Background: Falls are the leading cause of unintentional injuries and injury-related deaths among adults aged 65 years and older. FRIDs (such as antidepressants, sedatives-hypnotics, and opioids) continue to be a major contributor for risk of falls. At the same time, little is known about prevalence of use or interventions directed toward reduction of use in older adults presenting with fall.

Limitations of this review included high risk of bias in observational studies and unclear timeline definitions of interventions or outcome measurements in the intervention studies. In conclusion, there is a significant need for well-designed interventions targeted at reducing FRID use in conjunction with other risk factors to decrease the incidence of falls comprehensively. An aggressive approach directed toward patient education along with primary care communication may be the key to reducing FRID use in this population.

Bottom line: With limited evidence, there is a high prevalence of FRID use in older adults presenting with falls and no reduction in FRID use following the encounter.

Citation: Hart LA et al. Use of fall risk-increasing drugs around a fall-related injury in older adults: A systematic review. J Am Geriatr Soc. 2020 Feb 17. doi: 10.1111/jgs.16369.

Dr. Yarra is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

Background: Falls are the leading cause of unintentional injuries and injury-related deaths among adults aged 65 years and older. FRIDs (such as antidepressants, sedatives-hypnotics, and opioids) continue to be a major contributor for risk of falls. At the same time, little is known about prevalence of use or interventions directed toward reduction of use in older adults presenting with fall.

Limitations of this review included high risk of bias in observational studies and unclear timeline definitions of interventions or outcome measurements in the intervention studies. In conclusion, there is a significant need for well-designed interventions targeted at reducing FRID use in conjunction with other risk factors to decrease the incidence of falls comprehensively. An aggressive approach directed toward patient education along with primary care communication may be the key to reducing FRID use in this population.

Bottom line: With limited evidence, there is a high prevalence of FRID use in older adults presenting with falls and no reduction in FRID use following the encounter.

Citation: Hart LA et al. Use of fall risk-increasing drugs around a fall-related injury in older adults: A systematic review. J Am Geriatr Soc. 2020 Feb 17. doi: 10.1111/jgs.16369.

Dr. Yarra is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

Background: Falls are the leading cause of unintentional injuries and injury-related deaths among adults aged 65 years and older. FRIDs (such as antidepressants, sedatives-hypnotics, and opioids) continue to be a major contributor for risk of falls. At the same time, little is known about prevalence of use or interventions directed toward reduction of use in older adults presenting with fall.

Limitations of this review included high risk of bias in observational studies and unclear timeline definitions of interventions or outcome measurements in the intervention studies. In conclusion, there is a significant need for well-designed interventions targeted at reducing FRID use in conjunction with other risk factors to decrease the incidence of falls comprehensively. An aggressive approach directed toward patient education along with primary care communication may be the key to reducing FRID use in this population.

Bottom line: With limited evidence, there is a high prevalence of FRID use in older adults presenting with falls and no reduction in FRID use following the encounter.

Citation: Hart LA et al. Use of fall risk-increasing drugs around a fall-related injury in older adults: A systematic review. J Am Geriatr Soc. 2020 Feb 17. doi: 10.1111/jgs.16369.

Dr. Yarra is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

Due to broad social changes and efforts from leaders in GI, there is renewed interest in family planning and parental leave policies for GI trainees. The American Board of Medical Specialties now permits trainees a minimum of 6 weeks away during training, without automatically requiring an extension of training time or completely depleting vacation time, for boards eligibility.^1,2 However, national and institutional guidance for family planning and pregnancy during GI fellowship is lacking. How can gastroenterology fellowship programs support fellows taking parental leave and enact fair policies? We review the scope of the problem, describe our experience in developing resources within our GI fellowship program, and highlight areas that require further development.

The scope of the issue

There is no national data yet on the number of GI fellows that are parents prior to starting fellowship or who become parents during fellowship. We estimate that approximately 25% of fellows enter training as parents or become parents during fellowship, although 40%-50% may have an intention to have children.^3,4 Fellows may be worried that they will “fall behind” or be perceived as less committed if they devote time to childrearing or take parental leave.^5-7 Indeed, worries about discrimination based on pregnancy and parental leave are borne out by the experiences of older physicians (in particular, female physicians).^8,9

State- and institution-specific benefits vary from program to program. Nationally, the Family and Medical Leave Act provides only unpaid leave and applies only to trainees who have been employed for greater than 12 months.¹⁰ Benefits may not always be well advertised, and even when they are, trainees (and attendings) may feel uncomfortable taking full advantage. One survey of GIs revealed that, although two-thirds believed that 6-8 weeks of maternity leave was inadequate, half took less than that amount due to fears about financial and professional consequences.⁸

Pregnancy during GI fellowship is a special concern. GI fellowship consists of long work hours, includes night call, and can be physically demanding. All three of these factors have been associated with preterm delivery, infertility, and miscarriage.^11,12 In addition, there are no guidelines for ergonomic adjustments or infection precautions for pregnant endoscopists. We have compiled information about infection prevention guidance in pregnancy (available from the authors on request) derived from guidance from the National Institute for Occupational Safety and Health, which recommends the same precautions for pregnant health care workers as for nonpregnant health care workers.¹³ In regards to SARS-CoV-2, we believe that the decision to perform procedures on patients with COVID-19 infection should be individualized, although vaccinated endoscopists should be reassured by the exceedingly low rates of infection after vaccination and with appropriate personal protective equipment. Radiation is yet another concern. There are limited data on radiation dosages incurred by workers in the endoscopy suite and no pregnancy-specific data, which may lead trainees to avoid fluoroscopic procedures and unnecessarily double up on lead gowns.^8,11,14-17

Breastfeeding accommodations, and access to lactation rooms for trainees, are required by federal law for a minimum of 12 months.¹⁸ Should a trainee choose to breastfeed, education of staff and attendings is critical because many may be unaware of the specific needs pertaining to lactation. Staff should be aware that 30-45 minutes are needed to prepare, pump, and store milk. Trainees should not be solely responsible for educating their attendings and staff.
 

Our Experience in Creating a Policy

We developed a formal fellowship program policy on parental leave and pregnancy in the setting of a broader discussion about fellow workload and wellness. We agreed that trainees should be allowed to make changes to their schedule with co-fellows as needed for medical appointments or procedures and that our backup policy should be flexible enough to provide spot coverage for unexpected complications and family emergencies. We also incorporated a GI psychologist to provide wellness resources and suggestions for reducing burnout for our fellows.

We strove to follow certain principles in creating this policy. Trainees who are parents should have a comparable clinical experience to their nonparenting colleagues and should take the lead in rearranging their own schedule. Nonbirthing parents, adopting parents, and parents using surrogacy should be included in any parental leave policy. Fellowship leaders have an important responsibility in helping fellows proactively plan to meet requirements for graduation and maximize learning and exposure (Figure). We also recognized the importance of equitable coverage. For example, there is sometimes a perception that fellows with children “burden” fellows who are not parents.^3,19 On the other hand, fellows without children may feel that they are called on more than their colleagues with children to cover those with childcare issues. In addition, as a recent study of general surgery residency program directors indicates, there are complex interpersonal issues that play into a colleague’s willingness to provide coverage.²⁰ It behooves program leadership to be cognizant of group dynamics that might cause conflict over what should be a straightforward coverage situation.

We first researched national and societal guidelines if available, as well as our institution’s graduate medical education (GME) website. We categorized benefits by whether they were federal, state-mandated, or institutional. It is important to note that any concerns about trainee salaries should be discussed with one’s GME office to ensure the leave policy is in accordance with federal funding policies.²¹ We solicited experiences and advice from former and current fellows who had gone through, or were planning, pregnancy and parental leave. A few faculty members volunteered to serve as a resource for fellows; these “ambassadors” discussed their experiences during a lunchtime panel, as well as offered to provide one-on-one advice and participate in future panels. We also reached out to our infection control experts to review the literature and federal policies on infections of special consideration during pregnancy and endoscopy. As for radiation safety, given the importance of education and active monitoring, we offer the option of reaching out to our radiation safety officer for individualized counseling.²²

Based on these efforts, we drafted a written policy designed for pregnant fellows and fellows planning parental leave on expectations for the program and fellows, benefits, and advice, including childcare options, lactation room locations, and financial planning tips. We shared this document with fellows and incorporated feedback. As a “living document” it is subject to change and will be updated as needed (at least annually).
 

Additional planning considerations for fellows

Research childcare options (ideally 6 months or more before leave).

• Start to explore your institution’s resources for leave and childcare options (daycare waitlists may be greater than 1 year in some cities).

Inform your program director (4-5 months before leave).

• Consider informing your program director about pregnancy at the beginning of the second trimester.
• Discuss Accreditation Council for Graduate Medical Education requirements and scheduling responsibilities.
• Explicitly discuss whether you plan to graduate on time or extend fellowship.

Inform your colleagues and patients (at least 3-4 months before leave).

• If comfortable, consider getting advice from a co-fellow and/or faculty mentor parent to facilitate transition to parenthood.
• When you feel ready, begin trading rotations and calls with co-fellows. If you have a results inbox or pager, discuss who can help cover those during your leave.
• Inform research collaborators about your leave and make preparations to keep projects progressing during your leave.
• If you have “active” clinic patients, when appropriate, begin to inform them that you will be away and provide reassurance that a colleague will be covering you. Leave clear plans with contingencies for these patients in your last progress notes.

Complete institutional paperwork and map out facilities (at least 2-3 months before leave).

• Review your options for using time toward leave, including vacation, research, or Family and Medical Leave Act–provided leave (unpaid), and what paperwork you need to fill out.
• Contact your payroll and/or human resources office to inform them of birth/adoption.
• Research potential program parental benefits, such as dependent daycare and/or health care flexible spending accounts.
• If choosing to breastfeed, explore the lactation rooms that are closest to your workroom and endoscopy suite and determine how much time you will need to set aside for pumping.

Be prepared to make adjustments as needed.

• Endoscopy-heavy rotations may be more difficult in the third trimester of pregnancy.
• Make contingency plans for early or late delivery dates, as well as if you undergo a cesarean that requires additional recovery time.
• Consider scheduling elective rotations (research, clinic) toward the end of leave and for the first month of “return to work.”
• If you plan to join limited clinic or outpatient endoscopy blocks later in your leave, make early arrangements to work regularly with these attendings.

Conclusion

Trainee needs assessments in gastroenterology fellowship similar to those in other specialties should be performed, and are in fact underway.^19,23,24 There is a lack of data regarding the availability of fellowship program guidance and, specifically, adherence to required policies, and more data from program directors at a national level need to be collected.²⁰ We recommend that programs engage in identifying specific needs at their institutions with the goal of eventually sharing this knowledge with other programs. Gastroenterology society recommendations for performing endoscopy while pregnant, with regard to ergonomics, infection control, and radiation exposure, would be instrumental. GI fellowships should consolidate institutional knowledge and engage key stakeholders – including trainees, prior trainees, occupational safety experts, radiation safety offices, wellness experts, and GME – to create program-specific policies that are flexible but rigorous and generous but equitable.

Dr. Liu and Dr. Summa are gastroenterology fellows at Northwestern University, Chicago. Dr. Patel is an assistant professor of medicine and a gastroenterology fellowship assistant program director at Northwestern University, Chicago. Dr. Donnan and Dr. Guentner are assistant professors of medicine at Northwestern University. Dr. Kia is an assistant professor of medicine and the gastroenterology fellowship program director at Northwestern University. They have no conflicts of interest to disclose. The authors would like to thank Michelle Clermont, MD, and Maureen K. Bolon, MD, for their discussion and assistance during the drafting of this article.

References

1. Section on Medical Students, Residents, and Fellowship Trainees; Committee on Early Childhood. Pediatrics. 2013;131(2):387-90.

2. American Board of Medical Specialties. ABMS Announces Progressive Leave Policy for Residents and Fellows. July 13, 2020. Accessed May 1, 2021. https://www.abms.org/news-events/abms-announces-progressive-leave-policy-for-residents-and-fellows/.

3. Magudia K et al. J Grad Med Educ. 2020;12(2):162-7.

4. Blair JE et al. Acad Med. 2016;91(7):972-8.

5. Feld LD. Am J Gastroenterol. 2021;116(3):505-8.

6. Roubaud MS. Plast Reconstr Surg Glob Open. 2019. doi: 10.1097/GOX.0000000000002104.

7. Price J, Dunbar K. Gastrointest Endosc. 2009;69(1):121-3.

8. David YN et al. Gastrointest Endosc. 2020;91(6):AB75-AB76.

9. Webb AMB et al. Acad Med J Assoc Am Med Coll. 2019;94(11):1631-4.

10. Weinstein DF et al. N Engl J Med. 2019 Sep 12;381(11):995-7.

11. Anderson M, Goldman RH. JAMA Surg. 2020;155(3):243-9.

12. Palmer KT et al. Occup Environ Med. 2013;70(4):213-22.

13. Siegel JD et al; Healthcare Infection, Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). 2007. Last reviewed July 22, 2019. Accessed April 28, 2021. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

14. David YN et al. Am J Gastroenterol. 2021;116(3):539-50.

15. Sethi S et al. Dig Dis Sci. 2019;64(9):2455-66.

16. Alzimami K et al. Gastroenterol Res Pract. 2013;2013:587574.

17. Hayashi S et al. World J Clin Cases. 2018;6(16):1087-93.

18. U.S. Department of Labor, Wage and Hour Division. “Frequently Asked Questions – Break Time for Nursing Mothers.” Accessed May 1, 2021. https://www.dol.gov/agencies/whd/nursing-mothers/faq.

19. Mwakyanjala EJ et al. J Am Heart Assoc. 2019. doi: 10.1161/JAHA.119.012137.

20. Castillo-Angeles M et al. JAMA Surg. 2021 Jul 1;156(7):647-53.

21. Prasad S et al. J Grad Med Educ. 2021 Jun;13(3):349-54.

22. Ho IKH et al. Am J Gastroenterol. 2014;109(8):1180-94.

23. Sherbaf FG et al. AJNR Am J Neuroradiol. 2020;41(8):1348-54.

24. Altieri MS et al. JAMA Surg. 2019;154(10):952-58.

Due to broad social changes and efforts from leaders in GI, there is renewed interest in family planning and parental leave policies for GI trainees. The American Board of Medical Specialties now permits trainees a minimum of 6 weeks away during training, without automatically requiring an extension of training time or completely depleting vacation time, for boards eligibility.^1,2 However, national and institutional guidance for family planning and pregnancy during GI fellowship is lacking. How can gastroenterology fellowship programs support fellows taking parental leave and enact fair policies? We review the scope of the problem, describe our experience in developing resources within our GI fellowship program, and highlight areas that require further development.

The scope of the issue

There is no national data yet on the number of GI fellows that are parents prior to starting fellowship or who become parents during fellowship. We estimate that approximately 25% of fellows enter training as parents or become parents during fellowship, although 40%-50% may have an intention to have children.^3,4 Fellows may be worried that they will “fall behind” or be perceived as less committed if they devote time to childrearing or take parental leave.^5-7 Indeed, worries about discrimination based on pregnancy and parental leave are borne out by the experiences of older physicians (in particular, female physicians).^8,9

State- and institution-specific benefits vary from program to program. Nationally, the Family and Medical Leave Act provides only unpaid leave and applies only to trainees who have been employed for greater than 12 months.¹⁰ Benefits may not always be well advertised, and even when they are, trainees (and attendings) may feel uncomfortable taking full advantage. One survey of GIs revealed that, although two-thirds believed that 6-8 weeks of maternity leave was inadequate, half took less than that amount due to fears about financial and professional consequences.⁸

Pregnancy during GI fellowship is a special concern. GI fellowship consists of long work hours, includes night call, and can be physically demanding. All three of these factors have been associated with preterm delivery, infertility, and miscarriage.^11,12 In addition, there are no guidelines for ergonomic adjustments or infection precautions for pregnant endoscopists. We have compiled information about infection prevention guidance in pregnancy (available from the authors on request) derived from guidance from the National Institute for Occupational Safety and Health, which recommends the same precautions for pregnant health care workers as for nonpregnant health care workers.¹³ In regards to SARS-CoV-2, we believe that the decision to perform procedures on patients with COVID-19 infection should be individualized, although vaccinated endoscopists should be reassured by the exceedingly low rates of infection after vaccination and with appropriate personal protective equipment. Radiation is yet another concern. There are limited data on radiation dosages incurred by workers in the endoscopy suite and no pregnancy-specific data, which may lead trainees to avoid fluoroscopic procedures and unnecessarily double up on lead gowns.^8,11,14-17

Breastfeeding accommodations, and access to lactation rooms for trainees, are required by federal law for a minimum of 12 months.¹⁸ Should a trainee choose to breastfeed, education of staff and attendings is critical because many may be unaware of the specific needs pertaining to lactation. Staff should be aware that 30-45 minutes are needed to prepare, pump, and store milk. Trainees should not be solely responsible for educating their attendings and staff.
 

Our Experience in Creating a Policy

We developed a formal fellowship program policy on parental leave and pregnancy in the setting of a broader discussion about fellow workload and wellness. We agreed that trainees should be allowed to make changes to their schedule with co-fellows as needed for medical appointments or procedures and that our backup policy should be flexible enough to provide spot coverage for unexpected complications and family emergencies. We also incorporated a GI psychologist to provide wellness resources and suggestions for reducing burnout for our fellows.

We strove to follow certain principles in creating this policy. Trainees who are parents should have a comparable clinical experience to their nonparenting colleagues and should take the lead in rearranging their own schedule. Nonbirthing parents, adopting parents, and parents using surrogacy should be included in any parental leave policy. Fellowship leaders have an important responsibility in helping fellows proactively plan to meet requirements for graduation and maximize learning and exposure (Figure). We also recognized the importance of equitable coverage. For example, there is sometimes a perception that fellows with children “burden” fellows who are not parents.^3,19 On the other hand, fellows without children may feel that they are called on more than their colleagues with children to cover those with childcare issues. In addition, as a recent study of general surgery residency program directors indicates, there are complex interpersonal issues that play into a colleague’s willingness to provide coverage.²⁰ It behooves program leadership to be cognizant of group dynamics that might cause conflict over what should be a straightforward coverage situation.

We first researched national and societal guidelines if available, as well as our institution’s graduate medical education (GME) website. We categorized benefits by whether they were federal, state-mandated, or institutional. It is important to note that any concerns about trainee salaries should be discussed with one’s GME office to ensure the leave policy is in accordance with federal funding policies.²¹ We solicited experiences and advice from former and current fellows who had gone through, or were planning, pregnancy and parental leave. A few faculty members volunteered to serve as a resource for fellows; these “ambassadors” discussed their experiences during a lunchtime panel, as well as offered to provide one-on-one advice and participate in future panels. We also reached out to our infection control experts to review the literature and federal policies on infections of special consideration during pregnancy and endoscopy. As for radiation safety, given the importance of education and active monitoring, we offer the option of reaching out to our radiation safety officer for individualized counseling.²²

Based on these efforts, we drafted a written policy designed for pregnant fellows and fellows planning parental leave on expectations for the program and fellows, benefits, and advice, including childcare options, lactation room locations, and financial planning tips. We shared this document with fellows and incorporated feedback. As a “living document” it is subject to change and will be updated as needed (at least annually).
 

Additional planning considerations for fellows

Research childcare options (ideally 6 months or more before leave).

• Start to explore your institution’s resources for leave and childcare options (daycare waitlists may be greater than 1 year in some cities).

Inform your program director (4-5 months before leave).

• Consider informing your program director about pregnancy at the beginning of the second trimester.
• Discuss Accreditation Council for Graduate Medical Education requirements and scheduling responsibilities.
• Explicitly discuss whether you plan to graduate on time or extend fellowship.

Inform your colleagues and patients (at least 3-4 months before leave).

• If comfortable, consider getting advice from a co-fellow and/or faculty mentor parent to facilitate transition to parenthood.
• When you feel ready, begin trading rotations and calls with co-fellows. If you have a results inbox or pager, discuss who can help cover those during your leave.
• Inform research collaborators about your leave and make preparations to keep projects progressing during your leave.
• If you have “active” clinic patients, when appropriate, begin to inform them that you will be away and provide reassurance that a colleague will be covering you. Leave clear plans with contingencies for these patients in your last progress notes.

Complete institutional paperwork and map out facilities (at least 2-3 months before leave).

• Review your options for using time toward leave, including vacation, research, or Family and Medical Leave Act–provided leave (unpaid), and what paperwork you need to fill out.
• Contact your payroll and/or human resources office to inform them of birth/adoption.
• Research potential program parental benefits, such as dependent daycare and/or health care flexible spending accounts.
• If choosing to breastfeed, explore the lactation rooms that are closest to your workroom and endoscopy suite and determine how much time you will need to set aside for pumping.

Be prepared to make adjustments as needed.

• Endoscopy-heavy rotations may be more difficult in the third trimester of pregnancy.
• Make contingency plans for early or late delivery dates, as well as if you undergo a cesarean that requires additional recovery time.
• Consider scheduling elective rotations (research, clinic) toward the end of leave and for the first month of “return to work.”
• If you plan to join limited clinic or outpatient endoscopy blocks later in your leave, make early arrangements to work regularly with these attendings.

Conclusion

Trainee needs assessments in gastroenterology fellowship similar to those in other specialties should be performed, and are in fact underway.^19,23,24 There is a lack of data regarding the availability of fellowship program guidance and, specifically, adherence to required policies, and more data from program directors at a national level need to be collected.²⁰ We recommend that programs engage in identifying specific needs at their institutions with the goal of eventually sharing this knowledge with other programs. Gastroenterology society recommendations for performing endoscopy while pregnant, with regard to ergonomics, infection control, and radiation exposure, would be instrumental. GI fellowships should consolidate institutional knowledge and engage key stakeholders – including trainees, prior trainees, occupational safety experts, radiation safety offices, wellness experts, and GME – to create program-specific policies that are flexible but rigorous and generous but equitable.

Dr. Liu and Dr. Summa are gastroenterology fellows at Northwestern University, Chicago. Dr. Patel is an assistant professor of medicine and a gastroenterology fellowship assistant program director at Northwestern University, Chicago. Dr. Donnan and Dr. Guentner are assistant professors of medicine at Northwestern University. Dr. Kia is an assistant professor of medicine and the gastroenterology fellowship program director at Northwestern University. They have no conflicts of interest to disclose. The authors would like to thank Michelle Clermont, MD, and Maureen K. Bolon, MD, for their discussion and assistance during the drafting of this article.

References

1. Section on Medical Students, Residents, and Fellowship Trainees; Committee on Early Childhood. Pediatrics. 2013;131(2):387-90.

2. American Board of Medical Specialties. ABMS Announces Progressive Leave Policy for Residents and Fellows. July 13, 2020. Accessed May 1, 2021. https://www.abms.org/news-events/abms-announces-progressive-leave-policy-for-residents-and-fellows/.

3. Magudia K et al. J Grad Med Educ. 2020;12(2):162-7.

4. Blair JE et al. Acad Med. 2016;91(7):972-8.

5. Feld LD. Am J Gastroenterol. 2021;116(3):505-8.

6. Roubaud MS. Plast Reconstr Surg Glob Open. 2019. doi: 10.1097/GOX.0000000000002104.

7. Price J, Dunbar K. Gastrointest Endosc. 2009;69(1):121-3.

8. David YN et al. Gastrointest Endosc. 2020;91(6):AB75-AB76.

9. Webb AMB et al. Acad Med J Assoc Am Med Coll. 2019;94(11):1631-4.

10. Weinstein DF et al. N Engl J Med. 2019 Sep 12;381(11):995-7.

11. Anderson M, Goldman RH. JAMA Surg. 2020;155(3):243-9.

12. Palmer KT et al. Occup Environ Med. 2013;70(4):213-22.

13. Siegel JD et al; Healthcare Infection, Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). 2007. Last reviewed July 22, 2019. Accessed April 28, 2021. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

14. David YN et al. Am J Gastroenterol. 2021;116(3):539-50.

15. Sethi S et al. Dig Dis Sci. 2019;64(9):2455-66.

16. Alzimami K et al. Gastroenterol Res Pract. 2013;2013:587574.

17. Hayashi S et al. World J Clin Cases. 2018;6(16):1087-93.

18. U.S. Department of Labor, Wage and Hour Division. “Frequently Asked Questions – Break Time for Nursing Mothers.” Accessed May 1, 2021. https://www.dol.gov/agencies/whd/nursing-mothers/faq.

19. Mwakyanjala EJ et al. J Am Heart Assoc. 2019. doi: 10.1161/JAHA.119.012137.

20. Castillo-Angeles M et al. JAMA Surg. 2021 Jul 1;156(7):647-53.

21. Prasad S et al. J Grad Med Educ. 2021 Jun;13(3):349-54.

22. Ho IKH et al. Am J Gastroenterol. 2014;109(8):1180-94.

23. Sherbaf FG et al. AJNR Am J Neuroradiol. 2020;41(8):1348-54.

24. Altieri MS et al. JAMA Surg. 2019;154(10):952-58.

Due to broad social changes and efforts from leaders in GI, there is renewed interest in family planning and parental leave policies for GI trainees. The American Board of Medical Specialties now permits trainees a minimum of 6 weeks away during training, without automatically requiring an extension of training time or completely depleting vacation time, for boards eligibility.^1,2 However, national and institutional guidance for family planning and pregnancy during GI fellowship is lacking. How can gastroenterology fellowship programs support fellows taking parental leave and enact fair policies? We review the scope of the problem, describe our experience in developing resources within our GI fellowship program, and highlight areas that require further development.

The scope of the issue

There is no national data yet on the number of GI fellows that are parents prior to starting fellowship or who become parents during fellowship. We estimate that approximately 25% of fellows enter training as parents or become parents during fellowship, although 40%-50% may have an intention to have children.^3,4 Fellows may be worried that they will “fall behind” or be perceived as less committed if they devote time to childrearing or take parental leave.^5-7 Indeed, worries about discrimination based on pregnancy and parental leave are borne out by the experiences of older physicians (in particular, female physicians).^8,9

State- and institution-specific benefits vary from program to program. Nationally, the Family and Medical Leave Act provides only unpaid leave and applies only to trainees who have been employed for greater than 12 months.¹⁰ Benefits may not always be well advertised, and even when they are, trainees (and attendings) may feel uncomfortable taking full advantage. One survey of GIs revealed that, although two-thirds believed that 6-8 weeks of maternity leave was inadequate, half took less than that amount due to fears about financial and professional consequences.⁸

Pregnancy during GI fellowship is a special concern. GI fellowship consists of long work hours, includes night call, and can be physically demanding. All three of these factors have been associated with preterm delivery, infertility, and miscarriage.^11,12 In addition, there are no guidelines for ergonomic adjustments or infection precautions for pregnant endoscopists. We have compiled information about infection prevention guidance in pregnancy (available from the authors on request) derived from guidance from the National Institute for Occupational Safety and Health, which recommends the same precautions for pregnant health care workers as for nonpregnant health care workers.¹³ In regards to SARS-CoV-2, we believe that the decision to perform procedures on patients with COVID-19 infection should be individualized, although vaccinated endoscopists should be reassured by the exceedingly low rates of infection after vaccination and with appropriate personal protective equipment. Radiation is yet another concern. There are limited data on radiation dosages incurred by workers in the endoscopy suite and no pregnancy-specific data, which may lead trainees to avoid fluoroscopic procedures and unnecessarily double up on lead gowns.^8,11,14-17

Breastfeeding accommodations, and access to lactation rooms for trainees, are required by federal law for a minimum of 12 months.¹⁸ Should a trainee choose to breastfeed, education of staff and attendings is critical because many may be unaware of the specific needs pertaining to lactation. Staff should be aware that 30-45 minutes are needed to prepare, pump, and store milk. Trainees should not be solely responsible for educating their attendings and staff.
 

Our Experience in Creating a Policy

We developed a formal fellowship program policy on parental leave and pregnancy in the setting of a broader discussion about fellow workload and wellness. We agreed that trainees should be allowed to make changes to their schedule with co-fellows as needed for medical appointments or procedures and that our backup policy should be flexible enough to provide spot coverage for unexpected complications and family emergencies. We also incorporated a GI psychologist to provide wellness resources and suggestions for reducing burnout for our fellows.

We strove to follow certain principles in creating this policy. Trainees who are parents should have a comparable clinical experience to their nonparenting colleagues and should take the lead in rearranging their own schedule. Nonbirthing parents, adopting parents, and parents using surrogacy should be included in any parental leave policy. Fellowship leaders have an important responsibility in helping fellows proactively plan to meet requirements for graduation and maximize learning and exposure (Figure). We also recognized the importance of equitable coverage. For example, there is sometimes a perception that fellows with children “burden” fellows who are not parents.^3,19 On the other hand, fellows without children may feel that they are called on more than their colleagues with children to cover those with childcare issues. In addition, as a recent study of general surgery residency program directors indicates, there are complex interpersonal issues that play into a colleague’s willingness to provide coverage.²⁰ It behooves program leadership to be cognizant of group dynamics that might cause conflict over what should be a straightforward coverage situation.

We first researched national and societal guidelines if available, as well as our institution’s graduate medical education (GME) website. We categorized benefits by whether they were federal, state-mandated, or institutional. It is important to note that any concerns about trainee salaries should be discussed with one’s GME office to ensure the leave policy is in accordance with federal funding policies.²¹ We solicited experiences and advice from former and current fellows who had gone through, or were planning, pregnancy and parental leave. A few faculty members volunteered to serve as a resource for fellows; these “ambassadors” discussed their experiences during a lunchtime panel, as well as offered to provide one-on-one advice and participate in future panels. We also reached out to our infection control experts to review the literature and federal policies on infections of special consideration during pregnancy and endoscopy. As for radiation safety, given the importance of education and active monitoring, we offer the option of reaching out to our radiation safety officer for individualized counseling.²²

Based on these efforts, we drafted a written policy designed for pregnant fellows and fellows planning parental leave on expectations for the program and fellows, benefits, and advice, including childcare options, lactation room locations, and financial planning tips. We shared this document with fellows and incorporated feedback. As a “living document” it is subject to change and will be updated as needed (at least annually).
 

Additional planning considerations for fellows

Research childcare options (ideally 6 months or more before leave).

• Start to explore your institution’s resources for leave and childcare options (daycare waitlists may be greater than 1 year in some cities).

Inform your program director (4-5 months before leave).

• Consider informing your program director about pregnancy at the beginning of the second trimester.
• Discuss Accreditation Council for Graduate Medical Education requirements and scheduling responsibilities.
• Explicitly discuss whether you plan to graduate on time or extend fellowship.

Inform your colleagues and patients (at least 3-4 months before leave).

• If comfortable, consider getting advice from a co-fellow and/or faculty mentor parent to facilitate transition to parenthood.
• When you feel ready, begin trading rotations and calls with co-fellows. If you have a results inbox or pager, discuss who can help cover those during your leave.
• Inform research collaborators about your leave and make preparations to keep projects progressing during your leave.
• If you have “active” clinic patients, when appropriate, begin to inform them that you will be away and provide reassurance that a colleague will be covering you. Leave clear plans with contingencies for these patients in your last progress notes.

Complete institutional paperwork and map out facilities (at least 2-3 months before leave).

• Review your options for using time toward leave, including vacation, research, or Family and Medical Leave Act–provided leave (unpaid), and what paperwork you need to fill out.
• Contact your payroll and/or human resources office to inform them of birth/adoption.
• Research potential program parental benefits, such as dependent daycare and/or health care flexible spending accounts.
• If choosing to breastfeed, explore the lactation rooms that are closest to your workroom and endoscopy suite and determine how much time you will need to set aside for pumping.

Be prepared to make adjustments as needed.

• Endoscopy-heavy rotations may be more difficult in the third trimester of pregnancy.
• Make contingency plans for early or late delivery dates, as well as if you undergo a cesarean that requires additional recovery time.
• Consider scheduling elective rotations (research, clinic) toward the end of leave and for the first month of “return to work.”
• If you plan to join limited clinic or outpatient endoscopy blocks later in your leave, make early arrangements to work regularly with these attendings.

Conclusion

Trainee needs assessments in gastroenterology fellowship similar to those in other specialties should be performed, and are in fact underway.^19,23,24 There is a lack of data regarding the availability of fellowship program guidance and, specifically, adherence to required policies, and more data from program directors at a national level need to be collected.²⁰ We recommend that programs engage in identifying specific needs at their institutions with the goal of eventually sharing this knowledge with other programs. Gastroenterology society recommendations for performing endoscopy while pregnant, with regard to ergonomics, infection control, and radiation exposure, would be instrumental. GI fellowships should consolidate institutional knowledge and engage key stakeholders – including trainees, prior trainees, occupational safety experts, radiation safety offices, wellness experts, and GME – to create program-specific policies that are flexible but rigorous and generous but equitable.

Dr. Liu and Dr. Summa are gastroenterology fellows at Northwestern University, Chicago. Dr. Patel is an assistant professor of medicine and a gastroenterology fellowship assistant program director at Northwestern University, Chicago. Dr. Donnan and Dr. Guentner are assistant professors of medicine at Northwestern University. Dr. Kia is an assistant professor of medicine and the gastroenterology fellowship program director at Northwestern University. They have no conflicts of interest to disclose. The authors would like to thank Michelle Clermont, MD, and Maureen K. Bolon, MD, for their discussion and assistance during the drafting of this article.

References

1. Section on Medical Students, Residents, and Fellowship Trainees; Committee on Early Childhood. Pediatrics. 2013;131(2):387-90.

2. American Board of Medical Specialties. ABMS Announces Progressive Leave Policy for Residents and Fellows. July 13, 2020. Accessed May 1, 2021. https://www.abms.org/news-events/abms-announces-progressive-leave-policy-for-residents-and-fellows/.

3. Magudia K et al. J Grad Med Educ. 2020;12(2):162-7.

4. Blair JE et al. Acad Med. 2016;91(7):972-8.

5. Feld LD. Am J Gastroenterol. 2021;116(3):505-8.

6. Roubaud MS. Plast Reconstr Surg Glob Open. 2019. doi: 10.1097/GOX.0000000000002104.

7. Price J, Dunbar K. Gastrointest Endosc. 2009;69(1):121-3.

8. David YN et al. Gastrointest Endosc. 2020;91(6):AB75-AB76.

9. Webb AMB et al. Acad Med J Assoc Am Med Coll. 2019;94(11):1631-4.

10. Weinstein DF et al. N Engl J Med. 2019 Sep 12;381(11):995-7.

11. Anderson M, Goldman RH. JAMA Surg. 2020;155(3):243-9.

12. Palmer KT et al. Occup Environ Med. 2013;70(4):213-22.

13. Siegel JD et al; Healthcare Infection, Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). 2007. Last reviewed July 22, 2019. Accessed April 28, 2021. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

14. David YN et al. Am J Gastroenterol. 2021;116(3):539-50.

15. Sethi S et al. Dig Dis Sci. 2019;64(9):2455-66.

16. Alzimami K et al. Gastroenterol Res Pract. 2013;2013:587574.

17. Hayashi S et al. World J Clin Cases. 2018;6(16):1087-93.

18. U.S. Department of Labor, Wage and Hour Division. “Frequently Asked Questions – Break Time for Nursing Mothers.” Accessed May 1, 2021. https://www.dol.gov/agencies/whd/nursing-mothers/faq.

19. Mwakyanjala EJ et al. J Am Heart Assoc. 2019. doi: 10.1161/JAHA.119.012137.

20. Castillo-Angeles M et al. JAMA Surg. 2021 Jul 1;156(7):647-53.

21. Prasad S et al. J Grad Med Educ. 2021 Jun;13(3):349-54.

22. Ho IKH et al. Am J Gastroenterol. 2014;109(8):1180-94.

23. Sherbaf FG et al. AJNR Am J Neuroradiol. 2020;41(8):1348-54.

24. Altieri MS et al. JAMA Surg. 2019;154(10):952-58.

If COVID-19 has caused millions of deaths, it may also have prevented or at least led to a postponement of many births.

In an assessment of the pandemic’s early effects, Arnstein Aassve, PhD, and colleagues found a significant COVID-19–related decline in crude birth rates (CBRs) in 7 of 22 high-income countries, particularly in Southwestern Europe.

Dr. Aassve, an economist at the Carlo F. Dondena Center for Research on Social Dynamics and Public Policy at the Università Commerciale Luigi Bocconi, Milan, and colleagues report the results in an article published online August 30 in the Proceedings of the National Academy of Sciences.

Defining the start of the COVID-19 pandemic as February 2020, the study identifies strong declines in Italy (-9.1%), Hungary (-8.5%), Spain (-8.4%), and Portugal (-6.6%) beyond those predicted by past trends. In the United States, CBRs fell by 7.1% relative to 2019 for births occurring in Nov. and Dec. 2020 following conceptions in February and March of that year.

Significant declines in CBR also occurred in Belgium, Austria, and Singapore.

A year-to-year comparison of the mean for monthly CBRs per 1,000 population before and during the pandemic suggests a negative difference for all countries studied except for Denmark, Finland, Germany, and the Netherlands, Dr. Aassve and colleagues write. These findings may have policy implications for childcare, housing, and the labor market.

The Milan researchers compared monthly vital statistics data on live births from the international Human Fertility Database for the period of Jan. 2016 to March 2021. These figures reflect conceptions carried to term between April 2015 and June 2020. The 22 countries in the analysis represent 37% of the total reported COVID-19 cases and 34% of deaths worldwide.

The study findings align with surveys on “fertility intentions” collected early in the first COVID-19 wave in Germany, France, Spain, and the United Kingdom. These surveys indicated that 73% of people who were planning pregnancies in 2020 either decided to delay the pregnancy or they abandoned their plans.

“The popular media speculated that the lockdown would lead to a baby boom, as couples spent more time together,” Dr. Aassve told this news organization. “There’s very little evidence of this when you look to previous disasters and shocks, and the first data suggest more of an immediate collapse than a boom. But as you also see from the paper, the collapse is not seen everywhere.” Other current studies suggest the fertility drop is immediate but temporary, says Dr. Aassve, who is also a professor of demography.

Interestingly, Dr. Aassve and colleagues found that CBRs were relatively stable in Northern Europe. The authors point to supportive social and family policies in that region that might have reduced the effect of the pandemic on births. “These factors are likely to affect CBRs in the subsequent pandemic waves,” they write. They call for future studies to assess the full population implications of the pandemic, the moderating impact of policy interventions, and the nexus between short- and long-run effects in relation to the various waves of the COVID-19 pandemic.
 

Rebounds

Some regions have already reported a rebound from the COVID-19 fertility trough. Molly J. Stout, MD, director of maternal fetal medicine at the University of Michigan, Ann Arbor, and colleagues used electronic medical records to predict a surge in births after the initial decline.

“The surge we’ve seen at the end of this summer is exceeding the usual annual birth rate, as predicted,” she said in an interview. “But I think there’ll be a return to normal after this transient escalation. I don’t think birth rates will stay elevated above the normal because the birth surge is a temporary response to an event, although there will likely be regional differences.”

Looking ahead, Dr. Stout, who was not involved in Dr. Aassve’s analysis, is not certain how a fourth pandemic wave might ultimately modify a couple’s overall family size. But the toll the health crisis has taken on working women who have been forced to withdraw from the economy because of a lack of childcare points to a societal need that should be addressed.

According to Philip N. Cohen, PhD, a professor of sociology at the University of Maryland, College Park, who’s been tracking fertility trends since the onset of the COVID-19 emergency, the pandemic has combined a health crisis with an economic crisis, along with “the additional factor of social distancing and isolation, which all contributed to the decline in birth rates. Some people changed their plans to hold off on having children, while others didn’t get pregnant because they weren’t socializing and meeting people as much.”

Dr. Cohen, who was not involved in the study by Dr. Aassve and associates, said his provisional data show that although in many places, birth rates have rebounded more or less to prepandemic levels after a nadir around Jan. 2021, some areas of the United States still show substantially lower rates, including California, Hawaii, and Oregon.

As to the duration of the pandemic effect, Dr. Aassve cautions that his group’s estimates refer to the first wave only. “We then have the second, third, and currently the fourth wave. We can’t be sure about the impact of these waves on fertility since the data are not there yet, but I’d be surprised if they didn’t continue to have an impact on fertility rates,” he said.

Dr. Cohen agreed: “Some people who delayed childbearing will make up the delay. However, whenever there’s a delay, there’s inevitably some portion of the decline that’s not recouped.”

As for the wider effect across the world, Dr. Aassve said his team’s figures derive from high-income countries where data are readily available. For middle- and low-income countries, fewer data exist, and the quality of those data is not as good.

The lessons from this and other upheavals teach us that unforeseen shocks almost always have a negative impact on fertility, says Dr. Aassve. “[B]ut these effects may be separate from existing declining trends. The issue here is that those overall declining trends may be driven by other factors. In contrast, the shock of the pandemic is short-lived, and we may return to normal rather quickly. But if the pandemic also impacts other societal structures, such as the occupational and industrial sectors, then the pandemic might exacerbate the negative trend.”

The study was supported by funding from the European Research Council for funding under the European Union’s Horizon 2020 Research and Innovation Programme. The study authors, Dr. Stout, and Dr. Cohen have disclosed no relevant financial relationships.

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

If COVID-19 has caused millions of deaths, it may also have prevented or at least led to a postponement of many births.

In an assessment of the pandemic’s early effects, Arnstein Aassve, PhD, and colleagues found a significant COVID-19–related decline in crude birth rates (CBRs) in 7 of 22 high-income countries, particularly in Southwestern Europe.

Dr. Aassve, an economist at the Carlo F. Dondena Center for Research on Social Dynamics and Public Policy at the Università Commerciale Luigi Bocconi, Milan, and colleagues report the results in an article published online August 30 in the Proceedings of the National Academy of Sciences.

Defining the start of the COVID-19 pandemic as February 2020, the study identifies strong declines in Italy (-9.1%), Hungary (-8.5%), Spain (-8.4%), and Portugal (-6.6%) beyond those predicted by past trends. In the United States, CBRs fell by 7.1% relative to 2019 for births occurring in Nov. and Dec. 2020 following conceptions in February and March of that year.

Significant declines in CBR also occurred in Belgium, Austria, and Singapore.

A year-to-year comparison of the mean for monthly CBRs per 1,000 population before and during the pandemic suggests a negative difference for all countries studied except for Denmark, Finland, Germany, and the Netherlands, Dr. Aassve and colleagues write. These findings may have policy implications for childcare, housing, and the labor market.

The Milan researchers compared monthly vital statistics data on live births from the international Human Fertility Database for the period of Jan. 2016 to March 2021. These figures reflect conceptions carried to term between April 2015 and June 2020. The 22 countries in the analysis represent 37% of the total reported COVID-19 cases and 34% of deaths worldwide.

The study findings align with surveys on “fertility intentions” collected early in the first COVID-19 wave in Germany, France, Spain, and the United Kingdom. These surveys indicated that 73% of people who were planning pregnancies in 2020 either decided to delay the pregnancy or they abandoned their plans.

“The popular media speculated that the lockdown would lead to a baby boom, as couples spent more time together,” Dr. Aassve told this news organization. “There’s very little evidence of this when you look to previous disasters and shocks, and the first data suggest more of an immediate collapse than a boom. But as you also see from the paper, the collapse is not seen everywhere.” Other current studies suggest the fertility drop is immediate but temporary, says Dr. Aassve, who is also a professor of demography.

Interestingly, Dr. Aassve and colleagues found that CBRs were relatively stable in Northern Europe. The authors point to supportive social and family policies in that region that might have reduced the effect of the pandemic on births. “These factors are likely to affect CBRs in the subsequent pandemic waves,” they write. They call for future studies to assess the full population implications of the pandemic, the moderating impact of policy interventions, and the nexus between short- and long-run effects in relation to the various waves of the COVID-19 pandemic.
 

Rebounds

Some regions have already reported a rebound from the COVID-19 fertility trough. Molly J. Stout, MD, director of maternal fetal medicine at the University of Michigan, Ann Arbor, and colleagues used electronic medical records to predict a surge in births after the initial decline.

“The surge we’ve seen at the end of this summer is exceeding the usual annual birth rate, as predicted,” she said in an interview. “But I think there’ll be a return to normal after this transient escalation. I don’t think birth rates will stay elevated above the normal because the birth surge is a temporary response to an event, although there will likely be regional differences.”

Looking ahead, Dr. Stout, who was not involved in Dr. Aassve’s analysis, is not certain how a fourth pandemic wave might ultimately modify a couple’s overall family size. But the toll the health crisis has taken on working women who have been forced to withdraw from the economy because of a lack of childcare points to a societal need that should be addressed.

According to Philip N. Cohen, PhD, a professor of sociology at the University of Maryland, College Park, who’s been tracking fertility trends since the onset of the COVID-19 emergency, the pandemic has combined a health crisis with an economic crisis, along with “the additional factor of social distancing and isolation, which all contributed to the decline in birth rates. Some people changed their plans to hold off on having children, while others didn’t get pregnant because they weren’t socializing and meeting people as much.”

Dr. Cohen, who was not involved in the study by Dr. Aassve and associates, said his provisional data show that although in many places, birth rates have rebounded more or less to prepandemic levels after a nadir around Jan. 2021, some areas of the United States still show substantially lower rates, including California, Hawaii, and Oregon.

As to the duration of the pandemic effect, Dr. Aassve cautions that his group’s estimates refer to the first wave only. “We then have the second, third, and currently the fourth wave. We can’t be sure about the impact of these waves on fertility since the data are not there yet, but I’d be surprised if they didn’t continue to have an impact on fertility rates,” he said.

Dr. Cohen agreed: “Some people who delayed childbearing will make up the delay. However, whenever there’s a delay, there’s inevitably some portion of the decline that’s not recouped.”

As for the wider effect across the world, Dr. Aassve said his team’s figures derive from high-income countries where data are readily available. For middle- and low-income countries, fewer data exist, and the quality of those data is not as good.

The lessons from this and other upheavals teach us that unforeseen shocks almost always have a negative impact on fertility, says Dr. Aassve. “[B]ut these effects may be separate from existing declining trends. The issue here is that those overall declining trends may be driven by other factors. In contrast, the shock of the pandemic is short-lived, and we may return to normal rather quickly. But if the pandemic also impacts other societal structures, such as the occupational and industrial sectors, then the pandemic might exacerbate the negative trend.”

The study was supported by funding from the European Research Council for funding under the European Union’s Horizon 2020 Research and Innovation Programme. The study authors, Dr. Stout, and Dr. Cohen have disclosed no relevant financial relationships.

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

If COVID-19 has caused millions of deaths, it may also have prevented or at least led to a postponement of many births.

In an assessment of the pandemic’s early effects, Arnstein Aassve, PhD, and colleagues found a significant COVID-19–related decline in crude birth rates (CBRs) in 7 of 22 high-income countries, particularly in Southwestern Europe.

Dr. Aassve, an economist at the Carlo F. Dondena Center for Research on Social Dynamics and Public Policy at the Università Commerciale Luigi Bocconi, Milan, and colleagues report the results in an article published online August 30 in the Proceedings of the National Academy of Sciences.

Defining the start of the COVID-19 pandemic as February 2020, the study identifies strong declines in Italy (-9.1%), Hungary (-8.5%), Spain (-8.4%), and Portugal (-6.6%) beyond those predicted by past trends. In the United States, CBRs fell by 7.1% relative to 2019 for births occurring in Nov. and Dec. 2020 following conceptions in February and March of that year.

Significant declines in CBR also occurred in Belgium, Austria, and Singapore.

A year-to-year comparison of the mean for monthly CBRs per 1,000 population before and during the pandemic suggests a negative difference for all countries studied except for Denmark, Finland, Germany, and the Netherlands, Dr. Aassve and colleagues write. These findings may have policy implications for childcare, housing, and the labor market.

The Milan researchers compared monthly vital statistics data on live births from the international Human Fertility Database for the period of Jan. 2016 to March 2021. These figures reflect conceptions carried to term between April 2015 and June 2020. The 22 countries in the analysis represent 37% of the total reported COVID-19 cases and 34% of deaths worldwide.

The study findings align with surveys on “fertility intentions” collected early in the first COVID-19 wave in Germany, France, Spain, and the United Kingdom. These surveys indicated that 73% of people who were planning pregnancies in 2020 either decided to delay the pregnancy or they abandoned their plans.

“The popular media speculated that the lockdown would lead to a baby boom, as couples spent more time together,” Dr. Aassve told this news organization. “There’s very little evidence of this when you look to previous disasters and shocks, and the first data suggest more of an immediate collapse than a boom. But as you also see from the paper, the collapse is not seen everywhere.” Other current studies suggest the fertility drop is immediate but temporary, says Dr. Aassve, who is also a professor of demography.

Interestingly, Dr. Aassve and colleagues found that CBRs were relatively stable in Northern Europe. The authors point to supportive social and family policies in that region that might have reduced the effect of the pandemic on births. “These factors are likely to affect CBRs in the subsequent pandemic waves,” they write. They call for future studies to assess the full population implications of the pandemic, the moderating impact of policy interventions, and the nexus between short- and long-run effects in relation to the various waves of the COVID-19 pandemic.
 

Rebounds

Some regions have already reported a rebound from the COVID-19 fertility trough. Molly J. Stout, MD, director of maternal fetal medicine at the University of Michigan, Ann Arbor, and colleagues used electronic medical records to predict a surge in births after the initial decline.

“The surge we’ve seen at the end of this summer is exceeding the usual annual birth rate, as predicted,” she said in an interview. “But I think there’ll be a return to normal after this transient escalation. I don’t think birth rates will stay elevated above the normal because the birth surge is a temporary response to an event, although there will likely be regional differences.”

Looking ahead, Dr. Stout, who was not involved in Dr. Aassve’s analysis, is not certain how a fourth pandemic wave might ultimately modify a couple’s overall family size. But the toll the health crisis has taken on working women who have been forced to withdraw from the economy because of a lack of childcare points to a societal need that should be addressed.

According to Philip N. Cohen, PhD, a professor of sociology at the University of Maryland, College Park, who’s been tracking fertility trends since the onset of the COVID-19 emergency, the pandemic has combined a health crisis with an economic crisis, along with “the additional factor of social distancing and isolation, which all contributed to the decline in birth rates. Some people changed their plans to hold off on having children, while others didn’t get pregnant because they weren’t socializing and meeting people as much.”

Dr. Cohen, who was not involved in the study by Dr. Aassve and associates, said his provisional data show that although in many places, birth rates have rebounded more or less to prepandemic levels after a nadir around Jan. 2021, some areas of the United States still show substantially lower rates, including California, Hawaii, and Oregon.

As to the duration of the pandemic effect, Dr. Aassve cautions that his group’s estimates refer to the first wave only. “We then have the second, third, and currently the fourth wave. We can’t be sure about the impact of these waves on fertility since the data are not there yet, but I’d be surprised if they didn’t continue to have an impact on fertility rates,” he said.

Dr. Cohen agreed: “Some people who delayed childbearing will make up the delay. However, whenever there’s a delay, there’s inevitably some portion of the decline that’s not recouped.”

As for the wider effect across the world, Dr. Aassve said his team’s figures derive from high-income countries where data are readily available. For middle- and low-income countries, fewer data exist, and the quality of those data is not as good.

The lessons from this and other upheavals teach us that unforeseen shocks almost always have a negative impact on fertility, says Dr. Aassve. “[B]ut these effects may be separate from existing declining trends. The issue here is that those overall declining trends may be driven by other factors. In contrast, the shock of the pandemic is short-lived, and we may return to normal rather quickly. But if the pandemic also impacts other societal structures, such as the occupational and industrial sectors, then the pandemic might exacerbate the negative trend.”

The study was supported by funding from the European Research Council for funding under the European Union’s Horizon 2020 Research and Innovation Programme. The study authors, Dr. Stout, and Dr. Cohen have disclosed no relevant financial relationships.

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

The arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) poses an increased risk of serious cardiac events such as heart attack or stroke, cancer, blood clots, and death, the Food and Drug Administration announced Sept 1.

Manufacturers of this drug along with other Janus kinase (JAK) inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq) must update their boxed warnings to include information about these health risks. The FDA made the determination after new study data from Pfizer, which manufacturers Xeljanz, found an association between a lower dose of Xeljanz and increased risk of blood clots and death.

“Recommendations for healthcare professionals will include consideration of the benefits and risks for the individual patient prior to initiating or continuing therapy,” the agency stated.

The FDA is limiting all approved uses of these three medications to patients who have not responded well to tumor necrosis factor (TNF) blockers to ensure their benefits outweigh their risks. Tofacitinib is indicated for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. Baricitinib and upadacitinib are approved only for RA. The FDA included baricitinib and upadacitinib in the warning because of the similar properties they share with tofacitinib, even though they haven’t been studied as extensively.

“We believe this update will bring important clarity for healthcare plans on the risk/benefit profile of Xeljanz, which is a medicine informed by more clinical data than any other JAK inhibitor,” Pfizer said in a statement.

Investigators for the ORAL Surveillance trial compared two doses of tofacitinib (5 mg twice daily and 10 mg twice daily) with TNF blockers in patients with rheumatoid arthritis who were aged 50 years or older with at least one additional cardiovascular risk factor.

For both dose regimens of tofacitinib, they found an increased risk of major adverse cardiovascular events, malignancies, thrombosis, and death compared with the TNF blocker regimen. In addition, rates of lung cancers and lymphomas were higher with tofacitinib. In trial data released earlier this year, Pfizer revealed that the tofacitinib group had a much higher incidence of adjudicated malignancies compared with the TNF blocker group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09).

Impact on clinical practice

Physicians treating patients who have rheumatoid arthritis with tofacitinib may initially decrease prescriptions following the FDA’s drug safety communication, said Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and a research professor at the University of Florence (Italy) – particularly those with a principal mechanism of action slightly different from that of tofacitinib, he added.

“Tofacitinib is principally a JAK 1,3 inhibitor at usual concentrations, whereas upadacitinib and baricitinib are JAK 1,2 inhibitors. Thus, I speculate that the tofacitinib prescriptions will go down more than the upadacitinib and baricitinib prescriptions,” he said in an interview.

Some patients may also be worried about taking tofacitinib, particularly those with previous events or predisposing conditions, Dr. Furst noted.

“First and foremost, I think we need to actually look at the data in a publication rather than just an FDA statement before making huge changes in our practice,” he advised.

“I am looking forward to the data finally being published ... It’s interesting that the full data still isn’t really out there beyond the press releases and an abstract. I think there’s a lot more to learn about how these drugs work and who is really at risk for harmful events,” said Alexis R. Ogdie, MD, MSCE, associate professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia.

Pfizer’s data also may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

“I think many rheumatologists have already taken this information in, and begun to incorporate it into their discussions with their patients” since it has been over a year since the first public release of information about the ORAL Surveillance trial, said Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego. “I don’t know that it will affect the approvals, but it will impact their labels.”

Wariness to prescribing tofacitinib may be lower for patients younger than those in the ORAL Surveillance trial without additional cardiovascular risk factors who are taking tofacitinib for non-RA indications, said gastroenterologist Miguel Regueiro, MD.

“The JAK inhibitor warning by the FDA is an important consideration for any prescriber or patient. The risk of cardiovascular disease and venous thromboembolism with this class of medicine appears higher in older rheumatoid arthritis patients with underlying cardiovascular disease. While the warning applies to all JAK inhibitors and likely the newer selective JAK inhibitors to come, we need to weigh the risk and benefit based on the indication for prescribing,” said Dr. Regueiro, chair of the Digestive Disease and Surgery Institute and of the department of gastroenterology, hepatology and nutrition at the Cleveland Clinic in Ohio.

“I do think that there will be a heightened awareness and wariness for older RA patients and for the prescribers. However, for inflammatory bowel disease (and other non-RA indications), it does not appear that the risk for cardiovascular disease and VTE are significantly increased. To that end, in my own practice, I still use tofacitinib for ulcerative colitis and will do the same for the selective JAK inhibitors to come for IBD. Of course, as with any medication, we need to have discussions with our patients, alert them to potential side effects and have an open line of communication for any questions or concerns.”

Gastroenterologist Stephen Hanauer, MD, professor of medicine at Northwestern University, Chicago, thought that while patients with RA have many other treatment options besides JAK inhibitors, fewer options available to patients with IBD “may motivate the use of oral [sphingosine-1-phosphate receptor modulator] agents such as ozanimod, although IBD patients are younger and [have fewer] MACE risk factors than RA patients, so absolute risk is very small in the ulcerative colitis population.”

Pfizer’s data may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

The agency’s decision corroborates an earlier 2019 warning about the increased risk of blood clots and of death in patients with ulcerative colitis taking 10 mg tofacitinib twice daily.

The FDA said that two other JAK inhibitors, ruxolitinib (Jakafi) and fedratinib (Inrebic), are not indicated for the treatment of arthritis and other inflammatory conditions, and so are not a part of the updates being required.

Baricitinib, abrocitinib, and upadacitinib are currently under FDA review for treating atopic dermatitis (AD); a topical formulation of the JAK1/2 inhibitor ruxolitinib is under review for treating AD. Reviews for all 4 have been extended. In September 2020, baricitinib was approved for treating moderate to severe AD in Europe, at a dose of 4 mg once a day, with recommendations that the dose can be reduced to 2 mg once a day when the disease is under control, and that the dose may need to be reduced in patients with impaired kidney function, those with an increased risk of infections, and those older than aged 75 years.

In an interview, Jacob Thyssen, MD, PhD, professor of dermatology at the University of Copenhagen, said that in the EU, there has been “extensive education” about cardiovascular risks with baricitinib “and it is my impression that payers and dermatologists in Europe are confident that it is safe to use in AD.” In addition, there has been an emphasis on the differences in cardiovascular risk factors between RA and AD patients, “given that the latter group is generally young and lean.” In the United States, he added, it will be interesting to see which doses of the JAK inhibitors will be approved for AD.

Dr. Thyssen disclosed that he is a speaker, advisory board member and/or investigator for Regeneron, Sanofi-Genzyme, Eli Lilly, Pfizer, LEO Pharma, AbbVie, and Almirall.
 

*This story was updated 9/3/21 and 9/6/2021.

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

The arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) poses an increased risk of serious cardiac events such as heart attack or stroke, cancer, blood clots, and death, the Food and Drug Administration announced Sept 1.

Manufacturers of this drug along with other Janus kinase (JAK) inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq) must update their boxed warnings to include information about these health risks. The FDA made the determination after new study data from Pfizer, which manufacturers Xeljanz, found an association between a lower dose of Xeljanz and increased risk of blood clots and death.

“Recommendations for healthcare professionals will include consideration of the benefits and risks for the individual patient prior to initiating or continuing therapy,” the agency stated.

The FDA is limiting all approved uses of these three medications to patients who have not responded well to tumor necrosis factor (TNF) blockers to ensure their benefits outweigh their risks. Tofacitinib is indicated for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. Baricitinib and upadacitinib are approved only for RA. The FDA included baricitinib and upadacitinib in the warning because of the similar properties they share with tofacitinib, even though they haven’t been studied as extensively.

“We believe this update will bring important clarity for healthcare plans on the risk/benefit profile of Xeljanz, which is a medicine informed by more clinical data than any other JAK inhibitor,” Pfizer said in a statement.

Investigators for the ORAL Surveillance trial compared two doses of tofacitinib (5 mg twice daily and 10 mg twice daily) with TNF blockers in patients with rheumatoid arthritis who were aged 50 years or older with at least one additional cardiovascular risk factor.

For both dose regimens of tofacitinib, they found an increased risk of major adverse cardiovascular events, malignancies, thrombosis, and death compared with the TNF blocker regimen. In addition, rates of lung cancers and lymphomas were higher with tofacitinib. In trial data released earlier this year, Pfizer revealed that the tofacitinib group had a much higher incidence of adjudicated malignancies compared with the TNF blocker group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09).

Impact on clinical practice

Physicians treating patients who have rheumatoid arthritis with tofacitinib may initially decrease prescriptions following the FDA’s drug safety communication, said Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and a research professor at the University of Florence (Italy) – particularly those with a principal mechanism of action slightly different from that of tofacitinib, he added.

“Tofacitinib is principally a JAK 1,3 inhibitor at usual concentrations, whereas upadacitinib and baricitinib are JAK 1,2 inhibitors. Thus, I speculate that the tofacitinib prescriptions will go down more than the upadacitinib and baricitinib prescriptions,” he said in an interview.

Some patients may also be worried about taking tofacitinib, particularly those with previous events or predisposing conditions, Dr. Furst noted.

“First and foremost, I think we need to actually look at the data in a publication rather than just an FDA statement before making huge changes in our practice,” he advised.

“I am looking forward to the data finally being published ... It’s interesting that the full data still isn’t really out there beyond the press releases and an abstract. I think there’s a lot more to learn about how these drugs work and who is really at risk for harmful events,” said Alexis R. Ogdie, MD, MSCE, associate professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia.

Pfizer’s data also may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

“I think many rheumatologists have already taken this information in, and begun to incorporate it into their discussions with their patients” since it has been over a year since the first public release of information about the ORAL Surveillance trial, said Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego. “I don’t know that it will affect the approvals, but it will impact their labels.”

Wariness to prescribing tofacitinib may be lower for patients younger than those in the ORAL Surveillance trial without additional cardiovascular risk factors who are taking tofacitinib for non-RA indications, said gastroenterologist Miguel Regueiro, MD.

“The JAK inhibitor warning by the FDA is an important consideration for any prescriber or patient. The risk of cardiovascular disease and venous thromboembolism with this class of medicine appears higher in older rheumatoid arthritis patients with underlying cardiovascular disease. While the warning applies to all JAK inhibitors and likely the newer selective JAK inhibitors to come, we need to weigh the risk and benefit based on the indication for prescribing,” said Dr. Regueiro, chair of the Digestive Disease and Surgery Institute and of the department of gastroenterology, hepatology and nutrition at the Cleveland Clinic in Ohio.

“I do think that there will be a heightened awareness and wariness for older RA patients and for the prescribers. However, for inflammatory bowel disease (and other non-RA indications), it does not appear that the risk for cardiovascular disease and VTE are significantly increased. To that end, in my own practice, I still use tofacitinib for ulcerative colitis and will do the same for the selective JAK inhibitors to come for IBD. Of course, as with any medication, we need to have discussions with our patients, alert them to potential side effects and have an open line of communication for any questions or concerns.”

Gastroenterologist Stephen Hanauer, MD, professor of medicine at Northwestern University, Chicago, thought that while patients with RA have many other treatment options besides JAK inhibitors, fewer options available to patients with IBD “may motivate the use of oral [sphingosine-1-phosphate receptor modulator] agents such as ozanimod, although IBD patients are younger and [have fewer] MACE risk factors than RA patients, so absolute risk is very small in the ulcerative colitis population.”

Pfizer’s data may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

The agency’s decision corroborates an earlier 2019 warning about the increased risk of blood clots and of death in patients with ulcerative colitis taking 10 mg tofacitinib twice daily.

The FDA said that two other JAK inhibitors, ruxolitinib (Jakafi) and fedratinib (Inrebic), are not indicated for the treatment of arthritis and other inflammatory conditions, and so are not a part of the updates being required.

Baricitinib, abrocitinib, and upadacitinib are currently under FDA review for treating atopic dermatitis (AD); a topical formulation of the JAK1/2 inhibitor ruxolitinib is under review for treating AD. Reviews for all 4 have been extended. In September 2020, baricitinib was approved for treating moderate to severe AD in Europe, at a dose of 4 mg once a day, with recommendations that the dose can be reduced to 2 mg once a day when the disease is under control, and that the dose may need to be reduced in patients with impaired kidney function, those with an increased risk of infections, and those older than aged 75 years.

In an interview, Jacob Thyssen, MD, PhD, professor of dermatology at the University of Copenhagen, said that in the EU, there has been “extensive education” about cardiovascular risks with baricitinib “and it is my impression that payers and dermatologists in Europe are confident that it is safe to use in AD.” In addition, there has been an emphasis on the differences in cardiovascular risk factors between RA and AD patients, “given that the latter group is generally young and lean.” In the United States, he added, it will be interesting to see which doses of the JAK inhibitors will be approved for AD.

Dr. Thyssen disclosed that he is a speaker, advisory board member and/or investigator for Regeneron, Sanofi-Genzyme, Eli Lilly, Pfizer, LEO Pharma, AbbVie, and Almirall.
 

*This story was updated 9/3/21 and 9/6/2021.

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

The arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) poses an increased risk of serious cardiac events such as heart attack or stroke, cancer, blood clots, and death, the Food and Drug Administration announced Sept 1.

Manufacturers of this drug along with other Janus kinase (JAK) inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq) must update their boxed warnings to include information about these health risks. The FDA made the determination after new study data from Pfizer, which manufacturers Xeljanz, found an association between a lower dose of Xeljanz and increased risk of blood clots and death.

“Recommendations for healthcare professionals will include consideration of the benefits and risks for the individual patient prior to initiating or continuing therapy,” the agency stated.

The FDA is limiting all approved uses of these three medications to patients who have not responded well to tumor necrosis factor (TNF) blockers to ensure their benefits outweigh their risks. Tofacitinib is indicated for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. Baricitinib and upadacitinib are approved only for RA. The FDA included baricitinib and upadacitinib in the warning because of the similar properties they share with tofacitinib, even though they haven’t been studied as extensively.

“We believe this update will bring important clarity for healthcare plans on the risk/benefit profile of Xeljanz, which is a medicine informed by more clinical data than any other JAK inhibitor,” Pfizer said in a statement.

Investigators for the ORAL Surveillance trial compared two doses of tofacitinib (5 mg twice daily and 10 mg twice daily) with TNF blockers in patients with rheumatoid arthritis who were aged 50 years or older with at least one additional cardiovascular risk factor.

For both dose regimens of tofacitinib, they found an increased risk of major adverse cardiovascular events, malignancies, thrombosis, and death compared with the TNF blocker regimen. In addition, rates of lung cancers and lymphomas were higher with tofacitinib. In trial data released earlier this year, Pfizer revealed that the tofacitinib group had a much higher incidence of adjudicated malignancies compared with the TNF blocker group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09).

Impact on clinical practice

Physicians treating patients who have rheumatoid arthritis with tofacitinib may initially decrease prescriptions following the FDA’s drug safety communication, said Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and a research professor at the University of Florence (Italy) – particularly those with a principal mechanism of action slightly different from that of tofacitinib, he added.

“Tofacitinib is principally a JAK 1,3 inhibitor at usual concentrations, whereas upadacitinib and baricitinib are JAK 1,2 inhibitors. Thus, I speculate that the tofacitinib prescriptions will go down more than the upadacitinib and baricitinib prescriptions,” he said in an interview.

Some patients may also be worried about taking tofacitinib, particularly those with previous events or predisposing conditions, Dr. Furst noted.

“First and foremost, I think we need to actually look at the data in a publication rather than just an FDA statement before making huge changes in our practice,” he advised.

“I am looking forward to the data finally being published ... It’s interesting that the full data still isn’t really out there beyond the press releases and an abstract. I think there’s a lot more to learn about how these drugs work and who is really at risk for harmful events,” said Alexis R. Ogdie, MD, MSCE, associate professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia.

Pfizer’s data also may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

“I think many rheumatologists have already taken this information in, and begun to incorporate it into their discussions with their patients” since it has been over a year since the first public release of information about the ORAL Surveillance trial, said Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego. “I don’t know that it will affect the approvals, but it will impact their labels.”

Wariness to prescribing tofacitinib may be lower for patients younger than those in the ORAL Surveillance trial without additional cardiovascular risk factors who are taking tofacitinib for non-RA indications, said gastroenterologist Miguel Regueiro, MD.

“The JAK inhibitor warning by the FDA is an important consideration for any prescriber or patient. The risk of cardiovascular disease and venous thromboembolism with this class of medicine appears higher in older rheumatoid arthritis patients with underlying cardiovascular disease. While the warning applies to all JAK inhibitors and likely the newer selective JAK inhibitors to come, we need to weigh the risk and benefit based on the indication for prescribing,” said Dr. Regueiro, chair of the Digestive Disease and Surgery Institute and of the department of gastroenterology, hepatology and nutrition at the Cleveland Clinic in Ohio.

“I do think that there will be a heightened awareness and wariness for older RA patients and for the prescribers. However, for inflammatory bowel disease (and other non-RA indications), it does not appear that the risk for cardiovascular disease and VTE are significantly increased. To that end, in my own practice, I still use tofacitinib for ulcerative colitis and will do the same for the selective JAK inhibitors to come for IBD. Of course, as with any medication, we need to have discussions with our patients, alert them to potential side effects and have an open line of communication for any questions or concerns.”

Gastroenterologist Stephen Hanauer, MD, professor of medicine at Northwestern University, Chicago, thought that while patients with RA have many other treatment options besides JAK inhibitors, fewer options available to patients with IBD “may motivate the use of oral [sphingosine-1-phosphate receptor modulator] agents such as ozanimod, although IBD patients are younger and [have fewer] MACE risk factors than RA patients, so absolute risk is very small in the ulcerative colitis population.”

Pfizer’s data may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

The agency’s decision corroborates an earlier 2019 warning about the increased risk of blood clots and of death in patients with ulcerative colitis taking 10 mg tofacitinib twice daily.

The FDA said that two other JAK inhibitors, ruxolitinib (Jakafi) and fedratinib (Inrebic), are not indicated for the treatment of arthritis and other inflammatory conditions, and so are not a part of the updates being required.

Baricitinib, abrocitinib, and upadacitinib are currently under FDA review for treating atopic dermatitis (AD); a topical formulation of the JAK1/2 inhibitor ruxolitinib is under review for treating AD. Reviews for all 4 have been extended. In September 2020, baricitinib was approved for treating moderate to severe AD in Europe, at a dose of 4 mg once a day, with recommendations that the dose can be reduced to 2 mg once a day when the disease is under control, and that the dose may need to be reduced in patients with impaired kidney function, those with an increased risk of infections, and those older than aged 75 years.

In an interview, Jacob Thyssen, MD, PhD, professor of dermatology at the University of Copenhagen, said that in the EU, there has been “extensive education” about cardiovascular risks with baricitinib “and it is my impression that payers and dermatologists in Europe are confident that it is safe to use in AD.” In addition, there has been an emphasis on the differences in cardiovascular risk factors between RA and AD patients, “given that the latter group is generally young and lean.” In the United States, he added, it will be interesting to see which doses of the JAK inhibitors will be approved for AD.

Dr. Thyssen disclosed that he is a speaker, advisory board member and/or investigator for Regeneron, Sanofi-Genzyme, Eli Lilly, Pfizer, LEO Pharma, AbbVie, and Almirall.
 

*This story was updated 9/3/21 and 9/6/2021.

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

Climate change is a global threat, and it presents a dual problem to health care: The system must address health threats that may be caused or exacerbated by climate change, while at the same time minimizing its environmental impact, according to the authors of a paper in Techniques and Innovations in Gastrointestinal Endoscopy.

Because of how often it is performed, endoscopy may have one of the highest environmental impacts of any health care procedure. Waste produced by endoscopy is the third largest source in a typical hospital, equivalent yearly to burning 39 million pounds of coal or 13,500 tons of plastic. That makes endoscopy a key target in reducing the environmental footprint of health care, according to the authors, who were led by Rosemary Haddock, MBChB, MRCP, of Ninewells Hospital in Dundee, Scotland.

Climate change has direct impacts on health, ranging from the effects of wildfire smoke and pollution on respiratory and cardiac health to food insecurity, heat stroke, and alterations to the geographic ranges of vector-borne diseases. It also raises the risk of future pandemics like COVID-19. “Climate change is a major threat to health and threatens to undermine the last 50 years of public health gains,” the authors wrote.

Although the effects of climate change on gastrointestinal diseases has not been studied as extensively as other organ systems, there are known impacts. These include more gastrointestinal infections at higher temperatures, the risk of enteric pathogens and viral hepatitis as a result of flooding and higher water temperatures, and malnutrition caused by the disruption of food crops and distribution. “It seems a little unlikely that the organs which we are interested in as gastroenterologists and hepatologists are largely exempt from the direct effects of hotter temperatures, when every other human organ system appears to be affected almost without exception,” the authors wrote.

Those issues put an onus on health care to address climate change, not only in health care delivery but also to find ways to reduce emissions as an industry. Hospitals and other large facilities can act as “anchor institutions” that set an example within the community and influence others since they procure goods and services and own assets and land. To date, few institutions have adopted this stance.

A key question is how health care institutions can reduce resource use while maintaining quality of care. One approach is to identify areas of medical overuse, where wasteful practices have no patient benefit. The authors believe that a reduction in endoscopic procedures could have one of the largest impacts on carbon emissions. They emphasized that reduced numbers of procedures would likely have greater effect than making procedures “greener.”

Some endoscopic procedures offer little value to the patient. The approach of screening to combat disease, introduced in 1968, should be challenged in some patient groups because it can lead to unnecessary procedures.

The American Gastroenterological Association has identified some procedures as commonly overused, including screening colonoscopy in average-risk individuals, surveillance colonoscopy for low-risk polyps, and surveillance esophagogastroduodenoscopy in Barrett’s esophagus. The authors note that performing fewer endoscopies will require shifts in behavior, referral patterns, education, and culture, all of which will take time.

In the meantime, endoscopists can take some steps to reduce the footprint of existing procedures: source supplies through sustainable means, which is important because supply chain emissions account for more than half of health care emissions; seek out sources of renewable energy; use their institution’s status as an “anchor institution” to pressure suppliers into using sustainable practices; evaluate less invasive procedures, such as Cytosponge or fecal immunochemical test; employ reusable or recyclable equipment; minimize the use of nitrous oxide, which is a key greenhouse gas; segregate infectious waste; and develop multiple recycling streams.

The authors have no relevant financial disclosures.

Climate change is a global threat, and it presents a dual problem to health care: The system must address health threats that may be caused or exacerbated by climate change, while at the same time minimizing its environmental impact, according to the authors of a paper in Techniques and Innovations in Gastrointestinal Endoscopy.

Because of how often it is performed, endoscopy may have one of the highest environmental impacts of any health care procedure. Waste produced by endoscopy is the third largest source in a typical hospital, equivalent yearly to burning 39 million pounds of coal or 13,500 tons of plastic. That makes endoscopy a key target in reducing the environmental footprint of health care, according to the authors, who were led by Rosemary Haddock, MBChB, MRCP, of Ninewells Hospital in Dundee, Scotland.

Climate change has direct impacts on health, ranging from the effects of wildfire smoke and pollution on respiratory and cardiac health to food insecurity, heat stroke, and alterations to the geographic ranges of vector-borne diseases. It also raises the risk of future pandemics like COVID-19. “Climate change is a major threat to health and threatens to undermine the last 50 years of public health gains,” the authors wrote.

Although the effects of climate change on gastrointestinal diseases has not been studied as extensively as other organ systems, there are known impacts. These include more gastrointestinal infections at higher temperatures, the risk of enteric pathogens and viral hepatitis as a result of flooding and higher water temperatures, and malnutrition caused by the disruption of food crops and distribution. “It seems a little unlikely that the organs which we are interested in as gastroenterologists and hepatologists are largely exempt from the direct effects of hotter temperatures, when every other human organ system appears to be affected almost without exception,” the authors wrote.

Those issues put an onus on health care to address climate change, not only in health care delivery but also to find ways to reduce emissions as an industry. Hospitals and other large facilities can act as “anchor institutions” that set an example within the community and influence others since they procure goods and services and own assets and land. To date, few institutions have adopted this stance.

A key question is how health care institutions can reduce resource use while maintaining quality of care. One approach is to identify areas of medical overuse, where wasteful practices have no patient benefit. The authors believe that a reduction in endoscopic procedures could have one of the largest impacts on carbon emissions. They emphasized that reduced numbers of procedures would likely have greater effect than making procedures “greener.”

Some endoscopic procedures offer little value to the patient. The approach of screening to combat disease, introduced in 1968, should be challenged in some patient groups because it can lead to unnecessary procedures.

The American Gastroenterological Association has identified some procedures as commonly overused, including screening colonoscopy in average-risk individuals, surveillance colonoscopy for low-risk polyps, and surveillance esophagogastroduodenoscopy in Barrett’s esophagus. The authors note that performing fewer endoscopies will require shifts in behavior, referral patterns, education, and culture, all of which will take time.

In the meantime, endoscopists can take some steps to reduce the footprint of existing procedures: source supplies through sustainable means, which is important because supply chain emissions account for more than half of health care emissions; seek out sources of renewable energy; use their institution’s status as an “anchor institution” to pressure suppliers into using sustainable practices; evaluate less invasive procedures, such as Cytosponge or fecal immunochemical test; employ reusable or recyclable equipment; minimize the use of nitrous oxide, which is a key greenhouse gas; segregate infectious waste; and develop multiple recycling streams.

The authors have no relevant financial disclosures.

Climate change is a global threat, and it presents a dual problem to health care: The system must address health threats that may be caused or exacerbated by climate change, while at the same time minimizing its environmental impact, according to the authors of a paper in Techniques and Innovations in Gastrointestinal Endoscopy.

Because of how often it is performed, endoscopy may have one of the highest environmental impacts of any health care procedure. Waste produced by endoscopy is the third largest source in a typical hospital, equivalent yearly to burning 39 million pounds of coal or 13,500 tons of plastic. That makes endoscopy a key target in reducing the environmental footprint of health care, according to the authors, who were led by Rosemary Haddock, MBChB, MRCP, of Ninewells Hospital in Dundee, Scotland.

Climate change has direct impacts on health, ranging from the effects of wildfire smoke and pollution on respiratory and cardiac health to food insecurity, heat stroke, and alterations to the geographic ranges of vector-borne diseases. It also raises the risk of future pandemics like COVID-19. “Climate change is a major threat to health and threatens to undermine the last 50 years of public health gains,” the authors wrote.

Although the effects of climate change on gastrointestinal diseases has not been studied as extensively as other organ systems, there are known impacts. These include more gastrointestinal infections at higher temperatures, the risk of enteric pathogens and viral hepatitis as a result of flooding and higher water temperatures, and malnutrition caused by the disruption of food crops and distribution. “It seems a little unlikely that the organs which we are interested in as gastroenterologists and hepatologists are largely exempt from the direct effects of hotter temperatures, when every other human organ system appears to be affected almost without exception,” the authors wrote.

Those issues put an onus on health care to address climate change, not only in health care delivery but also to find ways to reduce emissions as an industry. Hospitals and other large facilities can act as “anchor institutions” that set an example within the community and influence others since they procure goods and services and own assets and land. To date, few institutions have adopted this stance.

A key question is how health care institutions can reduce resource use while maintaining quality of care. One approach is to identify areas of medical overuse, where wasteful practices have no patient benefit. The authors believe that a reduction in endoscopic procedures could have one of the largest impacts on carbon emissions. They emphasized that reduced numbers of procedures would likely have greater effect than making procedures “greener.”

Some endoscopic procedures offer little value to the patient. The approach of screening to combat disease, introduced in 1968, should be challenged in some patient groups because it can lead to unnecessary procedures.

The American Gastroenterological Association has identified some procedures as commonly overused, including screening colonoscopy in average-risk individuals, surveillance colonoscopy for low-risk polyps, and surveillance esophagogastroduodenoscopy in Barrett’s esophagus. The authors note that performing fewer endoscopies will require shifts in behavior, referral patterns, education, and culture, all of which will take time.

In the meantime, endoscopists can take some steps to reduce the footprint of existing procedures: source supplies through sustainable means, which is important because supply chain emissions account for more than half of health care emissions; seek out sources of renewable energy; use their institution’s status as an “anchor institution” to pressure suppliers into using sustainable practices; evaluate less invasive procedures, such as Cytosponge or fecal immunochemical test; employ reusable or recyclable equipment; minimize the use of nitrous oxide, which is a key greenhouse gas; segregate infectious waste; and develop multiple recycling streams.

The authors have no relevant financial disclosures.

In patients with moderate to severe ulcerative colitis (UC), treatment with vedolizumab leads to better histologic outcomes than treatment with adalimumab, according to findings from the VARSITY trial.

The findings come from an analysis in Gastroenterology of prespecified histologic exploratory endpoints from the phase 3, multicenter, randomized, controlled VARSITY trial, which was the first head-to-head comparison of two biologics in the treatment of UC. VARSITY demonstrated improved rates of clinical remission and endoscopic improvement at week 52 with vedolizumab.

The authors, led by Laurent Peyrin-Biroulet of the department of gastroenterology at Nancy (France) University Hospital, noted that there is general consensus that endoscopic improvement is considered the best endpoint for demonstrating effective maintenance therapy in UC. However, they added that “endoscopic changes do not necessarily reflect quiescent microscopic disease, and complete resolution of mucosal inflammation can only be confirmed by histologic assessment.” Still, histologic outcomes are not currently recommended as a goal of therapy in clinical practice, possibly due to a lack of standardized and validated scoring systems suitable for routine clinical use. Nevertheless, histologic outcomes have been shown to predict hospitalization, corticosteroid use, exacerbation, and the risk of advanced colorectal neoplasia.

To assess histologic outcomes in the two treatment regimens, the researchers included the Geboes Index score and the Robarts Histopathology Index (RHI) as two validated scoring systems.

During the 52-week study, 769 patients were assigned to vedolizumab (300 mg IV) or adalimumab (40 mg subcutaneously).

At week 14 and week 52, more patients in the vedolizumab group achieved histologic remission as determined by Geboes Index score less than 2 (week 52, 29.2% vs. 8.3%; difference, 20.9%; 95% confidence interval, 15.6%-26.2%; P < .0001) and RHI score of 2 or less (week 52, 37.6% vs. 19.9%; difference, 17.6%; 95% CI, 11.3%-23.8%; P < .0001).

At week 52, more patients in the vedolizumab group than in the adalimumab group achieved minimum histologic disease activity as determined by Geboes Index score of 3.1 or less (45.7% vs. 30.8%; difference, 14.8%; 95% CI, 8.0%-21.5%; P < .0001) and RHI score of 4 or less(42.3% vs. 25.6%; difference, 16.6%; 95% CI, 10.0%-23.1%; P < .0001).

The investigators performed post hoc analyses of mucosal healing, defined as a composite of the histologic and endoscopic outcomes, with the latter defined as Mayo endoscopic subscore of 1 or less. A greater proportion of patients treated with vedolizumab than with adalimumab met the composite of histologic remission on each score plus endoscopic improvement (Geboes, 35.0% vs. 20.2%; RHI, 33.7% vs. 18.1%), with similar findings for minimal histologic disease activity plus endoscopic improvement (Geboes, 35.0% vs. 20.2%; RHI, 33.7% vs. 18.1%).

The authors noted that the RHI scoring system revealed greater associations between histologic outcomes and endoscopic improvement than did the Geboes Index score, which is an important finding considering the European Crohn’s and Colitis Organisation’s stance recommending consideration of mucosal healing based on findings from endoscopy and histology.

Some study limitations included how the study design precluded dose escalation and a lack of long-term follow-up among these patients.

The researchers believe that the RHI score may be a better choice than the Geboes score for comparing efficacy in clinical trials because RHI is more reproducible, more sensitive to change, and is comparatively easy to interpret.

The study was funded by Takeda, which makes vedolizumab. The authors disclosed several relationships with industry, including some having stock options with or being employed by Takeda.

In patients with moderate to severe ulcerative colitis (UC), treatment with vedolizumab leads to better histologic outcomes than treatment with adalimumab, according to findings from the VARSITY trial.

The findings come from an analysis in Gastroenterology of prespecified histologic exploratory endpoints from the phase 3, multicenter, randomized, controlled VARSITY trial, which was the first head-to-head comparison of two biologics in the treatment of UC. VARSITY demonstrated improved rates of clinical remission and endoscopic improvement at week 52 with vedolizumab.

The authors, led by Laurent Peyrin-Biroulet of the department of gastroenterology at Nancy (France) University Hospital, noted that there is general consensus that endoscopic improvement is considered the best endpoint for demonstrating effective maintenance therapy in UC. However, they added that “endoscopic changes do not necessarily reflect quiescent microscopic disease, and complete resolution of mucosal inflammation can only be confirmed by histologic assessment.” Still, histologic outcomes are not currently recommended as a goal of therapy in clinical practice, possibly due to a lack of standardized and validated scoring systems suitable for routine clinical use. Nevertheless, histologic outcomes have been shown to predict hospitalization, corticosteroid use, exacerbation, and the risk of advanced colorectal neoplasia.

To assess histologic outcomes in the two treatment regimens, the researchers included the Geboes Index score and the Robarts Histopathology Index (RHI) as two validated scoring systems.

During the 52-week study, 769 patients were assigned to vedolizumab (300 mg IV) or adalimumab (40 mg subcutaneously).

At week 14 and week 52, more patients in the vedolizumab group achieved histologic remission as determined by Geboes Index score less than 2 (week 52, 29.2% vs. 8.3%; difference, 20.9%; 95% confidence interval, 15.6%-26.2%; P < .0001) and RHI score of 2 or less (week 52, 37.6% vs. 19.9%; difference, 17.6%; 95% CI, 11.3%-23.8%; P < .0001).

At week 52, more patients in the vedolizumab group than in the adalimumab group achieved minimum histologic disease activity as determined by Geboes Index score of 3.1 or less (45.7% vs. 30.8%; difference, 14.8%; 95% CI, 8.0%-21.5%; P < .0001) and RHI score of 4 or less(42.3% vs. 25.6%; difference, 16.6%; 95% CI, 10.0%-23.1%; P < .0001).

The investigators performed post hoc analyses of mucosal healing, defined as a composite of the histologic and endoscopic outcomes, with the latter defined as Mayo endoscopic subscore of 1 or less. A greater proportion of patients treated with vedolizumab than with adalimumab met the composite of histologic remission on each score plus endoscopic improvement (Geboes, 35.0% vs. 20.2%; RHI, 33.7% vs. 18.1%), with similar findings for minimal histologic disease activity plus endoscopic improvement (Geboes, 35.0% vs. 20.2%; RHI, 33.7% vs. 18.1%).

The authors noted that the RHI scoring system revealed greater associations between histologic outcomes and endoscopic improvement than did the Geboes Index score, which is an important finding considering the European Crohn’s and Colitis Organisation’s stance recommending consideration of mucosal healing based on findings from endoscopy and histology.

Some study limitations included how the study design precluded dose escalation and a lack of long-term follow-up among these patients.

The researchers believe that the RHI score may be a better choice than the Geboes score for comparing efficacy in clinical trials because RHI is more reproducible, more sensitive to change, and is comparatively easy to interpret.

The study was funded by Takeda, which makes vedolizumab. The authors disclosed several relationships with industry, including some having stock options with or being employed by Takeda.

In patients with moderate to severe ulcerative colitis (UC), treatment with vedolizumab leads to better histologic outcomes than treatment with adalimumab, according to findings from the VARSITY trial.

The findings come from an analysis in Gastroenterology of prespecified histologic exploratory endpoints from the phase 3, multicenter, randomized, controlled VARSITY trial, which was the first head-to-head comparison of two biologics in the treatment of UC. VARSITY demonstrated improved rates of clinical remission and endoscopic improvement at week 52 with vedolizumab.

The authors, led by Laurent Peyrin-Biroulet of the department of gastroenterology at Nancy (France) University Hospital, noted that there is general consensus that endoscopic improvement is considered the best endpoint for demonstrating effective maintenance therapy in UC. However, they added that “endoscopic changes do not necessarily reflect quiescent microscopic disease, and complete resolution of mucosal inflammation can only be confirmed by histologic assessment.” Still, histologic outcomes are not currently recommended as a goal of therapy in clinical practice, possibly due to a lack of standardized and validated scoring systems suitable for routine clinical use. Nevertheless, histologic outcomes have been shown to predict hospitalization, corticosteroid use, exacerbation, and the risk of advanced colorectal neoplasia.

To assess histologic outcomes in the two treatment regimens, the researchers included the Geboes Index score and the Robarts Histopathology Index (RHI) as two validated scoring systems.

During the 52-week study, 769 patients were assigned to vedolizumab (300 mg IV) or adalimumab (40 mg subcutaneously).

At week 14 and week 52, more patients in the vedolizumab group achieved histologic remission as determined by Geboes Index score less than 2 (week 52, 29.2% vs. 8.3%; difference, 20.9%; 95% confidence interval, 15.6%-26.2%; P < .0001) and RHI score of 2 or less (week 52, 37.6% vs. 19.9%; difference, 17.6%; 95% CI, 11.3%-23.8%; P < .0001).

At week 52, more patients in the vedolizumab group than in the adalimumab group achieved minimum histologic disease activity as determined by Geboes Index score of 3.1 or less (45.7% vs. 30.8%; difference, 14.8%; 95% CI, 8.0%-21.5%; P < .0001) and RHI score of 4 or less(42.3% vs. 25.6%; difference, 16.6%; 95% CI, 10.0%-23.1%; P < .0001).

The investigators performed post hoc analyses of mucosal healing, defined as a composite of the histologic and endoscopic outcomes, with the latter defined as Mayo endoscopic subscore of 1 or less. A greater proportion of patients treated with vedolizumab than with adalimumab met the composite of histologic remission on each score plus endoscopic improvement (Geboes, 35.0% vs. 20.2%; RHI, 33.7% vs. 18.1%), with similar findings for minimal histologic disease activity plus endoscopic improvement (Geboes, 35.0% vs. 20.2%; RHI, 33.7% vs. 18.1%).

The authors noted that the RHI scoring system revealed greater associations between histologic outcomes and endoscopic improvement than did the Geboes Index score, which is an important finding considering the European Crohn’s and Colitis Organisation’s stance recommending consideration of mucosal healing based on findings from endoscopy and histology.

Some study limitations included how the study design precluded dose escalation and a lack of long-term follow-up among these patients.

The researchers believe that the RHI score may be a better choice than the Geboes score for comparing efficacy in clinical trials because RHI is more reproducible, more sensitive to change, and is comparatively easy to interpret.

The study was funded by Takeda, which makes vedolizumab. The authors disclosed several relationships with industry, including some having stock options with or being employed by Takeda.

Exercising to lose weight is not for every ‘body’

This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.

Maya23K/Thinkstock

Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.

Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.

A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.

“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.

In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
 

When it comes to the mix, walnuts go nuts

When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.

PxHere

Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.

Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.

“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.

The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.

So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
 

Begun, the clone war has

Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.

Patrick Bursa/Pixabay

The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.

The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.

The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
 

Congratulations to our new favorite reader

The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.

Exercising to lose weight is not for every ‘body’

This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.

Maya23K/Thinkstock

Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.

Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.

A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.

“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.

In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
 

When it comes to the mix, walnuts go nuts

When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.

PxHere

Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.

Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.

“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.

The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.

So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
 

Begun, the clone war has

Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.

Patrick Bursa/Pixabay

The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.

The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.

The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
 

Congratulations to our new favorite reader

The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.

Exercising to lose weight is not for every ‘body’

This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.

Maya23K/Thinkstock

Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.

Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.

A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.

“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.

In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
 

When it comes to the mix, walnuts go nuts

When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.

PxHere

Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.

Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.

“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.

The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.

So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
 

Begun, the clone war has

Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.

Patrick Bursa/Pixabay

The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.

The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.

The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
 

Congratulations to our new favorite reader

The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.

People with breakthrough COVID-19 infections are two times more likely to be completely asymptomatic and are about two-thirds less likely to be hospitalized, compared with those who are unvaccinated, according to a new observational study.

Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.

“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”

For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.

They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.

Likelihood of severe symptoms dropped after one dose

After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.

Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.

When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.

The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.

Findings may have implications for health policies

“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”

The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.

The authors of the paper and Dr. Hijano disclosed no conflicts.

People with breakthrough COVID-19 infections are two times more likely to be completely asymptomatic and are about two-thirds less likely to be hospitalized, compared with those who are unvaccinated, according to a new observational study.

Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.

“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”

For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.

They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.

Likelihood of severe symptoms dropped after one dose

After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.

Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.

When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.

The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.

Findings may have implications for health policies

“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”

The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.

The authors of the paper and Dr. Hijano disclosed no conflicts.

People with breakthrough COVID-19 infections are two times more likely to be completely asymptomatic and are about two-thirds less likely to be hospitalized, compared with those who are unvaccinated, according to a new observational study.

Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.

“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”

For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.

They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.

Likelihood of severe symptoms dropped after one dose

After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.

Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.

When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.

The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.

Findings may have implications for health policies

“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”

The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.

The authors of the paper and Dr. Hijano disclosed no conflicts.

The American Gastroenterological Association recently updated their guideline for preendoscopy SARS-CoV-2 testing in light of population-wide vaccination programs, now recommending against routine viral screening regardless of patient vaccination status and local disease prevalence.

Centers electing to maintain a preprocedure testing strategy should use standard nucleic acid testing, preferably rapid reverse transcription polymerase chain reaction (RT-PCR) because this can be performed on the day of the procedure, thereby limiting patient testing burden, reported authors led by co–first authors Shahnaz Sultan, MD, of the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Healthcare System, and Shazia M. Siddique, MD, of the University of Pennsylvania, Philadelphia.

These new recommendations, both of which are conditional and based on very-low-certainty evidence, were drawn from a rapid evidence review of benefits and risks in the postvaccination period.

“Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety,” the guideline authors wrote in Gastroenterology. “Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a reevaluation of AGA’s prior recommendations was warranted.”

The 2020 AGA guideline, also led by Dr. Sultan, issued viral screening recommendations based on local prevalence rates of asymptomatic COVID-19, with pretesting reserved for moderately affected locations. Mildly affected areas were advised against pretesting, whereas centers in pandemic hot spots were cautioned against performing all but “emergency or time-sensitive procedures.”

Those recommendations have now been replaced by the present guideline, which no longer distinguishes between local prevalence rates. This decision was based on a variety of factors, the panelists noted, including endoscopy volumes, vaccine efficacy, HCW and patient anxiety, endoscopy-related risk of infection to both patients and HCWs, prevalence of asymptomatic COVID-19 among patients undergoing endoscopy, and the impact of delaying care on cancer burden.

“The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients,” Dr. Sultan and colleagues wrote.

The guideline includes a summary of evidence related to the two new recommendations, including several studies reporting prevalence of asymptomatic SARS-CoV-2 infection among patients tested prior to endoscopy procedures.

Luis Alvarez/Getty Images

The American Gastroenterological Association recently updated their guideline for preendoscopy SARS-CoV-2 testing in light of population-wide vaccination programs, now recommending against routine viral screening regardless of patient vaccination status and local disease prevalence.

Centers electing to maintain a preprocedure testing strategy should use standard nucleic acid testing, preferably rapid reverse transcription polymerase chain reaction (RT-PCR) because this can be performed on the day of the procedure, thereby limiting patient testing burden, reported authors led by co–first authors Shahnaz Sultan, MD, of the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Healthcare System, and Shazia M. Siddique, MD, of the University of Pennsylvania, Philadelphia.

These new recommendations, both of which are conditional and based on very-low-certainty evidence, were drawn from a rapid evidence review of benefits and risks in the postvaccination period.

“Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety,” the guideline authors wrote in Gastroenterology. “Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a reevaluation of AGA’s prior recommendations was warranted.”

The 2020 AGA guideline, also led by Dr. Sultan, issued viral screening recommendations based on local prevalence rates of asymptomatic COVID-19, with pretesting reserved for moderately affected locations. Mildly affected areas were advised against pretesting, whereas centers in pandemic hot spots were cautioned against performing all but “emergency or time-sensitive procedures.”

Those recommendations have now been replaced by the present guideline, which no longer distinguishes between local prevalence rates. This decision was based on a variety of factors, the panelists noted, including endoscopy volumes, vaccine efficacy, HCW and patient anxiety, endoscopy-related risk of infection to both patients and HCWs, prevalence of asymptomatic COVID-19 among patients undergoing endoscopy, and the impact of delaying care on cancer burden.

“The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients,” Dr. Sultan and colleagues wrote.

The guideline includes a summary of evidence related to the two new recommendations, including several studies reporting prevalence of asymptomatic SARS-CoV-2 infection among patients tested prior to endoscopy procedures.

Luis Alvarez/Getty Images

The American Gastroenterological Association recently updated their guideline for preendoscopy SARS-CoV-2 testing in light of population-wide vaccination programs, now recommending against routine viral screening regardless of patient vaccination status and local disease prevalence.

Centers electing to maintain a preprocedure testing strategy should use standard nucleic acid testing, preferably rapid reverse transcription polymerase chain reaction (RT-PCR) because this can be performed on the day of the procedure, thereby limiting patient testing burden, reported authors led by co–first authors Shahnaz Sultan, MD, of the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Healthcare System, and Shazia M. Siddique, MD, of the University of Pennsylvania, Philadelphia.

These new recommendations, both of which are conditional and based on very-low-certainty evidence, were drawn from a rapid evidence review of benefits and risks in the postvaccination period.

“Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety,” the guideline authors wrote in Gastroenterology. “Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a reevaluation of AGA’s prior recommendations was warranted.”

The 2020 AGA guideline, also led by Dr. Sultan, issued viral screening recommendations based on local prevalence rates of asymptomatic COVID-19, with pretesting reserved for moderately affected locations. Mildly affected areas were advised against pretesting, whereas centers in pandemic hot spots were cautioned against performing all but “emergency or time-sensitive procedures.”

Those recommendations have now been replaced by the present guideline, which no longer distinguishes between local prevalence rates. This decision was based on a variety of factors, the panelists noted, including endoscopy volumes, vaccine efficacy, HCW and patient anxiety, endoscopy-related risk of infection to both patients and HCWs, prevalence of asymptomatic COVID-19 among patients undergoing endoscopy, and the impact of delaying care on cancer burden.

“The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients,” Dr. Sultan and colleagues wrote.

The guideline includes a summary of evidence related to the two new recommendations, including several studies reporting prevalence of asymptomatic SARS-CoV-2 infection among patients tested prior to endoscopy procedures.

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People with multiple sclerosis (MS) and depression have an increased risk of death, compared with those with one or neither condition, as well as an increased risk of vascular disease, a new study has found. “The effects of depression and MS on all-cause mortality are synergistic,” wrote lead author Raffaele Palladino, MD, PhD, research associate, faculty of medicine, Imperial College London.

The study was published in Neurology.

To assess the association between depression, vascular disease, and death in patients with MS, the researchers launched a population-based retrospective cohort study that reviewed English medical records from January 1987 to December 2018 and matched people with and without MS. Ultimately, 12,251 people with MS were matched with 72,572 controls. At baseline, 21% of the MS group (n = 2,535) and 9% of the controls (n = 6,278) had depression. Women were the majority in both cohorts and were more likely than men to be depressed.

People with both MS and depression had an all-cause mortality rate of 10.3 cases per 100,000 person-years (95% confidence interval, 9.17-11.57), compared with 10.6 for people with MS without depression (95% CI, 9.99-11.21), 3.6 for people with depression but not MS (95% CI, 3.18-4.05), and 2.5 for people with neither condition (95% CI, 2.42-2.64). Compared with controls without depression, the 10-year hazard of all-cause mortality was increasingly greater in controls with depression (hazard ratio, 1.75; 95% CI, 1.59-1.91), people with MS but not depression (HR, 3.88; 95% CI, 3.66-4.10), and people with MS and depression (HR, 5.43; 95% CI, 4.88-5.96). Overall, 14% of the observed effect on mortality was attributable to the interaction between MS status and depression.

As for vascular diseases, people with MS had an increased risk regardless of their depression status. That said, people with MS and depression (HR, 3.30; 95% CI, 2.37-4.23) had a notably higher risk than people with MS and no depression (HR, 1.48; 95% CI, 1.23-1.74). Women with MS and depression also had a greater risk of vascular disease than women with MS and no depression, while men with MS did not have significantly different risks of acute coronary syndrome or composite macrovascular disease than those in the control group who did not suffer from depression.
 

Does treating depression decrease the likelihood of vascular disease?

“The take-home message for me is the importance of treating depression in this population, in which we see it with great regularity,” Joseph Berger, MD, professor of neurology and associate chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia, said in an interview. “The question that I have is: If you treat depression in an individual with MS or an individual who is simply depressed and thus at risk for the subsequent development of vascular disease, does it decrease the likelihood of their subsequent development of vascular disease in comparison to had you not?

“I presume it does,” he added, noting that “the theories underlying why depression would increase one’s risk of subsequent vascular disease are enumerated by the authors, including such things as increased inflammation. Now, the inflammation may be contributing to the depression, or the depression may be contributing to the inflammation; it may be one of those chicken-and-egg scenarios. But if you decrease the depression, do you thereby decrease the inflammation, which has a pernicious effect on endothelial cells and increases one’s vascular risk?

“Alternatively, lifestyle in depressed patients is also altered,” he said. “They’re far less likely to engage in exercise, healthy habits, and healthy diets, and more likely perhaps to smoke. These all need to be addressed, but this study certainly gives you a greater impetus as a MS neurologist to address the issue of depression, realizing that there is also this comorbidity of vascular disease.”
 

Evaluating the biological interaction between MS and depression

Based on this and other studies, the joint effect of MS and depression on all-cause mortality may qualify as a biological interaction, Amber Salter, PhD, of the University of Texas Southwestern Medical Center, Dallas, wrote in an accompanying editorial.

“Biological interactions consider whether the joint effect of two factors follow an additive pattern, or the joint effect of two factors is greater than the sum of the individual effects for each factor alone,” she wrote. And though the interaction was not found to be present for vascular disease and cardiovascular mortality, it was for all-cause mortality.

“When warranted, the evaluation of biological interactions in future studies should be considered to provide insight on target subpopulations for interventions or test for potential mechanistic forms of interaction,” she added.

Dr. Salter highlighted the study’s strengths, including a large sample size and six controls matched to each MS patient. She also stated that the researchers’ inability to control for risk factors like body mass index and physical activity means the 14% increase in mortality “may not be a large absolute increase in mortality when other covariates cannot be considered.” In addition, their lack of data on suicide – and its association with depression – offers up the possibility that increases in mortality could be tied to a “potentially modifiable risk” as opposed to a biologically increased one.

In acknowledging their study’s limitations, the authors stated that body mass index, though an important vascular risk factor, has a “modest” association with mortality, and that the average annual suicide rate in the MS population – though higher than in the non-MS population – is still “relatively low.”

Two of the authors disclosed receiving support, including grants and research funding, from various institutions and organizations in the United Kingdom, the United States, and Canada, as well as several pharmaceutical companies. Dr. Salter reported no relevant disclosures.

People with multiple sclerosis (MS) and depression have an increased risk of death, compared with those with one or neither condition, as well as an increased risk of vascular disease, a new study has found. “The effects of depression and MS on all-cause mortality are synergistic,” wrote lead author Raffaele Palladino, MD, PhD, research associate, faculty of medicine, Imperial College London.

The study was published in Neurology.

To assess the association between depression, vascular disease, and death in patients with MS, the researchers launched a population-based retrospective cohort study that reviewed English medical records from January 1987 to December 2018 and matched people with and without MS. Ultimately, 12,251 people with MS were matched with 72,572 controls. At baseline, 21% of the MS group (n = 2,535) and 9% of the controls (n = 6,278) had depression. Women were the majority in both cohorts and were more likely than men to be depressed.

People with both MS and depression had an all-cause mortality rate of 10.3 cases per 100,000 person-years (95% confidence interval, 9.17-11.57), compared with 10.6 for people with MS without depression (95% CI, 9.99-11.21), 3.6 for people with depression but not MS (95% CI, 3.18-4.05), and 2.5 for people with neither condition (95% CI, 2.42-2.64). Compared with controls without depression, the 10-year hazard of all-cause mortality was increasingly greater in controls with depression (hazard ratio, 1.75; 95% CI, 1.59-1.91), people with MS but not depression (HR, 3.88; 95% CI, 3.66-4.10), and people with MS and depression (HR, 5.43; 95% CI, 4.88-5.96). Overall, 14% of the observed effect on mortality was attributable to the interaction between MS status and depression.

As for vascular diseases, people with MS had an increased risk regardless of their depression status. That said, people with MS and depression (HR, 3.30; 95% CI, 2.37-4.23) had a notably higher risk than people with MS and no depression (HR, 1.48; 95% CI, 1.23-1.74). Women with MS and depression also had a greater risk of vascular disease than women with MS and no depression, while men with MS did not have significantly different risks of acute coronary syndrome or composite macrovascular disease than those in the control group who did not suffer from depression.
 

Does treating depression decrease the likelihood of vascular disease?

“The take-home message for me is the importance of treating depression in this population, in which we see it with great regularity,” Joseph Berger, MD, professor of neurology and associate chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia, said in an interview. “The question that I have is: If you treat depression in an individual with MS or an individual who is simply depressed and thus at risk for the subsequent development of vascular disease, does it decrease the likelihood of their subsequent development of vascular disease in comparison to had you not?

“I presume it does,” he added, noting that “the theories underlying why depression would increase one’s risk of subsequent vascular disease are enumerated by the authors, including such things as increased inflammation. Now, the inflammation may be contributing to the depression, or the depression may be contributing to the inflammation; it may be one of those chicken-and-egg scenarios. But if you decrease the depression, do you thereby decrease the inflammation, which has a pernicious effect on endothelial cells and increases one’s vascular risk?

“Alternatively, lifestyle in depressed patients is also altered,” he said. “They’re far less likely to engage in exercise, healthy habits, and healthy diets, and more likely perhaps to smoke. These all need to be addressed, but this study certainly gives you a greater impetus as a MS neurologist to address the issue of depression, realizing that there is also this comorbidity of vascular disease.”
 

Evaluating the biological interaction between MS and depression

Based on this and other studies, the joint effect of MS and depression on all-cause mortality may qualify as a biological interaction, Amber Salter, PhD, of the University of Texas Southwestern Medical Center, Dallas, wrote in an accompanying editorial.

“Biological interactions consider whether the joint effect of two factors follow an additive pattern, or the joint effect of two factors is greater than the sum of the individual effects for each factor alone,” she wrote. And though the interaction was not found to be present for vascular disease and cardiovascular mortality, it was for all-cause mortality.

“When warranted, the evaluation of biological interactions in future studies should be considered to provide insight on target subpopulations for interventions or test for potential mechanistic forms of interaction,” she added.

Dr. Salter highlighted the study’s strengths, including a large sample size and six controls matched to each MS patient. She also stated that the researchers’ inability to control for risk factors like body mass index and physical activity means the 14% increase in mortality “may not be a large absolute increase in mortality when other covariates cannot be considered.” In addition, their lack of data on suicide – and its association with depression – offers up the possibility that increases in mortality could be tied to a “potentially modifiable risk” as opposed to a biologically increased one.

In acknowledging their study’s limitations, the authors stated that body mass index, though an important vascular risk factor, has a “modest” association with mortality, and that the average annual suicide rate in the MS population – though higher than in the non-MS population – is still “relatively low.”

Two of the authors disclosed receiving support, including grants and research funding, from various institutions and organizations in the United Kingdom, the United States, and Canada, as well as several pharmaceutical companies. Dr. Salter reported no relevant disclosures.

People with multiple sclerosis (MS) and depression have an increased risk of death, compared with those with one or neither condition, as well as an increased risk of vascular disease, a new study has found. “The effects of depression and MS on all-cause mortality are synergistic,” wrote lead author Raffaele Palladino, MD, PhD, research associate, faculty of medicine, Imperial College London.

The study was published in Neurology.

To assess the association between depression, vascular disease, and death in patients with MS, the researchers launched a population-based retrospective cohort study that reviewed English medical records from January 1987 to December 2018 and matched people with and without MS. Ultimately, 12,251 people with MS were matched with 72,572 controls. At baseline, 21% of the MS group (n = 2,535) and 9% of the controls (n = 6,278) had depression. Women were the majority in both cohorts and were more likely than men to be depressed.

People with both MS and depression had an all-cause mortality rate of 10.3 cases per 100,000 person-years (95% confidence interval, 9.17-11.57), compared with 10.6 for people with MS without depression (95% CI, 9.99-11.21), 3.6 for people with depression but not MS (95% CI, 3.18-4.05), and 2.5 for people with neither condition (95% CI, 2.42-2.64). Compared with controls without depression, the 10-year hazard of all-cause mortality was increasingly greater in controls with depression (hazard ratio, 1.75; 95% CI, 1.59-1.91), people with MS but not depression (HR, 3.88; 95% CI, 3.66-4.10), and people with MS and depression (HR, 5.43; 95% CI, 4.88-5.96). Overall, 14% of the observed effect on mortality was attributable to the interaction between MS status and depression.

As for vascular diseases, people with MS had an increased risk regardless of their depression status. That said, people with MS and depression (HR, 3.30; 95% CI, 2.37-4.23) had a notably higher risk than people with MS and no depression (HR, 1.48; 95% CI, 1.23-1.74). Women with MS and depression also had a greater risk of vascular disease than women with MS and no depression, while men with MS did not have significantly different risks of acute coronary syndrome or composite macrovascular disease than those in the control group who did not suffer from depression.
 

Does treating depression decrease the likelihood of vascular disease?

“The take-home message for me is the importance of treating depression in this population, in which we see it with great regularity,” Joseph Berger, MD, professor of neurology and associate chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia, said in an interview. “The question that I have is: If you treat depression in an individual with MS or an individual who is simply depressed and thus at risk for the subsequent development of vascular disease, does it decrease the likelihood of their subsequent development of vascular disease in comparison to had you not?

“I presume it does,” he added, noting that “the theories underlying why depression would increase one’s risk of subsequent vascular disease are enumerated by the authors, including such things as increased inflammation. Now, the inflammation may be contributing to the depression, or the depression may be contributing to the inflammation; it may be one of those chicken-and-egg scenarios. But if you decrease the depression, do you thereby decrease the inflammation, which has a pernicious effect on endothelial cells and increases one’s vascular risk?

“Alternatively, lifestyle in depressed patients is also altered,” he said. “They’re far less likely to engage in exercise, healthy habits, and healthy diets, and more likely perhaps to smoke. These all need to be addressed, but this study certainly gives you a greater impetus as a MS neurologist to address the issue of depression, realizing that there is also this comorbidity of vascular disease.”
 

Evaluating the biological interaction between MS and depression

Based on this and other studies, the joint effect of MS and depression on all-cause mortality may qualify as a biological interaction, Amber Salter, PhD, of the University of Texas Southwestern Medical Center, Dallas, wrote in an accompanying editorial.

“Biological interactions consider whether the joint effect of two factors follow an additive pattern, or the joint effect of two factors is greater than the sum of the individual effects for each factor alone,” she wrote. And though the interaction was not found to be present for vascular disease and cardiovascular mortality, it was for all-cause mortality.

“When warranted, the evaluation of biological interactions in future studies should be considered to provide insight on target subpopulations for interventions or test for potential mechanistic forms of interaction,” she added.

Dr. Salter highlighted the study’s strengths, including a large sample size and six controls matched to each MS patient. She also stated that the researchers’ inability to control for risk factors like body mass index and physical activity means the 14% increase in mortality “may not be a large absolute increase in mortality when other covariates cannot be considered.” In addition, their lack of data on suicide – and its association with depression – offers up the possibility that increases in mortality could be tied to a “potentially modifiable risk” as opposed to a biologically increased one.

In acknowledging their study’s limitations, the authors stated that body mass index, though an important vascular risk factor, has a “modest” association with mortality, and that the average annual suicide rate in the MS population – though higher than in the non-MS population – is still “relatively low.”

Two of the authors disclosed receiving support, including grants and research funding, from various institutions and organizations in the United Kingdom, the United States, and Canada, as well as several pharmaceutical companies. Dr. Salter reported no relevant disclosures.