Updated Clinical Guidelines for the Treatment of Acne Vulgaris

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In January 2024, the American Academy of Dermatology released updated clinical guidelines for the treatment of acne. These guidelines include 18 evidence-based recommendations.

As primary care physicians, we commonly encounter acne vulgaris in our practices. While it may not be a life-threatening condition, it deeply affects the quality of life for many who suffer from it. It can be accompanied by stigmatization and bullying and can affect a person’s self-esteem; it can lead to suicidal ideation. It is important to treat it and know when to refer to a dermatologist.

Dr. Linda Girgis

According to the AAD, acne is the most common skin condition, affecting 50 million Americans annually. It can occur at any stage in life, often starting during puberty. It is so common that at least 85% of people between the ages of 12 and 24 experience at least mild acne.

The guidelines stress using multimodal therapies combining multiple mechanisms of action. For example, they show strong evidence for using topical retinoids with topical benzoyl peroxide or topical retinoids with topical antibiotics. They recommend against using oral antibiotics, except in severe cases, to prevent antibiotic resistance. The strongest evidence regarding antibiotics shows doxycycline or minocycline to be the most effective for treating acne and these can be combined with topical medications.

These guidelines also include isotretinoin to be used for severe acne patients, who are defined as “patients with psychosocial burden or scarring.” They recommend monitoring liver function and lipids as good practice and mandatory pregnancy prevention. These guidelines find no conclusive evidence for physical modalities such as lesion extraction, chemical peels, use of laser and light-based devices, microneedling, use of radiofrequency devices, and photodynamic therapy.

A conditional recommendation is given for the use of combined oral contraception pills and spironolactone. The AAD advises considering the risks of these agents along with other conditions present that they may be useful for.

In primary care, we see many complicated patients and often acne is not considered a serious condition. However, it can be as life-altering to the patient as other chronic diseases such as rheumatoid arthritis. We need to know the appropriate management of acne and start following the evidence-based guidelines. Acne needs follow-up as close as for other chronic diseases. We need to be able to assess the severity of disease and the effectiveness of treatments we have prescribed.

Some patients may be embarrassed to start the discussion about acne. If the patient doesn’t initiate the discussion, we should in an empathetic way. Acne is one of those diseases that doesn’t need any diagnostic tests to discover as it is readily apparent right in front of us.

Some patients may not be bothered by it, but for others, it may be ruining their lives, and they just don’t feel comfortable starting the conversation. Offering them a treatment will alleviate their disease but may also change their lives for the better.

Acne is also one of those conditions that has a host of misinformation and myths surrounding it. These myths range from dietary recommendations to hygiene and many others. As physicians, we need to educate ourselves about these myths and misconceptions. Patients will have questions regarding them and we need to be able to give them answers to their questions. We also shouldn’t give out misinformation ourselves. The evidence around acne treatment is readily available.

Given the availability of multiple acne therapies, shared-decision making is important. We need to discuss options with the patients and devise the best treatment regimen for them. If our therapies are not getting the results we would like, we need to consider referring the patient to a dermatologist.

We need to remember that acne is not just a cosmetic disease. It affects the lives of those suffering from it and we need to address it like any other chronic disease.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

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In January 2024, the American Academy of Dermatology released updated clinical guidelines for the treatment of acne. These guidelines include 18 evidence-based recommendations.

As primary care physicians, we commonly encounter acne vulgaris in our practices. While it may not be a life-threatening condition, it deeply affects the quality of life for many who suffer from it. It can be accompanied by stigmatization and bullying and can affect a person’s self-esteem; it can lead to suicidal ideation. It is important to treat it and know when to refer to a dermatologist.

Dr. Linda Girgis

According to the AAD, acne is the most common skin condition, affecting 50 million Americans annually. It can occur at any stage in life, often starting during puberty. It is so common that at least 85% of people between the ages of 12 and 24 experience at least mild acne.

The guidelines stress using multimodal therapies combining multiple mechanisms of action. For example, they show strong evidence for using topical retinoids with topical benzoyl peroxide or topical retinoids with topical antibiotics. They recommend against using oral antibiotics, except in severe cases, to prevent antibiotic resistance. The strongest evidence regarding antibiotics shows doxycycline or minocycline to be the most effective for treating acne and these can be combined with topical medications.

These guidelines also include isotretinoin to be used for severe acne patients, who are defined as “patients with psychosocial burden or scarring.” They recommend monitoring liver function and lipids as good practice and mandatory pregnancy prevention. These guidelines find no conclusive evidence for physical modalities such as lesion extraction, chemical peels, use of laser and light-based devices, microneedling, use of radiofrequency devices, and photodynamic therapy.

A conditional recommendation is given for the use of combined oral contraception pills and spironolactone. The AAD advises considering the risks of these agents along with other conditions present that they may be useful for.

In primary care, we see many complicated patients and often acne is not considered a serious condition. However, it can be as life-altering to the patient as other chronic diseases such as rheumatoid arthritis. We need to know the appropriate management of acne and start following the evidence-based guidelines. Acne needs follow-up as close as for other chronic diseases. We need to be able to assess the severity of disease and the effectiveness of treatments we have prescribed.

Some patients may be embarrassed to start the discussion about acne. If the patient doesn’t initiate the discussion, we should in an empathetic way. Acne is one of those diseases that doesn’t need any diagnostic tests to discover as it is readily apparent right in front of us.

Some patients may not be bothered by it, but for others, it may be ruining their lives, and they just don’t feel comfortable starting the conversation. Offering them a treatment will alleviate their disease but may also change their lives for the better.

Acne is also one of those conditions that has a host of misinformation and myths surrounding it. These myths range from dietary recommendations to hygiene and many others. As physicians, we need to educate ourselves about these myths and misconceptions. Patients will have questions regarding them and we need to be able to give them answers to their questions. We also shouldn’t give out misinformation ourselves. The evidence around acne treatment is readily available.

Given the availability of multiple acne therapies, shared-decision making is important. We need to discuss options with the patients and devise the best treatment regimen for them. If our therapies are not getting the results we would like, we need to consider referring the patient to a dermatologist.

We need to remember that acne is not just a cosmetic disease. It affects the lives of those suffering from it and we need to address it like any other chronic disease.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

In January 2024, the American Academy of Dermatology released updated clinical guidelines for the treatment of acne. These guidelines include 18 evidence-based recommendations.

As primary care physicians, we commonly encounter acne vulgaris in our practices. While it may not be a life-threatening condition, it deeply affects the quality of life for many who suffer from it. It can be accompanied by stigmatization and bullying and can affect a person’s self-esteem; it can lead to suicidal ideation. It is important to treat it and know when to refer to a dermatologist.

Dr. Linda Girgis

According to the AAD, acne is the most common skin condition, affecting 50 million Americans annually. It can occur at any stage in life, often starting during puberty. It is so common that at least 85% of people between the ages of 12 and 24 experience at least mild acne.

The guidelines stress using multimodal therapies combining multiple mechanisms of action. For example, they show strong evidence for using topical retinoids with topical benzoyl peroxide or topical retinoids with topical antibiotics. They recommend against using oral antibiotics, except in severe cases, to prevent antibiotic resistance. The strongest evidence regarding antibiotics shows doxycycline or minocycline to be the most effective for treating acne and these can be combined with topical medications.

These guidelines also include isotretinoin to be used for severe acne patients, who are defined as “patients with psychosocial burden or scarring.” They recommend monitoring liver function and lipids as good practice and mandatory pregnancy prevention. These guidelines find no conclusive evidence for physical modalities such as lesion extraction, chemical peels, use of laser and light-based devices, microneedling, use of radiofrequency devices, and photodynamic therapy.

A conditional recommendation is given for the use of combined oral contraception pills and spironolactone. The AAD advises considering the risks of these agents along with other conditions present that they may be useful for.

In primary care, we see many complicated patients and often acne is not considered a serious condition. However, it can be as life-altering to the patient as other chronic diseases such as rheumatoid arthritis. We need to know the appropriate management of acne and start following the evidence-based guidelines. Acne needs follow-up as close as for other chronic diseases. We need to be able to assess the severity of disease and the effectiveness of treatments we have prescribed.

Some patients may be embarrassed to start the discussion about acne. If the patient doesn’t initiate the discussion, we should in an empathetic way. Acne is one of those diseases that doesn’t need any diagnostic tests to discover as it is readily apparent right in front of us.

Some patients may not be bothered by it, but for others, it may be ruining their lives, and they just don’t feel comfortable starting the conversation. Offering them a treatment will alleviate their disease but may also change their lives for the better.

Acne is also one of those conditions that has a host of misinformation and myths surrounding it. These myths range from dietary recommendations to hygiene and many others. As physicians, we need to educate ourselves about these myths and misconceptions. Patients will have questions regarding them and we need to be able to give them answers to their questions. We also shouldn’t give out misinformation ourselves. The evidence around acne treatment is readily available.

Given the availability of multiple acne therapies, shared-decision making is important. We need to discuss options with the patients and devise the best treatment regimen for them. If our therapies are not getting the results we would like, we need to consider referring the patient to a dermatologist.

We need to remember that acne is not just a cosmetic disease. It affects the lives of those suffering from it and we need to address it like any other chronic disease.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

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Can Gargling With Mouthwash Help Manage Type 2 Diabetes?

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TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

  • A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
  • Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

  • Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
  • By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
  • Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
  • After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
  • However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
  • Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

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TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

  • A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
  • Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

  • Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
  • By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
  • Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
  • After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
  • However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
  • Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

  • A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
  • Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

  • Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
  • By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
  • Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
  • After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
  • However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
  • Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

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Patients Want the Facts Delivered in a Personal Story

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Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

  • Discover what the patient understands and why
  • Provide accurate information in an understandable manner
  • Promote the credibility of the information
  • Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

  • Affirming the patient’s values
  • Anticipating and addressing false or misleading information
  • Using simple, jargon-free language
  • Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

  • Discover what the patient understands and why
  • Provide accurate information in an understandable manner
  • Promote the credibility of the information
  • Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

  • Affirming the patient’s values
  • Anticipating and addressing false or misleading information
  • Using simple, jargon-free language
  • Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

  • Discover what the patient understands and why
  • Provide accurate information in an understandable manner
  • Promote the credibility of the information
  • Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

  • Affirming the patient’s values
  • Anticipating and addressing false or misleading information
  • Using simple, jargon-free language
  • Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Female Reproductive Factors Could Predict COPD Risk

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TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

  • The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
  • The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
  • The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

  • Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
  • Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
  • COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

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TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

  • The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
  • The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
  • The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

  • Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
  • Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
  • COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

 

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

  • The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
  • The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
  • The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

  • Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
  • Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
  • COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

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Lower Medication Costs Cut Diabetes Complications

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TOPLINE:

A value-based medication plan that lowers out-of-pocket costs for antidiabetic medications reduces health complications in commercially insured individuals with diabetes, especially those living in lower-income areas.

METHODOLOGY: 

  • Researchers assessed the 1-year impact on type 2 diabetes outcomes from a preventive drug list (PDL), which employers can add to plans to reduce out-of-pocket costs (copayments or deductibles) for high-value preventive medications.
  • Using data from a national insurer, they identified 10,588 members with diabetes newly enrolled in PDL plans between January 2004 and June 2017 (age, 12-64 years; 44.8% women; 45.5% from the South; 33.4% from employers with < 100 enrollees).
  • The members with diabetes on a PDL plan for a full follow-up year were matched and weighted against 690,075 control participants whose employers did not offer PDL.
  • In a subgroup analysis, health outcomes for members with diabetes residing in lower-income neighborhoods (53.1%) were evaluated.
  • The primary outcome was acute, preventable diabetes complications, such as bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis, measured as complication days per 1000 members per year.

TAKEAWAY: 

  • Out-of-pocket costs for noninsulin antidiabetic agents and insulin declined by 30.7% and 38.6%, respectively, in the PDL group vs controls. 
  • The 30-day prescription fills for noninsulin and insulin antidiabetic medication increased by 7.1% (95% CI, 5.0%-9.3%) and 5.3% (95% CI, 2.2%-8.4%), respectively, among PDL members and was slightly higher among PDL members residing in low-income areas. 
  • The PDL transition was associated with an 8.4% relative reduction (95% CI, −13.9% to −2.8%) in complication days overall (absolute reduction, −20.2 days per 1000 members per year). 
  • Among members from lower-income areas, PDL transition was associated with a 10.2% relative reduction (95% CI, −17.4% to −3.0%) in complication days (absolute reduction, −26.1 per 1000 members per year) compared with controls. 

IN PRACTICE:

“Targeting out-of-pocket cost reductions to specific populations, in this case patients with diabetes from lower-income areas, might enhance health outcomes,” wrote the authors.

SOURCE: 

The study was conducted by J. Franklin Wharam, MD, MPH, Department of Medicine, Duke University, Durham, North Carolina. It was published online in JAMA Health Forum

LIMITATIONS: 

The findings may be generalized only to patients with diabetes enrolled in commercial health plans. Instead of being randomized, the PDL coverage was chosen by certain employers. Moreover, only outcomes associated with new PDL enrollment over a single year were evaluated.

DISCLOSURES: 

The study was funded by grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases. One of the authors reported receiving postmarket safety study stipends from Pfizer and GlaxoSmithKline outside the submitted work.

A version of this article appeared on Medscape.com.

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TOPLINE:

A value-based medication plan that lowers out-of-pocket costs for antidiabetic medications reduces health complications in commercially insured individuals with diabetes, especially those living in lower-income areas.

METHODOLOGY: 

  • Researchers assessed the 1-year impact on type 2 diabetes outcomes from a preventive drug list (PDL), which employers can add to plans to reduce out-of-pocket costs (copayments or deductibles) for high-value preventive medications.
  • Using data from a national insurer, they identified 10,588 members with diabetes newly enrolled in PDL plans between January 2004 and June 2017 (age, 12-64 years; 44.8% women; 45.5% from the South; 33.4% from employers with < 100 enrollees).
  • The members with diabetes on a PDL plan for a full follow-up year were matched and weighted against 690,075 control participants whose employers did not offer PDL.
  • In a subgroup analysis, health outcomes for members with diabetes residing in lower-income neighborhoods (53.1%) were evaluated.
  • The primary outcome was acute, preventable diabetes complications, such as bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis, measured as complication days per 1000 members per year.

TAKEAWAY: 

  • Out-of-pocket costs for noninsulin antidiabetic agents and insulin declined by 30.7% and 38.6%, respectively, in the PDL group vs controls. 
  • The 30-day prescription fills for noninsulin and insulin antidiabetic medication increased by 7.1% (95% CI, 5.0%-9.3%) and 5.3% (95% CI, 2.2%-8.4%), respectively, among PDL members and was slightly higher among PDL members residing in low-income areas. 
  • The PDL transition was associated with an 8.4% relative reduction (95% CI, −13.9% to −2.8%) in complication days overall (absolute reduction, −20.2 days per 1000 members per year). 
  • Among members from lower-income areas, PDL transition was associated with a 10.2% relative reduction (95% CI, −17.4% to −3.0%) in complication days (absolute reduction, −26.1 per 1000 members per year) compared with controls. 

IN PRACTICE:

“Targeting out-of-pocket cost reductions to specific populations, in this case patients with diabetes from lower-income areas, might enhance health outcomes,” wrote the authors.

SOURCE: 

The study was conducted by J. Franklin Wharam, MD, MPH, Department of Medicine, Duke University, Durham, North Carolina. It was published online in JAMA Health Forum

LIMITATIONS: 

The findings may be generalized only to patients with diabetes enrolled in commercial health plans. Instead of being randomized, the PDL coverage was chosen by certain employers. Moreover, only outcomes associated with new PDL enrollment over a single year were evaluated.

DISCLOSURES: 

The study was funded by grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases. One of the authors reported receiving postmarket safety study stipends from Pfizer and GlaxoSmithKline outside the submitted work.

A version of this article appeared on Medscape.com.

 

TOPLINE:

A value-based medication plan that lowers out-of-pocket costs for antidiabetic medications reduces health complications in commercially insured individuals with diabetes, especially those living in lower-income areas.

METHODOLOGY: 

  • Researchers assessed the 1-year impact on type 2 diabetes outcomes from a preventive drug list (PDL), which employers can add to plans to reduce out-of-pocket costs (copayments or deductibles) for high-value preventive medications.
  • Using data from a national insurer, they identified 10,588 members with diabetes newly enrolled in PDL plans between January 2004 and June 2017 (age, 12-64 years; 44.8% women; 45.5% from the South; 33.4% from employers with < 100 enrollees).
  • The members with diabetes on a PDL plan for a full follow-up year were matched and weighted against 690,075 control participants whose employers did not offer PDL.
  • In a subgroup analysis, health outcomes for members with diabetes residing in lower-income neighborhoods (53.1%) were evaluated.
  • The primary outcome was acute, preventable diabetes complications, such as bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis, measured as complication days per 1000 members per year.

TAKEAWAY: 

  • Out-of-pocket costs for noninsulin antidiabetic agents and insulin declined by 30.7% and 38.6%, respectively, in the PDL group vs controls. 
  • The 30-day prescription fills for noninsulin and insulin antidiabetic medication increased by 7.1% (95% CI, 5.0%-9.3%) and 5.3% (95% CI, 2.2%-8.4%), respectively, among PDL members and was slightly higher among PDL members residing in low-income areas. 
  • The PDL transition was associated with an 8.4% relative reduction (95% CI, −13.9% to −2.8%) in complication days overall (absolute reduction, −20.2 days per 1000 members per year). 
  • Among members from lower-income areas, PDL transition was associated with a 10.2% relative reduction (95% CI, −17.4% to −3.0%) in complication days (absolute reduction, −26.1 per 1000 members per year) compared with controls. 

IN PRACTICE:

“Targeting out-of-pocket cost reductions to specific populations, in this case patients with diabetes from lower-income areas, might enhance health outcomes,” wrote the authors.

SOURCE: 

The study was conducted by J. Franklin Wharam, MD, MPH, Department of Medicine, Duke University, Durham, North Carolina. It was published online in JAMA Health Forum

LIMITATIONS: 

The findings may be generalized only to patients with diabetes enrolled in commercial health plans. Instead of being randomized, the PDL coverage was chosen by certain employers. Moreover, only outcomes associated with new PDL enrollment over a single year were evaluated.

DISCLOSURES: 

The study was funded by grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases. One of the authors reported receiving postmarket safety study stipends from Pfizer and GlaxoSmithKline outside the submitted work.

A version of this article appeared on Medscape.com.

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Unleashing Our Immune Response to Quash Cancer

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This article was originally published on February 10 in Eric Topol’s substack “Ground Truths.”

It’s astounding how devious cancer cells and tumor tissue can be. This week in Science we learned how certain lung cancer cells can function like “Catch Me If You Can” — changing their driver mutation and cell identity to escape targeted therapy. This histologic transformation, as seen in an experimental model, is just one of so many cancer tricks that we are learning about.

Recently, as shown by single-cell sequencing, cancer cells can steal the mitochondria from T cells, a double whammy that turbocharges cancer cells with the hijacked fuel supply and, at the same time, dismantles the immune response.

Last week, we saw how tumor cells can release a virus-like protein that unleashes a vicious autoimmune response.

And then there’s the finding that cancer cell spread predominantly is occurring while we sleep.

As I previously reviewed, the ability for cancer cells to hijack neurons and neural circuits is now well established, no less their ability to reprogram neurons to become adrenergic and stimulate tumor progression, and interfere with the immune response. Stay tuned on that for a new Ground Truths podcast with Prof Michelle Monje, a leader in cancer neuroscience, which will post soon.

Add advancing age’s immunosenescence as yet another challenge to the long and growing list of formidable ways that cancer cells, and the tumor microenvironment, evade our immune response.

An Ever-Expanding Armamentarium

All of this is telling us how we need to ramp up our game if we are going to be able to use our immune system to quash a cancer. Fortunately, we have abundant and ever-growing capabilities for doing just that.

Immune Checkpoint Inhibitors

The field of immunotherapies took off with the immune checkpoint inhibitors, first approved by the FDA in 2011, that take the brakes off of T cells, with the programmed death-1 (PD-1), PD-ligand1, and anti-CTLA-4 monoclonal antibodies.

But we’re clearly learning they are not enough to prevail over cancer with common recurrences, only short term success in most patients, with some notable exceptions. Adding other immune response strategies, such as a vaccine, or antibody-drug conjugates, or engineered T cells, are showing improved chances for success.

Therapeutic Cancer Vaccines

There are many therapeutic cancer vaccines in the works, as reviewed in depth here.

Here’s a list of ongoing clinical trials of cancer vaccines. You’ll note most of these are on top of a checkpoint inhibitor and use personalized neoantigens (cancer cell surface proteins) derived from sequencing (whole-exome or whole genome, RNA-sequencing and HLA-profiling) the patient’s tumor.

An example of positive findings is with the combination of an mRNA-nanoparticle vaccine with up to 34 personalized neoantigens and pembrolizumab (Keytruda) vs pembrolizumab alone in advanced melanoma after resection, with improved outcomes at 3-year follow-up, cutting death or relapse rate in half.

Antibody-Drug Conjugates (ADC)

There is considerable excitement about antibody-drug conjugates (ADC) whereby a linker is used to attach a chemotherapy agent to the checkpoint inhibitor antibody, specifically targeting the cancer cell and facilitating entry of the chemotherapy into the cell. Akin to these are bispecific antibodies (BiTEs, binding to a tumor antigen and T cell receptor simultaneously), both of these conjugates acting as “biologic” or “guided” missiles.

A very good example of the potency of an ADC was seen in a “HER2-low” breast cancer randomized trial. The absence or very low expression or amplification of the HER2 receptor is common in breast cancer and successful treatment has been elusive. A randomized trial of an ADC (trastuzumab deruxtecan) compared to physician’s choice therapy demonstrated a marked success for progression-free survival in HER2-low patients, which was characterized as “unheard-of success” by media coverage.

This strategy is being used to target some of the most difficult cancer driver mutations such as TP53 and KRAS.

Oncolytic Viruses

Modifying viruses to infect the tumor and make it more visible to the immune system, potentiating anti-tumor responses, known as oncolytic viruses, have been proposed as a way to rev up the immune response for a long time but without positive Phase 3 clinical trials.

After decades of failure, a recent trial in refractory bladder cancer showed marked success, along with others, summarized here, now providing very encouraging results. It looks like oncolytic viruses are on a comeback path.

Engineering T Cells (Chimeric Antigen Receptor [CAR-T])

As I recently reviewed, there are over 500 ongoing clinical trials to build on the success of the first CAR-T approval for leukemia 7 years ago. I won’t go through that all again here, but to reiterate most of the success to date has been in “liquid” blood (leukemia and lymphoma) cancer tumors. This week in Nature is the discovery of a T cell cancer mutation, a gene fusion CARD11-PIK3R3, from a T cell lymphoma that can potentially be used to augment CAR-T efficacy. It has pronounced and prolonged effects in the experimental model. Instead of 1 million cells needed for treatment, even 20,000 were enough to melt the tumor. This is a noteworthy discovery since CAR-T work to date has largely not exploited such naturally occurring mutations, while instead concentrating on those seen in the patient’s set of key tumor mutations.

As currently conceived, CAR-T, and what is being referred to more broadly as adoptive cell therapies, involves removing T cells from the patient’s body and engineering their activation, then reintroducing them back to the patient. This is laborious, technically difficult, and very expensive. Recently, the idea of achieving all of this via an injection of virus that specifically infects T cells and inserts the genes needed, was advanced by two biotech companies with preclinical results, one in non-human primates.

Gearing up to meet the challenge of solid tumor CAR-T intervention, there’s more work using CRISPR genome editing of T cell receptorsA.I. is increasingly being exploited to process the data from sequencing and identify optimal neoantigens.

Instead of just CAR-T, we’re seeing the emergence of CAR-macrophage and CAR-natural killer (NK) cells strategies, and rapidly expanding potential combinations of all the strategies I’ve mentioned. No less, there’s been maturation of on-off suicide switches programmed in, to limit cytokine release and promote safety of these interventions. Overall, major side effects of immunotherapies are not only cytokine release syndromes, but also include interstitial pneumonitis and neurotoxicity.

Summary

Given the multitude of ways cancer cells and tumor tissue can evade our immune response, durably successful treatment remains a daunting challenge. But the ingenuity of so many different approaches to unleash our immune response, and their combinations, provides considerable hope that we’ll increasingly meet the challenge in the years ahead. We have clearly learned that combining different immunotherapy strategies will be essential for many patients with the most resilient solid tumors.

Of concern, as noted by a recent editorial in The Lancet, entitled “Cancer Research Equity: Innovations For The Many, Not The Few,” is that these individualized, sophisticated strategies are not scalable; they will have limited reach and benefit. The movement towards “off the shelf” CAR-T and inexpensive, orally active checkpoint inhibitors may help mitigate this issue.

Notwithstanding this important concern, we’re seeing an array of diverse and potent immunotherapy strategies that are providing highly encouraging results, engendering more excitement than we’ve seen in this space for some time. These should propel substantial improvements in outcomes for patients in the years ahead. It can’t happen soon enough.

Thanks for reading this edition of Ground Truths. If you found it informative, please share it with your colleagues.

Dr. Topol has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for Dexcom; Illumina; Molecular Stethoscope; Quest Diagnostics; Blue Cross Blue Shield Association. Received research grant from National Institutes of Health.

A version of this article appeared on Medscape.com.

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This article was originally published on February 10 in Eric Topol’s substack “Ground Truths.”

It’s astounding how devious cancer cells and tumor tissue can be. This week in Science we learned how certain lung cancer cells can function like “Catch Me If You Can” — changing their driver mutation and cell identity to escape targeted therapy. This histologic transformation, as seen in an experimental model, is just one of so many cancer tricks that we are learning about.

Recently, as shown by single-cell sequencing, cancer cells can steal the mitochondria from T cells, a double whammy that turbocharges cancer cells with the hijacked fuel supply and, at the same time, dismantles the immune response.

Last week, we saw how tumor cells can release a virus-like protein that unleashes a vicious autoimmune response.

And then there’s the finding that cancer cell spread predominantly is occurring while we sleep.

As I previously reviewed, the ability for cancer cells to hijack neurons and neural circuits is now well established, no less their ability to reprogram neurons to become adrenergic and stimulate tumor progression, and interfere with the immune response. Stay tuned on that for a new Ground Truths podcast with Prof Michelle Monje, a leader in cancer neuroscience, which will post soon.

Add advancing age’s immunosenescence as yet another challenge to the long and growing list of formidable ways that cancer cells, and the tumor microenvironment, evade our immune response.

An Ever-Expanding Armamentarium

All of this is telling us how we need to ramp up our game if we are going to be able to use our immune system to quash a cancer. Fortunately, we have abundant and ever-growing capabilities for doing just that.

Immune Checkpoint Inhibitors

The field of immunotherapies took off with the immune checkpoint inhibitors, first approved by the FDA in 2011, that take the brakes off of T cells, with the programmed death-1 (PD-1), PD-ligand1, and anti-CTLA-4 monoclonal antibodies.

But we’re clearly learning they are not enough to prevail over cancer with common recurrences, only short term success in most patients, with some notable exceptions. Adding other immune response strategies, such as a vaccine, or antibody-drug conjugates, or engineered T cells, are showing improved chances for success.

Therapeutic Cancer Vaccines

There are many therapeutic cancer vaccines in the works, as reviewed in depth here.

Here’s a list of ongoing clinical trials of cancer vaccines. You’ll note most of these are on top of a checkpoint inhibitor and use personalized neoantigens (cancer cell surface proteins) derived from sequencing (whole-exome or whole genome, RNA-sequencing and HLA-profiling) the patient’s tumor.

An example of positive findings is with the combination of an mRNA-nanoparticle vaccine with up to 34 personalized neoantigens and pembrolizumab (Keytruda) vs pembrolizumab alone in advanced melanoma after resection, with improved outcomes at 3-year follow-up, cutting death or relapse rate in half.

Antibody-Drug Conjugates (ADC)

There is considerable excitement about antibody-drug conjugates (ADC) whereby a linker is used to attach a chemotherapy agent to the checkpoint inhibitor antibody, specifically targeting the cancer cell and facilitating entry of the chemotherapy into the cell. Akin to these are bispecific antibodies (BiTEs, binding to a tumor antigen and T cell receptor simultaneously), both of these conjugates acting as “biologic” or “guided” missiles.

A very good example of the potency of an ADC was seen in a “HER2-low” breast cancer randomized trial. The absence or very low expression or amplification of the HER2 receptor is common in breast cancer and successful treatment has been elusive. A randomized trial of an ADC (trastuzumab deruxtecan) compared to physician’s choice therapy demonstrated a marked success for progression-free survival in HER2-low patients, which was characterized as “unheard-of success” by media coverage.

This strategy is being used to target some of the most difficult cancer driver mutations such as TP53 and KRAS.

Oncolytic Viruses

Modifying viruses to infect the tumor and make it more visible to the immune system, potentiating anti-tumor responses, known as oncolytic viruses, have been proposed as a way to rev up the immune response for a long time but without positive Phase 3 clinical trials.

After decades of failure, a recent trial in refractory bladder cancer showed marked success, along with others, summarized here, now providing very encouraging results. It looks like oncolytic viruses are on a comeback path.

Engineering T Cells (Chimeric Antigen Receptor [CAR-T])

As I recently reviewed, there are over 500 ongoing clinical trials to build on the success of the first CAR-T approval for leukemia 7 years ago. I won’t go through that all again here, but to reiterate most of the success to date has been in “liquid” blood (leukemia and lymphoma) cancer tumors. This week in Nature is the discovery of a T cell cancer mutation, a gene fusion CARD11-PIK3R3, from a T cell lymphoma that can potentially be used to augment CAR-T efficacy. It has pronounced and prolonged effects in the experimental model. Instead of 1 million cells needed for treatment, even 20,000 were enough to melt the tumor. This is a noteworthy discovery since CAR-T work to date has largely not exploited such naturally occurring mutations, while instead concentrating on those seen in the patient’s set of key tumor mutations.

As currently conceived, CAR-T, and what is being referred to more broadly as adoptive cell therapies, involves removing T cells from the patient’s body and engineering their activation, then reintroducing them back to the patient. This is laborious, technically difficult, and very expensive. Recently, the idea of achieving all of this via an injection of virus that specifically infects T cells and inserts the genes needed, was advanced by two biotech companies with preclinical results, one in non-human primates.

Gearing up to meet the challenge of solid tumor CAR-T intervention, there’s more work using CRISPR genome editing of T cell receptorsA.I. is increasingly being exploited to process the data from sequencing and identify optimal neoantigens.

Instead of just CAR-T, we’re seeing the emergence of CAR-macrophage and CAR-natural killer (NK) cells strategies, and rapidly expanding potential combinations of all the strategies I’ve mentioned. No less, there’s been maturation of on-off suicide switches programmed in, to limit cytokine release and promote safety of these interventions. Overall, major side effects of immunotherapies are not only cytokine release syndromes, but also include interstitial pneumonitis and neurotoxicity.

Summary

Given the multitude of ways cancer cells and tumor tissue can evade our immune response, durably successful treatment remains a daunting challenge. But the ingenuity of so many different approaches to unleash our immune response, and their combinations, provides considerable hope that we’ll increasingly meet the challenge in the years ahead. We have clearly learned that combining different immunotherapy strategies will be essential for many patients with the most resilient solid tumors.

Of concern, as noted by a recent editorial in The Lancet, entitled “Cancer Research Equity: Innovations For The Many, Not The Few,” is that these individualized, sophisticated strategies are not scalable; they will have limited reach and benefit. The movement towards “off the shelf” CAR-T and inexpensive, orally active checkpoint inhibitors may help mitigate this issue.

Notwithstanding this important concern, we’re seeing an array of diverse and potent immunotherapy strategies that are providing highly encouraging results, engendering more excitement than we’ve seen in this space for some time. These should propel substantial improvements in outcomes for patients in the years ahead. It can’t happen soon enough.

Thanks for reading this edition of Ground Truths. If you found it informative, please share it with your colleagues.

Dr. Topol has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for Dexcom; Illumina; Molecular Stethoscope; Quest Diagnostics; Blue Cross Blue Shield Association. Received research grant from National Institutes of Health.

A version of this article appeared on Medscape.com.

This article was originally published on February 10 in Eric Topol’s substack “Ground Truths.”

It’s astounding how devious cancer cells and tumor tissue can be. This week in Science we learned how certain lung cancer cells can function like “Catch Me If You Can” — changing their driver mutation and cell identity to escape targeted therapy. This histologic transformation, as seen in an experimental model, is just one of so many cancer tricks that we are learning about.

Recently, as shown by single-cell sequencing, cancer cells can steal the mitochondria from T cells, a double whammy that turbocharges cancer cells with the hijacked fuel supply and, at the same time, dismantles the immune response.

Last week, we saw how tumor cells can release a virus-like protein that unleashes a vicious autoimmune response.

And then there’s the finding that cancer cell spread predominantly is occurring while we sleep.

As I previously reviewed, the ability for cancer cells to hijack neurons and neural circuits is now well established, no less their ability to reprogram neurons to become adrenergic and stimulate tumor progression, and interfere with the immune response. Stay tuned on that for a new Ground Truths podcast with Prof Michelle Monje, a leader in cancer neuroscience, which will post soon.

Add advancing age’s immunosenescence as yet another challenge to the long and growing list of formidable ways that cancer cells, and the tumor microenvironment, evade our immune response.

An Ever-Expanding Armamentarium

All of this is telling us how we need to ramp up our game if we are going to be able to use our immune system to quash a cancer. Fortunately, we have abundant and ever-growing capabilities for doing just that.

Immune Checkpoint Inhibitors

The field of immunotherapies took off with the immune checkpoint inhibitors, first approved by the FDA in 2011, that take the brakes off of T cells, with the programmed death-1 (PD-1), PD-ligand1, and anti-CTLA-4 monoclonal antibodies.

But we’re clearly learning they are not enough to prevail over cancer with common recurrences, only short term success in most patients, with some notable exceptions. Adding other immune response strategies, such as a vaccine, or antibody-drug conjugates, or engineered T cells, are showing improved chances for success.

Therapeutic Cancer Vaccines

There are many therapeutic cancer vaccines in the works, as reviewed in depth here.

Here’s a list of ongoing clinical trials of cancer vaccines. You’ll note most of these are on top of a checkpoint inhibitor and use personalized neoantigens (cancer cell surface proteins) derived from sequencing (whole-exome or whole genome, RNA-sequencing and HLA-profiling) the patient’s tumor.

An example of positive findings is with the combination of an mRNA-nanoparticle vaccine with up to 34 personalized neoantigens and pembrolizumab (Keytruda) vs pembrolizumab alone in advanced melanoma after resection, with improved outcomes at 3-year follow-up, cutting death or relapse rate in half.

Antibody-Drug Conjugates (ADC)

There is considerable excitement about antibody-drug conjugates (ADC) whereby a linker is used to attach a chemotherapy agent to the checkpoint inhibitor antibody, specifically targeting the cancer cell and facilitating entry of the chemotherapy into the cell. Akin to these are bispecific antibodies (BiTEs, binding to a tumor antigen and T cell receptor simultaneously), both of these conjugates acting as “biologic” or “guided” missiles.

A very good example of the potency of an ADC was seen in a “HER2-low” breast cancer randomized trial. The absence or very low expression or amplification of the HER2 receptor is common in breast cancer and successful treatment has been elusive. A randomized trial of an ADC (trastuzumab deruxtecan) compared to physician’s choice therapy demonstrated a marked success for progression-free survival in HER2-low patients, which was characterized as “unheard-of success” by media coverage.

This strategy is being used to target some of the most difficult cancer driver mutations such as TP53 and KRAS.

Oncolytic Viruses

Modifying viruses to infect the tumor and make it more visible to the immune system, potentiating anti-tumor responses, known as oncolytic viruses, have been proposed as a way to rev up the immune response for a long time but without positive Phase 3 clinical trials.

After decades of failure, a recent trial in refractory bladder cancer showed marked success, along with others, summarized here, now providing very encouraging results. It looks like oncolytic viruses are on a comeback path.

Engineering T Cells (Chimeric Antigen Receptor [CAR-T])

As I recently reviewed, there are over 500 ongoing clinical trials to build on the success of the first CAR-T approval for leukemia 7 years ago. I won’t go through that all again here, but to reiterate most of the success to date has been in “liquid” blood (leukemia and lymphoma) cancer tumors. This week in Nature is the discovery of a T cell cancer mutation, a gene fusion CARD11-PIK3R3, from a T cell lymphoma that can potentially be used to augment CAR-T efficacy. It has pronounced and prolonged effects in the experimental model. Instead of 1 million cells needed for treatment, even 20,000 were enough to melt the tumor. This is a noteworthy discovery since CAR-T work to date has largely not exploited such naturally occurring mutations, while instead concentrating on those seen in the patient’s set of key tumor mutations.

As currently conceived, CAR-T, and what is being referred to more broadly as adoptive cell therapies, involves removing T cells from the patient’s body and engineering their activation, then reintroducing them back to the patient. This is laborious, technically difficult, and very expensive. Recently, the idea of achieving all of this via an injection of virus that specifically infects T cells and inserts the genes needed, was advanced by two biotech companies with preclinical results, one in non-human primates.

Gearing up to meet the challenge of solid tumor CAR-T intervention, there’s more work using CRISPR genome editing of T cell receptorsA.I. is increasingly being exploited to process the data from sequencing and identify optimal neoantigens.

Instead of just CAR-T, we’re seeing the emergence of CAR-macrophage and CAR-natural killer (NK) cells strategies, and rapidly expanding potential combinations of all the strategies I’ve mentioned. No less, there’s been maturation of on-off suicide switches programmed in, to limit cytokine release and promote safety of these interventions. Overall, major side effects of immunotherapies are not only cytokine release syndromes, but also include interstitial pneumonitis and neurotoxicity.

Summary

Given the multitude of ways cancer cells and tumor tissue can evade our immune response, durably successful treatment remains a daunting challenge. But the ingenuity of so many different approaches to unleash our immune response, and their combinations, provides considerable hope that we’ll increasingly meet the challenge in the years ahead. We have clearly learned that combining different immunotherapy strategies will be essential for many patients with the most resilient solid tumors.

Of concern, as noted by a recent editorial in The Lancet, entitled “Cancer Research Equity: Innovations For The Many, Not The Few,” is that these individualized, sophisticated strategies are not scalable; they will have limited reach and benefit. The movement towards “off the shelf” CAR-T and inexpensive, orally active checkpoint inhibitors may help mitigate this issue.

Notwithstanding this important concern, we’re seeing an array of diverse and potent immunotherapy strategies that are providing highly encouraging results, engendering more excitement than we’ve seen in this space for some time. These should propel substantial improvements in outcomes for patients in the years ahead. It can’t happen soon enough.

Thanks for reading this edition of Ground Truths. If you found it informative, please share it with your colleagues.

Dr. Topol has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for Dexcom; Illumina; Molecular Stethoscope; Quest Diagnostics; Blue Cross Blue Shield Association. Received research grant from National Institutes of Health.

A version of this article appeared on Medscape.com.

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High Niacin Levels Linked to Major CV Events

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TOPLINE:

Two breakdown products from excess niacin, called 2PY and 4PY, were strongly associated with myocardial infarctionstroke, and other adverse cardiac events, suggesting that niacin supplementation may require a more “nuanced, titrated approach,” researchers said.

METHODOLOGY:

  • Investigators performed an untargeted metabolomics analysis of fasting plasma from stable cardiac patients in a prospective discovery cohort of 1162 individuals (36% women).
  • Additional analyses were performed in a US validation cohort, including measurement of soluble vascular adhesion molecule-1 (sVCAM-1), and on archival fasting samples from patients in a European validation cohort undergoing diagnostic coronary angiography.
  • Genetic analyses of samples from the UK Biobank were used to test the association with sVCAM-1 levels of a genetic variant, rs10496731, which was significantly associated with both N1-methyl-2-pyridone-5-carboxamide (2 PY) and N1-methyl-4-pyridone-3-carboxamide (4PY) levels.

TAKEAWAY:

  • Niacin metabolism was associated with incident major adverse cardiovascular events (MACE).
  • Plasma levels of the terminal metabolites of excess niacin, 2PY and 4PY, were associated with increased 3-year MACE risk in two validation cohorts (US: 2331 total, 33% women; European: 832 total, 30% women), with adjusted hazard ratios for 2PY of 1.64 and 2.02, respectively, and for 4PY, 1.89 and 1.99.
  • The genetic variant rs10496731 was significantly associated with levels of sVCAM-1.
  • Treatment with physiological levels of 4PY, but not 2PY, induced expression of VCAM-1 and leukocyte adherence to vascular endothelium in mice, suggesting an inflammation-dependent mechanism underlying the clinical association of 4PY, in particular, with MACE.
  • In functional testing, a physiological level of 4PY, but not 2PY, provoked messenger RNA and protein expression of VCAM-1 on human endothelial cells.

IN PRACTICE:

“Total niacin consumption in the US averaged 48 mg/d from 2017 to 2020 — more than triple the Recommended Daily Allowance — and 2PY and 4PY were also increased by nicotinamideriboside and nicotinamide mononucleotide, both of which are commonly sold supplements with claimed antiaging benefits,” the authors noted.

“The present studies suggest that niacin pool supplementation may optimally require a more nuanced, titrated approach to achieve intended health benefits,” while not fostering excess 4PY generation.

SOURCE:

Stanley Hazen, MD, PhD, of Cleveland Clinic, Cleveland, Ohio, was the principal author of the study, published online in Nature Medicine.

LIMITATIONS:

Measurement of 2PY and 4PY in the validation cohorts was performed only once, whereas serial measures might have provided enhanced prognostic value for incident cardiovascular disease (CVD) risks. Cohorts were recruited at quaternary referral centers and showed a high prevalence of CVD and cardiometabolic disease risk factors. Although the meta-analysis of the community-based genomic (Biobank) studies showed a link between 4PY and VCAM-1 expression in multiple ethnic groups, the clinical studies linking 4PY to CVD events were based on high-risk European ancestry populations in the US and European cohorts.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health (NIH; both the National Heart, Lung, and Blood Institute and the Office of Dietary Supplements: A), Pilot Project Programs of the USC Center for Genetic Epidemiology and Southern California Environmental Health Sciences Center, and the Deutsche Forschungsgemeinschaft. One co-author was supported, in part, by NIH training grants; another was a participant in the BIH-Charité Advanced Clinician Scientist Program funded by Charité – Universitätsmedizin Berlin and the Berlin Institute of Health. The LipidCardio study [validation cohort] was partially supported by Sanofi-Aventis Deutschland GmbH. The UK Biobank Resource provided access to their data. Dr. Hazen and a co-author reported being coinventors on pending and issued patents held by the Cleveland Clinic relating to cardiovascular diagnostics and therapeutics, and Dr. Hazen and two co-authors received funds from industry.

A version of the article appeared on Medscape.com.

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TOPLINE:

Two breakdown products from excess niacin, called 2PY and 4PY, were strongly associated with myocardial infarctionstroke, and other adverse cardiac events, suggesting that niacin supplementation may require a more “nuanced, titrated approach,” researchers said.

METHODOLOGY:

  • Investigators performed an untargeted metabolomics analysis of fasting plasma from stable cardiac patients in a prospective discovery cohort of 1162 individuals (36% women).
  • Additional analyses were performed in a US validation cohort, including measurement of soluble vascular adhesion molecule-1 (sVCAM-1), and on archival fasting samples from patients in a European validation cohort undergoing diagnostic coronary angiography.
  • Genetic analyses of samples from the UK Biobank were used to test the association with sVCAM-1 levels of a genetic variant, rs10496731, which was significantly associated with both N1-methyl-2-pyridone-5-carboxamide (2 PY) and N1-methyl-4-pyridone-3-carboxamide (4PY) levels.

TAKEAWAY:

  • Niacin metabolism was associated with incident major adverse cardiovascular events (MACE).
  • Plasma levels of the terminal metabolites of excess niacin, 2PY and 4PY, were associated with increased 3-year MACE risk in two validation cohorts (US: 2331 total, 33% women; European: 832 total, 30% women), with adjusted hazard ratios for 2PY of 1.64 and 2.02, respectively, and for 4PY, 1.89 and 1.99.
  • The genetic variant rs10496731 was significantly associated with levels of sVCAM-1.
  • Treatment with physiological levels of 4PY, but not 2PY, induced expression of VCAM-1 and leukocyte adherence to vascular endothelium in mice, suggesting an inflammation-dependent mechanism underlying the clinical association of 4PY, in particular, with MACE.
  • In functional testing, a physiological level of 4PY, but not 2PY, provoked messenger RNA and protein expression of VCAM-1 on human endothelial cells.

IN PRACTICE:

“Total niacin consumption in the US averaged 48 mg/d from 2017 to 2020 — more than triple the Recommended Daily Allowance — and 2PY and 4PY were also increased by nicotinamideriboside and nicotinamide mononucleotide, both of which are commonly sold supplements with claimed antiaging benefits,” the authors noted.

“The present studies suggest that niacin pool supplementation may optimally require a more nuanced, titrated approach to achieve intended health benefits,” while not fostering excess 4PY generation.

SOURCE:

Stanley Hazen, MD, PhD, of Cleveland Clinic, Cleveland, Ohio, was the principal author of the study, published online in Nature Medicine.

LIMITATIONS:

Measurement of 2PY and 4PY in the validation cohorts was performed only once, whereas serial measures might have provided enhanced prognostic value for incident cardiovascular disease (CVD) risks. Cohorts were recruited at quaternary referral centers and showed a high prevalence of CVD and cardiometabolic disease risk factors. Although the meta-analysis of the community-based genomic (Biobank) studies showed a link between 4PY and VCAM-1 expression in multiple ethnic groups, the clinical studies linking 4PY to CVD events were based on high-risk European ancestry populations in the US and European cohorts.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health (NIH; both the National Heart, Lung, and Blood Institute and the Office of Dietary Supplements: A), Pilot Project Programs of the USC Center for Genetic Epidemiology and Southern California Environmental Health Sciences Center, and the Deutsche Forschungsgemeinschaft. One co-author was supported, in part, by NIH training grants; another was a participant in the BIH-Charité Advanced Clinician Scientist Program funded by Charité – Universitätsmedizin Berlin and the Berlin Institute of Health. The LipidCardio study [validation cohort] was partially supported by Sanofi-Aventis Deutschland GmbH. The UK Biobank Resource provided access to their data. Dr. Hazen and a co-author reported being coinventors on pending and issued patents held by the Cleveland Clinic relating to cardiovascular diagnostics and therapeutics, and Dr. Hazen and two co-authors received funds from industry.

A version of the article appeared on Medscape.com.

 

TOPLINE:

Two breakdown products from excess niacin, called 2PY and 4PY, were strongly associated with myocardial infarctionstroke, and other adverse cardiac events, suggesting that niacin supplementation may require a more “nuanced, titrated approach,” researchers said.

METHODOLOGY:

  • Investigators performed an untargeted metabolomics analysis of fasting plasma from stable cardiac patients in a prospective discovery cohort of 1162 individuals (36% women).
  • Additional analyses were performed in a US validation cohort, including measurement of soluble vascular adhesion molecule-1 (sVCAM-1), and on archival fasting samples from patients in a European validation cohort undergoing diagnostic coronary angiography.
  • Genetic analyses of samples from the UK Biobank were used to test the association with sVCAM-1 levels of a genetic variant, rs10496731, which was significantly associated with both N1-methyl-2-pyridone-5-carboxamide (2 PY) and N1-methyl-4-pyridone-3-carboxamide (4PY) levels.

TAKEAWAY:

  • Niacin metabolism was associated with incident major adverse cardiovascular events (MACE).
  • Plasma levels of the terminal metabolites of excess niacin, 2PY and 4PY, were associated with increased 3-year MACE risk in two validation cohorts (US: 2331 total, 33% women; European: 832 total, 30% women), with adjusted hazard ratios for 2PY of 1.64 and 2.02, respectively, and for 4PY, 1.89 and 1.99.
  • The genetic variant rs10496731 was significantly associated with levels of sVCAM-1.
  • Treatment with physiological levels of 4PY, but not 2PY, induced expression of VCAM-1 and leukocyte adherence to vascular endothelium in mice, suggesting an inflammation-dependent mechanism underlying the clinical association of 4PY, in particular, with MACE.
  • In functional testing, a physiological level of 4PY, but not 2PY, provoked messenger RNA and protein expression of VCAM-1 on human endothelial cells.

IN PRACTICE:

“Total niacin consumption in the US averaged 48 mg/d from 2017 to 2020 — more than triple the Recommended Daily Allowance — and 2PY and 4PY were also increased by nicotinamideriboside and nicotinamide mononucleotide, both of which are commonly sold supplements with claimed antiaging benefits,” the authors noted.

“The present studies suggest that niacin pool supplementation may optimally require a more nuanced, titrated approach to achieve intended health benefits,” while not fostering excess 4PY generation.

SOURCE:

Stanley Hazen, MD, PhD, of Cleveland Clinic, Cleveland, Ohio, was the principal author of the study, published online in Nature Medicine.

LIMITATIONS:

Measurement of 2PY and 4PY in the validation cohorts was performed only once, whereas serial measures might have provided enhanced prognostic value for incident cardiovascular disease (CVD) risks. Cohorts were recruited at quaternary referral centers and showed a high prevalence of CVD and cardiometabolic disease risk factors. Although the meta-analysis of the community-based genomic (Biobank) studies showed a link between 4PY and VCAM-1 expression in multiple ethnic groups, the clinical studies linking 4PY to CVD events were based on high-risk European ancestry populations in the US and European cohorts.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health (NIH; both the National Heart, Lung, and Blood Institute and the Office of Dietary Supplements: A), Pilot Project Programs of the USC Center for Genetic Epidemiology and Southern California Environmental Health Sciences Center, and the Deutsche Forschungsgemeinschaft. One co-author was supported, in part, by NIH training grants; another was a participant in the BIH-Charité Advanced Clinician Scientist Program funded by Charité – Universitätsmedizin Berlin and the Berlin Institute of Health. The LipidCardio study [validation cohort] was partially supported by Sanofi-Aventis Deutschland GmbH. The UK Biobank Resource provided access to their data. Dr. Hazen and a co-author reported being coinventors on pending and issued patents held by the Cleveland Clinic relating to cardiovascular diagnostics and therapeutics, and Dr. Hazen and two co-authors received funds from industry.

A version of the article appeared on Medscape.com.

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Balancing Patient Satisfaction With Saying No

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Your patients come in wanting a script for the latest medication they saw on a television commercial (Ozempic anyone?), a request for a medical marijuana card for their shoulder ache, or any number of pleas for drugs, procedures, or tests that are medically inappropriate.

One of the toughest parts of the job as a physician is balancing patient requests with patient satisfaction. In the age of Healthgrades, Yelp reviews, and patients sharing their visit high points on multiple social media platforms, how can you keep patients happy and satisfied when you have to say no?

Turns out, you can likely reroute those patient-driven requests if you can get to the heart of the issue the patient is looking to resolve, suggested Peter Lee, MD, a plastic surgeon at Wave Plastic Surgery in Los Angeles.

“The conversation between physicians and patients hinges less on the answer ‘no’ than it does on being a careful listener,” he said. “This includes focusing on the different available treatment options and then deciding which of these is most suitable to the particular situation facing that patient.”

Here are a few failsafe ways to say no — and why physicians think these approaches can make the difference between a contentious appointment and a positive one.
 

Hear Patients Out

When patients book an appointment with a physician to discuss a noncritical issue, they likely have a sense from Google of what they might need, which is why Dara Kass, MD, an emergency medicine physician in Hartford, Connecticut, always asks patients “why did you come in” and “what test do you think you need.”

“For example, they may say, ‘I came for a CT scan of my head because I’ve had a headache for 2 years, and it’s frustrating trying to find a neurologist,’” she said. “Maybe they don’t need a CT scan after all, but it’s up to me to figure that out, and letting them share what they think they need frames out a feeling that we’re making joint decisions.”
 

Help Patients Rethink Requests

The ubiquity of online searching is just one reason patients may tend to arrive at your office armed with “information.” This is especially true for patients seeking plastic surgery, said Dr. Lee. “A plastic surgeon’s reaction to such a request may be less about saying ‘no’ than taking the patient a few steps back in the decision-making process,” he said. “The goal should be to educate the patient, in the case of plastic surgery, about what is actually causing the appearance he or she is trying to correct.”

For something like a marijuana card for a slight ache, explaining that it may not be appropriate and “here’s what we can do instead” goes a long way in getting the patient to rethink and understand that their request may not be legitimate.
 

Use Safety Concerns as an Out

Often, a patient just isn’t a good candidate for a procedure, said Samuel Lin, MD, a plastic surgeon in Boston and an associate professor of surgery at Harvard Medical School, Boston. “They may think they need to have a procedure, but it might not be a safe thing for them to have it,” he said.

“I would lean heavily on the fact that it may not be medically safe for this patient to have this procedure due to elements of their medical history or the fact that they have had prior surgeries. Then, if you pivot to the more conservative things you can do, this can help you say no when a patient is seeking a certain procedure.”

Likewise, explaining that a weight loss drug may have more risks than benefits and isn’t appropriate for that 15 pounds they’re struggling with couched as a safety concern can ease the disappointment of a no.
 

 

 

Remind Patients That Tests Can Be Costly

It’s one thing for a patient to request certain tests, say an MRI or a CT scan, but those same patients may grumble when they get the bill for the tests. That said, it’s always a good idea to remind them of the costs of these tests, said Dr. Kass. Patients will get bills in the mail after their visit for those extra tests and scans. “They may not realize this until after they asked for it, and if they, for example, have $1000 in coinsurance, that bill may be a very upsetting surprise.”
 

You Can’t Always Prevent a Negative Patient Review

No matter how hard you try, a patient may still be unhappy that you’ve declined their request, and this may show up in the form of a negative review for all to see. However, it’s always best to keep these reviews in perspective. “The ‘no’ that might result in a bad review can happen for everything from waiting 15 minutes to see the doctor to not getting a discount at checkout and everything in between including being told they don’t need the drug, test, or procedure they requested.”

“I feel like people who write bad reviews want money back, or they have an alternative agenda. That’s why, I educate patients and empower them to make the right decisions,” said Jody A. Levine, MD, director of dermatology at Plastic Surgery & Dermatology of New York City.

Dr. Lee told this news organization that the fundamental pledge to “do no harm” is as good as any other credo when saying no to patients. “If we don’t believe there is a likely probability that a surgery will be safe to perform on a patient and leave the patient satisfied with the result, then it is our duty to decline to perform that surgery.”

Ultimately, being transparent leads to a happy doctor-patient relationship. “As long as you are clear and honest in explaining to a patient why you are declining to perform a procedure, most patients, rather than being angry with you, will thank you for your candor,” he said. “They’ll leave your office a little bit wiser, too.”

A version of this article appeared on Medscape.com.

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Your patients come in wanting a script for the latest medication they saw on a television commercial (Ozempic anyone?), a request for a medical marijuana card for their shoulder ache, or any number of pleas for drugs, procedures, or tests that are medically inappropriate.

One of the toughest parts of the job as a physician is balancing patient requests with patient satisfaction. In the age of Healthgrades, Yelp reviews, and patients sharing their visit high points on multiple social media platforms, how can you keep patients happy and satisfied when you have to say no?

Turns out, you can likely reroute those patient-driven requests if you can get to the heart of the issue the patient is looking to resolve, suggested Peter Lee, MD, a plastic surgeon at Wave Plastic Surgery in Los Angeles.

“The conversation between physicians and patients hinges less on the answer ‘no’ than it does on being a careful listener,” he said. “This includes focusing on the different available treatment options and then deciding which of these is most suitable to the particular situation facing that patient.”

Here are a few failsafe ways to say no — and why physicians think these approaches can make the difference between a contentious appointment and a positive one.
 

Hear Patients Out

When patients book an appointment with a physician to discuss a noncritical issue, they likely have a sense from Google of what they might need, which is why Dara Kass, MD, an emergency medicine physician in Hartford, Connecticut, always asks patients “why did you come in” and “what test do you think you need.”

“For example, they may say, ‘I came for a CT scan of my head because I’ve had a headache for 2 years, and it’s frustrating trying to find a neurologist,’” she said. “Maybe they don’t need a CT scan after all, but it’s up to me to figure that out, and letting them share what they think they need frames out a feeling that we’re making joint decisions.”
 

Help Patients Rethink Requests

The ubiquity of online searching is just one reason patients may tend to arrive at your office armed with “information.” This is especially true for patients seeking plastic surgery, said Dr. Lee. “A plastic surgeon’s reaction to such a request may be less about saying ‘no’ than taking the patient a few steps back in the decision-making process,” he said. “The goal should be to educate the patient, in the case of plastic surgery, about what is actually causing the appearance he or she is trying to correct.”

For something like a marijuana card for a slight ache, explaining that it may not be appropriate and “here’s what we can do instead” goes a long way in getting the patient to rethink and understand that their request may not be legitimate.
 

Use Safety Concerns as an Out

Often, a patient just isn’t a good candidate for a procedure, said Samuel Lin, MD, a plastic surgeon in Boston and an associate professor of surgery at Harvard Medical School, Boston. “They may think they need to have a procedure, but it might not be a safe thing for them to have it,” he said.

“I would lean heavily on the fact that it may not be medically safe for this patient to have this procedure due to elements of their medical history or the fact that they have had prior surgeries. Then, if you pivot to the more conservative things you can do, this can help you say no when a patient is seeking a certain procedure.”

Likewise, explaining that a weight loss drug may have more risks than benefits and isn’t appropriate for that 15 pounds they’re struggling with couched as a safety concern can ease the disappointment of a no.
 

 

 

Remind Patients That Tests Can Be Costly

It’s one thing for a patient to request certain tests, say an MRI or a CT scan, but those same patients may grumble when they get the bill for the tests. That said, it’s always a good idea to remind them of the costs of these tests, said Dr. Kass. Patients will get bills in the mail after their visit for those extra tests and scans. “They may not realize this until after they asked for it, and if they, for example, have $1000 in coinsurance, that bill may be a very upsetting surprise.”
 

You Can’t Always Prevent a Negative Patient Review

No matter how hard you try, a patient may still be unhappy that you’ve declined their request, and this may show up in the form of a negative review for all to see. However, it’s always best to keep these reviews in perspective. “The ‘no’ that might result in a bad review can happen for everything from waiting 15 minutes to see the doctor to not getting a discount at checkout and everything in between including being told they don’t need the drug, test, or procedure they requested.”

“I feel like people who write bad reviews want money back, or they have an alternative agenda. That’s why, I educate patients and empower them to make the right decisions,” said Jody A. Levine, MD, director of dermatology at Plastic Surgery & Dermatology of New York City.

Dr. Lee told this news organization that the fundamental pledge to “do no harm” is as good as any other credo when saying no to patients. “If we don’t believe there is a likely probability that a surgery will be safe to perform on a patient and leave the patient satisfied with the result, then it is our duty to decline to perform that surgery.”

Ultimately, being transparent leads to a happy doctor-patient relationship. “As long as you are clear and honest in explaining to a patient why you are declining to perform a procedure, most patients, rather than being angry with you, will thank you for your candor,” he said. “They’ll leave your office a little bit wiser, too.”

A version of this article appeared on Medscape.com.

Your patients come in wanting a script for the latest medication they saw on a television commercial (Ozempic anyone?), a request for a medical marijuana card for their shoulder ache, or any number of pleas for drugs, procedures, or tests that are medically inappropriate.

One of the toughest parts of the job as a physician is balancing patient requests with patient satisfaction. In the age of Healthgrades, Yelp reviews, and patients sharing their visit high points on multiple social media platforms, how can you keep patients happy and satisfied when you have to say no?

Turns out, you can likely reroute those patient-driven requests if you can get to the heart of the issue the patient is looking to resolve, suggested Peter Lee, MD, a plastic surgeon at Wave Plastic Surgery in Los Angeles.

“The conversation between physicians and patients hinges less on the answer ‘no’ than it does on being a careful listener,” he said. “This includes focusing on the different available treatment options and then deciding which of these is most suitable to the particular situation facing that patient.”

Here are a few failsafe ways to say no — and why physicians think these approaches can make the difference between a contentious appointment and a positive one.
 

Hear Patients Out

When patients book an appointment with a physician to discuss a noncritical issue, they likely have a sense from Google of what they might need, which is why Dara Kass, MD, an emergency medicine physician in Hartford, Connecticut, always asks patients “why did you come in” and “what test do you think you need.”

“For example, they may say, ‘I came for a CT scan of my head because I’ve had a headache for 2 years, and it’s frustrating trying to find a neurologist,’” she said. “Maybe they don’t need a CT scan after all, but it’s up to me to figure that out, and letting them share what they think they need frames out a feeling that we’re making joint decisions.”
 

Help Patients Rethink Requests

The ubiquity of online searching is just one reason patients may tend to arrive at your office armed with “information.” This is especially true for patients seeking plastic surgery, said Dr. Lee. “A plastic surgeon’s reaction to such a request may be less about saying ‘no’ than taking the patient a few steps back in the decision-making process,” he said. “The goal should be to educate the patient, in the case of plastic surgery, about what is actually causing the appearance he or she is trying to correct.”

For something like a marijuana card for a slight ache, explaining that it may not be appropriate and “here’s what we can do instead” goes a long way in getting the patient to rethink and understand that their request may not be legitimate.
 

Use Safety Concerns as an Out

Often, a patient just isn’t a good candidate for a procedure, said Samuel Lin, MD, a plastic surgeon in Boston and an associate professor of surgery at Harvard Medical School, Boston. “They may think they need to have a procedure, but it might not be a safe thing for them to have it,” he said.

“I would lean heavily on the fact that it may not be medically safe for this patient to have this procedure due to elements of their medical history or the fact that they have had prior surgeries. Then, if you pivot to the more conservative things you can do, this can help you say no when a patient is seeking a certain procedure.”

Likewise, explaining that a weight loss drug may have more risks than benefits and isn’t appropriate for that 15 pounds they’re struggling with couched as a safety concern can ease the disappointment of a no.
 

 

 

Remind Patients That Tests Can Be Costly

It’s one thing for a patient to request certain tests, say an MRI or a CT scan, but those same patients may grumble when they get the bill for the tests. That said, it’s always a good idea to remind them of the costs of these tests, said Dr. Kass. Patients will get bills in the mail after their visit for those extra tests and scans. “They may not realize this until after they asked for it, and if they, for example, have $1000 in coinsurance, that bill may be a very upsetting surprise.”
 

You Can’t Always Prevent a Negative Patient Review

No matter how hard you try, a patient may still be unhappy that you’ve declined their request, and this may show up in the form of a negative review for all to see. However, it’s always best to keep these reviews in perspective. “The ‘no’ that might result in a bad review can happen for everything from waiting 15 minutes to see the doctor to not getting a discount at checkout and everything in between including being told they don’t need the drug, test, or procedure they requested.”

“I feel like people who write bad reviews want money back, or they have an alternative agenda. That’s why, I educate patients and empower them to make the right decisions,” said Jody A. Levine, MD, director of dermatology at Plastic Surgery & Dermatology of New York City.

Dr. Lee told this news organization that the fundamental pledge to “do no harm” is as good as any other credo when saying no to patients. “If we don’t believe there is a likely probability that a surgery will be safe to perform on a patient and leave the patient satisfied with the result, then it is our duty to decline to perform that surgery.”

Ultimately, being transparent leads to a happy doctor-patient relationship. “As long as you are clear and honest in explaining to a patient why you are declining to perform a procedure, most patients, rather than being angry with you, will thank you for your candor,” he said. “They’ll leave your office a little bit wiser, too.”

A version of this article appeared on Medscape.com.

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Eat Earlier and More Often to Prevent Obesity

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TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

  • According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
  • This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
  • In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
  • The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
  • The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

  • Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
  • Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
  • The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
  • On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

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TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

  • According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
  • This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
  • In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
  • The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
  • The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

  • Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
  • Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
  • The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
  • On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

 

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

  • According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
  • This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
  • In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
  • The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
  • The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

  • Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
  • Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
  • The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
  • On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

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Watchful Waiting Less Expensive, as Effective as Physical Therapy for Frozen Shoulder

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Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

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Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

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