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The perils of CA-125 as a diagnostic tool in patients with adnexal masses

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Tue, 05/24/2022 - 09:41

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.1 In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

Dr. Katherine Tucker

CA-125 has Food and Drug Administration approval for use in patients with a current or prior diagnosis of ovarian cancer to monitor treatment response, progression of disease, or disease recurrence.

It is frequently used off label in the workup of adnexal masses, while not FDA approved. CA-125 and other serum biomarkers may help determine the etiology of an adnexal mass; however, they are not diagnostic and should be used thoughtfully. It is important to have conversations with patients before ordering a CA-125 (or other serum biomarkers) about potential results and their effect on diagnosis and treatment. This will lessen some patient anxiety when tests results become available, especially in the setting of autoreleasing results under the Cures Act.

One of the reasons that CA-125 can be difficult to interpret when used as a diagnostic tool is the number of nonmalignant disease processes that can result in CA-125 elevations. CA-125 can be elevated in inflammatory and infectious disease states, including but not limited to, chronic obstructive pulmonary disease, pelvic inflammatory disease, diverticulitis, and pneumonia. Severe/critical COVID-19 infection has recently been found to be associated with increased levels of CA-125.2 It is important to obtain a complete medical history and to take specific note of any current or recent flares in inflammatory or infectious processes that could contribute to CA-125 elevations.

Special caution should be taken in premenopausal patients. The sensitivity and specificity of CA-125 are lower in this cohort of patients compared to postmenopausal women. This is multifactorial but in part due to gynecologic conditions that can increase CA-125, such as uterine fibroids and endometriosis, and the higher incidence of nonepithelial ovarian cancers (which frequently have different serum biomarkers) in younger patients. A patient’s gynecologic history, her age, and ultrasound or other imaging findings should help determine what, if any, serum biomarkers are appropriate for workup of an adnexal mass rather than the default ordering of CA-125 to determine need for referral to gynecologic oncology. If the decision has been made to take the patient to the operating room, CA-125 is not approved as a triage tool to guide who best to perform the surgery. In this case, one of two serum tumor marker panel tests that has received FDA approval for triage after the decision for surgery has been made (the multivariate index assay or the risk of ovarian malignancy algorithm) should be used.

When considering its ability to serve as a diagnostic test for ovarian cancer, the sensitivity of CA-125 is affected by the number of patients with epithelial ovarian cancer who have a test result that falls within the normal range (up to 50% of patients with stage I disease).3 The specificity of CA-125 is affected by the large number of nonmalignant conditions that can cause its elevation. Depending on the age of the patient, her menopausal status, comorbid conditions, and reason for obtaining serum biomarkers (e.g., decision for surgery has already been made), CA-125 (or CA-125 alone) may not be the best tool to use in the workup of an adnexal mass and can cause significant patient anxiety. In the setting of acute disease, such as COVID-19 infection, it may be better to delay obtaining serum biomarkers for the work-up of an adnexal mass. If delay is not feasible, then repeat serum biomarkers once the acute phase of illness has passed.

Dr. Tucker is assistant professor of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Thériault C et al. Gynecol Oncol. 2011 Jun 1;121(3):434-43.

2. Wei X et al. J Med Virol. 2020;92(10):2036-41.

3. Zurawski VR Jr et al. Int J Cancer. 1988;42:677-80.

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CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.1 In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

Dr. Katherine Tucker

CA-125 has Food and Drug Administration approval for use in patients with a current or prior diagnosis of ovarian cancer to monitor treatment response, progression of disease, or disease recurrence.

It is frequently used off label in the workup of adnexal masses, while not FDA approved. CA-125 and other serum biomarkers may help determine the etiology of an adnexal mass; however, they are not diagnostic and should be used thoughtfully. It is important to have conversations with patients before ordering a CA-125 (or other serum biomarkers) about potential results and their effect on diagnosis and treatment. This will lessen some patient anxiety when tests results become available, especially in the setting of autoreleasing results under the Cures Act.

One of the reasons that CA-125 can be difficult to interpret when used as a diagnostic tool is the number of nonmalignant disease processes that can result in CA-125 elevations. CA-125 can be elevated in inflammatory and infectious disease states, including but not limited to, chronic obstructive pulmonary disease, pelvic inflammatory disease, diverticulitis, and pneumonia. Severe/critical COVID-19 infection has recently been found to be associated with increased levels of CA-125.2 It is important to obtain a complete medical history and to take specific note of any current or recent flares in inflammatory or infectious processes that could contribute to CA-125 elevations.

Special caution should be taken in premenopausal patients. The sensitivity and specificity of CA-125 are lower in this cohort of patients compared to postmenopausal women. This is multifactorial but in part due to gynecologic conditions that can increase CA-125, such as uterine fibroids and endometriosis, and the higher incidence of nonepithelial ovarian cancers (which frequently have different serum biomarkers) in younger patients. A patient’s gynecologic history, her age, and ultrasound or other imaging findings should help determine what, if any, serum biomarkers are appropriate for workup of an adnexal mass rather than the default ordering of CA-125 to determine need for referral to gynecologic oncology. If the decision has been made to take the patient to the operating room, CA-125 is not approved as a triage tool to guide who best to perform the surgery. In this case, one of two serum tumor marker panel tests that has received FDA approval for triage after the decision for surgery has been made (the multivariate index assay or the risk of ovarian malignancy algorithm) should be used.

When considering its ability to serve as a diagnostic test for ovarian cancer, the sensitivity of CA-125 is affected by the number of patients with epithelial ovarian cancer who have a test result that falls within the normal range (up to 50% of patients with stage I disease).3 The specificity of CA-125 is affected by the large number of nonmalignant conditions that can cause its elevation. Depending on the age of the patient, her menopausal status, comorbid conditions, and reason for obtaining serum biomarkers (e.g., decision for surgery has already been made), CA-125 (or CA-125 alone) may not be the best tool to use in the workup of an adnexal mass and can cause significant patient anxiety. In the setting of acute disease, such as COVID-19 infection, it may be better to delay obtaining serum biomarkers for the work-up of an adnexal mass. If delay is not feasible, then repeat serum biomarkers once the acute phase of illness has passed.

Dr. Tucker is assistant professor of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Thériault C et al. Gynecol Oncol. 2011 Jun 1;121(3):434-43.

2. Wei X et al. J Med Virol. 2020;92(10):2036-41.

3. Zurawski VR Jr et al. Int J Cancer. 1988;42:677-80.

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.1 In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

Dr. Katherine Tucker

CA-125 has Food and Drug Administration approval for use in patients with a current or prior diagnosis of ovarian cancer to monitor treatment response, progression of disease, or disease recurrence.

It is frequently used off label in the workup of adnexal masses, while not FDA approved. CA-125 and other serum biomarkers may help determine the etiology of an adnexal mass; however, they are not diagnostic and should be used thoughtfully. It is important to have conversations with patients before ordering a CA-125 (or other serum biomarkers) about potential results and their effect on diagnosis and treatment. This will lessen some patient anxiety when tests results become available, especially in the setting of autoreleasing results under the Cures Act.

One of the reasons that CA-125 can be difficult to interpret when used as a diagnostic tool is the number of nonmalignant disease processes that can result in CA-125 elevations. CA-125 can be elevated in inflammatory and infectious disease states, including but not limited to, chronic obstructive pulmonary disease, pelvic inflammatory disease, diverticulitis, and pneumonia. Severe/critical COVID-19 infection has recently been found to be associated with increased levels of CA-125.2 It is important to obtain a complete medical history and to take specific note of any current or recent flares in inflammatory or infectious processes that could contribute to CA-125 elevations.

Special caution should be taken in premenopausal patients. The sensitivity and specificity of CA-125 are lower in this cohort of patients compared to postmenopausal women. This is multifactorial but in part due to gynecologic conditions that can increase CA-125, such as uterine fibroids and endometriosis, and the higher incidence of nonepithelial ovarian cancers (which frequently have different serum biomarkers) in younger patients. A patient’s gynecologic history, her age, and ultrasound or other imaging findings should help determine what, if any, serum biomarkers are appropriate for workup of an adnexal mass rather than the default ordering of CA-125 to determine need for referral to gynecologic oncology. If the decision has been made to take the patient to the operating room, CA-125 is not approved as a triage tool to guide who best to perform the surgery. In this case, one of two serum tumor marker panel tests that has received FDA approval for triage after the decision for surgery has been made (the multivariate index assay or the risk of ovarian malignancy algorithm) should be used.

When considering its ability to serve as a diagnostic test for ovarian cancer, the sensitivity of CA-125 is affected by the number of patients with epithelial ovarian cancer who have a test result that falls within the normal range (up to 50% of patients with stage I disease).3 The specificity of CA-125 is affected by the large number of nonmalignant conditions that can cause its elevation. Depending on the age of the patient, her menopausal status, comorbid conditions, and reason for obtaining serum biomarkers (e.g., decision for surgery has already been made), CA-125 (or CA-125 alone) may not be the best tool to use in the workup of an adnexal mass and can cause significant patient anxiety. In the setting of acute disease, such as COVID-19 infection, it may be better to delay obtaining serum biomarkers for the work-up of an adnexal mass. If delay is not feasible, then repeat serum biomarkers once the acute phase of illness has passed.

Dr. Tucker is assistant professor of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Thériault C et al. Gynecol Oncol. 2011 Jun 1;121(3):434-43.

2. Wei X et al. J Med Virol. 2020;92(10):2036-41.

3. Zurawski VR Jr et al. Int J Cancer. 1988;42:677-80.

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Food allergy risk not greater in C-section infants

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Tue, 05/24/2022 - 09:20

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Rachel L. Peters

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Terri Brown-Whitehorn

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

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Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Rachel L. Peters

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Terri Brown-Whitehorn

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Rachel L. Peters

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Terri Brown-Whitehorn

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

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FROM JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

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Contraceptive use boosted by enhanced counseling

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Tue, 10/18/2022 - 15:14

Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.

“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.

Dr. Heidi D. Nelson

“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.

“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.

In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.

Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.

Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.

Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).

“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.

“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”

The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.

“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
 

 

 

Make easy, effective contraception accessible to all

The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”

The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.

Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.

“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.

The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.

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Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.

“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.

Dr. Heidi D. Nelson

“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.

“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.

In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.

Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.

Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.

Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).

“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.

“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”

The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.

“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
 

 

 

Make easy, effective contraception accessible to all

The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”

The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.

Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.

“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.

The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.

Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.

“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.

Dr. Heidi D. Nelson

“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.

“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.

In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.

Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.

Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.

Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).

“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.

“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”

The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.

“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
 

 

 

Make easy, effective contraception accessible to all

The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”

The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.

Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.

“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.

The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.

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Doxycycline bests azithromycin for anorectal chlamydia in women

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Mon, 05/23/2022 - 13:34

 

NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.

Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.

“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.

However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”

“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”

As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.

Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).

The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).

Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).

Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.

Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”

Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”

“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”

Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”

“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
 

 

 

Reuters Health Information © 2022

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NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.

Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.

“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.

However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”

“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”

As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.

Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).

The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).

Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).

Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.

Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”

Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”

“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”

Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”

“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
 

 

 

Reuters Health Information © 2022

 

NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.

Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.

“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.

However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”

“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”

As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.

Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).

The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).

Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).

Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.

Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”

Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”

“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”

Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”

“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
 

 

 

Reuters Health Information © 2022

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CRC screening: Blood test accuracy compared to colonoscopy

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Tue, 05/24/2022 - 10:33

The first prospective study to evaluate the accuracy of a blood test for people being screened for colorectal cancer (CRC) revealed a high sensitivity and specificity.

At 90% specificity, the blood assay (Guardant Health) was 100% sensitive for detecting CRC. At 95% specificity, sensitivity was 88%.

The blood assay detects circulating tumor DNA from cancer in the bloodstream, which is then analyzed for multiple factors, including cancer genetics and methylation.

Lead author Paloma Peinado, MD, a medical oncologist at HM Hospitales, Madrid, and colleagues, called the results similar to those seen with noninvasive, stool-based testing, noting that the “sensitivity and specificity of the blood-based test reached clinically significant thresholds.”

“The reported performance, combined with a more acceptable mode of testing, suggests that this blood-based test may be a viable CRC screening option,” they added.

The study was presented at Digestive Disease Week® (DDW) 2022, held virtually and in San Diego.

Dr. Peinado and colleagues studied 557 people who agreed to have blood drawn at the time of their colonoscopy. They enrolled participants at four hospitals in Spain.

One-third of participants (33%) who sought CRC screening were at average risk. Of the remainder, 49% were symptomatic, 11% had a positive family history of CRC, 6% had a positive stool-based test result, and 1% presented for colonoscopy for other reasons.

The prospective observational study included people age 45-84 years. The median age of participants was 55 years, and just over half (52%) were women.

The prevalence rate of colorectal adenocarcinoma was 2.6%. Eight patients had stage I cancer, three had stage II cancer, two had stage III cancer, and two had stage IV cancer.

The study was designed to follow patients for 1 year after screening. To date, 14% of participants have reached this point.

Not a general population screening study

“We definitely we need more studies like this,” said Barbara H. Jung, MD, chair of the department of medicine at the University of Washington, Seattle, when asked to comment on the study.

“We need to find other ways to detect colorectal cancer early, to enhance the screening, and to broaden it to a larger population who may not be amenable to the other techniques.”

Dr. Jung added a caveat that the study population included people at a higher risk for CRC. Therefore, she said, it was a screening study but not a general population, average-risk screening study.

However, she said, “that does not mean that this could not be optimized in the future.”  

Ideally, we need tests for every application, including people who are asymptomatic, Dr. Jung said.

Dr. Peinado reports no relevant financial relationships. Some of the study authors are employees of Guardant Health. Dr. Jung reports no relevant financial relationships.

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

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The first prospective study to evaluate the accuracy of a blood test for people being screened for colorectal cancer (CRC) revealed a high sensitivity and specificity.

At 90% specificity, the blood assay (Guardant Health) was 100% sensitive for detecting CRC. At 95% specificity, sensitivity was 88%.

The blood assay detects circulating tumor DNA from cancer in the bloodstream, which is then analyzed for multiple factors, including cancer genetics and methylation.

Lead author Paloma Peinado, MD, a medical oncologist at HM Hospitales, Madrid, and colleagues, called the results similar to those seen with noninvasive, stool-based testing, noting that the “sensitivity and specificity of the blood-based test reached clinically significant thresholds.”

“The reported performance, combined with a more acceptable mode of testing, suggests that this blood-based test may be a viable CRC screening option,” they added.

The study was presented at Digestive Disease Week® (DDW) 2022, held virtually and in San Diego.

Dr. Peinado and colleagues studied 557 people who agreed to have blood drawn at the time of their colonoscopy. They enrolled participants at four hospitals in Spain.

One-third of participants (33%) who sought CRC screening were at average risk. Of the remainder, 49% were symptomatic, 11% had a positive family history of CRC, 6% had a positive stool-based test result, and 1% presented for colonoscopy for other reasons.

The prospective observational study included people age 45-84 years. The median age of participants was 55 years, and just over half (52%) were women.

The prevalence rate of colorectal adenocarcinoma was 2.6%. Eight patients had stage I cancer, three had stage II cancer, two had stage III cancer, and two had stage IV cancer.

The study was designed to follow patients for 1 year after screening. To date, 14% of participants have reached this point.

Not a general population screening study

“We definitely we need more studies like this,” said Barbara H. Jung, MD, chair of the department of medicine at the University of Washington, Seattle, when asked to comment on the study.

“We need to find other ways to detect colorectal cancer early, to enhance the screening, and to broaden it to a larger population who may not be amenable to the other techniques.”

Dr. Jung added a caveat that the study population included people at a higher risk for CRC. Therefore, she said, it was a screening study but not a general population, average-risk screening study.

However, she said, “that does not mean that this could not be optimized in the future.”  

Ideally, we need tests for every application, including people who are asymptomatic, Dr. Jung said.

Dr. Peinado reports no relevant financial relationships. Some of the study authors are employees of Guardant Health. Dr. Jung reports no relevant financial relationships.

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

The first prospective study to evaluate the accuracy of a blood test for people being screened for colorectal cancer (CRC) revealed a high sensitivity and specificity.

At 90% specificity, the blood assay (Guardant Health) was 100% sensitive for detecting CRC. At 95% specificity, sensitivity was 88%.

The blood assay detects circulating tumor DNA from cancer in the bloodstream, which is then analyzed for multiple factors, including cancer genetics and methylation.

Lead author Paloma Peinado, MD, a medical oncologist at HM Hospitales, Madrid, and colleagues, called the results similar to those seen with noninvasive, stool-based testing, noting that the “sensitivity and specificity of the blood-based test reached clinically significant thresholds.”

“The reported performance, combined with a more acceptable mode of testing, suggests that this blood-based test may be a viable CRC screening option,” they added.

The study was presented at Digestive Disease Week® (DDW) 2022, held virtually and in San Diego.

Dr. Peinado and colleagues studied 557 people who agreed to have blood drawn at the time of their colonoscopy. They enrolled participants at four hospitals in Spain.

One-third of participants (33%) who sought CRC screening were at average risk. Of the remainder, 49% were symptomatic, 11% had a positive family history of CRC, 6% had a positive stool-based test result, and 1% presented for colonoscopy for other reasons.

The prospective observational study included people age 45-84 years. The median age of participants was 55 years, and just over half (52%) were women.

The prevalence rate of colorectal adenocarcinoma was 2.6%. Eight patients had stage I cancer, three had stage II cancer, two had stage III cancer, and two had stage IV cancer.

The study was designed to follow patients for 1 year after screening. To date, 14% of participants have reached this point.

Not a general population screening study

“We definitely we need more studies like this,” said Barbara H. Jung, MD, chair of the department of medicine at the University of Washington, Seattle, when asked to comment on the study.

“We need to find other ways to detect colorectal cancer early, to enhance the screening, and to broaden it to a larger population who may not be amenable to the other techniques.”

Dr. Jung added a caveat that the study population included people at a higher risk for CRC. Therefore, she said, it was a screening study but not a general population, average-risk screening study.

However, she said, “that does not mean that this could not be optimized in the future.”  

Ideally, we need tests for every application, including people who are asymptomatic, Dr. Jung said.

Dr. Peinado reports no relevant financial relationships. Some of the study authors are employees of Guardant Health. Dr. Jung reports no relevant financial relationships.

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

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Roe v. Wade’s pending fall raises privacy concerns

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Mon, 05/23/2022 - 12:45

If Roe v. Wade is overturned, can criminal prosecutors or tech companies use smartphone data against someone?

Now that the future of U.S. abortion laws hangs in the balance, many women are questioning the degree of caution needed to keep their cyber activity confidential – especially period and fertility tracking apps, smartphone location data, and social media interactions.

Cybersecurity and legal experts say the answer largely boils down to one major issue: The right to privacy.

“There’s this notion of the expectation of privacy,” said Brad Malin, PhD, professor of biomedical informatics, biostatistics, and computer science at Vanderbilt University in Nashville, Tenn.

Dr. Malin said it’s directly related to bodily privacy that a person expects they have control of as part of their own environment.

According to Dr. Malin, this is “why this whole notion of Roe v. Wade at the present moment is really relevant. The right to privacy is mentioned about a dozen times within the law for the case.

“This is why we don’t know what’s going to happen with Roe v. Wade, but it worries a lot of privacy professionals,” he said. “It leads down this slippery slope of if you don’t even have control over your own body, then with electronic communications … we might as well not even start.”
 

Legal protections

The Fourth Amendment of the U.S. Constitution protects people against unreasonable searches and seizures.

To acquire cyber data that could be used as evidence in courts in states where abortion is deemed a crime, prosecutors would still have to go through standard criminal procedures, said Anthony Michael Kreis, JD, a constitutional law professor at Georgia State University, Atlanta.

But the data they do get could still be used in court against someone who is suspected of having had an abortion or who “miscarried under circumstances law enforcement officers found suspicious,” Mr. Kreis said.

And there’s another possibility, he noted: States holding women who end their pregnancies criminally or civilly responsible for “leaving their jurisdiction to obtain an abortion out-of-state.”

“That legal mechanism may abridge the constitutional right to travel, but it is not out of the realm of possibilities in a post-Roe America,” said Mr. Kreis.

But while many anti-abortion groups have said that criminalizing abortion or limiting access to contraception is not the end goal, “history is not promising here,” said Ellen Wright Clayton, MD, JD, professor of pediatrics and professor of law at Vanderbilt University.

She referred to a recent proposal from lawmakers in Louisiana to classify abortion as homicide.

The bill didn’t get far in the House of Representatives, but the concern is warranted, said Dr. Clayton.
 

Period and fertility tracking apps

Health information privacy laws, like the Health Insurance Portability and Accountability Act (HIPAA), do not protect information on period and fertility tracking apps.

Right now, there are no signs that people plan to use period and fertility tracking data to advance a prochoice agenda, according to Adam Levin, JD, a cybersecurity expert and founder of CyberScout, a global identity and data protection company.

Still, a cycle tracking app “created by a company owned by an antiabortion activist” is totally feasible, said Mr. Levin.

If you want to ensure your data is safe from such meddling, you may want to delete your app, he said, noting that using the notepad feature on your smartphone could be a safer alternative, as could using old-fashioned pen and paper.

You don’t have to stop with period and fertility tracking apps, either.

For any apps you share personal information with, set privacy settings “as tightly as possible” – and reconsider using apps if these options are unavailable, Mr. Levin advised.

“Make sure that company is not engaging in social or political activism that does not align with your politics.”

New York State Attorney General Letitia James recently spoke on the topic, noting on May 13 that “people use fertility tracking apps and location services every day, but if they’re not careful their personal information can end up in the wrong hands.

“With abortion rights in jeopardy, it’s more important than ever that everyone take their digital privacy seriously,” she said. “I urge everyone, especially those visiting abortion clinics or seeking abortion care, to follow the tips offered by my office and be more careful of the apps and websites they use.”

The New York State Attorney General’s Office recommends women use encrypted messaging when communicating about personal health information or behaviors, and to be careful about what they share on social media posts. The office also suggests turning off location and personalized advertising options on their smartphones.
 

 

 

Cellphone location data

Dr. Malin said there are several ways that location services could be used to track where a woman uses her smartphone. An app could track locations if someone grants permission through the app end user agreement, for example.

A second but less likely scenario would be the service provider tracking the pings coming off cellphone towers to find a smartphone.

So what recourse does a woman have if tracked by a third-party app?

“It’s a really tricky situation there because it depends on if the individual was put expressly in harm’s way,” Dr. Malin said. What’s more, tracking someone out in public is not prohibited in general.

“There’s a big difference between documenting what an individual does within a Planned Parenthood clinic versus what they do outside of it,” he said.

Dr. Malin said it’s better that regulations protect all smartphone users rather than requiring each person to remember to turn off the location tracker and then turn it back on again. Also, it should be more of an opt-in situation – where app developers must ask permission to track app usage or location services – versus making each woman opt out.
 

Think before you share

Vindictive or untrustworthy partners and family members of women in abusive relationships could also be a cause of concern, said Mr. Kreis.

“Individuals within a woman’s closest circles could hold abortions over their head or threaten reporting them for reproductive health care or miscarriages,” he said.

It’s not uncommon for women to experience domestic violence after having an abortion, particularly if their partners were unaware they had the procedure, according to Dr. Clayton.

She said women should also be mindful of what they share on social media.

Dr. Clayton gave the example of a woman seeking advice on where to get a safe abortion or how to order certain medications.

“If someone goes online to look for that, that’s potentially dangerous.”

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

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If Roe v. Wade is overturned, can criminal prosecutors or tech companies use smartphone data against someone?

Now that the future of U.S. abortion laws hangs in the balance, many women are questioning the degree of caution needed to keep their cyber activity confidential – especially period and fertility tracking apps, smartphone location data, and social media interactions.

Cybersecurity and legal experts say the answer largely boils down to one major issue: The right to privacy.

“There’s this notion of the expectation of privacy,” said Brad Malin, PhD, professor of biomedical informatics, biostatistics, and computer science at Vanderbilt University in Nashville, Tenn.

Dr. Malin said it’s directly related to bodily privacy that a person expects they have control of as part of their own environment.

According to Dr. Malin, this is “why this whole notion of Roe v. Wade at the present moment is really relevant. The right to privacy is mentioned about a dozen times within the law for the case.

“This is why we don’t know what’s going to happen with Roe v. Wade, but it worries a lot of privacy professionals,” he said. “It leads down this slippery slope of if you don’t even have control over your own body, then with electronic communications … we might as well not even start.”
 

Legal protections

The Fourth Amendment of the U.S. Constitution protects people against unreasonable searches and seizures.

To acquire cyber data that could be used as evidence in courts in states where abortion is deemed a crime, prosecutors would still have to go through standard criminal procedures, said Anthony Michael Kreis, JD, a constitutional law professor at Georgia State University, Atlanta.

But the data they do get could still be used in court against someone who is suspected of having had an abortion or who “miscarried under circumstances law enforcement officers found suspicious,” Mr. Kreis said.

And there’s another possibility, he noted: States holding women who end their pregnancies criminally or civilly responsible for “leaving their jurisdiction to obtain an abortion out-of-state.”

“That legal mechanism may abridge the constitutional right to travel, but it is not out of the realm of possibilities in a post-Roe America,” said Mr. Kreis.

But while many anti-abortion groups have said that criminalizing abortion or limiting access to contraception is not the end goal, “history is not promising here,” said Ellen Wright Clayton, MD, JD, professor of pediatrics and professor of law at Vanderbilt University.

She referred to a recent proposal from lawmakers in Louisiana to classify abortion as homicide.

The bill didn’t get far in the House of Representatives, but the concern is warranted, said Dr. Clayton.
 

Period and fertility tracking apps

Health information privacy laws, like the Health Insurance Portability and Accountability Act (HIPAA), do not protect information on period and fertility tracking apps.

Right now, there are no signs that people plan to use period and fertility tracking data to advance a prochoice agenda, according to Adam Levin, JD, a cybersecurity expert and founder of CyberScout, a global identity and data protection company.

Still, a cycle tracking app “created by a company owned by an antiabortion activist” is totally feasible, said Mr. Levin.

If you want to ensure your data is safe from such meddling, you may want to delete your app, he said, noting that using the notepad feature on your smartphone could be a safer alternative, as could using old-fashioned pen and paper.

You don’t have to stop with period and fertility tracking apps, either.

For any apps you share personal information with, set privacy settings “as tightly as possible” – and reconsider using apps if these options are unavailable, Mr. Levin advised.

“Make sure that company is not engaging in social or political activism that does not align with your politics.”

New York State Attorney General Letitia James recently spoke on the topic, noting on May 13 that “people use fertility tracking apps and location services every day, but if they’re not careful their personal information can end up in the wrong hands.

“With abortion rights in jeopardy, it’s more important than ever that everyone take their digital privacy seriously,” she said. “I urge everyone, especially those visiting abortion clinics or seeking abortion care, to follow the tips offered by my office and be more careful of the apps and websites they use.”

The New York State Attorney General’s Office recommends women use encrypted messaging when communicating about personal health information or behaviors, and to be careful about what they share on social media posts. The office also suggests turning off location and personalized advertising options on their smartphones.
 

 

 

Cellphone location data

Dr. Malin said there are several ways that location services could be used to track where a woman uses her smartphone. An app could track locations if someone grants permission through the app end user agreement, for example.

A second but less likely scenario would be the service provider tracking the pings coming off cellphone towers to find a smartphone.

So what recourse does a woman have if tracked by a third-party app?

“It’s a really tricky situation there because it depends on if the individual was put expressly in harm’s way,” Dr. Malin said. What’s more, tracking someone out in public is not prohibited in general.

“There’s a big difference between documenting what an individual does within a Planned Parenthood clinic versus what they do outside of it,” he said.

Dr. Malin said it’s better that regulations protect all smartphone users rather than requiring each person to remember to turn off the location tracker and then turn it back on again. Also, it should be more of an opt-in situation – where app developers must ask permission to track app usage or location services – versus making each woman opt out.
 

Think before you share

Vindictive or untrustworthy partners and family members of women in abusive relationships could also be a cause of concern, said Mr. Kreis.

“Individuals within a woman’s closest circles could hold abortions over their head or threaten reporting them for reproductive health care or miscarriages,” he said.

It’s not uncommon for women to experience domestic violence after having an abortion, particularly if their partners were unaware they had the procedure, according to Dr. Clayton.

She said women should also be mindful of what they share on social media.

Dr. Clayton gave the example of a woman seeking advice on where to get a safe abortion or how to order certain medications.

“If someone goes online to look for that, that’s potentially dangerous.”

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

If Roe v. Wade is overturned, can criminal prosecutors or tech companies use smartphone data against someone?

Now that the future of U.S. abortion laws hangs in the balance, many women are questioning the degree of caution needed to keep their cyber activity confidential – especially period and fertility tracking apps, smartphone location data, and social media interactions.

Cybersecurity and legal experts say the answer largely boils down to one major issue: The right to privacy.

“There’s this notion of the expectation of privacy,” said Brad Malin, PhD, professor of biomedical informatics, biostatistics, and computer science at Vanderbilt University in Nashville, Tenn.

Dr. Malin said it’s directly related to bodily privacy that a person expects they have control of as part of their own environment.

According to Dr. Malin, this is “why this whole notion of Roe v. Wade at the present moment is really relevant. The right to privacy is mentioned about a dozen times within the law for the case.

“This is why we don’t know what’s going to happen with Roe v. Wade, but it worries a lot of privacy professionals,” he said. “It leads down this slippery slope of if you don’t even have control over your own body, then with electronic communications … we might as well not even start.”
 

Legal protections

The Fourth Amendment of the U.S. Constitution protects people against unreasonable searches and seizures.

To acquire cyber data that could be used as evidence in courts in states where abortion is deemed a crime, prosecutors would still have to go through standard criminal procedures, said Anthony Michael Kreis, JD, a constitutional law professor at Georgia State University, Atlanta.

But the data they do get could still be used in court against someone who is suspected of having had an abortion or who “miscarried under circumstances law enforcement officers found suspicious,” Mr. Kreis said.

And there’s another possibility, he noted: States holding women who end their pregnancies criminally or civilly responsible for “leaving their jurisdiction to obtain an abortion out-of-state.”

“That legal mechanism may abridge the constitutional right to travel, but it is not out of the realm of possibilities in a post-Roe America,” said Mr. Kreis.

But while many anti-abortion groups have said that criminalizing abortion or limiting access to contraception is not the end goal, “history is not promising here,” said Ellen Wright Clayton, MD, JD, professor of pediatrics and professor of law at Vanderbilt University.

She referred to a recent proposal from lawmakers in Louisiana to classify abortion as homicide.

The bill didn’t get far in the House of Representatives, but the concern is warranted, said Dr. Clayton.
 

Period and fertility tracking apps

Health information privacy laws, like the Health Insurance Portability and Accountability Act (HIPAA), do not protect information on period and fertility tracking apps.

Right now, there are no signs that people plan to use period and fertility tracking data to advance a prochoice agenda, according to Adam Levin, JD, a cybersecurity expert and founder of CyberScout, a global identity and data protection company.

Still, a cycle tracking app “created by a company owned by an antiabortion activist” is totally feasible, said Mr. Levin.

If you want to ensure your data is safe from such meddling, you may want to delete your app, he said, noting that using the notepad feature on your smartphone could be a safer alternative, as could using old-fashioned pen and paper.

You don’t have to stop with period and fertility tracking apps, either.

For any apps you share personal information with, set privacy settings “as tightly as possible” – and reconsider using apps if these options are unavailable, Mr. Levin advised.

“Make sure that company is not engaging in social or political activism that does not align with your politics.”

New York State Attorney General Letitia James recently spoke on the topic, noting on May 13 that “people use fertility tracking apps and location services every day, but if they’re not careful their personal information can end up in the wrong hands.

“With abortion rights in jeopardy, it’s more important than ever that everyone take their digital privacy seriously,” she said. “I urge everyone, especially those visiting abortion clinics or seeking abortion care, to follow the tips offered by my office and be more careful of the apps and websites they use.”

The New York State Attorney General’s Office recommends women use encrypted messaging when communicating about personal health information or behaviors, and to be careful about what they share on social media posts. The office also suggests turning off location and personalized advertising options on their smartphones.
 

 

 

Cellphone location data

Dr. Malin said there are several ways that location services could be used to track where a woman uses her smartphone. An app could track locations if someone grants permission through the app end user agreement, for example.

A second but less likely scenario would be the service provider tracking the pings coming off cellphone towers to find a smartphone.

So what recourse does a woman have if tracked by a third-party app?

“It’s a really tricky situation there because it depends on if the individual was put expressly in harm’s way,” Dr. Malin said. What’s more, tracking someone out in public is not prohibited in general.

“There’s a big difference between documenting what an individual does within a Planned Parenthood clinic versus what they do outside of it,” he said.

Dr. Malin said it’s better that regulations protect all smartphone users rather than requiring each person to remember to turn off the location tracker and then turn it back on again. Also, it should be more of an opt-in situation – where app developers must ask permission to track app usage or location services – versus making each woman opt out.
 

Think before you share

Vindictive or untrustworthy partners and family members of women in abusive relationships could also be a cause of concern, said Mr. Kreis.

“Individuals within a woman’s closest circles could hold abortions over their head or threaten reporting them for reproductive health care or miscarriages,” he said.

It’s not uncommon for women to experience domestic violence after having an abortion, particularly if their partners were unaware they had the procedure, according to Dr. Clayton.

She said women should also be mindful of what they share on social media.

Dr. Clayton gave the example of a woman seeking advice on where to get a safe abortion or how to order certain medications.

“If someone goes online to look for that, that’s potentially dangerous.”

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

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How to manage drug interactions with Paxlovid for COVID-19

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Mon, 05/23/2022 - 14:38

Misinformation about nirmatrelvir/ritonavir (Paxlovid, Pfizer) for treating mild to moderate COVID-19 in patients at high risk for severe disease is feeding misunderstanding among prescribers and patients, two experts from the Infectious Diseases Society of America (IDSA) have said.

They briefed reporters on potential drug interactions and uncommon cases of a “rebound” effect with the drug, which was granted emergency use authorization by the Food and Drug Administration last December for patients at least 12 years old.

The drug combination works “like a pair of scissors chopping up proteins that are made as the virus replicates inside of cells. Inhibiting that enzyme leads to the cessation of replication,” said Jason C. Gallagher, PharmD, of Temple University School of Pharmacy, Philadelphia.

That’s important because other treatments that target the spike protein, such as monoclonal antibodies, can lose their efficacy as the virus changes. He said that while that’s not impossible for Paxlovid, “we have not seen variants emerging that are resistant to it.”
 

Potential drug interactions

IDSA recently published updated guidance on potential interactions between Paxlovid and the top 100 drugs, and important considerations for prescribing.

“There is a concern that people have not been prescribing it because of fear of these interactions,” Dr. Gallagher said, explaining that, while in some cases those fears may be valid, in many instances the interaction is manageable.

One example is in two popular statins for heart disease, lovastatin and simvastatin.

“That’s an interaction that can be managed by holding [those drugs] for the 5 days that someone receives Paxlovid,” he said.

Misinformation also is circulating about distribution status of Paxlovid, Dr. Gallagher said.

“We’re in a very different state from that standpoint than we were a month or 2 months ago,” he said, adding that it is widely available in not all but a large number of pharmacies throughout the United States.

He emphasized the importance of drug reconciliation, as many patients will go to a different pharmacy for Paxlovid than they might for their usual prescriptions, so without a full accounting of prescriptions and supplements potential interactions may be missed.
 

Important interactions to watch

Melanie Thompson, MD, cochair of the HIVMA/IDSA HIV Primary Care Guidance Panel, highlighted some classes of drugs to watch, among them the antiarrhythmics, most of which are contraindicated with Paxlovid.

There are also important interactions with a number of cancer drugs, and consults with oncologists will be critical, she said.

“Likewise, people who have had transplants are likely to be on drugs that have significant ritonavir interactions,” Dr. Thompson said.

People on ergot drugs for migraine cannot take Paxlovid, she said, and “people who take colchicine for gout have to be very careful.”

She said it’s better not to use colchicine while taking Paxlovid, as it is contraindicated, “but it can be managed in certain circumstances with substantial dose reduction.”

A number of mental health drugs can be managed with Paxlovid, Dr. Thompson said. For the antipsychotic drug quetiapine, (Seroquel), a “substantial decrease in dose is required.”
 

Viagra for ED can be managed

Use of Viagra depends on why it’s being used, Dr. Thompson said. If it’s used for pulmonary hypertension, it is used at a very high dose and that is contraindicated. But if used for erectile dysfunction, the dose needs to be managed when people are on Paxlovid.

She said prescribers must know the kidney function of patients.

“There is a dose reduction that is required if people have impaired kidney function but below a certain level of function, which is 30 mL/min, it’s not recommended to give Paxlovid.”

Dr. Thompson highlighted two other websites for thorough, printable information on drug-drug interactions with Paxlovid: the University of Liverpool’s drug interaction checker and a printable handout from the University of Waterloo in Ontario, Canada.

“We need a 24/7 clinician hotline for Paxlovid to really make it accessible,” she said.
 

No data yet on ‘rebound’ effect

As to a few recent reports of a “rebound” effect, of people developing COVID-19 symptoms after completing a course of Paxlovid, there are not enough data yet to determine a clear pattern or cause.

“All we have are anecdotal data,” Dr. Thompson said. Current questions for study include whether the 5-day course is not long enough, she said, and whether people more at risk should be given a second course of Paxlovid if they do rebound.

Dr. Gallagher said it’s important to remember that the therapy goal of the drug is to prevent hospitalizations and deaths, and while any rebound is problematic, “it’s possible the use of the medication has already saved a life.”

Dr. Gallagher and Dr. Thompson report no relevant financial relationships.

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

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Misinformation about nirmatrelvir/ritonavir (Paxlovid, Pfizer) for treating mild to moderate COVID-19 in patients at high risk for severe disease is feeding misunderstanding among prescribers and patients, two experts from the Infectious Diseases Society of America (IDSA) have said.

They briefed reporters on potential drug interactions and uncommon cases of a “rebound” effect with the drug, which was granted emergency use authorization by the Food and Drug Administration last December for patients at least 12 years old.

The drug combination works “like a pair of scissors chopping up proteins that are made as the virus replicates inside of cells. Inhibiting that enzyme leads to the cessation of replication,” said Jason C. Gallagher, PharmD, of Temple University School of Pharmacy, Philadelphia.

That’s important because other treatments that target the spike protein, such as monoclonal antibodies, can lose their efficacy as the virus changes. He said that while that’s not impossible for Paxlovid, “we have not seen variants emerging that are resistant to it.”
 

Potential drug interactions

IDSA recently published updated guidance on potential interactions between Paxlovid and the top 100 drugs, and important considerations for prescribing.

“There is a concern that people have not been prescribing it because of fear of these interactions,” Dr. Gallagher said, explaining that, while in some cases those fears may be valid, in many instances the interaction is manageable.

One example is in two popular statins for heart disease, lovastatin and simvastatin.

“That’s an interaction that can be managed by holding [those drugs] for the 5 days that someone receives Paxlovid,” he said.

Misinformation also is circulating about distribution status of Paxlovid, Dr. Gallagher said.

“We’re in a very different state from that standpoint than we were a month or 2 months ago,” he said, adding that it is widely available in not all but a large number of pharmacies throughout the United States.

He emphasized the importance of drug reconciliation, as many patients will go to a different pharmacy for Paxlovid than they might for their usual prescriptions, so without a full accounting of prescriptions and supplements potential interactions may be missed.
 

Important interactions to watch

Melanie Thompson, MD, cochair of the HIVMA/IDSA HIV Primary Care Guidance Panel, highlighted some classes of drugs to watch, among them the antiarrhythmics, most of which are contraindicated with Paxlovid.

There are also important interactions with a number of cancer drugs, and consults with oncologists will be critical, she said.

“Likewise, people who have had transplants are likely to be on drugs that have significant ritonavir interactions,” Dr. Thompson said.

People on ergot drugs for migraine cannot take Paxlovid, she said, and “people who take colchicine for gout have to be very careful.”

She said it’s better not to use colchicine while taking Paxlovid, as it is contraindicated, “but it can be managed in certain circumstances with substantial dose reduction.”

A number of mental health drugs can be managed with Paxlovid, Dr. Thompson said. For the antipsychotic drug quetiapine, (Seroquel), a “substantial decrease in dose is required.”
 

Viagra for ED can be managed

Use of Viagra depends on why it’s being used, Dr. Thompson said. If it’s used for pulmonary hypertension, it is used at a very high dose and that is contraindicated. But if used for erectile dysfunction, the dose needs to be managed when people are on Paxlovid.

She said prescribers must know the kidney function of patients.

“There is a dose reduction that is required if people have impaired kidney function but below a certain level of function, which is 30 mL/min, it’s not recommended to give Paxlovid.”

Dr. Thompson highlighted two other websites for thorough, printable information on drug-drug interactions with Paxlovid: the University of Liverpool’s drug interaction checker and a printable handout from the University of Waterloo in Ontario, Canada.

“We need a 24/7 clinician hotline for Paxlovid to really make it accessible,” she said.
 

No data yet on ‘rebound’ effect

As to a few recent reports of a “rebound” effect, of people developing COVID-19 symptoms after completing a course of Paxlovid, there are not enough data yet to determine a clear pattern or cause.

“All we have are anecdotal data,” Dr. Thompson said. Current questions for study include whether the 5-day course is not long enough, she said, and whether people more at risk should be given a second course of Paxlovid if they do rebound.

Dr. Gallagher said it’s important to remember that the therapy goal of the drug is to prevent hospitalizations and deaths, and while any rebound is problematic, “it’s possible the use of the medication has already saved a life.”

Dr. Gallagher and Dr. Thompson report no relevant financial relationships.

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

Misinformation about nirmatrelvir/ritonavir (Paxlovid, Pfizer) for treating mild to moderate COVID-19 in patients at high risk for severe disease is feeding misunderstanding among prescribers and patients, two experts from the Infectious Diseases Society of America (IDSA) have said.

They briefed reporters on potential drug interactions and uncommon cases of a “rebound” effect with the drug, which was granted emergency use authorization by the Food and Drug Administration last December for patients at least 12 years old.

The drug combination works “like a pair of scissors chopping up proteins that are made as the virus replicates inside of cells. Inhibiting that enzyme leads to the cessation of replication,” said Jason C. Gallagher, PharmD, of Temple University School of Pharmacy, Philadelphia.

That’s important because other treatments that target the spike protein, such as monoclonal antibodies, can lose their efficacy as the virus changes. He said that while that’s not impossible for Paxlovid, “we have not seen variants emerging that are resistant to it.”
 

Potential drug interactions

IDSA recently published updated guidance on potential interactions between Paxlovid and the top 100 drugs, and important considerations for prescribing.

“There is a concern that people have not been prescribing it because of fear of these interactions,” Dr. Gallagher said, explaining that, while in some cases those fears may be valid, in many instances the interaction is manageable.

One example is in two popular statins for heart disease, lovastatin and simvastatin.

“That’s an interaction that can be managed by holding [those drugs] for the 5 days that someone receives Paxlovid,” he said.

Misinformation also is circulating about distribution status of Paxlovid, Dr. Gallagher said.

“We’re in a very different state from that standpoint than we were a month or 2 months ago,” he said, adding that it is widely available in not all but a large number of pharmacies throughout the United States.

He emphasized the importance of drug reconciliation, as many patients will go to a different pharmacy for Paxlovid than they might for their usual prescriptions, so without a full accounting of prescriptions and supplements potential interactions may be missed.
 

Important interactions to watch

Melanie Thompson, MD, cochair of the HIVMA/IDSA HIV Primary Care Guidance Panel, highlighted some classes of drugs to watch, among them the antiarrhythmics, most of which are contraindicated with Paxlovid.

There are also important interactions with a number of cancer drugs, and consults with oncologists will be critical, she said.

“Likewise, people who have had transplants are likely to be on drugs that have significant ritonavir interactions,” Dr. Thompson said.

People on ergot drugs for migraine cannot take Paxlovid, she said, and “people who take colchicine for gout have to be very careful.”

She said it’s better not to use colchicine while taking Paxlovid, as it is contraindicated, “but it can be managed in certain circumstances with substantial dose reduction.”

A number of mental health drugs can be managed with Paxlovid, Dr. Thompson said. For the antipsychotic drug quetiapine, (Seroquel), a “substantial decrease in dose is required.”
 

Viagra for ED can be managed

Use of Viagra depends on why it’s being used, Dr. Thompson said. If it’s used for pulmonary hypertension, it is used at a very high dose and that is contraindicated. But if used for erectile dysfunction, the dose needs to be managed when people are on Paxlovid.

She said prescribers must know the kidney function of patients.

“There is a dose reduction that is required if people have impaired kidney function but below a certain level of function, which is 30 mL/min, it’s not recommended to give Paxlovid.”

Dr. Thompson highlighted two other websites for thorough, printable information on drug-drug interactions with Paxlovid: the University of Liverpool’s drug interaction checker and a printable handout from the University of Waterloo in Ontario, Canada.

“We need a 24/7 clinician hotline for Paxlovid to really make it accessible,” she said.
 

No data yet on ‘rebound’ effect

As to a few recent reports of a “rebound” effect, of people developing COVID-19 symptoms after completing a course of Paxlovid, there are not enough data yet to determine a clear pattern or cause.

“All we have are anecdotal data,” Dr. Thompson said. Current questions for study include whether the 5-day course is not long enough, she said, and whether people more at risk should be given a second course of Paxlovid if they do rebound.

Dr. Gallagher said it’s important to remember that the therapy goal of the drug is to prevent hospitalizations and deaths, and while any rebound is problematic, “it’s possible the use of the medication has already saved a life.”

Dr. Gallagher and Dr. Thompson report no relevant financial relationships.

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

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OTC meds, supplements, and other drugs may interact with HIV antiretrovirals

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Wed, 05/25/2022 - 15:44

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

  • Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
  • Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
  • Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
  • Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
  • Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

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Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

  • Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
  • Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
  • Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
  • Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
  • Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

  • Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
  • Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
  • Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
  • Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
  • Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

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Trade-offs doctors make to become mothers: Interview study

Article Type
Changed
Mon, 05/23/2022 - 10:25

Qualitative interviews with a group of female physicians identified several concerns about fertility and family planning and how those concerns affected their career choices.

Among the findings in a new study were that all 16 women interviewed said medical school education surrounding fertility was inadequate. Many said students should get comprehensive information about fertility’s decline with age and fertility preservation options and that information should be presented early in medical training so students can make choices. Yet, such issues are rarely discussed as part of medical training.

“[I]t would also be helpful for medical students and trainees to know what their options are, what insurance covers ... It wasn’t even touched at my orientation,” said one participant.

The findings from the hour-long interviews were used to build a survey. In a pilot test of the survey on 24 female physicians, researchers found that 71% had delayed childbearing and 67% had altered their careers to build families.

Kathryn S. Smith of Northwestern University, Chicago, led the research. Results were published online in JAMA Network Open.

In addition, 29% of survey respondents turned down career advancement opportunities; 21% chose a different specialty; and 17% changed from an academic to private practice setting to accommodate having children.

Women in the survey cited as factors in their decisions lack of support from physician peers and leadership, particularly around time off for pregnancy, maternity leave, infertility treatments, or parental responsibilities.
 

Results ‘alarming’

“These results are alarming, particularly in light of known gender disparities that exist within academic medicine in time to promotion, achievement of academic rank, and appointment to leadership positions,” the authors wrote.

As of 2020, women made up 43% of medical school faculty but only 21% of department chairs and 19% of medical school deans, according to Association of American Medical Colleges data.

Navigating motherhood as a physician also can take a physical and mental toll. Recent data presented at the American College of Obstetricians and Gynecologists (ACOG) 2022 annual meeting found that one in four physicians who are new mothers report struggling with postpartum depression, a rate twice that of the general population.

And one in four women in a recent survey of 600 female physicians who had attempted conception were diagnosed with infertility.
 

Lack of support ‘pronounced in medicine’

In an invited commentary, Ariela L. Marshall, MD, of the division of hematology-oncology at University of Pennsylvania, Philadelphia, and Arghavan Salles, MD, PhD, of the department of medicine at Stanford (Calif.) University, noted that career-family struggle is not unique to medicine but “the lack of support for pregnancy is particularly pronounced in medicine.”

The editorialists wrote that they have battled infertility and faced family-building challenges and have intimate familiarity with the struggles.

“Although other workplaces, such as Microsoft, Google, and Facebook, long ago adopted policies to support employees’ family building, including via cryopreservation, those in medicine all too frequently must pay back their parental leave, make up missed call, or even pay back money to their practice,” they wrote. “It is embarrassing that employees of tech companies have better support for reproductive health than do physicians.”

They advocate for change on the entire continuum from fertility awareness and infertility management, bringing children into a family by any method, and child care and career development support for physicians who become parents.

They urge establishing adequate paid parental leave, not just for parents who give birth but for all parents involved in rearing children. They say providing leave to only one parent sets up a discriminatory divide between the partner who continues to work and the person providing care.

Dr. Marshall and Dr. Salles wrote that lack of support is likely part of the reason that 40% of women in medicine switch to part-time positions within their first 6 years in practice.

They also note that too often fertility and family-building discussions focus on cisgendered women who are in heterosexual relationships.

They cite some “nonsensical“ policies around insurance. They give an example of coverage for fertility treatments that often requires trying to conceive before benefits are provided.

“How do two women, two men, or a single person try to conceive?” they ask.

Helen Kang Morgan, MD, clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor, said that she, too, has made the trade-off the researchers describe.

Dr. Helen Kang Morgan

She was in her first year as a faculty physician at the University of Michigan when she became a mom and decided to go part time.

Unlike some of the women interviewed in the Smith et al. study, she said she felt lucky to have peer support and the support of leaders in her department who made sure she wasn’t derailed from her career path because she chose part-time work for nearly 5 years.

“For some women, part-time is the right choice and for me, at the time, it was the right choice, but it should not be the only choice. It makes it so much harder for women to advance their careers if part-time is the only option,” she said.

Dr. Morgan said this work highlights that conversations about work and parenting needs in medicine have to go from informal conversations to formal conversations.

Department leaders should be asking what female physicians need and what flexibility is needed, she said.

The COVID-19 pandemic showed how bad things could get, she said.

In Ann Arbor, Dr. Morgan noted, schools were virtual until the spring of 2021, putting demands disproportionately on female physicians who absorbed much of the at-home child care responsibilities.

“That created gender inequities I think it is going to take women many, many years to catch up from,” she said.

COVID-19 also, however, forced medicine to incorporate more virtual options, something that should stay in finding solutions to ease the burden on physicians who are mothers, she said.

Reshma Jagsi, MD, deputy chair in the department of radiation oncology at the University of Michigan, said both policies and cultural norms need to change in medicine.

Courtesy Michigan Medicine
Dr. Reshma Jagsi


Hospitals must find alternative approaches to the historical reliance on residents to provide clinical service needs, she said in an interview.

“It’s not just about educating women or ensuring access to fertility services – it’s also about making it more possible and acceptable for women to combine their pursuit of a medical career and beginning a family during the peak years of fertility.”

She said the medical profession – dedicated to human well-being – seems to carve out an exception when it comes to optimizing the well-being of its future members.

“It breaks my heart to read about how hard we have made it for women to succeed in our profession,” she said.

This study was funded by the American Society for Reproductive Medicine. The authors report no relevant financial relationships. Dr. Marshall, Dr. Salles, Dr. Jagsi, and Dr. Morgan report no relevant financial relationships.

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Qualitative interviews with a group of female physicians identified several concerns about fertility and family planning and how those concerns affected their career choices.

Among the findings in a new study were that all 16 women interviewed said medical school education surrounding fertility was inadequate. Many said students should get comprehensive information about fertility’s decline with age and fertility preservation options and that information should be presented early in medical training so students can make choices. Yet, such issues are rarely discussed as part of medical training.

“[I]t would also be helpful for medical students and trainees to know what their options are, what insurance covers ... It wasn’t even touched at my orientation,” said one participant.

The findings from the hour-long interviews were used to build a survey. In a pilot test of the survey on 24 female physicians, researchers found that 71% had delayed childbearing and 67% had altered their careers to build families.

Kathryn S. Smith of Northwestern University, Chicago, led the research. Results were published online in JAMA Network Open.

In addition, 29% of survey respondents turned down career advancement opportunities; 21% chose a different specialty; and 17% changed from an academic to private practice setting to accommodate having children.

Women in the survey cited as factors in their decisions lack of support from physician peers and leadership, particularly around time off for pregnancy, maternity leave, infertility treatments, or parental responsibilities.
 

Results ‘alarming’

“These results are alarming, particularly in light of known gender disparities that exist within academic medicine in time to promotion, achievement of academic rank, and appointment to leadership positions,” the authors wrote.

As of 2020, women made up 43% of medical school faculty but only 21% of department chairs and 19% of medical school deans, according to Association of American Medical Colleges data.

Navigating motherhood as a physician also can take a physical and mental toll. Recent data presented at the American College of Obstetricians and Gynecologists (ACOG) 2022 annual meeting found that one in four physicians who are new mothers report struggling with postpartum depression, a rate twice that of the general population.

And one in four women in a recent survey of 600 female physicians who had attempted conception were diagnosed with infertility.
 

Lack of support ‘pronounced in medicine’

In an invited commentary, Ariela L. Marshall, MD, of the division of hematology-oncology at University of Pennsylvania, Philadelphia, and Arghavan Salles, MD, PhD, of the department of medicine at Stanford (Calif.) University, noted that career-family struggle is not unique to medicine but “the lack of support for pregnancy is particularly pronounced in medicine.”

The editorialists wrote that they have battled infertility and faced family-building challenges and have intimate familiarity with the struggles.

“Although other workplaces, such as Microsoft, Google, and Facebook, long ago adopted policies to support employees’ family building, including via cryopreservation, those in medicine all too frequently must pay back their parental leave, make up missed call, or even pay back money to their practice,” they wrote. “It is embarrassing that employees of tech companies have better support for reproductive health than do physicians.”

They advocate for change on the entire continuum from fertility awareness and infertility management, bringing children into a family by any method, and child care and career development support for physicians who become parents.

They urge establishing adequate paid parental leave, not just for parents who give birth but for all parents involved in rearing children. They say providing leave to only one parent sets up a discriminatory divide between the partner who continues to work and the person providing care.

Dr. Marshall and Dr. Salles wrote that lack of support is likely part of the reason that 40% of women in medicine switch to part-time positions within their first 6 years in practice.

They also note that too often fertility and family-building discussions focus on cisgendered women who are in heterosexual relationships.

They cite some “nonsensical“ policies around insurance. They give an example of coverage for fertility treatments that often requires trying to conceive before benefits are provided.

“How do two women, two men, or a single person try to conceive?” they ask.

Helen Kang Morgan, MD, clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor, said that she, too, has made the trade-off the researchers describe.

Dr. Helen Kang Morgan

She was in her first year as a faculty physician at the University of Michigan when she became a mom and decided to go part time.

Unlike some of the women interviewed in the Smith et al. study, she said she felt lucky to have peer support and the support of leaders in her department who made sure she wasn’t derailed from her career path because she chose part-time work for nearly 5 years.

“For some women, part-time is the right choice and for me, at the time, it was the right choice, but it should not be the only choice. It makes it so much harder for women to advance their careers if part-time is the only option,” she said.

Dr. Morgan said this work highlights that conversations about work and parenting needs in medicine have to go from informal conversations to formal conversations.

Department leaders should be asking what female physicians need and what flexibility is needed, she said.

The COVID-19 pandemic showed how bad things could get, she said.

In Ann Arbor, Dr. Morgan noted, schools were virtual until the spring of 2021, putting demands disproportionately on female physicians who absorbed much of the at-home child care responsibilities.

“That created gender inequities I think it is going to take women many, many years to catch up from,” she said.

COVID-19 also, however, forced medicine to incorporate more virtual options, something that should stay in finding solutions to ease the burden on physicians who are mothers, she said.

Reshma Jagsi, MD, deputy chair in the department of radiation oncology at the University of Michigan, said both policies and cultural norms need to change in medicine.

Courtesy Michigan Medicine
Dr. Reshma Jagsi


Hospitals must find alternative approaches to the historical reliance on residents to provide clinical service needs, she said in an interview.

“It’s not just about educating women or ensuring access to fertility services – it’s also about making it more possible and acceptable for women to combine their pursuit of a medical career and beginning a family during the peak years of fertility.”

She said the medical profession – dedicated to human well-being – seems to carve out an exception when it comes to optimizing the well-being of its future members.

“It breaks my heart to read about how hard we have made it for women to succeed in our profession,” she said.

This study was funded by the American Society for Reproductive Medicine. The authors report no relevant financial relationships. Dr. Marshall, Dr. Salles, Dr. Jagsi, and Dr. Morgan report no relevant financial relationships.

Qualitative interviews with a group of female physicians identified several concerns about fertility and family planning and how those concerns affected their career choices.

Among the findings in a new study were that all 16 women interviewed said medical school education surrounding fertility was inadequate. Many said students should get comprehensive information about fertility’s decline with age and fertility preservation options and that information should be presented early in medical training so students can make choices. Yet, such issues are rarely discussed as part of medical training.

“[I]t would also be helpful for medical students and trainees to know what their options are, what insurance covers ... It wasn’t even touched at my orientation,” said one participant.

The findings from the hour-long interviews were used to build a survey. In a pilot test of the survey on 24 female physicians, researchers found that 71% had delayed childbearing and 67% had altered their careers to build families.

Kathryn S. Smith of Northwestern University, Chicago, led the research. Results were published online in JAMA Network Open.

In addition, 29% of survey respondents turned down career advancement opportunities; 21% chose a different specialty; and 17% changed from an academic to private practice setting to accommodate having children.

Women in the survey cited as factors in their decisions lack of support from physician peers and leadership, particularly around time off for pregnancy, maternity leave, infertility treatments, or parental responsibilities.
 

Results ‘alarming’

“These results are alarming, particularly in light of known gender disparities that exist within academic medicine in time to promotion, achievement of academic rank, and appointment to leadership positions,” the authors wrote.

As of 2020, women made up 43% of medical school faculty but only 21% of department chairs and 19% of medical school deans, according to Association of American Medical Colleges data.

Navigating motherhood as a physician also can take a physical and mental toll. Recent data presented at the American College of Obstetricians and Gynecologists (ACOG) 2022 annual meeting found that one in four physicians who are new mothers report struggling with postpartum depression, a rate twice that of the general population.

And one in four women in a recent survey of 600 female physicians who had attempted conception were diagnosed with infertility.
 

Lack of support ‘pronounced in medicine’

In an invited commentary, Ariela L. Marshall, MD, of the division of hematology-oncology at University of Pennsylvania, Philadelphia, and Arghavan Salles, MD, PhD, of the department of medicine at Stanford (Calif.) University, noted that career-family struggle is not unique to medicine but “the lack of support for pregnancy is particularly pronounced in medicine.”

The editorialists wrote that they have battled infertility and faced family-building challenges and have intimate familiarity with the struggles.

“Although other workplaces, such as Microsoft, Google, and Facebook, long ago adopted policies to support employees’ family building, including via cryopreservation, those in medicine all too frequently must pay back their parental leave, make up missed call, or even pay back money to their practice,” they wrote. “It is embarrassing that employees of tech companies have better support for reproductive health than do physicians.”

They advocate for change on the entire continuum from fertility awareness and infertility management, bringing children into a family by any method, and child care and career development support for physicians who become parents.

They urge establishing adequate paid parental leave, not just for parents who give birth but for all parents involved in rearing children. They say providing leave to only one parent sets up a discriminatory divide between the partner who continues to work and the person providing care.

Dr. Marshall and Dr. Salles wrote that lack of support is likely part of the reason that 40% of women in medicine switch to part-time positions within their first 6 years in practice.

They also note that too often fertility and family-building discussions focus on cisgendered women who are in heterosexual relationships.

They cite some “nonsensical“ policies around insurance. They give an example of coverage for fertility treatments that often requires trying to conceive before benefits are provided.

“How do two women, two men, or a single person try to conceive?” they ask.

Helen Kang Morgan, MD, clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor, said that she, too, has made the trade-off the researchers describe.

Dr. Helen Kang Morgan

She was in her first year as a faculty physician at the University of Michigan when she became a mom and decided to go part time.

Unlike some of the women interviewed in the Smith et al. study, she said she felt lucky to have peer support and the support of leaders in her department who made sure she wasn’t derailed from her career path because she chose part-time work for nearly 5 years.

“For some women, part-time is the right choice and for me, at the time, it was the right choice, but it should not be the only choice. It makes it so much harder for women to advance their careers if part-time is the only option,” she said.

Dr. Morgan said this work highlights that conversations about work and parenting needs in medicine have to go from informal conversations to formal conversations.

Department leaders should be asking what female physicians need and what flexibility is needed, she said.

The COVID-19 pandemic showed how bad things could get, she said.

In Ann Arbor, Dr. Morgan noted, schools were virtual until the spring of 2021, putting demands disproportionately on female physicians who absorbed much of the at-home child care responsibilities.

“That created gender inequities I think it is going to take women many, many years to catch up from,” she said.

COVID-19 also, however, forced medicine to incorporate more virtual options, something that should stay in finding solutions to ease the burden on physicians who are mothers, she said.

Reshma Jagsi, MD, deputy chair in the department of radiation oncology at the University of Michigan, said both policies and cultural norms need to change in medicine.

Courtesy Michigan Medicine
Dr. Reshma Jagsi


Hospitals must find alternative approaches to the historical reliance on residents to provide clinical service needs, she said in an interview.

“It’s not just about educating women or ensuring access to fertility services – it’s also about making it more possible and acceptable for women to combine their pursuit of a medical career and beginning a family during the peak years of fertility.”

She said the medical profession – dedicated to human well-being – seems to carve out an exception when it comes to optimizing the well-being of its future members.

“It breaks my heart to read about how hard we have made it for women to succeed in our profession,” she said.

This study was funded by the American Society for Reproductive Medicine. The authors report no relevant financial relationships. Dr. Marshall, Dr. Salles, Dr. Jagsi, and Dr. Morgan report no relevant financial relationships.

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Many Americans missing an opportunity to prevent dementia

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Nearly half of all U.S. adults aged 45 and older have modifiable risk factors for Alzheimer’s disease and related dementias (ADRD), including hypertension, low levels of physical activity, and obesity, new research shows.

Data from the Centers for Disease Control and Prevention reveal that among nearly 162,000 adults aged 45 and older who were surveyed in 2019 as part of the Behavioral Risk Factor Surveillance System (BRFSS), nearly half had high blood pressure and did not achieve aerobic physical activity recommendations. These were the two most common modifiable risk factors for ADRD.

In addition, more than one-third (35%) of adults were obese, 19% had diabetes, 18% had depression, 15% were smokers, 11% had hearing loss, and 10% were binge drinkers.

The findings were published online in the CDC’s Morbidity and Mortality Weekly Report.
 

A missed prevention opportunity

More than 1 in 10 (11.3%) adults surveyed reported subjective cognitive decline (SCD), an early indicator of possible future ADRD. 

The prevalence of SCD increased from about 4% among adults with no modifiable risk factors for ADRD to 25% for those with four or more risk factors.

Adults with SCD were more apt to report having almost all modifiable risk factors and were more likely to report four or more risk factors (34%) than were peers without SCD (13%)

The prevalence of SCD ranged from a high of about 29% in those with depression and 25% in those with hearing loss to 11% in those who reported binge drinking.

In line with previous research, the findings indicate that American Indian or Alaska Native, Black or African American, and Hispanic populations were more likely to have modifiable risk factors for ADRD than other racial groups, the researchers reported.

The CDC’s National Healthy Brain Initiative supports culturally tailored interventions that address ADRD risk factors specifically in these populations.

In 2021, the federal government’s National Plan to Address Alzheimer’s Disease was updated to include a new goal to reduce risk factors for ADRD.

“Given the prevalence of modifiable risk factors for ADRD and anticipated growth of the older adult population and those with ADRD, this new goal has the potential to benefit a large proportion of U.S. adults,” the investigators wrote.

“In addition to helping patients discuss concerns about memory loss, health care professionals should also screen patients for modifiable risk factors, counsel patients with risk factors, and refer them to effective programs and interventions where recommended,” they advised.

A recent report from the Lancet Commission on Dementia Prevention, Intervention, and Care found that modifying 12 risk factors over the life course could delay or prevent 40% of dementia cases.

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

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Nearly half of all U.S. adults aged 45 and older have modifiable risk factors for Alzheimer’s disease and related dementias (ADRD), including hypertension, low levels of physical activity, and obesity, new research shows.

Data from the Centers for Disease Control and Prevention reveal that among nearly 162,000 adults aged 45 and older who were surveyed in 2019 as part of the Behavioral Risk Factor Surveillance System (BRFSS), nearly half had high blood pressure and did not achieve aerobic physical activity recommendations. These were the two most common modifiable risk factors for ADRD.

In addition, more than one-third (35%) of adults were obese, 19% had diabetes, 18% had depression, 15% were smokers, 11% had hearing loss, and 10% were binge drinkers.

The findings were published online in the CDC’s Morbidity and Mortality Weekly Report.
 

A missed prevention opportunity

More than 1 in 10 (11.3%) adults surveyed reported subjective cognitive decline (SCD), an early indicator of possible future ADRD. 

The prevalence of SCD increased from about 4% among adults with no modifiable risk factors for ADRD to 25% for those with four or more risk factors.

Adults with SCD were more apt to report having almost all modifiable risk factors and were more likely to report four or more risk factors (34%) than were peers without SCD (13%)

The prevalence of SCD ranged from a high of about 29% in those with depression and 25% in those with hearing loss to 11% in those who reported binge drinking.

In line with previous research, the findings indicate that American Indian or Alaska Native, Black or African American, and Hispanic populations were more likely to have modifiable risk factors for ADRD than other racial groups, the researchers reported.

The CDC’s National Healthy Brain Initiative supports culturally tailored interventions that address ADRD risk factors specifically in these populations.

In 2021, the federal government’s National Plan to Address Alzheimer’s Disease was updated to include a new goal to reduce risk factors for ADRD.

“Given the prevalence of modifiable risk factors for ADRD and anticipated growth of the older adult population and those with ADRD, this new goal has the potential to benefit a large proportion of U.S. adults,” the investigators wrote.

“In addition to helping patients discuss concerns about memory loss, health care professionals should also screen patients for modifiable risk factors, counsel patients with risk factors, and refer them to effective programs and interventions where recommended,” they advised.

A recent report from the Lancet Commission on Dementia Prevention, Intervention, and Care found that modifying 12 risk factors over the life course could delay or prevent 40% of dementia cases.

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

 

Nearly half of all U.S. adults aged 45 and older have modifiable risk factors for Alzheimer’s disease and related dementias (ADRD), including hypertension, low levels of physical activity, and obesity, new research shows.

Data from the Centers for Disease Control and Prevention reveal that among nearly 162,000 adults aged 45 and older who were surveyed in 2019 as part of the Behavioral Risk Factor Surveillance System (BRFSS), nearly half had high blood pressure and did not achieve aerobic physical activity recommendations. These were the two most common modifiable risk factors for ADRD.

In addition, more than one-third (35%) of adults were obese, 19% had diabetes, 18% had depression, 15% were smokers, 11% had hearing loss, and 10% were binge drinkers.

The findings were published online in the CDC’s Morbidity and Mortality Weekly Report.
 

A missed prevention opportunity

More than 1 in 10 (11.3%) adults surveyed reported subjective cognitive decline (SCD), an early indicator of possible future ADRD. 

The prevalence of SCD increased from about 4% among adults with no modifiable risk factors for ADRD to 25% for those with four or more risk factors.

Adults with SCD were more apt to report having almost all modifiable risk factors and were more likely to report four or more risk factors (34%) than were peers without SCD (13%)

The prevalence of SCD ranged from a high of about 29% in those with depression and 25% in those with hearing loss to 11% in those who reported binge drinking.

In line with previous research, the findings indicate that American Indian or Alaska Native, Black or African American, and Hispanic populations were more likely to have modifiable risk factors for ADRD than other racial groups, the researchers reported.

The CDC’s National Healthy Brain Initiative supports culturally tailored interventions that address ADRD risk factors specifically in these populations.

In 2021, the federal government’s National Plan to Address Alzheimer’s Disease was updated to include a new goal to reduce risk factors for ADRD.

“Given the prevalence of modifiable risk factors for ADRD and anticipated growth of the older adult population and those with ADRD, this new goal has the potential to benefit a large proportion of U.S. adults,” the investigators wrote.

“In addition to helping patients discuss concerns about memory loss, health care professionals should also screen patients for modifiable risk factors, counsel patients with risk factors, and refer them to effective programs and interventions where recommended,” they advised.

A recent report from the Lancet Commission on Dementia Prevention, Intervention, and Care found that modifying 12 risk factors over the life course could delay or prevent 40% of dementia cases.

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

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