted in at least a 30% reduction in the odds of pain, compared with placebo. A meta-analysis of five RCTs involving patients with neuropathic pain found a 30% reduction in pain over placebo with inhaled, vaporized cannabis. Varying results have been reported in additional studies for this indication. The National Academies of Sciences, Engineering, and Medicine concluded that there was a substantial body of evidence that cannabis is an effective treatment for chronic pain in adults.

The ongoing opioid epidemic has lent these results additional relevance. Data indicate that patients with chronic pain who undergo treatment with medical cannabis can reduce their intake of opioids by more than 60%.

Seeing this firsthand has caused Mark Steven Wallace, MD, a pain management specialist and chair of the division of pain medicine at the University of California San Diego Health, to reconsider offering cannabis to his patients.

“I think it’s probably more efficacious, just from my personal experience, and it’s a much lower risk of abuse and dependence than the opioids,” he said.

Dr. Wallace advised that clinicians who treat pain consider the ratios of cannabinoids.

“This is anecdotal, but we do find that with the combination of the two, CBD reduces the psychoactive effects of the THC. The ratios we use during the daytime range around 20 mg of CBD to 1 mg of THC,” he said.

In a recent secondary analysis of an RCT involving patients with painful diabetic peripheral neuropathy, Dr. Wallace and colleagues showed that THC’s effects appear to reverse themselves at a certain level.

“As the THC level goes up, the pain reduces until you reach about 16 ng/mL; then it starts going in the opposite direction, and pain will start to increase,” he said. “Even recreational cannabis users have reported that they avoid high doses because it’s very aversive. Using cannabis is all about, start low and go slow.”
 

A mixed bag for neurologic indications

There are relatively limited data on the use of medical cannabis for other neurologic conditions, and results have varied. For uses other than pain management, the evidence that does exist is strongest regarding epilepsy, said Daniel Freedman, DO, assistant professor of neurology at the University of Texas at Austin. He noted “multiple high-quality RCTs showing that pharmaceutical-grade CBD can reduce seizures associated with two particular epilepsy syndromes: Dravet Syndrome and Lennox Gastaut.”

These findings led to the FDA’s 2018 approval of Epidiolex for these syndromes. In earlier years, interest in CBD for pediatric seizures was largely driven by anecdotal parental reports of its benefits. NASEM’s 2017 overview on medical cannabis found evidence from subsequent RCTs in this indication to be insufficient. Clinicians who prescribe CBD for this indication must be vigilant because it can interact with several commonly used antiepileptic drugs.

Cannabinoid treatments have also shown success in alleviating muscle spasticity resulting from multiple sclerosis, most prominently in the form of nabiximols (Sativex), a standardized oralmucosal spray containing approximately equal quantities of THC and CBD. Nabiximols is approved in Europe but not in the United States. Moderate evidence supports the efficacy of these and other treatments over placebo in reducing muscle spasticity. Patient ratings of its effects tend to be higher than clinician assessment.

Parkinson’s disease has not yet been approved as an indication for treatment with cannabis or cannabinoids, yet a growing body of preclinical data suggests these could influence the dopaminergic system, said Carsten Buhmann, MD, from the department of neurology at the University Medical Center Hamburg-Eppendorf (Germany).

“In general, cannabinoids modulate basal-ganglia function on two levels which are especially relevant in Parkinson’s disease, i.e., the glutamatergic/dopaminergic synaptic neurotransmission and the corticostriatal plasticity,” he said. “Furthermore, activation of the endocannabinoid system might induce neuroprotective effects related to direct receptor-independent mechanisms, activation of anti-inflammatory cascades in glial cells via the cannabinoid receptor type 2, and antiglutamatergic antiexcitotoxic properties.”

Dr. Buhmann said that currently, clinical evidence is scarce, consisting of only four double-blind, placebo-controlled RCTs involving 49 patients. Various cannabinoids and methods of administering treatment were employed. Improvement was only observed in one of these RCTs, which found that the cannabinoid receptor agonist nabilone significantly reduced levodopa-induced dyskinesia for patients with Parkinson’s disease. Subjective data support a beneficial effect. In a nationwide survey of 1,348 respondents conducted by Dr. Buhmann and colleagues, the majority of medical cannabis users reported that it improved their symptoms (54% with oral CBD and 68% with inhaled THC-containing cannabis).

NASEM concluded that there was insufficient evidence to support the efficacy of medical cannabis for other neurologic conditions, including Tourette syndrome, amyotrophic lateral sclerosis, Huntington disease, dystonia, or dementia. A 2020 position statement from the American Academy of Neurology cited the lack of sufficient peer-reviewed research as the reason it could not currently support the use of cannabis for neurologic disorders.

Yet, according to Dr. Freedman, who served as a coauthor of the AAN position statement, this hasn’t stymied research interest in the topic. He’s seen a substantial uptick in studies of CBD over the past 2 years. “The body of evidence grows, but I still see many claims being made without evidence. And no one seems to care about all the negative trials.”
 

Cannabis as a treatment for, and cause of, psychiatric disorders

Mental health problems – such as anxiety, depression, and PTSD – are among the most common reasons patients seek out medical cannabis. There is an understandable interest in using cannabis and cannabinoids to treat psychiatric disorders. Preclinical studies suggest that the endocannabinoid system plays a prominent role in modulating feelings of anxiety, mood, and fear. As with opioids and chronic pain management, there is hope that medical cannabis may provide a means of reducing prescription anxiolytics and their associated risks.

The authors of the first systematic review (BMC Psychiatry. 2020 Jan 16;20[1]:24) of the use of medical cannabis for major psychiatric disorders noted that the current evidence was “encouraging, albeit embryonic.”

Meta-analyses have indicated a small but positive association between cannabis use and anxiety, although this may reflect the fact that patients with anxiety sought out this treatment. Given the risks for substance use disorders among patients with anxiety, CBD may present a more viable option. Positive results have been shown as treatment for generalized social anxiety disorder.

Limited but encouraging results have also been reported regarding the alleviation of PTSD symptoms with both cannabis and CBD, although the body of high-quality evidence hasn’t notably progressed since 2017, when NASEM declared that the evidence was insufficient. Supportive evidence is similarly lacking regarding the treatment of depression. Longitudinal studies suggest that cannabis use, particularly heavy use, may increase the risk of developing this disorder. Because THC is psychoactive, it is advised that it be avoided by patients at risk for psychotic disorders. However, CBD has yielded limited benefits for patients with treatment-resistant schizophrenia and for young people at risk for psychosis.

The use of medical cannabis for psychiatric conditions requires a complex balancing act, inasmuch as these treatments may exacerbate the very problems they are intended to alleviate.

Marta Di Forti, MD, PhD, professor of psychiatric research at Kings College London, has been at the forefront of determining the mental health risks of continued cannabis use. In 2019, Dr. Di Forti developed the first and only Cannabis Clinic for Patients With Psychosis in London where she and her colleagues have continued to elucidate this connection.

Dr. Di Forti and colleagues have linked daily cannabis use to an increase in the risk of experiencing psychotic disorder, compared with never using it. That risk was further increased among users of high-potency cannabis (≥10% THC). The latter finding has troubling implications, because concentrations of THC have steadily risen since 1970. By contrast, CBD concentrations have remained generally stable. High-potency cannabis products are common in both recreational and medicinal settings.

“For somebody prescribing medicinal cannabis that has a ≥10% concentration of THC, I’d be particularly wary of the risk of psychosis,” said Dr. Di Forti. “If you’re expecting people to use a high content of THC daily to medicate pain or a chronic condition, you even more so need to be aware that this is a potential side effect.”

Dr. Di Forti noted that her findings come from a cohort of recreational users, most of whom were aged 18-35 years.

“There have actually not been studies developed from collecting data in this area from groups specifically using cannabis for medicinal rather than recreational purposes,” she said.

She added that she personally has no concerns about the use of medical cannabis but wants clinicians to be aware of the risk for psychosis, to structure their patient conversations to identify risk factors or family histories of psychosis, and to become knowledgeable in detecting the often subtle signs of its initial onset.

When cannabis-associated psychosis occurs, Dr. Di Forti said it is primarily treated with conventional means, such as antipsychotics and therapeutic interventions and by refraining from using cannabis. Achieving the latter goal can be a challenge for patients who are daily users of high-potency cannabis. Currently, there are no treatment options such as those offered to patients withdrawing from the use of alcohol or opioids. Dr. Di Forti and colleagues are currently researching a solution to that problem through the use of another medical cannabis, the oromucosal spray Sativex, which has been approved in the European Union.
 

The regulatory obstacles to clarifying cannabis’ role in medicine

That currently there is limited or no evidence to support the use of medical cannabis for the treatment of neuropsychiatric conditions points to the inherent difficulties in conducting high-level research in this area.

“There’s a tremendous shortage of reliable data, largely due to regulatory barriers,” said Dr. Martinez.

Since 1970, cannabis has been listed as a Schedule I drug that is illegal to prescribe (the Agriculture Improvement Act of 2018 removed hemp from such restrictions). The FDA has issued guidance for researchers who wish to investigate treatments using Cannabis sativa or its derivatives in which the THC content is greater than 0.3%. Such research requires regular interactions with several federal agencies, including the Drug Enforcement Administration.

“It’s impossible to do multicenter RCTs with large numbers of patients, because you can’t transport cannabis across state lines,” said Dr. Wallace.

Regulatory restrictions regarding medical cannabis vary considerably throughout the world (the European Monitoring Center for Drugs and Drug Addiction provides a useful breakdown of this on their website). The lack of consistency in regulatory oversight acts as an impediment for conducting large-scale international multicenter studies on the topic.

Dr. Buhmann noted that, in Germany, cannabis has been broadly approved for treatment-resistant conditions with severe symptoms that impair quality of life. In addition, it is easy to be reimbursed for the use of cannabis as a medical treatment. These factors serve as disincentives for the funding of high-quality studies.

“It’s likely that no pharmaceutical company will do an expensive RCT to get an approval for Parkinson’s disease because it is already possible to prescribe medical cannabis of any type of THC-containing cannabinoid, dose, or route of application,” Dr. Buhmann said.

In the face of such restrictions and barriers, researchers are turning to ambitious real-world data projects to better understand medical cannabis’ efficacy and safety. A notable example is ProjectTwenty21, which is supported by the Royal College of Psychiatrists. The project is collecting outcomes of the use of medical cannabis among 20,000 U.K. patients whose conventional treatments of chronic pain, anxiety disorder, epilepsy, multiple sclerosis, PTSD, substance use disorder, and Tourette syndrome failed.

Dr. Freedman noted that the continued lack of high-quality data creates a void that commercial interests fill with unfounded claims.

“The danger is that patients might abandon a medication or intervention backed by robust science in favor of something without any science or evidence behind it,” he said. “There is no reason not to expect the same level of data for claims about cannabis products as we would expect from pharmaceutical products.”

Getting to that point, however, will require that the authorities governing clinical trials begin to view cannabis as the research community does, as a possible treatment with potential value, rather than as an illicit drug that needs to be tamped down.

A version of this article first appeared on Medscape.com.

Although the healing properties of cannabis have been touted for millennia, research into its potential neuropsychiatric applications truly began to take off in the 1990s following the discovery of the cannabinoid system in the brain. This led to speculation that cannabis could play a therapeutic role in regulating dopamine, serotonin, and other neurotransmitters and offer a new means of treating various ailments.

LPETTET/Getty Images

At the same time, efforts to liberalize marijuana laws have successfully played out in several nations, including the United States, where, as of April 29, 36 states provide some access to cannabis. These dual tracks – medical and political – have made cannabis an increasingly accepted part of the cultural fabric.

Yet with this development has come a new quandary for clinicians. Medical cannabis has been made widely available to patients and has largely outpaced the clinical evidence, leaving it unclear how and for which indications it should be used.
 

The many forms of medical cannabis

Cannabis is a genus of plants that includes marijuana (Cannabis sativa) and hemp. These plants contain over 100 compounds, including terpenes, flavonoids, and – most importantly for medicinal applications – cannabinoids.

The most abundant cannabinoid in marijuana is the psychotropic delta-9-tetrahydrocannabinol (THC), which imparts the “high” sensation. The next most abundant cannabinoid is cannabidiol (CBD), which is the nonpsychotropic. THC and CBD are the most extensively studied cannabinoids, together and in isolation. Evidence suggests that other cannabinoids and terpenoids may also hold medical promise and that cannabis’ various compounds can work synergistically to produce a so-called entourage effect.

Patients walking into a typical medical cannabis dispensary will be faced with several plant-derived and synthetic options, which can differ considerably in terms of the ratios and amounts of THC and CBD they contain, as well in how they are consumed (i.e., via smoke, vapor, ingestion, topical administration, or oromucosal spray), all of which can alter their effects. Further complicating matters is the varying level of oversight each state and country has in how and whether they test for and accurately label products’ potency, cannabinoid content, and possible impurities.

Medically authorized, prescription cannabis products go through an official regulatory review process, and indications/contraindications have been established for them. To date, the Food and Drug Administration has approved one cannabis-derived drug product – Epidiolex (purified CBD) – for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years and older. The FDA has also approved three synthetic cannabis-related drug products – Marinol, Syndros (or dronabinol, created from synthetic THC), and Cesamet (or nabilone, a synthetic cannabinoid similar to THC) – all of which are indicated for treatment-related nausea and anorexia associated with weight loss in AIDS patients.

Surveys of medical cannabis consumers indicate that most people cannot distinguish between THC and CBD, so the first role that physicians find themselves in when recommending this treatment may be in helping patients navigate the volume of options.
 

Promising treatment for pain

Chronic pain is the leading reason patients seek out medical cannabis. It is also the indication that most researchers agree has the strongest evidence to support its use.

“In my mind, the most promising immediate use for medical cannabis is with THC for pain,” Diana M. Martinez, MD, a professor of psychiatry at Columbia University, New York, who specializes in addiction research, said in a recent MDedge podcast. “THC could be added to the armamentarium of pain medications that we use today.”

In a 2015 systematic literature review, researchers assessed 28 randomized, controlled trials (RCTs) of the use of cannabinoids for chronic pain. They reported that a variety of formulations resulted in at least a 30% reduction in the odds of pain, compared with placebo. A meta-analysis of five RCTs involving patients with neuropathic pain found a 30% reduction in pain over placebo with inhaled, vaporized cannabis. Varying results have been reported in additional studies for this indication. The National Academies of Sciences, Engineering, and Medicine concluded that there was a substantial body of evidence that cannabis is an effective treatment for chronic pain in adults.

The ongoing opioid epidemic has lent these results additional relevance. Data indicate that patients with chronic pain who undergo treatment with medical cannabis can reduce their intake of opioids by more than 60%.

Seeing this firsthand has caused Mark Steven Wallace, MD, a pain management specialist and chair of the division of pain medicine at the University of California San Diego Health, to reconsider offering cannabis to his patients.

“I think it’s probably more efficacious, just from my personal experience, and it’s a much lower risk of abuse and dependence than the opioids,” he said.

Dr. Wallace advised that clinicians who treat pain consider the ratios of cannabinoids.

“This is anecdotal, but we do find that with the combination of the two, CBD reduces the psychoactive effects of the THC. The ratios we use during the daytime range around 20 mg of CBD to 1 mg of THC,” he said.

In a recent secondary analysis of an RCT involving patients with painful diabetic peripheral neuropathy, Dr. Wallace and colleagues showed that THC’s effects appear to reverse themselves at a certain level.

“As the THC level goes up, the pain reduces until you reach about 16 ng/mL; then it starts going in the opposite direction, and pain will start to increase,” he said. “Even recreational cannabis users have reported that they avoid high doses because it’s very aversive. Using cannabis is all about, start low and go slow.”
 

A mixed bag for neurologic indications

There are relatively limited data on the use of medical cannabis for other neurologic conditions, and results have varied. For uses other than pain management, the evidence that does exist is strongest regarding epilepsy, said Daniel Freedman, DO, assistant professor of neurology at the University of Texas at Austin. He noted “multiple high-quality RCTs showing that pharmaceutical-grade CBD can reduce seizures associated with two particular epilepsy syndromes: Dravet Syndrome and Lennox Gastaut.”

These findings led to the FDA’s 2018 approval of Epidiolex for these syndromes. In earlier years, interest in CBD for pediatric seizures was largely driven by anecdotal parental reports of its benefits. NASEM’s 2017 overview on medical cannabis found evidence from subsequent RCTs in this indication to be insufficient. Clinicians who prescribe CBD for this indication must be vigilant because it can interact with several commonly used antiepileptic drugs.

Cannabinoid treatments have also shown success in alleviating muscle spasticity resulting from multiple sclerosis, most prominently in the form of nabiximols (Sativex), a standardized oralmucosal spray containing approximately equal quantities of THC and CBD. Nabiximols is approved in Europe but not in the United States. Moderate evidence supports the efficacy of these and other treatments over placebo in reducing muscle spasticity. Patient ratings of its effects tend to be higher than clinician assessment.

Parkinson’s disease has not yet been approved as an indication for treatment with cannabis or cannabinoids, yet a growing body of preclinical data suggests these could influence the dopaminergic system, said Carsten Buhmann, MD, from the department of neurology at the University Medical Center Hamburg-Eppendorf (Germany).

“In general, cannabinoids modulate basal-ganglia function on two levels which are especially relevant in Parkinson’s disease, i.e., the glutamatergic/dopaminergic synaptic neurotransmission and the corticostriatal plasticity,” he said. “Furthermore, activation of the endocannabinoid system might induce neuroprotective effects related to direct receptor-independent mechanisms, activation of anti-inflammatory cascades in glial cells via the cannabinoid receptor type 2, and antiglutamatergic antiexcitotoxic properties.”

Dr. Buhmann said that currently, clinical evidence is scarce, consisting of only four double-blind, placebo-controlled RCTs involving 49 patients. Various cannabinoids and methods of administering treatment were employed. Improvement was only observed in one of these RCTs, which found that the cannabinoid receptor agonist nabilone significantly reduced levodopa-induced dyskinesia for patients with Parkinson’s disease. Subjective data support a beneficial effect. In a nationwide survey of 1,348 respondents conducted by Dr. Buhmann and colleagues, the majority of medical cannabis users reported that it improved their symptoms (54% with oral CBD and 68% with inhaled THC-containing cannabis).

NASEM concluded that there was insufficient evidence to support the efficacy of medical cannabis for other neurologic conditions, including Tourette syndrome, amyotrophic lateral sclerosis, Huntington disease, dystonia, or dementia. A 2020 position statement from the American Academy of Neurology cited the lack of sufficient peer-reviewed research as the reason it could not currently support the use of cannabis for neurologic disorders.

Yet, according to Dr. Freedman, who served as a coauthor of the AAN position statement, this hasn’t stymied research interest in the topic. He’s seen a substantial uptick in studies of CBD over the past 2 years. “The body of evidence grows, but I still see many claims being made without evidence. And no one seems to care about all the negative trials.”
 

Cannabis as a treatment for, and cause of, psychiatric disorders

Mental health problems – such as anxiety, depression, and PTSD – are among the most common reasons patients seek out medical cannabis. There is an understandable interest in using cannabis and cannabinoids to treat psychiatric disorders. Preclinical studies suggest that the endocannabinoid system plays a prominent role in modulating feelings of anxiety, mood, and fear. As with opioids and chronic pain management, there is hope that medical cannabis may provide a means of reducing prescription anxiolytics and their associated risks.

The authors of the first systematic review (BMC Psychiatry. 2020 Jan 16;20[1]:24) of the use of medical cannabis for major psychiatric disorders noted that the current evidence was “encouraging, albeit embryonic.”

Meta-analyses have indicated a small but positive association between cannabis use and anxiety, although this may reflect the fact that patients with anxiety sought out this treatment. Given the risks for substance use disorders among patients with anxiety, CBD may present a more viable option. Positive results have been shown as treatment for generalized social anxiety disorder.

Limited but encouraging results have also been reported regarding the alleviation of PTSD symptoms with both cannabis and CBD, although the body of high-quality evidence hasn’t notably progressed since 2017, when NASEM declared that the evidence was insufficient. Supportive evidence is similarly lacking regarding the treatment of depression. Longitudinal studies suggest that cannabis use, particularly heavy use, may increase the risk of developing this disorder. Because THC is psychoactive, it is advised that it be avoided by patients at risk for psychotic disorders. However, CBD has yielded limited benefits for patients with treatment-resistant schizophrenia and for young people at risk for psychosis.

The use of medical cannabis for psychiatric conditions requires a complex balancing act, inasmuch as these treatments may exacerbate the very problems they are intended to alleviate.

Marta Di Forti, MD, PhD, professor of psychiatric research at Kings College London, has been at the forefront of determining the mental health risks of continued cannabis use. In 2019, Dr. Di Forti developed the first and only Cannabis Clinic for Patients With Psychosis in London where she and her colleagues have continued to elucidate this connection.

Dr. Di Forti and colleagues have linked daily cannabis use to an increase in the risk of experiencing psychotic disorder, compared with never using it. That risk was further increased among users of high-potency cannabis (≥10% THC). The latter finding has troubling implications, because concentrations of THC have steadily risen since 1970. By contrast, CBD concentrations have remained generally stable. High-potency cannabis products are common in both recreational and medicinal settings.

“For somebody prescribing medicinal cannabis that has a ≥10% concentration of THC, I’d be particularly wary of the risk of psychosis,” said Dr. Di Forti. “If you’re expecting people to use a high content of THC daily to medicate pain or a chronic condition, you even more so need to be aware that this is a potential side effect.”

Dr. Di Forti noted that her findings come from a cohort of recreational users, most of whom were aged 18-35 years.

“There have actually not been studies developed from collecting data in this area from groups specifically using cannabis for medicinal rather than recreational purposes,” she said.

She added that she personally has no concerns about the use of medical cannabis but wants clinicians to be aware of the risk for psychosis, to structure their patient conversations to identify risk factors or family histories of psychosis, and to become knowledgeable in detecting the often subtle signs of its initial onset.

When cannabis-associated psychosis occurs, Dr. Di Forti said it is primarily treated with conventional means, such as antipsychotics and therapeutic interventions and by refraining from using cannabis. Achieving the latter goal can be a challenge for patients who are daily users of high-potency cannabis. Currently, there are no treatment options such as those offered to patients withdrawing from the use of alcohol or opioids. Dr. Di Forti and colleagues are currently researching a solution to that problem through the use of another medical cannabis, the oromucosal spray Sativex, which has been approved in the European Union.
 

The regulatory obstacles to clarifying cannabis’ role in medicine

That currently there is limited or no evidence to support the use of medical cannabis for the treatment of neuropsychiatric conditions points to the inherent difficulties in conducting high-level research in this area.

“There’s a tremendous shortage of reliable data, largely due to regulatory barriers,” said Dr. Martinez.

Since 1970, cannabis has been listed as a Schedule I drug that is illegal to prescribe (the Agriculture Improvement Act of 2018 removed hemp from such restrictions). The FDA has issued guidance for researchers who wish to investigate treatments using Cannabis sativa or its derivatives in which the THC content is greater than 0.3%. Such research requires regular interactions with several federal agencies, including the Drug Enforcement Administration.

“It’s impossible to do multicenter RCTs with large numbers of patients, because you can’t transport cannabis across state lines,” said Dr. Wallace.

Regulatory restrictions regarding medical cannabis vary considerably throughout the world (the European Monitoring Center for Drugs and Drug Addiction provides a useful breakdown of this on their website). The lack of consistency in regulatory oversight acts as an impediment for conducting large-scale international multicenter studies on the topic.

Dr. Buhmann noted that, in Germany, cannabis has been broadly approved for treatment-resistant conditions with severe symptoms that impair quality of life. In addition, it is easy to be reimbursed for the use of cannabis as a medical treatment. These factors serve as disincentives for the funding of high-quality studies.

“It’s likely that no pharmaceutical company will do an expensive RCT to get an approval for Parkinson’s disease because it is already possible to prescribe medical cannabis of any type of THC-containing cannabinoid, dose, or route of application,” Dr. Buhmann said.

In the face of such restrictions and barriers, researchers are turning to ambitious real-world data projects to better understand medical cannabis’ efficacy and safety. A notable example is ProjectTwenty21, which is supported by the Royal College of Psychiatrists. The project is collecting outcomes of the use of medical cannabis among 20,000 U.K. patients whose conventional treatments of chronic pain, anxiety disorder, epilepsy, multiple sclerosis, PTSD, substance use disorder, and Tourette syndrome failed.

Dr. Freedman noted that the continued lack of high-quality data creates a void that commercial interests fill with unfounded claims.

“The danger is that patients might abandon a medication or intervention backed by robust science in favor of something without any science or evidence behind it,” he said. “There is no reason not to expect the same level of data for claims about cannabis products as we would expect from pharmaceutical products.”

Getting to that point, however, will require that the authorities governing clinical trials begin to view cannabis as the research community does, as a possible treatment with potential value, rather than as an illicit drug that needs to be tamped down.

A version of this article first appeared on Medscape.com.

In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.

John Fedele/Getty Images

In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.

These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.

Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.

When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.

“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”

The COVID-19 pandemic put to the test physicians’ ability to speak publicly about troublesome issues. In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.

Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
 

The case of one physician who spoke out

One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.

In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
 

Postings on Facebook

Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.

Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.

He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.

Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.

In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
 

How employers react to physicians who speak out

Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.

“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”

Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.

Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.

“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
 

Administrator fires back

Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.

Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”

Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”

Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
 

Doctor allegedly offered “misinformation”

At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”

PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”

Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.

“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”

Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
 

Doctor gets a warning

Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.

Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.

“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.

“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.

Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.

In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.

Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.

Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.

Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”

He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
 

Do doctors who speak out have any rights?

Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.

The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.

The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.

In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.

Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
 

Conclusion

To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.

A version of this article first appeared on Medscape.com.

In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.

John Fedele/Getty Images

In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.

These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.

Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.

When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.

“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”

The COVID-19 pandemic put to the test physicians’ ability to speak publicly about troublesome issues. In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.

Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
 

The case of one physician who spoke out

One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.

In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
 

Postings on Facebook

Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.

Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.

He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.

Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.

In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
 

How employers react to physicians who speak out

Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.

“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”

Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.

Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.

“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
 

Administrator fires back

Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.

Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”

Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”

Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
 

Doctor allegedly offered “misinformation”

At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”

PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”

Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.

“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”

Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
 

Doctor gets a warning

Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.

Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.

“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.

“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.

Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.

In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.

Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.

Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.

Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”

He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
 

Do doctors who speak out have any rights?

Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.

The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.

The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.

In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.

Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
 

Conclusion

To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.

A version of this article first appeared on Medscape.com.

In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.

John Fedele/Getty Images

In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.

These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.

Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.

When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.

“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”

The COVID-19 pandemic put to the test physicians’ ability to speak publicly about troublesome issues. In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.

Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
 

The case of one physician who spoke out

One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.

In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
 

Postings on Facebook

Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.

Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.

He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.

Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.

In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
 

How employers react to physicians who speak out

Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.

“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”

Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.

Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.

“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
 

Administrator fires back

Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.

Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”

Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”

Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
 

Doctor allegedly offered “misinformation”

At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”

PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”

Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.

“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”

Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
 

Doctor gets a warning

Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.

Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.

“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.

“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.

Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.

In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.

Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.

Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.

Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”

He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
 

Do doctors who speak out have any rights?

Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.

The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.

The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.

In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.

Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
 

Conclusion

To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.

A version of this article first appeared on Medscape.com.

Rapid advances in imaging technology have led to better spatial resolution with lower radiation doses to patients. These advances have helped to increase the use of diagnostic chest imaging, particularly in emergency departments and oncology centers, and in screening for coronary artery disease. As a result, there has been an explosion of incidental findings on chest imaging—including indeterminate lung nodules.^1,2

Lung nodules are rounded and well-circumscribed lung opacities (≤ 3 cm in diameter) that may present as solitary or multiple lesions in usually asymptomatic patients. Most lung nodules are benign, the result of an infectious or inflammatory process. Nodules that are ≤ 8 mm in diameter, unless they show increase in size over time, often can be safely followed with imaging surveillance. In contrast, lung nodules > 8 mm could represent an early-stage lung cancer, especially among patients with high-risk for developing lung cancer (ie, those with advanced age, heavy tobacco abuse, or emphysema) and should be further assessed with close imaging surveillance, either chest computed tomography (CT) alone or positron-emission tomography (PET)/CT, or tissue biopsy, based on the underlying likelihood of malignancy.

Patients who receive an early-stage lung cancer diagnosis can be offered curative treatments leading to improved 5-year survival rates.^3,4 Consequently, health care systems need to be able to identify these nodules accurately, in order to categorize and manage them accordingly to the Fleischner radiographic and American College of Chest Physicians clinical guidelines.^5,6 Unfortunately, many hospitals struggle to identify patients with incidental lung nodules found during diagnostic chest and abdominal imaging, due in part to poor adherence to Fleischner guidelines among radiologists for categorizing pulmonary nodules.^7,8

The Veterans Health Administration (VHA) system is interested in effectively detecting patients with incidental lung nodules. Veterans have a higher risk of developing lung cancer when compared with the entire US population, mainly due to a higher incidence of tobacco use.⁶ The prevalence of lung nodules among veterans with significant risk factors for lung cancer is about 60% nationwide, and up to 85% in the Midwest, due to the high prevalence of histoplasmosis.⁷ However, only a small percentage of these nodules represent an early stage primary lung cancer.

Several Veterans Integrated Service Networks (VISNs) in the VHA use a radiology diagnostic code to systematically identify imaging studies with presence of lung nodules. In VISN 23, which includes Minnesota, North Dakota, South Dakota, Iowa, and portions of neighboring states, the code used to identify these radiology studies is 44. However, there is high variability in the reporting and coding of imaging studies among radiologists, which could lead to misclassifying patients with lung nodules.⁸

Some studies suggest that using an automated text search algorithm within radiology reports can be a highly effective strategy to identify patients with lung nodules.^9,10 In this study, we compared the diagnostic performance of a newly developed text search algorithm applied to radiology reports with the current standard practice of using a radiology diagnostic code for identifying patients with lung nodules at the Iowa City US Department of Veterans Affairs (VA) Health Care System (ICVAHCS) hospital in Iowa.

Methods

Since 2014, The ICVAHCS has used a radiology diagnostic code to identify any imaging studies with lung nodules. The radiologist enters “44” at the end of the reading process using the Nuance Powerscribe 360 radiation reporting system. The code is uploaded into the VHA Corporate Data Warehouse (CDW), and it is located within the radiology exam domain. This strategy was created and implemented by the Minneapolis VA Health Care System in Minnesota for all the VA hospitals in VISN 23. A lung nodule registry nurse was provided with a list of radiology studies flagged with this radiology diagnostic code every 2 weeks. A chart review was then performed for all these studies to determine the presence of a lung nodule. When detected, the ordering health care provider was alerted and given recommendations for managing the nodule.

We initially searched for the radiology studies with a presumptive lung nodule using the radiology code 44 within the CDW. Separately, we applied the text search strategy only to radiology reports from chest and abdomen studies (ie, X-rays, CT, magnetic resonance imaging [MRI], and PET) that contained any of the keyword phrases. The text search strategy was modeled based on a natural language processing (NLP) algorithm developed by the Puget Sound VA Healthcare System in Seattle, Washington to identify lung nodules on radiology reports.⁹ Our algorithm included a series of text searches using Microsoft SQL. After several simulations using a random group of radiology reports, we chose the keywords: “lung AND nodul”; “pulm AND nodul”; “pulm AND mass”; “lung AND mass”; and “ground glass”. We selected only chest and abdomen studies because on several simulations using a random group of radiology reports, the vast majority of lung nodules were identified on chest and abdomen imaging studies. Also, it would not have been feasible to chart review the approximately 30,000 total radiology reports that were generated during the study period.

From January 1, 2016 through November 30, 2016, we applied both search strategies independently: radiology diagnostic code for lung nodules to all imaging studies, and text search to all radiology reports of chest and abdomen imaging studies in the CDW (Figure). We also collected demographic (eg, age, sex, race, rurality) and clinical (eg, medical comorbidities, tobacco use) information that were uploaded to the database automatically from CDW using International Statistical Classification of Diseases, Tenth Edition and demographic codes. The VHA uses the Rural-Urban Commuting Areas (RUCA) system to define rurality, which takes into account population density and how closely a community is linked socioeconomically to larger urban centers.¹¹ The protocol was reviewed and approved by the institutional review board of ICVAHCS and the University of Iowa.

Results

We identified 12,983 radiology studies that required manual review during the study period. We confirmed that 8,516 imaging studies had lung nodules, representing 2,912 patients. Subjects with lung nodules were predominantly male (96%), aged between 60 and 79 years (71%), and lived in a rural area (72%). More than 50% of these patients had COPD and over a third were current smokers (Table 1). The text search algorithm identified all of the patients identified by the radiology diagnostic code (n = 1,251). It also identified an additional 1,661 patients with lung nodules that otherwise would have been missed by the radiology code. Compared with those identified only by the text search, those identified by both the radiology coding and text search were older, had lower Charlson comorbidity scores, and were more likely to be a current smoker.

The text search algorithm identified more than twice as many patients with potential lung nodules compared with the radiology diagnostic code (4,071 vs 1,363) (Table 2). However, the text search algorithm was associated with a much higher number of false positives than was the diagnostic code (1,159 vs 112) and a lower PPV (72% [95% CI, 70.6-73.4] vs 92% [95% CI, 90.6-93.4], respectively). The text search algorithm identified 130 patients with lung nodules of moderate to high risk for malignancy (> 8 mm diameter) that were not identified by the radiology code. When the PPV of each search strategy was calculated based on imaging studies with nodules (most patients had > 1 imaging study), the results remained similar (98% for radiology code and 66% for text search). A larger proportion of the lung nodules detected by code 44 vs the text search algorithm were from CT chest studies.

Discussion

In a population of predominantly older male veterans with significant risk factors for lung cancer and high incidence of incidental lung nodules, applying a text search algorithm on radiology reports identified a substantial number of patients with lung nodules, including some with nodules > 8 mm, that were missed by the radiologist-generated code.^9,10 Improving the yield of detection for lung nodules in a population with high risk for lung cancer would increase the likelihood of detecting patients with potentially curable early-stage lung cancers, decreasing lung cancer mortality.

The reasons for the high number of patients with lung nodules missed by the radiology code are unclear. Potential explanations may include the lack of standardization of imaging reports by the radiologists (ie, only 21% of chest CTs used a standardized template describing a lung nodule in our study), a problem well recognized both within and outside VHA.^8,12

The text search algorithm identified more patients with lung nodules but had a higher rate of false positives when compared with the diagnostic code. The high rate of false positives resulted in more charts to review and an increased workload for the lung nodule registry team. The challenges presented by an increased workload should be balanced against the potential harms of missing nodules that develop into advanced cancer.

Text Search Adjustments

Refining the text search criteria algorithm and the chart review process may decrease the rate of false positives significantly without affecting detection of lung nodules. In subsequent simulations, we found that by adding an exclusion criteria to text search algorithm to remove reports with specific keywords we could substantially reduce the number of false positive reports without affecting the detection rate of the lung nodules. These exclusion criteria would exclude any reports that: (1) contain “nodul” within the next 8 words after mentioning “no”; (2) contain “clear” within the next 8 words after mentioning “lung” in the text (eg, “lungs appear to be clear”); (3) contain “clear” within the next 4 words after mentioning “otherwise” in the text (eg, “otherwise appear to be clear”). Based on our study results, we further refined the text search strategy by limiting the search to only chest imaging studies. When we applied the revised algorithm to a random sample of imaging reports, we found all the code 44 radiology reports were still captured, but we were able to reduce the number of radiology reports needing review by about 80%.

Although classification approaches are being refined to improve radiology performance in multiple categories of nodules, this study suggests that alternative approaches based on text algorithms can improve the capture of pulmonary nodules that require surveillance. These algorithms also can be used to augment radiologist reporting systems. This represents an investment in resources to build a team that should include a bioinformatics specialist, lung nodule registry personnel (review charts of the detected imaging studies with lung nodules, populating the lung nodule database, and determining and tracking the need of imaging follow up), a lung nodule clinic nurse coordinator, and a dedicated lung nodule clinic pulmonologist.

Radiology departments could employ this text search approach to identify missed nodules and use an audit and feedback system to train radiologists to code lung nodules consistently at the time of the initial reading to avoid delays in identifying patients with nodules. Alternatively, the more widespread use of a standardized CT chest radiology reports using Fleischner or the American College of Radiology Lung Imaging Reporting and Data System (Lung RADS) templates might improve the detection of patients with lung nodules.^5,13,14

Limitations

This study was performed in a single VHA hospital and the findings may not be generalizable to other settings of care. Second, our study design is susceptible to work-up bias because the results of a diagnostic test (eg, chest or abdomen imaging) affected whether the chart review was used to verify the test result. It was not feasible to review the patient records of all radiology studies done at the facility during the study period, consequently complete 2 × 2 tables could not be created to calculate sensitivity, specificity, and negative predictive value.

Conclusion

A text search algorithm of radiology reports increased the detection of patients with lung nodules when compared with radiology diagnostic coding alone. However, the improved detection was associated with a higher rate of false positives, which requires manually reviewing a larger number of patient’s chart reports. Future research and quality improvement should focus on standardizing the radiology reporting process and improving the efficiency and reliability of follow up and tracking of incidental lung nodules.

Acknowledgments

The work reported here was supported by a grant from the Office of Rural Health (N32-FY16Q1-S1-P01577), US Department of Veterans Affairs, Veterans Health Administration. We also had the support from the Veterans Rural Health Resource Center-Iowa City, and the Health Services Research and Development (HSR&D) Service through the Comprehensive Access and Delivery Research and Evaluation (CADRE) Center (REA 09-220).

Rapid advances in imaging technology have led to better spatial resolution with lower radiation doses to patients. These advances have helped to increase the use of diagnostic chest imaging, particularly in emergency departments and oncology centers, and in screening for coronary artery disease. As a result, there has been an explosion of incidental findings on chest imaging—including indeterminate lung nodules.^1,2

Lung nodules are rounded and well-circumscribed lung opacities (≤ 3 cm in diameter) that may present as solitary or multiple lesions in usually asymptomatic patients. Most lung nodules are benign, the result of an infectious or inflammatory process. Nodules that are ≤ 8 mm in diameter, unless they show increase in size over time, often can be safely followed with imaging surveillance. In contrast, lung nodules > 8 mm could represent an early-stage lung cancer, especially among patients with high-risk for developing lung cancer (ie, those with advanced age, heavy tobacco abuse, or emphysema) and should be further assessed with close imaging surveillance, either chest computed tomography (CT) alone or positron-emission tomography (PET)/CT, or tissue biopsy, based on the underlying likelihood of malignancy.

Patients who receive an early-stage lung cancer diagnosis can be offered curative treatments leading to improved 5-year survival rates.^3,4 Consequently, health care systems need to be able to identify these nodules accurately, in order to categorize and manage them accordingly to the Fleischner radiographic and American College of Chest Physicians clinical guidelines.^5,6 Unfortunately, many hospitals struggle to identify patients with incidental lung nodules found during diagnostic chest and abdominal imaging, due in part to poor adherence to Fleischner guidelines among radiologists for categorizing pulmonary nodules.^7,8

The Veterans Health Administration (VHA) system is interested in effectively detecting patients with incidental lung nodules. Veterans have a higher risk of developing lung cancer when compared with the entire US population, mainly due to a higher incidence of tobacco use.⁶ The prevalence of lung nodules among veterans with significant risk factors for lung cancer is about 60% nationwide, and up to 85% in the Midwest, due to the high prevalence of histoplasmosis.⁷ However, only a small percentage of these nodules represent an early stage primary lung cancer.

Several Veterans Integrated Service Networks (VISNs) in the VHA use a radiology diagnostic code to systematically identify imaging studies with presence of lung nodules. In VISN 23, which includes Minnesota, North Dakota, South Dakota, Iowa, and portions of neighboring states, the code used to identify these radiology studies is 44. However, there is high variability in the reporting and coding of imaging studies among radiologists, which could lead to misclassifying patients with lung nodules.⁸

Some studies suggest that using an automated text search algorithm within radiology reports can be a highly effective strategy to identify patients with lung nodules.^9,10 In this study, we compared the diagnostic performance of a newly developed text search algorithm applied to radiology reports with the current standard practice of using a radiology diagnostic code for identifying patients with lung nodules at the Iowa City US Department of Veterans Affairs (VA) Health Care System (ICVAHCS) hospital in Iowa.

Methods

Since 2014, The ICVAHCS has used a radiology diagnostic code to identify any imaging studies with lung nodules. The radiologist enters “44” at the end of the reading process using the Nuance Powerscribe 360 radiation reporting system. The code is uploaded into the VHA Corporate Data Warehouse (CDW), and it is located within the radiology exam domain. This strategy was created and implemented by the Minneapolis VA Health Care System in Minnesota for all the VA hospitals in VISN 23. A lung nodule registry nurse was provided with a list of radiology studies flagged with this radiology diagnostic code every 2 weeks. A chart review was then performed for all these studies to determine the presence of a lung nodule. When detected, the ordering health care provider was alerted and given recommendations for managing the nodule.

We initially searched for the radiology studies with a presumptive lung nodule using the radiology code 44 within the CDW. Separately, we applied the text search strategy only to radiology reports from chest and abdomen studies (ie, X-rays, CT, magnetic resonance imaging [MRI], and PET) that contained any of the keyword phrases. The text search strategy was modeled based on a natural language processing (NLP) algorithm developed by the Puget Sound VA Healthcare System in Seattle, Washington to identify lung nodules on radiology reports.⁹ Our algorithm included a series of text searches using Microsoft SQL. After several simulations using a random group of radiology reports, we chose the keywords: “lung AND nodul”; “pulm AND nodul”; “pulm AND mass”; “lung AND mass”; and “ground glass”. We selected only chest and abdomen studies because on several simulations using a random group of radiology reports, the vast majority of lung nodules were identified on chest and abdomen imaging studies. Also, it would not have been feasible to chart review the approximately 30,000 total radiology reports that were generated during the study period.

From January 1, 2016 through November 30, 2016, we applied both search strategies independently: radiology diagnostic code for lung nodules to all imaging studies, and text search to all radiology reports of chest and abdomen imaging studies in the CDW (Figure). We also collected demographic (eg, age, sex, race, rurality) and clinical (eg, medical comorbidities, tobacco use) information that were uploaded to the database automatically from CDW using International Statistical Classification of Diseases, Tenth Edition and demographic codes. The VHA uses the Rural-Urban Commuting Areas (RUCA) system to define rurality, which takes into account population density and how closely a community is linked socioeconomically to larger urban centers.¹¹ The protocol was reviewed and approved by the institutional review board of ICVAHCS and the University of Iowa.

Results

We identified 12,983 radiology studies that required manual review during the study period. We confirmed that 8,516 imaging studies had lung nodules, representing 2,912 patients. Subjects with lung nodules were predominantly male (96%), aged between 60 and 79 years (71%), and lived in a rural area (72%). More than 50% of these patients had COPD and over a third were current smokers (Table 1). The text search algorithm identified all of the patients identified by the radiology diagnostic code (n = 1,251). It also identified an additional 1,661 patients with lung nodules that otherwise would have been missed by the radiology code. Compared with those identified only by the text search, those identified by both the radiology coding and text search were older, had lower Charlson comorbidity scores, and were more likely to be a current smoker.

The text search algorithm identified more than twice as many patients with potential lung nodules compared with the radiology diagnostic code (4,071 vs 1,363) (Table 2). However, the text search algorithm was associated with a much higher number of false positives than was the diagnostic code (1,159 vs 112) and a lower PPV (72% [95% CI, 70.6-73.4] vs 92% [95% CI, 90.6-93.4], respectively). The text search algorithm identified 130 patients with lung nodules of moderate to high risk for malignancy (> 8 mm diameter) that were not identified by the radiology code. When the PPV of each search strategy was calculated based on imaging studies with nodules (most patients had > 1 imaging study), the results remained similar (98% for radiology code and 66% for text search). A larger proportion of the lung nodules detected by code 44 vs the text search algorithm were from CT chest studies.

Discussion

In a population of predominantly older male veterans with significant risk factors for lung cancer and high incidence of incidental lung nodules, applying a text search algorithm on radiology reports identified a substantial number of patients with lung nodules, including some with nodules > 8 mm, that were missed by the radiologist-generated code.^9,10 Improving the yield of detection for lung nodules in a population with high risk for lung cancer would increase the likelihood of detecting patients with potentially curable early-stage lung cancers, decreasing lung cancer mortality.

The reasons for the high number of patients with lung nodules missed by the radiology code are unclear. Potential explanations may include the lack of standardization of imaging reports by the radiologists (ie, only 21% of chest CTs used a standardized template describing a lung nodule in our study), a problem well recognized both within and outside VHA.^8,12

The text search algorithm identified more patients with lung nodules but had a higher rate of false positives when compared with the diagnostic code. The high rate of false positives resulted in more charts to review and an increased workload for the lung nodule registry team. The challenges presented by an increased workload should be balanced against the potential harms of missing nodules that develop into advanced cancer.

Text Search Adjustments

Refining the text search criteria algorithm and the chart review process may decrease the rate of false positives significantly without affecting detection of lung nodules. In subsequent simulations, we found that by adding an exclusion criteria to text search algorithm to remove reports with specific keywords we could substantially reduce the number of false positive reports without affecting the detection rate of the lung nodules. These exclusion criteria would exclude any reports that: (1) contain “nodul” within the next 8 words after mentioning “no”; (2) contain “clear” within the next 8 words after mentioning “lung” in the text (eg, “lungs appear to be clear”); (3) contain “clear” within the next 4 words after mentioning “otherwise” in the text (eg, “otherwise appear to be clear”). Based on our study results, we further refined the text search strategy by limiting the search to only chest imaging studies. When we applied the revised algorithm to a random sample of imaging reports, we found all the code 44 radiology reports were still captured, but we were able to reduce the number of radiology reports needing review by about 80%.

Although classification approaches are being refined to improve radiology performance in multiple categories of nodules, this study suggests that alternative approaches based on text algorithms can improve the capture of pulmonary nodules that require surveillance. These algorithms also can be used to augment radiologist reporting systems. This represents an investment in resources to build a team that should include a bioinformatics specialist, lung nodule registry personnel (review charts of the detected imaging studies with lung nodules, populating the lung nodule database, and determining and tracking the need of imaging follow up), a lung nodule clinic nurse coordinator, and a dedicated lung nodule clinic pulmonologist.

Radiology departments could employ this text search approach to identify missed nodules and use an audit and feedback system to train radiologists to code lung nodules consistently at the time of the initial reading to avoid delays in identifying patients with nodules. Alternatively, the more widespread use of a standardized CT chest radiology reports using Fleischner or the American College of Radiology Lung Imaging Reporting and Data System (Lung RADS) templates might improve the detection of patients with lung nodules.^5,13,14

Limitations

This study was performed in a single VHA hospital and the findings may not be generalizable to other settings of care. Second, our study design is susceptible to work-up bias because the results of a diagnostic test (eg, chest or abdomen imaging) affected whether the chart review was used to verify the test result. It was not feasible to review the patient records of all radiology studies done at the facility during the study period, consequently complete 2 × 2 tables could not be created to calculate sensitivity, specificity, and negative predictive value.

Conclusion

A text search algorithm of radiology reports increased the detection of patients with lung nodules when compared with radiology diagnostic coding alone. However, the improved detection was associated with a higher rate of false positives, which requires manually reviewing a larger number of patient’s chart reports. Future research and quality improvement should focus on standardizing the radiology reporting process and improving the efficiency and reliability of follow up and tracking of incidental lung nodules.

Acknowledgments

The work reported here was supported by a grant from the Office of Rural Health (N32-FY16Q1-S1-P01577), US Department of Veterans Affairs, Veterans Health Administration. We also had the support from the Veterans Rural Health Resource Center-Iowa City, and the Health Services Research and Development (HSR&D) Service through the Comprehensive Access and Delivery Research and Evaluation (CADRE) Center (REA 09-220).

Rapid advances in imaging technology have led to better spatial resolution with lower radiation doses to patients. These advances have helped to increase the use of diagnostic chest imaging, particularly in emergency departments and oncology centers, and in screening for coronary artery disease. As a result, there has been an explosion of incidental findings on chest imaging—including indeterminate lung nodules.^1,2

Lung nodules are rounded and well-circumscribed lung opacities (≤ 3 cm in diameter) that may present as solitary or multiple lesions in usually asymptomatic patients. Most lung nodules are benign, the result of an infectious or inflammatory process. Nodules that are ≤ 8 mm in diameter, unless they show increase in size over time, often can be safely followed with imaging surveillance. In contrast, lung nodules > 8 mm could represent an early-stage lung cancer, especially among patients with high-risk for developing lung cancer (ie, those with advanced age, heavy tobacco abuse, or emphysema) and should be further assessed with close imaging surveillance, either chest computed tomography (CT) alone or positron-emission tomography (PET)/CT, or tissue biopsy, based on the underlying likelihood of malignancy.

Patients who receive an early-stage lung cancer diagnosis can be offered curative treatments leading to improved 5-year survival rates.^3,4 Consequently, health care systems need to be able to identify these nodules accurately, in order to categorize and manage them accordingly to the Fleischner radiographic and American College of Chest Physicians clinical guidelines.^5,6 Unfortunately, many hospitals struggle to identify patients with incidental lung nodules found during diagnostic chest and abdominal imaging, due in part to poor adherence to Fleischner guidelines among radiologists for categorizing pulmonary nodules.^7,8

The Veterans Health Administration (VHA) system is interested in effectively detecting patients with incidental lung nodules. Veterans have a higher risk of developing lung cancer when compared with the entire US population, mainly due to a higher incidence of tobacco use.⁶ The prevalence of lung nodules among veterans with significant risk factors for lung cancer is about 60% nationwide, and up to 85% in the Midwest, due to the high prevalence of histoplasmosis.⁷ However, only a small percentage of these nodules represent an early stage primary lung cancer.

Several Veterans Integrated Service Networks (VISNs) in the VHA use a radiology diagnostic code to systematically identify imaging studies with presence of lung nodules. In VISN 23, which includes Minnesota, North Dakota, South Dakota, Iowa, and portions of neighboring states, the code used to identify these radiology studies is 44. However, there is high variability in the reporting and coding of imaging studies among radiologists, which could lead to misclassifying patients with lung nodules.⁸

Some studies suggest that using an automated text search algorithm within radiology reports can be a highly effective strategy to identify patients with lung nodules.^9,10 In this study, we compared the diagnostic performance of a newly developed text search algorithm applied to radiology reports with the current standard practice of using a radiology diagnostic code for identifying patients with lung nodules at the Iowa City US Department of Veterans Affairs (VA) Health Care System (ICVAHCS) hospital in Iowa.

Methods

Since 2014, The ICVAHCS has used a radiology diagnostic code to identify any imaging studies with lung nodules. The radiologist enters “44” at the end of the reading process using the Nuance Powerscribe 360 radiation reporting system. The code is uploaded into the VHA Corporate Data Warehouse (CDW), and it is located within the radiology exam domain. This strategy was created and implemented by the Minneapolis VA Health Care System in Minnesota for all the VA hospitals in VISN 23. A lung nodule registry nurse was provided with a list of radiology studies flagged with this radiology diagnostic code every 2 weeks. A chart review was then performed for all these studies to determine the presence of a lung nodule. When detected, the ordering health care provider was alerted and given recommendations for managing the nodule.

We initially searched for the radiology studies with a presumptive lung nodule using the radiology code 44 within the CDW. Separately, we applied the text search strategy only to radiology reports from chest and abdomen studies (ie, X-rays, CT, magnetic resonance imaging [MRI], and PET) that contained any of the keyword phrases. The text search strategy was modeled based on a natural language processing (NLP) algorithm developed by the Puget Sound VA Healthcare System in Seattle, Washington to identify lung nodules on radiology reports.⁹ Our algorithm included a series of text searches using Microsoft SQL. After several simulations using a random group of radiology reports, we chose the keywords: “lung AND nodul”; “pulm AND nodul”; “pulm AND mass”; “lung AND mass”; and “ground glass”. We selected only chest and abdomen studies because on several simulations using a random group of radiology reports, the vast majority of lung nodules were identified on chest and abdomen imaging studies. Also, it would not have been feasible to chart review the approximately 30,000 total radiology reports that were generated during the study period.

From January 1, 2016 through November 30, 2016, we applied both search strategies independently: radiology diagnostic code for lung nodules to all imaging studies, and text search to all radiology reports of chest and abdomen imaging studies in the CDW (Figure). We also collected demographic (eg, age, sex, race, rurality) and clinical (eg, medical comorbidities, tobacco use) information that were uploaded to the database automatically from CDW using International Statistical Classification of Diseases, Tenth Edition and demographic codes. The VHA uses the Rural-Urban Commuting Areas (RUCA) system to define rurality, which takes into account population density and how closely a community is linked socioeconomically to larger urban centers.¹¹ The protocol was reviewed and approved by the institutional review board of ICVAHCS and the University of Iowa.

Results

We identified 12,983 radiology studies that required manual review during the study period. We confirmed that 8,516 imaging studies had lung nodules, representing 2,912 patients. Subjects with lung nodules were predominantly male (96%), aged between 60 and 79 years (71%), and lived in a rural area (72%). More than 50% of these patients had COPD and over a third were current smokers (Table 1). The text search algorithm identified all of the patients identified by the radiology diagnostic code (n = 1,251). It also identified an additional 1,661 patients with lung nodules that otherwise would have been missed by the radiology code. Compared with those identified only by the text search, those identified by both the radiology coding and text search were older, had lower Charlson comorbidity scores, and were more likely to be a current smoker.

The text search algorithm identified more than twice as many patients with potential lung nodules compared with the radiology diagnostic code (4,071 vs 1,363) (Table 2). However, the text search algorithm was associated with a much higher number of false positives than was the diagnostic code (1,159 vs 112) and a lower PPV (72% [95% CI, 70.6-73.4] vs 92% [95% CI, 90.6-93.4], respectively). The text search algorithm identified 130 patients with lung nodules of moderate to high risk for malignancy (> 8 mm diameter) that were not identified by the radiology code. When the PPV of each search strategy was calculated based on imaging studies with nodules (most patients had > 1 imaging study), the results remained similar (98% for radiology code and 66% for text search). A larger proportion of the lung nodules detected by code 44 vs the text search algorithm were from CT chest studies.

Discussion

In a population of predominantly older male veterans with significant risk factors for lung cancer and high incidence of incidental lung nodules, applying a text search algorithm on radiology reports identified a substantial number of patients with lung nodules, including some with nodules > 8 mm, that were missed by the radiologist-generated code.^9,10 Improving the yield of detection for lung nodules in a population with high risk for lung cancer would increase the likelihood of detecting patients with potentially curable early-stage lung cancers, decreasing lung cancer mortality.

The reasons for the high number of patients with lung nodules missed by the radiology code are unclear. Potential explanations may include the lack of standardization of imaging reports by the radiologists (ie, only 21% of chest CTs used a standardized template describing a lung nodule in our study), a problem well recognized both within and outside VHA.^8,12

The text search algorithm identified more patients with lung nodules but had a higher rate of false positives when compared with the diagnostic code. The high rate of false positives resulted in more charts to review and an increased workload for the lung nodule registry team. The challenges presented by an increased workload should be balanced against the potential harms of missing nodules that develop into advanced cancer.

Text Search Adjustments

Refining the text search criteria algorithm and the chart review process may decrease the rate of false positives significantly without affecting detection of lung nodules. In subsequent simulations, we found that by adding an exclusion criteria to text search algorithm to remove reports with specific keywords we could substantially reduce the number of false positive reports without affecting the detection rate of the lung nodules. These exclusion criteria would exclude any reports that: (1) contain “nodul” within the next 8 words after mentioning “no”; (2) contain “clear” within the next 8 words after mentioning “lung” in the text (eg, “lungs appear to be clear”); (3) contain “clear” within the next 4 words after mentioning “otherwise” in the text (eg, “otherwise appear to be clear”). Based on our study results, we further refined the text search strategy by limiting the search to only chest imaging studies. When we applied the revised algorithm to a random sample of imaging reports, we found all the code 44 radiology reports were still captured, but we were able to reduce the number of radiology reports needing review by about 80%.

Although classification approaches are being refined to improve radiology performance in multiple categories of nodules, this study suggests that alternative approaches based on text algorithms can improve the capture of pulmonary nodules that require surveillance. These algorithms also can be used to augment radiologist reporting systems. This represents an investment in resources to build a team that should include a bioinformatics specialist, lung nodule registry personnel (review charts of the detected imaging studies with lung nodules, populating the lung nodule database, and determining and tracking the need of imaging follow up), a lung nodule clinic nurse coordinator, and a dedicated lung nodule clinic pulmonologist.

Radiology departments could employ this text search approach to identify missed nodules and use an audit and feedback system to train radiologists to code lung nodules consistently at the time of the initial reading to avoid delays in identifying patients with nodules. Alternatively, the more widespread use of a standardized CT chest radiology reports using Fleischner or the American College of Radiology Lung Imaging Reporting and Data System (Lung RADS) templates might improve the detection of patients with lung nodules.^5,13,14

Limitations

This study was performed in a single VHA hospital and the findings may not be generalizable to other settings of care. Second, our study design is susceptible to work-up bias because the results of a diagnostic test (eg, chest or abdomen imaging) affected whether the chart review was used to verify the test result. It was not feasible to review the patient records of all radiology studies done at the facility during the study period, consequently complete 2 × 2 tables could not be created to calculate sensitivity, specificity, and negative predictive value.

Conclusion

A text search algorithm of radiology reports increased the detection of patients with lung nodules when compared with radiology diagnostic coding alone. However, the improved detection was associated with a higher rate of false positives, which requires manually reviewing a larger number of patient’s chart reports. Future research and quality improvement should focus on standardizing the radiology reporting process and improving the efficiency and reliability of follow up and tracking of incidental lung nodules.

Acknowledgments

The work reported here was supported by a grant from the Office of Rural Health (N32-FY16Q1-S1-P01577), US Department of Veterans Affairs, Veterans Health Administration. We also had the support from the Veterans Rural Health Resource Center-Iowa City, and the Health Services Research and Development (HSR&D) Service through the Comprehensive Access and Delivery Research and Evaluation (CADRE) Center (REA 09-220).

Single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is a well-established technique for the evaluation of coronary artery disease (CAD).¹ To improve image quality, low-resolution computed tomography (CT) is used commonly for anatomical correct and artifact attenuation during SPECT MPI.² The low resolution, unenhanced CT images are considered low quality and are, therefore, labeled by the manufacturer as nondiagnostic. The CT portion of the MPI in many centers is used only for image fusion and attenuation correction, and these images are not routinely reviewed or reported by cardiologists.

Incidental findings by these low-resolution CT were frequent. However, clinically significant findings, including lung cancer, although relatively infrequent, were serious enough for major clinical management.^3-5 Currently, there are no consensus recommendations for reviewing low-resolution CT images or the interpretation of such incidental findings during cardiac MPI.⁶ Clinically, low-dose CT were used for early detection and screening of lung cancer and were associated with reduced lung-cancer and any cause mortality in National Lung Screening Trial (NLST).^7,8 Therefore, low-dose CT is recommended for lung cancer screening of high-risk patients by the US Preventive Service Task Force (USPSTF).⁹ In the veteran population, current and past smoking history are more common when compared with the general population; therefore, veterans are potentially at increased risk of lung cancer.¹⁰ In this study, we did not intend to use low-resolution CT for lung cancer screening or detection but rather to identify and report incidental findings of pulmonary/hilar malignancy detected during cardiac MPI.

Methods

The Siemens’ (Munich, Germany) Symbia Intevo Excel SPECT/CT MPI cameras with dedicated cardiac collimators were used at both the Dwight D. Eisenhower VA Medical Center (VAMC) in Leavenworth, Kansas and Colmery-O'Neil VAMC in Topeka, Kansas. The integrated CT scanner (x-ray tube current 30 to 240 mA; voltage 110 Kv with a 40 kW power generator) has the capability to image up to a 2-slice/rotation, each of 5.0 mm per slice with a scan time of about 30 seconds. The SPECT/CT gamma camera has a low energy (140 KeV), high resolution, parallel hole collimator with IQ SPECT capabilities.

The radiation dose received by the patients were expressed in dose length product (DLP), which reflects the total energy absorbed by the patient and represents integrated dose in terms of the total scan length. Additionally, each patients received 2 injections of Technetium Tc 99m sestamibi (1-day Protocol: 10 mCi rest injection, 30 mCi stress injection: 2-day Protocol for patients weighing > 350 pounds: 30 mCi at rest injection and 30 mCi at stress injection) for myocardial perfusion imaging.

All CT images and cardiac MPI findings were reviewed and reported contemporaneously by 1 of 2 experienced, board-certified radiologists who were blinded to patients’ clinical information except the indication for the cardiac stress testing. When suspicious pulmonary/hilar nodules or masses were detected, these findings and recommendations for further evaluation were conveyed to primary care provider or ordering physician via the electronic health record system.

All CT images were reviewed with cardiac MPI from September 1, 2017 to August 31, 2018. When pulmonary/hilar malignancies were identified, the health records were reviewed. Patients with known history of prior pulmonary malignancy were excluded from the study.

Results

A total of 1,098 patients underwent cardiac MPI during the study period. When the CT imaging and cardiac MPI were reviewed, incidental findings led to the diagnosis of lung cancer in 5 patients and hilar mantle cell lymphoma in 1 patient. Their clinical characteristics, CT findings, and types of malignancies for these 6 patients are summarized in the Table and Figure. Only 0.55% (6 of 1,098) patients were found to have incidental pulmonary/hilar malignancy with the cardiac evaluation low-resolution CT. Four patients with prior, known history of lung cancer were excluded from the study.

For the 6 patients found to have cancer, the average CT radiation dose during the cardiac MPI was 100 mGy-cm (range, 77 -133 mCy-cm). The subsequent chest CT with or without contrast delivered a radiation dose of 726.4 mGy-cm (range, 279.4 - 1,075 mGy-cm).

Discussion

Although incidental findings on low-resolution CT during cardiac MPI are frequent, clinically significant findings are less common. However, some incidental findings may be of important clinical significance.^3-5 A multicenter analysis by Coward and colleagues reported that 2.4% findings on low-resolution CT were significant enough to warrant follow-up tests, but only 0.2% were deemed potentially detrimental to patient outcomes (ie, pathology confirmed malignancies).¹² Thus, the authors suggested that routine reporting of incidental findings on low-dose CT images was not beneficial.^12,13

Currently, the majority of cardiac MPIs are reviewed and interpreted by nuclear cardiologists, the use of hybrid SPECT/CT for attenuation correction give rise of issue of reviewing and interpreting these CT images during cardiac MPI. Since low-dose, low-resolution CT are considered nondiagnostic, these images are not routinely and readily reviewed by cardiologists who are not trained or skilled in CT interpretations.

Studies of high-resolution cardiac CT (including multidetector CT with contrast) suggest that incidental extracardiac findings should always be reported as there was a 0.7% incidence of previously unknown malignancies, while others have argued against “performing large field reconstructionsfor the explicit purpose of screening as it will lead to additional cost, liability and anxiety without proven benefits.”^14-16 A review of incidental findings of cardiac CT by Earls suggested that all cardiac CT should be reconstructed in the maximal field of view available and images should be adequately reviewed to detect pathological findings.¹⁷ This led to an interesting discussion by Douglas and colleagues regarding the role of cardiologists and radiologists in this issue.¹⁸ Currently there is no uniform or consensus recommendations regarding incidental findings during cardiac CT imaging. Guidances range from no recommendations to optional reporting or mandatory reporting.^19-23

Risk Factors for Veterans

Lung cancer is the second most common cancer and the leading cause of cancer-related death in the US.²⁴ Smoking is the most important risk factor for lung cancer and CAD.²⁵ Current or past smoking are more common among the veterans.¹⁰ According to a report for the US Centers for Disease Control and Prevention report, about 29.2% US veterans use tobacco products between 2010-2015, which is similar to the rate reported in 1997.²⁶

When low-dose CT was used for lung cancer screening, it was associated with a 20.0% reduction in lung cancer mortality and a 6.7% reduction in any cause mortality.⁷ Currently, the US Preventive Services Task Force (USPSTF) recommends annual low-dose CT screening for lung cancer in high-risk adults that includes patients aged 55 to 80 years who have a 30-pack-year smoking history and currently smoke or have quit within the past 15 years.⁸

It is likely that the cardiac patients in this study might have pulmonary malignancy mortality similar to those reported in the NLST. While other studies have shown a low incidence (0.2%) of detection of malignancy by low-resolution CT during cardiac MPI,^12,13 in this study we found pulmonary or hilar malignancy in 0.55% of patients.The higher incidence of malignancy in our study might be due in part to differences in the patient population studied (ie, our veterans patients have a higher proportion of current or past smoking history).¹⁰

The CT used in this study is part of the cardiac imaging process. Therefore, there was no additional radiation exposure besides that of the cardiac MPI for patients. Despite the limitations of low-resolution CT, which may miss small lesions, this study showed 0.55% incidence of incidental detection of pulmonary/hilar malignancy. This is comparable with 0.65%/year of diagnosing lung cancer using low-dose CT for lung cancer screening in NLST.⁸

Two of the 5 study patients who were found to have lung cancer, had quit smoking > 15 years previously and thus would not be considered as high-risk for lung cancer screening according to USPSTF guideline. These patients would not have been candidates for annual low-dose CT lung cancer screening. This study suggests that it is appropriate and necessary to review the low-resolution CT images for incidental findings during cardiac MPI.

Limitations

The study was retrospective in nature and limited by its small number of patients. The CT modality used in the study also has limitations, including low resolution, respiratory motion artifacts, and scans that did not include the entire chest area. Therefore, small and apical lesions may have been missed. However, both sets of CT at rest and after stress were reviewed to reduce or minimize the effects of respiratory motion artifacts. The true prevalence or incidence of pulmonary/hilar malignancies may have been higher than reported here. Our study population of veterans may not be representative of the general population with regards to gender (as most of our veteran patient population are of male gender, vs general population), smoking history, or lung cancer risk, thus the results should be interpreted with caution.

Conclusion

Low-resolution CTs used for attenuation correction during cardiac MPI should be routinely reviewed and interpreted by a physician or radiologist skilled in CT interpretation in order to identify incidental findings of pulmonary/hilar malignancy. This would require close collaboration between cardiologists and radiologists in the field to ensure unfragmented and high-quality patient care.

Acknowledgements

We want to thank all the staffs in cardiology and radiology department on both campuses for their dedication for our patients. Special thanks to Laura Knox, Radiation Safety Officer, Nuclear Medicine Supervisor for her technical assistance.

Single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is a well-established technique for the evaluation of coronary artery disease (CAD).¹ To improve image quality, low-resolution computed tomography (CT) is used commonly for anatomical correct and artifact attenuation during SPECT MPI.² The low resolution, unenhanced CT images are considered low quality and are, therefore, labeled by the manufacturer as nondiagnostic. The CT portion of the MPI in many centers is used only for image fusion and attenuation correction, and these images are not routinely reviewed or reported by cardiologists.

Incidental findings by these low-resolution CT were frequent. However, clinically significant findings, including lung cancer, although relatively infrequent, were serious enough for major clinical management.^3-5 Currently, there are no consensus recommendations for reviewing low-resolution CT images or the interpretation of such incidental findings during cardiac MPI.⁶ Clinically, low-dose CT were used for early detection and screening of lung cancer and were associated with reduced lung-cancer and any cause mortality in National Lung Screening Trial (NLST).^7,8 Therefore, low-dose CT is recommended for lung cancer screening of high-risk patients by the US Preventive Service Task Force (USPSTF).⁹ In the veteran population, current and past smoking history are more common when compared with the general population; therefore, veterans are potentially at increased risk of lung cancer.¹⁰ In this study, we did not intend to use low-resolution CT for lung cancer screening or detection but rather to identify and report incidental findings of pulmonary/hilar malignancy detected during cardiac MPI.

Methods

The Siemens’ (Munich, Germany) Symbia Intevo Excel SPECT/CT MPI cameras with dedicated cardiac collimators were used at both the Dwight D. Eisenhower VA Medical Center (VAMC) in Leavenworth, Kansas and Colmery-O'Neil VAMC in Topeka, Kansas. The integrated CT scanner (x-ray tube current 30 to 240 mA; voltage 110 Kv with a 40 kW power generator) has the capability to image up to a 2-slice/rotation, each of 5.0 mm per slice with a scan time of about 30 seconds. The SPECT/CT gamma camera has a low energy (140 KeV), high resolution, parallel hole collimator with IQ SPECT capabilities.

The radiation dose received by the patients were expressed in dose length product (DLP), which reflects the total energy absorbed by the patient and represents integrated dose in terms of the total scan length. Additionally, each patients received 2 injections of Technetium Tc 99m sestamibi (1-day Protocol: 10 mCi rest injection, 30 mCi stress injection: 2-day Protocol for patients weighing > 350 pounds: 30 mCi at rest injection and 30 mCi at stress injection) for myocardial perfusion imaging.

All CT images and cardiac MPI findings were reviewed and reported contemporaneously by 1 of 2 experienced, board-certified radiologists who were blinded to patients’ clinical information except the indication for the cardiac stress testing. When suspicious pulmonary/hilar nodules or masses were detected, these findings and recommendations for further evaluation were conveyed to primary care provider or ordering physician via the electronic health record system.

All CT images were reviewed with cardiac MPI from September 1, 2017 to August 31, 2018. When pulmonary/hilar malignancies were identified, the health records were reviewed. Patients with known history of prior pulmonary malignancy were excluded from the study.

Results

A total of 1,098 patients underwent cardiac MPI during the study period. When the CT imaging and cardiac MPI were reviewed, incidental findings led to the diagnosis of lung cancer in 5 patients and hilar mantle cell lymphoma in 1 patient. Their clinical characteristics, CT findings, and types of malignancies for these 6 patients are summarized in the Table and Figure. Only 0.55% (6 of 1,098) patients were found to have incidental pulmonary/hilar malignancy with the cardiac evaluation low-resolution CT. Four patients with prior, known history of lung cancer were excluded from the study.

For the 6 patients found to have cancer, the average CT radiation dose during the cardiac MPI was 100 mGy-cm (range, 77 -133 mCy-cm). The subsequent chest CT with or without contrast delivered a radiation dose of 726.4 mGy-cm (range, 279.4 - 1,075 mGy-cm).

Discussion

Although incidental findings on low-resolution CT during cardiac MPI are frequent, clinically significant findings are less common. However, some incidental findings may be of important clinical significance.^3-5 A multicenter analysis by Coward and colleagues reported that 2.4% findings on low-resolution CT were significant enough to warrant follow-up tests, but only 0.2% were deemed potentially detrimental to patient outcomes (ie, pathology confirmed malignancies).¹² Thus, the authors suggested that routine reporting of incidental findings on low-dose CT images was not beneficial.^12,13

Currently, the majority of cardiac MPIs are reviewed and interpreted by nuclear cardiologists, the use of hybrid SPECT/CT for attenuation correction give rise of issue of reviewing and interpreting these CT images during cardiac MPI. Since low-dose, low-resolution CT are considered nondiagnostic, these images are not routinely and readily reviewed by cardiologists who are not trained or skilled in CT interpretations.

Studies of high-resolution cardiac CT (including multidetector CT with contrast) suggest that incidental extracardiac findings should always be reported as there was a 0.7% incidence of previously unknown malignancies, while others have argued against “performing large field reconstructionsfor the explicit purpose of screening as it will lead to additional cost, liability and anxiety without proven benefits.”^14-16 A review of incidental findings of cardiac CT by Earls suggested that all cardiac CT should be reconstructed in the maximal field of view available and images should be adequately reviewed to detect pathological findings.¹⁷ This led to an interesting discussion by Douglas and colleagues regarding the role of cardiologists and radiologists in this issue.¹⁸ Currently there is no uniform or consensus recommendations regarding incidental findings during cardiac CT imaging. Guidances range from no recommendations to optional reporting or mandatory reporting.^19-23

Risk Factors for Veterans

Lung cancer is the second most common cancer and the leading cause of cancer-related death in the US.²⁴ Smoking is the most important risk factor for lung cancer and CAD.²⁵ Current or past smoking are more common among the veterans.¹⁰ According to a report for the US Centers for Disease Control and Prevention report, about 29.2% US veterans use tobacco products between 2010-2015, which is similar to the rate reported in 1997.²⁶

When low-dose CT was used for lung cancer screening, it was associated with a 20.0% reduction in lung cancer mortality and a 6.7% reduction in any cause mortality.⁷ Currently, the US Preventive Services Task Force (USPSTF) recommends annual low-dose CT screening for lung cancer in high-risk adults that includes patients aged 55 to 80 years who have a 30-pack-year smoking history and currently smoke or have quit within the past 15 years.⁸

It is likely that the cardiac patients in this study might have pulmonary malignancy mortality similar to those reported in the NLST. While other studies have shown a low incidence (0.2%) of detection of malignancy by low-resolution CT during cardiac MPI,^12,13 in this study we found pulmonary or hilar malignancy in 0.55% of patients.The higher incidence of malignancy in our study might be due in part to differences in the patient population studied (ie, our veterans patients have a higher proportion of current or past smoking history).¹⁰

The CT used in this study is part of the cardiac imaging process. Therefore, there was no additional radiation exposure besides that of the cardiac MPI for patients. Despite the limitations of low-resolution CT, which may miss small lesions, this study showed 0.55% incidence of incidental detection of pulmonary/hilar malignancy. This is comparable with 0.65%/year of diagnosing lung cancer using low-dose CT for lung cancer screening in NLST.⁸

Two of the 5 study patients who were found to have lung cancer, had quit smoking > 15 years previously and thus would not be considered as high-risk for lung cancer screening according to USPSTF guideline. These patients would not have been candidates for annual low-dose CT lung cancer screening. This study suggests that it is appropriate and necessary to review the low-resolution CT images for incidental findings during cardiac MPI.

Limitations

The study was retrospective in nature and limited by its small number of patients. The CT modality used in the study also has limitations, including low resolution, respiratory motion artifacts, and scans that did not include the entire chest area. Therefore, small and apical lesions may have been missed. However, both sets of CT at rest and after stress were reviewed to reduce or minimize the effects of respiratory motion artifacts. The true prevalence or incidence of pulmonary/hilar malignancies may have been higher than reported here. Our study population of veterans may not be representative of the general population with regards to gender (as most of our veteran patient population are of male gender, vs general population), smoking history, or lung cancer risk, thus the results should be interpreted with caution.

Conclusion

Low-resolution CTs used for attenuation correction during cardiac MPI should be routinely reviewed and interpreted by a physician or radiologist skilled in CT interpretation in order to identify incidental findings of pulmonary/hilar malignancy. This would require close collaboration between cardiologists and radiologists in the field to ensure unfragmented and high-quality patient care.

Acknowledgements

We want to thank all the staffs in cardiology and radiology department on both campuses for their dedication for our patients. Special thanks to Laura Knox, Radiation Safety Officer, Nuclear Medicine Supervisor for her technical assistance.