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Antidepressants: Is less more?
When it comes to antidepressant prescribing, less may be more, new research suggests.
A new review suggests antidepressants are overprescribed and that the efficacy of these agents is questionable, leading researchers to recommend that, when physicians prescribe these medications, it should be for shorter periods.
“Antidepressants have never been shown to have a clinically significant difference from placebo in the treatment of depression,” study co\investigator Mark Horowitz, GDPsych, PhD, division of psychiatry, University College London, said in an interview.
He added antidepressants “exert profound adverse effects on the body and brain” and can be difficult to stop because of physical dependence that occurs when the brain adapts to them.
“The best way to take people off these drugs is to do so gradually enough that the unpleasant effects are minimized and in a way that means the reductions in dose get smaller and smaller as the total dose gets lower,” Dr. Horowitz said.
However, at least one expert urged caution in interpreting the review’s findings.
“The reality is that millions of people do benefit from these medications, and this review minimizes those benefits,” Philip Muskin, MD, chief of consultation-liaison for psychiatry and professor of psychiatry, Columbia University Medical Center and New York–Presbyterian Hospital, said when approached for comment.
The findings were published online Dec. 20, 2021, in the Drug and Therapeutics Bulletin.
Personal experience
Prescribing of newer-generation antidepressants, such as SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), is increasing, with an estimated one in six adults in the United Kingdom receiving at least one prescription in 2019-2020, the investigators noted.
Dr. Horowitz noted a personal motivation for conducting the review. “As well as being an academic psychiatrist, I’m also a patient who has been prescribed antidepressants since age 21, when my mood was poor, due to life circumstances.”
The antidepressant “didn’t have particularly helpful effects,” but Dr. Horowitz continued taking it for 18 years. “I was told it was helpful and internalized that message. I came to understand that much of the information around antidepressants came from the drug companies that manufactured them or from academics paid by these companies.”
Dr. Horowitz is currently discontinuing his medication – a tapering process now in its third year. He said he has come to realize, in retrospect, that symptoms not initially attributed to the drug, such as fatigue, impaired concentration, and impaired memory, have improved since reducing the medication.
“That experience sensitized me to look for these symptoms in my patients and I see them; but most of my patients were told by their doctors that the cause of those problems was the depression or anxiety itself and not the drug,” he said.
Dr. Horowitz collaborated with Michael Wilcock, DTB, Pharmacy, Royal Cornwall Hospitals, NHS Trust, Truro, England, in conducting the review “to provide an independent assessment of benefits and harms of antidepressants.”
“Much of the evidence of the efficacy of antidepressants comes from randomized placebo-controlled trials,” Dr. Horowitz said. Several meta-analyses of these studies showed a difference of about two points between the agent and the placebo on the Hamilton Depression Rating Scale (HAM-D).
“Although this might be statistically significant, it does not meet the threshold for a clinical significance – those aren’t the same thing,” Dr. Horowitz said. Some analyses suggest that a “minimally clinically important difference” on the HAM-D would range from 3 to 6 points.
The findings in adolescents and children are “even less convincing,” the investigators noted, citing a Cochrane review.
“This is especially concerning because the number of children and adolescents being treated with antidepressants is rapidly increasing,” Dr. Horowitz said.
Additionally, the short duration of most trials, typically 6-12 weeks, is “largely uninformative for the clinical treatment of depression.”
Relapse or withdrawal?
The researchers reviewed the adverse effects of long-term antidepressant use, including daytime sleepiness, dry mouth, profuse sweating, weight gain, sexual dysfunction, restlessness, and feeling “foggy or detached.”
“Antidepressants have toxic effects on the brain and cause brain damage when they artificially increase serotonin and modify brain chemistry, which is why people become sick for years after stopping,” Dr. Horowitz said. “When the drug is reduced or stopped, the brain has difficulty dealing with the sudden drop in neurotransmitters, and withdrawal symptoms result, similar to stopping caffeine, nicotine, or opioids.”
He added it is not necessarily the original condition of depression or anxiety that is recurring but rather withdrawal, which can last for months or even years after medication discontinuation.
“Unfortunately, doctors have been taught that there are minimal withdrawal symptoms, euphemized as ‘discontinuation symptoms,’ and so when patients have reported withdrawal symptoms, they have been told it is a return of their underlying condition,” Dr. Horowitz said.
“This has led to many patients being incorrectly told that they need to get back on their antidepressants,” he added.
He likened this approach to “telling people that the need to continue smoking because when they stop, they get more anxiety.” Rather, the “correct response would be that they simply need to taper off the antidepressant more carefully,” he said.
Helpful in the short term
Patients should be informed prior to initiation of antidepressant treatment about the risk of withdrawal effects if they stop the drug, the investigators advise. They reference the Royal College of Psychiatrists’ updated guidance, which recommends slow tapering over a period long enough to mitigate withdrawal symptoms to “tolerable levels.”
The guidance suggests that patients start with a small “test reduction.” Withdrawal symptoms should be monitored for the following 2-4 weeks, using a symptom checklist such as the Discontinuation Emergent Signs and Symptoms Scale, with subsequent reductions based on the tolerability of the process.
Gradual dose reductions and very small final doses may necessitate the use of formulations of medication other than those commonly available in tablet forms, the researchers noted. During the tapering process, patients may benefit from increased psychosocial support.
Dr. Horowitz noted that antidepressants can be helpful on a short-term basis, and likened their use to the use of a cast to stabilize a broken arm.
“It’s useful for a short period. But if you leave someone in a plastic cast permanently, their arm will shrivel and you will disable them. These drugs should be prescribed minimally, and for the shortest possible period of time,” he said.
Dr. Horowitz recommended the recent draft National Institute for Health and Care Excellence depression guidance that recommends multiple other options beyond antidepressants, including cognitive-behavioral therapy, problem solving, counseling, and exercise.
Lack of balance
Dr. Muskin commented that the review is helpful in guiding clinicians on how to approach tapering of antidepressants and making patients aware of discontinuation symptoms.
However, “a lot of people will read this who need treatment, but they won’t get treated because they’ll take away the message that ‘drugs don’t work,’ ” he said.
“As it is, there is already stigma and prejudice toward psychiatric illness and using medications for treatment,” said Dr. Muskin, who was not involved with the research.
The current review “isn’t balanced, in terms of the efficacy of these drugs – both for the spectrum of depressive disorders and for panic or anxiety disorder. And there is nowhere that the authors say these drugs help people,” he added.
Moreover, the investigators’ assertion that long-term use of antidepressants causes harm is incorrect, he said.
“Yes, there are ongoing side effects that impose a burden, but that’s not the same as harm. And while the side effects are sometimes burdensome, ongoing depression is also terribly burdensome,” Dr. Muskin concluded.
Dr. Horowitz, Dr. Wilcock, and Dr. Muskin have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When it comes to antidepressant prescribing, less may be more, new research suggests.
A new review suggests antidepressants are overprescribed and that the efficacy of these agents is questionable, leading researchers to recommend that, when physicians prescribe these medications, it should be for shorter periods.
“Antidepressants have never been shown to have a clinically significant difference from placebo in the treatment of depression,” study co\investigator Mark Horowitz, GDPsych, PhD, division of psychiatry, University College London, said in an interview.
He added antidepressants “exert profound adverse effects on the body and brain” and can be difficult to stop because of physical dependence that occurs when the brain adapts to them.
“The best way to take people off these drugs is to do so gradually enough that the unpleasant effects are minimized and in a way that means the reductions in dose get smaller and smaller as the total dose gets lower,” Dr. Horowitz said.
However, at least one expert urged caution in interpreting the review’s findings.
“The reality is that millions of people do benefit from these medications, and this review minimizes those benefits,” Philip Muskin, MD, chief of consultation-liaison for psychiatry and professor of psychiatry, Columbia University Medical Center and New York–Presbyterian Hospital, said when approached for comment.
The findings were published online Dec. 20, 2021, in the Drug and Therapeutics Bulletin.
Personal experience
Prescribing of newer-generation antidepressants, such as SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), is increasing, with an estimated one in six adults in the United Kingdom receiving at least one prescription in 2019-2020, the investigators noted.
Dr. Horowitz noted a personal motivation for conducting the review. “As well as being an academic psychiatrist, I’m also a patient who has been prescribed antidepressants since age 21, when my mood was poor, due to life circumstances.”
The antidepressant “didn’t have particularly helpful effects,” but Dr. Horowitz continued taking it for 18 years. “I was told it was helpful and internalized that message. I came to understand that much of the information around antidepressants came from the drug companies that manufactured them or from academics paid by these companies.”
Dr. Horowitz is currently discontinuing his medication – a tapering process now in its third year. He said he has come to realize, in retrospect, that symptoms not initially attributed to the drug, such as fatigue, impaired concentration, and impaired memory, have improved since reducing the medication.
“That experience sensitized me to look for these symptoms in my patients and I see them; but most of my patients were told by their doctors that the cause of those problems was the depression or anxiety itself and not the drug,” he said.
Dr. Horowitz collaborated with Michael Wilcock, DTB, Pharmacy, Royal Cornwall Hospitals, NHS Trust, Truro, England, in conducting the review “to provide an independent assessment of benefits and harms of antidepressants.”
“Much of the evidence of the efficacy of antidepressants comes from randomized placebo-controlled trials,” Dr. Horowitz said. Several meta-analyses of these studies showed a difference of about two points between the agent and the placebo on the Hamilton Depression Rating Scale (HAM-D).
“Although this might be statistically significant, it does not meet the threshold for a clinical significance – those aren’t the same thing,” Dr. Horowitz said. Some analyses suggest that a “minimally clinically important difference” on the HAM-D would range from 3 to 6 points.
The findings in adolescents and children are “even less convincing,” the investigators noted, citing a Cochrane review.
“This is especially concerning because the number of children and adolescents being treated with antidepressants is rapidly increasing,” Dr. Horowitz said.
Additionally, the short duration of most trials, typically 6-12 weeks, is “largely uninformative for the clinical treatment of depression.”
Relapse or withdrawal?
The researchers reviewed the adverse effects of long-term antidepressant use, including daytime sleepiness, dry mouth, profuse sweating, weight gain, sexual dysfunction, restlessness, and feeling “foggy or detached.”
“Antidepressants have toxic effects on the brain and cause brain damage when they artificially increase serotonin and modify brain chemistry, which is why people become sick for years after stopping,” Dr. Horowitz said. “When the drug is reduced or stopped, the brain has difficulty dealing with the sudden drop in neurotransmitters, and withdrawal symptoms result, similar to stopping caffeine, nicotine, or opioids.”
He added it is not necessarily the original condition of depression or anxiety that is recurring but rather withdrawal, which can last for months or even years after medication discontinuation.
“Unfortunately, doctors have been taught that there are minimal withdrawal symptoms, euphemized as ‘discontinuation symptoms,’ and so when patients have reported withdrawal symptoms, they have been told it is a return of their underlying condition,” Dr. Horowitz said.
“This has led to many patients being incorrectly told that they need to get back on their antidepressants,” he added.
He likened this approach to “telling people that the need to continue smoking because when they stop, they get more anxiety.” Rather, the “correct response would be that they simply need to taper off the antidepressant more carefully,” he said.
Helpful in the short term
Patients should be informed prior to initiation of antidepressant treatment about the risk of withdrawal effects if they stop the drug, the investigators advise. They reference the Royal College of Psychiatrists’ updated guidance, which recommends slow tapering over a period long enough to mitigate withdrawal symptoms to “tolerable levels.”
The guidance suggests that patients start with a small “test reduction.” Withdrawal symptoms should be monitored for the following 2-4 weeks, using a symptom checklist such as the Discontinuation Emergent Signs and Symptoms Scale, with subsequent reductions based on the tolerability of the process.
Gradual dose reductions and very small final doses may necessitate the use of formulations of medication other than those commonly available in tablet forms, the researchers noted. During the tapering process, patients may benefit from increased psychosocial support.
Dr. Horowitz noted that antidepressants can be helpful on a short-term basis, and likened their use to the use of a cast to stabilize a broken arm.
“It’s useful for a short period. But if you leave someone in a plastic cast permanently, their arm will shrivel and you will disable them. These drugs should be prescribed minimally, and for the shortest possible period of time,” he said.
Dr. Horowitz recommended the recent draft National Institute for Health and Care Excellence depression guidance that recommends multiple other options beyond antidepressants, including cognitive-behavioral therapy, problem solving, counseling, and exercise.
Lack of balance
Dr. Muskin commented that the review is helpful in guiding clinicians on how to approach tapering of antidepressants and making patients aware of discontinuation symptoms.
However, “a lot of people will read this who need treatment, but they won’t get treated because they’ll take away the message that ‘drugs don’t work,’ ” he said.
“As it is, there is already stigma and prejudice toward psychiatric illness and using medications for treatment,” said Dr. Muskin, who was not involved with the research.
The current review “isn’t balanced, in terms of the efficacy of these drugs – both for the spectrum of depressive disorders and for panic or anxiety disorder. And there is nowhere that the authors say these drugs help people,” he added.
Moreover, the investigators’ assertion that long-term use of antidepressants causes harm is incorrect, he said.
“Yes, there are ongoing side effects that impose a burden, but that’s not the same as harm. And while the side effects are sometimes burdensome, ongoing depression is also terribly burdensome,” Dr. Muskin concluded.
Dr. Horowitz, Dr. Wilcock, and Dr. Muskin have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When it comes to antidepressant prescribing, less may be more, new research suggests.
A new review suggests antidepressants are overprescribed and that the efficacy of these agents is questionable, leading researchers to recommend that, when physicians prescribe these medications, it should be for shorter periods.
“Antidepressants have never been shown to have a clinically significant difference from placebo in the treatment of depression,” study co\investigator Mark Horowitz, GDPsych, PhD, division of psychiatry, University College London, said in an interview.
He added antidepressants “exert profound adverse effects on the body and brain” and can be difficult to stop because of physical dependence that occurs when the brain adapts to them.
“The best way to take people off these drugs is to do so gradually enough that the unpleasant effects are minimized and in a way that means the reductions in dose get smaller and smaller as the total dose gets lower,” Dr. Horowitz said.
However, at least one expert urged caution in interpreting the review’s findings.
“The reality is that millions of people do benefit from these medications, and this review minimizes those benefits,” Philip Muskin, MD, chief of consultation-liaison for psychiatry and professor of psychiatry, Columbia University Medical Center and New York–Presbyterian Hospital, said when approached for comment.
The findings were published online Dec. 20, 2021, in the Drug and Therapeutics Bulletin.
Personal experience
Prescribing of newer-generation antidepressants, such as SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), is increasing, with an estimated one in six adults in the United Kingdom receiving at least one prescription in 2019-2020, the investigators noted.
Dr. Horowitz noted a personal motivation for conducting the review. “As well as being an academic psychiatrist, I’m also a patient who has been prescribed antidepressants since age 21, when my mood was poor, due to life circumstances.”
The antidepressant “didn’t have particularly helpful effects,” but Dr. Horowitz continued taking it for 18 years. “I was told it was helpful and internalized that message. I came to understand that much of the information around antidepressants came from the drug companies that manufactured them or from academics paid by these companies.”
Dr. Horowitz is currently discontinuing his medication – a tapering process now in its third year. He said he has come to realize, in retrospect, that symptoms not initially attributed to the drug, such as fatigue, impaired concentration, and impaired memory, have improved since reducing the medication.
“That experience sensitized me to look for these symptoms in my patients and I see them; but most of my patients were told by their doctors that the cause of those problems was the depression or anxiety itself and not the drug,” he said.
Dr. Horowitz collaborated with Michael Wilcock, DTB, Pharmacy, Royal Cornwall Hospitals, NHS Trust, Truro, England, in conducting the review “to provide an independent assessment of benefits and harms of antidepressants.”
“Much of the evidence of the efficacy of antidepressants comes from randomized placebo-controlled trials,” Dr. Horowitz said. Several meta-analyses of these studies showed a difference of about two points between the agent and the placebo on the Hamilton Depression Rating Scale (HAM-D).
“Although this might be statistically significant, it does not meet the threshold for a clinical significance – those aren’t the same thing,” Dr. Horowitz said. Some analyses suggest that a “minimally clinically important difference” on the HAM-D would range from 3 to 6 points.
The findings in adolescents and children are “even less convincing,” the investigators noted, citing a Cochrane review.
“This is especially concerning because the number of children and adolescents being treated with antidepressants is rapidly increasing,” Dr. Horowitz said.
Additionally, the short duration of most trials, typically 6-12 weeks, is “largely uninformative for the clinical treatment of depression.”
Relapse or withdrawal?
The researchers reviewed the adverse effects of long-term antidepressant use, including daytime sleepiness, dry mouth, profuse sweating, weight gain, sexual dysfunction, restlessness, and feeling “foggy or detached.”
“Antidepressants have toxic effects on the brain and cause brain damage when they artificially increase serotonin and modify brain chemistry, which is why people become sick for years after stopping,” Dr. Horowitz said. “When the drug is reduced or stopped, the brain has difficulty dealing with the sudden drop in neurotransmitters, and withdrawal symptoms result, similar to stopping caffeine, nicotine, or opioids.”
He added it is not necessarily the original condition of depression or anxiety that is recurring but rather withdrawal, which can last for months or even years after medication discontinuation.
“Unfortunately, doctors have been taught that there are minimal withdrawal symptoms, euphemized as ‘discontinuation symptoms,’ and so when patients have reported withdrawal symptoms, they have been told it is a return of their underlying condition,” Dr. Horowitz said.
“This has led to many patients being incorrectly told that they need to get back on their antidepressants,” he added.
He likened this approach to “telling people that the need to continue smoking because when they stop, they get more anxiety.” Rather, the “correct response would be that they simply need to taper off the antidepressant more carefully,” he said.
Helpful in the short term
Patients should be informed prior to initiation of antidepressant treatment about the risk of withdrawal effects if they stop the drug, the investigators advise. They reference the Royal College of Psychiatrists’ updated guidance, which recommends slow tapering over a period long enough to mitigate withdrawal symptoms to “tolerable levels.”
The guidance suggests that patients start with a small “test reduction.” Withdrawal symptoms should be monitored for the following 2-4 weeks, using a symptom checklist such as the Discontinuation Emergent Signs and Symptoms Scale, with subsequent reductions based on the tolerability of the process.
Gradual dose reductions and very small final doses may necessitate the use of formulations of medication other than those commonly available in tablet forms, the researchers noted. During the tapering process, patients may benefit from increased psychosocial support.
Dr. Horowitz noted that antidepressants can be helpful on a short-term basis, and likened their use to the use of a cast to stabilize a broken arm.
“It’s useful for a short period. But if you leave someone in a plastic cast permanently, their arm will shrivel and you will disable them. These drugs should be prescribed minimally, and for the shortest possible period of time,” he said.
Dr. Horowitz recommended the recent draft National Institute for Health and Care Excellence depression guidance that recommends multiple other options beyond antidepressants, including cognitive-behavioral therapy, problem solving, counseling, and exercise.
Lack of balance
Dr. Muskin commented that the review is helpful in guiding clinicians on how to approach tapering of antidepressants and making patients aware of discontinuation symptoms.
However, “a lot of people will read this who need treatment, but they won’t get treated because they’ll take away the message that ‘drugs don’t work,’ ” he said.
“As it is, there is already stigma and prejudice toward psychiatric illness and using medications for treatment,” said Dr. Muskin, who was not involved with the research.
The current review “isn’t balanced, in terms of the efficacy of these drugs – both for the spectrum of depressive disorders and for panic or anxiety disorder. And there is nowhere that the authors say these drugs help people,” he added.
Moreover, the investigators’ assertion that long-term use of antidepressants causes harm is incorrect, he said.
“Yes, there are ongoing side effects that impose a burden, but that’s not the same as harm. And while the side effects are sometimes burdensome, ongoing depression is also terribly burdensome,” Dr. Muskin concluded.
Dr. Horowitz, Dr. Wilcock, and Dr. Muskin have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE DRUG AND THERAPEUTICS BULLETIN
Federal website for free COVID-19 tests opens Jan. 19
The tests will ship within 7 to 12 days after being ordered, senior officials from President Joe Biden’s administration said Jan. 14. The U.S. Postal Service will handle the shipping and delivery through first-class mail.
People will input their name and mailing address on the website and can share an email address to receive updates on the order, according to NPR. People won’t need to pay shipping costs or enter a credit card number to order tests, according to the website’s homepage.
The website will be offered in both English and Spanish. The Biden administration will also set up a phone number so those without internet access can place orders.
Officials didn’t share a specific time that the website will open, according to he New York Times — simply that it will go live sometime on Jan. 19. Each household will be limited to ordering four tests.
Starting Jan. 15, people with private insurance were able to seek reimbursement for tests they purchase on their own. At the same time, some insurers have said it could take weeks to set up a system for smooth reimbursement, the newspaper reported.
Last week’s announcement is the latest step in the president’s pledge to get coronavirus tests to Americans. In December, Biden said his administration would purchase 500 million tests and distribute them to Americans for free. On Jan. 13, he announced that the administration would buy another 500 million tests, bringing the total to 1 billion.
So far, the administration has signed contracts to produce 420 million tests, the newspaper reported. With the website opening this week and the lag in shipping, the tests will likely arrive by the end of January at the earliest, which could be after the peak of the current coronavirus surge in some parts of the country.
At-home tests have been in high demand, with some pharmacies, retailers, and websites reporting no stock in recent weeks. People have lined up at community testing sites for hours to get tested as the national average of daily cases has climbed above 800,000 last week.
Some consumers have also been confused about how or when to use at-home tests. On Jan. 14, Biden administration officials said that people should use rapid tests for three reasons:
- If they begin to experience COVID-19 symptoms;
- When it has been five or more days after being exposed to someone who tests positive;
- If they are gathering indoors with a high-risk person and want to check if they are negative.
A version of this article first appeared on WebMD.com.
The tests will ship within 7 to 12 days after being ordered, senior officials from President Joe Biden’s administration said Jan. 14. The U.S. Postal Service will handle the shipping and delivery through first-class mail.
People will input their name and mailing address on the website and can share an email address to receive updates on the order, according to NPR. People won’t need to pay shipping costs or enter a credit card number to order tests, according to the website’s homepage.
The website will be offered in both English and Spanish. The Biden administration will also set up a phone number so those without internet access can place orders.
Officials didn’t share a specific time that the website will open, according to he New York Times — simply that it will go live sometime on Jan. 19. Each household will be limited to ordering four tests.
Starting Jan. 15, people with private insurance were able to seek reimbursement for tests they purchase on their own. At the same time, some insurers have said it could take weeks to set up a system for smooth reimbursement, the newspaper reported.
Last week’s announcement is the latest step in the president’s pledge to get coronavirus tests to Americans. In December, Biden said his administration would purchase 500 million tests and distribute them to Americans for free. On Jan. 13, he announced that the administration would buy another 500 million tests, bringing the total to 1 billion.
So far, the administration has signed contracts to produce 420 million tests, the newspaper reported. With the website opening this week and the lag in shipping, the tests will likely arrive by the end of January at the earliest, which could be after the peak of the current coronavirus surge in some parts of the country.
At-home tests have been in high demand, with some pharmacies, retailers, and websites reporting no stock in recent weeks. People have lined up at community testing sites for hours to get tested as the national average of daily cases has climbed above 800,000 last week.
Some consumers have also been confused about how or when to use at-home tests. On Jan. 14, Biden administration officials said that people should use rapid tests for three reasons:
- If they begin to experience COVID-19 symptoms;
- When it has been five or more days after being exposed to someone who tests positive;
- If they are gathering indoors with a high-risk person and want to check if they are negative.
A version of this article first appeared on WebMD.com.
The tests will ship within 7 to 12 days after being ordered, senior officials from President Joe Biden’s administration said Jan. 14. The U.S. Postal Service will handle the shipping and delivery through first-class mail.
People will input their name and mailing address on the website and can share an email address to receive updates on the order, according to NPR. People won’t need to pay shipping costs or enter a credit card number to order tests, according to the website’s homepage.
The website will be offered in both English and Spanish. The Biden administration will also set up a phone number so those without internet access can place orders.
Officials didn’t share a specific time that the website will open, according to he New York Times — simply that it will go live sometime on Jan. 19. Each household will be limited to ordering four tests.
Starting Jan. 15, people with private insurance were able to seek reimbursement for tests they purchase on their own. At the same time, some insurers have said it could take weeks to set up a system for smooth reimbursement, the newspaper reported.
Last week’s announcement is the latest step in the president’s pledge to get coronavirus tests to Americans. In December, Biden said his administration would purchase 500 million tests and distribute them to Americans for free. On Jan. 13, he announced that the administration would buy another 500 million tests, bringing the total to 1 billion.
So far, the administration has signed contracts to produce 420 million tests, the newspaper reported. With the website opening this week and the lag in shipping, the tests will likely arrive by the end of January at the earliest, which could be after the peak of the current coronavirus surge in some parts of the country.
At-home tests have been in high demand, with some pharmacies, retailers, and websites reporting no stock in recent weeks. People have lined up at community testing sites for hours to get tested as the national average of daily cases has climbed above 800,000 last week.
Some consumers have also been confused about how or when to use at-home tests. On Jan. 14, Biden administration officials said that people should use rapid tests for three reasons:
- If they begin to experience COVID-19 symptoms;
- When it has been five or more days after being exposed to someone who tests positive;
- If they are gathering indoors with a high-risk person and want to check if they are negative.
A version of this article first appeared on WebMD.com.
Should you dismiss that patient?
After a recent column about the dilemma of dealing with patients who refuse to be vaccinated against COVID-19, several readers raised the
Contrary to what seems to be the popular opinion, there are no statutory laws that I am aware of that directly apply to patient dismissal, beyond the obvious ones prohibiting discrimination that I’ve discussed many times. The more realistic concern is leaving yourself vulnerable to civil litigation – usually charges of abandonment.
Criteria will vary by region, jurisdiction, and practice. Since there are no hard and fast rules, your reasons for dismissal should be determined in advance, written out, and included in your practice manual. Once you have laid down your rules, follow them. Exceptions should be rare and made only under extraordinary circumstances.
Most patients are dismissed because of interpersonal conflicts between physician or staff members. Usually, that involves noncompliance with a reasonable treatment plan (including vaccinations), but there are other valid reasons. These include threats of violence, inappropriate sexual advances, providing false or misleading medical history, demands for inappropriate treatments or medications, and repeated failure to keep appointments or pay bills. And most ethics experts agree that you can dismiss someone who insists on treatment outside your area of expertise, or at a location other than your private office.
Even when circumstances warrant, dismissal should be a last resort. As with most interpersonal conflicts, your best option is usually reconciliation. Sit down with the patient, explain your concerns, and discuss what must be done if your doctor-patient relationship is to continue. Often, such patients are not aware (or willing to admit) that they are violating your office policies. Honest communication will often save such relationships. But be sure to make it clear that failure to address the problems you have outlined will result in dismissal from your practice. Document this conversation in detail in the patient’s chart, and follow up with a written communication reconfirming what you discussed.
If, despite your best (documented) efforts, the problems continue and dismissal becomes necessary, following a few generally accepted guidelines will help keep the process smooth and consequence free.
First, try to avoid dismissing a patient in the middle of a course of treatment. If that is unavoidable, you might want to contact your malpractice carrier and review the case with them prior to doing so.
Inform the patient, preferably by certified mail, of your decision. Spell out your reasons, with a reminder that these problems were discussed, and that a warning was issued and not heeded. If the patient belongs to a third-party health plan, be certain that you are acting within the stipulations of your contract with that plan, and inform the payer in writing of your action.
Once again, you must clearly document in the patient’s chart exactly how he or she violated your office policies. This will minimize grounds for charges of discrimination of any sort. Be especially diligent about this step if the patient has any known physical or mental disability.
Give the patient a reasonable amount of time (30 days is common) to find another physician, and mention that you will address any emergent problems within the scope of your specialty within that 30-day period. To minimize any potential allegations of abandonment, include a list of competent physicians in your area (without any guarantees) who might be willing to assume the patient’s care. Alternatively, you can list the phone number or website of a local medical society that they can contact to find a replacement. Offer to transfer medical records to the new physician upon receipt of written permission.
File a copy or scan of the letter, the certified delivery receipt, and the returned signature card in the patient’s chart. While the law states that a first-class letter, properly addressed and stamped, is presumed to have been delivered, you don’t want any question as to whether the patient received written notice of dismissal.
Forcibly ending a physician-patient relationship is a significant event that should not be undertaken lightly. Again, dismissal should be a rare occurrence, a last resort.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
After a recent column about the dilemma of dealing with patients who refuse to be vaccinated against COVID-19, several readers raised the
Contrary to what seems to be the popular opinion, there are no statutory laws that I am aware of that directly apply to patient dismissal, beyond the obvious ones prohibiting discrimination that I’ve discussed many times. The more realistic concern is leaving yourself vulnerable to civil litigation – usually charges of abandonment.
Criteria will vary by region, jurisdiction, and practice. Since there are no hard and fast rules, your reasons for dismissal should be determined in advance, written out, and included in your practice manual. Once you have laid down your rules, follow them. Exceptions should be rare and made only under extraordinary circumstances.
Most patients are dismissed because of interpersonal conflicts between physician or staff members. Usually, that involves noncompliance with a reasonable treatment plan (including vaccinations), but there are other valid reasons. These include threats of violence, inappropriate sexual advances, providing false or misleading medical history, demands for inappropriate treatments or medications, and repeated failure to keep appointments or pay bills. And most ethics experts agree that you can dismiss someone who insists on treatment outside your area of expertise, or at a location other than your private office.
Even when circumstances warrant, dismissal should be a last resort. As with most interpersonal conflicts, your best option is usually reconciliation. Sit down with the patient, explain your concerns, and discuss what must be done if your doctor-patient relationship is to continue. Often, such patients are not aware (or willing to admit) that they are violating your office policies. Honest communication will often save such relationships. But be sure to make it clear that failure to address the problems you have outlined will result in dismissal from your practice. Document this conversation in detail in the patient’s chart, and follow up with a written communication reconfirming what you discussed.
If, despite your best (documented) efforts, the problems continue and dismissal becomes necessary, following a few generally accepted guidelines will help keep the process smooth and consequence free.
First, try to avoid dismissing a patient in the middle of a course of treatment. If that is unavoidable, you might want to contact your malpractice carrier and review the case with them prior to doing so.
Inform the patient, preferably by certified mail, of your decision. Spell out your reasons, with a reminder that these problems were discussed, and that a warning was issued and not heeded. If the patient belongs to a third-party health plan, be certain that you are acting within the stipulations of your contract with that plan, and inform the payer in writing of your action.
Once again, you must clearly document in the patient’s chart exactly how he or she violated your office policies. This will minimize grounds for charges of discrimination of any sort. Be especially diligent about this step if the patient has any known physical or mental disability.
Give the patient a reasonable amount of time (30 days is common) to find another physician, and mention that you will address any emergent problems within the scope of your specialty within that 30-day period. To minimize any potential allegations of abandonment, include a list of competent physicians in your area (without any guarantees) who might be willing to assume the patient’s care. Alternatively, you can list the phone number or website of a local medical society that they can contact to find a replacement. Offer to transfer medical records to the new physician upon receipt of written permission.
File a copy or scan of the letter, the certified delivery receipt, and the returned signature card in the patient’s chart. While the law states that a first-class letter, properly addressed and stamped, is presumed to have been delivered, you don’t want any question as to whether the patient received written notice of dismissal.
Forcibly ending a physician-patient relationship is a significant event that should not be undertaken lightly. Again, dismissal should be a rare occurrence, a last resort.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
After a recent column about the dilemma of dealing with patients who refuse to be vaccinated against COVID-19, several readers raised the
Contrary to what seems to be the popular opinion, there are no statutory laws that I am aware of that directly apply to patient dismissal, beyond the obvious ones prohibiting discrimination that I’ve discussed many times. The more realistic concern is leaving yourself vulnerable to civil litigation – usually charges of abandonment.
Criteria will vary by region, jurisdiction, and practice. Since there are no hard and fast rules, your reasons for dismissal should be determined in advance, written out, and included in your practice manual. Once you have laid down your rules, follow them. Exceptions should be rare and made only under extraordinary circumstances.
Most patients are dismissed because of interpersonal conflicts between physician or staff members. Usually, that involves noncompliance with a reasonable treatment plan (including vaccinations), but there are other valid reasons. These include threats of violence, inappropriate sexual advances, providing false or misleading medical history, demands for inappropriate treatments or medications, and repeated failure to keep appointments or pay bills. And most ethics experts agree that you can dismiss someone who insists on treatment outside your area of expertise, or at a location other than your private office.
Even when circumstances warrant, dismissal should be a last resort. As with most interpersonal conflicts, your best option is usually reconciliation. Sit down with the patient, explain your concerns, and discuss what must be done if your doctor-patient relationship is to continue. Often, such patients are not aware (or willing to admit) that they are violating your office policies. Honest communication will often save such relationships. But be sure to make it clear that failure to address the problems you have outlined will result in dismissal from your practice. Document this conversation in detail in the patient’s chart, and follow up with a written communication reconfirming what you discussed.
If, despite your best (documented) efforts, the problems continue and dismissal becomes necessary, following a few generally accepted guidelines will help keep the process smooth and consequence free.
First, try to avoid dismissing a patient in the middle of a course of treatment. If that is unavoidable, you might want to contact your malpractice carrier and review the case with them prior to doing so.
Inform the patient, preferably by certified mail, of your decision. Spell out your reasons, with a reminder that these problems were discussed, and that a warning was issued and not heeded. If the patient belongs to a third-party health plan, be certain that you are acting within the stipulations of your contract with that plan, and inform the payer in writing of your action.
Once again, you must clearly document in the patient’s chart exactly how he or she violated your office policies. This will minimize grounds for charges of discrimination of any sort. Be especially diligent about this step if the patient has any known physical or mental disability.
Give the patient a reasonable amount of time (30 days is common) to find another physician, and mention that you will address any emergent problems within the scope of your specialty within that 30-day period. To minimize any potential allegations of abandonment, include a list of competent physicians in your area (without any guarantees) who might be willing to assume the patient’s care. Alternatively, you can list the phone number or website of a local medical society that they can contact to find a replacement. Offer to transfer medical records to the new physician upon receipt of written permission.
File a copy or scan of the letter, the certified delivery receipt, and the returned signature card in the patient’s chart. While the law states that a first-class letter, properly addressed and stamped, is presumed to have been delivered, you don’t want any question as to whether the patient received written notice of dismissal.
Forcibly ending a physician-patient relationship is a significant event that should not be undertaken lightly. Again, dismissal should be a rare occurrence, a last resort.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
ACP advocates outpatient treatment of uncomplicated diverticulitis
The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”
Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.
The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.
In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
Guidance on diagnosis and management
In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.
Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.
The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.
All three recommendations are conditional, with low-certainty evidence, according to the authors.
Colonoscopy for diagnostic evaluation and interventions
In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.
Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.
A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.
The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.
The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.
This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
Update confirms best practices
“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”
Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.
Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.
Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
Curbing antibiotic use
It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.
“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”
“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”
As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”
The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.
The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”
Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.
The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.
In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
Guidance on diagnosis and management
In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.
Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.
The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.
All three recommendations are conditional, with low-certainty evidence, according to the authors.
Colonoscopy for diagnostic evaluation and interventions
In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.
Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.
A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.
The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.
The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.
This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
Update confirms best practices
“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”
Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.
Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.
Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
Curbing antibiotic use
It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.
“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”
“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”
As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”
The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.
The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”
Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.
The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.
In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
Guidance on diagnosis and management
In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.
Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.
The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.
All three recommendations are conditional, with low-certainty evidence, according to the authors.
Colonoscopy for diagnostic evaluation and interventions
In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.
Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.
A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.
The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.
The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.
This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
Update confirms best practices
“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”
Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.
Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.
Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
Curbing antibiotic use
It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.
“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”
“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”
As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”
The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.
FROM ANNALS OF INTERNAL MEDICINE
Docs pen open letter to support Fauci against partisan ‘attacks’
“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.
Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.
“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.
Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).
At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”
Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
‘Sagacious counsel’
The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.
“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.
“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.
“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”
“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.
A version of this article first appeared on Medscape.com.
“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.
Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.
“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.
Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).
At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”
Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
‘Sagacious counsel’
The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.
“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.
“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.
“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”
“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.
A version of this article first appeared on Medscape.com.
“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.
Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.
“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.
Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).
At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”
Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
‘Sagacious counsel’
The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.
“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.
“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.
“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”
“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.
A version of this article first appeared on Medscape.com.
One-third of trials for connective tissue diseases go unpublished
Approximately one-third of registered randomized, controlled trials for connective tissue diseases are incomplete or unpublished, based on data from 175 studies.
“The failure to complete a trial is a waste of time and money, and a missed opportunity to contribute to patient’s health,” Alejandro Brigante, MD, of the Internal Medicine–Rheumatology service at Güemes Sanitorium in Buenos Aires, and colleagues wrote.
Patients with connective tissue diseases (CTDs) experience high levels of disability, poor quality of life, and poor survival, and more randomized, controlled trials are needed to explore treatment options, they said.
In a study published in Arthritis Care & Research, the researchers examined factors leading to the failure of CTD studies. They identified 175 studies of CTDs registered at clinicaltrials.gov since 2000. Most of the studies were phase 3, placebo-controlled trials involving pharmacologic treatments; 117 (67%) were identified as completed, 58 (33%) were identified as discontinued. Approximately half (51%) of the studies involved systemic lupus erythematosus, and half were funded by industry. The median sample size planned for the studies was 101 patients, and 83 studies stated a plan to recruit less than 100 patients.
Of the 58 discontinued trials, 12 were withdrawn, 33 were terminated, and 13 had an unknown status. These trials represented a potential enrollment of 11,389 patients, 31% of the estimated number of patients across all 175 studies.
The researchers found identified reasons for discontinuation for 39 of the 58 discontinued trials. The main reasons included insufficient patient accrual in 11 trials, interim results showing futility (8 trials), safety concerns (5 trials), funding issues (5 trials), conduct problems (4 trials), company decisions (2 trials), administrative reasons (2 trials), and departure of the principal investigator (1 trial); the reason for discontinuation was unclear in 1 trial. Discontinuation rates were not significantly different across disease types.
“By subtracting from the 58 discontinued trials the 13 studies for which early termination was justified (e.g., discontinuation for futility or safety concerns), we considered 45 (26%) trials prematurely terminated,” the researchers wrote. Overall, completed studies were less likely than discontinued studies to have a placebo group, and they had longer treatment periods to evaluate primary outcomes. A sample size of less than 100 patients was the only factor significantly associated with early study termination (odds ratio, 2.1), after controlling for multiple variables.
The researchers checked the publication status of 130 studies, including 94 completed and 36 discontinued randomized, controlled trials. Of these, 44 were unpublished and 86 were published in a peer-reviewed journal at a median of 24 months after study completion. The publication rate was significantly higher for completed studies, compared with discontinued studies (81% vs. 22%), and the rates were not significantly different among diseases. The main reasons for nonpublication included poor recruitment, study rejection and preparation for resubmission, lack of time, low priority, and the fact that the study was ongoing. A sample size of less than 100 patients was the main barrier to publication for completed studies.
The study findings were limited by several factors including selection bias and inability to study factors, such as study complexity or the nature of interventions that might have affected trial completion, the researchers noted. Other limitations include a lack of data on negative results and the possible missed publication of some of the studies.
However, the results illustrate the waste of resources in CTD trials, which are needed to identify effective treatments for these patients, the researchers said. “A better understanding of the factors leading to waste will guide future allocation of resources and could help to maximize the successful conduct of RCTs.”
More research is needed to determine the most effective interventions and reduce the risk of trial noncompletion and nonpublication, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Approximately one-third of registered randomized, controlled trials for connective tissue diseases are incomplete or unpublished, based on data from 175 studies.
“The failure to complete a trial is a waste of time and money, and a missed opportunity to contribute to patient’s health,” Alejandro Brigante, MD, of the Internal Medicine–Rheumatology service at Güemes Sanitorium in Buenos Aires, and colleagues wrote.
Patients with connective tissue diseases (CTDs) experience high levels of disability, poor quality of life, and poor survival, and more randomized, controlled trials are needed to explore treatment options, they said.
In a study published in Arthritis Care & Research, the researchers examined factors leading to the failure of CTD studies. They identified 175 studies of CTDs registered at clinicaltrials.gov since 2000. Most of the studies were phase 3, placebo-controlled trials involving pharmacologic treatments; 117 (67%) were identified as completed, 58 (33%) were identified as discontinued. Approximately half (51%) of the studies involved systemic lupus erythematosus, and half were funded by industry. The median sample size planned for the studies was 101 patients, and 83 studies stated a plan to recruit less than 100 patients.
Of the 58 discontinued trials, 12 were withdrawn, 33 were terminated, and 13 had an unknown status. These trials represented a potential enrollment of 11,389 patients, 31% of the estimated number of patients across all 175 studies.
The researchers found identified reasons for discontinuation for 39 of the 58 discontinued trials. The main reasons included insufficient patient accrual in 11 trials, interim results showing futility (8 trials), safety concerns (5 trials), funding issues (5 trials), conduct problems (4 trials), company decisions (2 trials), administrative reasons (2 trials), and departure of the principal investigator (1 trial); the reason for discontinuation was unclear in 1 trial. Discontinuation rates were not significantly different across disease types.
“By subtracting from the 58 discontinued trials the 13 studies for which early termination was justified (e.g., discontinuation for futility or safety concerns), we considered 45 (26%) trials prematurely terminated,” the researchers wrote. Overall, completed studies were less likely than discontinued studies to have a placebo group, and they had longer treatment periods to evaluate primary outcomes. A sample size of less than 100 patients was the only factor significantly associated with early study termination (odds ratio, 2.1), after controlling for multiple variables.
The researchers checked the publication status of 130 studies, including 94 completed and 36 discontinued randomized, controlled trials. Of these, 44 were unpublished and 86 were published in a peer-reviewed journal at a median of 24 months after study completion. The publication rate was significantly higher for completed studies, compared with discontinued studies (81% vs. 22%), and the rates were not significantly different among diseases. The main reasons for nonpublication included poor recruitment, study rejection and preparation for resubmission, lack of time, low priority, and the fact that the study was ongoing. A sample size of less than 100 patients was the main barrier to publication for completed studies.
The study findings were limited by several factors including selection bias and inability to study factors, such as study complexity or the nature of interventions that might have affected trial completion, the researchers noted. Other limitations include a lack of data on negative results and the possible missed publication of some of the studies.
However, the results illustrate the waste of resources in CTD trials, which are needed to identify effective treatments for these patients, the researchers said. “A better understanding of the factors leading to waste will guide future allocation of resources and could help to maximize the successful conduct of RCTs.”
More research is needed to determine the most effective interventions and reduce the risk of trial noncompletion and nonpublication, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Approximately one-third of registered randomized, controlled trials for connective tissue diseases are incomplete or unpublished, based on data from 175 studies.
“The failure to complete a trial is a waste of time and money, and a missed opportunity to contribute to patient’s health,” Alejandro Brigante, MD, of the Internal Medicine–Rheumatology service at Güemes Sanitorium in Buenos Aires, and colleagues wrote.
Patients with connective tissue diseases (CTDs) experience high levels of disability, poor quality of life, and poor survival, and more randomized, controlled trials are needed to explore treatment options, they said.
In a study published in Arthritis Care & Research, the researchers examined factors leading to the failure of CTD studies. They identified 175 studies of CTDs registered at clinicaltrials.gov since 2000. Most of the studies were phase 3, placebo-controlled trials involving pharmacologic treatments; 117 (67%) were identified as completed, 58 (33%) were identified as discontinued. Approximately half (51%) of the studies involved systemic lupus erythematosus, and half were funded by industry. The median sample size planned for the studies was 101 patients, and 83 studies stated a plan to recruit less than 100 patients.
Of the 58 discontinued trials, 12 were withdrawn, 33 were terminated, and 13 had an unknown status. These trials represented a potential enrollment of 11,389 patients, 31% of the estimated number of patients across all 175 studies.
The researchers found identified reasons for discontinuation for 39 of the 58 discontinued trials. The main reasons included insufficient patient accrual in 11 trials, interim results showing futility (8 trials), safety concerns (5 trials), funding issues (5 trials), conduct problems (4 trials), company decisions (2 trials), administrative reasons (2 trials), and departure of the principal investigator (1 trial); the reason for discontinuation was unclear in 1 trial. Discontinuation rates were not significantly different across disease types.
“By subtracting from the 58 discontinued trials the 13 studies for which early termination was justified (e.g., discontinuation for futility or safety concerns), we considered 45 (26%) trials prematurely terminated,” the researchers wrote. Overall, completed studies were less likely than discontinued studies to have a placebo group, and they had longer treatment periods to evaluate primary outcomes. A sample size of less than 100 patients was the only factor significantly associated with early study termination (odds ratio, 2.1), after controlling for multiple variables.
The researchers checked the publication status of 130 studies, including 94 completed and 36 discontinued randomized, controlled trials. Of these, 44 were unpublished and 86 were published in a peer-reviewed journal at a median of 24 months after study completion. The publication rate was significantly higher for completed studies, compared with discontinued studies (81% vs. 22%), and the rates were not significantly different among diseases. The main reasons for nonpublication included poor recruitment, study rejection and preparation for resubmission, lack of time, low priority, and the fact that the study was ongoing. A sample size of less than 100 patients was the main barrier to publication for completed studies.
The study findings were limited by several factors including selection bias and inability to study factors, such as study complexity or the nature of interventions that might have affected trial completion, the researchers noted. Other limitations include a lack of data on negative results and the possible missed publication of some of the studies.
However, the results illustrate the waste of resources in CTD trials, which are needed to identify effective treatments for these patients, the researchers said. “A better understanding of the factors leading to waste will guide future allocation of resources and could help to maximize the successful conduct of RCTs.”
More research is needed to determine the most effective interventions and reduce the risk of trial noncompletion and nonpublication, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM ARTHRITIS CARE & RESEARCH
Program targets preschoolers to promote heart health
Creators of a pilot program that educates preschoolers about good heart health have validated a template for successful early childhood intervention that, they claim, provides a pathway for translating scientific evidence into the community and classroom for educational purposes to encourage long-lasting lifestyle changes.
That validation supports the creators' plans to take the program into more schools.
They reported key lessons in crafting the program, known as the SI! Program (for Salud Integral-Comprehensive Health), online in the Journal of the American College of Cardiology.
“This is a research-based program that uses randomized clinical trial evidence with implementation strategies to design educational health promotion programs,” senior author Valentin Fuster, MD, PhD, founder and trustees chairman of the Foundation for Science, Health, and Education (SHE) based in Barcelona, under whose aegis the SI! Program was implemented, said in an interview. Dr. Fuster is also director of Mount Sinai Heart and physician-in-chief at Mount Sinai Hospital in New York, and general director of the National Center for Cardiovascular Investigation (CNIC) in Madrid, Spain’s equivalent of the National Heart, Lung, and Blood Institute.
“There are specific times in a child’s life when improvements can be made to enhance long-term cardiovascular health status,” said Rodrigo Fernández-Jiménez, MD, PhD, group leader of the cardiovascular health and imaging lab at CNIC and study coauthor. “Our review, and previous studies, suggest that 4-5 years of age is the most favorable time to start a school-based intervention focused on healthy habits.”
A key piece of the SI! Program used a Sesame Street character, known as Dr. Ruster, a Muppet based on Dr. Fuster, to introduce and convey most messages and activities to the preschool children. The program also used a heart-shaped mascot named “Cardio” to teach about healthy behaviors. Other components include video segments, a colorful storybook, an interactive board game, flash cards, and a teacher’s guide. The activities and messages were tailored based on the country in which the program was implemented.
A decade of experience
The review evaluated 10 years of experience with the preschool-based program, drawing upon cluster-randomized clinical trials of the program in three countries with different socioeconomic conditions: Colombia, Spain, and the United States. The studies randomized schools to receive the SI! Program for 4 months or to a control group and included more than 3,800 children from 50 schools, along with their parents or caregivers and teachers. The studies found significant increases in preschoolers’ knowledge, attitudes, and habits toward healthy eating and living an active lifestyle. Now, the SI! Program is expanding into more than 250 schools in Spain and more than 40 schools in all five boroughs of New York City.
“This is a multidimensional program,” Dr. Fuster said. The review identified five stages for implementing the program: dissemination; adoption; implementation; evaluation; and institutionalization.
Dissemination involves three substages for intervention: components, design, and strategy. With regard to the components, said Dr. Fuster, “We’re targeting children to educate them in four topics: how the body works; nutritional and dietary requirements; physical activity; and the need to control emotions – to say no in the future when they’re confronted with alcohol, drugs, and tobacco.”
Design involved a multidisciplinary team of experts to develop the intervention, Dr. Fuster said. The strategy itself enlists parents and teachers in the implementation, but goes beyond that. “This is a community,” Dr. Fuster said. Hence, the school environment and classroom itself are also engaged to support the message of the four topics.
Dr. Fuster said future research should look at knowledge, attitude, and habits and biological outcomes in children who’ve been in the SI! Program when they reach adolescence. “Our hypothesis is that we can do this in older children, but when they reach age 10 we want to reintervene in them,” Dr. Fuster said. “Humans need reintervention. Our findings don’t get into sustainability.” He added that further research should also identify socioeconomic factors that influence child health.
Expanding the program across the New York City’s five boroughs “offers a unique opportunity to explore which socioeconomic factors, at both the family and borough level, and may eventually affect children’s health, how they are implicated in the intervention’s effectiveness, and how they can be addressed to reduce the gap in health inequalities,” he said.
Karalyn Kinsella, MD, a pediatrician affiliated with Yale New Haven (Conn.) Medical Center, noted the program’s multidimensional nature is an important element. “I think what is so important about this intervention is that it is not one single intervention but a curriculum that takes a significant amount of time (up to 50 hours) that allows for repetition of the information, which allows it to become remembered,” she said in an interview. “I also think incorporating families in the intervention is key as that is where change often has to happen.”
While she said the program may provide a template for a mental health curriculum, she added, “My concern is that teachers are already feeling overwhelmed and this may be viewed as another burden.”
The American Heart Association provided funding for the study in the United States. Dr Fernández-Jiménez has received funding from the Fondo de Investigación Sanitaria–Instituto de Salud Carlos III, which is cofunded by the European Regional Development Fund/European Social Fund. Dr. Fuster and Dr. Kinsella have no relevant disclosures.
Creators of a pilot program that educates preschoolers about good heart health have validated a template for successful early childhood intervention that, they claim, provides a pathway for translating scientific evidence into the community and classroom for educational purposes to encourage long-lasting lifestyle changes.
That validation supports the creators' plans to take the program into more schools.
They reported key lessons in crafting the program, known as the SI! Program (for Salud Integral-Comprehensive Health), online in the Journal of the American College of Cardiology.
“This is a research-based program that uses randomized clinical trial evidence with implementation strategies to design educational health promotion programs,” senior author Valentin Fuster, MD, PhD, founder and trustees chairman of the Foundation for Science, Health, and Education (SHE) based in Barcelona, under whose aegis the SI! Program was implemented, said in an interview. Dr. Fuster is also director of Mount Sinai Heart and physician-in-chief at Mount Sinai Hospital in New York, and general director of the National Center for Cardiovascular Investigation (CNIC) in Madrid, Spain’s equivalent of the National Heart, Lung, and Blood Institute.
“There are specific times in a child’s life when improvements can be made to enhance long-term cardiovascular health status,” said Rodrigo Fernández-Jiménez, MD, PhD, group leader of the cardiovascular health and imaging lab at CNIC and study coauthor. “Our review, and previous studies, suggest that 4-5 years of age is the most favorable time to start a school-based intervention focused on healthy habits.”
A key piece of the SI! Program used a Sesame Street character, known as Dr. Ruster, a Muppet based on Dr. Fuster, to introduce and convey most messages and activities to the preschool children. The program also used a heart-shaped mascot named “Cardio” to teach about healthy behaviors. Other components include video segments, a colorful storybook, an interactive board game, flash cards, and a teacher’s guide. The activities and messages were tailored based on the country in which the program was implemented.
A decade of experience
The review evaluated 10 years of experience with the preschool-based program, drawing upon cluster-randomized clinical trials of the program in three countries with different socioeconomic conditions: Colombia, Spain, and the United States. The studies randomized schools to receive the SI! Program for 4 months or to a control group and included more than 3,800 children from 50 schools, along with their parents or caregivers and teachers. The studies found significant increases in preschoolers’ knowledge, attitudes, and habits toward healthy eating and living an active lifestyle. Now, the SI! Program is expanding into more than 250 schools in Spain and more than 40 schools in all five boroughs of New York City.
“This is a multidimensional program,” Dr. Fuster said. The review identified five stages for implementing the program: dissemination; adoption; implementation; evaluation; and institutionalization.
Dissemination involves three substages for intervention: components, design, and strategy. With regard to the components, said Dr. Fuster, “We’re targeting children to educate them in four topics: how the body works; nutritional and dietary requirements; physical activity; and the need to control emotions – to say no in the future when they’re confronted with alcohol, drugs, and tobacco.”
Design involved a multidisciplinary team of experts to develop the intervention, Dr. Fuster said. The strategy itself enlists parents and teachers in the implementation, but goes beyond that. “This is a community,” Dr. Fuster said. Hence, the school environment and classroom itself are also engaged to support the message of the four topics.
Dr. Fuster said future research should look at knowledge, attitude, and habits and biological outcomes in children who’ve been in the SI! Program when they reach adolescence. “Our hypothesis is that we can do this in older children, but when they reach age 10 we want to reintervene in them,” Dr. Fuster said. “Humans need reintervention. Our findings don’t get into sustainability.” He added that further research should also identify socioeconomic factors that influence child health.
Expanding the program across the New York City’s five boroughs “offers a unique opportunity to explore which socioeconomic factors, at both the family and borough level, and may eventually affect children’s health, how they are implicated in the intervention’s effectiveness, and how they can be addressed to reduce the gap in health inequalities,” he said.
Karalyn Kinsella, MD, a pediatrician affiliated with Yale New Haven (Conn.) Medical Center, noted the program’s multidimensional nature is an important element. “I think what is so important about this intervention is that it is not one single intervention but a curriculum that takes a significant amount of time (up to 50 hours) that allows for repetition of the information, which allows it to become remembered,” she said in an interview. “I also think incorporating families in the intervention is key as that is where change often has to happen.”
While she said the program may provide a template for a mental health curriculum, she added, “My concern is that teachers are already feeling overwhelmed and this may be viewed as another burden.”
The American Heart Association provided funding for the study in the United States. Dr Fernández-Jiménez has received funding from the Fondo de Investigación Sanitaria–Instituto de Salud Carlos III, which is cofunded by the European Regional Development Fund/European Social Fund. Dr. Fuster and Dr. Kinsella have no relevant disclosures.
Creators of a pilot program that educates preschoolers about good heart health have validated a template for successful early childhood intervention that, they claim, provides a pathway for translating scientific evidence into the community and classroom for educational purposes to encourage long-lasting lifestyle changes.
That validation supports the creators' plans to take the program into more schools.
They reported key lessons in crafting the program, known as the SI! Program (for Salud Integral-Comprehensive Health), online in the Journal of the American College of Cardiology.
“This is a research-based program that uses randomized clinical trial evidence with implementation strategies to design educational health promotion programs,” senior author Valentin Fuster, MD, PhD, founder and trustees chairman of the Foundation for Science, Health, and Education (SHE) based in Barcelona, under whose aegis the SI! Program was implemented, said in an interview. Dr. Fuster is also director of Mount Sinai Heart and physician-in-chief at Mount Sinai Hospital in New York, and general director of the National Center for Cardiovascular Investigation (CNIC) in Madrid, Spain’s equivalent of the National Heart, Lung, and Blood Institute.
“There are specific times in a child’s life when improvements can be made to enhance long-term cardiovascular health status,” said Rodrigo Fernández-Jiménez, MD, PhD, group leader of the cardiovascular health and imaging lab at CNIC and study coauthor. “Our review, and previous studies, suggest that 4-5 years of age is the most favorable time to start a school-based intervention focused on healthy habits.”
A key piece of the SI! Program used a Sesame Street character, known as Dr. Ruster, a Muppet based on Dr. Fuster, to introduce and convey most messages and activities to the preschool children. The program also used a heart-shaped mascot named “Cardio” to teach about healthy behaviors. Other components include video segments, a colorful storybook, an interactive board game, flash cards, and a teacher’s guide. The activities and messages were tailored based on the country in which the program was implemented.
A decade of experience
The review evaluated 10 years of experience with the preschool-based program, drawing upon cluster-randomized clinical trials of the program in three countries with different socioeconomic conditions: Colombia, Spain, and the United States. The studies randomized schools to receive the SI! Program for 4 months or to a control group and included more than 3,800 children from 50 schools, along with their parents or caregivers and teachers. The studies found significant increases in preschoolers’ knowledge, attitudes, and habits toward healthy eating and living an active lifestyle. Now, the SI! Program is expanding into more than 250 schools in Spain and more than 40 schools in all five boroughs of New York City.
“This is a multidimensional program,” Dr. Fuster said. The review identified five stages for implementing the program: dissemination; adoption; implementation; evaluation; and institutionalization.
Dissemination involves three substages for intervention: components, design, and strategy. With regard to the components, said Dr. Fuster, “We’re targeting children to educate them in four topics: how the body works; nutritional and dietary requirements; physical activity; and the need to control emotions – to say no in the future when they’re confronted with alcohol, drugs, and tobacco.”
Design involved a multidisciplinary team of experts to develop the intervention, Dr. Fuster said. The strategy itself enlists parents and teachers in the implementation, but goes beyond that. “This is a community,” Dr. Fuster said. Hence, the school environment and classroom itself are also engaged to support the message of the four topics.
Dr. Fuster said future research should look at knowledge, attitude, and habits and biological outcomes in children who’ve been in the SI! Program when they reach adolescence. “Our hypothesis is that we can do this in older children, but when they reach age 10 we want to reintervene in them,” Dr. Fuster said. “Humans need reintervention. Our findings don’t get into sustainability.” He added that further research should also identify socioeconomic factors that influence child health.
Expanding the program across the New York City’s five boroughs “offers a unique opportunity to explore which socioeconomic factors, at both the family and borough level, and may eventually affect children’s health, how they are implicated in the intervention’s effectiveness, and how they can be addressed to reduce the gap in health inequalities,” he said.
Karalyn Kinsella, MD, a pediatrician affiliated with Yale New Haven (Conn.) Medical Center, noted the program’s multidimensional nature is an important element. “I think what is so important about this intervention is that it is not one single intervention but a curriculum that takes a significant amount of time (up to 50 hours) that allows for repetition of the information, which allows it to become remembered,” she said in an interview. “I also think incorporating families in the intervention is key as that is where change often has to happen.”
While she said the program may provide a template for a mental health curriculum, she added, “My concern is that teachers are already feeling overwhelmed and this may be viewed as another burden.”
The American Heart Association provided funding for the study in the United States. Dr Fernández-Jiménez has received funding from the Fondo de Investigación Sanitaria–Instituto de Salud Carlos III, which is cofunded by the European Regional Development Fund/European Social Fund. Dr. Fuster and Dr. Kinsella have no relevant disclosures.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
How safe is a drug holiday from bisphosphonates for osteoporosis?
Researchers found a small but greater risk of a hip fracture after 2 years of taking a “drug holiday” – stopping therapy – after long-term (≥3-year) use of one bisphosphonate, risedronate, versus another, alendronate.
The risk of a hip fracture after stopping either of these oral bisphosphonate osteoporosis drugs was similar until 2 years, suggesting that patients who take a drug holiday from risedronate should be revaluated before 2 years.
These top-line findings from a propensity-matched cohort study of older patients in Ontario, Canada, were reported at the annual American Society of Bone and Mineral Research (ASBMR) last fall.
The full study, led by Kaleen N. Hayes, PharmD, PhD, Brown University School of Public Health, Providence, R.I., was published online in the Annals of Internal Medicine.
“We emphasize that our results do not indicate that alendronate therapy should be preferred over risedronate therapy,” the researchers stress, as several real-world studies found a similar risk of fractures while patients were receiving either drug.
“The decision to initiate alendronate or risedronate therapy [the two most commonly prescribed bisphosphonates] is driven by the prescriber,” they note, adding that some patients may prefer risedronate because it is available as a monthly dose or a weekly delayed-release formula that does not require fasting.
“We found little difference in the association between risedronate versus alendronate drug holidays and hip fractures until approximately 2 years of not receiving therapy,” Dr. Hayes and colleagues summarize.
Over 3 years, risedronate drug holidays were associated with an 18% relative and 0.6% absolute increased risk for hip fracture compared with alendronate drug holidays.
“To further inform clinical decision-making on drug holidays,” they conclude, “future research should examine when to start and restart osteoporosis therapy on the basis of initial length and type of treatment, patient characteristics, and relative risk for hip fractures versus [atypical femoral fracture].”
Hip fracture risk with risedronate vs. alendronate drug holiday
Long-term bisphosphonate use is associated with a rare risk of osteonecrosis of the jaw or atypical femoral fractures. At the same time, bisphosphonates continue to have a therapeutic effect after therapy is discontinued.
Guidelines recommend that patients at low risk of fracture should therefore have a “drug holiday” after 3 to 5 years of bisphosphonate use and be reassessed 2 to 3 years later, largely based on the Fracture Intervention Trial Long-Term Extension (FLEX) study of alendronate. But risedronate has a shorter half-life, so it may provide shorter residual fracture protection.
Using Ontario administrative data, Dr. Hayes and associates identified more than 60,000 patients who were over aged 65, had received at least 3 years of continuous alendronate or risedronate, and had a subsequent 3-year drug holiday between 2000 and 2020.
They excluded patients who had a fracture or entered a nursing home within 120 days of starting a drug holiday who may have stopped the bisphosphonate due to declining health rather than a drug holiday.
Roughly half (55%) had been taking risedronate and 45% had been taking alendronate.
Using propensity scores, the researchers matched 25,077 patients who had been taking risedronate with an equal number who had been taking alendronate.
Most of the patients were women (82%) and were White.
They started the drug holiday when they were on average 81 years old, after taking the bisphosphonate for 5.9 years on average.
During the 3-year drug holiday, 915 of the 50,154 patients had hip fractures.
This was equivalent to 12.4 hip fractures per 1,000 patients per year during a risedronate holiday and 10.6 hip fractures per 1,000 patients per year during an alendronate holiday (hazard ratio, 1.18).
The risk of hip fracture was not significantly higher at 1 year (HR, 1.03) or at 2 years of a risedronate holiday versus an alendronate holiday (HR, 1.14).
However, the risk of a hip fracture was significantly higher at 2 to 3 years of a risedronate holiday than after an alendronate holiday (HR, 1.34).
There was no significant difference in the risk of any osteoporotic fracture overall (including hip, vertebrae, pelvis, ribs, forearm), however, during a 3-year risedronate versus alendronate drug holiday (HR, 1.07).
The research was supported by the Canadian Institutes of Health Research and Institute for Clinical Evaluative Sciences. Dr. Hayes was supported by a CIHR doctoral research award. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers found a small but greater risk of a hip fracture after 2 years of taking a “drug holiday” – stopping therapy – after long-term (≥3-year) use of one bisphosphonate, risedronate, versus another, alendronate.
The risk of a hip fracture after stopping either of these oral bisphosphonate osteoporosis drugs was similar until 2 years, suggesting that patients who take a drug holiday from risedronate should be revaluated before 2 years.
These top-line findings from a propensity-matched cohort study of older patients in Ontario, Canada, were reported at the annual American Society of Bone and Mineral Research (ASBMR) last fall.
The full study, led by Kaleen N. Hayes, PharmD, PhD, Brown University School of Public Health, Providence, R.I., was published online in the Annals of Internal Medicine.
“We emphasize that our results do not indicate that alendronate therapy should be preferred over risedronate therapy,” the researchers stress, as several real-world studies found a similar risk of fractures while patients were receiving either drug.
“The decision to initiate alendronate or risedronate therapy [the two most commonly prescribed bisphosphonates] is driven by the prescriber,” they note, adding that some patients may prefer risedronate because it is available as a monthly dose or a weekly delayed-release formula that does not require fasting.
“We found little difference in the association between risedronate versus alendronate drug holidays and hip fractures until approximately 2 years of not receiving therapy,” Dr. Hayes and colleagues summarize.
Over 3 years, risedronate drug holidays were associated with an 18% relative and 0.6% absolute increased risk for hip fracture compared with alendronate drug holidays.
“To further inform clinical decision-making on drug holidays,” they conclude, “future research should examine when to start and restart osteoporosis therapy on the basis of initial length and type of treatment, patient characteristics, and relative risk for hip fractures versus [atypical femoral fracture].”
Hip fracture risk with risedronate vs. alendronate drug holiday
Long-term bisphosphonate use is associated with a rare risk of osteonecrosis of the jaw or atypical femoral fractures. At the same time, bisphosphonates continue to have a therapeutic effect after therapy is discontinued.
Guidelines recommend that patients at low risk of fracture should therefore have a “drug holiday” after 3 to 5 years of bisphosphonate use and be reassessed 2 to 3 years later, largely based on the Fracture Intervention Trial Long-Term Extension (FLEX) study of alendronate. But risedronate has a shorter half-life, so it may provide shorter residual fracture protection.
Using Ontario administrative data, Dr. Hayes and associates identified more than 60,000 patients who were over aged 65, had received at least 3 years of continuous alendronate or risedronate, and had a subsequent 3-year drug holiday between 2000 and 2020.
They excluded patients who had a fracture or entered a nursing home within 120 days of starting a drug holiday who may have stopped the bisphosphonate due to declining health rather than a drug holiday.
Roughly half (55%) had been taking risedronate and 45% had been taking alendronate.
Using propensity scores, the researchers matched 25,077 patients who had been taking risedronate with an equal number who had been taking alendronate.
Most of the patients were women (82%) and were White.
They started the drug holiday when they were on average 81 years old, after taking the bisphosphonate for 5.9 years on average.
During the 3-year drug holiday, 915 of the 50,154 patients had hip fractures.
This was equivalent to 12.4 hip fractures per 1,000 patients per year during a risedronate holiday and 10.6 hip fractures per 1,000 patients per year during an alendronate holiday (hazard ratio, 1.18).
The risk of hip fracture was not significantly higher at 1 year (HR, 1.03) or at 2 years of a risedronate holiday versus an alendronate holiday (HR, 1.14).
However, the risk of a hip fracture was significantly higher at 2 to 3 years of a risedronate holiday than after an alendronate holiday (HR, 1.34).
There was no significant difference in the risk of any osteoporotic fracture overall (including hip, vertebrae, pelvis, ribs, forearm), however, during a 3-year risedronate versus alendronate drug holiday (HR, 1.07).
The research was supported by the Canadian Institutes of Health Research and Institute for Clinical Evaluative Sciences. Dr. Hayes was supported by a CIHR doctoral research award. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers found a small but greater risk of a hip fracture after 2 years of taking a “drug holiday” – stopping therapy – after long-term (≥3-year) use of one bisphosphonate, risedronate, versus another, alendronate.
The risk of a hip fracture after stopping either of these oral bisphosphonate osteoporosis drugs was similar until 2 years, suggesting that patients who take a drug holiday from risedronate should be revaluated before 2 years.
These top-line findings from a propensity-matched cohort study of older patients in Ontario, Canada, were reported at the annual American Society of Bone and Mineral Research (ASBMR) last fall.
The full study, led by Kaleen N. Hayes, PharmD, PhD, Brown University School of Public Health, Providence, R.I., was published online in the Annals of Internal Medicine.
“We emphasize that our results do not indicate that alendronate therapy should be preferred over risedronate therapy,” the researchers stress, as several real-world studies found a similar risk of fractures while patients were receiving either drug.
“The decision to initiate alendronate or risedronate therapy [the two most commonly prescribed bisphosphonates] is driven by the prescriber,” they note, adding that some patients may prefer risedronate because it is available as a monthly dose or a weekly delayed-release formula that does not require fasting.
“We found little difference in the association between risedronate versus alendronate drug holidays and hip fractures until approximately 2 years of not receiving therapy,” Dr. Hayes and colleagues summarize.
Over 3 years, risedronate drug holidays were associated with an 18% relative and 0.6% absolute increased risk for hip fracture compared with alendronate drug holidays.
“To further inform clinical decision-making on drug holidays,” they conclude, “future research should examine when to start and restart osteoporosis therapy on the basis of initial length and type of treatment, patient characteristics, and relative risk for hip fractures versus [atypical femoral fracture].”
Hip fracture risk with risedronate vs. alendronate drug holiday
Long-term bisphosphonate use is associated with a rare risk of osteonecrosis of the jaw or atypical femoral fractures. At the same time, bisphosphonates continue to have a therapeutic effect after therapy is discontinued.
Guidelines recommend that patients at low risk of fracture should therefore have a “drug holiday” after 3 to 5 years of bisphosphonate use and be reassessed 2 to 3 years later, largely based on the Fracture Intervention Trial Long-Term Extension (FLEX) study of alendronate. But risedronate has a shorter half-life, so it may provide shorter residual fracture protection.
Using Ontario administrative data, Dr. Hayes and associates identified more than 60,000 patients who were over aged 65, had received at least 3 years of continuous alendronate or risedronate, and had a subsequent 3-year drug holiday between 2000 and 2020.
They excluded patients who had a fracture or entered a nursing home within 120 days of starting a drug holiday who may have stopped the bisphosphonate due to declining health rather than a drug holiday.
Roughly half (55%) had been taking risedronate and 45% had been taking alendronate.
Using propensity scores, the researchers matched 25,077 patients who had been taking risedronate with an equal number who had been taking alendronate.
Most of the patients were women (82%) and were White.
They started the drug holiday when they were on average 81 years old, after taking the bisphosphonate for 5.9 years on average.
During the 3-year drug holiday, 915 of the 50,154 patients had hip fractures.
This was equivalent to 12.4 hip fractures per 1,000 patients per year during a risedronate holiday and 10.6 hip fractures per 1,000 patients per year during an alendronate holiday (hazard ratio, 1.18).
The risk of hip fracture was not significantly higher at 1 year (HR, 1.03) or at 2 years of a risedronate holiday versus an alendronate holiday (HR, 1.14).
However, the risk of a hip fracture was significantly higher at 2 to 3 years of a risedronate holiday than after an alendronate holiday (HR, 1.34).
There was no significant difference in the risk of any osteoporotic fracture overall (including hip, vertebrae, pelvis, ribs, forearm), however, during a 3-year risedronate versus alendronate drug holiday (HR, 1.07).
The research was supported by the Canadian Institutes of Health Research and Institute for Clinical Evaluative Sciences. Dr. Hayes was supported by a CIHR doctoral research award. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Hypertension protocols curb racial bias in therapeutic inertia
Therapeutic inertia regarding intensification of blood pressure treatment has been shown to be more of an issue in Black patients, but this was not the case in the SPRINT trial, which involved a strict standardized approach to blood pressure management, a new analysis shows.
“Overall, we found that therapeutic inertia was similar in different races in the SPRINT trial. We did not see disparities that have been reported in previous observational studies,” lead author, Alexander Zheutlin, MD, University of Utah School of Medicine, Salt Lake City, told this news organization.
“These results show that a well-resourced approach in which a standardized approach to blood pressure measurement and treatment intensification is followed can overcome the racial disparity that is seen in therapeutic inertia and the treatment of blood pressure,” he added.
The study was published online in JAMA Network Open on Jan. 10.
The authors explain that hypertension remains a leading modifiable cause of racial disparities in cardiovascular disease. Despite similar treatment rates and increased availability of safe, effective, and affordable antihypertensive medications, blood pressure control rates among Black and Hispanic adults remain significantly lower than among White adults in the United States, and one of the factors contributing to this is thought to be therapeutic inertia – the phenomenon of clinicians not initiating or up-titrating clinically indicated therapy in the setting of unmet treatment goals.
The current analysis of the SPRINT trial was conducted to investigate whether racial and ethnic differences in therapeutic inertia in hypertension were present when blood pressure care was standardized and protocolized.
The landmark SPRINT trial compared intensive (<120 mm Hg) with standard (<140 mm Hg) systolic blood pressure treatment goals in adults 50 years and older at high risk for cardiovascular disease. The present analysis was restricted to participant visits with measured blood pressure above the target goal and included 4,141 patients in the standard group and 4,415 patients in the intensive group.
Results showed that the overall prevalence of therapeutic inertia – defined as no antihypertensive medication intensification at each study visit where the blood pressure was above target goal – was either similar or lower for Black and Hispanic participants than for White participants. This pattern was observed whether participants were randomized to the standard or intensive treatment group.
“These findings support the idea that a standardized approach to blood pressure management, as implemented in SPRINT, may help ensure equitable care is provided to all patients and could reduce the contribution of therapeutic inertia to disparities in uncontrolled blood pressure,” the authors say.
They point out that therapeutic inertia has been identified as a key clinician-level barrier to blood pressure control and is estimated to be present in more than 80% of clinic visits in community practice, whereas in the current analysis of the SPRINT trial, therapeutic inertia was present in 50% to 60% of participant visits with uncontrolled blood pressure.
“In SPRINT, blood pressure had to be measured at defined intervals with a specific method, and there were clear instructions on intensifying treatment if blood pressure was above a certain goal,” Dr. Zheutlin noted. “Our results show that within such strict confines, therapeutic inertia does not seem to be different between different racial groups. This suggests that we could make better gains in blood pressure control and more equitable treatment if we adopted a standardized approach to hypertension management.”
He added: “Many guidelines have been published on when to start treatment and the targets for blood pressure, but there is a lot of variation in how we turn these guidelines into protocols. We need to bring in more consistent protocols on blood pressure measurement and intensification and ensure they are followed. In practice, if the BP is 5 or 10 mm Hg above target, a clinician may defer a decision to intensify treatment and intensification never gets done. But if there was a strict protocol to follow, there would be less chance of this happening.”
Therapeutic inertia still high
In an accompanying commentary, Matthew Rivara, MD, Nisha Bansal, MD, and Bessie Young, MD, University of Washington, Seattle, say the current SPRINT analysis has broad implications for reducing racial and ethnic disparities in achievement of evidence-based treatment targets in the general population.
“In hypertension management, standardized protocols for medication adjustments may limit clinician practice heterogeneity to ultimately reduce differences in blood pressure control among racial and ethnic minority populations,” they write. But they add that such protocols must be implemented thoughtfully to incorporate individualized clinical assessment and clinician-patient shared decision-making.
Dr. Rivara et al. point out that the rates of therapeutic inertia in SPRINT, while lower than community-based estimates, were still very high. They suggest reasons for this could include clinician concerns about medication efficacy, adverse effects, and patient mistrust of medical professionals. Outside the clinical trial environment, additional considerations may include prescription drug and laboratory test costs, pharmacy access, and competing demands during busy clinic visits.
To address these challenges, they say that clinicians need education on current clinical practice guidelines, managing complications of intensified antihypertensive therapies, and shared decisionmaking, including culturally sensitive collaborative care. Similarly, care systems must support patients on how to address concerns about treatments.
Finally, further research is needed to better define the specific factors associated with therapeutic inertia to allow tailored interventions to overcome this inertia.
“In designing and performing such research, it is vital that investigators engage with racial and ethnic minority groups to better explore the intersection of race, ethnicity, therapeutic decision-making, trust, and shared decisionmaking,” they add.
The SPRINT trial was funded with federal funds from the National Institutes of Health. Dr. Zheutlin reported receiving grants from the NIH during the conduct of the study.
A version of this article first appeared on Medscape.com.
Therapeutic inertia regarding intensification of blood pressure treatment has been shown to be more of an issue in Black patients, but this was not the case in the SPRINT trial, which involved a strict standardized approach to blood pressure management, a new analysis shows.
“Overall, we found that therapeutic inertia was similar in different races in the SPRINT trial. We did not see disparities that have been reported in previous observational studies,” lead author, Alexander Zheutlin, MD, University of Utah School of Medicine, Salt Lake City, told this news organization.
“These results show that a well-resourced approach in which a standardized approach to blood pressure measurement and treatment intensification is followed can overcome the racial disparity that is seen in therapeutic inertia and the treatment of blood pressure,” he added.
The study was published online in JAMA Network Open on Jan. 10.
The authors explain that hypertension remains a leading modifiable cause of racial disparities in cardiovascular disease. Despite similar treatment rates and increased availability of safe, effective, and affordable antihypertensive medications, blood pressure control rates among Black and Hispanic adults remain significantly lower than among White adults in the United States, and one of the factors contributing to this is thought to be therapeutic inertia – the phenomenon of clinicians not initiating or up-titrating clinically indicated therapy in the setting of unmet treatment goals.
The current analysis of the SPRINT trial was conducted to investigate whether racial and ethnic differences in therapeutic inertia in hypertension were present when blood pressure care was standardized and protocolized.
The landmark SPRINT trial compared intensive (<120 mm Hg) with standard (<140 mm Hg) systolic blood pressure treatment goals in adults 50 years and older at high risk for cardiovascular disease. The present analysis was restricted to participant visits with measured blood pressure above the target goal and included 4,141 patients in the standard group and 4,415 patients in the intensive group.
Results showed that the overall prevalence of therapeutic inertia – defined as no antihypertensive medication intensification at each study visit where the blood pressure was above target goal – was either similar or lower for Black and Hispanic participants than for White participants. This pattern was observed whether participants were randomized to the standard or intensive treatment group.
“These findings support the idea that a standardized approach to blood pressure management, as implemented in SPRINT, may help ensure equitable care is provided to all patients and could reduce the contribution of therapeutic inertia to disparities in uncontrolled blood pressure,” the authors say.
They point out that therapeutic inertia has been identified as a key clinician-level barrier to blood pressure control and is estimated to be present in more than 80% of clinic visits in community practice, whereas in the current analysis of the SPRINT trial, therapeutic inertia was present in 50% to 60% of participant visits with uncontrolled blood pressure.
“In SPRINT, blood pressure had to be measured at defined intervals with a specific method, and there were clear instructions on intensifying treatment if blood pressure was above a certain goal,” Dr. Zheutlin noted. “Our results show that within such strict confines, therapeutic inertia does not seem to be different between different racial groups. This suggests that we could make better gains in blood pressure control and more equitable treatment if we adopted a standardized approach to hypertension management.”
He added: “Many guidelines have been published on when to start treatment and the targets for blood pressure, but there is a lot of variation in how we turn these guidelines into protocols. We need to bring in more consistent protocols on blood pressure measurement and intensification and ensure they are followed. In practice, if the BP is 5 or 10 mm Hg above target, a clinician may defer a decision to intensify treatment and intensification never gets done. But if there was a strict protocol to follow, there would be less chance of this happening.”
Therapeutic inertia still high
In an accompanying commentary, Matthew Rivara, MD, Nisha Bansal, MD, and Bessie Young, MD, University of Washington, Seattle, say the current SPRINT analysis has broad implications for reducing racial and ethnic disparities in achievement of evidence-based treatment targets in the general population.
“In hypertension management, standardized protocols for medication adjustments may limit clinician practice heterogeneity to ultimately reduce differences in blood pressure control among racial and ethnic minority populations,” they write. But they add that such protocols must be implemented thoughtfully to incorporate individualized clinical assessment and clinician-patient shared decision-making.
Dr. Rivara et al. point out that the rates of therapeutic inertia in SPRINT, while lower than community-based estimates, were still very high. They suggest reasons for this could include clinician concerns about medication efficacy, adverse effects, and patient mistrust of medical professionals. Outside the clinical trial environment, additional considerations may include prescription drug and laboratory test costs, pharmacy access, and competing demands during busy clinic visits.
To address these challenges, they say that clinicians need education on current clinical practice guidelines, managing complications of intensified antihypertensive therapies, and shared decisionmaking, including culturally sensitive collaborative care. Similarly, care systems must support patients on how to address concerns about treatments.
Finally, further research is needed to better define the specific factors associated with therapeutic inertia to allow tailored interventions to overcome this inertia.
“In designing and performing such research, it is vital that investigators engage with racial and ethnic minority groups to better explore the intersection of race, ethnicity, therapeutic decision-making, trust, and shared decisionmaking,” they add.
The SPRINT trial was funded with federal funds from the National Institutes of Health. Dr. Zheutlin reported receiving grants from the NIH during the conduct of the study.
A version of this article first appeared on Medscape.com.
Therapeutic inertia regarding intensification of blood pressure treatment has been shown to be more of an issue in Black patients, but this was not the case in the SPRINT trial, which involved a strict standardized approach to blood pressure management, a new analysis shows.
“Overall, we found that therapeutic inertia was similar in different races in the SPRINT trial. We did not see disparities that have been reported in previous observational studies,” lead author, Alexander Zheutlin, MD, University of Utah School of Medicine, Salt Lake City, told this news organization.
“These results show that a well-resourced approach in which a standardized approach to blood pressure measurement and treatment intensification is followed can overcome the racial disparity that is seen in therapeutic inertia and the treatment of blood pressure,” he added.
The study was published online in JAMA Network Open on Jan. 10.
The authors explain that hypertension remains a leading modifiable cause of racial disparities in cardiovascular disease. Despite similar treatment rates and increased availability of safe, effective, and affordable antihypertensive medications, blood pressure control rates among Black and Hispanic adults remain significantly lower than among White adults in the United States, and one of the factors contributing to this is thought to be therapeutic inertia – the phenomenon of clinicians not initiating or up-titrating clinically indicated therapy in the setting of unmet treatment goals.
The current analysis of the SPRINT trial was conducted to investigate whether racial and ethnic differences in therapeutic inertia in hypertension were present when blood pressure care was standardized and protocolized.
The landmark SPRINT trial compared intensive (<120 mm Hg) with standard (<140 mm Hg) systolic blood pressure treatment goals in adults 50 years and older at high risk for cardiovascular disease. The present analysis was restricted to participant visits with measured blood pressure above the target goal and included 4,141 patients in the standard group and 4,415 patients in the intensive group.
Results showed that the overall prevalence of therapeutic inertia – defined as no antihypertensive medication intensification at each study visit where the blood pressure was above target goal – was either similar or lower for Black and Hispanic participants than for White participants. This pattern was observed whether participants were randomized to the standard or intensive treatment group.
“These findings support the idea that a standardized approach to blood pressure management, as implemented in SPRINT, may help ensure equitable care is provided to all patients and could reduce the contribution of therapeutic inertia to disparities in uncontrolled blood pressure,” the authors say.
They point out that therapeutic inertia has been identified as a key clinician-level barrier to blood pressure control and is estimated to be present in more than 80% of clinic visits in community practice, whereas in the current analysis of the SPRINT trial, therapeutic inertia was present in 50% to 60% of participant visits with uncontrolled blood pressure.
“In SPRINT, blood pressure had to be measured at defined intervals with a specific method, and there were clear instructions on intensifying treatment if blood pressure was above a certain goal,” Dr. Zheutlin noted. “Our results show that within such strict confines, therapeutic inertia does not seem to be different between different racial groups. This suggests that we could make better gains in blood pressure control and more equitable treatment if we adopted a standardized approach to hypertension management.”
He added: “Many guidelines have been published on when to start treatment and the targets for blood pressure, but there is a lot of variation in how we turn these guidelines into protocols. We need to bring in more consistent protocols on blood pressure measurement and intensification and ensure they are followed. In practice, if the BP is 5 or 10 mm Hg above target, a clinician may defer a decision to intensify treatment and intensification never gets done. But if there was a strict protocol to follow, there would be less chance of this happening.”
Therapeutic inertia still high
In an accompanying commentary, Matthew Rivara, MD, Nisha Bansal, MD, and Bessie Young, MD, University of Washington, Seattle, say the current SPRINT analysis has broad implications for reducing racial and ethnic disparities in achievement of evidence-based treatment targets in the general population.
“In hypertension management, standardized protocols for medication adjustments may limit clinician practice heterogeneity to ultimately reduce differences in blood pressure control among racial and ethnic minority populations,” they write. But they add that such protocols must be implemented thoughtfully to incorporate individualized clinical assessment and clinician-patient shared decision-making.
Dr. Rivara et al. point out that the rates of therapeutic inertia in SPRINT, while lower than community-based estimates, were still very high. They suggest reasons for this could include clinician concerns about medication efficacy, adverse effects, and patient mistrust of medical professionals. Outside the clinical trial environment, additional considerations may include prescription drug and laboratory test costs, pharmacy access, and competing demands during busy clinic visits.
To address these challenges, they say that clinicians need education on current clinical practice guidelines, managing complications of intensified antihypertensive therapies, and shared decisionmaking, including culturally sensitive collaborative care. Similarly, care systems must support patients on how to address concerns about treatments.
Finally, further research is needed to better define the specific factors associated with therapeutic inertia to allow tailored interventions to overcome this inertia.
“In designing and performing such research, it is vital that investigators engage with racial and ethnic minority groups to better explore the intersection of race, ethnicity, therapeutic decision-making, trust, and shared decisionmaking,” they add.
The SPRINT trial was funded with federal funds from the National Institutes of Health. Dr. Zheutlin reported receiving grants from the NIH during the conduct of the study.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Cervical cancer screening rates on the decline in the U.S.
The number of women screened for cervical cancer in the United States declined between 2005 and 2019 with lack of knowledge about the need for screening being cited as the most common reason for not receiving up-to-date screening. These are the results of a population-based, cross-sectional study conducted by the U.S. Preventive Services Task Force and were published online in JAMA Network Open.
“The fact that this reason increased over time across most sociodemographic groups suggests a need for interventions targeting screening awareness for all women,” lead author Ryan Suk, PhD, MS, from the University of Texas Health Science Center, Houston, and colleagues wrote.
Between 2005 and 2019, the researchers evaluated data from 20,557 women (weighted, 113.1 million women) included in the U.S. National Health Interview Survey. The cohort included women aged 21-65 years without previous hysterectomy and included data on sociodemographic factors such as race, ethnicity, sexual orientation, health insurance type, and rurality of residence.
Dr. Suk and colleagues found that the proportion of women without current screening increased from 2005 to 2019 (from 14.4% to 23.0%; P < .001) and that a higher proportion of those women were in the 21- to 29-year age group (weighted, 29.1%), compared with women in the 30- to 65-year age group (weighted, 21.1%; P < .001). Regardless of age, not knowing that screening was indicated was the most common reason cited for not having up-to-date screening.
Sociodemographic factors influence on rates and reasons for overdue screening
Based on weighted population estimates, 6.1% of women included were Asian, 17.2% were Hispanic, 13.1% were non-Hispanic Black, 61% were non-Hispanic White, and 2.7% were other races and/or ethnicities.
Dr. Suk and colleagues found that Asian women had the highest rates of overdue screening, compared with non-Hispanic White women, who had the lowest rates (weighted, 31.4% vs. 20.1%, respectively). The authors also found that reasons for overdue screening varied by sociodemographic factors. For example, while both Asian and Hispanic women cited lack of knowledge as a barrier to routine screening, Asian women were more likely to also report lack of recommendation from a health care professional as a barrier while Hispanic women were more likely to also report lack of access as a barrier to timely screening.
Over the 14-year study period, higher rates of overdue screening were also noted among those identifying as LGBTQ+ versus heterosexual (32.0% vs. 22.2%; P < .001), those with no insurance versus private insurance (41.7% vs. 18.1%; P < .001), and those living in rural versus urban areas (26.2% vs. 22.6%; P = .04).
For the study, guideline-concordant, up-to-date screening in 2005 was defined as screening every 3 years for women aged 21-65 years based on USPSTF guidelines and clinical recommendations. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou (Pap smear) test alone for women aged 21-29 years and screening every 3 years with a Pap smear alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30-65 years.
Dr. Suk and colleagues suggested that guideline updates over the study period could have led to uncertainty regarding appropriate timing and recommended screening intervals, which in turn, may have played a role in decreased cancer screening recommendations.
“Studies have suggested that changing guidelines may produce an increase in both overscreening and underscreening but those already at higher risk of cervical cancer may be most susceptible to underscreening,” wrote the authors.
In an interview, Ruchi Garg, MD, from Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates, Fairfax, Va., commented: “I think it has been hard to keep up with the guidelines changing so frequently. Furthermore it’s not clearly delineated (or at least there seems to be confusion or extrapolation) that the guidelines are just for Pap smear and that it doesn’t translate into a well woman checkup/pelvic exam; [however], if physicians continue to tell the patients to come in every year, then there won’t be so much underscreening since the physicians/providers will be able to keep track of when the Pap smears need to get done.”
Similar to the study authors, Dr. Garg also suggested that community lectures and public health announcements, particularly when guidelines are updated, will be helpful in enhancing patient education and reducing the rate of this preventable cancer.
The study authors and commentator disclosed no relevant financial relationships.
The number of women screened for cervical cancer in the United States declined between 2005 and 2019 with lack of knowledge about the need for screening being cited as the most common reason for not receiving up-to-date screening. These are the results of a population-based, cross-sectional study conducted by the U.S. Preventive Services Task Force and were published online in JAMA Network Open.
“The fact that this reason increased over time across most sociodemographic groups suggests a need for interventions targeting screening awareness for all women,” lead author Ryan Suk, PhD, MS, from the University of Texas Health Science Center, Houston, and colleagues wrote.
Between 2005 and 2019, the researchers evaluated data from 20,557 women (weighted, 113.1 million women) included in the U.S. National Health Interview Survey. The cohort included women aged 21-65 years without previous hysterectomy and included data on sociodemographic factors such as race, ethnicity, sexual orientation, health insurance type, and rurality of residence.
Dr. Suk and colleagues found that the proportion of women without current screening increased from 2005 to 2019 (from 14.4% to 23.0%; P < .001) and that a higher proportion of those women were in the 21- to 29-year age group (weighted, 29.1%), compared with women in the 30- to 65-year age group (weighted, 21.1%; P < .001). Regardless of age, not knowing that screening was indicated was the most common reason cited for not having up-to-date screening.
Sociodemographic factors influence on rates and reasons for overdue screening
Based on weighted population estimates, 6.1% of women included were Asian, 17.2% were Hispanic, 13.1% were non-Hispanic Black, 61% were non-Hispanic White, and 2.7% were other races and/or ethnicities.
Dr. Suk and colleagues found that Asian women had the highest rates of overdue screening, compared with non-Hispanic White women, who had the lowest rates (weighted, 31.4% vs. 20.1%, respectively). The authors also found that reasons for overdue screening varied by sociodemographic factors. For example, while both Asian and Hispanic women cited lack of knowledge as a barrier to routine screening, Asian women were more likely to also report lack of recommendation from a health care professional as a barrier while Hispanic women were more likely to also report lack of access as a barrier to timely screening.
Over the 14-year study period, higher rates of overdue screening were also noted among those identifying as LGBTQ+ versus heterosexual (32.0% vs. 22.2%; P < .001), those with no insurance versus private insurance (41.7% vs. 18.1%; P < .001), and those living in rural versus urban areas (26.2% vs. 22.6%; P = .04).
For the study, guideline-concordant, up-to-date screening in 2005 was defined as screening every 3 years for women aged 21-65 years based on USPSTF guidelines and clinical recommendations. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou (Pap smear) test alone for women aged 21-29 years and screening every 3 years with a Pap smear alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30-65 years.
Dr. Suk and colleagues suggested that guideline updates over the study period could have led to uncertainty regarding appropriate timing and recommended screening intervals, which in turn, may have played a role in decreased cancer screening recommendations.
“Studies have suggested that changing guidelines may produce an increase in both overscreening and underscreening but those already at higher risk of cervical cancer may be most susceptible to underscreening,” wrote the authors.
In an interview, Ruchi Garg, MD, from Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates, Fairfax, Va., commented: “I think it has been hard to keep up with the guidelines changing so frequently. Furthermore it’s not clearly delineated (or at least there seems to be confusion or extrapolation) that the guidelines are just for Pap smear and that it doesn’t translate into a well woman checkup/pelvic exam; [however], if physicians continue to tell the patients to come in every year, then there won’t be so much underscreening since the physicians/providers will be able to keep track of when the Pap smears need to get done.”
Similar to the study authors, Dr. Garg also suggested that community lectures and public health announcements, particularly when guidelines are updated, will be helpful in enhancing patient education and reducing the rate of this preventable cancer.
The study authors and commentator disclosed no relevant financial relationships.
The number of women screened for cervical cancer in the United States declined between 2005 and 2019 with lack of knowledge about the need for screening being cited as the most common reason for not receiving up-to-date screening. These are the results of a population-based, cross-sectional study conducted by the U.S. Preventive Services Task Force and were published online in JAMA Network Open.
“The fact that this reason increased over time across most sociodemographic groups suggests a need for interventions targeting screening awareness for all women,” lead author Ryan Suk, PhD, MS, from the University of Texas Health Science Center, Houston, and colleagues wrote.
Between 2005 and 2019, the researchers evaluated data from 20,557 women (weighted, 113.1 million women) included in the U.S. National Health Interview Survey. The cohort included women aged 21-65 years without previous hysterectomy and included data on sociodemographic factors such as race, ethnicity, sexual orientation, health insurance type, and rurality of residence.
Dr. Suk and colleagues found that the proportion of women without current screening increased from 2005 to 2019 (from 14.4% to 23.0%; P < .001) and that a higher proportion of those women were in the 21- to 29-year age group (weighted, 29.1%), compared with women in the 30- to 65-year age group (weighted, 21.1%; P < .001). Regardless of age, not knowing that screening was indicated was the most common reason cited for not having up-to-date screening.
Sociodemographic factors influence on rates and reasons for overdue screening
Based on weighted population estimates, 6.1% of women included were Asian, 17.2% were Hispanic, 13.1% were non-Hispanic Black, 61% were non-Hispanic White, and 2.7% were other races and/or ethnicities.
Dr. Suk and colleagues found that Asian women had the highest rates of overdue screening, compared with non-Hispanic White women, who had the lowest rates (weighted, 31.4% vs. 20.1%, respectively). The authors also found that reasons for overdue screening varied by sociodemographic factors. For example, while both Asian and Hispanic women cited lack of knowledge as a barrier to routine screening, Asian women were more likely to also report lack of recommendation from a health care professional as a barrier while Hispanic women were more likely to also report lack of access as a barrier to timely screening.
Over the 14-year study period, higher rates of overdue screening were also noted among those identifying as LGBTQ+ versus heterosexual (32.0% vs. 22.2%; P < .001), those with no insurance versus private insurance (41.7% vs. 18.1%; P < .001), and those living in rural versus urban areas (26.2% vs. 22.6%; P = .04).
For the study, guideline-concordant, up-to-date screening in 2005 was defined as screening every 3 years for women aged 21-65 years based on USPSTF guidelines and clinical recommendations. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou (Pap smear) test alone for women aged 21-29 years and screening every 3 years with a Pap smear alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30-65 years.
Dr. Suk and colleagues suggested that guideline updates over the study period could have led to uncertainty regarding appropriate timing and recommended screening intervals, which in turn, may have played a role in decreased cancer screening recommendations.
“Studies have suggested that changing guidelines may produce an increase in both overscreening and underscreening but those already at higher risk of cervical cancer may be most susceptible to underscreening,” wrote the authors.
In an interview, Ruchi Garg, MD, from Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates, Fairfax, Va., commented: “I think it has been hard to keep up with the guidelines changing so frequently. Furthermore it’s not clearly delineated (or at least there seems to be confusion or extrapolation) that the guidelines are just for Pap smear and that it doesn’t translate into a well woman checkup/pelvic exam; [however], if physicians continue to tell the patients to come in every year, then there won’t be so much underscreening since the physicians/providers will be able to keep track of when the Pap smears need to get done.”
Similar to the study authors, Dr. Garg also suggested that community lectures and public health announcements, particularly when guidelines are updated, will be helpful in enhancing patient education and reducing the rate of this preventable cancer.
The study authors and commentator disclosed no relevant financial relationships.
FROM JAMA NETWORK OPEN