Mixed Topics

HOW TO CHOOSE THE RIGHT VAGINAL MOISTURIZER OR LUBRICANT FOR YOUR PATIENT

JOHN PENNYCUFF, MD, MSPH, AND CHERYL IGLESIA, MD (JUNE 2021)

Which vaginal products to recommend

We applaud Drs. Pennycuff and Iglesia for providing education on lubricants and vaginal moisturizers in their recent article, and agree that ObGyns, urogynecologists, and primary care providers should be aware of the types of products available. However, the authors underplayed the health risks associated with the use of poor-quality lubricants and moisturizers.

Women often turn to lubricants or vaginal moisturizers because they experience vaginal dryness during intercourse, related to menopause, and from certain medications. Vaginal fluid is primarily composed of exudate from capillaries in the vaginal wall. During sexual arousal, blood flow to the vaginal wall increases, and in turn, this should increase exudate. But chronic inflammation can suppress these increases in vaginal blood flow, preventing adequate vaginal fluid production. One such cause of chronic inflammation is using hyperosmolar lubricants, as this has been shown to negatively affect the vaginal epithelium.^1,2 In this way, use of hyperosmolar lubricants can actually worsen symptoms, creating a vicious circle of dryness, lubricant use, and worsening dryness.

In addition, hyperosmolar lubricants have been shown to reduce the epithelial barrier properties of the vaginal epithelium, increasing susceptibility to microbes associated with bacterial vaginosis and to true pathogens, including herpes simplex virus type 2.³ In fact, hyperosmolar lubricants are a serious enough problem that the World Health Organization has weighed in, recommending osmolality of personal lubricants be under 380 mOsm/kg to prevent damage to the vaginal epithelium.⁴

Appropriately acidic pH is just as critical as osmolality. Using products with a pH higher than 4.5 will reduce amounts of protective lactobacilli and other commensal vaginal bacteria, encouraging growth of opportunistic bacteria and yeast already present. This can lead to bacterial vaginosis, aerobic vaginitis, and candidiasis. Bacterial vaginosis can lead to other serious sequelae such as increased risk in acquisition of HIV infection and preterm birth in pregnancy. Unfortunately, much of the data cited in Drs. Pennycuff and Iglesia’s article were sourced from another study (by Edwards and Panay published in Climacteric in 2016), which measured product pH values with an inappropriately calibrated device; the study’s supplemental information stated that calibration was between 5 and 9, and so any measurement below 5 was invalid and subject to error. For example, the Good Clean Love lubricant is listed as having a pH of 4.7, but its pH is never higher than 4.4.

The products on the market that meet the dual criteria of appropriate pH and isotonicity to vaginal epithelial cells may be less well known to consumers. But this should not be a reason to encourage use of hyperosmolar products whose main selling point is that they are the “leading brand.” Educating women on their choices in personal lubricants should include a full discussion of product ingredients and properties, based upon the available literature to help them select a product that supports the health of their intimate tissues.

Members of the Scientific Advisory Board for the Sexual Health and Wellness Institute: Jill Krapf, MD, MEd, IF; Cathy Chung Hwa Yi, MD; Christine Enzmann, MD, PhD, NMCP; Susan Kellogg-Spadt, PhD, CRNP, IF, CSC, FCST; Betsy Greenleaf, DO, MBA; Elizabeth DuPriest, PhD

References

1. Dezzutti CS, Brown ER, Moncla B, et al. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One. 2012;7:e48328. doi: 10.1371/journal .pone.0048328.
2. Ayehunie S, Wang YY, Landry T, et al. Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a threedimensional vaginal epithelium model. Toxicol Rep. 2017;5:134-140. doi: 10.1016 /j.toxrep.2017.12.011.
3. Moench TR, Mumper RJ, Hoen TE, et al. Microbicide excipients can greatly increase susceptibility to genital herpes transmission in the mouse. BMC Infect Dis.  2010;10:331. doi: 10.1186/1471 -2334-10-331.
4. Use and procurement of additional lubricants for male and female condoms: WHO/UNFPA /FHI360 Advisory note. World Health Organization, 2012. http://apps.who.int/iris/bitstream /handle/10665/76580/WHO_RHR_12.33_eng .pdf?sequence=1. Accessed December 27, 2021.

Drs. Pennycuff And Iglesia Respond

We thank the members of the scientific advisory board for the Sexual Health and Wellness Institute for their thoughtful and insightful comments to our article. We agree with their comments on the importance of both pH and osmolality for vaginal moisturizers and lubricants. We also agree that selection of an incorrectly formulated product may lead to worsening of vulvovaginal symptoms as well as dysbiosis and all of its sequelae as the letter writers mentioned.

In writing the review article, we attempted to address the role that pH and osmolality play in vaginal moisturizers and lubricants and make clinicians more aware of the importance of these factors in product formulation. Our goal was to help to improve patient counseling. We tried to amass as much of the available literature as we could to act as a resource for practitioners, such as the table included in the article as well as the supplemental table included online. We hoped that by writing this article we would heighten awareness among female health practitioners about vaginal health products and encourage them to consider those products that may be better suited for their patients based on pH and osmolality.

While there remains a paucity of research on vaginal moisturizers and lubricants, there is even less consumer knowledge regarding ingredients and formulations of these products. We wholeheartedly agree with the scientific advisory board that we as health providers need to help educate women on the full spectrum of products available beyond the “leading brands.” Furthermore, we advocate that there be continued research on these products as well as more manufacturer transparency regarding not only the ingredients contained within these products but also the pH and osmolality. Simple steps such as these would ensure that providers could help counsel patients to make informed decisions regarding products for their pelvic health.

Continue to: DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES...

DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES

CASSANDRA CARBERRY, MD, MS; ANNETTA MADSEN, MD; OLIVIA CARDENAS-TROWERS, MD; OLUWATENIOLA BROWN, MD; MOIURI SIDDIQUE, MD; AND BLAIR WASHINGTON, MD, MHA (AUGUST 2021)

Dissenting opinion

“Race is real but it’s not biologic.” “Race is not based on genetic or biologic inheritance.” Am I the only one with a dissenting voice of opinion when it comes to these types of statements?

Scott Peters, MD

Oak Ridge, Tennessee

The Authors Respond

Thank you for your opinion, Dr. Peters. Although it is not completely clear what your question is, it seems that it concerns the validity of the idea that race is a social construct. We will address this question with the assumption that this letter was an effort to invite discussion and increase understanding.

The National Human Genome Research Institute describes race in this way: “Race is a fluid concept used to group people according to various factors, including ancestral background and social identity. Race is also used to group people that share a set of visible characteristics, such as skin color and facial features. Though these visible traits are influenced by genes, the vast majority of genetic variation exists within racial groups and not between them.”¹

The understanding that race is a social construct has been upheld by numerous medical organizations. In August 2020, a Joint Statement was published by the American College of Obstetricians and Gynecologists, the American Board of Obstetricians and Gynecologists, and 22 other organizations representing our specialty.  This document states: “Recognizing that race is a social construct, not biologically based, is important to understanding that racism, not race, impacts health care, health, and health outcomes.”²

This idea is also endorsed by the AMA, who in November 2020 adopted the following policies³:

• “Recognize that race is a social construct and is distinct from ethnicity, genetic ancestry, or biology
• Support ending the practice of using race as a proxy for biology or genetics in medical education, research, and clinical practice.”

There are numerous sources that further illuminate why race is a social construct. Here are a few:

• https://www.racepowerofanillusion .org/resources/
• https ://www.pewresearch.org /fact-tank/2020/02/25/the-changing -categories-the-u-s-has-used-to -measure-race/
• Roberts D. Fatal Invention: How Science, Politics and Big Business Re-create Race in the Twenty-First Century. The New Press. 2011.
• Yudell M, Roberts D, DeSalle R, et al. Science and society. Taking race out of human genetics. Science. 2016;351(6273):564-5. doi: 10.1126/science.aac4951.

References 

1. National Human Genome Research Institute. Race. https://www.genome.gov/genetic-glossary /Race. Accessed December 27, 2021.
2. The American College of Obstetricians and Gynecologists. Joint Statement: Collective Action Addressing Racism. https://www.acog.org /news/news-articles/2020/08/joint-statementobstetrics-and-gynecology-collective-actionaddressing-racism.
3. O’Reilly KB. AMA: Racism is a threat to public health. November 16, 2020. https://www.ama -assn.org/delivering-care/health-equity/ama -racism-threat-public-health. Accessed December 27, 2021.

HOW TO CHOOSE THE RIGHT VAGINAL MOISTURIZER OR LUBRICANT FOR YOUR PATIENT

JOHN PENNYCUFF, MD, MSPH, AND CHERYL IGLESIA, MD (JUNE 2021)

Which vaginal products to recommend

We applaud Drs. Pennycuff and Iglesia for providing education on lubricants and vaginal moisturizers in their recent article, and agree that ObGyns, urogynecologists, and primary care providers should be aware of the types of products available. However, the authors underplayed the health risks associated with the use of poor-quality lubricants and moisturizers.

Women often turn to lubricants or vaginal moisturizers because they experience vaginal dryness during intercourse, related to menopause, and from certain medications. Vaginal fluid is primarily composed of exudate from capillaries in the vaginal wall. During sexual arousal, blood flow to the vaginal wall increases, and in turn, this should increase exudate. But chronic inflammation can suppress these increases in vaginal blood flow, preventing adequate vaginal fluid production. One such cause of chronic inflammation is using hyperosmolar lubricants, as this has been shown to negatively affect the vaginal epithelium.^1,2 In this way, use of hyperosmolar lubricants can actually worsen symptoms, creating a vicious circle of dryness, lubricant use, and worsening dryness.

In addition, hyperosmolar lubricants have been shown to reduce the epithelial barrier properties of the vaginal epithelium, increasing susceptibility to microbes associated with bacterial vaginosis and to true pathogens, including herpes simplex virus type 2.³ In fact, hyperosmolar lubricants are a serious enough problem that the World Health Organization has weighed in, recommending osmolality of personal lubricants be under 380 mOsm/kg to prevent damage to the vaginal epithelium.⁴

Appropriately acidic pH is just as critical as osmolality. Using products with a pH higher than 4.5 will reduce amounts of protective lactobacilli and other commensal vaginal bacteria, encouraging growth of opportunistic bacteria and yeast already present. This can lead to bacterial vaginosis, aerobic vaginitis, and candidiasis. Bacterial vaginosis can lead to other serious sequelae such as increased risk in acquisition of HIV infection and preterm birth in pregnancy. Unfortunately, much of the data cited in Drs. Pennycuff and Iglesia’s article were sourced from another study (by Edwards and Panay published in Climacteric in 2016), which measured product pH values with an inappropriately calibrated device; the study’s supplemental information stated that calibration was between 5 and 9, and so any measurement below 5 was invalid and subject to error. For example, the Good Clean Love lubricant is listed as having a pH of 4.7, but its pH is never higher than 4.4.

The products on the market that meet the dual criteria of appropriate pH and isotonicity to vaginal epithelial cells may be less well known to consumers. But this should not be a reason to encourage use of hyperosmolar products whose main selling point is that they are the “leading brand.” Educating women on their choices in personal lubricants should include a full discussion of product ingredients and properties, based upon the available literature to help them select a product that supports the health of their intimate tissues.

Members of the Scientific Advisory Board for the Sexual Health and Wellness Institute: Jill Krapf, MD, MEd, IF; Cathy Chung Hwa Yi, MD; Christine Enzmann, MD, PhD, NMCP; Susan Kellogg-Spadt, PhD, CRNP, IF, CSC, FCST; Betsy Greenleaf, DO, MBA; Elizabeth DuPriest, PhD

References

1. Dezzutti CS, Brown ER, Moncla B, et al. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One. 2012;7:e48328. doi: 10.1371/journal .pone.0048328.
2. Ayehunie S, Wang YY, Landry T, et al. Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a threedimensional vaginal epithelium model. Toxicol Rep. 2017;5:134-140. doi: 10.1016 /j.toxrep.2017.12.011.
3. Moench TR, Mumper RJ, Hoen TE, et al. Microbicide excipients can greatly increase susceptibility to genital herpes transmission in the mouse. BMC Infect Dis.  2010;10:331. doi: 10.1186/1471 -2334-10-331.
4. Use and procurement of additional lubricants for male and female condoms: WHO/UNFPA /FHI360 Advisory note. World Health Organization, 2012. http://apps.who.int/iris/bitstream /handle/10665/76580/WHO_RHR_12.33_eng .pdf?sequence=1. Accessed December 27, 2021.

Drs. Pennycuff And Iglesia Respond

We thank the members of the scientific advisory board for the Sexual Health and Wellness Institute for their thoughtful and insightful comments to our article. We agree with their comments on the importance of both pH and osmolality for vaginal moisturizers and lubricants. We also agree that selection of an incorrectly formulated product may lead to worsening of vulvovaginal symptoms as well as dysbiosis and all of its sequelae as the letter writers mentioned.

In writing the review article, we attempted to address the role that pH and osmolality play in vaginal moisturizers and lubricants and make clinicians more aware of the importance of these factors in product formulation. Our goal was to help to improve patient counseling. We tried to amass as much of the available literature as we could to act as a resource for practitioners, such as the table included in the article as well as the supplemental table included online. We hoped that by writing this article we would heighten awareness among female health practitioners about vaginal health products and encourage them to consider those products that may be better suited for their patients based on pH and osmolality.

While there remains a paucity of research on vaginal moisturizers and lubricants, there is even less consumer knowledge regarding ingredients and formulations of these products. We wholeheartedly agree with the scientific advisory board that we as health providers need to help educate women on the full spectrum of products available beyond the “leading brands.” Furthermore, we advocate that there be continued research on these products as well as more manufacturer transparency regarding not only the ingredients contained within these products but also the pH and osmolality. Simple steps such as these would ensure that providers could help counsel patients to make informed decisions regarding products for their pelvic health.

Continue to: DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES...

DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES

CASSANDRA CARBERRY, MD, MS; ANNETTA MADSEN, MD; OLIVIA CARDENAS-TROWERS, MD; OLUWATENIOLA BROWN, MD; MOIURI SIDDIQUE, MD; AND BLAIR WASHINGTON, MD, MHA (AUGUST 2021)

Dissenting opinion

“Race is real but it’s not biologic.” “Race is not based on genetic or biologic inheritance.” Am I the only one with a dissenting voice of opinion when it comes to these types of statements?

Scott Peters, MD

Oak Ridge, Tennessee

The Authors Respond

Thank you for your opinion, Dr. Peters. Although it is not completely clear what your question is, it seems that it concerns the validity of the idea that race is a social construct. We will address this question with the assumption that this letter was an effort to invite discussion and increase understanding.

The National Human Genome Research Institute describes race in this way: “Race is a fluid concept used to group people according to various factors, including ancestral background and social identity. Race is also used to group people that share a set of visible characteristics, such as skin color and facial features. Though these visible traits are influenced by genes, the vast majority of genetic variation exists within racial groups and not between them.”¹

The understanding that race is a social construct has been upheld by numerous medical organizations. In August 2020, a Joint Statement was published by the American College of Obstetricians and Gynecologists, the American Board of Obstetricians and Gynecologists, and 22 other organizations representing our specialty.  This document states: “Recognizing that race is a social construct, not biologically based, is important to understanding that racism, not race, impacts health care, health, and health outcomes.”²

This idea is also endorsed by the AMA, who in November 2020 adopted the following policies³:

• “Recognize that race is a social construct and is distinct from ethnicity, genetic ancestry, or biology
• Support ending the practice of using race as a proxy for biology or genetics in medical education, research, and clinical practice.”

There are numerous sources that further illuminate why race is a social construct. Here are a few:

• https://www.racepowerofanillusion .org/resources/
• https ://www.pewresearch.org /fact-tank/2020/02/25/the-changing -categories-the-u-s-has-used-to -measure-race/
• Roberts D. Fatal Invention: How Science, Politics and Big Business Re-create Race in the Twenty-First Century. The New Press. 2011.
• Yudell M, Roberts D, DeSalle R, et al. Science and society. Taking race out of human genetics. Science. 2016;351(6273):564-5. doi: 10.1126/science.aac4951.

References 

1. National Human Genome Research Institute. Race. https://www.genome.gov/genetic-glossary /Race. Accessed December 27, 2021.
2. The American College of Obstetricians and Gynecologists. Joint Statement: Collective Action Addressing Racism. https://www.acog.org /news/news-articles/2020/08/joint-statementobstetrics-and-gynecology-collective-actionaddressing-racism.
3. O’Reilly KB. AMA: Racism is a threat to public health. November 16, 2020. https://www.ama -assn.org/delivering-care/health-equity/ama -racism-threat-public-health. Accessed December 27, 2021.

HOW TO CHOOSE THE RIGHT VAGINAL MOISTURIZER OR LUBRICANT FOR YOUR PATIENT

JOHN PENNYCUFF, MD, MSPH, AND CHERYL IGLESIA, MD (JUNE 2021)

Which vaginal products to recommend

We applaud Drs. Pennycuff and Iglesia for providing education on lubricants and vaginal moisturizers in their recent article, and agree that ObGyns, urogynecologists, and primary care providers should be aware of the types of products available. However, the authors underplayed the health risks associated with the use of poor-quality lubricants and moisturizers.

Women often turn to lubricants or vaginal moisturizers because they experience vaginal dryness during intercourse, related to menopause, and from certain medications. Vaginal fluid is primarily composed of exudate from capillaries in the vaginal wall. During sexual arousal, blood flow to the vaginal wall increases, and in turn, this should increase exudate. But chronic inflammation can suppress these increases in vaginal blood flow, preventing adequate vaginal fluid production. One such cause of chronic inflammation is using hyperosmolar lubricants, as this has been shown to negatively affect the vaginal epithelium.^1,2 In this way, use of hyperosmolar lubricants can actually worsen symptoms, creating a vicious circle of dryness, lubricant use, and worsening dryness.

In addition, hyperosmolar lubricants have been shown to reduce the epithelial barrier properties of the vaginal epithelium, increasing susceptibility to microbes associated with bacterial vaginosis and to true pathogens, including herpes simplex virus type 2.³ In fact, hyperosmolar lubricants are a serious enough problem that the World Health Organization has weighed in, recommending osmolality of personal lubricants be under 380 mOsm/kg to prevent damage to the vaginal epithelium.⁴

Appropriately acidic pH is just as critical as osmolality. Using products with a pH higher than 4.5 will reduce amounts of protective lactobacilli and other commensal vaginal bacteria, encouraging growth of opportunistic bacteria and yeast already present. This can lead to bacterial vaginosis, aerobic vaginitis, and candidiasis. Bacterial vaginosis can lead to other serious sequelae such as increased risk in acquisition of HIV infection and preterm birth in pregnancy. Unfortunately, much of the data cited in Drs. Pennycuff and Iglesia’s article were sourced from another study (by Edwards and Panay published in Climacteric in 2016), which measured product pH values with an inappropriately calibrated device; the study’s supplemental information stated that calibration was between 5 and 9, and so any measurement below 5 was invalid and subject to error. For example, the Good Clean Love lubricant is listed as having a pH of 4.7, but its pH is never higher than 4.4.

The products on the market that meet the dual criteria of appropriate pH and isotonicity to vaginal epithelial cells may be less well known to consumers. But this should not be a reason to encourage use of hyperosmolar products whose main selling point is that they are the “leading brand.” Educating women on their choices in personal lubricants should include a full discussion of product ingredients and properties, based upon the available literature to help them select a product that supports the health of their intimate tissues.

Members of the Scientific Advisory Board for the Sexual Health and Wellness Institute: Jill Krapf, MD, MEd, IF; Cathy Chung Hwa Yi, MD; Christine Enzmann, MD, PhD, NMCP; Susan Kellogg-Spadt, PhD, CRNP, IF, CSC, FCST; Betsy Greenleaf, DO, MBA; Elizabeth DuPriest, PhD

References

1. Dezzutti CS, Brown ER, Moncla B, et al. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One. 2012;7:e48328. doi: 10.1371/journal .pone.0048328.
2. Ayehunie S, Wang YY, Landry T, et al. Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a threedimensional vaginal epithelium model. Toxicol Rep. 2017;5:134-140. doi: 10.1016 /j.toxrep.2017.12.011.
3. Moench TR, Mumper RJ, Hoen TE, et al. Microbicide excipients can greatly increase susceptibility to genital herpes transmission in the mouse. BMC Infect Dis.  2010;10:331. doi: 10.1186/1471 -2334-10-331.
4. Use and procurement of additional lubricants for male and female condoms: WHO/UNFPA /FHI360 Advisory note. World Health Organization, 2012. http://apps.who.int/iris/bitstream /handle/10665/76580/WHO_RHR_12.33_eng .pdf?sequence=1. Accessed December 27, 2021.

Drs. Pennycuff And Iglesia Respond

We thank the members of the scientific advisory board for the Sexual Health and Wellness Institute for their thoughtful and insightful comments to our article. We agree with their comments on the importance of both pH and osmolality for vaginal moisturizers and lubricants. We also agree that selection of an incorrectly formulated product may lead to worsening of vulvovaginal symptoms as well as dysbiosis and all of its sequelae as the letter writers mentioned.

In writing the review article, we attempted to address the role that pH and osmolality play in vaginal moisturizers and lubricants and make clinicians more aware of the importance of these factors in product formulation. Our goal was to help to improve patient counseling. We tried to amass as much of the available literature as we could to act as a resource for practitioners, such as the table included in the article as well as the supplemental table included online. We hoped that by writing this article we would heighten awareness among female health practitioners about vaginal health products and encourage them to consider those products that may be better suited for their patients based on pH and osmolality.

While there remains a paucity of research on vaginal moisturizers and lubricants, there is even less consumer knowledge regarding ingredients and formulations of these products. We wholeheartedly agree with the scientific advisory board that we as health providers need to help educate women on the full spectrum of products available beyond the “leading brands.” Furthermore, we advocate that there be continued research on these products as well as more manufacturer transparency regarding not only the ingredients contained within these products but also the pH and osmolality. Simple steps such as these would ensure that providers could help counsel patients to make informed decisions regarding products for their pelvic health.

Continue to: DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES...

DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES

CASSANDRA CARBERRY, MD, MS; ANNETTA MADSEN, MD; OLIVIA CARDENAS-TROWERS, MD; OLUWATENIOLA BROWN, MD; MOIURI SIDDIQUE, MD; AND BLAIR WASHINGTON, MD, MHA (AUGUST 2021)

Dissenting opinion

“Race is real but it’s not biologic.” “Race is not based on genetic or biologic inheritance.” Am I the only one with a dissenting voice of opinion when it comes to these types of statements?

Scott Peters, MD

Oak Ridge, Tennessee

The Authors Respond

Thank you for your opinion, Dr. Peters. Although it is not completely clear what your question is, it seems that it concerns the validity of the idea that race is a social construct. We will address this question with the assumption that this letter was an effort to invite discussion and increase understanding.

The National Human Genome Research Institute describes race in this way: “Race is a fluid concept used to group people according to various factors, including ancestral background and social identity. Race is also used to group people that share a set of visible characteristics, such as skin color and facial features. Though these visible traits are influenced by genes, the vast majority of genetic variation exists within racial groups and not between them.”¹

The understanding that race is a social construct has been upheld by numerous medical organizations. In August 2020, a Joint Statement was published by the American College of Obstetricians and Gynecologists, the American Board of Obstetricians and Gynecologists, and 22 other organizations representing our specialty.  This document states: “Recognizing that race is a social construct, not biologically based, is important to understanding that racism, not race, impacts health care, health, and health outcomes.”²

This idea is also endorsed by the AMA, who in November 2020 adopted the following policies³:

• “Recognize that race is a social construct and is distinct from ethnicity, genetic ancestry, or biology
• Support ending the practice of using race as a proxy for biology or genetics in medical education, research, and clinical practice.”

There are numerous sources that further illuminate why race is a social construct. Here are a few:

• https://www.racepowerofanillusion .org/resources/
• https ://www.pewresearch.org /fact-tank/2020/02/25/the-changing -categories-the-u-s-has-used-to -measure-race/
• Roberts D. Fatal Invention: How Science, Politics and Big Business Re-create Race in the Twenty-First Century. The New Press. 2011.
• Yudell M, Roberts D, DeSalle R, et al. Science and society. Taking race out of human genetics. Science. 2016;351(6273):564-5. doi: 10.1126/science.aac4951.

References 

1. National Human Genome Research Institute. Race. https://www.genome.gov/genetic-glossary /Race. Accessed December 27, 2021.
2. The American College of Obstetricians and Gynecologists. Joint Statement: Collective Action Addressing Racism. https://www.acog.org /news/news-articles/2020/08/joint-statementobstetrics-and-gynecology-collective-actionaddressing-racism.
3. O’Reilly KB. AMA: Racism is a threat to public health. November 16, 2020. https://www.ama -assn.org/delivering-care/health-equity/ama -racism-threat-public-health. Accessed December 27, 2021.

One of the unexpected consequences of the pandemic is that many people are rethinking their priorities and lifestyles, and physicians are no exception.

This year’s Medscape Physician Lifestyle and Happiness Report surveyed more than 10,000 physicians in 29 specialties about how they are prioritizing wellness, work-life balance, and their family lives during this challenging time.

Pets, prayer, and partners

The pandemic has taken a toll on physicians outside of work as well as on the job. Eight in 10 physicians (82% of men and 80% of women) said they were “somewhat” or “very” happy outside of work before the pandemic. This is almost exactly the same result as in last year’s survey.

However, when asked how happy they are outside of work currently, only 6 in 10 (59%) reported being “somewhat” or “very” happy. While the pandemic has made life difficult for everyone, health care professionals face particular stresses even outside of work. Wayne M. Sotile, PhD, founder of the Center for Physician Resilience, says he has counseled doctors who witnessed COVID-related suffering and death at work, then came home to a partner who didn’t believe that the pandemic was real.

Still, physicians reported that spending time with people they love and engaging in favorite activities helps them stay happy. “Spending time with pets” and “religious practice/prayer” were frequent “other” responses to the question, “What do you do to maintain happiness and mental health?” Seven in 10 physicians reported having some kind of religious or spiritual beliefs.

The majority of physicians (83%) are either married or living with a partner, with male physicians edging out their female peers (89% vs. 75%). Among married physicians, 8 in 10 physicians reported that their union is “good” or “very good.” The pandemic may have helped in this respect. Dr. Sotile says he’s heard physicians say that they’ve connected more with their families in the past 18 months. Specialists with the highest rates of happy marriages were otolaryngologists and immunologists (both 91%), followed closely by dermatologists, rheumatologists, and nephrologists (all 90%).

Among physicians balancing a medical career and parenthood, female physicians reported feeling conflicted more often than males (48% vs. 29%). Nicole A. Sparks, MD, an ob.gyn. and a health and lifestyle blogger, cites not being there for her kids as a source of stress. She notes that her two young children notice when she’s not there to help with homework, read bedtime stories, or make their dinner. “Mom guilt can definitely set in if I have to miss important events,” she says.

Work-life balance is an important, if elusive, goal for physicians, and not just females. Sixty percent of female doctors and 53% of male doctors said they would be willing to take a cut in pay if it meant more free time and a better work-life balance. Many doctors do manage to get away from work occasionally, with one-fifth of all physicians taking 5 or more weeks of vacation each year.

Seeking a ‘balanced life’

Alexis Polles, MD, medical director for the Professionals Resource Network, points out the importance of taking time for personal health and wellness. “When we work with professionals who have problems with mental health or substance abuse, they often don’t have a balanced life,” she says. “They are usually in a workaholic mindset and disregard their own needs.”

Few physicians seem to prioritize self-care, with a third indicating they “always” or “most of the time” spend enough time on their own health and wellness. But of those who do, males (38%) are more likely than females (27%) to spend enough time on their own health and wellness. Dr. Polles adds that exercising after a shift can help physicians better make the transition from professional to personal life. Though they did not report when they exercised, about a third of physicians reported doing so four or more times per week. Controlling weight is an issue as well, with 49% of male and 55% of female physicians saying they are currently trying to lose weight.

Of physicians who drink alcohol, about a third have three or more drinks per week. (The CDC defines “heavy drinking” as consuming 15 drinks or more per week for men and eight drinks or more per week for women.)

Of those surveyed, 92% say they do not regularly use cannabidiol or cannabis, and a mere 4% of respondents said they would use at least one of these substances if they were to become legal in their state.

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

One of the unexpected consequences of the pandemic is that many people are rethinking their priorities and lifestyles, and physicians are no exception.

This year’s Medscape Physician Lifestyle and Happiness Report surveyed more than 10,000 physicians in 29 specialties about how they are prioritizing wellness, work-life balance, and their family lives during this challenging time.

Pets, prayer, and partners

The pandemic has taken a toll on physicians outside of work as well as on the job. Eight in 10 physicians (82% of men and 80% of women) said they were “somewhat” or “very” happy outside of work before the pandemic. This is almost exactly the same result as in last year’s survey.

However, when asked how happy they are outside of work currently, only 6 in 10 (59%) reported being “somewhat” or “very” happy. While the pandemic has made life difficult for everyone, health care professionals face particular stresses even outside of work. Wayne M. Sotile, PhD, founder of the Center for Physician Resilience, says he has counseled doctors who witnessed COVID-related suffering and death at work, then came home to a partner who didn’t believe that the pandemic was real.

Still, physicians reported that spending time with people they love and engaging in favorite activities helps them stay happy. “Spending time with pets” and “religious practice/prayer” were frequent “other” responses to the question, “What do you do to maintain happiness and mental health?” Seven in 10 physicians reported having some kind of religious or spiritual beliefs.

The majority of physicians (83%) are either married or living with a partner, with male physicians edging out their female peers (89% vs. 75%). Among married physicians, 8 in 10 physicians reported that their union is “good” or “very good.” The pandemic may have helped in this respect. Dr. Sotile says he’s heard physicians say that they’ve connected more with their families in the past 18 months. Specialists with the highest rates of happy marriages were otolaryngologists and immunologists (both 91%), followed closely by dermatologists, rheumatologists, and nephrologists (all 90%).

Among physicians balancing a medical career and parenthood, female physicians reported feeling conflicted more often than males (48% vs. 29%). Nicole A. Sparks, MD, an ob.gyn. and a health and lifestyle blogger, cites not being there for her kids as a source of stress. She notes that her two young children notice when she’s not there to help with homework, read bedtime stories, or make their dinner. “Mom guilt can definitely set in if I have to miss important events,” she says.

Work-life balance is an important, if elusive, goal for physicians, and not just females. Sixty percent of female doctors and 53% of male doctors said they would be willing to take a cut in pay if it meant more free time and a better work-life balance. Many doctors do manage to get away from work occasionally, with one-fifth of all physicians taking 5 or more weeks of vacation each year.

Seeking a ‘balanced life’

Alexis Polles, MD, medical director for the Professionals Resource Network, points out the importance of taking time for personal health and wellness. “When we work with professionals who have problems with mental health or substance abuse, they often don’t have a balanced life,” she says. “They are usually in a workaholic mindset and disregard their own needs.”

Few physicians seem to prioritize self-care, with a third indicating they “always” or “most of the time” spend enough time on their own health and wellness. But of those who do, males (38%) are more likely than females (27%) to spend enough time on their own health and wellness. Dr. Polles adds that exercising after a shift can help physicians better make the transition from professional to personal life. Though they did not report when they exercised, about a third of physicians reported doing so four or more times per week. Controlling weight is an issue as well, with 49% of male and 55% of female physicians saying they are currently trying to lose weight.

Of physicians who drink alcohol, about a third have three or more drinks per week. (The CDC defines “heavy drinking” as consuming 15 drinks or more per week for men and eight drinks or more per week for women.)

Of those surveyed, 92% say they do not regularly use cannabidiol or cannabis, and a mere 4% of respondents said they would use at least one of these substances if they were to become legal in their state.

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

One of the unexpected consequences of the pandemic is that many people are rethinking their priorities and lifestyles, and physicians are no exception.

This year’s Medscape Physician Lifestyle and Happiness Report surveyed more than 10,000 physicians in 29 specialties about how they are prioritizing wellness, work-life balance, and their family lives during this challenging time.

Pets, prayer, and partners

The pandemic has taken a toll on physicians outside of work as well as on the job. Eight in 10 physicians (82% of men and 80% of women) said they were “somewhat” or “very” happy outside of work before the pandemic. This is almost exactly the same result as in last year’s survey.

However, when asked how happy they are outside of work currently, only 6 in 10 (59%) reported being “somewhat” or “very” happy. While the pandemic has made life difficult for everyone, health care professionals face particular stresses even outside of work. Wayne M. Sotile, PhD, founder of the Center for Physician Resilience, says he has counseled doctors who witnessed COVID-related suffering and death at work, then came home to a partner who didn’t believe that the pandemic was real.

Still, physicians reported that spending time with people they love and engaging in favorite activities helps them stay happy. “Spending time with pets” and “religious practice/prayer” were frequent “other” responses to the question, “What do you do to maintain happiness and mental health?” Seven in 10 physicians reported having some kind of religious or spiritual beliefs.

The majority of physicians (83%) are either married or living with a partner, with male physicians edging out their female peers (89% vs. 75%). Among married physicians, 8 in 10 physicians reported that their union is “good” or “very good.” The pandemic may have helped in this respect. Dr. Sotile says he’s heard physicians say that they’ve connected more with their families in the past 18 months. Specialists with the highest rates of happy marriages were otolaryngologists and immunologists (both 91%), followed closely by dermatologists, rheumatologists, and nephrologists (all 90%).

Among physicians balancing a medical career and parenthood, female physicians reported feeling conflicted more often than males (48% vs. 29%). Nicole A. Sparks, MD, an ob.gyn. and a health and lifestyle blogger, cites not being there for her kids as a source of stress. She notes that her two young children notice when she’s not there to help with homework, read bedtime stories, or make their dinner. “Mom guilt can definitely set in if I have to miss important events,” she says.

Work-life balance is an important, if elusive, goal for physicians, and not just females. Sixty percent of female doctors and 53% of male doctors said they would be willing to take a cut in pay if it meant more free time and a better work-life balance. Many doctors do manage to get away from work occasionally, with one-fifth of all physicians taking 5 or more weeks of vacation each year.

Seeking a ‘balanced life’

Alexis Polles, MD, medical director for the Professionals Resource Network, points out the importance of taking time for personal health and wellness. “When we work with professionals who have problems with mental health or substance abuse, they often don’t have a balanced life,” she says. “They are usually in a workaholic mindset and disregard their own needs.”

Few physicians seem to prioritize self-care, with a third indicating they “always” or “most of the time” spend enough time on their own health and wellness. But of those who do, males (38%) are more likely than females (27%) to spend enough time on their own health and wellness. Dr. Polles adds that exercising after a shift can help physicians better make the transition from professional to personal life. Though they did not report when they exercised, about a third of physicians reported doing so four or more times per week. Controlling weight is an issue as well, with 49% of male and 55% of female physicians saying they are currently trying to lose weight.

Of physicians who drink alcohol, about a third have three or more drinks per week. (The CDC defines “heavy drinking” as consuming 15 drinks or more per week for men and eight drinks or more per week for women.)

Of those surveyed, 92% say they do not regularly use cannabidiol or cannabis, and a mere 4% of respondents said they would use at least one of these substances if they were to become legal in their state.

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

A new analysis of data from a major U.S. trial comparing antibiotics with surgery for appendicitis yielded more information that can help patients weigh options for treatment.

The presence of mineralized stool, known as appendicolith, was associated with a nearly twofold increased risk of undergoing appendectomy within 30 days of initiating antibiotics, write David Flum, MD, of the University of Washington, Seattle, and coauthors in a paper published in JAMA Surgery on Jan. 12, 2021.

But the surprise was the lack of an association between appendectomy and factors often presumed to be consistent with more severe appendicitis.

Physicians have had their own ideas about what factors make a patient more likely to need an appendectomy after an initial round of treatment with antibiotics, such as a high white blood cell count or a perforation seen on CT scan, Dr. Flum said in an interview. But the research didn’t support some of these theories.

“This is why we do the studies,” Dr. Flum said. “Sometimes we find out that our hunches were wrong.”

Dr. Flum and coauthors measured the association between different patient factors and disease severity and the need for appendectomy following a course of antibiotics. They used adjusted odds ratios to describe these relationships while accounting for other differences.

An OR of 1.0 – or when the confidence interval around an OR crosses 1 – signals that there is no association between that factor and appendectomy. Positive ORs with confidence intervals that exclude 1.0 suggest the factor was associated with appendectomy.

The OR was 1.99 for the presence of appendicolith, a finding with a 95% confidence interval of 1.28-3.10. The OR was 1.53 (95% CI, 1.01-2.31) for female sex.

But the OR was 1.14 (95% CI, 0.66-1.98) for perforation, abscess, or fat stranding.

The OR was 1.09 (95% CI, 1.00-1.18) for radiographic finding of a larger appendix, as measured by diameter.

And the OR was 1.03 (95% CI, 0.98-1.09) for having a higher white blood cell count, as measured by a 1,000-cells/mcL increase.
 

Appy or not?

This paper draws from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial (NCT02800785), for which top-line results were published in 2020 in the New England Journal of Medicine. In that paper, Dr. Flum and colleagues reported on results for 1,552 adults (414 with an appendicolith) who were evenly randomized to either antibiotics treatment or appendectomy. After 30 days, antibiotics were found to be noninferior to appendectomy, as reported by this news organization.

The federal Patient-Centered Outcomes Research Institute funded the CODA research. Dr. Flum said the National Institutes of Health had not appeared interested in funding a look at the different options available to patients experiencing appendicitis. Congress created PCORI as part of the Affordable Care Act of 2010, seeking to encourage researchers to study which treatments best serve patients through direct comparisons. Its support was critical for Dr. Flum and colleagues in seeking to help people weigh their options for treating appendicitis.

The CODA study “models what the patient’s experience is like, and this has not been the focus of NIH as much,” Dr. Flum said.

The CODA team has sought to make it easy for patients to consider what its findings and other research on appendicitis mean for them. They created an online decision-making tool, available at the aptly named http://www.appyornot.org/ website, which has videos in English and Spanish explaining patients’ options in simple terms. The website also asks questions about personal preferences, priorities, and resources to help them choose a treatment based on their individual situation.
 

Shift away from ‘paternalistic framing’

In the past, surgeons focused on the risk for patients from procedures, making the decisions for them about whether or not to proceed. There’s now a drive to shift away from this “paternalistic framing” toward shared decision-making, Dr. Flum said.

Surgeons need to have conversations with their patients about what’s happening in their lives as well as to assess their fears and concerns about treatment options, he said. These are aspects of patient care that were not covered in medical school or surgical training, but they lead to “less paternalistic” treatment. A patient’s decision about whether to choose surgery or antibiotics for appendicitis may hinge on factors such as insurance coverage, access to childcare, and the ability to miss days of work.

Dr. Flum said his fellow surgeons by and large have reacted well to the CODA team’s work.

“To their credit, the surgical community has embraced a healthy skepticism about the role of surgery,” Dr. Flum said.

The guidelines of the American College of Surgeons state that there is “high-quality evidence” that most patients with appendicitis can be managed with antibiotics instead of appendectomy (69% overall avoid appendectomy by 90 days, 75% of those without appendicolith, and 59% of those with appendicolith).

“Based on the surgeon’s judgment, patient preferences, and local resources (e.g., hospital staff, bed, and PPE supply availability) antibiotics are an acceptable first-line treatment, with appendectomy offered for those with worsening or recurrent symptoms,” the ACS guidelines say.

In an interview, Samir M. Fakhry, MD, vice president of HCA Center for Trauma and Acute Care Surgery Research in Nashville, Tenn., agreed with Dr. Flum about the shift taking place in medicine.

The CODA research, including the new paper in JAMA Surgery, makes it easier for physicians to work with patients and their families to reach decisions about how to treat appendicitis, Dr. Fakhry said.

These important discussions take time, he said, and patients must be allowed that time. Patients might feel misled, for example, if a surgeon pressed for appendectomy without explaining that a course of antibiotics may have served them well. Other patients may opt for surgery right away, especially in cases with appendicoliths, to avoid the potential for repeat episodes of medical care.

“You’ve got people who just want to get it done and over with. You’ve got people who want to avoid surgery no matter what,” Dr. Fakhry said. “It’s not just about the science and the data.”

This study was supported by a grant from PCORI. The authors reported having served as consultants or reviewers or have received fees for work outside of this paper from Stryker, Kerecis, Acera, Medline, Shriner’s Research Fund, UpToDate, and Tetraphase Pharmaceuticals Stryker.

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

A new analysis of data from a major U.S. trial comparing antibiotics with surgery for appendicitis yielded more information that can help patients weigh options for treatment.

The presence of mineralized stool, known as appendicolith, was associated with a nearly twofold increased risk of undergoing appendectomy within 30 days of initiating antibiotics, write David Flum, MD, of the University of Washington, Seattle, and coauthors in a paper published in JAMA Surgery on Jan. 12, 2021.

But the surprise was the lack of an association between appendectomy and factors often presumed to be consistent with more severe appendicitis.

Physicians have had their own ideas about what factors make a patient more likely to need an appendectomy after an initial round of treatment with antibiotics, such as a high white blood cell count or a perforation seen on CT scan, Dr. Flum said in an interview. But the research didn’t support some of these theories.

“This is why we do the studies,” Dr. Flum said. “Sometimes we find out that our hunches were wrong.”

Dr. Flum and coauthors measured the association between different patient factors and disease severity and the need for appendectomy following a course of antibiotics. They used adjusted odds ratios to describe these relationships while accounting for other differences.

An OR of 1.0 – or when the confidence interval around an OR crosses 1 – signals that there is no association between that factor and appendectomy. Positive ORs with confidence intervals that exclude 1.0 suggest the factor was associated with appendectomy.

The OR was 1.99 for the presence of appendicolith, a finding with a 95% confidence interval of 1.28-3.10. The OR was 1.53 (95% CI, 1.01-2.31) for female sex.

But the OR was 1.14 (95% CI, 0.66-1.98) for perforation, abscess, or fat stranding.

The OR was 1.09 (95% CI, 1.00-1.18) for radiographic finding of a larger appendix, as measured by diameter.

And the OR was 1.03 (95% CI, 0.98-1.09) for having a higher white blood cell count, as measured by a 1,000-cells/mcL increase.
 

Appy or not?

This paper draws from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial (NCT02800785), for which top-line results were published in 2020 in the New England Journal of Medicine. In that paper, Dr. Flum and colleagues reported on results for 1,552 adults (414 with an appendicolith) who were evenly randomized to either antibiotics treatment or appendectomy. After 30 days, antibiotics were found to be noninferior to appendectomy, as reported by this news organization.

The federal Patient-Centered Outcomes Research Institute funded the CODA research. Dr. Flum said the National Institutes of Health had not appeared interested in funding a look at the different options available to patients experiencing appendicitis. Congress created PCORI as part of the Affordable Care Act of 2010, seeking to encourage researchers to study which treatments best serve patients through direct comparisons. Its support was critical for Dr. Flum and colleagues in seeking to help people weigh their options for treating appendicitis.

The CODA study “models what the patient’s experience is like, and this has not been the focus of NIH as much,” Dr. Flum said.

The CODA team has sought to make it easy for patients to consider what its findings and other research on appendicitis mean for them. They created an online decision-making tool, available at the aptly named http://www.appyornot.org/ website, which has videos in English and Spanish explaining patients’ options in simple terms. The website also asks questions about personal preferences, priorities, and resources to help them choose a treatment based on their individual situation.
 

Shift away from ‘paternalistic framing’

In the past, surgeons focused on the risk for patients from procedures, making the decisions for them about whether or not to proceed. There’s now a drive to shift away from this “paternalistic framing” toward shared decision-making, Dr. Flum said.

Surgeons need to have conversations with their patients about what’s happening in their lives as well as to assess their fears and concerns about treatment options, he said. These are aspects of patient care that were not covered in medical school or surgical training, but they lead to “less paternalistic” treatment. A patient’s decision about whether to choose surgery or antibiotics for appendicitis may hinge on factors such as insurance coverage, access to childcare, and the ability to miss days of work.

Dr. Flum said his fellow surgeons by and large have reacted well to the CODA team’s work.

“To their credit, the surgical community has embraced a healthy skepticism about the role of surgery,” Dr. Flum said.

The guidelines of the American College of Surgeons state that there is “high-quality evidence” that most patients with appendicitis can be managed with antibiotics instead of appendectomy (69% overall avoid appendectomy by 90 days, 75% of those without appendicolith, and 59% of those with appendicolith).

“Based on the surgeon’s judgment, patient preferences, and local resources (e.g., hospital staff, bed, and PPE supply availability) antibiotics are an acceptable first-line treatment, with appendectomy offered for those with worsening or recurrent symptoms,” the ACS guidelines say.

In an interview, Samir M. Fakhry, MD, vice president of HCA Center for Trauma and Acute Care Surgery Research in Nashville, Tenn., agreed with Dr. Flum about the shift taking place in medicine.

The CODA research, including the new paper in JAMA Surgery, makes it easier for physicians to work with patients and their families to reach decisions about how to treat appendicitis, Dr. Fakhry said.

These important discussions take time, he said, and patients must be allowed that time. Patients might feel misled, for example, if a surgeon pressed for appendectomy without explaining that a course of antibiotics may have served them well. Other patients may opt for surgery right away, especially in cases with appendicoliths, to avoid the potential for repeat episodes of medical care.

“You’ve got people who just want to get it done and over with. You’ve got people who want to avoid surgery no matter what,” Dr. Fakhry said. “It’s not just about the science and the data.”

This study was supported by a grant from PCORI. The authors reported having served as consultants or reviewers or have received fees for work outside of this paper from Stryker, Kerecis, Acera, Medline, Shriner’s Research Fund, UpToDate, and Tetraphase Pharmaceuticals Stryker.

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

A new analysis of data from a major U.S. trial comparing antibiotics with surgery for appendicitis yielded more information that can help patients weigh options for treatment.

The presence of mineralized stool, known as appendicolith, was associated with a nearly twofold increased risk of undergoing appendectomy within 30 days of initiating antibiotics, write David Flum, MD, of the University of Washington, Seattle, and coauthors in a paper published in JAMA Surgery on Jan. 12, 2021.

But the surprise was the lack of an association between appendectomy and factors often presumed to be consistent with more severe appendicitis.

Physicians have had their own ideas about what factors make a patient more likely to need an appendectomy after an initial round of treatment with antibiotics, such as a high white blood cell count or a perforation seen on CT scan, Dr. Flum said in an interview. But the research didn’t support some of these theories.

“This is why we do the studies,” Dr. Flum said. “Sometimes we find out that our hunches were wrong.”

Dr. Flum and coauthors measured the association between different patient factors and disease severity and the need for appendectomy following a course of antibiotics. They used adjusted odds ratios to describe these relationships while accounting for other differences.

An OR of 1.0 – or when the confidence interval around an OR crosses 1 – signals that there is no association between that factor and appendectomy. Positive ORs with confidence intervals that exclude 1.0 suggest the factor was associated with appendectomy.

The OR was 1.99 for the presence of appendicolith, a finding with a 95% confidence interval of 1.28-3.10. The OR was 1.53 (95% CI, 1.01-2.31) for female sex.

But the OR was 1.14 (95% CI, 0.66-1.98) for perforation, abscess, or fat stranding.

The OR was 1.09 (95% CI, 1.00-1.18) for radiographic finding of a larger appendix, as measured by diameter.

And the OR was 1.03 (95% CI, 0.98-1.09) for having a higher white blood cell count, as measured by a 1,000-cells/mcL increase.
 

Appy or not?

This paper draws from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial (NCT02800785), for which top-line results were published in 2020 in the New England Journal of Medicine. In that paper, Dr. Flum and colleagues reported on results for 1,552 adults (414 with an appendicolith) who were evenly randomized to either antibiotics treatment or appendectomy. After 30 days, antibiotics were found to be noninferior to appendectomy, as reported by this news organization.

The federal Patient-Centered Outcomes Research Institute funded the CODA research. Dr. Flum said the National Institutes of Health had not appeared interested in funding a look at the different options available to patients experiencing appendicitis. Congress created PCORI as part of the Affordable Care Act of 2010, seeking to encourage researchers to study which treatments best serve patients through direct comparisons. Its support was critical for Dr. Flum and colleagues in seeking to help people weigh their options for treating appendicitis.

The CODA study “models what the patient’s experience is like, and this has not been the focus of NIH as much,” Dr. Flum said.

The CODA team has sought to make it easy for patients to consider what its findings and other research on appendicitis mean for them. They created an online decision-making tool, available at the aptly named http://www.appyornot.org/ website, which has videos in English and Spanish explaining patients’ options in simple terms. The website also asks questions about personal preferences, priorities, and resources to help them choose a treatment based on their individual situation.
 

Shift away from ‘paternalistic framing’

In the past, surgeons focused on the risk for patients from procedures, making the decisions for them about whether or not to proceed. There’s now a drive to shift away from this “paternalistic framing” toward shared decision-making, Dr. Flum said.

Surgeons need to have conversations with their patients about what’s happening in their lives as well as to assess their fears and concerns about treatment options, he said. These are aspects of patient care that were not covered in medical school or surgical training, but they lead to “less paternalistic” treatment. A patient’s decision about whether to choose surgery or antibiotics for appendicitis may hinge on factors such as insurance coverage, access to childcare, and the ability to miss days of work.

Dr. Flum said his fellow surgeons by and large have reacted well to the CODA team’s work.

“To their credit, the surgical community has embraced a healthy skepticism about the role of surgery,” Dr. Flum said.

The guidelines of the American College of Surgeons state that there is “high-quality evidence” that most patients with appendicitis can be managed with antibiotics instead of appendectomy (69% overall avoid appendectomy by 90 days, 75% of those without appendicolith, and 59% of those with appendicolith).

“Based on the surgeon’s judgment, patient preferences, and local resources (e.g., hospital staff, bed, and PPE supply availability) antibiotics are an acceptable first-line treatment, with appendectomy offered for those with worsening or recurrent symptoms,” the ACS guidelines say.

In an interview, Samir M. Fakhry, MD, vice president of HCA Center for Trauma and Acute Care Surgery Research in Nashville, Tenn., agreed with Dr. Flum about the shift taking place in medicine.

The CODA research, including the new paper in JAMA Surgery, makes it easier for physicians to work with patients and their families to reach decisions about how to treat appendicitis, Dr. Fakhry said.

These important discussions take time, he said, and patients must be allowed that time. Patients might feel misled, for example, if a surgeon pressed for appendectomy without explaining that a course of antibiotics may have served them well. Other patients may opt for surgery right away, especially in cases with appendicoliths, to avoid the potential for repeat episodes of medical care.

“You’ve got people who just want to get it done and over with. You’ve got people who want to avoid surgery no matter what,” Dr. Fakhry said. “It’s not just about the science and the data.”

This study was supported by a grant from PCORI. The authors reported having served as consultants or reviewers or have received fees for work outside of this paper from Stryker, Kerecis, Acera, Medline, Shriner’s Research Fund, UpToDate, and Tetraphase Pharmaceuticals Stryker.

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

A majority of adults support the use of medical cannabis for the treatment of skin conditions, but relatively few have actually tried such a product, according to the results of a recent survey.

Almost 89% of respondents were in favor of medical cannabis use for dermatologic diseases, and 73% said that they would be comfortable seeing a dermatologist who recommended such products to them, Samuel Yeroushalmi, a 4th-year medical student at George Washington University, Washington, and associates reported.

“Consumers and patients are already using MCPs [medical cannabis products] to treat inflammatory skin conditions, such as acne, rosacea, atopic dermatitis, and psoriasis, even without guidance from a dermatologist. While acceptance was high, there were clear barriers reported limiting use and uptake, such as patient skepticism and a lack of understanding,” Adam Friedman, MD, senior author and chair of the department of dermatology at the university, said in a separate statement.

Dermatologic use of OTC cannabis products without the recommendation of a dermatologist was reported by 18% of the 504 of 700 adults who responded in the SurveyMonkey online panel. Of the two-thirds who had seen a dermatologist, 20% received a recommendation for an OTC product and 11% were recommended a product that required a department of health medical card, the investigators said.

Uptake among the patients who did receive a recommendation, however, was high: 76% for OTC products and 72% for those that required a medical card. Among those who had received an OTC recommendation, 32% used the cannabis product for psoriasis and 30% each for acne and rosacea, Mr. Yeroushalmi and his coauthors said.

The most common indication among the respondents with dermatologist recommendations for products requiring a medical card was for acne (68%), followed by psoriasis and rosacea (28% each). Cost was the main deterrent (60%) for those who declined to use the recommended cannabis product, with skepticism, limited understanding, and product illegality in their state each at 50%, the researchers said.

“Though cost and legality concerns are nonmodifiable barriers, dermatologists have an opportunity to educate those who know little in the way of medical cannabis or are skeptic[s],” they wrote. The survey results show that many patients are interested, and “the future should be bright for MCPs; we just need to show and disseminate the science,” Dr. Friedman commented in the statement.

One of the authors was from the University of Maryland, College Park. The authors had no disclosures to report.

A majority of adults support the use of medical cannabis for the treatment of skin conditions, but relatively few have actually tried such a product, according to the results of a recent survey.

Almost 89% of respondents were in favor of medical cannabis use for dermatologic diseases, and 73% said that they would be comfortable seeing a dermatologist who recommended such products to them, Samuel Yeroushalmi, a 4th-year medical student at George Washington University, Washington, and associates reported.

“Consumers and patients are already using MCPs [medical cannabis products] to treat inflammatory skin conditions, such as acne, rosacea, atopic dermatitis, and psoriasis, even without guidance from a dermatologist. While acceptance was high, there were clear barriers reported limiting use and uptake, such as patient skepticism and a lack of understanding,” Adam Friedman, MD, senior author and chair of the department of dermatology at the university, said in a separate statement.

Dermatologic use of OTC cannabis products without the recommendation of a dermatologist was reported by 18% of the 504 of 700 adults who responded in the SurveyMonkey online panel. Of the two-thirds who had seen a dermatologist, 20% received a recommendation for an OTC product and 11% were recommended a product that required a department of health medical card, the investigators said.

Uptake among the patients who did receive a recommendation, however, was high: 76% for OTC products and 72% for those that required a medical card. Among those who had received an OTC recommendation, 32% used the cannabis product for psoriasis and 30% each for acne and rosacea, Mr. Yeroushalmi and his coauthors said.

The most common indication among the respondents with dermatologist recommendations for products requiring a medical card was for acne (68%), followed by psoriasis and rosacea (28% each). Cost was the main deterrent (60%) for those who declined to use the recommended cannabis product, with skepticism, limited understanding, and product illegality in their state each at 50%, the researchers said.

“Though cost and legality concerns are nonmodifiable barriers, dermatologists have an opportunity to educate those who know little in the way of medical cannabis or are skeptic[s],” they wrote. The survey results show that many patients are interested, and “the future should be bright for MCPs; we just need to show and disseminate the science,” Dr. Friedman commented in the statement.

One of the authors was from the University of Maryland, College Park. The authors had no disclosures to report.

A majority of adults support the use of medical cannabis for the treatment of skin conditions, but relatively few have actually tried such a product, according to the results of a recent survey.

Almost 89% of respondents were in favor of medical cannabis use for dermatologic diseases, and 73% said that they would be comfortable seeing a dermatologist who recommended such products to them, Samuel Yeroushalmi, a 4th-year medical student at George Washington University, Washington, and associates reported.

“Consumers and patients are already using MCPs [medical cannabis products] to treat inflammatory skin conditions, such as acne, rosacea, atopic dermatitis, and psoriasis, even without guidance from a dermatologist. While acceptance was high, there were clear barriers reported limiting use and uptake, such as patient skepticism and a lack of understanding,” Adam Friedman, MD, senior author and chair of the department of dermatology at the university, said in a separate statement.

Dermatologic use of OTC cannabis products without the recommendation of a dermatologist was reported by 18% of the 504 of 700 adults who responded in the SurveyMonkey online panel. Of the two-thirds who had seen a dermatologist, 20% received a recommendation for an OTC product and 11% were recommended a product that required a department of health medical card, the investigators said.

Uptake among the patients who did receive a recommendation, however, was high: 76% for OTC products and 72% for those that required a medical card. Among those who had received an OTC recommendation, 32% used the cannabis product for psoriasis and 30% each for acne and rosacea, Mr. Yeroushalmi and his coauthors said.

The most common indication among the respondents with dermatologist recommendations for products requiring a medical card was for acne (68%), followed by psoriasis and rosacea (28% each). Cost was the main deterrent (60%) for those who declined to use the recommended cannabis product, with skepticism, limited understanding, and product illegality in their state each at 50%, the researchers said.

“Though cost and legality concerns are nonmodifiable barriers, dermatologists have an opportunity to educate those who know little in the way of medical cannabis or are skeptic[s],” they wrote. The survey results show that many patients are interested, and “the future should be bright for MCPs; we just need to show and disseminate the science,” Dr. Friedman commented in the statement.

One of the authors was from the University of Maryland, College Park. The authors had no disclosures to report.

An adult brain contains about 86 billion neurons and even more supercomputing power to closely monitor the entire human brain.

All those neurons have trillions of synapses – or connection points – that make up the circuitry the brain uses to control everything we do from reasoning to breathing to walking. And scientists with the Human Brain Project are trying to build new computing tools that can zoom in on every one of these synapses, peer inside cells, and zoom out to focus on entire regions of the brain at once.

Imaging the human brain at the cellular level would require several petabytes of data, researchers from the Human Brain Project report in Science. If you have an old smartphone or tablet with 32GB of storage, you’d need more than 31,000 of them to get a single petabyte of storage.

Using an electron microscope to image the entire brain would require more than one exabyte of data, the scientists point out. That’s more than a million petabytes.

Giacomo Indiveri, PhD, professor of neuroinformatics at the University of Zurich, Switzerland, says we need to fundamentally change the way we build computers. Delivering the keynote address at the Human Brain Project Summit in October, he warned we will use 20% of all the world’s electricity on computing by the year 2025.

To meet the computing challenges posed by the quest to map every bit of the human brain, researchers are working to produce the first two exascale supercomputers within the next 5 years. When they’re done, these machines will provide brain scientists with supercomputers powerful enough to explore the human brain in all its complexities.

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

An adult brain contains about 86 billion neurons and even more supercomputing power to closely monitor the entire human brain.

All those neurons have trillions of synapses – or connection points – that make up the circuitry the brain uses to control everything we do from reasoning to breathing to walking. And scientists with the Human Brain Project are trying to build new computing tools that can zoom in on every one of these synapses, peer inside cells, and zoom out to focus on entire regions of the brain at once.

Imaging the human brain at the cellular level would require several petabytes of data, researchers from the Human Brain Project report in Science. If you have an old smartphone or tablet with 32GB of storage, you’d need more than 31,000 of them to get a single petabyte of storage.

Using an electron microscope to image the entire brain would require more than one exabyte of data, the scientists point out. That’s more than a million petabytes.

Giacomo Indiveri, PhD, professor of neuroinformatics at the University of Zurich, Switzerland, says we need to fundamentally change the way we build computers. Delivering the keynote address at the Human Brain Project Summit in October, he warned we will use 20% of all the world’s electricity on computing by the year 2025.

To meet the computing challenges posed by the quest to map every bit of the human brain, researchers are working to produce the first two exascale supercomputers within the next 5 years. When they’re done, these machines will provide brain scientists with supercomputers powerful enough to explore the human brain in all its complexities.

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

An adult brain contains about 86 billion neurons and even more supercomputing power to closely monitor the entire human brain.

All those neurons have trillions of synapses – or connection points – that make up the circuitry the brain uses to control everything we do from reasoning to breathing to walking. And scientists with the Human Brain Project are trying to build new computing tools that can zoom in on every one of these synapses, peer inside cells, and zoom out to focus on entire regions of the brain at once.

Imaging the human brain at the cellular level would require several petabytes of data, researchers from the Human Brain Project report in Science. If you have an old smartphone or tablet with 32GB of storage, you’d need more than 31,000 of them to get a single petabyte of storage.

Using an electron microscope to image the entire brain would require more than one exabyte of data, the scientists point out. That’s more than a million petabytes.

Giacomo Indiveri, PhD, professor of neuroinformatics at the University of Zurich, Switzerland, says we need to fundamentally change the way we build computers. Delivering the keynote address at the Human Brain Project Summit in October, he warned we will use 20% of all the world’s electricity on computing by the year 2025.

To meet the computing challenges posed by the quest to map every bit of the human brain, researchers are working to produce the first two exascale supercomputers within the next 5 years. When they’re done, these machines will provide brain scientists with supercomputers powerful enough to explore the human brain in all its complexities.

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

The Isotretinoin Products Manufacturers Group (IPMG) reports that most users of the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) should now have access to their accounts, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.

The IPMG has “created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal,” the FDA statement said.

“Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account,” and users should check their emails for messages from iPLEDGE, including spam folders, the FDA advises. The iPLEDGE strategy is designed to prevent fetal exposure to isotretinoin, which is highly teratogenic.

Days after the new, gender-neutral approach to the isotretinoin risk mitigation program was launched on Dec. 13, the FDA convened an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the problematic rollout of the program, which was described as disastrous, chaotic, and a failure, with dermatologists on Twitter and elsewhere expressing anger and frustration over not being able to access the program or reach the call center.

A statement by the FDA on Dec. 23 followed, urging manufacturers to develop solutions for the website and to work with the AADA and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition.

The modified REMS, launched on Dec. 13, is designed to make it more inclusive for transgender patients prescribed isotretinoin. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), patients who are prescribed isotretinoin for acne are assigned to one of two risk categories: those who can get pregnant and those who cannot get pregnant.

In the Jan. 14 statement, the FDA notes that the agency is continuing to work with the IPMG regarding the problems clinicians, pharmacists, and patients have had with accessing iPLEDGE over the last month.

“Although there has been progress, there is a significant amount of work still to be done,” the FDA acknowledged. “While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users.”

The Isotretinoin Products Manufacturers Group (IPMG) reports that most users of the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) should now have access to their accounts, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.

The IPMG has “created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal,” the FDA statement said.

“Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account,” and users should check their emails for messages from iPLEDGE, including spam folders, the FDA advises. The iPLEDGE strategy is designed to prevent fetal exposure to isotretinoin, which is highly teratogenic.

Days after the new, gender-neutral approach to the isotretinoin risk mitigation program was launched on Dec. 13, the FDA convened an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the problematic rollout of the program, which was described as disastrous, chaotic, and a failure, with dermatologists on Twitter and elsewhere expressing anger and frustration over not being able to access the program or reach the call center.

A statement by the FDA on Dec. 23 followed, urging manufacturers to develop solutions for the website and to work with the AADA and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition.

The modified REMS, launched on Dec. 13, is designed to make it more inclusive for transgender patients prescribed isotretinoin. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), patients who are prescribed isotretinoin for acne are assigned to one of two risk categories: those who can get pregnant and those who cannot get pregnant.

In the Jan. 14 statement, the FDA notes that the agency is continuing to work with the IPMG regarding the problems clinicians, pharmacists, and patients have had with accessing iPLEDGE over the last month.

“Although there has been progress, there is a significant amount of work still to be done,” the FDA acknowledged. “While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users.”

The Isotretinoin Products Manufacturers Group (IPMG) reports that most users of the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) should now have access to their accounts, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.

The IPMG has “created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal,” the FDA statement said.

“Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account,” and users should check their emails for messages from iPLEDGE, including spam folders, the FDA advises. The iPLEDGE strategy is designed to prevent fetal exposure to isotretinoin, which is highly teratogenic.

Days after the new, gender-neutral approach to the isotretinoin risk mitigation program was launched on Dec. 13, the FDA convened an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the problematic rollout of the program, which was described as disastrous, chaotic, and a failure, with dermatologists on Twitter and elsewhere expressing anger and frustration over not being able to access the program or reach the call center.

A statement by the FDA on Dec. 23 followed, urging manufacturers to develop solutions for the website and to work with the AADA and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition.

The modified REMS, launched on Dec. 13, is designed to make it more inclusive for transgender patients prescribed isotretinoin. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), patients who are prescribed isotretinoin for acne are assigned to one of two risk categories: those who can get pregnant and those who cannot get pregnant.

In the Jan. 14 statement, the FDA notes that the agency is continuing to work with the IPMG regarding the problems clinicians, pharmacists, and patients have had with accessing iPLEDGE over the last month.

“Although there has been progress, there is a significant amount of work still to be done,” the FDA acknowledged. “While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users.”

Routine checks of vital signs during the night often prevent hospitalized patients from getting sufficient recuperative sleep. But patients who are judged to be clinically stable by an algorithm that uses real-time data can be safely spared these checks, according to a recent study published in JAMA Internal Medicine.

In their study, Nader Najafi, MD, MAS, from the University of California, San Francisco, and his colleagues were able to significantly reduce the number of checks at night without increasing transfers to the intensive care ward or heart-alarm triggers.

“Sleep is crucial to health,” writes Hyung J. Cho, MD, from the New York University Grossman School of Medicine, in an accompanying editorial. “Ironically, hospitals, where people go to recover from illness, are among the most difficult places to sleep.”

Number of night-time checks successfully reduced

The mean number of night-time checks was significantly lower in the algorithm group than in the standard-care group (0.97 vs. 1.41; P < .001).

The reduction in night-time checks had no effect on patient safety. There was no increase in transfers to the intensive care unit in the algorithm or standard-care groups (5% vs 5%; P = .92), and no difference between the number of heart alarms (0.2% vs. 0.9%; P = .07).

However, the reduction also had no effect on the incidence of episodes of delirium in the algorithm or standard-care groups (11% vs. 13%; P = .32).

“The reduction in vital signs checking, although statistically significant, was relatively small,” Dr. Cho explains. But the primary endpoint might have been different had the adherence to intervention been better, he notes.

In fact, the analysis confirmed that changes to routine daily practice in a hospital are not always easy to implement. In 35% of cases, the patients’ vital signs were checked at night, despite the physician’s order to the contrary.

“Busy patient-care assistants and nurses may check vital signs out of habit without noticing that the order has changed for some of the patients,” Dr. Najafi and his coauthors write. Many hospitals are used to thinking that regular measurements of the vital signs are part of good practice.
 

Include nursing staff

Future projects should use an interdisciplinary approach that includes nursing staff, Dr. Cho recommends. More user-friendly displays and optimized alerts in the electronic patient records could also encourage better implementation of the orders.

Less frequent checks of the vital signs would be welcomed by frontline staff because it would lighten their already heavy workload, he adds.

Although the study didn’t meet its primary endpoint, patients subjected to fewer night-time checks because of the algorithm were able to get a good night’s sleep. Other aspects of hospital care that are based on the patient’s stability, such as cardiac monitoring, could also potentially benefit from this type of intervention, Dr. Najafi and his colleagues suggest.

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

Routine checks of vital signs during the night often prevent hospitalized patients from getting sufficient recuperative sleep. But patients who are judged to be clinically stable by an algorithm that uses real-time data can be safely spared these checks, according to a recent study published in JAMA Internal Medicine.

In their study, Nader Najafi, MD, MAS, from the University of California, San Francisco, and his colleagues were able to significantly reduce the number of checks at night without increasing transfers to the intensive care ward or heart-alarm triggers.

“Sleep is crucial to health,” writes Hyung J. Cho, MD, from the New York University Grossman School of Medicine, in an accompanying editorial. “Ironically, hospitals, where people go to recover from illness, are among the most difficult places to sleep.”

Number of night-time checks successfully reduced

The mean number of night-time checks was significantly lower in the algorithm group than in the standard-care group (0.97 vs. 1.41; P < .001).

The reduction in night-time checks had no effect on patient safety. There was no increase in transfers to the intensive care unit in the algorithm or standard-care groups (5% vs 5%; P = .92), and no difference between the number of heart alarms (0.2% vs. 0.9%; P = .07).

However, the reduction also had no effect on the incidence of episodes of delirium in the algorithm or standard-care groups (11% vs. 13%; P = .32).

“The reduction in vital signs checking, although statistically significant, was relatively small,” Dr. Cho explains. But the primary endpoint might have been different had the adherence to intervention been better, he notes.

In fact, the analysis confirmed that changes to routine daily practice in a hospital are not always easy to implement. In 35% of cases, the patients’ vital signs were checked at night, despite the physician’s order to the contrary.

“Busy patient-care assistants and nurses may check vital signs out of habit without noticing that the order has changed for some of the patients,” Dr. Najafi and his coauthors write. Many hospitals are used to thinking that regular measurements of the vital signs are part of good practice.
 

Include nursing staff

Future projects should use an interdisciplinary approach that includes nursing staff, Dr. Cho recommends. More user-friendly displays and optimized alerts in the electronic patient records could also encourage better implementation of the orders.

Less frequent checks of the vital signs would be welcomed by frontline staff because it would lighten their already heavy workload, he adds.

Although the study didn’t meet its primary endpoint, patients subjected to fewer night-time checks because of the algorithm were able to get a good night’s sleep. Other aspects of hospital care that are based on the patient’s stability, such as cardiac monitoring, could also potentially benefit from this type of intervention, Dr. Najafi and his colleagues suggest.

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

Routine checks of vital signs during the night often prevent hospitalized patients from getting sufficient recuperative sleep. But patients who are judged to be clinically stable by an algorithm that uses real-time data can be safely spared these checks, according to a recent study published in JAMA Internal Medicine.

In their study, Nader Najafi, MD, MAS, from the University of California, San Francisco, and his colleagues were able to significantly reduce the number of checks at night without increasing transfers to the intensive care ward or heart-alarm triggers.

“Sleep is crucial to health,” writes Hyung J. Cho, MD, from the New York University Grossman School of Medicine, in an accompanying editorial. “Ironically, hospitals, where people go to recover from illness, are among the most difficult places to sleep.”

Number of night-time checks successfully reduced

The mean number of night-time checks was significantly lower in the algorithm group than in the standard-care group (0.97 vs. 1.41; P < .001).

The reduction in night-time checks had no effect on patient safety. There was no increase in transfers to the intensive care unit in the algorithm or standard-care groups (5% vs 5%; P = .92), and no difference between the number of heart alarms (0.2% vs. 0.9%; P = .07).

However, the reduction also had no effect on the incidence of episodes of delirium in the algorithm or standard-care groups (11% vs. 13%; P = .32).

“The reduction in vital signs checking, although statistically significant, was relatively small,” Dr. Cho explains. But the primary endpoint might have been different had the adherence to intervention been better, he notes.

In fact, the analysis confirmed that changes to routine daily practice in a hospital are not always easy to implement. In 35% of cases, the patients’ vital signs were checked at night, despite the physician’s order to the contrary.

“Busy patient-care assistants and nurses may check vital signs out of habit without noticing that the order has changed for some of the patients,” Dr. Najafi and his coauthors write. Many hospitals are used to thinking that regular measurements of the vital signs are part of good practice.
 

Include nursing staff

Future projects should use an interdisciplinary approach that includes nursing staff, Dr. Cho recommends. More user-friendly displays and optimized alerts in the electronic patient records could also encourage better implementation of the orders.

Less frequent checks of the vital signs would be welcomed by frontline staff because it would lighten their already heavy workload, he adds.

Although the study didn’t meet its primary endpoint, patients subjected to fewer night-time checks because of the algorithm were able to get a good night’s sleep. Other aspects of hospital care that are based on the patient’s stability, such as cardiac monitoring, could also potentially benefit from this type of intervention, Dr. Najafi and his colleagues suggest.

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

What are the characteristic mucocutaneous lesions of primary, secondary, and tertiary syphilis?

Continue to answer...

The characteristic mucosal lesion of primary syphilis is the painless chancre. The usual mucocutaneous manifestations of secondary syphilis are maculopapular lesions (red or violet in color) on the palms and soles, mucous patches on the oral membranes, and condyloma lata on the genitalia. The classic mucocutaneous lesion of tertiary syphilis is the gumma.

Other serious manifestations of advanced syphilis include central nervous system abnormalities, such as tabes dorsalis, the Argyll Robertson pupil, and dementia, and cardiac abnormalities, such as aortitis, which can lead to a dissecting aneurysm of the aortic root. (Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;64[RR3]:1-137.)

What are the characteristic mucocutaneous lesions of primary, secondary, and tertiary syphilis?

Continue to answer...

The characteristic mucosal lesion of primary syphilis is the painless chancre. The usual mucocutaneous manifestations of secondary syphilis are maculopapular lesions (red or violet in color) on the palms and soles, mucous patches on the oral membranes, and condyloma lata on the genitalia. The classic mucocutaneous lesion of tertiary syphilis is the gumma.

Other serious manifestations of advanced syphilis include central nervous system abnormalities, such as tabes dorsalis, the Argyll Robertson pupil, and dementia, and cardiac abnormalities, such as aortitis, which can lead to a dissecting aneurysm of the aortic root. (Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;64[RR3]:1-137.)

What are the characteristic mucocutaneous lesions of primary, secondary, and tertiary syphilis?

Continue to answer...

The characteristic mucosal lesion of primary syphilis is the painless chancre. The usual mucocutaneous manifestations of secondary syphilis are maculopapular lesions (red or violet in color) on the palms and soles, mucous patches on the oral membranes, and condyloma lata on the genitalia. The classic mucocutaneous lesion of tertiary syphilis is the gumma.

Other serious manifestations of advanced syphilis include central nervous system abnormalities, such as tabes dorsalis, the Argyll Robertson pupil, and dementia, and cardiac abnormalities, such as aortitis, which can lead to a dissecting aneurysm of the aortic root. (Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;64[RR3]:1-137.)

The recently published “Clinical Practice Guidelines for the Prevention and Management of Tick-Borne Illness,” from the Wilderness Medical Society, are a good compilation of treatment suggestions but are not, in fact, new recommendations, lead author Benjamin Ho, MD, of Southern Wisconsin Emergency Associates in Janesville, acknowledged in an interview.

Dr. Ho emphasized that the focus of the report was on “practitioners who practice in resource-limited settings” and are “the group’s way of solidifying a ... standard of practice” for such physicians. Dr. Ho also said that, while “a lot of the recommendations aren’t well supported, the risk-benefit ratio, we believe, supports the recommendations.”

The article first reviewed the different types of ticks and their distribution in the United States, the specific pathogen associated with each, the disease it causes, and comments about seasonal variations in biting behavior. Another table outlines the most common clinical syndromes, typical lab findings, recommended diagnostic testing, and antibiotic treatments. A third section contains images of different types of ticks and photos of ticks in various life-cycle stages and different levels of engorgement.

The authors were careful to note: “Several tick species are able to carry multiple pathogens. In one study, nearly 25% of Ixodes were coinfected with some combination of the bacteria or parasites causing Lyme disease, anaplasmosis, or babesiosis. Although TBI [tick-borne illness] diagnosis is not the focus of this [clinical practice guideline], providers should be aware of high rates of coinfection; the presence of one TBI should in many instances prompt testing for others.”

In terms of recommendations for preventing TBIs, the authors challenge the suggestion of wearing light-colored clothing. For repellents, they recommend DEET, picaridin, and permethrin. And they also give instructions for laundering clothing and removing ticks.

One recommendation is controversial: that of providing single-dose doxycycline as prophylaxis against Lyme disease. Dr. Ho stresses that this was only for “high-risk” tick bites, defined as a tick bite from an identified Ixodes vector species in which the tick was attached for at least 36 hours and that occurred in an endemic area.

The recommendation for prophylactic doxycycline originated with an article by Robert Nadelman and colleagues in the New England Journal of Medicine and has been strongly challenged by ILADS (International Lyme and Associated Diseases Society) physicians, including Daniel Cameron, MD, and others.

Sam Donta, MD, a recent member of the Department of Health & Human Services Tick-borne Working Group and a member of the Infectious Disease Society of America, said in an interview: “The problem with the one-dose doxycycline is you may not begin to develop symptoms until 2 months later.” It might mask the early symptoms of Lyme. “My impression is that the doxycycline – even the single dose – might have abrogated the ability to see an immune response. The idea, though, if you’ve had a tick bite, is to do nothing and to wait for symptoms to develop. That becomes a little bit more complex. But even then, you could choose to follow the patient and see the patient in 2 weeks and then get blood testing.”

Dr. Donta added: “I think the screening test is inadequate. So you have to go directly to the Western blot. And you have to do both the IgM and IgG” and look for specific bands.

Dr. Donta emphasized that patients should be encouraged to save any ticks that were attached and that, if at all possible, ticks should be sent to a reference lab for testing before committing a patient to a course of antibiotics. There is no harm in that brief delay, he said, and most labs can identify an array of pathogens.

The Wilderness Society guidelines on TBIs provide a good overview for clinicians practicing in limited resource settings and mirror those from the IDSA.

Dr. Ho and Dr. Donta reported no relevant financial relationships.

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

The recently published “Clinical Practice Guidelines for the Prevention and Management of Tick-Borne Illness,” from the Wilderness Medical Society, are a good compilation of treatment suggestions but are not, in fact, new recommendations, lead author Benjamin Ho, MD, of Southern Wisconsin Emergency Associates in Janesville, acknowledged in an interview.

Dr. Ho emphasized that the focus of the report was on “practitioners who practice in resource-limited settings” and are “the group’s way of solidifying a ... standard of practice” for such physicians. Dr. Ho also said that, while “a lot of the recommendations aren’t well supported, the risk-benefit ratio, we believe, supports the recommendations.”

The article first reviewed the different types of ticks and their distribution in the United States, the specific pathogen associated with each, the disease it causes, and comments about seasonal variations in biting behavior. Another table outlines the most common clinical syndromes, typical lab findings, recommended diagnostic testing, and antibiotic treatments. A third section contains images of different types of ticks and photos of ticks in various life-cycle stages and different levels of engorgement.

The authors were careful to note: “Several tick species are able to carry multiple pathogens. In one study, nearly 25% of Ixodes were coinfected with some combination of the bacteria or parasites causing Lyme disease, anaplasmosis, or babesiosis. Although TBI [tick-borne illness] diagnosis is not the focus of this [clinical practice guideline], providers should be aware of high rates of coinfection; the presence of one TBI should in many instances prompt testing for others.”

In terms of recommendations for preventing TBIs, the authors challenge the suggestion of wearing light-colored clothing. For repellents, they recommend DEET, picaridin, and permethrin. And they also give instructions for laundering clothing and removing ticks.

One recommendation is controversial: that of providing single-dose doxycycline as prophylaxis against Lyme disease. Dr. Ho stresses that this was only for “high-risk” tick bites, defined as a tick bite from an identified Ixodes vector species in which the tick was attached for at least 36 hours and that occurred in an endemic area.

The recommendation for prophylactic doxycycline originated with an article by Robert Nadelman and colleagues in the New England Journal of Medicine and has been strongly challenged by ILADS (International Lyme and Associated Diseases Society) physicians, including Daniel Cameron, MD, and others.

Sam Donta, MD, a recent member of the Department of Health & Human Services Tick-borne Working Group and a member of the Infectious Disease Society of America, said in an interview: “The problem with the one-dose doxycycline is you may not begin to develop symptoms until 2 months later.” It might mask the early symptoms of Lyme. “My impression is that the doxycycline – even the single dose – might have abrogated the ability to see an immune response. The idea, though, if you’ve had a tick bite, is to do nothing and to wait for symptoms to develop. That becomes a little bit more complex. But even then, you could choose to follow the patient and see the patient in 2 weeks and then get blood testing.”

Dr. Donta added: “I think the screening test is inadequate. So you have to go directly to the Western blot. And you have to do both the IgM and IgG” and look for specific bands.

Dr. Donta emphasized that patients should be encouraged to save any ticks that were attached and that, if at all possible, ticks should be sent to a reference lab for testing before committing a patient to a course of antibiotics. There is no harm in that brief delay, he said, and most labs can identify an array of pathogens.

The Wilderness Society guidelines on TBIs provide a good overview for clinicians practicing in limited resource settings and mirror those from the IDSA.

Dr. Ho and Dr. Donta reported no relevant financial relationships.

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

The recently published “Clinical Practice Guidelines for the Prevention and Management of Tick-Borne Illness,” from the Wilderness Medical Society, are a good compilation of treatment suggestions but are not, in fact, new recommendations, lead author Benjamin Ho, MD, of Southern Wisconsin Emergency Associates in Janesville, acknowledged in an interview.

Dr. Ho emphasized that the focus of the report was on “practitioners who practice in resource-limited settings” and are “the group’s way of solidifying a ... standard of practice” for such physicians. Dr. Ho also said that, while “a lot of the recommendations aren’t well supported, the risk-benefit ratio, we believe, supports the recommendations.”

The article first reviewed the different types of ticks and their distribution in the United States, the specific pathogen associated with each, the disease it causes, and comments about seasonal variations in biting behavior. Another table outlines the most common clinical syndromes, typical lab findings, recommended diagnostic testing, and antibiotic treatments. A third section contains images of different types of ticks and photos of ticks in various life-cycle stages and different levels of engorgement.

The authors were careful to note: “Several tick species are able to carry multiple pathogens. In one study, nearly 25% of Ixodes were coinfected with some combination of the bacteria or parasites causing Lyme disease, anaplasmosis, or babesiosis. Although TBI [tick-borne illness] diagnosis is not the focus of this [clinical practice guideline], providers should be aware of high rates of coinfection; the presence of one TBI should in many instances prompt testing for others.”

In terms of recommendations for preventing TBIs, the authors challenge the suggestion of wearing light-colored clothing. For repellents, they recommend DEET, picaridin, and permethrin. And they also give instructions for laundering clothing and removing ticks.

One recommendation is controversial: that of providing single-dose doxycycline as prophylaxis against Lyme disease. Dr. Ho stresses that this was only for “high-risk” tick bites, defined as a tick bite from an identified Ixodes vector species in which the tick was attached for at least 36 hours and that occurred in an endemic area.

The recommendation for prophylactic doxycycline originated with an article by Robert Nadelman and colleagues in the New England Journal of Medicine and has been strongly challenged by ILADS (International Lyme and Associated Diseases Society) physicians, including Daniel Cameron, MD, and others.

Sam Donta, MD, a recent member of the Department of Health & Human Services Tick-borne Working Group and a member of the Infectious Disease Society of America, said in an interview: “The problem with the one-dose doxycycline is you may not begin to develop symptoms until 2 months later.” It might mask the early symptoms of Lyme. “My impression is that the doxycycline – even the single dose – might have abrogated the ability to see an immune response. The idea, though, if you’ve had a tick bite, is to do nothing and to wait for symptoms to develop. That becomes a little bit more complex. But even then, you could choose to follow the patient and see the patient in 2 weeks and then get blood testing.”

Dr. Donta added: “I think the screening test is inadequate. So you have to go directly to the Western blot. And you have to do both the IgM and IgG” and look for specific bands.

Dr. Donta emphasized that patients should be encouraged to save any ticks that were attached and that, if at all possible, ticks should be sent to a reference lab for testing before committing a patient to a course of antibiotics. There is no harm in that brief delay, he said, and most labs can identify an array of pathogens.

The Wilderness Society guidelines on TBIs provide a good overview for clinicians practicing in limited resource settings and mirror those from the IDSA.

Dr. Ho and Dr. Donta reported no relevant financial relationships.

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

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D₃ supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D₃ supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D₃, or 80 mcg (3,200 IU) of daily vitamin D₃.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D₃ was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D₃ levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

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

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D₃ supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D₃ supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D₃, or 80 mcg (3,200 IU) of daily vitamin D₃.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D₃ was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D₃ levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

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

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D₃ supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D₃ supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D₃, or 80 mcg (3,200 IU) of daily vitamin D₃.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D₃ was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D₃ levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

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