MDedge ObGyn

Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.

Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.

“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”

According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.

The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.

Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.

From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.

The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.

The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.

Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.

Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.

“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”

Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.

“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”

Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.

“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”

Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.

The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.

Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.

Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.

“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”

According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.

The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.

Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.

From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.

The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.

The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.

Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.

Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.

“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”

Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.

“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”

Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.

“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”

Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.

The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.

Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.

Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.

“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”

According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.

The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.

Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.

From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.

The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.

The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.

Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.

Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.

“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”

Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.

“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”

Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.

“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”

Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.

The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.

Key clinical point: Among Black women, ambient concentrations of ozone (O₃), but not particulate matter <2.5 microns (PM_2.5) or nitrogen dioxide (NO₂), were associated with an increased risk for uterine fibroids.

Major finding: Ambient O₃ concentrations were significantly associated with an increased risk for uterine fibroids (hazard ratio for a 1-interquartile range increase, 1.19; 95% confidence interval, 1.07-1.32), particularly in women aged <35 years and parous women. However, concentrations of PM_2.5 and NO₂ had no significant associations with uterine fibroids risk.

Study details: The data come from a prospective cohort study of 21,998 premenopausal Black women in the US.

Disclosures: This study was funded by the National Cancer Institute and the National Institute of Environmental Health Sciences. LA Wise reported relationships with AbbVie, Inc., Swiss Precision Diagnostics, Sandstone Diagnostics, FertilityFriend.com, and Kindara.com. M Jerrett reported receiving consultancy fees from the Health Effects Institute. The remaining authors declared no conflict of interests.

Source: Wesselink AK et al. Hum Reprod. 2021 May 13. doi: 10.1093/humrep/deab095.

Key clinical point: Among Black women, ambient concentrations of ozone (O₃), but not particulate matter <2.5 microns (PM_2.5) or nitrogen dioxide (NO₂), were associated with an increased risk for uterine fibroids.

Major finding: Ambient O₃ concentrations were significantly associated with an increased risk for uterine fibroids (hazard ratio for a 1-interquartile range increase, 1.19; 95% confidence interval, 1.07-1.32), particularly in women aged <35 years and parous women. However, concentrations of PM_2.5 and NO₂ had no significant associations with uterine fibroids risk.

Study details: The data come from a prospective cohort study of 21,998 premenopausal Black women in the US.

Disclosures: This study was funded by the National Cancer Institute and the National Institute of Environmental Health Sciences. LA Wise reported relationships with AbbVie, Inc., Swiss Precision Diagnostics, Sandstone Diagnostics, FertilityFriend.com, and Kindara.com. M Jerrett reported receiving consultancy fees from the Health Effects Institute. The remaining authors declared no conflict of interests.

Source: Wesselink AK et al. Hum Reprod. 2021 May 13. doi: 10.1093/humrep/deab095.

Key clinical point: Among Black women, ambient concentrations of ozone (O₃), but not particulate matter <2.5 microns (PM_2.5) or nitrogen dioxide (NO₂), were associated with an increased risk for uterine fibroids.

Major finding: Ambient O₃ concentrations were significantly associated with an increased risk for uterine fibroids (hazard ratio for a 1-interquartile range increase, 1.19; 95% confidence interval, 1.07-1.32), particularly in women aged <35 years and parous women. However, concentrations of PM_2.5 and NO₂ had no significant associations with uterine fibroids risk.

Study details: The data come from a prospective cohort study of 21,998 premenopausal Black women in the US.

Disclosures: This study was funded by the National Cancer Institute and the National Institute of Environmental Health Sciences. LA Wise reported relationships with AbbVie, Inc., Swiss Precision Diagnostics, Sandstone Diagnostics, FertilityFriend.com, and Kindara.com. M Jerrett reported receiving consultancy fees from the Health Effects Institute. The remaining authors declared no conflict of interests.

Source: Wesselink AK et al. Hum Reprod. 2021 May 13. doi: 10.1093/humrep/deab095.

Key clinical point: Single-port access (SPA) myomectomy in combination with uterine artery ligation (UAL) enables removal of large uterine fibroids while reducing blood loss.

Major finding: The median weight of total resected uterine fibroids was higher for the patients who received UAL vs those who did not (210 g vs 119 g; P = .023). There were no significant differences between the groups in terms of total surgery time, estimated blood loss, perioperative hemoglobin changes, postoperative analgesic use, and postoperative complications.

Study details: Surgical outcomes of 24 patients who underwent SPA myomectomy with UAL and 32 patients who underwent SPA myomectomy only were retrospectively reviewed.

Disclosures: No information on funding was available. The authors declared no conflict of interests.

Source: Noh JJ et al. Taiwan J Obstet Gynecol. 2021 Jul 8. doi: 10.1016/j.tjog.2021.05.029.

Key clinical point: Single-port access (SPA) myomectomy in combination with uterine artery ligation (UAL) enables removal of large uterine fibroids while reducing blood loss.

Major finding: The median weight of total resected uterine fibroids was higher for the patients who received UAL vs those who did not (210 g vs 119 g; P = .023). There were no significant differences between the groups in terms of total surgery time, estimated blood loss, perioperative hemoglobin changes, postoperative analgesic use, and postoperative complications.

Study details: Surgical outcomes of 24 patients who underwent SPA myomectomy with UAL and 32 patients who underwent SPA myomectomy only were retrospectively reviewed.

Disclosures: No information on funding was available. The authors declared no conflict of interests.

Source: Noh JJ et al. Taiwan J Obstet Gynecol. 2021 Jul 8. doi: 10.1016/j.tjog.2021.05.029.

Key clinical point: Single-port access (SPA) myomectomy in combination with uterine artery ligation (UAL) enables removal of large uterine fibroids while reducing blood loss.

Major finding: The median weight of total resected uterine fibroids was higher for the patients who received UAL vs those who did not (210 g vs 119 g; P = .023). There were no significant differences between the groups in terms of total surgery time, estimated blood loss, perioperative hemoglobin changes, postoperative analgesic use, and postoperative complications.

Study details: Surgical outcomes of 24 patients who underwent SPA myomectomy with UAL and 32 patients who underwent SPA myomectomy only were retrospectively reviewed.

Disclosures: No information on funding was available. The authors declared no conflict of interests.

Source: Noh JJ et al. Taiwan J Obstet Gynecol. 2021 Jul 8. doi: 10.1016/j.tjog.2021.05.029.

Key clinical point: A prognostic index (PI) model was effective in predicting the recurrence of uterine fibroids following myomectomy.

Major finding: The high- and intermediate-risk groups had a 4.55- and 2.81-fold greater recurrence risk, respectively, for uterine fibroids than the low-risk group.

Study details: A retrospective multicenter study of 725 women who underwent myomectomy was used to develop the PI model. The PI formula was 1.5 (if 3-5 fibroids) or 2 (if >5 fibroids)+1 (if residue)+1 (if not submucosal)+1 (if combined endometriosis). Patients were characterized into low, intermediate, and high risks by PI cut-off values 1.25 and 3.75.

Disclosures: The study was supported by a grant from the Applied Basic Research Programs of Science and Technology Department of Sichuan Province. The authors declared no conflict of interests.

Source: Ming X et al. PLoS One. 2021 Jul 1. doi: 10.1371/journal.pone.0254142.

Key clinical point: A prognostic index (PI) model was effective in predicting the recurrence of uterine fibroids following myomectomy.

Major finding: The high- and intermediate-risk groups had a 4.55- and 2.81-fold greater recurrence risk, respectively, for uterine fibroids than the low-risk group.

Study details: A retrospective multicenter study of 725 women who underwent myomectomy was used to develop the PI model. The PI formula was 1.5 (if 3-5 fibroids) or 2 (if >5 fibroids)+1 (if residue)+1 (if not submucosal)+1 (if combined endometriosis). Patients were characterized into low, intermediate, and high risks by PI cut-off values 1.25 and 3.75.

Disclosures: The study was supported by a grant from the Applied Basic Research Programs of Science and Technology Department of Sichuan Province. The authors declared no conflict of interests.

Source: Ming X et al. PLoS One. 2021 Jul 1. doi: 10.1371/journal.pone.0254142.

Key clinical point: A prognostic index (PI) model was effective in predicting the recurrence of uterine fibroids following myomectomy.

Major finding: The high- and intermediate-risk groups had a 4.55- and 2.81-fold greater recurrence risk, respectively, for uterine fibroids than the low-risk group.

Study details: A retrospective multicenter study of 725 women who underwent myomectomy was used to develop the PI model. The PI formula was 1.5 (if 3-5 fibroids) or 2 (if >5 fibroids)+1 (if residue)+1 (if not submucosal)+1 (if combined endometriosis). Patients were characterized into low, intermediate, and high risks by PI cut-off values 1.25 and 3.75.

Disclosures: The study was supported by a grant from the Applied Basic Research Programs of Science and Technology Department of Sichuan Province. The authors declared no conflict of interests.

Source: Ming X et al. PLoS One. 2021 Jul 1. doi: 10.1371/journal.pone.0254142.

Key clinical point: High-intensity focused ultrasound (HIFU) for the treatment of symptomatic uterine fibroids demonstrated superior outcomes in terms of symptomatic relief, improvement in quality of life (QoL), recovery, and complications compared with surgery.

Major finding: Compared with the surgery group, the HIFU group demonstrated a greater reduction in uterine fibroid severity score at 6- and 12-month follow-up (P less than .05), greater increase in QoL score at 6- and 12-month follow-up (P < .05), and shorter duration of hospital stay and return to work (P less than .05). Differences in adverse events, symptom recurrence, reintervention, and pregnancy between the groups were not significant (P greater than .05).

Study details: The data come from a meta-analysis of 10 studies involving 4,450 women.

Disclosures: The study did not receive any funding. The authors declared no conflict of interests.

Source: Liu L et al. Eur Radiol. 2021 Aug 1. doi: 10.1007/s00330-021-08156-6.

Key clinical point: High-intensity focused ultrasound (HIFU) for the treatment of symptomatic uterine fibroids demonstrated superior outcomes in terms of symptomatic relief, improvement in quality of life (QoL), recovery, and complications compared with surgery.

Major finding: Compared with the surgery group, the HIFU group demonstrated a greater reduction in uterine fibroid severity score at 6- and 12-month follow-up (P less than .05), greater increase in QoL score at 6- and 12-month follow-up (P < .05), and shorter duration of hospital stay and return to work (P less than .05). Differences in adverse events, symptom recurrence, reintervention, and pregnancy between the groups were not significant (P greater than .05).

Study details: The data come from a meta-analysis of 10 studies involving 4,450 women.

Disclosures: The study did not receive any funding. The authors declared no conflict of interests.

Source: Liu L et al. Eur Radiol. 2021 Aug 1. doi: 10.1007/s00330-021-08156-6.

Key clinical point: High-intensity focused ultrasound (HIFU) for the treatment of symptomatic uterine fibroids demonstrated superior outcomes in terms of symptomatic relief, improvement in quality of life (QoL), recovery, and complications compared with surgery.

Major finding: Compared with the surgery group, the HIFU group demonstrated a greater reduction in uterine fibroid severity score at 6- and 12-month follow-up (P less than .05), greater increase in QoL score at 6- and 12-month follow-up (P < .05), and shorter duration of hospital stay and return to work (P less than .05). Differences in adverse events, symptom recurrence, reintervention, and pregnancy between the groups were not significant (P greater than .05).

Study details: The data come from a meta-analysis of 10 studies involving 4,450 women.

Disclosures: The study did not receive any funding. The authors declared no conflict of interests.

Source: Liu L et al. Eur Radiol. 2021 Aug 1. doi: 10.1007/s00330-021-08156-6.

Key clinical point: Three-dimensional (3D) laparoscopic myomectomy for uterine fibroids has no additional surgical benefit compared with conventional two-dimensional (2D) laparoscopic myomectomy.

Major finding: There were no significant differences between the 3D and 2D groups in terms of operative blood loss (P = .421), change in serum hemoglobin levels (P = .553), and operative time (P = .344).

Study details: In a randomized controlled trial, 64 patients with symptomatic uterine fibroids were assigned either to 3D (n=32) or 2D (n=32) laparoscopic myomectomy.

Disclosures: No information on funding was available. The authors declared no conflict of interests.

Source: Song T and Kang DY. Eur J Obstet Gynecol Reprod Biol. 2021 Jul 23. doi: 10.1016/j.ejogrb.2021.07.036.

Key clinical point: Three-dimensional (3D) laparoscopic myomectomy for uterine fibroids has no additional surgical benefit compared with conventional two-dimensional (2D) laparoscopic myomectomy.

Major finding: There were no significant differences between the 3D and 2D groups in terms of operative blood loss (P = .421), change in serum hemoglobin levels (P = .553), and operative time (P = .344).

Study details: In a randomized controlled trial, 64 patients with symptomatic uterine fibroids were assigned either to 3D (n=32) or 2D (n=32) laparoscopic myomectomy.

Disclosures: No information on funding was available. The authors declared no conflict of interests.

Source: Song T and Kang DY. Eur J Obstet Gynecol Reprod Biol. 2021 Jul 23. doi: 10.1016/j.ejogrb.2021.07.036.

Key clinical point: Three-dimensional (3D) laparoscopic myomectomy for uterine fibroids has no additional surgical benefit compared with conventional two-dimensional (2D) laparoscopic myomectomy.

Major finding: There were no significant differences between the 3D and 2D groups in terms of operative blood loss (P = .421), change in serum hemoglobin levels (P = .553), and operative time (P = .344).

Study details: In a randomized controlled trial, 64 patients with symptomatic uterine fibroids were assigned either to 3D (n=32) or 2D (n=32) laparoscopic myomectomy.

Disclosures: No information on funding was available. The authors declared no conflict of interests.

Source: Song T and Kang DY. Eur J Obstet Gynecol Reprod Biol. 2021 Jul 23. doi: 10.1016/j.ejogrb.2021.07.036.

Key clinical point: Women with uterine fibroids, especially those with pain symptoms or who have had a hysterectomy, may have an increased risk for certain mental health outcomes.

Major finding: After adjusting for confounders, women with uterine fibroids vs those without had higher rates of depression (hazard ratio [HR], 1.12; 95% confidence interval [CI], 1.10-1.13), anxiety (HR, 1.12; 95% CI, 1.10-1.13), and self-directed violence (HR, 1.46; 95% CI, 1.29-1.64). These associations were more pronounced in women experiencing pain symptoms and in those who underwent a hysterectomy.

Study details: The data come from a cohort study of 313,754 women aged 18-50 years with diagnosed uterine fibroids who were matched to 627,539 women without uterine fibroids.

Disclosures: The research was funded by AbbVie, and Aetion received funding for conducting the study. SE Chiuve, C Huisingh, and C Owens are employees of AbbVie receiving stock and/or stock options. N Petruski-Ivleva was an employee of Aetion when the study was being conducted and may hold stock options at Aetion. W Kuohung and LA Wise received consultancy fees from AbbVie, but did not receive payment for authorship.

Source: Chiuve SE et al. J Epidemiol Community Health. 2021 Jul 22. doi: 10.1136/jech-2020-214565.

Key clinical point: Women with uterine fibroids, especially those with pain symptoms or who have had a hysterectomy, may have an increased risk for certain mental health outcomes.

Major finding: After adjusting for confounders, women with uterine fibroids vs those without had higher rates of depression (hazard ratio [HR], 1.12; 95% confidence interval [CI], 1.10-1.13), anxiety (HR, 1.12; 95% CI, 1.10-1.13), and self-directed violence (HR, 1.46; 95% CI, 1.29-1.64). These associations were more pronounced in women experiencing pain symptoms and in those who underwent a hysterectomy.

Study details: The data come from a cohort study of 313,754 women aged 18-50 years with diagnosed uterine fibroids who were matched to 627,539 women without uterine fibroids.

Disclosures: The research was funded by AbbVie, and Aetion received funding for conducting the study. SE Chiuve, C Huisingh, and C Owens are employees of AbbVie receiving stock and/or stock options. N Petruski-Ivleva was an employee of Aetion when the study was being conducted and may hold stock options at Aetion. W Kuohung and LA Wise received consultancy fees from AbbVie, but did not receive payment for authorship.

Source: Chiuve SE et al. J Epidemiol Community Health. 2021 Jul 22. doi: 10.1136/jech-2020-214565.

Key clinical point: Women with uterine fibroids, especially those with pain symptoms or who have had a hysterectomy, may have an increased risk for certain mental health outcomes.

Major finding: After adjusting for confounders, women with uterine fibroids vs those without had higher rates of depression (hazard ratio [HR], 1.12; 95% confidence interval [CI], 1.10-1.13), anxiety (HR, 1.12; 95% CI, 1.10-1.13), and self-directed violence (HR, 1.46; 95% CI, 1.29-1.64). These associations were more pronounced in women experiencing pain symptoms and in those who underwent a hysterectomy.

Study details: The data come from a cohort study of 313,754 women aged 18-50 years with diagnosed uterine fibroids who were matched to 627,539 women without uterine fibroids.

Disclosures: The research was funded by AbbVie, and Aetion received funding for conducting the study. SE Chiuve, C Huisingh, and C Owens are employees of AbbVie receiving stock and/or stock options. N Petruski-Ivleva was an employee of Aetion when the study was being conducted and may hold stock options at Aetion. W Kuohung and LA Wise received consultancy fees from AbbVie, but did not receive payment for authorship.

Source: Chiuve SE et al. J Epidemiol Community Health. 2021 Jul 22. doi: 10.1136/jech-2020-214565.

As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”

While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”

Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.

The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
 

The concept of blame

So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.

Labeling reminds me of one of the saddest cases in my career.
 

An unfortunate case

I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.

He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
 

The comparison

Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.

Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.

Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
 

Conclusion

We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.

Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.

In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.

It could be any of us.

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

As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”

While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”

Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.

The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
 

The concept of blame

So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.

Labeling reminds me of one of the saddest cases in my career.
 

An unfortunate case

I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.

He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
 

The comparison

Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.

Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.

Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
 

Conclusion

We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.

Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.

In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.

It could be any of us.

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

As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”

While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”

Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.

The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
 

The concept of blame

So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.

Labeling reminds me of one of the saddest cases in my career.
 

An unfortunate case

I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.

He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
 

The comparison

Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.

Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.

Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
 

Conclusion

We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.

Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.

In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.

It could be any of us.

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

Doctor sentenced for unlawful prescriptions leading to five patient deaths

Darrel R. Rinehart, MD, was sentenced to 3 years in prison in June 2021 for unlawfully distributing controlled substances, primarily opioids, out of his clinic in Columbia, Tenn. Five of his patients who received prescriptions died of fatal overdoses within a year, according to the Indianapolis Star. Dr. Rinehart agreed to leave Tennessee to avoid punishment in that state before setting up his Indiana clinic.

Dr. Rinehart, 66, admitted to distributing Schedule II controlled substances to four different patients without legitimate medical purpose on 18 occasions between December 2014 and December 2015. He also admitted to knowingly distributing hydrocodone, also a Schedule II controlled substance, in January 2016 to a patient who did not have any health issues justifying the prescription. His medical license has been revoked. 
 

Judge approves $15 million settlement in patient’s sexual assault

An incapacitated woman at Hacienda Healthcare, a long-term care center in Phoenix, Ariz., gave birth in late 2018 after being raped by one of the nursing staff, according to Insurance Journal. In June 2021, a judge approved a $15 million settlement in a lawsuit by the woman’s parents against Phillip E. Gear Jr., MD, the woman’s caregiver for 26 years at the center. The woman had been in a vegetative state at Hacienda Healthcare since childhood, and the judge ruled that she had been the victim of numerous sexual assaults prior to the birth. 

The pregnancy was discovered when an employee was changing the garments of the then 29-year-old victim and saw that she was delivering a child. Employees told police they had no idea the woman was pregnant. Police have said that DNA from Nathan Sutherland, a licensed practical nurse who worked at Hacienda and has since given up his nursing license, matched a genetic sample taken from the woman’s son.

The woman’s parents, who care for her son, also sued the state of Arizona and another doctor, Thanh Nguyen, MD, who cared for their daughter. Arizona, which contracts with companies like Hacienda to provide services to people with developmental disabilities, settled last year for $7.5 million. Both Hacienda and Dr. Nguyen, who cared for the woman in the months before the birth, settled for undisclosed amounts.

The insurer for Dr. Gear, who died in late 2020, said it has no obligation to pay the amount, arguing that the doctor’s policy didn’t cover claims arising from a sexual act. The insurer also argued that Dr. Gear wasn’t the woman’s primary care physician when she gave birth and couldn’t be held responsible for sexual assault. 

The judge declared the $15 million settlement reasonable, concluding that Dr. Gear’s treatment of the woman had fallen below the standard of care, which included failing to examine her regularly and to diagnose her pregnancy. Requests by the woman’s mother to have exclusively female employees tend to her were not followed, as shown by medical records.
 

Doctor fired for contributing to suffering and death of prisoners

Washington’s prison system will pay $3.25 million and has fired the medical director of one of its facilities, stemming from the death of an inmate. 

John Kleutsch, a 57-year-old prisoner, died in late 2018 of septic shock, acute pancreatitis, and a perforated intestine caused by an improperly treated abdominal wound, according to the Seattle Times. A lawsuit filed by his wife, Julia Kleutsch, said that the staff offered him only Tylenol for his pain and that Julia Barnett, MD, the former prison medical director, refused to take him to a hospital.

Dr. Barnett, whose medical license has been indefinitely suspended, was fired in 2019 after an internal investigation found that her medical care and supervision contributed to the suffering and deaths of several men in the prison, including Mr. Kleutsch. 

Mr. Kleutsch, imprisoned for child molestation, was recovering from outpatient cancer surgery and sent back to the prison infirmary to recover. The lawsuit says that Mr. Kleutsch asked staff for help when his abdominal wound became excruciatingly painful, puffy, and oozing, and that at least one nurse asked Dr. Barnett to transfer him to a hospital, but she refused. Dr. Kleutsch’s causes of death were conditions never diagnosed at the prison.

Plaintiff attorney Marta O’Brien called the case “one of the worst medical malpractice cases I have encountered” and said it showed “a systemic failure” by the Department of Corrections.
 

SNF pays $11 million to resolve Medicare fraud allegations

SavaSeniorCare (Sava) and related entities agreed to pay $11.2 million in May 2021 to resolve allegations that they violated the False Claims Act by making their skilled nursing facilities (SNFs) bill Medicare for rehabilitation therapy services that were not reasonable, necessary, or skilled. The payment was also to resolve allegations that Sava billed the Medicare and Medicaid programs for substandard skilled nursing services, according to the U.S. Department of Justice. Sava is based in Georgia but owns and operates SNFs across the country.

The government filed a complaint against Sava in 2015, alleging that between October 2008 and September 2012, Sava intentionally submitted false claims for rehabilitation therapy services as a result of a systematic effort to increase its Medicare and Medicaid billings. The claim alleged that Sava exerted significant pressure on its SNFs to meet unrealistic financial goals, resulting in the provision of medically unreasonable, unnecessary, or unskilled services to Medicare patients. Sava also allegedly sought to increase its Medicare payments by delaying the discharge of patients from its facilities, even though the patients were medically ready to be discharged. 

Additionally, the government alleged that some of Sava’s nursing services failed to meet federal standards of care, including failing to have sufficient staffing at certain facilities, failing to follow appropriate pressure ulcer and falls protocols, and failing to appropriately administer medications. 

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

Doctor sentenced for unlawful prescriptions leading to five patient deaths

Darrel R. Rinehart, MD, was sentenced to 3 years in prison in June 2021 for unlawfully distributing controlled substances, primarily opioids, out of his clinic in Columbia, Tenn. Five of his patients who received prescriptions died of fatal overdoses within a year, according to the Indianapolis Star. Dr. Rinehart agreed to leave Tennessee to avoid punishment in that state before setting up his Indiana clinic.

Dr. Rinehart, 66, admitted to distributing Schedule II controlled substances to four different patients without legitimate medical purpose on 18 occasions between December 2014 and December 2015. He also admitted to knowingly distributing hydrocodone, also a Schedule II controlled substance, in January 2016 to a patient who did not have any health issues justifying the prescription. His medical license has been revoked. 
 

Judge approves $15 million settlement in patient’s sexual assault

An incapacitated woman at Hacienda Healthcare, a long-term care center in Phoenix, Ariz., gave birth in late 2018 after being raped by one of the nursing staff, according to Insurance Journal. In June 2021, a judge approved a $15 million settlement in a lawsuit by the woman’s parents against Phillip E. Gear Jr., MD, the woman’s caregiver for 26 years at the center. The woman had been in a vegetative state at Hacienda Healthcare since childhood, and the judge ruled that she had been the victim of numerous sexual assaults prior to the birth. 

The pregnancy was discovered when an employee was changing the garments of the then 29-year-old victim and saw that she was delivering a child. Employees told police they had no idea the woman was pregnant. Police have said that DNA from Nathan Sutherland, a licensed practical nurse who worked at Hacienda and has since given up his nursing license, matched a genetic sample taken from the woman’s son.

The woman’s parents, who care for her son, also sued the state of Arizona and another doctor, Thanh Nguyen, MD, who cared for their daughter. Arizona, which contracts with companies like Hacienda to provide services to people with developmental disabilities, settled last year for $7.5 million. Both Hacienda and Dr. Nguyen, who cared for the woman in the months before the birth, settled for undisclosed amounts.

The insurer for Dr. Gear, who died in late 2020, said it has no obligation to pay the amount, arguing that the doctor’s policy didn’t cover claims arising from a sexual act. The insurer also argued that Dr. Gear wasn’t the woman’s primary care physician when she gave birth and couldn’t be held responsible for sexual assault. 

The judge declared the $15 million settlement reasonable, concluding that Dr. Gear’s treatment of the woman had fallen below the standard of care, which included failing to examine her regularly and to diagnose her pregnancy. Requests by the woman’s mother to have exclusively female employees tend to her were not followed, as shown by medical records.
 

Doctor fired for contributing to suffering and death of prisoners

Washington’s prison system will pay $3.25 million and has fired the medical director of one of its facilities, stemming from the death of an inmate. 

John Kleutsch, a 57-year-old prisoner, died in late 2018 of septic shock, acute pancreatitis, and a perforated intestine caused by an improperly treated abdominal wound, according to the Seattle Times. A lawsuit filed by his wife, Julia Kleutsch, said that the staff offered him only Tylenol for his pain and that Julia Barnett, MD, the former prison medical director, refused to take him to a hospital.

Dr. Barnett, whose medical license has been indefinitely suspended, was fired in 2019 after an internal investigation found that her medical care and supervision contributed to the suffering and deaths of several men in the prison, including Mr. Kleutsch. 

Mr. Kleutsch, imprisoned for child molestation, was recovering from outpatient cancer surgery and sent back to the prison infirmary to recover. The lawsuit says that Mr. Kleutsch asked staff for help when his abdominal wound became excruciatingly painful, puffy, and oozing, and that at least one nurse asked Dr. Barnett to transfer him to a hospital, but she refused. Dr. Kleutsch’s causes of death were conditions never diagnosed at the prison.

Plaintiff attorney Marta O’Brien called the case “one of the worst medical malpractice cases I have encountered” and said it showed “a systemic failure” by the Department of Corrections.
 

SNF pays $11 million to resolve Medicare fraud allegations

SavaSeniorCare (Sava) and related entities agreed to pay $11.2 million in May 2021 to resolve allegations that they violated the False Claims Act by making their skilled nursing facilities (SNFs) bill Medicare for rehabilitation therapy services that were not reasonable, necessary, or skilled. The payment was also to resolve allegations that Sava billed the Medicare and Medicaid programs for substandard skilled nursing services, according to the U.S. Department of Justice. Sava is based in Georgia but owns and operates SNFs across the country.

The government filed a complaint against Sava in 2015, alleging that between October 2008 and September 2012, Sava intentionally submitted false claims for rehabilitation therapy services as a result of a systematic effort to increase its Medicare and Medicaid billings. The claim alleged that Sava exerted significant pressure on its SNFs to meet unrealistic financial goals, resulting in the provision of medically unreasonable, unnecessary, or unskilled services to Medicare patients. Sava also allegedly sought to increase its Medicare payments by delaying the discharge of patients from its facilities, even though the patients were medically ready to be discharged. 

Additionally, the government alleged that some of Sava’s nursing services failed to meet federal standards of care, including failing to have sufficient staffing at certain facilities, failing to follow appropriate pressure ulcer and falls protocols, and failing to appropriately administer medications. 

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

Doctor sentenced for unlawful prescriptions leading to five patient deaths

Darrel R. Rinehart, MD, was sentenced to 3 years in prison in June 2021 for unlawfully distributing controlled substances, primarily opioids, out of his clinic in Columbia, Tenn. Five of his patients who received prescriptions died of fatal overdoses within a year, according to the Indianapolis Star. Dr. Rinehart agreed to leave Tennessee to avoid punishment in that state before setting up his Indiana clinic.

Dr. Rinehart, 66, admitted to distributing Schedule II controlled substances to four different patients without legitimate medical purpose on 18 occasions between December 2014 and December 2015. He also admitted to knowingly distributing hydrocodone, also a Schedule II controlled substance, in January 2016 to a patient who did not have any health issues justifying the prescription. His medical license has been revoked. 
 

Judge approves $15 million settlement in patient’s sexual assault

An incapacitated woman at Hacienda Healthcare, a long-term care center in Phoenix, Ariz., gave birth in late 2018 after being raped by one of the nursing staff, according to Insurance Journal. In June 2021, a judge approved a $15 million settlement in a lawsuit by the woman’s parents against Phillip E. Gear Jr., MD, the woman’s caregiver for 26 years at the center. The woman had been in a vegetative state at Hacienda Healthcare since childhood, and the judge ruled that she had been the victim of numerous sexual assaults prior to the birth. 

The pregnancy was discovered when an employee was changing the garments of the then 29-year-old victim and saw that she was delivering a child. Employees told police they had no idea the woman was pregnant. Police have said that DNA from Nathan Sutherland, a licensed practical nurse who worked at Hacienda and has since given up his nursing license, matched a genetic sample taken from the woman’s son.

The woman’s parents, who care for her son, also sued the state of Arizona and another doctor, Thanh Nguyen, MD, who cared for their daughter. Arizona, which contracts with companies like Hacienda to provide services to people with developmental disabilities, settled last year for $7.5 million. Both Hacienda and Dr. Nguyen, who cared for the woman in the months before the birth, settled for undisclosed amounts.

The insurer for Dr. Gear, who died in late 2020, said it has no obligation to pay the amount, arguing that the doctor’s policy didn’t cover claims arising from a sexual act. The insurer also argued that Dr. Gear wasn’t the woman’s primary care physician when she gave birth and couldn’t be held responsible for sexual assault. 

The judge declared the $15 million settlement reasonable, concluding that Dr. Gear’s treatment of the woman had fallen below the standard of care, which included failing to examine her regularly and to diagnose her pregnancy. Requests by the woman’s mother to have exclusively female employees tend to her were not followed, as shown by medical records.
 

Doctor fired for contributing to suffering and death of prisoners

Washington’s prison system will pay $3.25 million and has fired the medical director of one of its facilities, stemming from the death of an inmate. 

John Kleutsch, a 57-year-old prisoner, died in late 2018 of septic shock, acute pancreatitis, and a perforated intestine caused by an improperly treated abdominal wound, according to the Seattle Times. A lawsuit filed by his wife, Julia Kleutsch, said that the staff offered him only Tylenol for his pain and that Julia Barnett, MD, the former prison medical director, refused to take him to a hospital.

Dr. Barnett, whose medical license has been indefinitely suspended, was fired in 2019 after an internal investigation found that her medical care and supervision contributed to the suffering and deaths of several men in the prison, including Mr. Kleutsch. 

Mr. Kleutsch, imprisoned for child molestation, was recovering from outpatient cancer surgery and sent back to the prison infirmary to recover. The lawsuit says that Mr. Kleutsch asked staff for help when his abdominal wound became excruciatingly painful, puffy, and oozing, and that at least one nurse asked Dr. Barnett to transfer him to a hospital, but she refused. Dr. Kleutsch’s causes of death were conditions never diagnosed at the prison.

Plaintiff attorney Marta O’Brien called the case “one of the worst medical malpractice cases I have encountered” and said it showed “a systemic failure” by the Department of Corrections.
 

SNF pays $11 million to resolve Medicare fraud allegations

SavaSeniorCare (Sava) and related entities agreed to pay $11.2 million in May 2021 to resolve allegations that they violated the False Claims Act by making their skilled nursing facilities (SNFs) bill Medicare for rehabilitation therapy services that were not reasonable, necessary, or skilled. The payment was also to resolve allegations that Sava billed the Medicare and Medicaid programs for substandard skilled nursing services, according to the U.S. Department of Justice. Sava is based in Georgia but owns and operates SNFs across the country.

The government filed a complaint against Sava in 2015, alleging that between October 2008 and September 2012, Sava intentionally submitted false claims for rehabilitation therapy services as a result of a systematic effort to increase its Medicare and Medicaid billings. The claim alleged that Sava exerted significant pressure on its SNFs to meet unrealistic financial goals, resulting in the provision of medically unreasonable, unnecessary, or unskilled services to Medicare patients. Sava also allegedly sought to increase its Medicare payments by delaying the discharge of patients from its facilities, even though the patients were medically ready to be discharged. 

Additionally, the government alleged that some of Sava’s nursing services failed to meet federal standards of care, including failing to have sufficient staffing at certain facilities, failing to follow appropriate pressure ulcer and falls protocols, and failing to appropriately administer medications. 

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

Since the reversal of the Medicare exclusion in 2014, the rates of gender-affirming surgery have increased markedly in the United States.¹ Gender-affirming mastectomy, otherwise known as “top surgery,” is one of the more commonly performed procedures; with 97% of patients having either undergone or expressed desire for the surgery.² The goals of this procedure are to remove all visible breast tissue and reconstruct the chest wall so it is more masculine in appearance. For transmasculine and nonbinary patients, this procedure is associated with significant improvements in mental health and quality of life.^3,4 While the mastectomy procedure is often performed by plastic surgeons, patients will see an ob.gyn. in the preoperative or postoperative period. Ob.gyns. should have a general understanding of the procedure, but most importantly know how to screen for breast cancer in patients who have undergone a gender-affirming mastectomy.

Providers will likely encounter transmasculine or nonbinary patients during annual screening examinations or for a preoperative exam. If a patient is seeking a preoperative risk assessment prior to undergoing a gender-affirming mastectomy, assessing a patient’s risk status for breast cancer is paramount. While testosterone therapy is no longer a prerequisite for gender-affirming mastectomies, documenting hormone use, age at initiation, and dosage is important.⁵ The overall effects of testosterone on breast tissue are inconsistent. However, studies have demonstrated that patients taking testosterone are not at an increased risk of breast cancer secondary to testosterone use.^5-7 Patients should be asked about a personal of family history of breast cancer, breast surgery, history of prior breast biopsies, parity, age at menarche, smoking status, and breastfeeding history if applicable. Patients with high-risk mutations or a strong family history of breast cancer should be referred to genetic counselors, surgical oncologists, and possibly undergo genetic testing.⁸ Before an examination, providers should counsel patients about the nature of the examination and use gender-neutral language such as “chest” to avoid exacerbating gender dysphoria.

It is important to educate transmasculine patients about their risk for the development of breast cancer after mastectomy. Larger-scale, population-based studies of breast cancer in the transgender population have reported an incidence of 5.9 per 100,000 patients-years and an overall incidence comparable to cisgender men in age-standardized national samples.^5-7 Unfortunately, data on the rates of breast cancer in transmasculine patients after gender-affirming mastectomy are limited, which makes defining postoperative guidelines challenging. Additionally, the amount of residual breast tissue remaining varies based on the surgeon and technique.

Several techniques are described for mastectomy procedures with differences that can affect the amount of residual breast tissue. The most common type of gender-affirming mastectomy is the double incision. With this procedure, the nipple-areolar complex is reduced in size, removed, and thinned to improve graft take. Dissection is then carried to the level of the breast capsule and the breast tissue and axillary tail are removed en bloc.⁵ During the dissection, the subcutaneous fat is left on the skin flap to provide appropriate contour and to avoid creating a concave-appearing chest wall. Prior to closure, the superior and inferior flaps are inspected for any visible residual breast tissue, which is removed if needed. In a circumareolar mastectomy, the nipple-areolar complex is also reduced but is preserved on a 1- to 1.5-cm-thick pedicle to maintain perfusion.⁵ The mastectomy is performed through an inferior periareolar incision and all visible breast tissue and the axillary tail are removed. Breast tissue specimens are sent for pathologic evaluation at the end of the procedure.

Following gender-affirming mastectomy, there is limited evidence to guide screening. During the patient visit, the provider should obtain a thorough history regarding mastectomy type, and if unknown, attempt to acquire the operative report detailing the procedure. For low-risk patients who undergo a subcutaneous mastectomy such as the double incision or circumareolar technique, screening mammography is not indicated nor is it technically feasible.⁹ For patients with a high-risk genetic mutation or a strong family history of breast cancer, monitoring with alternative modalities such as breast ultrasound or breast MRI may be beneficial, although there is no evidence to currently support this suggestion. Given the variety of surgical techniques of breast tissue removal, it is difficult to develop strong evidence-based guidelines. Annual chest wall examinations have been suggested as a screening modality; however, the clinical utility of clinical breast and chest exams has been debated and is no longer recommended as a screening method in cisgender patients.⁹ Clinicians can promote chest self-awareness and discuss the possibility of breast cancer in postmastectomy patients at annual examination visits. As research continues to resolve some of these unknowns, it is important that patients are informed of these areas of ambiguity and updated regarding any changes in screening recommendations.¹⁰

Dr. Brandt is an ob.gyn. and fellowship-trained gender affirming surgeon in West Reading, Pa.

References

1. American Society of Plastic Surgeons. 2018 plastic surgery statistics report. https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed Aug. 20, 2021.

2. James SE et al. The report of the 2015 U.S. Transgender survey. Washington, D.C.: National Center for Transgender Equality, 2016.

3. Agarwal CA et al. J Plast Reconstr Aesthet Surg. 2018;71:651-7.

4. Poudrier G et al. Plast Reconstr Surg. 2018;80:679-83.

5. Salibian AA et al. Plast Reconstr Surg. 2020;147:213e-21e.

6. Gooren LJ et al. J Sex Med. 2013;10:3129-34.

7. Brown GR and Jones KT. Breast Cancer Res Treat. 2015;149:191-8.

8. Deutsch MF et al. Semin Reprod Med. 2017;35:434-41.

9. Phillips J et al. AJR Am J Roentgenol. 2014;202:1149-59.

10. Smith RA et al. CA Cancer J Clin. 2018;68:297-316.

Since the reversal of the Medicare exclusion in 2014, the rates of gender-affirming surgery have increased markedly in the United States.¹ Gender-affirming mastectomy, otherwise known as “top surgery,” is one of the more commonly performed procedures; with 97% of patients having either undergone or expressed desire for the surgery.² The goals of this procedure are to remove all visible breast tissue and reconstruct the chest wall so it is more masculine in appearance. For transmasculine and nonbinary patients, this procedure is associated with significant improvements in mental health and quality of life.^3,4 While the mastectomy procedure is often performed by plastic surgeons, patients will see an ob.gyn. in the preoperative or postoperative period. Ob.gyns. should have a general understanding of the procedure, but most importantly know how to screen for breast cancer in patients who have undergone a gender-affirming mastectomy.

Providers will likely encounter transmasculine or nonbinary patients during annual screening examinations or for a preoperative exam. If a patient is seeking a preoperative risk assessment prior to undergoing a gender-affirming mastectomy, assessing a patient’s risk status for breast cancer is paramount. While testosterone therapy is no longer a prerequisite for gender-affirming mastectomies, documenting hormone use, age at initiation, and dosage is important.⁵ The overall effects of testosterone on breast tissue are inconsistent. However, studies have demonstrated that patients taking testosterone are not at an increased risk of breast cancer secondary to testosterone use.^5-7 Patients should be asked about a personal of family history of breast cancer, breast surgery, history of prior breast biopsies, parity, age at menarche, smoking status, and breastfeeding history if applicable. Patients with high-risk mutations or a strong family history of breast cancer should be referred to genetic counselors, surgical oncologists, and possibly undergo genetic testing.⁸ Before an examination, providers should counsel patients about the nature of the examination and use gender-neutral language such as “chest” to avoid exacerbating gender dysphoria.

It is important to educate transmasculine patients about their risk for the development of breast cancer after mastectomy. Larger-scale, population-based studies of breast cancer in the transgender population have reported an incidence of 5.9 per 100,000 patients-years and an overall incidence comparable to cisgender men in age-standardized national samples.^5-7 Unfortunately, data on the rates of breast cancer in transmasculine patients after gender-affirming mastectomy are limited, which makes defining postoperative guidelines challenging. Additionally, the amount of residual breast tissue remaining varies based on the surgeon and technique.

Several techniques are described for mastectomy procedures with differences that can affect the amount of residual breast tissue. The most common type of gender-affirming mastectomy is the double incision. With this procedure, the nipple-areolar complex is reduced in size, removed, and thinned to improve graft take. Dissection is then carried to the level of the breast capsule and the breast tissue and axillary tail are removed en bloc.⁵ During the dissection, the subcutaneous fat is left on the skin flap to provide appropriate contour and to avoid creating a concave-appearing chest wall. Prior to closure, the superior and inferior flaps are inspected for any visible residual breast tissue, which is removed if needed. In a circumareolar mastectomy, the nipple-areolar complex is also reduced but is preserved on a 1- to 1.5-cm-thick pedicle to maintain perfusion.⁵ The mastectomy is performed through an inferior periareolar incision and all visible breast tissue and the axillary tail are removed. Breast tissue specimens are sent for pathologic evaluation at the end of the procedure.

Following gender-affirming mastectomy, there is limited evidence to guide screening. During the patient visit, the provider should obtain a thorough history regarding mastectomy type, and if unknown, attempt to acquire the operative report detailing the procedure. For low-risk patients who undergo a subcutaneous mastectomy such as the double incision or circumareolar technique, screening mammography is not indicated nor is it technically feasible.⁹ For patients with a high-risk genetic mutation or a strong family history of breast cancer, monitoring with alternative modalities such as breast ultrasound or breast MRI may be beneficial, although there is no evidence to currently support this suggestion. Given the variety of surgical techniques of breast tissue removal, it is difficult to develop strong evidence-based guidelines. Annual chest wall examinations have been suggested as a screening modality; however, the clinical utility of clinical breast and chest exams has been debated and is no longer recommended as a screening method in cisgender patients.⁹ Clinicians can promote chest self-awareness and discuss the possibility of breast cancer in postmastectomy patients at annual examination visits. As research continues to resolve some of these unknowns, it is important that patients are informed of these areas of ambiguity and updated regarding any changes in screening recommendations.¹⁰

Dr. Brandt is an ob.gyn. and fellowship-trained gender affirming surgeon in West Reading, Pa.

References

1. American Society of Plastic Surgeons. 2018 plastic surgery statistics report. https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed Aug. 20, 2021.

2. James SE et al. The report of the 2015 U.S. Transgender survey. Washington, D.C.: National Center for Transgender Equality, 2016.

3. Agarwal CA et al. J Plast Reconstr Aesthet Surg. 2018;71:651-7.

4. Poudrier G et al. Plast Reconstr Surg. 2018;80:679-83.

5. Salibian AA et al. Plast Reconstr Surg. 2020;147:213e-21e.

6. Gooren LJ et al. J Sex Med. 2013;10:3129-34.

7. Brown GR and Jones KT. Breast Cancer Res Treat. 2015;149:191-8.

8. Deutsch MF et al. Semin Reprod Med. 2017;35:434-41.

9. Phillips J et al. AJR Am J Roentgenol. 2014;202:1149-59.

10. Smith RA et al. CA Cancer J Clin. 2018;68:297-316.

Since the reversal of the Medicare exclusion in 2014, the rates of gender-affirming surgery have increased markedly in the United States.¹ Gender-affirming mastectomy, otherwise known as “top surgery,” is one of the more commonly performed procedures; with 97% of patients having either undergone or expressed desire for the surgery.² The goals of this procedure are to remove all visible breast tissue and reconstruct the chest wall so it is more masculine in appearance. For transmasculine and nonbinary patients, this procedure is associated with significant improvements in mental health and quality of life.^3,4 While the mastectomy procedure is often performed by plastic surgeons, patients will see an ob.gyn. in the preoperative or postoperative period. Ob.gyns. should have a general understanding of the procedure, but most importantly know how to screen for breast cancer in patients who have undergone a gender-affirming mastectomy.

Providers will likely encounter transmasculine or nonbinary patients during annual screening examinations or for a preoperative exam. If a patient is seeking a preoperative risk assessment prior to undergoing a gender-affirming mastectomy, assessing a patient’s risk status for breast cancer is paramount. While testosterone therapy is no longer a prerequisite for gender-affirming mastectomies, documenting hormone use, age at initiation, and dosage is important.⁵ The overall effects of testosterone on breast tissue are inconsistent. However, studies have demonstrated that patients taking testosterone are not at an increased risk of breast cancer secondary to testosterone use.^5-7 Patients should be asked about a personal of family history of breast cancer, breast surgery, history of prior breast biopsies, parity, age at menarche, smoking status, and breastfeeding history if applicable. Patients with high-risk mutations or a strong family history of breast cancer should be referred to genetic counselors, surgical oncologists, and possibly undergo genetic testing.⁸ Before an examination, providers should counsel patients about the nature of the examination and use gender-neutral language such as “chest” to avoid exacerbating gender dysphoria.

It is important to educate transmasculine patients about their risk for the development of breast cancer after mastectomy. Larger-scale, population-based studies of breast cancer in the transgender population have reported an incidence of 5.9 per 100,000 patients-years and an overall incidence comparable to cisgender men in age-standardized national samples.^5-7 Unfortunately, data on the rates of breast cancer in transmasculine patients after gender-affirming mastectomy are limited, which makes defining postoperative guidelines challenging. Additionally, the amount of residual breast tissue remaining varies based on the surgeon and technique.

Several techniques are described for mastectomy procedures with differences that can affect the amount of residual breast tissue. The most common type of gender-affirming mastectomy is the double incision. With this procedure, the nipple-areolar complex is reduced in size, removed, and thinned to improve graft take. Dissection is then carried to the level of the breast capsule and the breast tissue and axillary tail are removed en bloc.⁵ During the dissection, the subcutaneous fat is left on the skin flap to provide appropriate contour and to avoid creating a concave-appearing chest wall. Prior to closure, the superior and inferior flaps are inspected for any visible residual breast tissue, which is removed if needed. In a circumareolar mastectomy, the nipple-areolar complex is also reduced but is preserved on a 1- to 1.5-cm-thick pedicle to maintain perfusion.⁵ The mastectomy is performed through an inferior periareolar incision and all visible breast tissue and the axillary tail are removed. Breast tissue specimens are sent for pathologic evaluation at the end of the procedure.

Following gender-affirming mastectomy, there is limited evidence to guide screening. During the patient visit, the provider should obtain a thorough history regarding mastectomy type, and if unknown, attempt to acquire the operative report detailing the procedure. For low-risk patients who undergo a subcutaneous mastectomy such as the double incision or circumareolar technique, screening mammography is not indicated nor is it technically feasible.⁹ For patients with a high-risk genetic mutation or a strong family history of breast cancer, monitoring with alternative modalities such as breast ultrasound or breast MRI may be beneficial, although there is no evidence to currently support this suggestion. Given the variety of surgical techniques of breast tissue removal, it is difficult to develop strong evidence-based guidelines. Annual chest wall examinations have been suggested as a screening modality; however, the clinical utility of clinical breast and chest exams has been debated and is no longer recommended as a screening method in cisgender patients.⁹ Clinicians can promote chest self-awareness and discuss the possibility of breast cancer in postmastectomy patients at annual examination visits. As research continues to resolve some of these unknowns, it is important that patients are informed of these areas of ambiguity and updated regarding any changes in screening recommendations.¹⁰

Dr. Brandt is an ob.gyn. and fellowship-trained gender affirming surgeon in West Reading, Pa.

References

1. American Society of Plastic Surgeons. 2018 plastic surgery statistics report. https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed Aug. 20, 2021.

2. James SE et al. The report of the 2015 U.S. Transgender survey. Washington, D.C.: National Center for Transgender Equality, 2016.

3. Agarwal CA et al. J Plast Reconstr Aesthet Surg. 2018;71:651-7.

4. Poudrier G et al. Plast Reconstr Surg. 2018;80:679-83.

5. Salibian AA et al. Plast Reconstr Surg. 2020;147:213e-21e.

6. Gooren LJ et al. J Sex Med. 2013;10:3129-34.

7. Brown GR and Jones KT. Breast Cancer Res Treat. 2015;149:191-8.

8. Deutsch MF et al. Semin Reprod Med. 2017;35:434-41.

9. Phillips J et al. AJR Am J Roentgenol. 2014;202:1149-59.

10. Smith RA et al. CA Cancer J Clin. 2018;68:297-316.