Key clinical point: Interruption of upadacitinib treatment caused rapid loss of skin clearance response and upadacitinib retreatment led to rapid recovery or improvement in the response in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A dose of 30 mg upadacitinib vs placebo led to a 72.9% least-squares mean percentage improvement in the Eczema Area and Severity Index (EASI) score by week 16, which decreased to 24.6% within 4 weeks of upadacitinib withdrawal; however, an 8-week rescue therapy (30 mg upadacitinib) improved the mean percentage EASI score (pre- vs post-therapy: 2.8% vs 84.7%).

Study details: This post hoc analysis of a phase 2b study included 167 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (7.5, 15, or 30 mg) or placebo; at week 16, each group was reassigned to receive upadacitinib (same dose) or placebo, with rescue therapy (30 mg upadacitinib) initiated in those with < 50% EASI response at week 20.

Disclosures: This study was sponsored by AbbVie, Inc. Six authors declared being employees of or holding stock or stock options in AbbVie. Several authors reported ties with AbbVie and others.

Source: Guttman-Yassky E et al. Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial. J Eur Acad Dermatol Venereol. 2023 (Aug 1). doi: 10.1111/jdv.19391

Key clinical point: Interruption of upadacitinib treatment caused rapid loss of skin clearance response and upadacitinib retreatment led to rapid recovery or improvement in the response in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A dose of 30 mg upadacitinib vs placebo led to a 72.9% least-squares mean percentage improvement in the Eczema Area and Severity Index (EASI) score by week 16, which decreased to 24.6% within 4 weeks of upadacitinib withdrawal; however, an 8-week rescue therapy (30 mg upadacitinib) improved the mean percentage EASI score (pre- vs post-therapy: 2.8% vs 84.7%).

Study details: This post hoc analysis of a phase 2b study included 167 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (7.5, 15, or 30 mg) or placebo; at week 16, each group was reassigned to receive upadacitinib (same dose) or placebo, with rescue therapy (30 mg upadacitinib) initiated in those with < 50% EASI response at week 20.

Disclosures: This study was sponsored by AbbVie, Inc. Six authors declared being employees of or holding stock or stock options in AbbVie. Several authors reported ties with AbbVie and others.

Source: Guttman-Yassky E et al. Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial. J Eur Acad Dermatol Venereol. 2023 (Aug 1). doi: 10.1111/jdv.19391

Key clinical point: Interruption of upadacitinib treatment caused rapid loss of skin clearance response and upadacitinib retreatment led to rapid recovery or improvement in the response in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A dose of 30 mg upadacitinib vs placebo led to a 72.9% least-squares mean percentage improvement in the Eczema Area and Severity Index (EASI) score by week 16, which decreased to 24.6% within 4 weeks of upadacitinib withdrawal; however, an 8-week rescue therapy (30 mg upadacitinib) improved the mean percentage EASI score (pre- vs post-therapy: 2.8% vs 84.7%).

Study details: This post hoc analysis of a phase 2b study included 167 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (7.5, 15, or 30 mg) or placebo; at week 16, each group was reassigned to receive upadacitinib (same dose) or placebo, with rescue therapy (30 mg upadacitinib) initiated in those with < 50% EASI response at week 20.

Disclosures: This study was sponsored by AbbVie, Inc. Six authors declared being employees of or holding stock or stock options in AbbVie. Several authors reported ties with AbbVie and others.

Source: Guttman-Yassky E et al. Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial. J Eur Acad Dermatol Venereol. 2023 (Aug 1). doi: 10.1111/jdv.19391

Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.

Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.

Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.

Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.

Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240

Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.

Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.

Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.

Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.

Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240

Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.

Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.

Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.

Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.

Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240

Key clinical point: Nemolizumab is safe and effectively reduces pruritus in pediatric patients with atopic dermatitis (AD) whose pruritus has not been sufficiently improved with topical corticosteroids/calcineurin inhibitors or antihistamines.

Major finding: At week 16, the nemolizumab vs placebo group had a significantly greater improvement in the weekly mean 5-level itch score (−1.3 vs −0.5; P < .0001), with a significantly higher proportion of patients achieving a weekly mean 5-level itch score ≤ 1 (24.4% vs 2.3%; P = .0035). Most adverse events were mild in severity and none led to treatment discontinuation or death.

Study details: Findings are a from multicenter phase 3 study including patients age 6-12 years with AD and inadequately controlled moderate-to-severe pruritus who were randomly assigned to receive nemolizumab (n = 45) or placebo (n = 44) with concomitant topical agents.

Disclosures: This study was sponsored by Maruho Co. Ltd., Osaka, Japan. Two authors declared receiving grants and honoraria from various sources, including Maruho, and other two authors declared being employees of Maruho.

Source: Igarashi A et al. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: Results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. 2023 (Jul 31). doi: 10.1093/bjd/ljad268

Key clinical point: Nemolizumab is safe and effectively reduces pruritus in pediatric patients with atopic dermatitis (AD) whose pruritus has not been sufficiently improved with topical corticosteroids/calcineurin inhibitors or antihistamines.

Major finding: At week 16, the nemolizumab vs placebo group had a significantly greater improvement in the weekly mean 5-level itch score (−1.3 vs −0.5; P < .0001), with a significantly higher proportion of patients achieving a weekly mean 5-level itch score ≤ 1 (24.4% vs 2.3%; P = .0035). Most adverse events were mild in severity and none led to treatment discontinuation or death.

Study details: Findings are a from multicenter phase 3 study including patients age 6-12 years with AD and inadequately controlled moderate-to-severe pruritus who were randomly assigned to receive nemolizumab (n = 45) or placebo (n = 44) with concomitant topical agents.

Disclosures: This study was sponsored by Maruho Co. Ltd., Osaka, Japan. Two authors declared receiving grants and honoraria from various sources, including Maruho, and other two authors declared being employees of Maruho.

Source: Igarashi A et al. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: Results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. 2023 (Jul 31). doi: 10.1093/bjd/ljad268

Key clinical point: Nemolizumab is safe and effectively reduces pruritus in pediatric patients with atopic dermatitis (AD) whose pruritus has not been sufficiently improved with topical corticosteroids/calcineurin inhibitors or antihistamines.

Major finding: At week 16, the nemolizumab vs placebo group had a significantly greater improvement in the weekly mean 5-level itch score (−1.3 vs −0.5; P < .0001), with a significantly higher proportion of patients achieving a weekly mean 5-level itch score ≤ 1 (24.4% vs 2.3%; P = .0035). Most adverse events were mild in severity and none led to treatment discontinuation or death.

Study details: Findings are a from multicenter phase 3 study including patients age 6-12 years with AD and inadequately controlled moderate-to-severe pruritus who were randomly assigned to receive nemolizumab (n = 45) or placebo (n = 44) with concomitant topical agents.

Disclosures: This study was sponsored by Maruho Co. Ltd., Osaka, Japan. Two authors declared receiving grants and honoraria from various sources, including Maruho, and other two authors declared being employees of Maruho.

Source: Igarashi A et al. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: Results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. 2023 (Jul 31). doi: 10.1093/bjd/ljad268

Abiomed has voluntarily recalled the labeling for one model of its Impella circulatory assist pumps because it doesn’t “appropriately address” certain safety issues, the U.S. Food and Drug Administration has announced.

The current labeling doesn’t adequately describe safety precautions clinicians can take when patients’ clotting times are below the recommended range, according to the company and cited by the FDA.

The action applies to 65 units of the Impella RP Flex with SmartAssist, model number 1000323, first distributed by the company in November 2022, the statement notes.

Twelve related injuries but no deaths have been reported, the agency said.

The devices themselves are not part of the recall; clinicians may continue to use them, the FDA says.

However, “the use of affected catheters may cause serious adverse health consequences, including the risk of blood clots or particle deposits forming or death,” says the statement, which outlines instructions for mitigating the risk.

Abiomed says it is revising the label’s Instructions for Use section “to clarify the risk factors and recommendations related to the potential of thrombus formation or deposition.”

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

Abiomed has voluntarily recalled the labeling for one model of its Impella circulatory assist pumps because it doesn’t “appropriately address” certain safety issues, the U.S. Food and Drug Administration has announced.

The current labeling doesn’t adequately describe safety precautions clinicians can take when patients’ clotting times are below the recommended range, according to the company and cited by the FDA.

The action applies to 65 units of the Impella RP Flex with SmartAssist, model number 1000323, first distributed by the company in November 2022, the statement notes.

Twelve related injuries but no deaths have been reported, the agency said.

The devices themselves are not part of the recall; clinicians may continue to use them, the FDA says.

However, “the use of affected catheters may cause serious adverse health consequences, including the risk of blood clots or particle deposits forming or death,” says the statement, which outlines instructions for mitigating the risk.

Abiomed says it is revising the label’s Instructions for Use section “to clarify the risk factors and recommendations related to the potential of thrombus formation or deposition.”

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

Abiomed has voluntarily recalled the labeling for one model of its Impella circulatory assist pumps because it doesn’t “appropriately address” certain safety issues, the U.S. Food and Drug Administration has announced.

The current labeling doesn’t adequately describe safety precautions clinicians can take when patients’ clotting times are below the recommended range, according to the company and cited by the FDA.

The action applies to 65 units of the Impella RP Flex with SmartAssist, model number 1000323, first distributed by the company in November 2022, the statement notes.

Twelve related injuries but no deaths have been reported, the agency said.

The devices themselves are not part of the recall; clinicians may continue to use them, the FDA says.

However, “the use of affected catheters may cause serious adverse health consequences, including the risk of blood clots or particle deposits forming or death,” says the statement, which outlines instructions for mitigating the risk.

Abiomed says it is revising the label’s Instructions for Use section “to clarify the risk factors and recommendations related to the potential of thrombus formation or deposition.”

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

You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.

Professional liability insurance

According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.

And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.

Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.

But it is what the policies don’t pay for that should be of most interest to practitioners.
 

Exclusions to medical malpractice insurance

All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:

• Reckless or intentional acts.
• Illegal/criminal activities, including theft.
• Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
• Practicing under the influence of alcohol or drugs.
• Altering patient or hospital records.
• Sexual misconduct.
• Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.

It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.

Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
 

The case

Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.

The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.

However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.

The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.

The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.

A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.

After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
 

Court and jury decide

In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.

The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.

However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.

The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.

While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
 

Protecting yourself

The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.

Other ways to protect yourself:

• Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
• Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
• Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
• Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
• The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.

The future

In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.

The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.

In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”

Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
 

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

You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.

Professional liability insurance

According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.

And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.

Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.

But it is what the policies don’t pay for that should be of most interest to practitioners.
 

Exclusions to medical malpractice insurance

All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:

• Reckless or intentional acts.
• Illegal/criminal activities, including theft.
• Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
• Practicing under the influence of alcohol or drugs.
• Altering patient or hospital records.
• Sexual misconduct.
• Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.

It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.

Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
 

The case

Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.

The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.

However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.

The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.

The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.

A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.

After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
 

Court and jury decide

In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.

The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.

However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.

The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.

While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
 

Protecting yourself

The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.

Other ways to protect yourself:

• Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
• Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
• Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
• Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
• The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.

The future

In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.

The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.

In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”

Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
 

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

You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.

Professional liability insurance

According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.

And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.

Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.

But it is what the policies don’t pay for that should be of most interest to practitioners.
 

Exclusions to medical malpractice insurance

All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:

• Reckless or intentional acts.
• Illegal/criminal activities, including theft.
• Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
• Practicing under the influence of alcohol or drugs.
• Altering patient or hospital records.
• Sexual misconduct.
• Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.

It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.

Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
 

The case

Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.

The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.

However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.

The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.

The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.

A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.

After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
 

Court and jury decide

In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.

The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.

However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.

The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.

While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
 

Protecting yourself

The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.

Other ways to protect yourself:

• Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
• Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
• Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
• Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
• The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.

The future

In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.

The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.

In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”

Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
 

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

Perinatal depression (PND) is the most common obstetric complication in the United States. Even when screening results are positive, mothers often do not receive further evaluation, and even when PND is diagnosed, mothers do not receive evidence-based treatments. PND has potential long-term adverse health complications for the mother, her partner, the infant, and the mother-infant dyad.

Courtesy Dr. Alison M. Heru

Meta-analytic estimates show that pregnant women suffer from PND at rates from 6.5% to 12.9% across pregnancy to 3-months post partum.¹ Women from low-income families and adolescent mothers are at highest risk, where rates are double and triple respectively.

Fathers also suffer from PND, with a prevalence rate from 2% to 25%, increasing to 50% when the mother experiences PND.

The American Academy of Pediatrics issued a Policy Statement (January 2019) about the need to recognize and manage PND. They recommended that pediatric medical homes establish a system to implement the screening of mothers at the 1-, 2-, 4-, and 6-month well-child visits, to use community resources for the treatment and referral of the mother with depression, and to provide support for the maternal-child relationship.²

The American Academy of Pediatrics also recommends advocacy for workforce development for mental health professionals who care for young children and mother-infant dyads, and for promotion of evidence-based interventions focused on healthy attachment and parent-child relationships.
 

Family research

There is a bidirectional association between family relational stress and PND. Lack of family support is both a predictor and a consequence of perinatal depression. Frequent arguments, conflict because one or both partners did not want the pregnancy, division of labor, poor support following stressful life events, lack of partner availability, and low intimacy are associated with increased perinatal depressive symptoms.

Gender role stress is also included as a risk factor. For example, men may fear performance failure related to work and sex, and women may fear disruption in the couple relationship due to the introduction of a child.

When depressed and nondepressed women at 2 months post delivery were compared, the women with depressive symptoms perceived that their partners did not share similar interests, provided little companionship, expressed disinterest in infant care, did not provide a feeling of connection, did not encourage them to get assistance to cope with difficulties, and expressed disagreement in infant care.³

A high-quality intimate relationship is protective for many illnesses and PND is no exception.⁴

Assessment

Despite the availability of effective treatments, perinatal mental health utilization rates are strikingly low. There are limited providers and a general lack of awareness of the need for this care. The stigma for assessing and treating PND is high because the perception is that pregnancy is supposed to be a joyous time and with time, PND will pass.

The first step is a timely and accurate assessment of the mother, which should, if possible, include the father and other family support people. The preferred standard for women is the Edinburgh Postnatal Depression Scale (EPDS), a checklist of 10 items (listed below) with a maximum score of 30, and any score over 10 warrants further assessment.⁵ This scale is used worldwide in obstetric clinics and has been used to identify PND in fathers.

• I have been able to laugh and see the funny side of things.
• I have looked forward with enjoyment to things.
• I have blamed myself unnecessarily when things went wrong.
• I have been anxious or worried for no good reason.
• I have felt scared or panicky for no good reason.
• Things have been getting to me.
• I have been so unhappy that I have had difficulty sleeping.
• I have felt sad or miserable.
• I have been so unhappy that I have been crying.
• The thought of harming myself has occurred to me.

A new ultrabrief tool with only four questions is the Brief Multidimensional Assessment Scale (BMAS), which measures the ability to get things done, emotional support in important relationships, quality of life, and sense of purpose in life. It demonstrates concurrent validity with other measures and discriminates between nonclinical participants and participants from most clinical contexts.⁶

For those interested in assessing family health, an easy-to-use assessment tool is the 12-item Family Assessment Device (FAD).⁷

Family therapy interventions

A systematic review and meta-analysis of the current evidence on the usefulness of family therapy interventions in the prevention and treatment of PND identified seven studies.

In these studies, there were statistically significant reductions in depressive symptoms at postintervention in intervention group mothers. Intervention intensity and level of family involvement moderated the impacts of intervention on maternal depression, and there was a trend in improved family functioning in intervention group couples.⁸

Evidence-based interventions are usually psychoeducational or cognitive-behavioral family therapy models where focused interventions target the following three areas:

• Communication skills related to expectations (including those that pertain to gender roles and the transition to parenthood) and emotional support.
• Conflict management.
• Problem-solving skills related to shared responsibility in infant care and household activities.

Intensive day program for mothers and babies

There is a growing awareness of the effectiveness of specialized mother-baby day hospital programs for women with psychiatric distress during the peripartum period.⁹

The Women & Infants’ Hospital (WIH) in Providence, R.I., established a mother-baby postpartum depression day program in 2000, adjacent to the obstetrical hospital, the ninth largest obstetrical service in the United States. The day program is integrated with the hospital’s obstetric medicine team and referrals are also accepted from the perinatal practices in the surrounding community. The treatment day includes group, individual, and milieu treatment, as well as consultation with psychiatrists, nutritionists, social workers, lactation specialists and others.

The primary theoretical model utilized by the program is interpersonal psychotherapy (IPT), with essential elements of the program incorporating cognitive behavioral therapy (CBT), and experiential strategies (for instance, mindfulness, breathing, progressive muscle relaxation) to improve self-care and relaxation skills. Patient satisfaction surveys collected from 800 women, (54% identified as White) treated at the program between 2007 and 2012 found that women were highly satisfied with the treatment received, noting that the inclusion of the baby in their treatment is a highly valued aspect of care.

A similar program in Minnesota reported that 328 women who consented to participation in research had significant improvements (P < .001) in self-report scales assessing depression, anxiety, and maternal functioning, improving mental health and parenting functioning.¹⁰

Lastly, a recent study out of Brussels, on the benefit of a mother-baby day program analyzed patient data from 2015 and 2020. This clinical population of 92 patients (43% identifying as North African) was comparable to the population of the inpatient mother-baby units in terms of psychosocial fragility except that the parents entering the day program had less severe illnesses, more anxiety disorder, and less postpartum psychosis. In the day program, all the babies improved in terms of symptoms and relationships, except for those with significant developmental difficulties.

The dyadic relationship was measured using “levels of adaptation of the parent–child relationship” scale which has four general levels of adjustment, from well-adjusted to troubled or dangerous relationship. Unlike programs in the United States, this program takes children up to 2.5 years old and the assessment period is up to 8 weeks.¹¹

Prevention of mental illness is best achieved by reducing the known determinants of illness. For PND, the research is clear, so why not start at the earliest possible stage, when we know that change is possible? Pushing health care systems to change is not easy, but as the research accumulates and the positive results grow, our arguments become stronger.

Dr. Heru is a psychiatrist in Aurora, Colo. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].

References

1. Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.

2. Rafferty J et al. Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics. 2019 Jan;143(1):e20183260. doi: 10.1542/peds.2018-3260.

3. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

4. Kumar SA et al. Promoting resilience to depression among couples during pregnancy: The protective functions of intimate relationship satisfaction and self-compassion. Family Process. 2022 May;62(1):387-405. doi: 10.1111/famp.12788.

5. Cox JL et al. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

6. Keitner GI et al. The Brief Multidimensional Assessment Scale (BMAS): A broad measure of patient well-being. Am J Psychother. 2023 Feb 1;76(2):75-81. doi: 10.1176/appi.psychotherapy.20220032.

7. Boterhoven de Haan KL et al. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113.

8. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

9. Battle CL, Howard MM. A mother-baby psychiatric day hospital: History, rationale, and why perinatal mental health is important for obstetric medicine. Obstet Med. 2014 Jun;7(2):66-70. doi: 10.1177/1753495X13514402.

10. Kim HG et al. Keeping Parent, Child, and Relationship in Mind: Clinical Effectiveness of a Trauma-informed, Multigenerational, Attachment-Based, Mother-Baby Partial Hospital Program in an Urban Safety Net Hospital. Matern Child Health J. 2021 Nov;25(11):1776-86. doi: 10.1007/s10995-021-03221-4.

11. Moureau A et al. A 5 years’ experience of a parent-baby day unit: impact on baby’s development. Front Psychiatry. 2023 June 15;14. doi: 10.3389/fpsyt.2023.1121894.

Perinatal depression (PND) is the most common obstetric complication in the United States. Even when screening results are positive, mothers often do not receive further evaluation, and even when PND is diagnosed, mothers do not receive evidence-based treatments. PND has potential long-term adverse health complications for the mother, her partner, the infant, and the mother-infant dyad.

Courtesy Dr. Alison M. Heru

Meta-analytic estimates show that pregnant women suffer from PND at rates from 6.5% to 12.9% across pregnancy to 3-months post partum.¹ Women from low-income families and adolescent mothers are at highest risk, where rates are double and triple respectively.

Fathers also suffer from PND, with a prevalence rate from 2% to 25%, increasing to 50% when the mother experiences PND.

The American Academy of Pediatrics issued a Policy Statement (January 2019) about the need to recognize and manage PND. They recommended that pediatric medical homes establish a system to implement the screening of mothers at the 1-, 2-, 4-, and 6-month well-child visits, to use community resources for the treatment and referral of the mother with depression, and to provide support for the maternal-child relationship.²

The American Academy of Pediatrics also recommends advocacy for workforce development for mental health professionals who care for young children and mother-infant dyads, and for promotion of evidence-based interventions focused on healthy attachment and parent-child relationships.
 

Family research

There is a bidirectional association between family relational stress and PND. Lack of family support is both a predictor and a consequence of perinatal depression. Frequent arguments, conflict because one or both partners did not want the pregnancy, division of labor, poor support following stressful life events, lack of partner availability, and low intimacy are associated with increased perinatal depressive symptoms.

Gender role stress is also included as a risk factor. For example, men may fear performance failure related to work and sex, and women may fear disruption in the couple relationship due to the introduction of a child.

When depressed and nondepressed women at 2 months post delivery were compared, the women with depressive symptoms perceived that their partners did not share similar interests, provided little companionship, expressed disinterest in infant care, did not provide a feeling of connection, did not encourage them to get assistance to cope with difficulties, and expressed disagreement in infant care.³

A high-quality intimate relationship is protective for many illnesses and PND is no exception.⁴

Assessment

Despite the availability of effective treatments, perinatal mental health utilization rates are strikingly low. There are limited providers and a general lack of awareness of the need for this care. The stigma for assessing and treating PND is high because the perception is that pregnancy is supposed to be a joyous time and with time, PND will pass.

The first step is a timely and accurate assessment of the mother, which should, if possible, include the father and other family support people. The preferred standard for women is the Edinburgh Postnatal Depression Scale (EPDS), a checklist of 10 items (listed below) with a maximum score of 30, and any score over 10 warrants further assessment.⁵ This scale is used worldwide in obstetric clinics and has been used to identify PND in fathers.

• I have been able to laugh and see the funny side of things.
• I have looked forward with enjoyment to things.
• I have blamed myself unnecessarily when things went wrong.
• I have been anxious or worried for no good reason.
• I have felt scared or panicky for no good reason.
• Things have been getting to me.
• I have been so unhappy that I have had difficulty sleeping.
• I have felt sad or miserable.
• I have been so unhappy that I have been crying.
• The thought of harming myself has occurred to me.

A new ultrabrief tool with only four questions is the Brief Multidimensional Assessment Scale (BMAS), which measures the ability to get things done, emotional support in important relationships, quality of life, and sense of purpose in life. It demonstrates concurrent validity with other measures and discriminates between nonclinical participants and participants from most clinical contexts.⁶

For those interested in assessing family health, an easy-to-use assessment tool is the 12-item Family Assessment Device (FAD).⁷

Family therapy interventions

A systematic review and meta-analysis of the current evidence on the usefulness of family therapy interventions in the prevention and treatment of PND identified seven studies.

In these studies, there were statistically significant reductions in depressive symptoms at postintervention in intervention group mothers. Intervention intensity and level of family involvement moderated the impacts of intervention on maternal depression, and there was a trend in improved family functioning in intervention group couples.⁸

Evidence-based interventions are usually psychoeducational or cognitive-behavioral family therapy models where focused interventions target the following three areas:

• Communication skills related to expectations (including those that pertain to gender roles and the transition to parenthood) and emotional support.
• Conflict management.
• Problem-solving skills related to shared responsibility in infant care and household activities.

Intensive day program for mothers and babies

There is a growing awareness of the effectiveness of specialized mother-baby day hospital programs for women with psychiatric distress during the peripartum period.⁹

The Women & Infants’ Hospital (WIH) in Providence, R.I., established a mother-baby postpartum depression day program in 2000, adjacent to the obstetrical hospital, the ninth largest obstetrical service in the United States. The day program is integrated with the hospital’s obstetric medicine team and referrals are also accepted from the perinatal practices in the surrounding community. The treatment day includes group, individual, and milieu treatment, as well as consultation with psychiatrists, nutritionists, social workers, lactation specialists and others.

The primary theoretical model utilized by the program is interpersonal psychotherapy (IPT), with essential elements of the program incorporating cognitive behavioral therapy (CBT), and experiential strategies (for instance, mindfulness, breathing, progressive muscle relaxation) to improve self-care and relaxation skills. Patient satisfaction surveys collected from 800 women, (54% identified as White) treated at the program between 2007 and 2012 found that women were highly satisfied with the treatment received, noting that the inclusion of the baby in their treatment is a highly valued aspect of care.

A similar program in Minnesota reported that 328 women who consented to participation in research had significant improvements (P < .001) in self-report scales assessing depression, anxiety, and maternal functioning, improving mental health and parenting functioning.¹⁰

Lastly, a recent study out of Brussels, on the benefit of a mother-baby day program analyzed patient data from 2015 and 2020. This clinical population of 92 patients (43% identifying as North African) was comparable to the population of the inpatient mother-baby units in terms of psychosocial fragility except that the parents entering the day program had less severe illnesses, more anxiety disorder, and less postpartum psychosis. In the day program, all the babies improved in terms of symptoms and relationships, except for those with significant developmental difficulties.

The dyadic relationship was measured using “levels of adaptation of the parent–child relationship” scale which has four general levels of adjustment, from well-adjusted to troubled or dangerous relationship. Unlike programs in the United States, this program takes children up to 2.5 years old and the assessment period is up to 8 weeks.¹¹

Prevention of mental illness is best achieved by reducing the known determinants of illness. For PND, the research is clear, so why not start at the earliest possible stage, when we know that change is possible? Pushing health care systems to change is not easy, but as the research accumulates and the positive results grow, our arguments become stronger.

Dr. Heru is a psychiatrist in Aurora, Colo. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].

References

1. Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.

2. Rafferty J et al. Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics. 2019 Jan;143(1):e20183260. doi: 10.1542/peds.2018-3260.

3. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

4. Kumar SA et al. Promoting resilience to depression among couples during pregnancy: The protective functions of intimate relationship satisfaction and self-compassion. Family Process. 2022 May;62(1):387-405. doi: 10.1111/famp.12788.

5. Cox JL et al. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

6. Keitner GI et al. The Brief Multidimensional Assessment Scale (BMAS): A broad measure of patient well-being. Am J Psychother. 2023 Feb 1;76(2):75-81. doi: 10.1176/appi.psychotherapy.20220032.

7. Boterhoven de Haan KL et al. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113.

8. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

9. Battle CL, Howard MM. A mother-baby psychiatric day hospital: History, rationale, and why perinatal mental health is important for obstetric medicine. Obstet Med. 2014 Jun;7(2):66-70. doi: 10.1177/1753495X13514402.

10. Kim HG et al. Keeping Parent, Child, and Relationship in Mind: Clinical Effectiveness of a Trauma-informed, Multigenerational, Attachment-Based, Mother-Baby Partial Hospital Program in an Urban Safety Net Hospital. Matern Child Health J. 2021 Nov;25(11):1776-86. doi: 10.1007/s10995-021-03221-4.

11. Moureau A et al. A 5 years’ experience of a parent-baby day unit: impact on baby’s development. Front Psychiatry. 2023 June 15;14. doi: 10.3389/fpsyt.2023.1121894.

Perinatal depression (PND) is the most common obstetric complication in the United States. Even when screening results are positive, mothers often do not receive further evaluation, and even when PND is diagnosed, mothers do not receive evidence-based treatments. PND has potential long-term adverse health complications for the mother, her partner, the infant, and the mother-infant dyad.

Courtesy Dr. Alison M. Heru

Meta-analytic estimates show that pregnant women suffer from PND at rates from 6.5% to 12.9% across pregnancy to 3-months post partum.¹ Women from low-income families and adolescent mothers are at highest risk, where rates are double and triple respectively.

Fathers also suffer from PND, with a prevalence rate from 2% to 25%, increasing to 50% when the mother experiences PND.

The American Academy of Pediatrics issued a Policy Statement (January 2019) about the need to recognize and manage PND. They recommended that pediatric medical homes establish a system to implement the screening of mothers at the 1-, 2-, 4-, and 6-month well-child visits, to use community resources for the treatment and referral of the mother with depression, and to provide support for the maternal-child relationship.²

The American Academy of Pediatrics also recommends advocacy for workforce development for mental health professionals who care for young children and mother-infant dyads, and for promotion of evidence-based interventions focused on healthy attachment and parent-child relationships.
 

Family research

There is a bidirectional association between family relational stress and PND. Lack of family support is both a predictor and a consequence of perinatal depression. Frequent arguments, conflict because one or both partners did not want the pregnancy, division of labor, poor support following stressful life events, lack of partner availability, and low intimacy are associated with increased perinatal depressive symptoms.

Gender role stress is also included as a risk factor. For example, men may fear performance failure related to work and sex, and women may fear disruption in the couple relationship due to the introduction of a child.

When depressed and nondepressed women at 2 months post delivery were compared, the women with depressive symptoms perceived that their partners did not share similar interests, provided little companionship, expressed disinterest in infant care, did not provide a feeling of connection, did not encourage them to get assistance to cope with difficulties, and expressed disagreement in infant care.³

A high-quality intimate relationship is protective for many illnesses and PND is no exception.⁴

Assessment

Despite the availability of effective treatments, perinatal mental health utilization rates are strikingly low. There are limited providers and a general lack of awareness of the need for this care. The stigma for assessing and treating PND is high because the perception is that pregnancy is supposed to be a joyous time and with time, PND will pass.

The first step is a timely and accurate assessment of the mother, which should, if possible, include the father and other family support people. The preferred standard for women is the Edinburgh Postnatal Depression Scale (EPDS), a checklist of 10 items (listed below) with a maximum score of 30, and any score over 10 warrants further assessment.⁵ This scale is used worldwide in obstetric clinics and has been used to identify PND in fathers.

• I have been able to laugh and see the funny side of things.
• I have looked forward with enjoyment to things.
• I have blamed myself unnecessarily when things went wrong.
• I have been anxious or worried for no good reason.
• I have felt scared or panicky for no good reason.
• Things have been getting to me.
• I have been so unhappy that I have had difficulty sleeping.
• I have felt sad or miserable.
• I have been so unhappy that I have been crying.
• The thought of harming myself has occurred to me.

A new ultrabrief tool with only four questions is the Brief Multidimensional Assessment Scale (BMAS), which measures the ability to get things done, emotional support in important relationships, quality of life, and sense of purpose in life. It demonstrates concurrent validity with other measures and discriminates between nonclinical participants and participants from most clinical contexts.⁶

For those interested in assessing family health, an easy-to-use assessment tool is the 12-item Family Assessment Device (FAD).⁷

Family therapy interventions

A systematic review and meta-analysis of the current evidence on the usefulness of family therapy interventions in the prevention and treatment of PND identified seven studies.

In these studies, there were statistically significant reductions in depressive symptoms at postintervention in intervention group mothers. Intervention intensity and level of family involvement moderated the impacts of intervention on maternal depression, and there was a trend in improved family functioning in intervention group couples.⁸

Evidence-based interventions are usually psychoeducational or cognitive-behavioral family therapy models where focused interventions target the following three areas:

• Communication skills related to expectations (including those that pertain to gender roles and the transition to parenthood) and emotional support.
• Conflict management.
• Problem-solving skills related to shared responsibility in infant care and household activities.

Intensive day program for mothers and babies

There is a growing awareness of the effectiveness of specialized mother-baby day hospital programs for women with psychiatric distress during the peripartum period.⁹

The Women & Infants’ Hospital (WIH) in Providence, R.I., established a mother-baby postpartum depression day program in 2000, adjacent to the obstetrical hospital, the ninth largest obstetrical service in the United States. The day program is integrated with the hospital’s obstetric medicine team and referrals are also accepted from the perinatal practices in the surrounding community. The treatment day includes group, individual, and milieu treatment, as well as consultation with psychiatrists, nutritionists, social workers, lactation specialists and others.

The primary theoretical model utilized by the program is interpersonal psychotherapy (IPT), with essential elements of the program incorporating cognitive behavioral therapy (CBT), and experiential strategies (for instance, mindfulness, breathing, progressive muscle relaxation) to improve self-care and relaxation skills. Patient satisfaction surveys collected from 800 women, (54% identified as White) treated at the program between 2007 and 2012 found that women were highly satisfied with the treatment received, noting that the inclusion of the baby in their treatment is a highly valued aspect of care.

A similar program in Minnesota reported that 328 women who consented to participation in research had significant improvements (P < .001) in self-report scales assessing depression, anxiety, and maternal functioning, improving mental health and parenting functioning.¹⁰

Lastly, a recent study out of Brussels, on the benefit of a mother-baby day program analyzed patient data from 2015 and 2020. This clinical population of 92 patients (43% identifying as North African) was comparable to the population of the inpatient mother-baby units in terms of psychosocial fragility except that the parents entering the day program had less severe illnesses, more anxiety disorder, and less postpartum psychosis. In the day program, all the babies improved in terms of symptoms and relationships, except for those with significant developmental difficulties.

The dyadic relationship was measured using “levels of adaptation of the parent–child relationship” scale which has four general levels of adjustment, from well-adjusted to troubled or dangerous relationship. Unlike programs in the United States, this program takes children up to 2.5 years old and the assessment period is up to 8 weeks.¹¹

Prevention of mental illness is best achieved by reducing the known determinants of illness. For PND, the research is clear, so why not start at the earliest possible stage, when we know that change is possible? Pushing health care systems to change is not easy, but as the research accumulates and the positive results grow, our arguments become stronger.

Dr. Heru is a psychiatrist in Aurora, Colo. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].

References

1. Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.

2. Rafferty J et al. Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics. 2019 Jan;143(1):e20183260. doi: 10.1542/peds.2018-3260.

3. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

4. Kumar SA et al. Promoting resilience to depression among couples during pregnancy: The protective functions of intimate relationship satisfaction and self-compassion. Family Process. 2022 May;62(1):387-405. doi: 10.1111/famp.12788.

5. Cox JL et al. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

6. Keitner GI et al. The Brief Multidimensional Assessment Scale (BMAS): A broad measure of patient well-being. Am J Psychother. 2023 Feb 1;76(2):75-81. doi: 10.1176/appi.psychotherapy.20220032.

7. Boterhoven de Haan KL et al. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113.

8. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

9. Battle CL, Howard MM. A mother-baby psychiatric day hospital: History, rationale, and why perinatal mental health is important for obstetric medicine. Obstet Med. 2014 Jun;7(2):66-70. doi: 10.1177/1753495X13514402.

10. Kim HG et al. Keeping Parent, Child, and Relationship in Mind: Clinical Effectiveness of a Trauma-informed, Multigenerational, Attachment-Based, Mother-Baby Partial Hospital Program in an Urban Safety Net Hospital. Matern Child Health J. 2021 Nov;25(11):1776-86. doi: 10.1007/s10995-021-03221-4.

11. Moureau A et al. A 5 years’ experience of a parent-baby day unit: impact on baby’s development. Front Psychiatry. 2023 June 15;14. doi: 10.3389/fpsyt.2023.1121894.

The results of a recent study in JAMA Oncology suggest that even short periods of intense, intermittent physical activity are associated with a lower risk for cancer. This activity could be a promising measure for cancer prevention in people who otherwise find it difficult to exercise regularly.

Periods of intense, intermittent physical activity are short phases of strenuous physical exercise that normally last for 1 or 2 minutes, such as a short sprint for the bus or walking up the stairs. In the prospective cohort study conducted in a large group of unathletic adults, researchers investigated a potential dose-effect relationship between intense and daily intermittent physical activity and the cancer incidence rate.

Using data gathered from wearable arm trackers, the researchers analyzed the physical activity of 22,398 people with an average age of 62 years from the UK Biobank. Of these participants, 54.8% were women. After a median follow-up of 6.7 years, corresponding to 149,650 person-years, they determined the general cancer incidence rate in this cohort and the incidence rate of 13 kinds of cancer associated with minimal physical activity (physical-activity related cancers).

Over the study period, 2,356 cancer events occurred, of which 1,084 could be attributed to kinds of cancer associated with minimal physical activity. Nearly all of the intense physical activity (92.3%) was achieved in bursts of up to 1 minute.
 

Four minutes

The daily duration of activity was almost linearly associated with the outcome, wrote Emmanuel Stamatakis, PhD, professor of physical activity, lifestyle, and population health at the University of Sydney. “The dose-effect curve was more vertical, and the extent of the risk reduction for kinds of cancer associated with minimal activity was larger than for the overall cancer incidence rate.”

For example, the lowest dose of intense, intermittent physical activity of up to 1 minute was generally 3.4 minutes per day for cancer in general and 3.7 minutes per day for cancer associated with minimal activity (hazard ratio, 0.83 and 0.72, respectively).

“The results of the study with an average follow-up time of almost 7 years suggest that people with a little less than 4 minutes per day of sporadic intense activity had an overall 17% lower risk of cancer,” wrote Yvonne Wengström, PhD, professor of nursing at Karolinska Institutet in Stockholm, in an accompanying editorial.

For kinds of cancer possibly associated with minimal activity, the researchers found the risk to be reduced by 28% through daily intermittent physical activity. “Even a few minutes of short, intense physical exercise in people with less leisure activity could lower their cancer risk,” wrote Dr. Wengström and colleagues.

Only at the end of 2022 did the data from Dr. Stamatakis and his colleagues suggest a correlation between a little more than 4 minutes of intense physical activity per day and a lower risk for cardiovascular diseases, cancer, and overall mortality in athletes and nonathletes.
 

Wearable arm trackers

The authors of the recent study used an existing cohort’s activity data from an earlier substudy of the UK Biobank that measured acceleration in the wrist. The movement behavior here was recorded over a period of 7 days in more than 90,000 people between 2013 and 2015.

Dr. Wengström and her colleagues rated the arm trackers to be more reliable than the questionnaires that were completed by the subjects. “One strength of the present study is that physical activity was evaluated with the help of wrist acceleration meters, even though nonathletes were defined using the questionnaire data.”

Information about the general lifestyle of healthy living people also had to be included. Dr. Wengström believes that the researchers succeeded in this, because they adjusted the analyses for the following important factors:

• Age.
• Sex.
• Body mass index.
• Level of education.
• Smoking status.
• Alcohol consumption.
• Duration of sleep.
• Fruit and vegetable consumption.
• Medication intake.
• Parental cancer history.

Clinical implications

According to Dr. Wengström, more studies are required to see whether the results of this study can also be transferred to patients who already have a cancer disease. This is because patients with cancer such as premenopausal and postmenopausal women with breast cancer diseases, who have different biologies and hormonal environments, are affected differently by physical activity.

However, physical activity does play a role in patients with cancer “since physical fitness improves muscle strength, cancer-related fatigue, and the survivors’ quality of life,” said Dr. Wengström. However, it is still important to find the correct amount of physical activity for each group of patients and for each patient. Nevertheless, “any physical activity is better than none,” wrote Dr. Wengström and her colleagues.

This article was translated from Medscape’s German edition. A version of this article appeared on Medscape.com.

The results of a recent study in JAMA Oncology suggest that even short periods of intense, intermittent physical activity are associated with a lower risk for cancer. This activity could be a promising measure for cancer prevention in people who otherwise find it difficult to exercise regularly.

Periods of intense, intermittent physical activity are short phases of strenuous physical exercise that normally last for 1 or 2 minutes, such as a short sprint for the bus or walking up the stairs. In the prospective cohort study conducted in a large group of unathletic adults, researchers investigated a potential dose-effect relationship between intense and daily intermittent physical activity and the cancer incidence rate.

Using data gathered from wearable arm trackers, the researchers analyzed the physical activity of 22,398 people with an average age of 62 years from the UK Biobank. Of these participants, 54.8% were women. After a median follow-up of 6.7 years, corresponding to 149,650 person-years, they determined the general cancer incidence rate in this cohort and the incidence rate of 13 kinds of cancer associated with minimal physical activity (physical-activity related cancers).

Over the study period, 2,356 cancer events occurred, of which 1,084 could be attributed to kinds of cancer associated with minimal physical activity. Nearly all of the intense physical activity (92.3%) was achieved in bursts of up to 1 minute.
 

Four minutes

The daily duration of activity was almost linearly associated with the outcome, wrote Emmanuel Stamatakis, PhD, professor of physical activity, lifestyle, and population health at the University of Sydney. “The dose-effect curve was more vertical, and the extent of the risk reduction for kinds of cancer associated with minimal activity was larger than for the overall cancer incidence rate.”

For example, the lowest dose of intense, intermittent physical activity of up to 1 minute was generally 3.4 minutes per day for cancer in general and 3.7 minutes per day for cancer associated with minimal activity (hazard ratio, 0.83 and 0.72, respectively).

“The results of the study with an average follow-up time of almost 7 years suggest that people with a little less than 4 minutes per day of sporadic intense activity had an overall 17% lower risk of cancer,” wrote Yvonne Wengström, PhD, professor of nursing at Karolinska Institutet in Stockholm, in an accompanying editorial.

For kinds of cancer possibly associated with minimal activity, the researchers found the risk to be reduced by 28% through daily intermittent physical activity. “Even a few minutes of short, intense physical exercise in people with less leisure activity could lower their cancer risk,” wrote Dr. Wengström and colleagues.

Only at the end of 2022 did the data from Dr. Stamatakis and his colleagues suggest a correlation between a little more than 4 minutes of intense physical activity per day and a lower risk for cardiovascular diseases, cancer, and overall mortality in athletes and nonathletes.
 

Wearable arm trackers

The authors of the recent study used an existing cohort’s activity data from an earlier substudy of the UK Biobank that measured acceleration in the wrist. The movement behavior here was recorded over a period of 7 days in more than 90,000 people between 2013 and 2015.

Dr. Wengström and her colleagues rated the arm trackers to be more reliable than the questionnaires that were completed by the subjects. “One strength of the present study is that physical activity was evaluated with the help of wrist acceleration meters, even though nonathletes were defined using the questionnaire data.”

Information about the general lifestyle of healthy living people also had to be included. Dr. Wengström believes that the researchers succeeded in this, because they adjusted the analyses for the following important factors:

• Age.
• Sex.
• Body mass index.
• Level of education.
• Smoking status.
• Alcohol consumption.
• Duration of sleep.
• Fruit and vegetable consumption.
• Medication intake.
• Parental cancer history.

Clinical implications

According to Dr. Wengström, more studies are required to see whether the results of this study can also be transferred to patients who already have a cancer disease. This is because patients with cancer such as premenopausal and postmenopausal women with breast cancer diseases, who have different biologies and hormonal environments, are affected differently by physical activity.

However, physical activity does play a role in patients with cancer “since physical fitness improves muscle strength, cancer-related fatigue, and the survivors’ quality of life,” said Dr. Wengström. However, it is still important to find the correct amount of physical activity for each group of patients and for each patient. Nevertheless, “any physical activity is better than none,” wrote Dr. Wengström and her colleagues.

This article was translated from Medscape’s German edition. A version of this article appeared on Medscape.com.

The results of a recent study in JAMA Oncology suggest that even short periods of intense, intermittent physical activity are associated with a lower risk for cancer. This activity could be a promising measure for cancer prevention in people who otherwise find it difficult to exercise regularly.

Periods of intense, intermittent physical activity are short phases of strenuous physical exercise that normally last for 1 or 2 minutes, such as a short sprint for the bus or walking up the stairs. In the prospective cohort study conducted in a large group of unathletic adults, researchers investigated a potential dose-effect relationship between intense and daily intermittent physical activity and the cancer incidence rate.

Using data gathered from wearable arm trackers, the researchers analyzed the physical activity of 22,398 people with an average age of 62 years from the UK Biobank. Of these participants, 54.8% were women. After a median follow-up of 6.7 years, corresponding to 149,650 person-years, they determined the general cancer incidence rate in this cohort and the incidence rate of 13 kinds of cancer associated with minimal physical activity (physical-activity related cancers).

Over the study period, 2,356 cancer events occurred, of which 1,084 could be attributed to kinds of cancer associated with minimal physical activity. Nearly all of the intense physical activity (92.3%) was achieved in bursts of up to 1 minute.
 

Four minutes

The daily duration of activity was almost linearly associated with the outcome, wrote Emmanuel Stamatakis, PhD, professor of physical activity, lifestyle, and population health at the University of Sydney. “The dose-effect curve was more vertical, and the extent of the risk reduction for kinds of cancer associated with minimal activity was larger than for the overall cancer incidence rate.”

For example, the lowest dose of intense, intermittent physical activity of up to 1 minute was generally 3.4 minutes per day for cancer in general and 3.7 minutes per day for cancer associated with minimal activity (hazard ratio, 0.83 and 0.72, respectively).

“The results of the study with an average follow-up time of almost 7 years suggest that people with a little less than 4 minutes per day of sporadic intense activity had an overall 17% lower risk of cancer,” wrote Yvonne Wengström, PhD, professor of nursing at Karolinska Institutet in Stockholm, in an accompanying editorial.

For kinds of cancer possibly associated with minimal activity, the researchers found the risk to be reduced by 28% through daily intermittent physical activity. “Even a few minutes of short, intense physical exercise in people with less leisure activity could lower their cancer risk,” wrote Dr. Wengström and colleagues.

Only at the end of 2022 did the data from Dr. Stamatakis and his colleagues suggest a correlation between a little more than 4 minutes of intense physical activity per day and a lower risk for cardiovascular diseases, cancer, and overall mortality in athletes and nonathletes.
 

Wearable arm trackers

The authors of the recent study used an existing cohort’s activity data from an earlier substudy of the UK Biobank that measured acceleration in the wrist. The movement behavior here was recorded over a period of 7 days in more than 90,000 people between 2013 and 2015.

Dr. Wengström and her colleagues rated the arm trackers to be more reliable than the questionnaires that were completed by the subjects. “One strength of the present study is that physical activity was evaluated with the help of wrist acceleration meters, even though nonathletes were defined using the questionnaire data.”

Information about the general lifestyle of healthy living people also had to be included. Dr. Wengström believes that the researchers succeeded in this, because they adjusted the analyses for the following important factors:

• Age.
• Sex.
• Body mass index.
• Level of education.
• Smoking status.
• Alcohol consumption.
• Duration of sleep.
• Fruit and vegetable consumption.
• Medication intake.
• Parental cancer history.

Clinical implications

According to Dr. Wengström, more studies are required to see whether the results of this study can also be transferred to patients who already have a cancer disease. This is because patients with cancer such as premenopausal and postmenopausal women with breast cancer diseases, who have different biologies and hormonal environments, are affected differently by physical activity.

However, physical activity does play a role in patients with cancer “since physical fitness improves muscle strength, cancer-related fatigue, and the survivors’ quality of life,” said Dr. Wengström. However, it is still important to find the correct amount of physical activity for each group of patients and for each patient. Nevertheless, “any physical activity is better than none,” wrote Dr. Wengström and her colleagues.

This article was translated from Medscape’s German edition. A version of this article appeared on Medscape.com.

If you’re looking to grow hair, you might just have a solution in your kitchen cabinet – if TikTok and some dermatologists are correct.

A small study published in 2015 suggested that rosemary oil may help regrow hair in people with androgenetic alopecia. The herb might also protect hair from the sun, pollution, and other environmental elements, according to an article in Insider.

The study published in Skinmed found that rosemary oil was similar to the effectiveness of minoxidil for regrowing hair in men with androgenetic alopecia. The scalp was also less itchy after 3-6 months of use.

The study included only men.

Still, dermatologist Shilpi Khetarpal, MD, told the Cleveland Clinic that it seems to work.

“The study really prompted people to look at rosemary oil for hair growth,” she said. “It became much more common in over-the-counter products after that, too.”

The Cleveland Clinic also reports that rosemary oil might help against dandruff and premature graying.

Dr. Khetarpal suggested massaging rosemary oil into the scalp, letting it soak overnight, and then washing it out. This should be done two or three times a week. 

She also noted that only a few drops of rosemary oil are needed, and that the focus should be on the scalp rather than the hair, which rosemary oil makes look greasy.

It may take 6 months for “meaningful improvement,” Dr. Khetarpal said.

Meanwhile, TikTok users love hyping the oil’s hair care qualities. On the social media platform, videos with the hashtag #rosemaryoil have been viewed more than 2 billion times.
 

A version of this article appeared on WebMD.com.

If you’re looking to grow hair, you might just have a solution in your kitchen cabinet – if TikTok and some dermatologists are correct.

A small study published in 2015 suggested that rosemary oil may help regrow hair in people with androgenetic alopecia. The herb might also protect hair from the sun, pollution, and other environmental elements, according to an article in Insider.

The study published in Skinmed found that rosemary oil was similar to the effectiveness of minoxidil for regrowing hair in men with androgenetic alopecia. The scalp was also less itchy after 3-6 months of use.

The study included only men.

Still, dermatologist Shilpi Khetarpal, MD, told the Cleveland Clinic that it seems to work.

“The study really prompted people to look at rosemary oil for hair growth,” she said. “It became much more common in over-the-counter products after that, too.”

The Cleveland Clinic also reports that rosemary oil might help against dandruff and premature graying.

Dr. Khetarpal suggested massaging rosemary oil into the scalp, letting it soak overnight, and then washing it out. This should be done two or three times a week. 

She also noted that only a few drops of rosemary oil are needed, and that the focus should be on the scalp rather than the hair, which rosemary oil makes look greasy.

It may take 6 months for “meaningful improvement,” Dr. Khetarpal said.

Meanwhile, TikTok users love hyping the oil’s hair care qualities. On the social media platform, videos with the hashtag #rosemaryoil have been viewed more than 2 billion times.
 

A version of this article appeared on WebMD.com.

If you’re looking to grow hair, you might just have a solution in your kitchen cabinet – if TikTok and some dermatologists are correct.

A small study published in 2015 suggested that rosemary oil may help regrow hair in people with androgenetic alopecia. The herb might also protect hair from the sun, pollution, and other environmental elements, according to an article in Insider.

The study published in Skinmed found that rosemary oil was similar to the effectiveness of minoxidil for regrowing hair in men with androgenetic alopecia. The scalp was also less itchy after 3-6 months of use.

The study included only men.

Still, dermatologist Shilpi Khetarpal, MD, told the Cleveland Clinic that it seems to work.

“The study really prompted people to look at rosemary oil for hair growth,” she said. “It became much more common in over-the-counter products after that, too.”

The Cleveland Clinic also reports that rosemary oil might help against dandruff and premature graying.

Dr. Khetarpal suggested massaging rosemary oil into the scalp, letting it soak overnight, and then washing it out. This should be done two or three times a week. 

She also noted that only a few drops of rosemary oil are needed, and that the focus should be on the scalp rather than the hair, which rosemary oil makes look greasy.

It may take 6 months for “meaningful improvement,” Dr. Khetarpal said.

Meanwhile, TikTok users love hyping the oil’s hair care qualities. On the social media platform, videos with the hashtag #rosemaryoil have been viewed more than 2 billion times.
 

A version of this article appeared on WebMD.com.

Nonradiographic axial spondyloarthritis (nr-axSpA) is a chronic, immune-mediated, inflammatory disease characterized by active inflammation of the spine and the sacroiliac joints. There is no cure for nr-axSpA, although tumor necrosis factor inhibitors (TNFi) have been established as the recommended standard treatment. Nevertheless, a considerable portion of patients either have an inadequate response to TNFi or are intolerant of the side effects of these agents. 

Dr Eric Ruderman, of Northwestern University Feinberg School of Medicine, Chicago, Illinois, discusses treatment goals for patients with active nr-axSpA, which include symptom control, preservation of function, and suppression of symptoms that interfere with daily activities. He also highlights treatment options for patients who have an inadequate response to or are intolerant of TNFi therapy. These therapies include interleukin-17 inhibitors (IL-17i), ixekizumab and secukinumab, and the Janus kinase inhibitor (JAKi) upadacitinib. 

IL-17i therapy carries a lower risk for infection compared with TNFi but is contraindicated in patients with irritable bowel disease. Dr Ruderman also notes that IL-17i are administered by subcutaneous injection while JAKi are taken orally, and these factors may influence patient preference.

--

Eric M. Ruderman, MD, Professor, Department of Medicine, Division of Rheumatology, Northwestern University Feinberg School of Medicine; Associate Chief, Clinical Affairs, Department of Rheumatology, Northwestern Medical Group, Chicago, Illinois 

Eric M. Ruderman, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Aurinia; Bristol Myers Squibb; Exagen; Janssen; Lilly; Novartis; Selecta 

Nonradiographic axial spondyloarthritis (nr-axSpA) is a chronic, immune-mediated, inflammatory disease characterized by active inflammation of the spine and the sacroiliac joints. There is no cure for nr-axSpA, although tumor necrosis factor inhibitors (TNFi) have been established as the recommended standard treatment. Nevertheless, a considerable portion of patients either have an inadequate response to TNFi or are intolerant of the side effects of these agents. 

Dr Eric Ruderman, of Northwestern University Feinberg School of Medicine, Chicago, Illinois, discusses treatment goals for patients with active nr-axSpA, which include symptom control, preservation of function, and suppression of symptoms that interfere with daily activities. He also highlights treatment options for patients who have an inadequate response to or are intolerant of TNFi therapy. These therapies include interleukin-17 inhibitors (IL-17i), ixekizumab and secukinumab, and the Janus kinase inhibitor (JAKi) upadacitinib. 

IL-17i therapy carries a lower risk for infection compared with TNFi but is contraindicated in patients with irritable bowel disease. Dr Ruderman also notes that IL-17i are administered by subcutaneous injection while JAKi are taken orally, and these factors may influence patient preference.

--

Eric M. Ruderman, MD, Professor, Department of Medicine, Division of Rheumatology, Northwestern University Feinberg School of Medicine; Associate Chief, Clinical Affairs, Department of Rheumatology, Northwestern Medical Group, Chicago, Illinois 

Eric M. Ruderman, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Aurinia; Bristol Myers Squibb; Exagen; Janssen; Lilly; Novartis; Selecta 

Nonradiographic axial spondyloarthritis (nr-axSpA) is a chronic, immune-mediated, inflammatory disease characterized by active inflammation of the spine and the sacroiliac joints. There is no cure for nr-axSpA, although tumor necrosis factor inhibitors (TNFi) have been established as the recommended standard treatment. Nevertheless, a considerable portion of patients either have an inadequate response to TNFi or are intolerant of the side effects of these agents. 

Dr Eric Ruderman, of Northwestern University Feinberg School of Medicine, Chicago, Illinois, discusses treatment goals for patients with active nr-axSpA, which include symptom control, preservation of function, and suppression of symptoms that interfere with daily activities. He also highlights treatment options for patients who have an inadequate response to or are intolerant of TNFi therapy. These therapies include interleukin-17 inhibitors (IL-17i), ixekizumab and secukinumab, and the Janus kinase inhibitor (JAKi) upadacitinib. 

IL-17i therapy carries a lower risk for infection compared with TNFi but is contraindicated in patients with irritable bowel disease. Dr Ruderman also notes that IL-17i are administered by subcutaneous injection while JAKi are taken orally, and these factors may influence patient preference.

--

Eric M. Ruderman, MD, Professor, Department of Medicine, Division of Rheumatology, Northwestern University Feinberg School of Medicine; Associate Chief, Clinical Affairs, Department of Rheumatology, Northwestern Medical Group, Chicago, Illinois 

Eric M. Ruderman, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Aurinia; Bristol Myers Squibb; Exagen; Janssen; Lilly; Novartis; Selecta 

When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.

“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.

Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.

He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”

The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.

Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.

More than half of the respondents not using AI said they first want more evidence that the technology works as intended.

“None of them work as advertised,” said one respondent.

MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.

Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.

Doctors may also be skeptical of AI based on their experience with EHRs, she said.

“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
 

Drawing the line at patient care

Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.

“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.

Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:

• Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
• Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
• Improving billing operations and predictive analytics.

Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.

They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
 

Is regulation needed?

Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.

“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.

In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.

Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.

In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.

There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
 

What should doctors do?

Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.

There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.

“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.

Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
 

A version of this article appeared on Medscape.com.

When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.

“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.

Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.

He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”

The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.

Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.

More than half of the respondents not using AI said they first want more evidence that the technology works as intended.

“None of them work as advertised,” said one respondent.

MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.

Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.

Doctors may also be skeptical of AI based on their experience with EHRs, she said.

“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
 

Drawing the line at patient care

Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.

“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.

Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:

• Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
• Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
• Improving billing operations and predictive analytics.

Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.

They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
 

Is regulation needed?

Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.

“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.

In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.

Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.

In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.

There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
 

What should doctors do?

Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.

There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.

“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.

Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
 

A version of this article appeared on Medscape.com.

When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.

“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.

Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.

He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”

The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.

Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.

More than half of the respondents not using AI said they first want more evidence that the technology works as intended.

“None of them work as advertised,” said one respondent.

MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.

Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.

Doctors may also be skeptical of AI based on their experience with EHRs, she said.

“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
 

Drawing the line at patient care

Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.

“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.

Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:

• Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
• Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
• Improving billing operations and predictive analytics.

Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.

They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
 

Is regulation needed?

Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.

“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.

In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.

Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.

In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.

There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
 

What should doctors do?

Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.

There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.

“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.

Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
 

A version of this article appeared on Medscape.com.