Women's Health

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

A number of clinical trials in gynecologic cancers have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Uterine precancer (endometrial intraepithelial neoplasia). A phase 2 study sponsored by the National Cancer Institute is seeking adults with endometrial intraepithelial neoplasia (also called complex atypical hyperplasia or atypical hyperplasia) who are scheduled for hysterectomy within 3 months. Researchers are using the window of opportunity before an already-scheduled hysterectomy to see whether adding metformin to megestrol acetate, a treatment standard for nonsurgical patients, increases the effectiveness of megestrol in slowing this type of neoplasia. Participants will receive twice-daily oral medication for 4 weeks then undergo hysterectomy. The trial aims to enroll 50 participants. It began recruiting on Sept. 21 at its Northwestern University site in Evanston, Ill.; sites in California, Colorado, and North Carolina are also planned. The primary outcome is the change in endometrial cell proliferation. Overall survival (OS) and quality of life (QoL) will not be measured. .

Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, who is not involved in this trial, was approached for comment. “This is an interesting study concept, and patients with endometrial atypical hyperplasia may certainly wish to consider participation,” Dr. Markman said. He noted the “limited sample size” of the study.

Advanced, recurrent or refractory ovarian, fallopian, and endometrial cancers overexpressing folate receptor (FR)–alpha. Patients with these types of cancers are eligible for a phase 1/2 study of a new-concept targeted therapy called ELU-001. The molecular structure of ELU001 – called a C’Dot drug conjugate – consists of a drug “payload” riding with an FR-alpha–targeting molecule. For the first 28 days of the study, patients will receive escalating intravenous doses of ELU001 to determine the highest tolerated dose of the drug. All participants will then receive the selected dose for up to 12 months until lesions disappear (complete response) or there is a 30% decrease in the sum of the tumors’ longest diameter (partial response). This “basket” study – a trial involving a “basket” of different cancers with one genetic target – is hosted by New Experimental Therapeutics of San Antonio, which started recruitment for 166 patients on Sept. 13. Neither OS nor QoL will be tracked. .

Dr. Markman commented: “There is considerable interest in examining antineoplastic agents directed to tumor antigens overexpressed in ovarian cancer.”

Locally recurrent, unresectable, or metastatic cervical or endometrial cancer positive for PD-L1. Adults with these types of cancers are invited to join another basket trial, this time testing MK-7684A, a new coformulation of pembrolizumab (Keytruda) and the investigational drug vibostolimab. Most participants will receive intravenous infusions of either MK-7684A, MK-7684A plus chemotherapy, or pembrolizumab alone every 3 weeks for up to 3 years. One group will be given MK-7684A every 3 weeks plus paclitaxel weekly. People with endometrial cancer will also take a daily capsule of lenvatinib (Lenvima). The primary outcomes are response rate and progression-free survival; OS and QoL are secondary outcomes. The study opened on Sept. 16 and hopes to recruit 480 participants in eight countries with several different cancers, including cervical and endometrial cancers. U.S. patients can join at the City of Hope National Medical Center, Duarte, Calif. .

Persistent or recurrent rare epithelial tumors of the ovary, fallopian tube, or peritoneum. Adults with these cancers are sought for a phase 2 trial comparing four targeted-therapy regimens. Participants will receive either ipatasertib plus paclitaxel (Taxol); cobimetinib (Cotellic); trastuzumab emtansine (Kadcyla); or atezolizumab (Tecentriq) plus bevacizumab (Avastin) for up to 5 years until disease progression or unacceptable toxicity. Ipatasertib and cobimetinib are oral medications; all the others are administered intravenously on schedules that vary from once every 3 weeks (atezolizumab, trastuzumab) to weekly infusions 3 weeks out of 4 (paclitaxel). The study opened on Oct. 7 and hopes to enroll 200 participants at sites in Arizona, California, Minnesota, Missouri, Texas, Virginia, and worldwide. OS will be tracked, QoL will not. 

Dr. Markman commented: “This is an interesting early study of the potential efficacy of a novel AKT inhibitor [ipatasertib] in rare gynecologic cancers.”

Platinum-resistant or refractory high-grade serous ovarian cancer. Adult women whose high-grade serous ovarian cancer is platinum resistant or refractory and who do not have germline BRCA mutations are sought for a phase 3 study comparing alpelisib (Piqray) plus olaparib (Lynparza) to investigator’s choice of chemotherapy. Alpelisib is approved for breast cancer in combination with fulvestrant; olaparib is approved for advanced ovarian cancer in platinum-responsive patients and/or those with BRCA- or HRD-positive tumors, so this study could lead to labeling changes for these drugs. Participants will either take daily oral doses of alpelisib plus olaparib or receive intravenous chemo on the appropriate schedules for approximately 2 years. Progression-free survival is the primary outcome measure; OS and QoL are secondary outcomes. The trial opened on July 2 and hopes to recruit 358 individuals in Singapore, Australia, Europe, and the United States (Arizona, Illinois, and Texas). .

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).

Dr. Markman is not involved with any of these trials. He is a regular contributor to Medscape Oncology. He has received income in an amount equal to or greater than $250 from Genentech, AstraZeneca Celgene, Clovis, Amgen.

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

A number of clinical trials in gynecologic cancers have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Uterine precancer (endometrial intraepithelial neoplasia). A phase 2 study sponsored by the National Cancer Institute is seeking adults with endometrial intraepithelial neoplasia (also called complex atypical hyperplasia or atypical hyperplasia) who are scheduled for hysterectomy within 3 months. Researchers are using the window of opportunity before an already-scheduled hysterectomy to see whether adding metformin to megestrol acetate, a treatment standard for nonsurgical patients, increases the effectiveness of megestrol in slowing this type of neoplasia. Participants will receive twice-daily oral medication for 4 weeks then undergo hysterectomy. The trial aims to enroll 50 participants. It began recruiting on Sept. 21 at its Northwestern University site in Evanston, Ill.; sites in California, Colorado, and North Carolina are also planned. The primary outcome is the change in endometrial cell proliferation. Overall survival (OS) and quality of life (QoL) will not be measured. .

Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, who is not involved in this trial, was approached for comment. “This is an interesting study concept, and patients with endometrial atypical hyperplasia may certainly wish to consider participation,” Dr. Markman said. He noted the “limited sample size” of the study.

Advanced, recurrent or refractory ovarian, fallopian, and endometrial cancers overexpressing folate receptor (FR)–alpha. Patients with these types of cancers are eligible for a phase 1/2 study of a new-concept targeted therapy called ELU-001. The molecular structure of ELU001 – called a C’Dot drug conjugate – consists of a drug “payload” riding with an FR-alpha–targeting molecule. For the first 28 days of the study, patients will receive escalating intravenous doses of ELU001 to determine the highest tolerated dose of the drug. All participants will then receive the selected dose for up to 12 months until lesions disappear (complete response) or there is a 30% decrease in the sum of the tumors’ longest diameter (partial response). This “basket” study – a trial involving a “basket” of different cancers with one genetic target – is hosted by New Experimental Therapeutics of San Antonio, which started recruitment for 166 patients on Sept. 13. Neither OS nor QoL will be tracked. .

Dr. Markman commented: “There is considerable interest in examining antineoplastic agents directed to tumor antigens overexpressed in ovarian cancer.”

Locally recurrent, unresectable, or metastatic cervical or endometrial cancer positive for PD-L1. Adults with these types of cancers are invited to join another basket trial, this time testing MK-7684A, a new coformulation of pembrolizumab (Keytruda) and the investigational drug vibostolimab. Most participants will receive intravenous infusions of either MK-7684A, MK-7684A plus chemotherapy, or pembrolizumab alone every 3 weeks for up to 3 years. One group will be given MK-7684A every 3 weeks plus paclitaxel weekly. People with endometrial cancer will also take a daily capsule of lenvatinib (Lenvima). The primary outcomes are response rate and progression-free survival; OS and QoL are secondary outcomes. The study opened on Sept. 16 and hopes to recruit 480 participants in eight countries with several different cancers, including cervical and endometrial cancers. U.S. patients can join at the City of Hope National Medical Center, Duarte, Calif. .

Persistent or recurrent rare epithelial tumors of the ovary, fallopian tube, or peritoneum. Adults with these cancers are sought for a phase 2 trial comparing four targeted-therapy regimens. Participants will receive either ipatasertib plus paclitaxel (Taxol); cobimetinib (Cotellic); trastuzumab emtansine (Kadcyla); or atezolizumab (Tecentriq) plus bevacizumab (Avastin) for up to 5 years until disease progression or unacceptable toxicity. Ipatasertib and cobimetinib are oral medications; all the others are administered intravenously on schedules that vary from once every 3 weeks (atezolizumab, trastuzumab) to weekly infusions 3 weeks out of 4 (paclitaxel). The study opened on Oct. 7 and hopes to enroll 200 participants at sites in Arizona, California, Minnesota, Missouri, Texas, Virginia, and worldwide. OS will be tracked, QoL will not. 

Dr. Markman commented: “This is an interesting early study of the potential efficacy of a novel AKT inhibitor [ipatasertib] in rare gynecologic cancers.”

Platinum-resistant or refractory high-grade serous ovarian cancer. Adult women whose high-grade serous ovarian cancer is platinum resistant or refractory and who do not have germline BRCA mutations are sought for a phase 3 study comparing alpelisib (Piqray) plus olaparib (Lynparza) to investigator’s choice of chemotherapy. Alpelisib is approved for breast cancer in combination with fulvestrant; olaparib is approved for advanced ovarian cancer in platinum-responsive patients and/or those with BRCA- or HRD-positive tumors, so this study could lead to labeling changes for these drugs. Participants will either take daily oral doses of alpelisib plus olaparib or receive intravenous chemo on the appropriate schedules for approximately 2 years. Progression-free survival is the primary outcome measure; OS and QoL are secondary outcomes. The trial opened on July 2 and hopes to recruit 358 individuals in Singapore, Australia, Europe, and the United States (Arizona, Illinois, and Texas). .

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).

Dr. Markman is not involved with any of these trials. He is a regular contributor to Medscape Oncology. He has received income in an amount equal to or greater than $250 from Genentech, AstraZeneca Celgene, Clovis, Amgen.

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

A number of clinical trials in gynecologic cancers have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Uterine precancer (endometrial intraepithelial neoplasia). A phase 2 study sponsored by the National Cancer Institute is seeking adults with endometrial intraepithelial neoplasia (also called complex atypical hyperplasia or atypical hyperplasia) who are scheduled for hysterectomy within 3 months. Researchers are using the window of opportunity before an already-scheduled hysterectomy to see whether adding metformin to megestrol acetate, a treatment standard for nonsurgical patients, increases the effectiveness of megestrol in slowing this type of neoplasia. Participants will receive twice-daily oral medication for 4 weeks then undergo hysterectomy. The trial aims to enroll 50 participants. It began recruiting on Sept. 21 at its Northwestern University site in Evanston, Ill.; sites in California, Colorado, and North Carolina are also planned. The primary outcome is the change in endometrial cell proliferation. Overall survival (OS) and quality of life (QoL) will not be measured. .

Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, who is not involved in this trial, was approached for comment. “This is an interesting study concept, and patients with endometrial atypical hyperplasia may certainly wish to consider participation,” Dr. Markman said. He noted the “limited sample size” of the study.

Advanced, recurrent or refractory ovarian, fallopian, and endometrial cancers overexpressing folate receptor (FR)–alpha. Patients with these types of cancers are eligible for a phase 1/2 study of a new-concept targeted therapy called ELU-001. The molecular structure of ELU001 – called a C’Dot drug conjugate – consists of a drug “payload” riding with an FR-alpha–targeting molecule. For the first 28 days of the study, patients will receive escalating intravenous doses of ELU001 to determine the highest tolerated dose of the drug. All participants will then receive the selected dose for up to 12 months until lesions disappear (complete response) or there is a 30% decrease in the sum of the tumors’ longest diameter (partial response). This “basket” study – a trial involving a “basket” of different cancers with one genetic target – is hosted by New Experimental Therapeutics of San Antonio, which started recruitment for 166 patients on Sept. 13. Neither OS nor QoL will be tracked. .

Dr. Markman commented: “There is considerable interest in examining antineoplastic agents directed to tumor antigens overexpressed in ovarian cancer.”

Locally recurrent, unresectable, or metastatic cervical or endometrial cancer positive for PD-L1. Adults with these types of cancers are invited to join another basket trial, this time testing MK-7684A, a new coformulation of pembrolizumab (Keytruda) and the investigational drug vibostolimab. Most participants will receive intravenous infusions of either MK-7684A, MK-7684A plus chemotherapy, or pembrolizumab alone every 3 weeks for up to 3 years. One group will be given MK-7684A every 3 weeks plus paclitaxel weekly. People with endometrial cancer will also take a daily capsule of lenvatinib (Lenvima). The primary outcomes are response rate and progression-free survival; OS and QoL are secondary outcomes. The study opened on Sept. 16 and hopes to recruit 480 participants in eight countries with several different cancers, including cervical and endometrial cancers. U.S. patients can join at the City of Hope National Medical Center, Duarte, Calif. .

Persistent or recurrent rare epithelial tumors of the ovary, fallopian tube, or peritoneum. Adults with these cancers are sought for a phase 2 trial comparing four targeted-therapy regimens. Participants will receive either ipatasertib plus paclitaxel (Taxol); cobimetinib (Cotellic); trastuzumab emtansine (Kadcyla); or atezolizumab (Tecentriq) plus bevacizumab (Avastin) for up to 5 years until disease progression or unacceptable toxicity. Ipatasertib and cobimetinib are oral medications; all the others are administered intravenously on schedules that vary from once every 3 weeks (atezolizumab, trastuzumab) to weekly infusions 3 weeks out of 4 (paclitaxel). The study opened on Oct. 7 and hopes to enroll 200 participants at sites in Arizona, California, Minnesota, Missouri, Texas, Virginia, and worldwide. OS will be tracked, QoL will not. 

Dr. Markman commented: “This is an interesting early study of the potential efficacy of a novel AKT inhibitor [ipatasertib] in rare gynecologic cancers.”

Platinum-resistant or refractory high-grade serous ovarian cancer. Adult women whose high-grade serous ovarian cancer is platinum resistant or refractory and who do not have germline BRCA mutations are sought for a phase 3 study comparing alpelisib (Piqray) plus olaparib (Lynparza) to investigator’s choice of chemotherapy. Alpelisib is approved for breast cancer in combination with fulvestrant; olaparib is approved for advanced ovarian cancer in platinum-responsive patients and/or those with BRCA- or HRD-positive tumors, so this study could lead to labeling changes for these drugs. Participants will either take daily oral doses of alpelisib plus olaparib or receive intravenous chemo on the appropriate schedules for approximately 2 years. Progression-free survival is the primary outcome measure; OS and QoL are secondary outcomes. The trial opened on July 2 and hopes to recruit 358 individuals in Singapore, Australia, Europe, and the United States (Arizona, Illinois, and Texas). .

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).

Dr. Markman is not involved with any of these trials. He is a regular contributor to Medscape Oncology. He has received income in an amount equal to or greater than $250 from Genentech, AstraZeneca Celgene, Clovis, Amgen.

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

From Illawarra Shoalhaven Local Health District, New South Wales, Australia (Maren Jones, Dr. Hewitt, Philippa King, Rhiannon Thorn, Edward Davidson, and Tiana-Lee Elphick), and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia (Dr. Hewitt)

Objective: To assess the association between change scores in the Functional Independence Measure (FIM) with evaluative measures used in physiotherapy to objectively show that use of the FIM in isolation is limited.

Design: Retrospective observational study.

Setting: Five rehabilitation inpatient wards from 1 public local health district in NSW Australia.

Participants: Patient data over a 5-year time frame (2015 to 2019) were reviewed (N = 2378). The patient data from the 3 most prevalent impairment groups (Australasian Rehabilitation Outcome Centre classification) were identified for inclusion in this study: Reconditioning (n = 742, mean age 76.88 years); Orthopedic Fracture (n = 585, mean age 77.46 years); and Orthopedic Replacement (n = 377, mean age 73.84 years).

Measurements: The difference between the admission and discharge scores were calculated for each measure. Kruskal-Wallis and χ² tests were used to analyze the data.

Results: Pearson correlation (r) coefficients between FIM Motor change to the de Morton’s Mobility Index (DEMMI) change was r = 0.396, FIM Motor change to the Timed Up and Go (TUG) change was r = -0.217, and the FIM Motor change to the Ten Meter Walk Test (10MWT) change was .194.

Conclusion: The FIM Motor change scores showed a weak positive association to the DEMMI change and no association to the TUG and 10MWT change, demonstrating that the outcome measures do not measure the same attributes. To review rehabilitation effectiveness from a management perspective, it is recommended that all measures are reviewed to assess the burden of care, functional mobility, and dynamic balance.

Keywords: physiotherapy; rehabilitation; clinical outcome measures.

Patients receive interdisciplinary inpatient rehabilitation treatment after they have sustained a lower limb fracture, a lower limb joint replacement, or have generalized deconditioning (muscle wasting and disuse atrophy) following hospitalization for surgery or illness. The degree of a patient’s impairment or loss of functional capacity, as well as their ability to manage at home safely, is assessed using standardized outcome measures during their recovery and rehabilitation.^1,2

Physiotherapists routinely use validated outcome measures to assess patient progress and to measure goal attainment through assessment of functional independence, dynamic balance performance, and ambulatory ability. These objective assessments provide clinicians with information about the effectiveness of the rehabilitation program, as well as the patient’s ability to manage in their home environment, to determine the need for assistive devices, level of caregiver support, future level of autonomy, and strategies for falls prevention.^3-7

There is a view among service providers that rehabilitation decisions can be based on a singular measure of function known as the Functional Independence Measure (FIM). This is an understandable position because not only is the FIM an internationally recognized, valid, and reliable tool, but, as a singular measure, it also means measurement consistency across rehabilitation sites is more likely. However, rehabilitation is complex, and it is risky to base decisions on a single measure, which might not capture the results of rehabilitation treatment ingredients on individual patient targets.^8,9

The patient’s progress is objectively assessed using functional outcome measures such as the FIM. Other measures used typically in our service include the de Morton’s Mobility Index (DEMMI), Timed Up and Go (TUG), and the Ten Meter Walk Test (10MWT), which measure patient mobility, balance during directional changes, and walking ability, respectively. Additional measures include patient progression to a less supportive level of assistance (ie, number of persons required to assist or level of supervision) or the selection of a walking aid (eg, forearm support frame, crutches). This progression—or lack thereof—assists in decision-making regarding the individual’s future once they are discharged from rehabilitation. Such considerations would include the need to modify the home environment, selection of assistive devices, community access (walking indoors, outdoors, and shopping), personal care needs, and age-appropriate care facility recommendations (ie, level of care). The use of outcome measures also indicates the need for further referrals to other care providers upon discharge from the rehabilitation facility.

There is widespread support in the literature for the use of the FIM, DEMMI, TUG, and 10MWT in rehabilitation population groups. For example, DEMMI has been validated in hip fracture patients during rehabilitation,¹⁰ as well as among older people hospitalized for medical illness.^11-13 It has also been shown to be a predictor of discharge destination for patients living with frailty in geriatric rehabilitation settings,¹⁴ and to have moderate predictive validity for functional independence after 4 weeks of rehabilitation.¹⁵ Similarly, TUG has been validated for use among hospitalized and community-dwelling individuals,^16-18 and for patients after joint arthroplasty^19,20 or hip fracture.²¹ It has also been shown to be an indicator of fall risk,^22-24 as well as a predictor of fracture incidence.²⁵ Furthermore, TUG has been identified as an indicator of a patient’s ability to walk in the community without the need for a walking device.²⁶ It has also been shown to be an early identifier of patients in need of rehabilitation.²⁷ Normative values for TUG have been reported, and the association with gait time established.²⁸

Gait speed has been shown to predict adverse outcomes in community-dwelling older people.²⁹ In fact, the 10MWT has been established as a powerful tool to benchmark rehabilitation recovery after a medical event.³⁰ Results of the test relate to overall quality of walking, health status, morbidity, and the rate of mortality.^31-33 Meaningful improvement, minimum detectable change (0.19-0.34 m/s), and responsiveness in common physical performance in older adults has been reported.^26,34,36

Structural and functional impairment has been used to define rehabilitation classes by the Australasian Rehabilitation Outcome Centre (AROC) in the Australian National Sub-Acute and Non-Acute Patient Classification (AN-SNAP) Version 4.^37-43 Variables used for grouping are age, care type, function, and impairment for rehabilitation. FIM was developed in order to assess patients’ outcomes after inpatient multidisciplinary care, and is an internationally accepted measure of functioning.⁴⁴ It is a holistic outcome measure, which can be used to determine the patient’s level of disability and burden of care, and is widely used in both public and private inpatient rehabilitation settings. Each patient classification is reported separately within the case mix structure.⁴⁵ Inpatient rehabilitation centers are evaluated and compared by the AROC,⁴⁶ with an emphasis on length of stay and the FIM change. The most successful centers demonstrate shorter length of stay and greater FIM improvement. Although the FIM is a valuable measure, it does not provide a complete picture of the individual patient’s rehabilitation gain: ie, the specific attributes of patients’ mobility, walking ability, or balance during directional changes.

A large-scale analysis of the association between the holistic disability measure of the FIM and the more mobility- and ambulation-focused physiotherapy outcomes has not been documented.

The well-documented DEMMI accumulates points for the patient’s mobility in a similar fashion to the FIM, but with more mobility detail. These 2 outcome measures allow for the full range of patients, from the very dependent up to and including the independently ambulant patients. The DEMMI may show a positive relationship to the FIM, yet the association is unknown. The association of the TUG to the 10MWT has been established²⁸; however, their relationship to the FIM is unknown.

Current practice in the participating public health inpatient rehabilitation wards is to use the DEMMI, TUG, 10MWT, and FIM to ensure physiotherapy and allow the wider multidisciplinary team to more effectively evaluate patient mobility outcomes. The 3 most frequent patient groups identified within the current patient population are expected to present clinical differences and will be analyzed for comparison. If an association is found between the outcome measures in question, clinical efficiency could be improved.

The aim of the current study is to assess the association between change scores in the FIM with evaluative measures of outcomes typically used in physiotherapy to objectively show that use of the FIM in isolation is limited in our population of patients.

Methods

Study design and setting

This retrospective descriptive observational study complied with the STROBE-RECORD guidance and checklist (available at mdedge.com/jcomjournal) and analyzed the routinely collected data from rehabilitation patients who were admitted to 5 different rehabilitation wards in 4 different public hospitals from 1 regional local health district (20-24 beds per ward) from 2015 to 2019. As this study conducted secondary analyses using existing de-identified data from a public health facility and did not involve interaction with any human subjects, ethical approval was not required.⁴⁶ Approval to conduct this study was granted by the health district’s institutional review committee, as per the National Statement on Ethical Conduct in Human Research 2015.

Participants

Patient data over a 5-year time frame were reviewed (N = 2378). The patient data from the 3 most prevalent impairment groups were identified for inclusion in this study: reconditioning, orthopedic fracture, and orthopedic replacement. (See Table 1 for the specific AN-SNAP impairment groups used in this study.)

Patient data from the less-frequent impairment groups were excluded (n = 673, 28.19%), including stroke (n = 343), brain dysfunction (n = 45), amputation of limb (n = 45), spinal cord dysfunction (n  = 36), neurological dysfunction (n = 34), cardiac (n = 24), and others (n = 25) who may have benefitted from other outcome measures due to their medical condition. Ten patient data sets were excluded for missing discharge outcome measure data, from when the patient became ill and returned to acute services or was discharged at short notice. To be included in the study, both the admission and discharge scores from the FIM and the admission and discharge scores from at least 1 of the physiotherapy outcome measures were required for each patient (n = 1704, 71.39%): Reconditioning (n = 742), Orthopedic Fracture (n = 585), and Orthopedic Replacement (n = 377). Information regarding the type of walking aid and the amount of assistance required for safe ambulation was also recorded. These items were included in the study’s descriptive analysis. Only 1.7% of these descriptors were missing.

Outcome measures

DEMMI tasks of bed mobility, sitting balance, transfers, walking, and balance were scored with an assigned value according to the patient’s performance. This was then tallied and the results scaled, to provide an overall score out of 100 available points. The total score from admission and discharge was then compared. Improvement (change) was identified by the increase in scores.

The TUG assesses a patient’s dynamic balance performance.⁴⁷ The number of seconds it took the patient to complete the procedure was recorded at admission and discharge. Improvement (change) was identified by the reduction in time taken at discharge from the admission score.

The 10MWT measures the unidirectional walking speed of a person over 10 meters and is recorded in seconds and reported in meters per second. Improvement (change) was identified by the reduction in the time taken to increase walking speed.

Concurrent to the physiotherapy measures were the FIM scores, recorded by the accredited nursing staff from each rehabilitation ward. Improvement is demonstrated by the accumulation of points on the ordinal scale of the FIM Total, including mobility, dressing, bladder and bowel care, cognition, and social interaction, and is represented as a score between 18 and 126. The FIM Motor category is reported as a score between 13 and 91.

The 2 data sets were matched by unique identifier and admission dates, then de-identified for analysis.

Statistical analysis

Patient demographic information was analyzed using descriptive statistics (mean, SD, frequencies, percentages) for each impairment group (orthopedic fracture, orthopedic replacement, reconditioning). Differences in continuous demographic variables for each impairment group were assessed using Kruskal-Wallis tests and χ² tests for categorical variables. Functional outcome scores were compared at admission, discharge, and change between the impairment groups. Association of the functional outcome change scores was determined with the Pearson correlation coefficient (r) between the FIM and the DEMMI, TUG, and 10MWT. Graphs were plotted for each of these (Figure available online at mdedge.com/jcomjournal). A strong, moderate, and weak association was described as > 0.6, > 0.4, and > 0.2, respectively.⁴⁶ Statistical significance was set at P < .05. Analyses were conducted using Stata (StataCorp LLC, USA).

Results

The patient descriptive data (site from which data were collected, admission length of stay, age at admission, discharge destination, walk aid improvement, and walk assistance improvement) from the 3 impairment groups are reported in Table 2. The functional outcomes for DEMMI, TUG, 10MWT, FIM Motor, FIM Total at admission, discharge, and the change scores are presented in Table 3.

Orthopedic fracture patients had the greatest improvement in their functional outcomes, with a DEMMI improvement of 18 points, TUG score change of 23.49 seconds (s), 10MWT change of 0.30 meters/second (m/s), FIM Motor change of 20.62, and a FIM Total change of 21.9 points. The outcome measures exceeded the minimum detectable change as reported in the literature for DEMMI (8.8 points⁴⁸), TUG (2.08 s²⁶), walking speed 0.19 m/s²⁶, and FIM Motor (14.6 points⁴⁹).

Association of functional outcomes (change scores)

There was a significant weak positive correlation between DEMMI change score and both the FIM Motor (r = 0.396) and FIM Total change scores (r = 0.373). When viewing the specific items within the FIM Motor labelled FIM Walk change, FIM MobilityBedChair change, and FIM stairs change, r values were 0.100, 0.379, and 0.126, respectively. In addition, there was a weak negative correlation between TUG change scores and both FIM Motor (r = -0.217) and FIM Total change scores (r = -0.207). There was a very weak positive correlation between 10MWT (m/s) change scores and both FIM Motor (r = 0.194) and FIM Total change scores (r = 0.187) (Table 4, Figure). There was a moderate correlation between 10MWT change (s) and TUG change (s) (r = 0.72, P < .001).

Discussion

The purpose of this study was to ascertain the association between the DEMMI, TUG, 10MWT, and FIM measures using retrospective data collected from 5 public hospital inpatient rehabilitation wards. The results of this retrospective analysis demonstrate that a variety of objective outcome measures are required for the multidisciplinary team to accurately measure a patient’s functional improvement during their inpatient rehabilitation stay. No single outcome measure in this study fully reported all mobility attributes, and we note the risk of basing decisions on a single measure evaluating rehabilitation outcomes. Although the internationally used FIM has a strong place in rehabilitation reporting and benchmarking, it does not predict change nor provide a proxy for the patient’s whole-body motor control as they extend their mobility, dynamic balance, and ambulatory ability. Multiple objective outcome measures should therefore be required to evaluate the patient’s progress and functional performance toward discharge planning.

The FIM is a measure of disability or care needs, incorporating cognitive, social, and physical components of disability. It is a valid, holistic measure of an individual’s functional ability at a given time. Rehabilitation sites internationally utilize this assessment tool to evaluate a patient’s progress and the efficacy of intervention. The strength of this measure is its widespread use and the inclusion of the personal activities of daily living to provide an overall evaluation encompassing all aspects of a person’s ability to function independently. However, as our study results suggest, patient improvement measured by the FIM Motor components were not correlated to other widely used physiotherapy measures of ambulation and balance, such as the 10MWT or TUG. This is perhaps largely because the FIM Motor components only consider the level of assistance (eg, physical assistance, assistive device, independence) and do not consider assessment of balance and gait ability as assessed in the 10MWT and TUG. The 10MWT and TUG provide assessment of velocity and dynamic balance during walking, which have been shown to predict an individual’s risk of falling.^22,23 This is a pertinent issue in the rehabilitation and geriatric population.²⁹ Furthermore, the use of the FIM as a benchmarking tool to compare facility efficiency may not provide a complete assessment of all outcomes achieved on the inpatient rehabilitation ward, such as reduced falls risk or improved ambulatory ability and balance.

It has previously been confirmed that there is a significant positive correlation between the 10MWT and the TUG.²⁷ This retrospective analysis has also supported these findings. This is possibly due to the similarity in the assessments, as they both incorporate ambulation ability and dynamic movement.

Each of the 4 outcome measures assess different yet vital aspects of an individual’s functional mobility and ambulation ability during their subacute rehabilitation journey. The diversity of patient age, functional impairment, and mobility level needs a range of outcomes to provide baselines, targets, and goal attainment for discharge home.

Consistent with the AROC AN-SNAP reporting of Length of Stay and FIM change separated into the weighted impairment groups, the data analysis of this study demonstrated significant differences between the Reconditioning, Orthopedic Fracture, and Orthopedic Replacement patient data. Tables 2 and 3 describe the differences between the groups. The fracture population in this study improved the most across each outcome measure. In contrast, the reconditioning population showed the least improvement. This may be expected due to the pathophysiological differences between the groups. Furthermore, for the elderly who sustain fractures because of a fall, rehabilitation will be required to address not only the presenting injury but also the premorbid falls risk factors which may include polypharmacy or impaired balance.

Any conclusions drawn from the findings of this study need to take into consideration that it has focused on patients from 1 local health district and therefore may not be generalizable to a wider national or international context. As this study was a retrospective study, controlling for data collection quality, measurement bias due to nonblinding and missing data is a limitation. However, clinicians regularly completed these outcome assessments and recorded this information as part of their standard care practices within this health district. There may have been slight differences in definitions of practice between the 5 rehabilitation sites. To ensure reliability, each individual site’s protocols for the FIM, DEMMI, TUG, and 10MWT were reviewed and confirmed to be consistent.

Conclusion

The FIM Motor change scores showed a weak positive association to the DEMMI change, and no association to the TUG and 10MWT change, demonstrating that the outcome measures do not measure the same attributes. Thorough reporting of clinical outcomes is much more meaningful to assess and guide the physiotherapy component of rehabilitation. To review rehabilitation effectiveness from a management perspective, it is recommended that all measures are reviewed to assess the burden of care, mobility, functional capacity, and dynamic balance.

Acknowledgements: The authors thank Anne Smith, MSHLM, BAppSc, Head of the Physiotherapy Department, and the physiotherapists and allied health assistants who have contributed to the collection of this valuable data over several years. They also thank Lina Baytieh, MS, BS, from Research Central, Illawarra Shoalhaven Local Health District, for her assistance with the analysis.

Corresponding author: Maren Jones, MPH, BS, Physiotherapy Department, Port Kembla Hospital, Illawarra Shoalhaven Local Health District, Warrawong, New South Wales, 2505 Australia; [email protected].

Financial disclosures: None.

From Illawarra Shoalhaven Local Health District, New South Wales, Australia (Maren Jones, Dr. Hewitt, Philippa King, Rhiannon Thorn, Edward Davidson, and Tiana-Lee Elphick), and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia (Dr. Hewitt)

Objective: To assess the association between change scores in the Functional Independence Measure (FIM) with evaluative measures used in physiotherapy to objectively show that use of the FIM in isolation is limited.

Design: Retrospective observational study.

Setting: Five rehabilitation inpatient wards from 1 public local health district in NSW Australia.

Participants: Patient data over a 5-year time frame (2015 to 2019) were reviewed (N = 2378). The patient data from the 3 most prevalent impairment groups (Australasian Rehabilitation Outcome Centre classification) were identified for inclusion in this study: Reconditioning (n = 742, mean age 76.88 years); Orthopedic Fracture (n = 585, mean age 77.46 years); and Orthopedic Replacement (n = 377, mean age 73.84 years).

Measurements: The difference between the admission and discharge scores were calculated for each measure. Kruskal-Wallis and χ² tests were used to analyze the data.

Results: Pearson correlation (r) coefficients between FIM Motor change to the de Morton’s Mobility Index (DEMMI) change was r = 0.396, FIM Motor change to the Timed Up and Go (TUG) change was r = -0.217, and the FIM Motor change to the Ten Meter Walk Test (10MWT) change was .194.

Conclusion: The FIM Motor change scores showed a weak positive association to the DEMMI change and no association to the TUG and 10MWT change, demonstrating that the outcome measures do not measure the same attributes. To review rehabilitation effectiveness from a management perspective, it is recommended that all measures are reviewed to assess the burden of care, functional mobility, and dynamic balance.

Keywords: physiotherapy; rehabilitation; clinical outcome measures.

Patients receive interdisciplinary inpatient rehabilitation treatment after they have sustained a lower limb fracture, a lower limb joint replacement, or have generalized deconditioning (muscle wasting and disuse atrophy) following hospitalization for surgery or illness. The degree of a patient’s impairment or loss of functional capacity, as well as their ability to manage at home safely, is assessed using standardized outcome measures during their recovery and rehabilitation.^1,2

Physiotherapists routinely use validated outcome measures to assess patient progress and to measure goal attainment through assessment of functional independence, dynamic balance performance, and ambulatory ability. These objective assessments provide clinicians with information about the effectiveness of the rehabilitation program, as well as the patient’s ability to manage in their home environment, to determine the need for assistive devices, level of caregiver support, future level of autonomy, and strategies for falls prevention.^3-7

There is a view among service providers that rehabilitation decisions can be based on a singular measure of function known as the Functional Independence Measure (FIM). This is an understandable position because not only is the FIM an internationally recognized, valid, and reliable tool, but, as a singular measure, it also means measurement consistency across rehabilitation sites is more likely. However, rehabilitation is complex, and it is risky to base decisions on a single measure, which might not capture the results of rehabilitation treatment ingredients on individual patient targets.^8,9

The patient’s progress is objectively assessed using functional outcome measures such as the FIM. Other measures used typically in our service include the de Morton’s Mobility Index (DEMMI), Timed Up and Go (TUG), and the Ten Meter Walk Test (10MWT), which measure patient mobility, balance during directional changes, and walking ability, respectively. Additional measures include patient progression to a less supportive level of assistance (ie, number of persons required to assist or level of supervision) or the selection of a walking aid (eg, forearm support frame, crutches). This progression—or lack thereof—assists in decision-making regarding the individual’s future once they are discharged from rehabilitation. Such considerations would include the need to modify the home environment, selection of assistive devices, community access (walking indoors, outdoors, and shopping), personal care needs, and age-appropriate care facility recommendations (ie, level of care). The use of outcome measures also indicates the need for further referrals to other care providers upon discharge from the rehabilitation facility.

There is widespread support in the literature for the use of the FIM, DEMMI, TUG, and 10MWT in rehabilitation population groups. For example, DEMMI has been validated in hip fracture patients during rehabilitation,¹⁰ as well as among older people hospitalized for medical illness.^11-13 It has also been shown to be a predictor of discharge destination for patients living with frailty in geriatric rehabilitation settings,¹⁴ and to have moderate predictive validity for functional independence after 4 weeks of rehabilitation.¹⁵ Similarly, TUG has been validated for use among hospitalized and community-dwelling individuals,^16-18 and for patients after joint arthroplasty^19,20 or hip fracture.²¹ It has also been shown to be an indicator of fall risk,^22-24 as well as a predictor of fracture incidence.²⁵ Furthermore, TUG has been identified as an indicator of a patient’s ability to walk in the community without the need for a walking device.²⁶ It has also been shown to be an early identifier of patients in need of rehabilitation.²⁷ Normative values for TUG have been reported, and the association with gait time established.²⁸

Gait speed has been shown to predict adverse outcomes in community-dwelling older people.²⁹ In fact, the 10MWT has been established as a powerful tool to benchmark rehabilitation recovery after a medical event.³⁰ Results of the test relate to overall quality of walking, health status, morbidity, and the rate of mortality.^31-33 Meaningful improvement, minimum detectable change (0.19-0.34 m/s), and responsiveness in common physical performance in older adults has been reported.^26,34,36

Structural and functional impairment has been used to define rehabilitation classes by the Australasian Rehabilitation Outcome Centre (AROC) in the Australian National Sub-Acute and Non-Acute Patient Classification (AN-SNAP) Version 4.^37-43 Variables used for grouping are age, care type, function, and impairment for rehabilitation. FIM was developed in order to assess patients’ outcomes after inpatient multidisciplinary care, and is an internationally accepted measure of functioning.⁴⁴ It is a holistic outcome measure, which can be used to determine the patient’s level of disability and burden of care, and is widely used in both public and private inpatient rehabilitation settings. Each patient classification is reported separately within the case mix structure.⁴⁵ Inpatient rehabilitation centers are evaluated and compared by the AROC,⁴⁶ with an emphasis on length of stay and the FIM change. The most successful centers demonstrate shorter length of stay and greater FIM improvement. Although the FIM is a valuable measure, it does not provide a complete picture of the individual patient’s rehabilitation gain: ie, the specific attributes of patients’ mobility, walking ability, or balance during directional changes.

A large-scale analysis of the association between the holistic disability measure of the FIM and the more mobility- and ambulation-focused physiotherapy outcomes has not been documented.

The well-documented DEMMI accumulates points for the patient’s mobility in a similar fashion to the FIM, but with more mobility detail. These 2 outcome measures allow for the full range of patients, from the very dependent up to and including the independently ambulant patients. The DEMMI may show a positive relationship to the FIM, yet the association is unknown. The association of the TUG to the 10MWT has been established²⁸; however, their relationship to the FIM is unknown.

Current practice in the participating public health inpatient rehabilitation wards is to use the DEMMI, TUG, 10MWT, and FIM to ensure physiotherapy and allow the wider multidisciplinary team to more effectively evaluate patient mobility outcomes. The 3 most frequent patient groups identified within the current patient population are expected to present clinical differences and will be analyzed for comparison. If an association is found between the outcome measures in question, clinical efficiency could be improved.

The aim of the current study is to assess the association between change scores in the FIM with evaluative measures of outcomes typically used in physiotherapy to objectively show that use of the FIM in isolation is limited in our population of patients.

Methods

Study design and setting

This retrospective descriptive observational study complied with the STROBE-RECORD guidance and checklist (available at mdedge.com/jcomjournal) and analyzed the routinely collected data from rehabilitation patients who were admitted to 5 different rehabilitation wards in 4 different public hospitals from 1 regional local health district (20-24 beds per ward) from 2015 to 2019. As this study conducted secondary analyses using existing de-identified data from a public health facility and did not involve interaction with any human subjects, ethical approval was not required.⁴⁶ Approval to conduct this study was granted by the health district’s institutional review committee, as per the National Statement on Ethical Conduct in Human Research 2015.

Participants

Patient data over a 5-year time frame were reviewed (N = 2378). The patient data from the 3 most prevalent impairment groups were identified for inclusion in this study: reconditioning, orthopedic fracture, and orthopedic replacement. (See Table 1 for the specific AN-SNAP impairment groups used in this study.)

Patient data from the less-frequent impairment groups were excluded (n = 673, 28.19%), including stroke (n = 343), brain dysfunction (n = 45), amputation of limb (n = 45), spinal cord dysfunction (n  = 36), neurological dysfunction (n = 34), cardiac (n = 24), and others (n = 25) who may have benefitted from other outcome measures due to their medical condition. Ten patient data sets were excluded for missing discharge outcome measure data, from when the patient became ill and returned to acute services or was discharged at short notice. To be included in the study, both the admission and discharge scores from the FIM and the admission and discharge scores from at least 1 of the physiotherapy outcome measures were required for each patient (n = 1704, 71.39%): Reconditioning (n = 742), Orthopedic Fracture (n = 585), and Orthopedic Replacement (n = 377). Information regarding the type of walking aid and the amount of assistance required for safe ambulation was also recorded. These items were included in the study’s descriptive analysis. Only 1.7% of these descriptors were missing.

Outcome measures

DEMMI tasks of bed mobility, sitting balance, transfers, walking, and balance were scored with an assigned value according to the patient’s performance. This was then tallied and the results scaled, to provide an overall score out of 100 available points. The total score from admission and discharge was then compared. Improvement (change) was identified by the increase in scores.

The TUG assesses a patient’s dynamic balance performance.⁴⁷ The number of seconds it took the patient to complete the procedure was recorded at admission and discharge. Improvement (change) was identified by the reduction in time taken at discharge from the admission score.

The 10MWT measures the unidirectional walking speed of a person over 10 meters and is recorded in seconds and reported in meters per second. Improvement (change) was identified by the reduction in the time taken to increase walking speed.

Concurrent to the physiotherapy measures were the FIM scores, recorded by the accredited nursing staff from each rehabilitation ward. Improvement is demonstrated by the accumulation of points on the ordinal scale of the FIM Total, including mobility, dressing, bladder and bowel care, cognition, and social interaction, and is represented as a score between 18 and 126. The FIM Motor category is reported as a score between 13 and 91.

The 2 data sets were matched by unique identifier and admission dates, then de-identified for analysis.

Statistical analysis

Patient demographic information was analyzed using descriptive statistics (mean, SD, frequencies, percentages) for each impairment group (orthopedic fracture, orthopedic replacement, reconditioning). Differences in continuous demographic variables for each impairment group were assessed using Kruskal-Wallis tests and χ² tests for categorical variables. Functional outcome scores were compared at admission, discharge, and change between the impairment groups. Association of the functional outcome change scores was determined with the Pearson correlation coefficient (r) between the FIM and the DEMMI, TUG, and 10MWT. Graphs were plotted for each of these (Figure available online at mdedge.com/jcomjournal). A strong, moderate, and weak association was described as > 0.6, > 0.4, and > 0.2, respectively.⁴⁶ Statistical significance was set at P < .05. Analyses were conducted using Stata (StataCorp LLC, USA).

Results

The patient descriptive data (site from which data were collected, admission length of stay, age at admission, discharge destination, walk aid improvement, and walk assistance improvement) from the 3 impairment groups are reported in Table 2. The functional outcomes for DEMMI, TUG, 10MWT, FIM Motor, FIM Total at admission, discharge, and the change scores are presented in Table 3.

Orthopedic fracture patients had the greatest improvement in their functional outcomes, with a DEMMI improvement of 18 points, TUG score change of 23.49 seconds (s), 10MWT change of 0.30 meters/second (m/s), FIM Motor change of 20.62, and a FIM Total change of 21.9 points. The outcome measures exceeded the minimum detectable change as reported in the literature for DEMMI (8.8 points⁴⁸), TUG (2.08 s²⁶), walking speed 0.19 m/s²⁶, and FIM Motor (14.6 points⁴⁹).

Association of functional outcomes (change scores)

There was a significant weak positive correlation between DEMMI change score and both the FIM Motor (r = 0.396) and FIM Total change scores (r = 0.373). When viewing the specific items within the FIM Motor labelled FIM Walk change, FIM MobilityBedChair change, and FIM stairs change, r values were 0.100, 0.379, and 0.126, respectively. In addition, there was a weak negative correlation between TUG change scores and both FIM Motor (r = -0.217) and FIM Total change scores (r = -0.207). There was a very weak positive correlation between 10MWT (m/s) change scores and both FIM Motor (r = 0.194) and FIM Total change scores (r = 0.187) (Table 4, Figure). There was a moderate correlation between 10MWT change (s) and TUG change (s) (r = 0.72, P < .001).

Discussion

The purpose of this study was to ascertain the association between the DEMMI, TUG, 10MWT, and FIM measures using retrospective data collected from 5 public hospital inpatient rehabilitation wards. The results of this retrospective analysis demonstrate that a variety of objective outcome measures are required for the multidisciplinary team to accurately measure a patient’s functional improvement during their inpatient rehabilitation stay. No single outcome measure in this study fully reported all mobility attributes, and we note the risk of basing decisions on a single measure evaluating rehabilitation outcomes. Although the internationally used FIM has a strong place in rehabilitation reporting and benchmarking, it does not predict change nor provide a proxy for the patient’s whole-body motor control as they extend their mobility, dynamic balance, and ambulatory ability. Multiple objective outcome measures should therefore be required to evaluate the patient’s progress and functional performance toward discharge planning.

The FIM is a measure of disability or care needs, incorporating cognitive, social, and physical components of disability. It is a valid, holistic measure of an individual’s functional ability at a given time. Rehabilitation sites internationally utilize this assessment tool to evaluate a patient’s progress and the efficacy of intervention. The strength of this measure is its widespread use and the inclusion of the personal activities of daily living to provide an overall evaluation encompassing all aspects of a person’s ability to function independently. However, as our study results suggest, patient improvement measured by the FIM Motor components were not correlated to other widely used physiotherapy measures of ambulation and balance, such as the 10MWT or TUG. This is perhaps largely because the FIM Motor components only consider the level of assistance (eg, physical assistance, assistive device, independence) and do not consider assessment of balance and gait ability as assessed in the 10MWT and TUG. The 10MWT and TUG provide assessment of velocity and dynamic balance during walking, which have been shown to predict an individual’s risk of falling.^22,23 This is a pertinent issue in the rehabilitation and geriatric population.²⁹ Furthermore, the use of the FIM as a benchmarking tool to compare facility efficiency may not provide a complete assessment of all outcomes achieved on the inpatient rehabilitation ward, such as reduced falls risk or improved ambulatory ability and balance.

It has previously been confirmed that there is a significant positive correlation between the 10MWT and the TUG.²⁷ This retrospective analysis has also supported these findings. This is possibly due to the similarity in the assessments, as they both incorporate ambulation ability and dynamic movement.

Each of the 4 outcome measures assess different yet vital aspects of an individual’s functional mobility and ambulation ability during their subacute rehabilitation journey. The diversity of patient age, functional impairment, and mobility level needs a range of outcomes to provide baselines, targets, and goal attainment for discharge home.

Consistent with the AROC AN-SNAP reporting of Length of Stay and FIM change separated into the weighted impairment groups, the data analysis of this study demonstrated significant differences between the Reconditioning, Orthopedic Fracture, and Orthopedic Replacement patient data. Tables 2 and 3 describe the differences between the groups. The fracture population in this study improved the most across each outcome measure. In contrast, the reconditioning population showed the least improvement. This may be expected due to the pathophysiological differences between the groups. Furthermore, for the elderly who sustain fractures because of a fall, rehabilitation will be required to address not only the presenting injury but also the premorbid falls risk factors which may include polypharmacy or impaired balance.

Any conclusions drawn from the findings of this study need to take into consideration that it has focused on patients from 1 local health district and therefore may not be generalizable to a wider national or international context. As this study was a retrospective study, controlling for data collection quality, measurement bias due to nonblinding and missing data is a limitation. However, clinicians regularly completed these outcome assessments and recorded this information as part of their standard care practices within this health district. There may have been slight differences in definitions of practice between the 5 rehabilitation sites. To ensure reliability, each individual site’s protocols for the FIM, DEMMI, TUG, and 10MWT were reviewed and confirmed to be consistent.

Conclusion

The FIM Motor change scores showed a weak positive association to the DEMMI change, and no association to the TUG and 10MWT change, demonstrating that the outcome measures do not measure the same attributes. Thorough reporting of clinical outcomes is much more meaningful to assess and guide the physiotherapy component of rehabilitation. To review rehabilitation effectiveness from a management perspective, it is recommended that all measures are reviewed to assess the burden of care, mobility, functional capacity, and dynamic balance.

Acknowledgements: The authors thank Anne Smith, MSHLM, BAppSc, Head of the Physiotherapy Department, and the physiotherapists and allied health assistants who have contributed to the collection of this valuable data over several years. They also thank Lina Baytieh, MS, BS, from Research Central, Illawarra Shoalhaven Local Health District, for her assistance with the analysis.

Corresponding author: Maren Jones, MPH, BS, Physiotherapy Department, Port Kembla Hospital, Illawarra Shoalhaven Local Health District, Warrawong, New South Wales, 2505 Australia; [email protected].

Financial disclosures: None.

From Illawarra Shoalhaven Local Health District, New South Wales, Australia (Maren Jones, Dr. Hewitt, Philippa King, Rhiannon Thorn, Edward Davidson, and Tiana-Lee Elphick), and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia (Dr. Hewitt)

Objective: To assess the association between change scores in the Functional Independence Measure (FIM) with evaluative measures used in physiotherapy to objectively show that use of the FIM in isolation is limited.

Design: Retrospective observational study.

Setting: Five rehabilitation inpatient wards from 1 public local health district in NSW Australia.

Participants: Patient data over a 5-year time frame (2015 to 2019) were reviewed (N = 2378). The patient data from the 3 most prevalent impairment groups (Australasian Rehabilitation Outcome Centre classification) were identified for inclusion in this study: Reconditioning (n = 742, mean age 76.88 years); Orthopedic Fracture (n = 585, mean age 77.46 years); and Orthopedic Replacement (n = 377, mean age 73.84 years).

Measurements: The difference between the admission and discharge scores were calculated for each measure. Kruskal-Wallis and χ² tests were used to analyze the data.

Results: Pearson correlation (r) coefficients between FIM Motor change to the de Morton’s Mobility Index (DEMMI) change was r = 0.396, FIM Motor change to the Timed Up and Go (TUG) change was r = -0.217, and the FIM Motor change to the Ten Meter Walk Test (10MWT) change was .194.

Conclusion: The FIM Motor change scores showed a weak positive association to the DEMMI change and no association to the TUG and 10MWT change, demonstrating that the outcome measures do not measure the same attributes. To review rehabilitation effectiveness from a management perspective, it is recommended that all measures are reviewed to assess the burden of care, functional mobility, and dynamic balance.

Keywords: physiotherapy; rehabilitation; clinical outcome measures.

Patients receive interdisciplinary inpatient rehabilitation treatment after they have sustained a lower limb fracture, a lower limb joint replacement, or have generalized deconditioning (muscle wasting and disuse atrophy) following hospitalization for surgery or illness. The degree of a patient’s impairment or loss of functional capacity, as well as their ability to manage at home safely, is assessed using standardized outcome measures during their recovery and rehabilitation.^1,2

Physiotherapists routinely use validated outcome measures to assess patient progress and to measure goal attainment through assessment of functional independence, dynamic balance performance, and ambulatory ability. These objective assessments provide clinicians with information about the effectiveness of the rehabilitation program, as well as the patient’s ability to manage in their home environment, to determine the need for assistive devices, level of caregiver support, future level of autonomy, and strategies for falls prevention.^3-7

There is a view among service providers that rehabilitation decisions can be based on a singular measure of function known as the Functional Independence Measure (FIM). This is an understandable position because not only is the FIM an internationally recognized, valid, and reliable tool, but, as a singular measure, it also means measurement consistency across rehabilitation sites is more likely. However, rehabilitation is complex, and it is risky to base decisions on a single measure, which might not capture the results of rehabilitation treatment ingredients on individual patient targets.^8,9

The patient’s progress is objectively assessed using functional outcome measures such as the FIM. Other measures used typically in our service include the de Morton’s Mobility Index (DEMMI), Timed Up and Go (TUG), and the Ten Meter Walk Test (10MWT), which measure patient mobility, balance during directional changes, and walking ability, respectively. Additional measures include patient progression to a less supportive level of assistance (ie, number of persons required to assist or level of supervision) or the selection of a walking aid (eg, forearm support frame, crutches). This progression—or lack thereof—assists in decision-making regarding the individual’s future once they are discharged from rehabilitation. Such considerations would include the need to modify the home environment, selection of assistive devices, community access (walking indoors, outdoors, and shopping), personal care needs, and age-appropriate care facility recommendations (ie, level of care). The use of outcome measures also indicates the need for further referrals to other care providers upon discharge from the rehabilitation facility.

There is widespread support in the literature for the use of the FIM, DEMMI, TUG, and 10MWT in rehabilitation population groups. For example, DEMMI has been validated in hip fracture patients during rehabilitation,¹⁰ as well as among older people hospitalized for medical illness.^11-13 It has also been shown to be a predictor of discharge destination for patients living with frailty in geriatric rehabilitation settings,¹⁴ and to have moderate predictive validity for functional independence after 4 weeks of rehabilitation.¹⁵ Similarly, TUG has been validated for use among hospitalized and community-dwelling individuals,^16-18 and for patients after joint arthroplasty^19,20 or hip fracture.²¹ It has also been shown to be an indicator of fall risk,^22-24 as well as a predictor of fracture incidence.²⁵ Furthermore, TUG has been identified as an indicator of a patient’s ability to walk in the community without the need for a walking device.²⁶ It has also been shown to be an early identifier of patients in need of rehabilitation.²⁷ Normative values for TUG have been reported, and the association with gait time established.²⁸

Gait speed has been shown to predict adverse outcomes in community-dwelling older people.²⁹ In fact, the 10MWT has been established as a powerful tool to benchmark rehabilitation recovery after a medical event.³⁰ Results of the test relate to overall quality of walking, health status, morbidity, and the rate of mortality.^31-33 Meaningful improvement, minimum detectable change (0.19-0.34 m/s), and responsiveness in common physical performance in older adults has been reported.^26,34,36

Structural and functional impairment has been used to define rehabilitation classes by the Australasian Rehabilitation Outcome Centre (AROC) in the Australian National Sub-Acute and Non-Acute Patient Classification (AN-SNAP) Version 4.^37-43 Variables used for grouping are age, care type, function, and impairment for rehabilitation. FIM was developed in order to assess patients’ outcomes after inpatient multidisciplinary care, and is an internationally accepted measure of functioning.⁴⁴ It is a holistic outcome measure, which can be used to determine the patient’s level of disability and burden of care, and is widely used in both public and private inpatient rehabilitation settings. Each patient classification is reported separately within the case mix structure.⁴⁵ Inpatient rehabilitation centers are evaluated and compared by the AROC,⁴⁶ with an emphasis on length of stay and the FIM change. The most successful centers demonstrate shorter length of stay and greater FIM improvement. Although the FIM is a valuable measure, it does not provide a complete picture of the individual patient’s rehabilitation gain: ie, the specific attributes of patients’ mobility, walking ability, or balance during directional changes.

A large-scale analysis of the association between the holistic disability measure of the FIM and the more mobility- and ambulation-focused physiotherapy outcomes has not been documented.

The well-documented DEMMI accumulates points for the patient’s mobility in a similar fashion to the FIM, but with more mobility detail. These 2 outcome measures allow for the full range of patients, from the very dependent up to and including the independently ambulant patients. The DEMMI may show a positive relationship to the FIM, yet the association is unknown. The association of the TUG to the 10MWT has been established²⁸; however, their relationship to the FIM is unknown.

Current practice in the participating public health inpatient rehabilitation wards is to use the DEMMI, TUG, 10MWT, and FIM to ensure physiotherapy and allow the wider multidisciplinary team to more effectively evaluate patient mobility outcomes. The 3 most frequent patient groups identified within the current patient population are expected to present clinical differences and will be analyzed for comparison. If an association is found between the outcome measures in question, clinical efficiency could be improved.

The aim of the current study is to assess the association between change scores in the FIM with evaluative measures of outcomes typically used in physiotherapy to objectively show that use of the FIM in isolation is limited in our population of patients.

Methods

Study design and setting

This retrospective descriptive observational study complied with the STROBE-RECORD guidance and checklist (available at mdedge.com/jcomjournal) and analyzed the routinely collected data from rehabilitation patients who were admitted to 5 different rehabilitation wards in 4 different public hospitals from 1 regional local health district (20-24 beds per ward) from 2015 to 2019. As this study conducted secondary analyses using existing de-identified data from a public health facility and did not involve interaction with any human subjects, ethical approval was not required.⁴⁶ Approval to conduct this study was granted by the health district’s institutional review committee, as per the National Statement on Ethical Conduct in Human Research 2015.

Participants

Patient data over a 5-year time frame were reviewed (N = 2378). The patient data from the 3 most prevalent impairment groups were identified for inclusion in this study: reconditioning, orthopedic fracture, and orthopedic replacement. (See Table 1 for the specific AN-SNAP impairment groups used in this study.)

Patient data from the less-frequent impairment groups were excluded (n = 673, 28.19%), including stroke (n = 343), brain dysfunction (n = 45), amputation of limb (n = 45), spinal cord dysfunction (n  = 36), neurological dysfunction (n = 34), cardiac (n = 24), and others (n = 25) who may have benefitted from other outcome measures due to their medical condition. Ten patient data sets were excluded for missing discharge outcome measure data, from when the patient became ill and returned to acute services or was discharged at short notice. To be included in the study, both the admission and discharge scores from the FIM and the admission and discharge scores from at least 1 of the physiotherapy outcome measures were required for each patient (n = 1704, 71.39%): Reconditioning (n = 742), Orthopedic Fracture (n = 585), and Orthopedic Replacement (n = 377). Information regarding the type of walking aid and the amount of assistance required for safe ambulation was also recorded. These items were included in the study’s descriptive analysis. Only 1.7% of these descriptors were missing.

Outcome measures

DEMMI tasks of bed mobility, sitting balance, transfers, walking, and balance were scored with an assigned value according to the patient’s performance. This was then tallied and the results scaled, to provide an overall score out of 100 available points. The total score from admission and discharge was then compared. Improvement (change) was identified by the increase in scores.

The TUG assesses a patient’s dynamic balance performance.⁴⁷ The number of seconds it took the patient to complete the procedure was recorded at admission and discharge. Improvement (change) was identified by the reduction in time taken at discharge from the admission score.

The 10MWT measures the unidirectional walking speed of a person over 10 meters and is recorded in seconds and reported in meters per second. Improvement (change) was identified by the reduction in the time taken to increase walking speed.

Concurrent to the physiotherapy measures were the FIM scores, recorded by the accredited nursing staff from each rehabilitation ward. Improvement is demonstrated by the accumulation of points on the ordinal scale of the FIM Total, including mobility, dressing, bladder and bowel care, cognition, and social interaction, and is represented as a score between 18 and 126. The FIM Motor category is reported as a score between 13 and 91.

The 2 data sets were matched by unique identifier and admission dates, then de-identified for analysis.

Statistical analysis

Patient demographic information was analyzed using descriptive statistics (mean, SD, frequencies, percentages) for each impairment group (orthopedic fracture, orthopedic replacement, reconditioning). Differences in continuous demographic variables for each impairment group were assessed using Kruskal-Wallis tests and χ² tests for categorical variables. Functional outcome scores were compared at admission, discharge, and change between the impairment groups. Association of the functional outcome change scores was determined with the Pearson correlation coefficient (r) between the FIM and the DEMMI, TUG, and 10MWT. Graphs were plotted for each of these (Figure available online at mdedge.com/jcomjournal). A strong, moderate, and weak association was described as > 0.6, > 0.4, and > 0.2, respectively.⁴⁶ Statistical significance was set at P < .05. Analyses were conducted using Stata (StataCorp LLC, USA).

Results

The patient descriptive data (site from which data were collected, admission length of stay, age at admission, discharge destination, walk aid improvement, and walk assistance improvement) from the 3 impairment groups are reported in Table 2. The functional outcomes for DEMMI, TUG, 10MWT, FIM Motor, FIM Total at admission, discharge, and the change scores are presented in Table 3.

Orthopedic fracture patients had the greatest improvement in their functional outcomes, with a DEMMI improvement of 18 points, TUG score change of 23.49 seconds (s), 10MWT change of 0.30 meters/second (m/s), FIM Motor change of 20.62, and a FIM Total change of 21.9 points. The outcome measures exceeded the minimum detectable change as reported in the literature for DEMMI (8.8 points⁴⁸), TUG (2.08 s²⁶), walking speed 0.19 m/s²⁶, and FIM Motor (14.6 points⁴⁹).

Association of functional outcomes (change scores)

There was a significant weak positive correlation between DEMMI change score and both the FIM Motor (r = 0.396) and FIM Total change scores (r = 0.373). When viewing the specific items within the FIM Motor labelled FIM Walk change, FIM MobilityBedChair change, and FIM stairs change, r values were 0.100, 0.379, and 0.126, respectively. In addition, there was a weak negative correlation between TUG change scores and both FIM Motor (r = -0.217) and FIM Total change scores (r = -0.207). There was a very weak positive correlation between 10MWT (m/s) change scores and both FIM Motor (r = 0.194) and FIM Total change scores (r = 0.187) (Table 4, Figure). There was a moderate correlation between 10MWT change (s) and TUG change (s) (r = 0.72, P < .001).

Discussion

The purpose of this study was to ascertain the association between the DEMMI, TUG, 10MWT, and FIM measures using retrospective data collected from 5 public hospital inpatient rehabilitation wards. The results of this retrospective analysis demonstrate that a variety of objective outcome measures are required for the multidisciplinary team to accurately measure a patient’s functional improvement during their inpatient rehabilitation stay. No single outcome measure in this study fully reported all mobility attributes, and we note the risk of basing decisions on a single measure evaluating rehabilitation outcomes. Although the internationally used FIM has a strong place in rehabilitation reporting and benchmarking, it does not predict change nor provide a proxy for the patient’s whole-body motor control as they extend their mobility, dynamic balance, and ambulatory ability. Multiple objective outcome measures should therefore be required to evaluate the patient’s progress and functional performance toward discharge planning.

The FIM is a measure of disability or care needs, incorporating cognitive, social, and physical components of disability. It is a valid, holistic measure of an individual’s functional ability at a given time. Rehabilitation sites internationally utilize this assessment tool to evaluate a patient’s progress and the efficacy of intervention. The strength of this measure is its widespread use and the inclusion of the personal activities of daily living to provide an overall evaluation encompassing all aspects of a person’s ability to function independently. However, as our study results suggest, patient improvement measured by the FIM Motor components were not correlated to other widely used physiotherapy measures of ambulation and balance, such as the 10MWT or TUG. This is perhaps largely because the FIM Motor components only consider the level of assistance (eg, physical assistance, assistive device, independence) and do not consider assessment of balance and gait ability as assessed in the 10MWT and TUG. The 10MWT and TUG provide assessment of velocity and dynamic balance during walking, which have been shown to predict an individual’s risk of falling.^22,23 This is a pertinent issue in the rehabilitation and geriatric population.²⁹ Furthermore, the use of the FIM as a benchmarking tool to compare facility efficiency may not provide a complete assessment of all outcomes achieved on the inpatient rehabilitation ward, such as reduced falls risk or improved ambulatory ability and balance.

It has previously been confirmed that there is a significant positive correlation between the 10MWT and the TUG.²⁷ This retrospective analysis has also supported these findings. This is possibly due to the similarity in the assessments, as they both incorporate ambulation ability and dynamic movement.

Each of the 4 outcome measures assess different yet vital aspects of an individual’s functional mobility and ambulation ability during their subacute rehabilitation journey. The diversity of patient age, functional impairment, and mobility level needs a range of outcomes to provide baselines, targets, and goal attainment for discharge home.

Consistent with the AROC AN-SNAP reporting of Length of Stay and FIM change separated into the weighted impairment groups, the data analysis of this study demonstrated significant differences between the Reconditioning, Orthopedic Fracture, and Orthopedic Replacement patient data. Tables 2 and 3 describe the differences between the groups. The fracture population in this study improved the most across each outcome measure. In contrast, the reconditioning population showed the least improvement. This may be expected due to the pathophysiological differences between the groups. Furthermore, for the elderly who sustain fractures because of a fall, rehabilitation will be required to address not only the presenting injury but also the premorbid falls risk factors which may include polypharmacy or impaired balance.

Any conclusions drawn from the findings of this study need to take into consideration that it has focused on patients from 1 local health district and therefore may not be generalizable to a wider national or international context. As this study was a retrospective study, controlling for data collection quality, measurement bias due to nonblinding and missing data is a limitation. However, clinicians regularly completed these outcome assessments and recorded this information as part of their standard care practices within this health district. There may have been slight differences in definitions of practice between the 5 rehabilitation sites. To ensure reliability, each individual site’s protocols for the FIM, DEMMI, TUG, and 10MWT were reviewed and confirmed to be consistent.

Conclusion

The FIM Motor change scores showed a weak positive association to the DEMMI change, and no association to the TUG and 10MWT change, demonstrating that the outcome measures do not measure the same attributes. Thorough reporting of clinical outcomes is much more meaningful to assess and guide the physiotherapy component of rehabilitation. To review rehabilitation effectiveness from a management perspective, it is recommended that all measures are reviewed to assess the burden of care, mobility, functional capacity, and dynamic balance.

Acknowledgements: The authors thank Anne Smith, MSHLM, BAppSc, Head of the Physiotherapy Department, and the physiotherapists and allied health assistants who have contributed to the collection of this valuable data over several years. They also thank Lina Baytieh, MS, BS, from Research Central, Illawarra Shoalhaven Local Health District, for her assistance with the analysis.

Corresponding author: Maren Jones, MPH, BS, Physiotherapy Department, Port Kembla Hospital, Illawarra Shoalhaven Local Health District, Warrawong, New South Wales, 2505 Australia; [email protected].

Financial disclosures: None.

Because hepatitis C virus (HCV) infection is typically asymptomatic, its presence can easily be overlooked without appropriate screening efforts. For those screening efforts to be effective, they must keep pace with the changing demographic face of this increasingly prevalent but treatable disease.

Perhaps the most dramatic shift in HCV demographics in recent years has been the increase of infections among those born after 1965, a trend primarily driven by the opioid epidemic. In addition, data from the National Notifiable Diseases Surveillance System show that cases of diagnosed HCV doubled among women of childbearing age from 2006 to 2014, with new infections in younger women surpassing those in older age groups.

With such trends in mind, the Centers for Disease Control and Prevention broadened their recommendations regarding HCV in 2020 to include one-time testing in all adults aged 18 years and older and screening of all pregnant women during each pregnancy, except where the prevalence of infection is less than 0.1%, a threshold that no state has yet achieved.

The US Preventive Services Task Force (USPSTF) subsequently followed suit in their own recommendations.

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America have long advocated for extensive expansion in their screening recommendations for HCV, including pregnancy.

Although the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine did not immediately adopt these recommendations, they have since endorsed them in May 2021 and June 2021, respectively.
 

The hepatologist perspective

As a practicing hepatologist, this seems like an uncontroversial recommendation. Obstetricians already screen for hepatitis B virus in each pregnancy. It should be easy to add HCV testing to the same lab testing.

Risk-based screening has repeatedly been demonstrated to be ineffective. It should be easier to test all women than to ask prying questions about high-risk behaviors.

Given the increase of injection drug use and resultant HCV infections in women of childbearing age, this seems like a perfect opportunity to identify chronically infected women and counsel them on transmission and cure. And pregnancy is also unique in that it is a time of near-universal health coverage.

Let’s address some of the operational issues.

The diagnostic cascade for HCV can be made very easy. HCV antibody testing is our standard screening test and, when positive, can automatically reflex to HCV polymerase chain reaction (PCR), the diagnostic test. Thus, with one blood sample, you can both screen for and diagnose infection.

Current guidelines do not recommend treating HCV during pregnancy, although therapy can be considered on an individual basis. Linkage to a knowledgeable provider who can discuss transmission and treatment, as well as assess the stage of liver injury, should decrease the burden on the ob.gyn.

The impact on pregnancy is marginal. HCV should not change either the mode of delivery or the decision to breastfeed. The AASLD/IDSA guidance outlines only four recommendations for monitoring during pregnancy:

• Obtain HCV RNA to see whether the infection is active and assess liver function at initiation of prenatal care.
• Prenatal care should be tailored to the pregnancy. There is no modification recommended to decrease mother-to-child transmission (MTCT).
• Be aware that intrahepatic is more common with HCV.
• Women with have a higher rate of adverse outcomes and should be linked to a high-risk obstetrics specialist.

But of course, what seems easy to one specialist may not be true of another. With that in mind, let’s hear the ob.gyn. perspective on these updated screening recommendations.
 

The ob.gyn. perspective

Recent guidelines from the CDC, ACOG, and SMFM recommend universal screening for HCV in all pregnant women. The increased availability of highly effective antiviral regimens makes universal screening a logical strategy, especially to identify candidates for this curative treatment. What is questionable, however, is the recommended timing by which this screening should take place.

HCV screening during pregnancy, as currently recommended, provides no immediate benefit for the pregnant woman or the fetus/neonate, given that antiviral treatments have not been approved during gestation, and there are no known measures that decrease MTCT or change routine perinatal care.

We also must not forget that a significant proportion of women in the United States, particularly those with limited resources, do not receive prenatal care at all. Most of them, however, will present to a hospital for delivery. Consequently, compliance with screening might be higher if performed at the time of delivery rather than antepartum.

Deferring screening until the intrapartum or immediate postpartum period, at least until antiviral treatment during pregnancy becomes a reality, was discussed. The rationale was that this approach might obviate the need to deal with the unintended consequences and burden of testing for HCV during pregnancy. Ultimately, ACOG and SMFM fell in line with the CDC recommendations.

Despite the lack of robust evidence regarding the risk for MTCT associated with commonly performed obstetric procedures (for example, genetic amniocentesis, artificial rupture of the membranes during labor, placement of an intrauterine pressure catheter), clinicians may be reluctant to perform them in HCV-infected women, resulting in potential deviations from the obstetric standard of care.

Similarly, it is likely that patients may choose to have a cesarean delivery for the sole purpose of decreasing MTCT, despite the lack of evidence for this. Such ill-advised patient-driven decisions are increasingly likely in the current environment, where social media can rapidly disseminate misinformation.
 

Implications for pediatric patients

One cannot isolate HCV screening in pregnancy from the consequences that may potentially occur as part of the infant’s transition to the care of a pediatrician.

Even though MTCT is estimated to occur in just 5%-15% of cases, all children born to HCV viremic mothers should be screened for HCV.

Traditionally, screening for HCV antibodies occurred after 18 months of age. In those who test positive, HCV PCR testing is recommended at 3 years. However, this algorithm is being called into question because only approximately one-third of infants are successfully screened.

HCV RNA testing in the first year after birth has been suggested. However, even proponents of this approach concur that all management decisions should be deferred until after the age of 3 years, when medications are approved for pediatric use.

In addition, HCV testing would be required again before considering therapy because children have higher rates of spontaneous clearance.
 

Seeking consensus beyond the controversy

Controversy remains surrounding the most recent update to the HCV screening guidelines. The current recommendation to screen during pregnancy cannot modify the risk for MTCT, has no impact on decisions regarding mode of delivery or breastfeeding, and could potentially cause harm by making obstetricians defer necessary invasive procedures even though there are no data linking them to an increase in MTCT.

Yet after extensive debate, the CDC, USPSTF, AASLD/IDSA, ACOG, and SMFM all developed their current recommendations to initiate HCV screening during pregnancy. To make this successful, screening algorithms need to be simple and consistent across all society recommendations.

HCV antibody testing should always reflex to the diagnostic test (HCV PCR) to allow confirmation in those who test positive without requiring an additional blood test. Viremic mothers (those who are HCV positive on PCR) should be linked to a provider who can discuss prognosis, transmission, and treatment. The importance of screening the infant also must be communicated to the parents and pediatrician alike.

Dr. Reau has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Gilead, Arbutus, Intercept, and Salix; received research grants from AbbVie and Gilead; and received income from AASLD. Dr. Pacheco disclosed no relevant financial relationships.
 

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

Because hepatitis C virus (HCV) infection is typically asymptomatic, its presence can easily be overlooked without appropriate screening efforts. For those screening efforts to be effective, they must keep pace with the changing demographic face of this increasingly prevalent but treatable disease.

Perhaps the most dramatic shift in HCV demographics in recent years has been the increase of infections among those born after 1965, a trend primarily driven by the opioid epidemic. In addition, data from the National Notifiable Diseases Surveillance System show that cases of diagnosed HCV doubled among women of childbearing age from 2006 to 2014, with new infections in younger women surpassing those in older age groups.

With such trends in mind, the Centers for Disease Control and Prevention broadened their recommendations regarding HCV in 2020 to include one-time testing in all adults aged 18 years and older and screening of all pregnant women during each pregnancy, except where the prevalence of infection is less than 0.1%, a threshold that no state has yet achieved.

The US Preventive Services Task Force (USPSTF) subsequently followed suit in their own recommendations.

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America have long advocated for extensive expansion in their screening recommendations for HCV, including pregnancy.

Although the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine did not immediately adopt these recommendations, they have since endorsed them in May 2021 and June 2021, respectively.
 

The hepatologist perspective

As a practicing hepatologist, this seems like an uncontroversial recommendation. Obstetricians already screen for hepatitis B virus in each pregnancy. It should be easy to add HCV testing to the same lab testing.

Risk-based screening has repeatedly been demonstrated to be ineffective. It should be easier to test all women than to ask prying questions about high-risk behaviors.

Given the increase of injection drug use and resultant HCV infections in women of childbearing age, this seems like a perfect opportunity to identify chronically infected women and counsel them on transmission and cure. And pregnancy is also unique in that it is a time of near-universal health coverage.

Let’s address some of the operational issues.

The diagnostic cascade for HCV can be made very easy. HCV antibody testing is our standard screening test and, when positive, can automatically reflex to HCV polymerase chain reaction (PCR), the diagnostic test. Thus, with one blood sample, you can both screen for and diagnose infection.

Current guidelines do not recommend treating HCV during pregnancy, although therapy can be considered on an individual basis. Linkage to a knowledgeable provider who can discuss transmission and treatment, as well as assess the stage of liver injury, should decrease the burden on the ob.gyn.

The impact on pregnancy is marginal. HCV should not change either the mode of delivery or the decision to breastfeed. The AASLD/IDSA guidance outlines only four recommendations for monitoring during pregnancy:

• Obtain HCV RNA to see whether the infection is active and assess liver function at initiation of prenatal care.
• Prenatal care should be tailored to the pregnancy. There is no modification recommended to decrease mother-to-child transmission (MTCT).
• Be aware that intrahepatic is more common with HCV.
• Women with have a higher rate of adverse outcomes and should be linked to a high-risk obstetrics specialist.

But of course, what seems easy to one specialist may not be true of another. With that in mind, let’s hear the ob.gyn. perspective on these updated screening recommendations.
 

The ob.gyn. perspective

Recent guidelines from the CDC, ACOG, and SMFM recommend universal screening for HCV in all pregnant women. The increased availability of highly effective antiviral regimens makes universal screening a logical strategy, especially to identify candidates for this curative treatment. What is questionable, however, is the recommended timing by which this screening should take place.

HCV screening during pregnancy, as currently recommended, provides no immediate benefit for the pregnant woman or the fetus/neonate, given that antiviral treatments have not been approved during gestation, and there are no known measures that decrease MTCT or change routine perinatal care.

We also must not forget that a significant proportion of women in the United States, particularly those with limited resources, do not receive prenatal care at all. Most of them, however, will present to a hospital for delivery. Consequently, compliance with screening might be higher if performed at the time of delivery rather than antepartum.

Deferring screening until the intrapartum or immediate postpartum period, at least until antiviral treatment during pregnancy becomes a reality, was discussed. The rationale was that this approach might obviate the need to deal with the unintended consequences and burden of testing for HCV during pregnancy. Ultimately, ACOG and SMFM fell in line with the CDC recommendations.

Despite the lack of robust evidence regarding the risk for MTCT associated with commonly performed obstetric procedures (for example, genetic amniocentesis, artificial rupture of the membranes during labor, placement of an intrauterine pressure catheter), clinicians may be reluctant to perform them in HCV-infected women, resulting in potential deviations from the obstetric standard of care.

Similarly, it is likely that patients may choose to have a cesarean delivery for the sole purpose of decreasing MTCT, despite the lack of evidence for this. Such ill-advised patient-driven decisions are increasingly likely in the current environment, where social media can rapidly disseminate misinformation.
 

Implications for pediatric patients

One cannot isolate HCV screening in pregnancy from the consequences that may potentially occur as part of the infant’s transition to the care of a pediatrician.

Even though MTCT is estimated to occur in just 5%-15% of cases, all children born to HCV viremic mothers should be screened for HCV.

Traditionally, screening for HCV antibodies occurred after 18 months of age. In those who test positive, HCV PCR testing is recommended at 3 years. However, this algorithm is being called into question because only approximately one-third of infants are successfully screened.

HCV RNA testing in the first year after birth has been suggested. However, even proponents of this approach concur that all management decisions should be deferred until after the age of 3 years, when medications are approved for pediatric use.

In addition, HCV testing would be required again before considering therapy because children have higher rates of spontaneous clearance.
 

Seeking consensus beyond the controversy

Controversy remains surrounding the most recent update to the HCV screening guidelines. The current recommendation to screen during pregnancy cannot modify the risk for MTCT, has no impact on decisions regarding mode of delivery or breastfeeding, and could potentially cause harm by making obstetricians defer necessary invasive procedures even though there are no data linking them to an increase in MTCT.

Yet after extensive debate, the CDC, USPSTF, AASLD/IDSA, ACOG, and SMFM all developed their current recommendations to initiate HCV screening during pregnancy. To make this successful, screening algorithms need to be simple and consistent across all society recommendations.

HCV antibody testing should always reflex to the diagnostic test (HCV PCR) to allow confirmation in those who test positive without requiring an additional blood test. Viremic mothers (those who are HCV positive on PCR) should be linked to a provider who can discuss prognosis, transmission, and treatment. The importance of screening the infant also must be communicated to the parents and pediatrician alike.

Dr. Reau has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Gilead, Arbutus, Intercept, and Salix; received research grants from AbbVie and Gilead; and received income from AASLD. Dr. Pacheco disclosed no relevant financial relationships.
 

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

Because hepatitis C virus (HCV) infection is typically asymptomatic, its presence can easily be overlooked without appropriate screening efforts. For those screening efforts to be effective, they must keep pace with the changing demographic face of this increasingly prevalent but treatable disease.

Perhaps the most dramatic shift in HCV demographics in recent years has been the increase of infections among those born after 1965, a trend primarily driven by the opioid epidemic. In addition, data from the National Notifiable Diseases Surveillance System show that cases of diagnosed HCV doubled among women of childbearing age from 2006 to 2014, with new infections in younger women surpassing those in older age groups.

With such trends in mind, the Centers for Disease Control and Prevention broadened their recommendations regarding HCV in 2020 to include one-time testing in all adults aged 18 years and older and screening of all pregnant women during each pregnancy, except where the prevalence of infection is less than 0.1%, a threshold that no state has yet achieved.

The US Preventive Services Task Force (USPSTF) subsequently followed suit in their own recommendations.

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America have long advocated for extensive expansion in their screening recommendations for HCV, including pregnancy.

Although the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine did not immediately adopt these recommendations, they have since endorsed them in May 2021 and June 2021, respectively.
 

The hepatologist perspective

As a practicing hepatologist, this seems like an uncontroversial recommendation. Obstetricians already screen for hepatitis B virus in each pregnancy. It should be easy to add HCV testing to the same lab testing.

Risk-based screening has repeatedly been demonstrated to be ineffective. It should be easier to test all women than to ask prying questions about high-risk behaviors.

Given the increase of injection drug use and resultant HCV infections in women of childbearing age, this seems like a perfect opportunity to identify chronically infected women and counsel them on transmission and cure. And pregnancy is also unique in that it is a time of near-universal health coverage.

Let’s address some of the operational issues.

The diagnostic cascade for HCV can be made very easy. HCV antibody testing is our standard screening test and, when positive, can automatically reflex to HCV polymerase chain reaction (PCR), the diagnostic test. Thus, with one blood sample, you can both screen for and diagnose infection.

Current guidelines do not recommend treating HCV during pregnancy, although therapy can be considered on an individual basis. Linkage to a knowledgeable provider who can discuss transmission and treatment, as well as assess the stage of liver injury, should decrease the burden on the ob.gyn.

The impact on pregnancy is marginal. HCV should not change either the mode of delivery or the decision to breastfeed. The AASLD/IDSA guidance outlines only four recommendations for monitoring during pregnancy:

• Obtain HCV RNA to see whether the infection is active and assess liver function at initiation of prenatal care.
• Prenatal care should be tailored to the pregnancy. There is no modification recommended to decrease mother-to-child transmission (MTCT).
• Be aware that intrahepatic is more common with HCV.
• Women with have a higher rate of adverse outcomes and should be linked to a high-risk obstetrics specialist.

But of course, what seems easy to one specialist may not be true of another. With that in mind, let’s hear the ob.gyn. perspective on these updated screening recommendations.
 

The ob.gyn. perspective

Recent guidelines from the CDC, ACOG, and SMFM recommend universal screening for HCV in all pregnant women. The increased availability of highly effective antiviral regimens makes universal screening a logical strategy, especially to identify candidates for this curative treatment. What is questionable, however, is the recommended timing by which this screening should take place.

HCV screening during pregnancy, as currently recommended, provides no immediate benefit for the pregnant woman or the fetus/neonate, given that antiviral treatments have not been approved during gestation, and there are no known measures that decrease MTCT or change routine perinatal care.

We also must not forget that a significant proportion of women in the United States, particularly those with limited resources, do not receive prenatal care at all. Most of them, however, will present to a hospital for delivery. Consequently, compliance with screening might be higher if performed at the time of delivery rather than antepartum.

Deferring screening until the intrapartum or immediate postpartum period, at least until antiviral treatment during pregnancy becomes a reality, was discussed. The rationale was that this approach might obviate the need to deal with the unintended consequences and burden of testing for HCV during pregnancy. Ultimately, ACOG and SMFM fell in line with the CDC recommendations.

Despite the lack of robust evidence regarding the risk for MTCT associated with commonly performed obstetric procedures (for example, genetic amniocentesis, artificial rupture of the membranes during labor, placement of an intrauterine pressure catheter), clinicians may be reluctant to perform them in HCV-infected women, resulting in potential deviations from the obstetric standard of care.

Similarly, it is likely that patients may choose to have a cesarean delivery for the sole purpose of decreasing MTCT, despite the lack of evidence for this. Such ill-advised patient-driven decisions are increasingly likely in the current environment, where social media can rapidly disseminate misinformation.
 

Implications for pediatric patients

One cannot isolate HCV screening in pregnancy from the consequences that may potentially occur as part of the infant’s transition to the care of a pediatrician.

Even though MTCT is estimated to occur in just 5%-15% of cases, all children born to HCV viremic mothers should be screened for HCV.

Traditionally, screening for HCV antibodies occurred after 18 months of age. In those who test positive, HCV PCR testing is recommended at 3 years. However, this algorithm is being called into question because only approximately one-third of infants are successfully screened.

HCV RNA testing in the first year after birth has been suggested. However, even proponents of this approach concur that all management decisions should be deferred until after the age of 3 years, when medications are approved for pediatric use.

In addition, HCV testing would be required again before considering therapy because children have higher rates of spontaneous clearance.
 

Seeking consensus beyond the controversy

Controversy remains surrounding the most recent update to the HCV screening guidelines. The current recommendation to screen during pregnancy cannot modify the risk for MTCT, has no impact on decisions regarding mode of delivery or breastfeeding, and could potentially cause harm by making obstetricians defer necessary invasive procedures even though there are no data linking them to an increase in MTCT.

Yet after extensive debate, the CDC, USPSTF, AASLD/IDSA, ACOG, and SMFM all developed their current recommendations to initiate HCV screening during pregnancy. To make this successful, screening algorithms need to be simple and consistent across all society recommendations.

HCV antibody testing should always reflex to the diagnostic test (HCV PCR) to allow confirmation in those who test positive without requiring an additional blood test. Viremic mothers (those who are HCV positive on PCR) should be linked to a provider who can discuss prognosis, transmission, and treatment. The importance of screening the infant also must be communicated to the parents and pediatrician alike.

Dr. Reau has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Gilead, Arbutus, Intercept, and Salix; received research grants from AbbVie and Gilead; and received income from AASLD. Dr. Pacheco disclosed no relevant financial relationships.
 

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

For the last 25 years, my colleagues have spent midday on Wednesdays at clinical rounds as a group – a time spent reviewing cases in perinatal psychiatry and important new scientific findings in the literature that inform patient care. At the start of the pandemic, my colleague Marlene Freeman, MD, and I started Virtual Rounds at the Center for Women’s Mental Health to open our rounds to colleagues involved in multiple aspects of perinatal psychiatric care.

In my last column of 2021, I wanted to take the opportunity to reflect on some of what we have learned from 19 months of virtual rounding as a community of clinicians during the pandemic.

Telemedicine

Telemedicine allows us to see into the homes, relationships, and environments of our pregnant and postpartum women in a way we could never have imagined. It’s an opportunity to follow patients closely and intervene sooner rather than later, which might have been constrained by pre–COVID-19 typical scheduled office appointments. Telemedicine also gives us a clearer sense of some of the issues faced by underserved and marginalized populations of patients as we look to increase outreach to those groups.

COVID-19 vaccines in pregnancy

We now know much more about the potential for COVID-19 to cause complications during pregnancy than we did earlier in the pandemic. Although there may be a variety of factors fueling whether those in the general population decide to get vaccinated or not, there is no ambiguity in the message from our colleagues in obstetrics about the importance of vaccination for pregnant and postpartum women.

Bipolar disorder

Appropriate treatment for the spectrum of subtypes of bipolar disorder during pregnancy in the postpartum period is a frequent topic of discussion that colleagues raise. The pandemic has kindled clinical worsening for women with mood and anxiety disorders presumably driven by a host of factors ranging from shifts in medication adherence to sleep dysregulation to name just a few. Bipolar II disorder is underdiagnosed, yet there’s a growing appreciation of the morbidity associated with this subtype of bipolar disorder, which probably equals that of other groups on the bipolar spectrum such as those with bipolar I disorder.

Sustaining emotional well-being for bipolar women during pregnancy has never been more important than during the pandemic since psychiatric illness during pregnancy is the strongest predictor of risk for postpartum psychiatric disorder and the literature demonstrates that bipolar women are at particular risk for postpartum mood disorder. Historically, treatment of bipolar disorder during pregnancy was particularly problematic for clinicians and patients deciding about potential use of pharmacotherapy because options were finite; some treatments were known teratogens (valproate and to a far less extent lithium) and other newer treatments for bipolar disorder had sparse reproductive safety data (second-generation antipsychotics).

The message today is we have tools to safely treat bipolar disorder during pregnancy and the postpartum period not available 10 years ago. Lithium is likely underused and can be safely used during pregnancy; we have vast data on the effectiveness of lithium in bipolar disorder. Clinicians should also know that lamotrigine is safe to use for pregnant women with bipolar disorder and the data show no increased risk for major malformations associated with first trimester exposure. In the case of atypical antipsychotics, which increasingly are used in the treatment of bipolar disorder, the take-home message is our comfort level using these medicines during pregnancy is growing given more data supporting that atypical antipsychotics are not major teratogens.

We’ve also learned polytherapy is the rule, not the exception. As my colleague Adele Viguera, MD, recently referenced in Virtual Rounds: Polytherapy is a small price to pay when the other side is sustaining euthymia in bipolar disorder.

What we’ve learned about treating perinatal mood disorder is it takes a village of clinicians and resources to treat and mitigate risk for recurrence. Nothing is more important than either ensuring or recapturing maternal euthymia. The flip side is a recent report that maternal self-harm/suicide is the leading cause of death in the first year postpartum. It is a charge to the medical community at large to screen for maternal psychiatric illness and, more importantly, to refer patients and ensure they receive adequate care during the postpartum period.
 

Anxiety

Anxiety and insomnia have been prevalent during the pandemic. Pregnancy-associated and postpartum anxiety have been underappreciated in lieu of focusing on perinatal depression, and we lack consensus regarding the most appropriate treatment of perinatal anxiety. Nonpharmacologic interventions have been extremely helpful for women whose anxiety is mild to moderate or as an adjunct to pharmacologic intervention for patients with more severe anxiety disorders.

Robust data on untreated anxiety during pregnancy suggest it leads to adverse outcomes. The reproductive safety rules above for depression also apply for anxiety. Here, we find a multimodal approach, both nonpharmacologic and pharmacologic, optimizes treatment for that population.

Clinicians have asked about other medicines many women take to treat anxiety including gabapentin, hydroxyzine, and benzodiazepines. Because of concerns about dependence and about using benzodiazepines during pregnancy, hydroxyzine is frequently used despite sparse reproductive safety data. Data on the effectiveness of hydroxyzine is even smaller and tends to be incomplete for patients with more moderate to severe anxiety.

Our comfort level in our center is greater for using benzodiazepines in patients who are clearly not at risk for substance use disorder because particularly when used with selective serotonin reuptake inhibitors, we find it optimizes treatment, mitigates symptoms, and attenuates suffering.
 

Insomnia

For insomnia, cognitive behavioral therapy for insomnia (CBTI) has the most data for effectiveness. Pharmacologic interventions such as gabapentin and benzodiazepines are also frequently used as therapies for insomnia.

Concern about treating insomnia by perinatal psychiatrists comes from the knowledge that insomnia is so often comorbid with anxiety and depression. Psychiatrists must consider the possibility that complaints of insomnia are part of an underlying mood or anxiety disorder; it would be unfortunate to miss the underlying illness and only treat just symptoms of insomnia. That being said, circumscribed insomnia is not uncommon during pregnancy and needs to be managed accordingly.
 

Postpartum psychosis

It’s been noteworthy the extent to which rare cases of postpartum psychosis have been presented in our Virtual Round meetings during the pandemic. As discussed previously, postpartum psychosis is one of the most serious illnesses we treat in reproductive psychiatry.

The debate as to whether postpartum psychosis is a discrete circumscribed illness or an illness that recurs over time won’t be answered without better longitudinal data. What we can say is there is no role, particularly during the pandemic, for outpatient management of postpartum psychosis. The waxing and waning of psychotic symptoms, while reassuring when patients are compensated, are of great concern when patients are psychotic and not in a safe environment.

While there are no consensus guidelines for postpartum psychosis treatment, the data support use of agents such as lithium. Growing data exist on the use of atypical antipsychotics to ameliorate psychotic symptoms and get patients functioning as quickly as possible. Resolution of postpartum psychosis may take a considerable amount of time. During the pandemic, it is critical that appropriate resources be managed before patients leave the hospital, including support by family, open communication with community-based providers, and support groups.

Nineteen months into the pandemic, it seems we’ve learned much: how to leverage technology like telemedicine, and the upsides of folding in our multidisciplinary colleagues to reduce barriers around collaboration and learn from one another to provide the best care for our shared patients.

*This column was updated on Jan. 11. 2022.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

For the last 25 years, my colleagues have spent midday on Wednesdays at clinical rounds as a group – a time spent reviewing cases in perinatal psychiatry and important new scientific findings in the literature that inform patient care. At the start of the pandemic, my colleague Marlene Freeman, MD, and I started Virtual Rounds at the Center for Women’s Mental Health to open our rounds to colleagues involved in multiple aspects of perinatal psychiatric care.

In my last column of 2021, I wanted to take the opportunity to reflect on some of what we have learned from 19 months of virtual rounding as a community of clinicians during the pandemic.

Telemedicine

Telemedicine allows us to see into the homes, relationships, and environments of our pregnant and postpartum women in a way we could never have imagined. It’s an opportunity to follow patients closely and intervene sooner rather than later, which might have been constrained by pre–COVID-19 typical scheduled office appointments. Telemedicine also gives us a clearer sense of some of the issues faced by underserved and marginalized populations of patients as we look to increase outreach to those groups.

COVID-19 vaccines in pregnancy

We now know much more about the potential for COVID-19 to cause complications during pregnancy than we did earlier in the pandemic. Although there may be a variety of factors fueling whether those in the general population decide to get vaccinated or not, there is no ambiguity in the message from our colleagues in obstetrics about the importance of vaccination for pregnant and postpartum women.

Bipolar disorder

Appropriate treatment for the spectrum of subtypes of bipolar disorder during pregnancy in the postpartum period is a frequent topic of discussion that colleagues raise. The pandemic has kindled clinical worsening for women with mood and anxiety disorders presumably driven by a host of factors ranging from shifts in medication adherence to sleep dysregulation to name just a few. Bipolar II disorder is underdiagnosed, yet there’s a growing appreciation of the morbidity associated with this subtype of bipolar disorder, which probably equals that of other groups on the bipolar spectrum such as those with bipolar I disorder.

Sustaining emotional well-being for bipolar women during pregnancy has never been more important than during the pandemic since psychiatric illness during pregnancy is the strongest predictor of risk for postpartum psychiatric disorder and the literature demonstrates that bipolar women are at particular risk for postpartum mood disorder. Historically, treatment of bipolar disorder during pregnancy was particularly problematic for clinicians and patients deciding about potential use of pharmacotherapy because options were finite; some treatments were known teratogens (valproate and to a far less extent lithium) and other newer treatments for bipolar disorder had sparse reproductive safety data (second-generation antipsychotics).

The message today is we have tools to safely treat bipolar disorder during pregnancy and the postpartum period not available 10 years ago. Lithium is likely underused and can be safely used during pregnancy; we have vast data on the effectiveness of lithium in bipolar disorder. Clinicians should also know that lamotrigine is safe to use for pregnant women with bipolar disorder and the data show no increased risk for major malformations associated with first trimester exposure. In the case of atypical antipsychotics, which increasingly are used in the treatment of bipolar disorder, the take-home message is our comfort level using these medicines during pregnancy is growing given more data supporting that atypical antipsychotics are not major teratogens.

We’ve also learned polytherapy is the rule, not the exception. As my colleague Adele Viguera, MD, recently referenced in Virtual Rounds: Polytherapy is a small price to pay when the other side is sustaining euthymia in bipolar disorder.

What we’ve learned about treating perinatal mood disorder is it takes a village of clinicians and resources to treat and mitigate risk for recurrence. Nothing is more important than either ensuring or recapturing maternal euthymia. The flip side is a recent report that maternal self-harm/suicide is the leading cause of death in the first year postpartum. It is a charge to the medical community at large to screen for maternal psychiatric illness and, more importantly, to refer patients and ensure they receive adequate care during the postpartum period.
 

Anxiety

Anxiety and insomnia have been prevalent during the pandemic. Pregnancy-associated and postpartum anxiety have been underappreciated in lieu of focusing on perinatal depression, and we lack consensus regarding the most appropriate treatment of perinatal anxiety. Nonpharmacologic interventions have been extremely helpful for women whose anxiety is mild to moderate or as an adjunct to pharmacologic intervention for patients with more severe anxiety disorders.

Robust data on untreated anxiety during pregnancy suggest it leads to adverse outcomes. The reproductive safety rules above for depression also apply for anxiety. Here, we find a multimodal approach, both nonpharmacologic and pharmacologic, optimizes treatment for that population.

Clinicians have asked about other medicines many women take to treat anxiety including gabapentin, hydroxyzine, and benzodiazepines. Because of concerns about dependence and about using benzodiazepines during pregnancy, hydroxyzine is frequently used despite sparse reproductive safety data. Data on the effectiveness of hydroxyzine is even smaller and tends to be incomplete for patients with more moderate to severe anxiety.

Our comfort level in our center is greater for using benzodiazepines in patients who are clearly not at risk for substance use disorder because particularly when used with selective serotonin reuptake inhibitors, we find it optimizes treatment, mitigates symptoms, and attenuates suffering.
 

Insomnia

For insomnia, cognitive behavioral therapy for insomnia (CBTI) has the most data for effectiveness. Pharmacologic interventions such as gabapentin and benzodiazepines are also frequently used as therapies for insomnia.

Concern about treating insomnia by perinatal psychiatrists comes from the knowledge that insomnia is so often comorbid with anxiety and depression. Psychiatrists must consider the possibility that complaints of insomnia are part of an underlying mood or anxiety disorder; it would be unfortunate to miss the underlying illness and only treat just symptoms of insomnia. That being said, circumscribed insomnia is not uncommon during pregnancy and needs to be managed accordingly.
 

Postpartum psychosis

It’s been noteworthy the extent to which rare cases of postpartum psychosis have been presented in our Virtual Round meetings during the pandemic. As discussed previously, postpartum psychosis is one of the most serious illnesses we treat in reproductive psychiatry.

The debate as to whether postpartum psychosis is a discrete circumscribed illness or an illness that recurs over time won’t be answered without better longitudinal data. What we can say is there is no role, particularly during the pandemic, for outpatient management of postpartum psychosis. The waxing and waning of psychotic symptoms, while reassuring when patients are compensated, are of great concern when patients are psychotic and not in a safe environment.

While there are no consensus guidelines for postpartum psychosis treatment, the data support use of agents such as lithium. Growing data exist on the use of atypical antipsychotics to ameliorate psychotic symptoms and get patients functioning as quickly as possible. Resolution of postpartum psychosis may take a considerable amount of time. During the pandemic, it is critical that appropriate resources be managed before patients leave the hospital, including support by family, open communication with community-based providers, and support groups.

Nineteen months into the pandemic, it seems we’ve learned much: how to leverage technology like telemedicine, and the upsides of folding in our multidisciplinary colleagues to reduce barriers around collaboration and learn from one another to provide the best care for our shared patients.

*This column was updated on Jan. 11. 2022.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

For the last 25 years, my colleagues have spent midday on Wednesdays at clinical rounds as a group – a time spent reviewing cases in perinatal psychiatry and important new scientific findings in the literature that inform patient care. At the start of the pandemic, my colleague Marlene Freeman, MD, and I started Virtual Rounds at the Center for Women’s Mental Health to open our rounds to colleagues involved in multiple aspects of perinatal psychiatric care.

In my last column of 2021, I wanted to take the opportunity to reflect on some of what we have learned from 19 months of virtual rounding as a community of clinicians during the pandemic.

Telemedicine

Telemedicine allows us to see into the homes, relationships, and environments of our pregnant and postpartum women in a way we could never have imagined. It’s an opportunity to follow patients closely and intervene sooner rather than later, which might have been constrained by pre–COVID-19 typical scheduled office appointments. Telemedicine also gives us a clearer sense of some of the issues faced by underserved and marginalized populations of patients as we look to increase outreach to those groups.

COVID-19 vaccines in pregnancy

We now know much more about the potential for COVID-19 to cause complications during pregnancy than we did earlier in the pandemic. Although there may be a variety of factors fueling whether those in the general population decide to get vaccinated or not, there is no ambiguity in the message from our colleagues in obstetrics about the importance of vaccination for pregnant and postpartum women.

Bipolar disorder

Appropriate treatment for the spectrum of subtypes of bipolar disorder during pregnancy in the postpartum period is a frequent topic of discussion that colleagues raise. The pandemic has kindled clinical worsening for women with mood and anxiety disorders presumably driven by a host of factors ranging from shifts in medication adherence to sleep dysregulation to name just a few. Bipolar II disorder is underdiagnosed, yet there’s a growing appreciation of the morbidity associated with this subtype of bipolar disorder, which probably equals that of other groups on the bipolar spectrum such as those with bipolar I disorder.

Sustaining emotional well-being for bipolar women during pregnancy has never been more important than during the pandemic since psychiatric illness during pregnancy is the strongest predictor of risk for postpartum psychiatric disorder and the literature demonstrates that bipolar women are at particular risk for postpartum mood disorder. Historically, treatment of bipolar disorder during pregnancy was particularly problematic for clinicians and patients deciding about potential use of pharmacotherapy because options were finite; some treatments were known teratogens (valproate and to a far less extent lithium) and other newer treatments for bipolar disorder had sparse reproductive safety data (second-generation antipsychotics).

The message today is we have tools to safely treat bipolar disorder during pregnancy and the postpartum period not available 10 years ago. Lithium is likely underused and can be safely used during pregnancy; we have vast data on the effectiveness of lithium in bipolar disorder. Clinicians should also know that lamotrigine is safe to use for pregnant women with bipolar disorder and the data show no increased risk for major malformations associated with first trimester exposure. In the case of atypical antipsychotics, which increasingly are used in the treatment of bipolar disorder, the take-home message is our comfort level using these medicines during pregnancy is growing given more data supporting that atypical antipsychotics are not major teratogens.

We’ve also learned polytherapy is the rule, not the exception. As my colleague Adele Viguera, MD, recently referenced in Virtual Rounds: Polytherapy is a small price to pay when the other side is sustaining euthymia in bipolar disorder.

What we’ve learned about treating perinatal mood disorder is it takes a village of clinicians and resources to treat and mitigate risk for recurrence. Nothing is more important than either ensuring or recapturing maternal euthymia. The flip side is a recent report that maternal self-harm/suicide is the leading cause of death in the first year postpartum. It is a charge to the medical community at large to screen for maternal psychiatric illness and, more importantly, to refer patients and ensure they receive adequate care during the postpartum period.
 

Anxiety

Anxiety and insomnia have been prevalent during the pandemic. Pregnancy-associated and postpartum anxiety have been underappreciated in lieu of focusing on perinatal depression, and we lack consensus regarding the most appropriate treatment of perinatal anxiety. Nonpharmacologic interventions have been extremely helpful for women whose anxiety is mild to moderate or as an adjunct to pharmacologic intervention for patients with more severe anxiety disorders.

Robust data on untreated anxiety during pregnancy suggest it leads to adverse outcomes. The reproductive safety rules above for depression also apply for anxiety. Here, we find a multimodal approach, both nonpharmacologic and pharmacologic, optimizes treatment for that population.

Clinicians have asked about other medicines many women take to treat anxiety including gabapentin, hydroxyzine, and benzodiazepines. Because of concerns about dependence and about using benzodiazepines during pregnancy, hydroxyzine is frequently used despite sparse reproductive safety data. Data on the effectiveness of hydroxyzine is even smaller and tends to be incomplete for patients with more moderate to severe anxiety.

Our comfort level in our center is greater for using benzodiazepines in patients who are clearly not at risk for substance use disorder because particularly when used with selective serotonin reuptake inhibitors, we find it optimizes treatment, mitigates symptoms, and attenuates suffering.
 

Insomnia

For insomnia, cognitive behavioral therapy for insomnia (CBTI) has the most data for effectiveness. Pharmacologic interventions such as gabapentin and benzodiazepines are also frequently used as therapies for insomnia.

Concern about treating insomnia by perinatal psychiatrists comes from the knowledge that insomnia is so often comorbid with anxiety and depression. Psychiatrists must consider the possibility that complaints of insomnia are part of an underlying mood or anxiety disorder; it would be unfortunate to miss the underlying illness and only treat just symptoms of insomnia. That being said, circumscribed insomnia is not uncommon during pregnancy and needs to be managed accordingly.
 

Postpartum psychosis

It’s been noteworthy the extent to which rare cases of postpartum psychosis have been presented in our Virtual Round meetings during the pandemic. As discussed previously, postpartum psychosis is one of the most serious illnesses we treat in reproductive psychiatry.

The debate as to whether postpartum psychosis is a discrete circumscribed illness or an illness that recurs over time won’t be answered without better longitudinal data. What we can say is there is no role, particularly during the pandemic, for outpatient management of postpartum psychosis. The waxing and waning of psychotic symptoms, while reassuring when patients are compensated, are of great concern when patients are psychotic and not in a safe environment.

While there are no consensus guidelines for postpartum psychosis treatment, the data support use of agents such as lithium. Growing data exist on the use of atypical antipsychotics to ameliorate psychotic symptoms and get patients functioning as quickly as possible. Resolution of postpartum psychosis may take a considerable amount of time. During the pandemic, it is critical that appropriate resources be managed before patients leave the hospital, including support by family, open communication with community-based providers, and support groups.

Nineteen months into the pandemic, it seems we’ve learned much: how to leverage technology like telemedicine, and the upsides of folding in our multidisciplinary colleagues to reduce barriers around collaboration and learn from one another to provide the best care for our shared patients.

*This column was updated on Jan. 11. 2022.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Women whose ovaries were surgically removed before the age of 46 had a higher risk of mild cognitive impairment (MCI) around 30 years later, compared with those who did not undergo bilateral oophorectomy, according to a population-based linkage study published in JAMA Network Open.

The findings suggest that “physicians treating women with premenopausal bilateral oophorectomy need to be aware of their patients’ risk of cognitive impairment or MCI and should consider implementing treatment-monitoring plans,” noted lead author Walter A. Rocca, MD, MPH, from the division of epidemiology, department of quantitative health sciences, at the Mayo Clinic, Rochester, Minn. and colleagues.

The results may particularly “help women at mean risk levels of ovarian cancer to better evaluate the risk-to-benefit ratio of undergoing bilateral oophorectomy prior to spontaneous menopause for the prevention of ovarian cancer,” they emphasized.

While the link between premenopausal bilateral oophorectomy and higher risk of cognitive impairment has been previously suggested, this new study “contributes valuable new data to a major public health importance issue and addresses a number of important shortcomings of existing literature,” Marios K. Georgakis, MD, PhD, and Eleni T. Petridou, MD, PhD, noted in an accompanying commentary.

“As bilateral oophorectomy is still a common procedure at least in well-resourced countries, the results of these studies should alert clinicians about its potential public health consequences. Given that the abrupt cessation of ovarian hormones might be accompanied by previously underestimated long-term adverse effects, treating physicians proposing the operation should weigh its benefits against potential long-term harmful effects, especially among women without an absolute indication,” noted Dr. Georgakis and Dr. Petridou, respectively from the Center for Genomic Medicine at Massachusetts General Hospital in Boston and the National and Kapodistrian University of Athens.

The case-control cross-sectional study used data from the Mayo Clinic Study of Aging (MCSA), a prospective, population-based study examining risk factors for, as well as prevalence and incidence of cognitive decline and MCI among a representative sample of women in Olmsted County, Minn. It included 2,732 women aged 50-89 years who participated in the MCSA study from 2004 to 2019 and underwent a clinical evaluation and comprehensive cognitive testing including nine tests covering four cognitive domains. Almost all of the subjects (98.4%) were White. The mean age of cognitive evaluation was 74 years – at which time 283 women (10.4%) were diagnosed with MCI (197 with amnestic and 86 with nonamnestic MCI). Data from the Rochester Epidemiology Project medical record–linkage system showed a total of 625 women (22.9%) had a history of bilateral oophorectomy. Among this group, 161 women underwent the procedure both before age 46, and before menopause, with 46 (28.6%) receiving oral conjugated equine estrogen (unopposed) and the remaining 95 (59.0%) receiving no estrogen therapy.

The study found that, compared with women who did not undergo bilateral oophorectomy, those who did so before age 46, but not after this age, had statistically significantly increased odds of MCI (adjusted odds ratio, 2.21; P < .001). When type of MCI was examined, the risk was statistically significant for nonamnestic MCI (aOR, 2.96; P < .001), and amnestic (aOR, 1.87; P =.03). The study also found no evidence that estrogen therapy was associated with decreased risk of MCI among women aged less than 46 years, with an aOR of 2.56 in those who received estrogen therapy and 2.05 in those who did not (P = .01 for both).

Finally, in women who had bilateral oophorectomy before menopause and before age 50, surgical indication for the procedure affected the association with MCI. Indications of either cancer or “no ovarian condition” (i.e., performed at the time of hysterectomy) were associated with no increased risk, whereas there was a statistically significantly increased risk associated with benign indications such as an adnexal mass, cyst or endometriosis (aOR, 2.43; P = .003). “This is important,” noted the commentators, “because in many of those cases removal of both ovaries could be avoided.”

The study also found that, compared with women who had not undergone bilateral oophorectomy, those who had also had increased frequency of cardiovascular risk factors, heart disease, and stroke at the time of their cognitive evaluation. “Additional research is needed to clarify the biological explanation of the association,” the investigators said.

The prevailing hypothesis for why premenopausal bilateral oophorectomy is associated with cognitive decline “is that the abrupt endocrine cessation of exposure to ovarian hormones accelerates the aging process,” the commentators noted. “Most important from a clinical perspective is whether these women would benefit from specific hormone replacement therapy schemes. Observational studies cannot reliably answer this question, and possibly it is time to rethink designing trials in specific groups of women who underwent bilateral oophorectomy before 46 years of age starting treatment immediately thereafter.”

In an interview Dr. Georgakis elaborated on this point, saying that, while the Women’s Health Study clearly showed no benefit of hormone replacement therapy for preventing dementia, it recruited women who were aged 65 years or older and had therefore undergone menopause more than 10-15 years earlier. “A hypothesis suggests that a critical vulnerability window exists shortly after menopause during which hormone replacement therapy might be needed to ameliorate any elevated risk,” he said. “Thus, it might make sense to reconsider a trial focused on this group of premenopausal women, who need to undergo oophorectomy at a young age (<46 years). Early initiation would be important. Unfortunately, such a trial would be difficult to conduct, because these women would need to be followed up for very long periods, as cognitive decline usually does not occur before the age of 65.”

Asked to comment on the study, Meadow Good, DO, an ob.gyn., female pelvic medicine and reconstructive surgeon, and physician adviser for Winnie Palmer Hospital for Women & Babies in Orlando, said this study adds credibility to previous studies showing the cognitive risk associated with premenopausal bilateral oophorectomy. “The literature is now pointing to a need to refrain from elective bilateral oophorectomy in women less than 60,” she said in an interview. “It should not be common that a women receives a bilateral oophorectomy before 60 for benign reasons.”

She added that cognition is not the only think at stake. “Bilateral oophorectomy before the age of 60 has a higher risk of incident heart disease, stroke, lung cancer and total cancers,” she said, citing a prospective cohort study within the Nurses’ Health Study.

Dr. Rocca reported financial support from the Mayo Clinic Research Committee during the conduct of the study. One coauthor reported unrestricted grants from Biogen and consulting fees from Brain Protection outside the submitted work. No other disclosures were reported from the authors. Dr. Georgakis, Dr. Petridou, and Dr. Good reported no conflicts of interest. The study was funded by the National Institute on Aging. It also used resources of the Rochester Epidemiology Project medical record–linkage system, which is supported by the NIA, the Mayo Clinic Research Committee, and user fees. Dr. Rocca was partly funded by the Ralph S. and Beverley E. Caulkins Professorship of Neurodegenerative Diseases Research of the Mayo Clinic.

Women whose ovaries were surgically removed before the age of 46 had a higher risk of mild cognitive impairment (MCI) around 30 years later, compared with those who did not undergo bilateral oophorectomy, according to a population-based linkage study published in JAMA Network Open.

The findings suggest that “physicians treating women with premenopausal bilateral oophorectomy need to be aware of their patients’ risk of cognitive impairment or MCI and should consider implementing treatment-monitoring plans,” noted lead author Walter A. Rocca, MD, MPH, from the division of epidemiology, department of quantitative health sciences, at the Mayo Clinic, Rochester, Minn. and colleagues.

The results may particularly “help women at mean risk levels of ovarian cancer to better evaluate the risk-to-benefit ratio of undergoing bilateral oophorectomy prior to spontaneous menopause for the prevention of ovarian cancer,” they emphasized.

While the link between premenopausal bilateral oophorectomy and higher risk of cognitive impairment has been previously suggested, this new study “contributes valuable new data to a major public health importance issue and addresses a number of important shortcomings of existing literature,” Marios K. Georgakis, MD, PhD, and Eleni T. Petridou, MD, PhD, noted in an accompanying commentary.

“As bilateral oophorectomy is still a common procedure at least in well-resourced countries, the results of these studies should alert clinicians about its potential public health consequences. Given that the abrupt cessation of ovarian hormones might be accompanied by previously underestimated long-term adverse effects, treating physicians proposing the operation should weigh its benefits against potential long-term harmful effects, especially among women without an absolute indication,” noted Dr. Georgakis and Dr. Petridou, respectively from the Center for Genomic Medicine at Massachusetts General Hospital in Boston and the National and Kapodistrian University of Athens.

The case-control cross-sectional study used data from the Mayo Clinic Study of Aging (MCSA), a prospective, population-based study examining risk factors for, as well as prevalence and incidence of cognitive decline and MCI among a representative sample of women in Olmsted County, Minn. It included 2,732 women aged 50-89 years who participated in the MCSA study from 2004 to 2019 and underwent a clinical evaluation and comprehensive cognitive testing including nine tests covering four cognitive domains. Almost all of the subjects (98.4%) were White. The mean age of cognitive evaluation was 74 years – at which time 283 women (10.4%) were diagnosed with MCI (197 with amnestic and 86 with nonamnestic MCI). Data from the Rochester Epidemiology Project medical record–linkage system showed a total of 625 women (22.9%) had a history of bilateral oophorectomy. Among this group, 161 women underwent the procedure both before age 46, and before menopause, with 46 (28.6%) receiving oral conjugated equine estrogen (unopposed) and the remaining 95 (59.0%) receiving no estrogen therapy.

The study found that, compared with women who did not undergo bilateral oophorectomy, those who did so before age 46, but not after this age, had statistically significantly increased odds of MCI (adjusted odds ratio, 2.21; P < .001). When type of MCI was examined, the risk was statistically significant for nonamnestic MCI (aOR, 2.96; P < .001), and amnestic (aOR, 1.87; P =.03). The study also found no evidence that estrogen therapy was associated with decreased risk of MCI among women aged less than 46 years, with an aOR of 2.56 in those who received estrogen therapy and 2.05 in those who did not (P = .01 for both).

Finally, in women who had bilateral oophorectomy before menopause and before age 50, surgical indication for the procedure affected the association with MCI. Indications of either cancer or “no ovarian condition” (i.e., performed at the time of hysterectomy) were associated with no increased risk, whereas there was a statistically significantly increased risk associated with benign indications such as an adnexal mass, cyst or endometriosis (aOR, 2.43; P = .003). “This is important,” noted the commentators, “because in many of those cases removal of both ovaries could be avoided.”

The study also found that, compared with women who had not undergone bilateral oophorectomy, those who had also had increased frequency of cardiovascular risk factors, heart disease, and stroke at the time of their cognitive evaluation. “Additional research is needed to clarify the biological explanation of the association,” the investigators said.

The prevailing hypothesis for why premenopausal bilateral oophorectomy is associated with cognitive decline “is that the abrupt endocrine cessation of exposure to ovarian hormones accelerates the aging process,” the commentators noted. “Most important from a clinical perspective is whether these women would benefit from specific hormone replacement therapy schemes. Observational studies cannot reliably answer this question, and possibly it is time to rethink designing trials in specific groups of women who underwent bilateral oophorectomy before 46 years of age starting treatment immediately thereafter.”

In an interview Dr. Georgakis elaborated on this point, saying that, while the Women’s Health Study clearly showed no benefit of hormone replacement therapy for preventing dementia, it recruited women who were aged 65 years or older and had therefore undergone menopause more than 10-15 years earlier. “A hypothesis suggests that a critical vulnerability window exists shortly after menopause during which hormone replacement therapy might be needed to ameliorate any elevated risk,” he said. “Thus, it might make sense to reconsider a trial focused on this group of premenopausal women, who need to undergo oophorectomy at a young age (<46 years). Early initiation would be important. Unfortunately, such a trial would be difficult to conduct, because these women would need to be followed up for very long periods, as cognitive decline usually does not occur before the age of 65.”

Asked to comment on the study, Meadow Good, DO, an ob.gyn., female pelvic medicine and reconstructive surgeon, and physician adviser for Winnie Palmer Hospital for Women & Babies in Orlando, said this study adds credibility to previous studies showing the cognitive risk associated with premenopausal bilateral oophorectomy. “The literature is now pointing to a need to refrain from elective bilateral oophorectomy in women less than 60,” she said in an interview. “It should not be common that a women receives a bilateral oophorectomy before 60 for benign reasons.”

She added that cognition is not the only think at stake. “Bilateral oophorectomy before the age of 60 has a higher risk of incident heart disease, stroke, lung cancer and total cancers,” she said, citing a prospective cohort study within the Nurses’ Health Study.

Dr. Rocca reported financial support from the Mayo Clinic Research Committee during the conduct of the study. One coauthor reported unrestricted grants from Biogen and consulting fees from Brain Protection outside the submitted work. No other disclosures were reported from the authors. Dr. Georgakis, Dr. Petridou, and Dr. Good reported no conflicts of interest. The study was funded by the National Institute on Aging. It also used resources of the Rochester Epidemiology Project medical record–linkage system, which is supported by the NIA, the Mayo Clinic Research Committee, and user fees. Dr. Rocca was partly funded by the Ralph S. and Beverley E. Caulkins Professorship of Neurodegenerative Diseases Research of the Mayo Clinic.

Women whose ovaries were surgically removed before the age of 46 had a higher risk of mild cognitive impairment (MCI) around 30 years later, compared with those who did not undergo bilateral oophorectomy, according to a population-based linkage study published in JAMA Network Open.

The findings suggest that “physicians treating women with premenopausal bilateral oophorectomy need to be aware of their patients’ risk of cognitive impairment or MCI and should consider implementing treatment-monitoring plans,” noted lead author Walter A. Rocca, MD, MPH, from the division of epidemiology, department of quantitative health sciences, at the Mayo Clinic, Rochester, Minn. and colleagues.

The results may particularly “help women at mean risk levels of ovarian cancer to better evaluate the risk-to-benefit ratio of undergoing bilateral oophorectomy prior to spontaneous menopause for the prevention of ovarian cancer,” they emphasized.

While the link between premenopausal bilateral oophorectomy and higher risk of cognitive impairment has been previously suggested, this new study “contributes valuable new data to a major public health importance issue and addresses a number of important shortcomings of existing literature,” Marios K. Georgakis, MD, PhD, and Eleni T. Petridou, MD, PhD, noted in an accompanying commentary.

“As bilateral oophorectomy is still a common procedure at least in well-resourced countries, the results of these studies should alert clinicians about its potential public health consequences. Given that the abrupt cessation of ovarian hormones might be accompanied by previously underestimated long-term adverse effects, treating physicians proposing the operation should weigh its benefits against potential long-term harmful effects, especially among women without an absolute indication,” noted Dr. Georgakis and Dr. Petridou, respectively from the Center for Genomic Medicine at Massachusetts General Hospital in Boston and the National and Kapodistrian University of Athens.

The case-control cross-sectional study used data from the Mayo Clinic Study of Aging (MCSA), a prospective, population-based study examining risk factors for, as well as prevalence and incidence of cognitive decline and MCI among a representative sample of women in Olmsted County, Minn. It included 2,732 women aged 50-89 years who participated in the MCSA study from 2004 to 2019 and underwent a clinical evaluation and comprehensive cognitive testing including nine tests covering four cognitive domains. Almost all of the subjects (98.4%) were White. The mean age of cognitive evaluation was 74 years – at which time 283 women (10.4%) were diagnosed with MCI (197 with amnestic and 86 with nonamnestic MCI). Data from the Rochester Epidemiology Project medical record–linkage system showed a total of 625 women (22.9%) had a history of bilateral oophorectomy. Among this group, 161 women underwent the procedure both before age 46, and before menopause, with 46 (28.6%) receiving oral conjugated equine estrogen (unopposed) and the remaining 95 (59.0%) receiving no estrogen therapy.

The study found that, compared with women who did not undergo bilateral oophorectomy, those who did so before age 46, but not after this age, had statistically significantly increased odds of MCI (adjusted odds ratio, 2.21; P < .001). When type of MCI was examined, the risk was statistically significant for nonamnestic MCI (aOR, 2.96; P < .001), and amnestic (aOR, 1.87; P =.03). The study also found no evidence that estrogen therapy was associated with decreased risk of MCI among women aged less than 46 years, with an aOR of 2.56 in those who received estrogen therapy and 2.05 in those who did not (P = .01 for both).

Finally, in women who had bilateral oophorectomy before menopause and before age 50, surgical indication for the procedure affected the association with MCI. Indications of either cancer or “no ovarian condition” (i.e., performed at the time of hysterectomy) were associated with no increased risk, whereas there was a statistically significantly increased risk associated with benign indications such as an adnexal mass, cyst or endometriosis (aOR, 2.43; P = .003). “This is important,” noted the commentators, “because in many of those cases removal of both ovaries could be avoided.”

The study also found that, compared with women who had not undergone bilateral oophorectomy, those who had also had increased frequency of cardiovascular risk factors, heart disease, and stroke at the time of their cognitive evaluation. “Additional research is needed to clarify the biological explanation of the association,” the investigators said.

The prevailing hypothesis for why premenopausal bilateral oophorectomy is associated with cognitive decline “is that the abrupt endocrine cessation of exposure to ovarian hormones accelerates the aging process,” the commentators noted. “Most important from a clinical perspective is whether these women would benefit from specific hormone replacement therapy schemes. Observational studies cannot reliably answer this question, and possibly it is time to rethink designing trials in specific groups of women who underwent bilateral oophorectomy before 46 years of age starting treatment immediately thereafter.”

In an interview Dr. Georgakis elaborated on this point, saying that, while the Women’s Health Study clearly showed no benefit of hormone replacement therapy for preventing dementia, it recruited women who were aged 65 years or older and had therefore undergone menopause more than 10-15 years earlier. “A hypothesis suggests that a critical vulnerability window exists shortly after menopause during which hormone replacement therapy might be needed to ameliorate any elevated risk,” he said. “Thus, it might make sense to reconsider a trial focused on this group of premenopausal women, who need to undergo oophorectomy at a young age (<46 years). Early initiation would be important. Unfortunately, such a trial would be difficult to conduct, because these women would need to be followed up for very long periods, as cognitive decline usually does not occur before the age of 65.”

Asked to comment on the study, Meadow Good, DO, an ob.gyn., female pelvic medicine and reconstructive surgeon, and physician adviser for Winnie Palmer Hospital for Women & Babies in Orlando, said this study adds credibility to previous studies showing the cognitive risk associated with premenopausal bilateral oophorectomy. “The literature is now pointing to a need to refrain from elective bilateral oophorectomy in women less than 60,” she said in an interview. “It should not be common that a women receives a bilateral oophorectomy before 60 for benign reasons.”

She added that cognition is not the only think at stake. “Bilateral oophorectomy before the age of 60 has a higher risk of incident heart disease, stroke, lung cancer and total cancers,” she said, citing a prospective cohort study within the Nurses’ Health Study.

Dr. Rocca reported financial support from the Mayo Clinic Research Committee during the conduct of the study. One coauthor reported unrestricted grants from Biogen and consulting fees from Brain Protection outside the submitted work. No other disclosures were reported from the authors. Dr. Georgakis, Dr. Petridou, and Dr. Good reported no conflicts of interest. The study was funded by the National Institute on Aging. It also used resources of the Rochester Epidemiology Project medical record–linkage system, which is supported by the NIA, the Mayo Clinic Research Committee, and user fees. Dr. Rocca was partly funded by the Ralph S. and Beverley E. Caulkins Professorship of Neurodegenerative Diseases Research of the Mayo Clinic.

Women with a history of stage III to stage IV breast cancer had significantly more pathologic vertebral fractures compared to those with stage I and stage II disease, based on data from approximately 5,000 adult women.

Breast cancer remains associated with increased fracture risk in part because of estrogen deficiency, aromatase inhibitors, frailty, and skeletal metastases, wrote Joan C. Lo, MD, of Kaiser Permanente Northern California, Oakland, and colleagues. Fractures associated with these factors have been studied, but many of the existing epidemiologic studies lack detail on fractures related to cancer, they noted. The researchers examined the association between pathologic fractures and major osteoporotic fractures in women with invasive breast cancer who received endocrine therapy.

In a study published in JAMA Network Open (2021 Nov 18. doi: 10.1001/jamanetworkopen.2021.33861), the researchers reviewed data from 5,010 women enrolled in the Pathways Study (3,312 women) or Research Program on Genes, Environment, and Health (RPGEH) study (1,698 women) with newly diagnosed invasive breast cancer who received endocrine therapy. The women were followed for up to 10 years for incident fracture, with a median follow-up period of 6.7 years.

The average age of the women was 60.2 years; 73.3% were non-Hispanic White, 4.9% were Black, 9.4% were Hispanic, and 1.6% were women whose ethnicity was unknown. Approximately 90% of the women were at stage I to stage II at initial diagnosis.

Overall, 340 (6.8%) had incident fractures during the follow-up period. The incident fractures included 46 hip, 104 vertebral, 78 humerus, and 137 wrist fractures. Significantly more women with hip fracture (43.5%) were age 80 years or older, compared with less than 25% of women with vertebral fractures (22.1%), humerus (19.2%), or wrist fracture (15.3%).

Pathologic fractures accounted for 22 of 104 incident vertebral fractures (21.2%) and fewer than 5 of 46 incident hip fractures (8.7%); few wrist and humerus fractures were pathologic. According to tumor stage, 15 of 87 (17.2%) vertebral fractures in women with initial stage I and II were pathologic, compared to 7 of 17 (41.2%) in women with initial stage III to stage IV breast cancer (P < .05).

The results emphasized the need to consider vertebral fracture risk in women with breast cancer, notably advanced stage cancer, as approximately one-third of the incident vertebral fractures in this subset of patients was deemed cancer-related, the researchers noted.

“As the axial skeleton is a common site for breast cancer metastasis and vertebrae a common site for pathologic fracture, primary care physicians should consider the possibility of pathologic fracture in women with higher risk based on advanced-stage cancer history,” the researchers wrote.

The study findings were limited by several factors, including the lack of data on fracture risk factors, treatment, and chemotherapy, and the inclusion only of clinically diagnosed fractures and not asymptomatic vertebral fractures, the researchers noted. However, the results were strengthened by the large sample size and comprehensive fracture assessment, they said. Additional studies to examine nonpathologic fracture risk according to breast cancer treatment, such as the use of aromatase inhibitors versus cytotoxic chemotherapy, may inform which women would benefit from more aggressive osteoporotic fracture prevention, they concluded.
 

Findings inform shared decision-making

“This study highlights the apparent association between an initial diagnosis of stage III or IV breast cancer and an increased risk for pathologic vertebral fracture,” said Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., in an interview. “Most likely this finding is secondary to breast cancer metastases,” Dr. Bohon noted. However, she questioned whether there is a difference in fracture rates between women who received only aromatase inhibitors, those who received tamoxifen, and those who received both treatments.

“Additional data to determine the age of menopause, exercise frequency, current weight, and family history of osteoporosis may serve to identify those at highest risk for pathologic vertebral fracture,” said Dr. Bohon. “Until further data are available, clinicians should review this study and counsel their patients regarding options to potentially mitigate their apparent increased risk for pathologic vertebral fracture,” she emphasized.

The study was supported by the National Cancer Institute, National Institutes of Health, and the Research Program on Genes, Environment, and Health of Kaiser Permanente Northern California. The researchers had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose but serves on the Editorial Advisory Board of Ob.Gyn. News.

[email protected]

Women with a history of stage III to stage IV breast cancer had significantly more pathologic vertebral fractures compared to those with stage I and stage II disease, based on data from approximately 5,000 adult women.

Breast cancer remains associated with increased fracture risk in part because of estrogen deficiency, aromatase inhibitors, frailty, and skeletal metastases, wrote Joan C. Lo, MD, of Kaiser Permanente Northern California, Oakland, and colleagues. Fractures associated with these factors have been studied, but many of the existing epidemiologic studies lack detail on fractures related to cancer, they noted. The researchers examined the association between pathologic fractures and major osteoporotic fractures in women with invasive breast cancer who received endocrine therapy.

In a study published in JAMA Network Open (2021 Nov 18. doi: 10.1001/jamanetworkopen.2021.33861), the researchers reviewed data from 5,010 women enrolled in the Pathways Study (3,312 women) or Research Program on Genes, Environment, and Health (RPGEH) study (1,698 women) with newly diagnosed invasive breast cancer who received endocrine therapy. The women were followed for up to 10 years for incident fracture, with a median follow-up period of 6.7 years.

The average age of the women was 60.2 years; 73.3% were non-Hispanic White, 4.9% were Black, 9.4% were Hispanic, and 1.6% were women whose ethnicity was unknown. Approximately 90% of the women were at stage I to stage II at initial diagnosis.

Overall, 340 (6.8%) had incident fractures during the follow-up period. The incident fractures included 46 hip, 104 vertebral, 78 humerus, and 137 wrist fractures. Significantly more women with hip fracture (43.5%) were age 80 years or older, compared with less than 25% of women with vertebral fractures (22.1%), humerus (19.2%), or wrist fracture (15.3%).

Pathologic fractures accounted for 22 of 104 incident vertebral fractures (21.2%) and fewer than 5 of 46 incident hip fractures (8.7%); few wrist and humerus fractures were pathologic. According to tumor stage, 15 of 87 (17.2%) vertebral fractures in women with initial stage I and II were pathologic, compared to 7 of 17 (41.2%) in women with initial stage III to stage IV breast cancer (P < .05).

The results emphasized the need to consider vertebral fracture risk in women with breast cancer, notably advanced stage cancer, as approximately one-third of the incident vertebral fractures in this subset of patients was deemed cancer-related, the researchers noted.

“As the axial skeleton is a common site for breast cancer metastasis and vertebrae a common site for pathologic fracture, primary care physicians should consider the possibility of pathologic fracture in women with higher risk based on advanced-stage cancer history,” the researchers wrote.

The study findings were limited by several factors, including the lack of data on fracture risk factors, treatment, and chemotherapy, and the inclusion only of clinically diagnosed fractures and not asymptomatic vertebral fractures, the researchers noted. However, the results were strengthened by the large sample size and comprehensive fracture assessment, they said. Additional studies to examine nonpathologic fracture risk according to breast cancer treatment, such as the use of aromatase inhibitors versus cytotoxic chemotherapy, may inform which women would benefit from more aggressive osteoporotic fracture prevention, they concluded.
 

Findings inform shared decision-making

“This study highlights the apparent association between an initial diagnosis of stage III or IV breast cancer and an increased risk for pathologic vertebral fracture,” said Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., in an interview. “Most likely this finding is secondary to breast cancer metastases,” Dr. Bohon noted. However, she questioned whether there is a difference in fracture rates between women who received only aromatase inhibitors, those who received tamoxifen, and those who received both treatments.

“Additional data to determine the age of menopause, exercise frequency, current weight, and family history of osteoporosis may serve to identify those at highest risk for pathologic vertebral fracture,” said Dr. Bohon. “Until further data are available, clinicians should review this study and counsel their patients regarding options to potentially mitigate their apparent increased risk for pathologic vertebral fracture,” she emphasized.

The study was supported by the National Cancer Institute, National Institutes of Health, and the Research Program on Genes, Environment, and Health of Kaiser Permanente Northern California. The researchers had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose but serves on the Editorial Advisory Board of Ob.Gyn. News.

[email protected]

Women with a history of stage III to stage IV breast cancer had significantly more pathologic vertebral fractures compared to those with stage I and stage II disease, based on data from approximately 5,000 adult women.

Breast cancer remains associated with increased fracture risk in part because of estrogen deficiency, aromatase inhibitors, frailty, and skeletal metastases, wrote Joan C. Lo, MD, of Kaiser Permanente Northern California, Oakland, and colleagues. Fractures associated with these factors have been studied, but many of the existing epidemiologic studies lack detail on fractures related to cancer, they noted. The researchers examined the association between pathologic fractures and major osteoporotic fractures in women with invasive breast cancer who received endocrine therapy.

In a study published in JAMA Network Open (2021 Nov 18. doi: 10.1001/jamanetworkopen.2021.33861), the researchers reviewed data from 5,010 women enrolled in the Pathways Study (3,312 women) or Research Program on Genes, Environment, and Health (RPGEH) study (1,698 women) with newly diagnosed invasive breast cancer who received endocrine therapy. The women were followed for up to 10 years for incident fracture, with a median follow-up period of 6.7 years.

The average age of the women was 60.2 years; 73.3% were non-Hispanic White, 4.9% were Black, 9.4% were Hispanic, and 1.6% were women whose ethnicity was unknown. Approximately 90% of the women were at stage I to stage II at initial diagnosis.

Overall, 340 (6.8%) had incident fractures during the follow-up period. The incident fractures included 46 hip, 104 vertebral, 78 humerus, and 137 wrist fractures. Significantly more women with hip fracture (43.5%) were age 80 years or older, compared with less than 25% of women with vertebral fractures (22.1%), humerus (19.2%), or wrist fracture (15.3%).

Pathologic fractures accounted for 22 of 104 incident vertebral fractures (21.2%) and fewer than 5 of 46 incident hip fractures (8.7%); few wrist and humerus fractures were pathologic. According to tumor stage, 15 of 87 (17.2%) vertebral fractures in women with initial stage I and II were pathologic, compared to 7 of 17 (41.2%) in women with initial stage III to stage IV breast cancer (P < .05).

The results emphasized the need to consider vertebral fracture risk in women with breast cancer, notably advanced stage cancer, as approximately one-third of the incident vertebral fractures in this subset of patients was deemed cancer-related, the researchers noted.

“As the axial skeleton is a common site for breast cancer metastasis and vertebrae a common site for pathologic fracture, primary care physicians should consider the possibility of pathologic fracture in women with higher risk based on advanced-stage cancer history,” the researchers wrote.

The study findings were limited by several factors, including the lack of data on fracture risk factors, treatment, and chemotherapy, and the inclusion only of clinically diagnosed fractures and not asymptomatic vertebral fractures, the researchers noted. However, the results were strengthened by the large sample size and comprehensive fracture assessment, they said. Additional studies to examine nonpathologic fracture risk according to breast cancer treatment, such as the use of aromatase inhibitors versus cytotoxic chemotherapy, may inform which women would benefit from more aggressive osteoporotic fracture prevention, they concluded.
 

Findings inform shared decision-making

“This study highlights the apparent association between an initial diagnosis of stage III or IV breast cancer and an increased risk for pathologic vertebral fracture,” said Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., in an interview. “Most likely this finding is secondary to breast cancer metastases,” Dr. Bohon noted. However, she questioned whether there is a difference in fracture rates between women who received only aromatase inhibitors, those who received tamoxifen, and those who received both treatments.

“Additional data to determine the age of menopause, exercise frequency, current weight, and family history of osteoporosis may serve to identify those at highest risk for pathologic vertebral fracture,” said Dr. Bohon. “Until further data are available, clinicians should review this study and counsel their patients regarding options to potentially mitigate their apparent increased risk for pathologic vertebral fracture,” she emphasized.

The study was supported by the National Cancer Institute, National Institutes of Health, and the Research Program on Genes, Environment, and Health of Kaiser Permanente Northern California. The researchers had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose but serves on the Editorial Advisory Board of Ob.Gyn. News.

[email protected]

SACRAMENTO – With access to abortion at stake across America, California is preparing to become the nation’s abortion provider.

Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January.

Abortion clinics are already girding themselves for a surge in demand.

Janet Jacobson, MD, medical director of Planned Parenthood of Orange and San Bernardino Counties, said three or four out-of-state patients visit her clinics each day – about double the number that sought treatment before a near-total ban on abortion took effect in Texas in September.

While the nine clinics can absorb that slow trickle, they expect up to 50 out-of-state patients a week if the U.S. Supreme Court’s conservative majority guts abortion rights nationally, Dr. Jacobson said. She bases her estimate on new data from the Guttmacher Institute, a research organization that supports abortion and reproductive health rights.

She is adding staff members and appointment capacity, hoping to accommodate everyone.

“We have to make sure we can still continue to care for all of our California patients,” Dr. Jacobson said. “We don’t want them getting squeezed out” of appointments.

The Texas law banned nearly all abortions after about 6 weeks of pregnancy and empowered private citizens to sue anyone who performs or “aids and abets” an abortion after that time. The Supreme Court heard arguments in that case on Nov. 1 and is expected to announce a ruling on its constitutionality in June. Nonetheless, Florida and Ohio have announced plans for copycat laws.

Next month the high court will hear another abortion case with even broader implications, Dobbs v. Jackson Women’s Health Organization, a lawsuit challenging the constitutionality of a 2018 Mississippi law that prohibited abortion after 15 weeks. If the court sides with Mississippi, its decision could overturn existing abortion rights set by the landmark Roe v. Wade case.

Should that happen, reproductive rights experts predict, 26 states will ban the procedure altogether, and states with stronger protections for abortion, like California, will draw even more patients. There could be up to a 3,000% increase in people who “may drive to California for abortion care” each year, according to the Guttmacher data.

In 2017, the most recent year for which data are available from Guttmacher, California – by far the nation’s most populous state – had more abortion providers than any other state, with 419 hospitals, clinics, or doctors’ offices performing the procedure. The next highest were New York, with 252, and Florida, with 85. Neighboring Arizona and Nevada each had 11. Of the 862,320 abortions performed in the United States that year, 132.680, about 15% were in California.

Planned Parenthood clinics in California say they already serve about 7,000 out-of-state patients a year and are expecting a surge of new ones, especially in travel hubs like the Los Angeles area.

In September, Planned Parenthood and groups such as Black Women for Wellness convened the California Future of Abortion Council with backing from influential Democratic leaders including Gov. Newsom, state Senate leader Toni Atkins, and Assembly Speaker Anthony Rendon.

Ms. Atkins, who was the director of a San Diego women’s health clinic in the 1980s, said she spent time with women from states where it was hard to get an abortion. She said California is committed to ensuring abortion access in the state and beyond.

The council is focused on increasing funding for abortion services, providing logistical and financial help for women who need to travel, increasing the number of health care providers who perform abortions, and strengthening legal protections for them.

Increasing capacity could mean licensing more practitioners to provide abortions or pumping more resources into telehealth so people can see a doctor online to prescribe pills for a medical abortion – a service California doctors currently can provide to patients only in California.

The most important thing the state should do is fix its shortage of providers, especially those who perform second-trimester abortions, which are more expensive and complicated than first-trimester abortions, said council member Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.

It’s not feasible to place an abortion provider in every corner of the state, Dr. Grossman said. Instead, the council should focus on creating “hubs that can provide abortion care for large numbers of people” in easy-to-get-to locations.

California already struggles to provide abortions to all who seek them, especially low-income women covered by Medi-Cal, California’s Medicaid program. For example, 28 counties – home to 10% of Medi-Cal recipients of childbearing age – don’t have facilities that provide abortions to Medi-Cal patients.

A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to an analysis by the California Health Benefits Review Program, but isn’t available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California.

One of the council’s recommendations will likely be to increase the rate Medi-Cal payments for abortions so more providers will perform them, said council member Fabiola Carrión, interim director for reproductive and sexual health at the National Health Law Program.

Medi-Cal pays $354.43 for a second-trimester abortion. A 2020 study in the journal Contraception found that states paid between $79 and $626 for a second-trimester abortion in 2017.

Increasing Medi-Cal rates won’t help patients traveling from outside California. Generally, private insurance doesn’t cover out-of-state abortions, so most women will be on the hook for the full cost, and those enrolled in other states’ Medicaid programs must pay out-of-pocket, too.

The council hopes to reduce costs for state residents and visitors, said Brandon Richards, director of communications for Planned Parenthood Affiliates of California. “It’s about making it easy for people to access abortion in California, whether they reside here or are coming in from out of state,” he said.

One way to target costs is by funding the practical support, like helping to pay for transportation, child care, hotels, or time off work, said council member Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.

Ms. Pinckney said she’s working with Los Angeles County to set up a public abortion fund to cover some of those costs for anyone seeking an abortion in the county. It would be modeled after similar pots maintained by the cities of New York; Austin, Tex.; and Portland, Ore., and could eventually be a template for the first statewide fund, Ms. Pinckney said.

Most Texans seeking abortions since that state’s law took effect are going to nearby states like Colorado, New Mexico, and Oklahoma, said Sierra Harris, deputy director of network strategies for the National Network of Abortion Funds. Women in those states, in turn, are having trouble getting care and are looking to California for appointments.

Practical support is important for out-of-state patients, said Alissa Perrucci, PhD, MPH, operations manager at the Women’s Options Center at Zuckerberg San Francisco General Hospital, one of five abortion clinics inside California hospitals.

Dr. Perrucci’s clinic is focusing on telemedicine, phone counseling, and other ways to save time so it can add appointments for out-of-state patients if necessary.

But more slots are useless if women can’t make it to California. The clinic has booked about 10 appointments for Texans since the state’s ban went into effect, but only half have shown up, mostly women with family connections in California.

“Most people just don’t have the money to get here,” she said. “If the burden of abortion was borne predominantly by the wealthy, yeah, they’d just fly here.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO – With access to abortion at stake across America, California is preparing to become the nation’s abortion provider.

Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January.

Abortion clinics are already girding themselves for a surge in demand.

Janet Jacobson, MD, medical director of Planned Parenthood of Orange and San Bernardino Counties, said three or four out-of-state patients visit her clinics each day – about double the number that sought treatment before a near-total ban on abortion took effect in Texas in September.

While the nine clinics can absorb that slow trickle, they expect up to 50 out-of-state patients a week if the U.S. Supreme Court’s conservative majority guts abortion rights nationally, Dr. Jacobson said. She bases her estimate on new data from the Guttmacher Institute, a research organization that supports abortion and reproductive health rights.

She is adding staff members and appointment capacity, hoping to accommodate everyone.

“We have to make sure we can still continue to care for all of our California patients,” Dr. Jacobson said. “We don’t want them getting squeezed out” of appointments.

The Texas law banned nearly all abortions after about 6 weeks of pregnancy and empowered private citizens to sue anyone who performs or “aids and abets” an abortion after that time. The Supreme Court heard arguments in that case on Nov. 1 and is expected to announce a ruling on its constitutionality in June. Nonetheless, Florida and Ohio have announced plans for copycat laws.

Next month the high court will hear another abortion case with even broader implications, Dobbs v. Jackson Women’s Health Organization, a lawsuit challenging the constitutionality of a 2018 Mississippi law that prohibited abortion after 15 weeks. If the court sides with Mississippi, its decision could overturn existing abortion rights set by the landmark Roe v. Wade case.

Should that happen, reproductive rights experts predict, 26 states will ban the procedure altogether, and states with stronger protections for abortion, like California, will draw even more patients. There could be up to a 3,000% increase in people who “may drive to California for abortion care” each year, according to the Guttmacher data.

In 2017, the most recent year for which data are available from Guttmacher, California – by far the nation’s most populous state – had more abortion providers than any other state, with 419 hospitals, clinics, or doctors’ offices performing the procedure. The next highest were New York, with 252, and Florida, with 85. Neighboring Arizona and Nevada each had 11. Of the 862,320 abortions performed in the United States that year, 132.680, about 15% were in California.

Planned Parenthood clinics in California say they already serve about 7,000 out-of-state patients a year and are expecting a surge of new ones, especially in travel hubs like the Los Angeles area.

In September, Planned Parenthood and groups such as Black Women for Wellness convened the California Future of Abortion Council with backing from influential Democratic leaders including Gov. Newsom, state Senate leader Toni Atkins, and Assembly Speaker Anthony Rendon.

Ms. Atkins, who was the director of a San Diego women’s health clinic in the 1980s, said she spent time with women from states where it was hard to get an abortion. She said California is committed to ensuring abortion access in the state and beyond.

The council is focused on increasing funding for abortion services, providing logistical and financial help for women who need to travel, increasing the number of health care providers who perform abortions, and strengthening legal protections for them.

Increasing capacity could mean licensing more practitioners to provide abortions or pumping more resources into telehealth so people can see a doctor online to prescribe pills for a medical abortion – a service California doctors currently can provide to patients only in California.

The most important thing the state should do is fix its shortage of providers, especially those who perform second-trimester abortions, which are more expensive and complicated than first-trimester abortions, said council member Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.

It’s not feasible to place an abortion provider in every corner of the state, Dr. Grossman said. Instead, the council should focus on creating “hubs that can provide abortion care for large numbers of people” in easy-to-get-to locations.

California already struggles to provide abortions to all who seek them, especially low-income women covered by Medi-Cal, California’s Medicaid program. For example, 28 counties – home to 10% of Medi-Cal recipients of childbearing age – don’t have facilities that provide abortions to Medi-Cal patients.

A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to an analysis by the California Health Benefits Review Program, but isn’t available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California.

One of the council’s recommendations will likely be to increase the rate Medi-Cal payments for abortions so more providers will perform them, said council member Fabiola Carrión, interim director for reproductive and sexual health at the National Health Law Program.

Medi-Cal pays $354.43 for a second-trimester abortion. A 2020 study in the journal Contraception found that states paid between $79 and $626 for a second-trimester abortion in 2017.

Increasing Medi-Cal rates won’t help patients traveling from outside California. Generally, private insurance doesn’t cover out-of-state abortions, so most women will be on the hook for the full cost, and those enrolled in other states’ Medicaid programs must pay out-of-pocket, too.

The council hopes to reduce costs for state residents and visitors, said Brandon Richards, director of communications for Planned Parenthood Affiliates of California. “It’s about making it easy for people to access abortion in California, whether they reside here or are coming in from out of state,” he said.

One way to target costs is by funding the practical support, like helping to pay for transportation, child care, hotels, or time off work, said council member Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.

Ms. Pinckney said she’s working with Los Angeles County to set up a public abortion fund to cover some of those costs for anyone seeking an abortion in the county. It would be modeled after similar pots maintained by the cities of New York; Austin, Tex.; and Portland, Ore., and could eventually be a template for the first statewide fund, Ms. Pinckney said.

Most Texans seeking abortions since that state’s law took effect are going to nearby states like Colorado, New Mexico, and Oklahoma, said Sierra Harris, deputy director of network strategies for the National Network of Abortion Funds. Women in those states, in turn, are having trouble getting care and are looking to California for appointments.

Practical support is important for out-of-state patients, said Alissa Perrucci, PhD, MPH, operations manager at the Women’s Options Center at Zuckerberg San Francisco General Hospital, one of five abortion clinics inside California hospitals.

Dr. Perrucci’s clinic is focusing on telemedicine, phone counseling, and other ways to save time so it can add appointments for out-of-state patients if necessary.

But more slots are useless if women can’t make it to California. The clinic has booked about 10 appointments for Texans since the state’s ban went into effect, but only half have shown up, mostly women with family connections in California.

“Most people just don’t have the money to get here,” she said. “If the burden of abortion was borne predominantly by the wealthy, yeah, they’d just fly here.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO – With access to abortion at stake across America, California is preparing to become the nation’s abortion provider.

Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January.

Abortion clinics are already girding themselves for a surge in demand.

Janet Jacobson, MD, medical director of Planned Parenthood of Orange and San Bernardino Counties, said three or four out-of-state patients visit her clinics each day – about double the number that sought treatment before a near-total ban on abortion took effect in Texas in September.

While the nine clinics can absorb that slow trickle, they expect up to 50 out-of-state patients a week if the U.S. Supreme Court’s conservative majority guts abortion rights nationally, Dr. Jacobson said. She bases her estimate on new data from the Guttmacher Institute, a research organization that supports abortion and reproductive health rights.

She is adding staff members and appointment capacity, hoping to accommodate everyone.

“We have to make sure we can still continue to care for all of our California patients,” Dr. Jacobson said. “We don’t want them getting squeezed out” of appointments.

The Texas law banned nearly all abortions after about 6 weeks of pregnancy and empowered private citizens to sue anyone who performs or “aids and abets” an abortion after that time. The Supreme Court heard arguments in that case on Nov. 1 and is expected to announce a ruling on its constitutionality in June. Nonetheless, Florida and Ohio have announced plans for copycat laws.

Next month the high court will hear another abortion case with even broader implications, Dobbs v. Jackson Women’s Health Organization, a lawsuit challenging the constitutionality of a 2018 Mississippi law that prohibited abortion after 15 weeks. If the court sides with Mississippi, its decision could overturn existing abortion rights set by the landmark Roe v. Wade case.

Should that happen, reproductive rights experts predict, 26 states will ban the procedure altogether, and states with stronger protections for abortion, like California, will draw even more patients. There could be up to a 3,000% increase in people who “may drive to California for abortion care” each year, according to the Guttmacher data.

In 2017, the most recent year for which data are available from Guttmacher, California – by far the nation’s most populous state – had more abortion providers than any other state, with 419 hospitals, clinics, or doctors’ offices performing the procedure. The next highest were New York, with 252, and Florida, with 85. Neighboring Arizona and Nevada each had 11. Of the 862,320 abortions performed in the United States that year, 132.680, about 15% were in California.

Planned Parenthood clinics in California say they already serve about 7,000 out-of-state patients a year and are expecting a surge of new ones, especially in travel hubs like the Los Angeles area.

In September, Planned Parenthood and groups such as Black Women for Wellness convened the California Future of Abortion Council with backing from influential Democratic leaders including Gov. Newsom, state Senate leader Toni Atkins, and Assembly Speaker Anthony Rendon.

Ms. Atkins, who was the director of a San Diego women’s health clinic in the 1980s, said she spent time with women from states where it was hard to get an abortion. She said California is committed to ensuring abortion access in the state and beyond.

The council is focused on increasing funding for abortion services, providing logistical and financial help for women who need to travel, increasing the number of health care providers who perform abortions, and strengthening legal protections for them.

Increasing capacity could mean licensing more practitioners to provide abortions or pumping more resources into telehealth so people can see a doctor online to prescribe pills for a medical abortion – a service California doctors currently can provide to patients only in California.

The most important thing the state should do is fix its shortage of providers, especially those who perform second-trimester abortions, which are more expensive and complicated than first-trimester abortions, said council member Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.

It’s not feasible to place an abortion provider in every corner of the state, Dr. Grossman said. Instead, the council should focus on creating “hubs that can provide abortion care for large numbers of people” in easy-to-get-to locations.

California already struggles to provide abortions to all who seek them, especially low-income women covered by Medi-Cal, California’s Medicaid program. For example, 28 counties – home to 10% of Medi-Cal recipients of childbearing age – don’t have facilities that provide abortions to Medi-Cal patients.

A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to an analysis by the California Health Benefits Review Program, but isn’t available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California.

One of the council’s recommendations will likely be to increase the rate Medi-Cal payments for abortions so more providers will perform them, said council member Fabiola Carrión, interim director for reproductive and sexual health at the National Health Law Program.

Medi-Cal pays $354.43 for a second-trimester abortion. A 2020 study in the journal Contraception found that states paid between $79 and $626 for a second-trimester abortion in 2017.

Increasing Medi-Cal rates won’t help patients traveling from outside California. Generally, private insurance doesn’t cover out-of-state abortions, so most women will be on the hook for the full cost, and those enrolled in other states’ Medicaid programs must pay out-of-pocket, too.

The council hopes to reduce costs for state residents and visitors, said Brandon Richards, director of communications for Planned Parenthood Affiliates of California. “It’s about making it easy for people to access abortion in California, whether they reside here or are coming in from out of state,” he said.

One way to target costs is by funding the practical support, like helping to pay for transportation, child care, hotels, or time off work, said council member Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.

Ms. Pinckney said she’s working with Los Angeles County to set up a public abortion fund to cover some of those costs for anyone seeking an abortion in the county. It would be modeled after similar pots maintained by the cities of New York; Austin, Tex.; and Portland, Ore., and could eventually be a template for the first statewide fund, Ms. Pinckney said.

Most Texans seeking abortions since that state’s law took effect are going to nearby states like Colorado, New Mexico, and Oklahoma, said Sierra Harris, deputy director of network strategies for the National Network of Abortion Funds. Women in those states, in turn, are having trouble getting care and are looking to California for appointments.

Practical support is important for out-of-state patients, said Alissa Perrucci, PhD, MPH, operations manager at the Women’s Options Center at Zuckerberg San Francisco General Hospital, one of five abortion clinics inside California hospitals.

Dr. Perrucci’s clinic is focusing on telemedicine, phone counseling, and other ways to save time so it can add appointments for out-of-state patients if necessary.

But more slots are useless if women can’t make it to California. The clinic has booked about 10 appointments for Texans since the state’s ban went into effect, but only half have shown up, mostly women with family connections in California.

“Most people just don’t have the money to get here,” she said. “If the burden of abortion was borne predominantly by the wealthy, yeah, they’d just fly here.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

How much did you get per tooth from the Tooth Fairy? How much do your children or grandchildren receive each time they lose a baby tooth? In my family the Tooth Fairy seems to be more than keeping with inflation. Has she ever been caught in the act of swapping cash for enamel in your home? Has she every slipped up one night but managed to resurrect her credibility the following night by doubling the reward? And, by the way, what does the Tooth Fairy do with all those teeth, and who’s funding her nocturnal switcheroos?

A recent study from the Center for Genomic Medicine at the Massachusetts General Hospital in Boston may provide an answer to at least one of those questions. It turns out some researchers have been collecting baby teeth in hopes of assessing prenatal and perinatal stress in infants.

Not surprisingly, teeth are like trees, preserving a history of the environment in their growth rings. The Boston researchers hypothesized that the thickness of one particular growth line referred to as the neonatal line (NNL) might reflect prenatal and immediate postnatal environmental stress. Using data and naturally shed teeth collected in an English longitudinal study, the authors discovered that the teeth of children whose mothers had a long history of severe depression or other psychiatric problems and children of mothers who at 32 weeks’ gestation experienced anxiety and/or depression were more likely to have thicker NNLs. On the other hand, the teeth of children whose mothers had received “significant social support” in the immediate postnatal period exhibited thinner NNLs.

Based on anecdotal observations, I think most of us already suspected that the children whose mothers had significant psychiatric illness began life with a challenge, but it is nice to know that we may now have a tool to document one small bit of evidence of the structural damage that occurred during this period of stress. Of course, the prior owners of these baby teeth won’t benefit from the findings in this study; however, the evidence that social support during the critical perinatal period can ameliorate the damage might stimulate more robust prenatal programs for mother and infants at risk in the future.

It will be interesting to see if this investigative tool becomes more widely used to determine the degree to which a variety of potential perinatal stressors are manifesting themselves in structural change in newborns. For example, collecting baby teeth from neonatal ICU graduates may answer some questions about how certain environmental conditions such as sound, vibration, bright light, and temperature may result in long-term damage to the infants. Most of us suspect that skin-to-skin contact with mother and kangaroo care are beneficial. A study that includes a survey of NNLs might go a long way toward supporting our suspicions.

I can even imagine that a deep retrospective study of NNLs in baby teeth collected over the last 100 years might demonstrate the effect of phenomena such as wars, natural disasters, forced migration, and pandemics, to name a few.

It may be time to put out a nationwide call to all Tooth Fairies both active and retired to dig deep in their top bureau drawers. Those little bits of long-forgotten enamel may hold the answers to a plethora of unanswered questions about those critical months surrounding the birth of a child.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

How much did you get per tooth from the Tooth Fairy? How much do your children or grandchildren receive each time they lose a baby tooth? In my family the Tooth Fairy seems to be more than keeping with inflation. Has she ever been caught in the act of swapping cash for enamel in your home? Has she every slipped up one night but managed to resurrect her credibility the following night by doubling the reward? And, by the way, what does the Tooth Fairy do with all those teeth, and who’s funding her nocturnal switcheroos?

A recent study from the Center for Genomic Medicine at the Massachusetts General Hospital in Boston may provide an answer to at least one of those questions. It turns out some researchers have been collecting baby teeth in hopes of assessing prenatal and perinatal stress in infants.

Not surprisingly, teeth are like trees, preserving a history of the environment in their growth rings. The Boston researchers hypothesized that the thickness of one particular growth line referred to as the neonatal line (NNL) might reflect prenatal and immediate postnatal environmental stress. Using data and naturally shed teeth collected in an English longitudinal study, the authors discovered that the teeth of children whose mothers had a long history of severe depression or other psychiatric problems and children of mothers who at 32 weeks’ gestation experienced anxiety and/or depression were more likely to have thicker NNLs. On the other hand, the teeth of children whose mothers had received “significant social support” in the immediate postnatal period exhibited thinner NNLs.

Based on anecdotal observations, I think most of us already suspected that the children whose mothers had significant psychiatric illness began life with a challenge, but it is nice to know that we may now have a tool to document one small bit of evidence of the structural damage that occurred during this period of stress. Of course, the prior owners of these baby teeth won’t benefit from the findings in this study; however, the evidence that social support during the critical perinatal period can ameliorate the damage might stimulate more robust prenatal programs for mother and infants at risk in the future.

It will be interesting to see if this investigative tool becomes more widely used to determine the degree to which a variety of potential perinatal stressors are manifesting themselves in structural change in newborns. For example, collecting baby teeth from neonatal ICU graduates may answer some questions about how certain environmental conditions such as sound, vibration, bright light, and temperature may result in long-term damage to the infants. Most of us suspect that skin-to-skin contact with mother and kangaroo care are beneficial. A study that includes a survey of NNLs might go a long way toward supporting our suspicions.

I can even imagine that a deep retrospective study of NNLs in baby teeth collected over the last 100 years might demonstrate the effect of phenomena such as wars, natural disasters, forced migration, and pandemics, to name a few.

It may be time to put out a nationwide call to all Tooth Fairies both active and retired to dig deep in their top bureau drawers. Those little bits of long-forgotten enamel may hold the answers to a plethora of unanswered questions about those critical months surrounding the birth of a child.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

How much did you get per tooth from the Tooth Fairy? How much do your children or grandchildren receive each time they lose a baby tooth? In my family the Tooth Fairy seems to be more than keeping with inflation. Has she ever been caught in the act of swapping cash for enamel in your home? Has she every slipped up one night but managed to resurrect her credibility the following night by doubling the reward? And, by the way, what does the Tooth Fairy do with all those teeth, and who’s funding her nocturnal switcheroos?

A recent study from the Center for Genomic Medicine at the Massachusetts General Hospital in Boston may provide an answer to at least one of those questions. It turns out some researchers have been collecting baby teeth in hopes of assessing prenatal and perinatal stress in infants.

Not surprisingly, teeth are like trees, preserving a history of the environment in their growth rings. The Boston researchers hypothesized that the thickness of one particular growth line referred to as the neonatal line (NNL) might reflect prenatal and immediate postnatal environmental stress. Using data and naturally shed teeth collected in an English longitudinal study, the authors discovered that the teeth of children whose mothers had a long history of severe depression or other psychiatric problems and children of mothers who at 32 weeks’ gestation experienced anxiety and/or depression were more likely to have thicker NNLs. On the other hand, the teeth of children whose mothers had received “significant social support” in the immediate postnatal period exhibited thinner NNLs.

Based on anecdotal observations, I think most of us already suspected that the children whose mothers had significant psychiatric illness began life with a challenge, but it is nice to know that we may now have a tool to document one small bit of evidence of the structural damage that occurred during this period of stress. Of course, the prior owners of these baby teeth won’t benefit from the findings in this study; however, the evidence that social support during the critical perinatal period can ameliorate the damage might stimulate more robust prenatal programs for mother and infants at risk in the future.

It will be interesting to see if this investigative tool becomes more widely used to determine the degree to which a variety of potential perinatal stressors are manifesting themselves in structural change in newborns. For example, collecting baby teeth from neonatal ICU graduates may answer some questions about how certain environmental conditions such as sound, vibration, bright light, and temperature may result in long-term damage to the infants. Most of us suspect that skin-to-skin contact with mother and kangaroo care are beneficial. A study that includes a survey of NNLs might go a long way toward supporting our suspicions.

I can even imagine that a deep retrospective study of NNLs in baby teeth collected over the last 100 years might demonstrate the effect of phenomena such as wars, natural disasters, forced migration, and pandemics, to name a few.

It may be time to put out a nationwide call to all Tooth Fairies both active and retired to dig deep in their top bureau drawers. Those little bits of long-forgotten enamel may hold the answers to a plethora of unanswered questions about those critical months surrounding the birth of a child.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].