NEW ORLEANS – Nemolizumab monotherapy for 16 weeks improved itch, skin lesions, and sleep disturbances in adults with prurigo nodularis (PN), results from a phase 3 trial demonstrated.

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the interleukin-31 receptor alpha that blocks signaling from IL-31. “From prior studies we know that it modulates pruritus, but also alters keratinocyte differentiation, inflammation, and fibrosis,” one of the investigators, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said during a late-breaking research session at the annual meeting of the American Academy of Dermatology.

OLYMPIA 2 was a phase 3, multicenter, double-blind study in adults with PN presenting with 20 or more nodules, and Investigator’s Global Assessment (IGA) score of 3 or more, and the Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7 or more. Exclusion criteria included chronic pruritus resulting from an active condition other than PN, such as neuropathic and psychogenic pruritus and active atopic dermatitis. In addition, the use of topical steroids, considered a rescue therapy, was not allowed in the trial, Dr. Kwatra said.

After an initial screening period, 274 patients at 73 sites in nine countries were randomized 2:1 either to the nemolizumab monotherapy or placebo. Following an initial 60-mg subcutaneous dose, patients received 30 mg or 60 mg (depending on their baseline weight) every 4 weeks for 16 weeks. The primary endpoint was the proportion of patients with a 4-point or greater improvement in the PP-NRS from baseline at week 16 and the proportion of patients with IGA success at week 16.

Selected key secondary endpoints included the proportion of patients with a 4 point or greater improvement from baseline in the PP-NRS at week 4, the Sleep Disturbance Numerical Rating Scale at week 4, and the SD-NRS at week 16. Safety endpoints included the incidence and severity of all adverse events.

Of the 274 patients randomized, 183 received nemolizumab and 91 received placebo. A total of 174 patients in the nemolizumab group completed the study, compared with 88 in the placebo group. The mean age of study participants was 53 years, 61% were women, 79% were White, 14% were Asian, and the rest were from other racial groups. More than half (57%) had IGA category 3 disease (moderate) and the remainder had IGA category 4 disease (severe); 63% had 20-100 lesions, and the remainder had more than 100. About one-third of study enrollees (32%) had a history of atopy.
 

Primary, secondary endpoint results

Dr. Kwatra reported that 56.3% of the patients in the nemolizumab group achieved a 4-point or greater improvement in the PP-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001), while 37.7% of those in the nemolizumab group achieved IGA success at week 16, compared with 11% of those in the placebo group (P < .0001).

As for secondary endpoints, 41% of patients in the nemolizumab group achieved a 4-point or greater improvement in PP-NRS at week 4, compared with 7.7% of those in the placebo group (P < .0001); and 37.2% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 4, compared with 9.9% of those in the placebo group (P < .0001). Almost 52% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001); and 9.8% of those in the nemolizumab group achieved IGA success at week 4, compared with 1.1% of those in the placebo group (P < .0074).
 

Adverse events

Treatment-emergent adverse events occurred in 61.2% of subjects in the nemolizumab group, compared with 52.7% of those in the placebo group. “There were no imbalances overall, [including] no injection-related reactions in either group,” Dr. Kwatra said. There was one case of newly diagnosed asthma in the placebo arm, and none in the treatment arm.

The researchers observed a slightly increased onset of atopic dermatitis in the treatment arm, compared with the placebo arm (5.5% vs. 0%). “Seven out of those 10 patients actually had a history of atopic dermatitis or high IgE [levels] and they were mostly managed with topical steroids without study drug discontinuation,” Dr. Kwatra added. Neurodermatitis, or worsening of PN, occurred in 3.8% of patients in the nemolizumab group, compared with 11% of those in the placebo group.

“The results of this study extend the efficacy and safety findings from the phase 2 study of nemolizumab in patients with PN,” Dr. Kwatra concluded. “I think they also help to usher in a new era of PN [treatment] in prime time.”

Kenneth B. Gordon, MD, who chairs the department of dermatology at the Medical College of Wisconsin, Milwaukee, and was asked to comment on the study, was impressed with nemolizumab’s propensity for blocking IL-31. “To be able to treat PN effectively by simply blocking the itch and not having a significant inflammatory function is really interesting,” he said in an interview at the meeting. If approved, nemolizumab “gives us another treatment option for a disease that is really debilitating. It’s very promising and we hope [the drug] will be available to us in the near future.”

Nemolizumab is being developed by Galderma. According to a press release from the company, nemolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration in December 2019 for the treatment of pruritus associated with PN, a status that was reconfirmed in February 2023.

Dr. Kwatra disclosed that he is an advisory board member/consultant for Galderma, AbbVie, Amgen, Arcutis, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex, Incyte, Johnson and Johnson, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Gordon disclosed that he is a consultant to, an investigator for, and/or a member of the advisory board for several pharmaceutical companies, but not Galderma.

NEW ORLEANS – Nemolizumab monotherapy for 16 weeks improved itch, skin lesions, and sleep disturbances in adults with prurigo nodularis (PN), results from a phase 3 trial demonstrated.

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the interleukin-31 receptor alpha that blocks signaling from IL-31. “From prior studies we know that it modulates pruritus, but also alters keratinocyte differentiation, inflammation, and fibrosis,” one of the investigators, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said during a late-breaking research session at the annual meeting of the American Academy of Dermatology.

OLYMPIA 2 was a phase 3, multicenter, double-blind study in adults with PN presenting with 20 or more nodules, and Investigator’s Global Assessment (IGA) score of 3 or more, and the Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7 or more. Exclusion criteria included chronic pruritus resulting from an active condition other than PN, such as neuropathic and psychogenic pruritus and active atopic dermatitis. In addition, the use of topical steroids, considered a rescue therapy, was not allowed in the trial, Dr. Kwatra said.

After an initial screening period, 274 patients at 73 sites in nine countries were randomized 2:1 either to the nemolizumab monotherapy or placebo. Following an initial 60-mg subcutaneous dose, patients received 30 mg or 60 mg (depending on their baseline weight) every 4 weeks for 16 weeks. The primary endpoint was the proportion of patients with a 4-point or greater improvement in the PP-NRS from baseline at week 16 and the proportion of patients with IGA success at week 16.

Selected key secondary endpoints included the proportion of patients with a 4 point or greater improvement from baseline in the PP-NRS at week 4, the Sleep Disturbance Numerical Rating Scale at week 4, and the SD-NRS at week 16. Safety endpoints included the incidence and severity of all adverse events.

Of the 274 patients randomized, 183 received nemolizumab and 91 received placebo. A total of 174 patients in the nemolizumab group completed the study, compared with 88 in the placebo group. The mean age of study participants was 53 years, 61% were women, 79% were White, 14% were Asian, and the rest were from other racial groups. More than half (57%) had IGA category 3 disease (moderate) and the remainder had IGA category 4 disease (severe); 63% had 20-100 lesions, and the remainder had more than 100. About one-third of study enrollees (32%) had a history of atopy.
 

Primary, secondary endpoint results

Dr. Kwatra reported that 56.3% of the patients in the nemolizumab group achieved a 4-point or greater improvement in the PP-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001), while 37.7% of those in the nemolizumab group achieved IGA success at week 16, compared with 11% of those in the placebo group (P < .0001).

As for secondary endpoints, 41% of patients in the nemolizumab group achieved a 4-point or greater improvement in PP-NRS at week 4, compared with 7.7% of those in the placebo group (P < .0001); and 37.2% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 4, compared with 9.9% of those in the placebo group (P < .0001). Almost 52% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001); and 9.8% of those in the nemolizumab group achieved IGA success at week 4, compared with 1.1% of those in the placebo group (P < .0074).
 

Adverse events

Treatment-emergent adverse events occurred in 61.2% of subjects in the nemolizumab group, compared with 52.7% of those in the placebo group. “There were no imbalances overall, [including] no injection-related reactions in either group,” Dr. Kwatra said. There was one case of newly diagnosed asthma in the placebo arm, and none in the treatment arm.

The researchers observed a slightly increased onset of atopic dermatitis in the treatment arm, compared with the placebo arm (5.5% vs. 0%). “Seven out of those 10 patients actually had a history of atopic dermatitis or high IgE [levels] and they were mostly managed with topical steroids without study drug discontinuation,” Dr. Kwatra added. Neurodermatitis, or worsening of PN, occurred in 3.8% of patients in the nemolizumab group, compared with 11% of those in the placebo group.

“The results of this study extend the efficacy and safety findings from the phase 2 study of nemolizumab in patients with PN,” Dr. Kwatra concluded. “I think they also help to usher in a new era of PN [treatment] in prime time.”

Kenneth B. Gordon, MD, who chairs the department of dermatology at the Medical College of Wisconsin, Milwaukee, and was asked to comment on the study, was impressed with nemolizumab’s propensity for blocking IL-31. “To be able to treat PN effectively by simply blocking the itch and not having a significant inflammatory function is really interesting,” he said in an interview at the meeting. If approved, nemolizumab “gives us another treatment option for a disease that is really debilitating. It’s very promising and we hope [the drug] will be available to us in the near future.”

Nemolizumab is being developed by Galderma. According to a press release from the company, nemolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration in December 2019 for the treatment of pruritus associated with PN, a status that was reconfirmed in February 2023.

Dr. Kwatra disclosed that he is an advisory board member/consultant for Galderma, AbbVie, Amgen, Arcutis, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex, Incyte, Johnson and Johnson, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Gordon disclosed that he is a consultant to, an investigator for, and/or a member of the advisory board for several pharmaceutical companies, but not Galderma.

NEW ORLEANS – Nemolizumab monotherapy for 16 weeks improved itch, skin lesions, and sleep disturbances in adults with prurigo nodularis (PN), results from a phase 3 trial demonstrated.

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the interleukin-31 receptor alpha that blocks signaling from IL-31. “From prior studies we know that it modulates pruritus, but also alters keratinocyte differentiation, inflammation, and fibrosis,” one of the investigators, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said during a late-breaking research session at the annual meeting of the American Academy of Dermatology.

OLYMPIA 2 was a phase 3, multicenter, double-blind study in adults with PN presenting with 20 or more nodules, and Investigator’s Global Assessment (IGA) score of 3 or more, and the Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7 or more. Exclusion criteria included chronic pruritus resulting from an active condition other than PN, such as neuropathic and psychogenic pruritus and active atopic dermatitis. In addition, the use of topical steroids, considered a rescue therapy, was not allowed in the trial, Dr. Kwatra said.

After an initial screening period, 274 patients at 73 sites in nine countries were randomized 2:1 either to the nemolizumab monotherapy or placebo. Following an initial 60-mg subcutaneous dose, patients received 30 mg or 60 mg (depending on their baseline weight) every 4 weeks for 16 weeks. The primary endpoint was the proportion of patients with a 4-point or greater improvement in the PP-NRS from baseline at week 16 and the proportion of patients with IGA success at week 16.

Selected key secondary endpoints included the proportion of patients with a 4 point or greater improvement from baseline in the PP-NRS at week 4, the Sleep Disturbance Numerical Rating Scale at week 4, and the SD-NRS at week 16. Safety endpoints included the incidence and severity of all adverse events.

Of the 274 patients randomized, 183 received nemolizumab and 91 received placebo. A total of 174 patients in the nemolizumab group completed the study, compared with 88 in the placebo group. The mean age of study participants was 53 years, 61% were women, 79% were White, 14% were Asian, and the rest were from other racial groups. More than half (57%) had IGA category 3 disease (moderate) and the remainder had IGA category 4 disease (severe); 63% had 20-100 lesions, and the remainder had more than 100. About one-third of study enrollees (32%) had a history of atopy.
 

Primary, secondary endpoint results

Dr. Kwatra reported that 56.3% of the patients in the nemolizumab group achieved a 4-point or greater improvement in the PP-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001), while 37.7% of those in the nemolizumab group achieved IGA success at week 16, compared with 11% of those in the placebo group (P < .0001).

As for secondary endpoints, 41% of patients in the nemolizumab group achieved a 4-point or greater improvement in PP-NRS at week 4, compared with 7.7% of those in the placebo group (P < .0001); and 37.2% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 4, compared with 9.9% of those in the placebo group (P < .0001). Almost 52% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001); and 9.8% of those in the nemolizumab group achieved IGA success at week 4, compared with 1.1% of those in the placebo group (P < .0074).
 

Adverse events

Treatment-emergent adverse events occurred in 61.2% of subjects in the nemolizumab group, compared with 52.7% of those in the placebo group. “There were no imbalances overall, [including] no injection-related reactions in either group,” Dr. Kwatra said. There was one case of newly diagnosed asthma in the placebo arm, and none in the treatment arm.

The researchers observed a slightly increased onset of atopic dermatitis in the treatment arm, compared with the placebo arm (5.5% vs. 0%). “Seven out of those 10 patients actually had a history of atopic dermatitis or high IgE [levels] and they were mostly managed with topical steroids without study drug discontinuation,” Dr. Kwatra added. Neurodermatitis, or worsening of PN, occurred in 3.8% of patients in the nemolizumab group, compared with 11% of those in the placebo group.

“The results of this study extend the efficacy and safety findings from the phase 2 study of nemolizumab in patients with PN,” Dr. Kwatra concluded. “I think they also help to usher in a new era of PN [treatment] in prime time.”

Kenneth B. Gordon, MD, who chairs the department of dermatology at the Medical College of Wisconsin, Milwaukee, and was asked to comment on the study, was impressed with nemolizumab’s propensity for blocking IL-31. “To be able to treat PN effectively by simply blocking the itch and not having a significant inflammatory function is really interesting,” he said in an interview at the meeting. If approved, nemolizumab “gives us another treatment option for a disease that is really debilitating. It’s very promising and we hope [the drug] will be available to us in the near future.”

Nemolizumab is being developed by Galderma. According to a press release from the company, nemolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration in December 2019 for the treatment of pruritus associated with PN, a status that was reconfirmed in February 2023.

Dr. Kwatra disclosed that he is an advisory board member/consultant for Galderma, AbbVie, Amgen, Arcutis, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex, Incyte, Johnson and Johnson, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Gordon disclosed that he is a consultant to, an investigator for, and/or a member of the advisory board for several pharmaceutical companies, but not Galderma.

CASE Intervention approaches for decreasing the risk of cervical cancer

A 25-year-old woman presents to your practice for routine examination. She has never undergone cervical cancer screening or received the human papillomavirus (HPV) vaccine series. The patient has had 3 lifetime sexual partners and currently uses condoms as contraception. What interventions are appropriate to offer this patient to decrease her risk of cervical cancer? Choose as many that may apply:

1. cervical cytology with reflex HPV testing

2. cervical cytology with HPV cotesting

3. primary HPV testing

4. HPV vaccine series (3 doses)

5. all of the above

The answer is number 5, all of the above.

Choices 1, 2, and 3 are acceptable methods of cervical cancer screening for this patient. Catch-up HPV vaccination should be offered as well.

Equitable preventive care is needed

Cervical cancer is a unique cancer because it has a known preventative strategy. HPV vaccination, paired with cervical screening and management of abnormal results, has contributed to decreased rates of cervical cancer in the United States, from 13,914 cases in 1999 to 12,795 cases in 2019.¹ In less-developed countries, however, cervical cancer continues to be a leading cause of mortality, with 90% of cervical cancer deaths in 2020 occurring in low- and middle-income countries.²

Disparate outcomes in cervical cancer are often a reflection of disparities in health access. Within the United States, Black women have a higher incidence of cervical cancer, advanced-stage disease, and mortality from cervical cancer than White women.^3,4 Furthermore, the incidence of cervical cancer increased among American Indian and Alaska Native people between 2000 and 2019.⁵ The rate for patients who are overdue for cervical cancer screening is higher among Asian and Hispanic patients compared with non-Hispanic White patients (31.4% vs 20.1%; P=.01) and among patients who identify as LGBTQ+ compared with patients who identify as heterosexual (32.0% vs 22.2%; P<.001).⁶ Younger patients have a significantly higher rate for overdue screening compared with their older counterparts (29.1% vs 21.1%; P<.001), as do uninsured patients compared with those who are privately insured (41.7% vs 18.1%; P<.001). Overall, the proportion of women without up-to-date screening increased significantly from 2005 to 2019 (14.4% vs 23.0%; P<.001).⁶

Unfortunately, despite a known strategy to eliminate cervical cancer, we are not accomplishing equitable preventative care. Barriers to care can include patient-centered issues, such as fear of cancer or of painful evaluations, lack of trust in the health care system, and inadequate understanding of the benefits of cancer prevention, in addition to systemic and structural barriers. As we assess new technologies, one of our most important goals is to consider how such innovations can increase health access—whether through increasing ease and acceptability of testing or by creating more effective screening tests.

Updates to cervical screening guidance

In 2020, the American Cancer Society (ACS) updated its cervical screening guidelines to start screening at age 25 years with the “preferred” strategy of HPV primary testing every 5 years.⁷ By contrast, the US Preventive Services Task Force (USPSTF) continues to recommend 1 of 3 methods: cytology alone every 3 years; cytology alone every 3 years between ages 21 and 29 followed by cytology and HPV cotesting every 5 years at age 30 or older; or high-risk HPV testing alone every 5 years (TABLE).⁸

To successfully prevent cervical cancer, abnormal results are managed by performing either colposcopy with biopsy, immediate treatment, or close surveillance based on the risk of developing cervical intraepithelial neoplasia (CIN) 3 or worse. A patient’s risk is determined based on both current and prior test results. The ASCCP (American Society for Colposcopy and Cervical Pathology) transitioned to risk-based management guidelines in 2019 and has both an app and a web-based risk assessment tool available for clinicians (https://www.asccp.org).⁹

All organizations recommend stopping screening after age 65 provided there has been a history of adequate screening in the prior 10 years (defined as 2 normal cotests or 3 normal cytology tests, with the most recent test within 5 years) and no history of CIN 2 or worse within the prior 25 years.^10,11 Recent studies that examined the rate of cervical cancer diagnosed in patients older than 65 years have questioned whether patients should continue screening beyond 65.¹⁰ In the United States, 20% of cervical cancer still occurs in women older than age 65.¹¹ One reason may be that many women have not met the requirement for adequate and normal prior screening and may still need ongoing testing.¹²

Continue to: Primary HPV screening...

Primary HPV testing means that an HPV test is performed first, and if it is positive for high-risk HPV, further testing is performed to determine next steps. This contrasts with the currently used method of obtaining cytology (Pap) first with either concurrent HPV testing or reflex HPV testing. The first HPV primary screening test was approved by the US Food and Drug Administration (FDA) in 2014.¹³

Multiple randomized controlled trials in Europe have demonstrated the accuracy of HPV-based screening compared with cytology in the detection of cervical cancer and its precursors.^14-17 The HPV FOCAL trial demonstrated increased efficacy of primary HPV screening in the detection of CIN 2+ lesions.¹⁸ This trial recruited a total of 19,000 women, ages 25 to 65, in Canada and randomly assigned them to receive primary HPV testing or liquid-based cytology. If primary HPV testing was negative, participants would return in 48 months for cytology and HPV cotesting. If primary liquid-based cytology testing was negative, participants would return at 24 months for cytology testing alone and at 48 months for cytology and HPV cotesting. Both groups had similar incidences of CIN 2+ over the study period. HPV testing was shown to detect CIN 2+ at higher rates at the time of initial screen (risk ratio [RR], 1.61; 95% confidence interval [CI], 1.24–2.09) and then significantly lower rates at the time of exit screening at 48 months (RR, 0.36; 95% CI, 0.24–0.54).¹⁸ These results demonstrated that primary HPV testing detects CIN 2+ earlier than cytology alone. In follow-up analyses, primary HPV screening missed fewer CIN 2+ diagnoses than cytology screening.¹⁹

While not as many studies have compared primary HPV testing to cytology with an HPV cotest, the current most common practice in the United States, one study performed in the United States found that a negative cytology result did not further decrease the risk of CIN 3 for HPV-negative patients (risk of CIN 3+ at 5 years: 0.16% vs 0.17%; P=0.8) and concluded that a negative HPV test was enough reassurance for a low risk of CIN 3+.²⁰

Another study, the ATHENA trial, evaluated more than 42,000 women who were 25 years and older over a 3-year period.²¹ Patients underwent either primary HPV testing or combination cytology and reflex HPV (if ages 25–29) or HPV cotesting (if age 30 or older). Primary HPV testing was found to have a sensitivity and specificity of 76.1% and 93.5%, respectively, compared with 61.7% and 94.6% for cytology with HPV cotesting, but it also increased the total number of colposcopies performed.²¹

Subsequent management of a primary HPV-positive result can be triaged using genotyping, cytology, or a combination of both. FDA-approved HPV screening tests provide genotyping and current management guidelines use genotyping to triage positive HPV results into HPV 16, 18, or 1 of 12 other high-risk HPV genotypes.

In the ATHENA trial, the 3-year incidence of CIN 3+ for HPV 16/18-positive results was 21.16% (95% CI, 18.39%–24.01%) compared with 5.4% (95% CI, 4.5%–6.4%) among patients with an HPV test positive for 1 of the other HPV genotypes.²¹ While a patient with an HPV result positive for HPV 16/18 should directly undergo colposcopy, clinical guidance for an HPV-positive result for one of the other genotypes suggests using reflex cytology to triage patients. The ASCCP recommended management of primary HPV testing is included in the FIGURE.²²

Many barriers remain to transitioning to primary HPV testing, including laboratory test availability as well as patient and provider acceptance. At present, 2 FDA-approved primary HPV screening tests are available: the Cobas HPV test (Roche Molecular Systems, Inc) and the BD Onclarity HPV assay (Becton, Dickinson and Company). Changes to screening recommendations need to be accompanied by patient and provider outreach and education.

In a survey of more than 500 US women in 2015 after guidelines allowed for increased screening intervals after negative results, a majority of women (55.6%; 95% CI, 51.4%–59.8%) were aware that screening recommendations had changed; however, 74.1% (95% CI, 70.3%–77.7%) still believed that women should be screened annually.²³ By contrast, participants in the HPV FOCAL trial, who were able to learn more about HPV-based screening, were surveyed about their willingness to undergo primary HPV testing rather than Pap testing at the conclusion of the trial.²⁴ Of the participants, 63% were comfortable with primary HPV testing, and 54% were accepting of an extended screening interval of 4 to 5 years.²⁴

Continue to: p16/Ki-67 dual-stain cytology...

An additional tool for triaging HPV-positive patients is the p16/Ki-67 dual stain test (CINtec Plus Cytology; Roche), which was FDA approved in March 2020. A tumor suppressor protein, p16 is found to be overexpressed by HPV oncogenic activity, and Ki-67 is a marker of cellular proliferation. Coexpression of p16 and Ki-67 indicates a loss of cell cycle regulation and is a hallmark of neoplastic transformation. When positive, this test is supportive of active HPV infection and of a high-grade lesion. While the dual stain test is not yet formally incorporated into triage algorithms by national guidelines, it has demonstrated efficacy in detecting CIN 3+

In the IMPACT trial, nearly 5,000 HPV-positive patients underwent p16/Ki-67 dual stain testing compared with cytology and HPV genotyping.²⁵ The sensitivity of dual stain for CIN 3+ was 91.9% (95% CI, 86.1%–95.4%) in HPV 16/18–positive and 86.0% (95% CI, 77.5%–91.6%) in the 12 other genotypes. Using dual stain testing alone to triage HPV-positive results showed significantly higher sensitivity but lower specificity than using cytology alone to triage HPV-positive results. Importantly, triage with dual stain testing alone would have referred significantly fewer women to colposcopy than HPV 16/18 genotyping with cytology triage for the 12 other genotypes (48.6% vs 56.0%; P< .0001).

Self-sampling methods: An approach for potentially improving access to screening

One technology that may help bridge gaps in access to cervical cancer screening is self-collected HPV testing, which would preclude the need for a clinician-performed pelvic exam. At present, no self-sampling method is approved by the FDA. However, many studies have examined the efficacy and safety of various self-sampling kits.²⁶

One randomized controlled trial in the Netherlands compared sensitivity and specificity of CIN 2+ detection in patient-collected versus clinician-collected swabs.²⁷ After a median follow-up of 20 months, the sensitivity and specificity of HPV testing did not differ between the patient-collected and the clinician-collected groups (specificity 100%; 95% CI, 0.91–1.08; sensitivity 96%; 95% CI, 0.90–1.03).²⁷ This analysis did not include patients who did not return their self-collected sample, which leaves the question of whether self-sampling may exacerbate issues with patients who are lost to follow-up.

In a study performed in the United States, 16,590 patients who were overdue for cervical cancer screening were randomly assigned to usual care reminders (annual mailed reminders and phone calls from clinics) or to the addition of a mailed HPV self-sampling test kit.²⁸ While the study did not demonstrate significant difference in the detection of overall CIN 2+ between the 2 groups, screening uptake was higher in the self-sampling kit group than in the usual care reminders group (RR, 1.51; 95% CI, 1.43–1.60), and the number of abnormal screens that warranted colposcopy referral was similar between the 2 groups (36.4% vs 36.8%).²⁸ In qualitative interviews of the participants of this trial, patients who were sent at-home self-sampling kits found that the convenience of at-home testing lowered barriers to scheduling an in-office appointment.²⁹ The hope is that self-sampling methods will expand access of cervical cancer screening to vulnerable populations that face significant barriers to having an in-office pelvic exam.

It is important to note that self-collection and self-sample testing requires multidisciplinary systems for processing results and assuring necessary patient follow-up. Implementing and disseminating such a program has been well tested only in developed countries^27,30 with universal health care systems or within an integrated care delivery system. Bringing such technology broadly to the United States and less developed countries will require continued commitment to increasing laboratory capacity, a central electronic health record or system for monitoring results, educational materials for clinicians and patients, and expanding insurance reimbursement for such testing.

HPV vaccination rates must increase

While we continue to investigate which screening methods will most improve our secondary prevention of cervical cancer, our path to increasing primary prevention of cervical cancer is clear: We must increase rates of HPV vaccination. The 9-valent HPV vaccine is FDA approved for use in all patients aged 9 to 45 years.

The American College of Obstetricians and Gynecologists and other organizations recommend HPV vaccination between the ages of 9 and 13, and a “catch-up period” from ages 13 to 26 in which patients previously not vaccinated should receive the vaccine.³¹ Initiation of the vaccine course earlier (ages 9–10) compared with later (ages 11–12) is correlated with higher overall completion rates by age 15 and has been suggested to be associated with a stronger immune response.³²

A study from Sweden found that HPV vaccination before age 17 was most strongly correlated with the lowest rates of cervical cancer, although vaccination between ages 17 and 30 still significantly decreased the risk of cervical cancer compared with those who were unvaccinated.³³

Overall HPV vaccination rates in the United States continue to improve, with 58.6%³⁴ of US adolescents having completed vaccination in 2020. However, these rates still are significantly lower than those in many other developed countries, including Australia, which had a complete vaccination rate of 80.5% in 2020.³⁵ Continued disparities in vaccination rates could be contributing to the rise in cervical cancer among certain groups, such as American Indian and Alaska Native populations.⁵

Work—and innovations—must continue

In conclusion, the incidence of cervical cancer in the United States continues to decrease, although at disparate rates among marginalized populations. To ensure that we are working toward eliminating cervical cancer for all patients, we must continue efforts to eliminate disparities in health access. Continued innovations, including primary HPV testing and self-collection samples, may contribute to lowering barriers to all patients being able to access the preventative care they need. ●

CASE Intervention approaches for decreasing the risk of cervical cancer

A 25-year-old woman presents to your practice for routine examination. She has never undergone cervical cancer screening or received the human papillomavirus (HPV) vaccine series. The patient has had 3 lifetime sexual partners and currently uses condoms as contraception. What interventions are appropriate to offer this patient to decrease her risk of cervical cancer? Choose as many that may apply:

1. cervical cytology with reflex HPV testing

2. cervical cytology with HPV cotesting

3. primary HPV testing

4. HPV vaccine series (3 doses)

5. all of the above

The answer is number 5, all of the above.

Choices 1, 2, and 3 are acceptable methods of cervical cancer screening for this patient. Catch-up HPV vaccination should be offered as well.

Equitable preventive care is needed

Cervical cancer is a unique cancer because it has a known preventative strategy. HPV vaccination, paired with cervical screening and management of abnormal results, has contributed to decreased rates of cervical cancer in the United States, from 13,914 cases in 1999 to 12,795 cases in 2019.¹ In less-developed countries, however, cervical cancer continues to be a leading cause of mortality, with 90% of cervical cancer deaths in 2020 occurring in low- and middle-income countries.²

Disparate outcomes in cervical cancer are often a reflection of disparities in health access. Within the United States, Black women have a higher incidence of cervical cancer, advanced-stage disease, and mortality from cervical cancer than White women.^3,4 Furthermore, the incidence of cervical cancer increased among American Indian and Alaska Native people between 2000 and 2019.⁵ The rate for patients who are overdue for cervical cancer screening is higher among Asian and Hispanic patients compared with non-Hispanic White patients (31.4% vs 20.1%; P=.01) and among patients who identify as LGBTQ+ compared with patients who identify as heterosexual (32.0% vs 22.2%; P<.001).⁶ Younger patients have a significantly higher rate for overdue screening compared with their older counterparts (29.1% vs 21.1%; P<.001), as do uninsured patients compared with those who are privately insured (41.7% vs 18.1%; P<.001). Overall, the proportion of women without up-to-date screening increased significantly from 2005 to 2019 (14.4% vs 23.0%; P<.001).⁶

Unfortunately, despite a known strategy to eliminate cervical cancer, we are not accomplishing equitable preventative care. Barriers to care can include patient-centered issues, such as fear of cancer or of painful evaluations, lack of trust in the health care system, and inadequate understanding of the benefits of cancer prevention, in addition to systemic and structural barriers. As we assess new technologies, one of our most important goals is to consider how such innovations can increase health access—whether through increasing ease and acceptability of testing or by creating more effective screening tests.

Updates to cervical screening guidance

In 2020, the American Cancer Society (ACS) updated its cervical screening guidelines to start screening at age 25 years with the “preferred” strategy of HPV primary testing every 5 years.⁷ By contrast, the US Preventive Services Task Force (USPSTF) continues to recommend 1 of 3 methods: cytology alone every 3 years; cytology alone every 3 years between ages 21 and 29 followed by cytology and HPV cotesting every 5 years at age 30 or older; or high-risk HPV testing alone every 5 years (TABLE).⁸

To successfully prevent cervical cancer, abnormal results are managed by performing either colposcopy with biopsy, immediate treatment, or close surveillance based on the risk of developing cervical intraepithelial neoplasia (CIN) 3 or worse. A patient’s risk is determined based on both current and prior test results. The ASCCP (American Society for Colposcopy and Cervical Pathology) transitioned to risk-based management guidelines in 2019 and has both an app and a web-based risk assessment tool available for clinicians (https://www.asccp.org).⁹

All organizations recommend stopping screening after age 65 provided there has been a history of adequate screening in the prior 10 years (defined as 2 normal cotests or 3 normal cytology tests, with the most recent test within 5 years) and no history of CIN 2 or worse within the prior 25 years.^10,11 Recent studies that examined the rate of cervical cancer diagnosed in patients older than 65 years have questioned whether patients should continue screening beyond 65.¹⁰ In the United States, 20% of cervical cancer still occurs in women older than age 65.¹¹ One reason may be that many women have not met the requirement for adequate and normal prior screening and may still need ongoing testing.¹²

Continue to: Primary HPV screening...

Primary HPV testing means that an HPV test is performed first, and if it is positive for high-risk HPV, further testing is performed to determine next steps. This contrasts with the currently used method of obtaining cytology (Pap) first with either concurrent HPV testing or reflex HPV testing. The first HPV primary screening test was approved by the US Food and Drug Administration (FDA) in 2014.¹³

Multiple randomized controlled trials in Europe have demonstrated the accuracy of HPV-based screening compared with cytology in the detection of cervical cancer and its precursors.^14-17 The HPV FOCAL trial demonstrated increased efficacy of primary HPV screening in the detection of CIN 2+ lesions.¹⁸ This trial recruited a total of 19,000 women, ages 25 to 65, in Canada and randomly assigned them to receive primary HPV testing or liquid-based cytology. If primary HPV testing was negative, participants would return in 48 months for cytology and HPV cotesting. If primary liquid-based cytology testing was negative, participants would return at 24 months for cytology testing alone and at 48 months for cytology and HPV cotesting. Both groups had similar incidences of CIN 2+ over the study period. HPV testing was shown to detect CIN 2+ at higher rates at the time of initial screen (risk ratio [RR], 1.61; 95% confidence interval [CI], 1.24–2.09) and then significantly lower rates at the time of exit screening at 48 months (RR, 0.36; 95% CI, 0.24–0.54).¹⁸ These results demonstrated that primary HPV testing detects CIN 2+ earlier than cytology alone. In follow-up analyses, primary HPV screening missed fewer CIN 2+ diagnoses than cytology screening.¹⁹

While not as many studies have compared primary HPV testing to cytology with an HPV cotest, the current most common practice in the United States, one study performed in the United States found that a negative cytology result did not further decrease the risk of CIN 3 for HPV-negative patients (risk of CIN 3+ at 5 years: 0.16% vs 0.17%; P=0.8) and concluded that a negative HPV test was enough reassurance for a low risk of CIN 3+.²⁰

Another study, the ATHENA trial, evaluated more than 42,000 women who were 25 years and older over a 3-year period.²¹ Patients underwent either primary HPV testing or combination cytology and reflex HPV (if ages 25–29) or HPV cotesting (if age 30 or older). Primary HPV testing was found to have a sensitivity and specificity of 76.1% and 93.5%, respectively, compared with 61.7% and 94.6% for cytology with HPV cotesting, but it also increased the total number of colposcopies performed.²¹

Subsequent management of a primary HPV-positive result can be triaged using genotyping, cytology, or a combination of both. FDA-approved HPV screening tests provide genotyping and current management guidelines use genotyping to triage positive HPV results into HPV 16, 18, or 1 of 12 other high-risk HPV genotypes.

In the ATHENA trial, the 3-year incidence of CIN 3+ for HPV 16/18-positive results was 21.16% (95% CI, 18.39%–24.01%) compared with 5.4% (95% CI, 4.5%–6.4%) among patients with an HPV test positive for 1 of the other HPV genotypes.²¹ While a patient with an HPV result positive for HPV 16/18 should directly undergo colposcopy, clinical guidance for an HPV-positive result for one of the other genotypes suggests using reflex cytology to triage patients. The ASCCP recommended management of primary HPV testing is included in the FIGURE.²²

Many barriers remain to transitioning to primary HPV testing, including laboratory test availability as well as patient and provider acceptance. At present, 2 FDA-approved primary HPV screening tests are available: the Cobas HPV test (Roche Molecular Systems, Inc) and the BD Onclarity HPV assay (Becton, Dickinson and Company). Changes to screening recommendations need to be accompanied by patient and provider outreach and education.

In a survey of more than 500 US women in 2015 after guidelines allowed for increased screening intervals after negative results, a majority of women (55.6%; 95% CI, 51.4%–59.8%) were aware that screening recommendations had changed; however, 74.1% (95% CI, 70.3%–77.7%) still believed that women should be screened annually.²³ By contrast, participants in the HPV FOCAL trial, who were able to learn more about HPV-based screening, were surveyed about their willingness to undergo primary HPV testing rather than Pap testing at the conclusion of the trial.²⁴ Of the participants, 63% were comfortable with primary HPV testing, and 54% were accepting of an extended screening interval of 4 to 5 years.²⁴

Continue to: p16/Ki-67 dual-stain cytology...

An additional tool for triaging HPV-positive patients is the p16/Ki-67 dual stain test (CINtec Plus Cytology; Roche), which was FDA approved in March 2020. A tumor suppressor protein, p16 is found to be overexpressed by HPV oncogenic activity, and Ki-67 is a marker of cellular proliferation. Coexpression of p16 and Ki-67 indicates a loss of cell cycle regulation and is a hallmark of neoplastic transformation. When positive, this test is supportive of active HPV infection and of a high-grade lesion. While the dual stain test is not yet formally incorporated into triage algorithms by national guidelines, it has demonstrated efficacy in detecting CIN 3+

In the IMPACT trial, nearly 5,000 HPV-positive patients underwent p16/Ki-67 dual stain testing compared with cytology and HPV genotyping.²⁵ The sensitivity of dual stain for CIN 3+ was 91.9% (95% CI, 86.1%–95.4%) in HPV 16/18–positive and 86.0% (95% CI, 77.5%–91.6%) in the 12 other genotypes. Using dual stain testing alone to triage HPV-positive results showed significantly higher sensitivity but lower specificity than using cytology alone to triage HPV-positive results. Importantly, triage with dual stain testing alone would have referred significantly fewer women to colposcopy than HPV 16/18 genotyping with cytology triage for the 12 other genotypes (48.6% vs 56.0%; P< .0001).

Self-sampling methods: An approach for potentially improving access to screening

One technology that may help bridge gaps in access to cervical cancer screening is self-collected HPV testing, which would preclude the need for a clinician-performed pelvic exam. At present, no self-sampling method is approved by the FDA. However, many studies have examined the efficacy and safety of various self-sampling kits.²⁶

One randomized controlled trial in the Netherlands compared sensitivity and specificity of CIN 2+ detection in patient-collected versus clinician-collected swabs.²⁷ After a median follow-up of 20 months, the sensitivity and specificity of HPV testing did not differ between the patient-collected and the clinician-collected groups (specificity 100%; 95% CI, 0.91–1.08; sensitivity 96%; 95% CI, 0.90–1.03).²⁷ This analysis did not include patients who did not return their self-collected sample, which leaves the question of whether self-sampling may exacerbate issues with patients who are lost to follow-up.

In a study performed in the United States, 16,590 patients who were overdue for cervical cancer screening were randomly assigned to usual care reminders (annual mailed reminders and phone calls from clinics) or to the addition of a mailed HPV self-sampling test kit.²⁸ While the study did not demonstrate significant difference in the detection of overall CIN 2+ between the 2 groups, screening uptake was higher in the self-sampling kit group than in the usual care reminders group (RR, 1.51; 95% CI, 1.43–1.60), and the number of abnormal screens that warranted colposcopy referral was similar between the 2 groups (36.4% vs 36.8%).²⁸ In qualitative interviews of the participants of this trial, patients who were sent at-home self-sampling kits found that the convenience of at-home testing lowered barriers to scheduling an in-office appointment.²⁹ The hope is that self-sampling methods will expand access of cervical cancer screening to vulnerable populations that face significant barriers to having an in-office pelvic exam.

It is important to note that self-collection and self-sample testing requires multidisciplinary systems for processing results and assuring necessary patient follow-up. Implementing and disseminating such a program has been well tested only in developed countries^27,30 with universal health care systems or within an integrated care delivery system. Bringing such technology broadly to the United States and less developed countries will require continued commitment to increasing laboratory capacity, a central electronic health record or system for monitoring results, educational materials for clinicians and patients, and expanding insurance reimbursement for such testing.

HPV vaccination rates must increase

While we continue to investigate which screening methods will most improve our secondary prevention of cervical cancer, our path to increasing primary prevention of cervical cancer is clear: We must increase rates of HPV vaccination. The 9-valent HPV vaccine is FDA approved for use in all patients aged 9 to 45 years.

The American College of Obstetricians and Gynecologists and other organizations recommend HPV vaccination between the ages of 9 and 13, and a “catch-up period” from ages 13 to 26 in which patients previously not vaccinated should receive the vaccine.³¹ Initiation of the vaccine course earlier (ages 9–10) compared with later (ages 11–12) is correlated with higher overall completion rates by age 15 and has been suggested to be associated with a stronger immune response.³²

A study from Sweden found that HPV vaccination before age 17 was most strongly correlated with the lowest rates of cervical cancer, although vaccination between ages 17 and 30 still significantly decreased the risk of cervical cancer compared with those who were unvaccinated.³³

Overall HPV vaccination rates in the United States continue to improve, with 58.6%³⁴ of US adolescents having completed vaccination in 2020. However, these rates still are significantly lower than those in many other developed countries, including Australia, which had a complete vaccination rate of 80.5% in 2020.³⁵ Continued disparities in vaccination rates could be contributing to the rise in cervical cancer among certain groups, such as American Indian and Alaska Native populations.⁵

Work—and innovations—must continue

In conclusion, the incidence of cervical cancer in the United States continues to decrease, although at disparate rates among marginalized populations. To ensure that we are working toward eliminating cervical cancer for all patients, we must continue efforts to eliminate disparities in health access. Continued innovations, including primary HPV testing and self-collection samples, may contribute to lowering barriers to all patients being able to access the preventative care they need. ●

CASE Intervention approaches for decreasing the risk of cervical cancer

A 25-year-old woman presents to your practice for routine examination. She has never undergone cervical cancer screening or received the human papillomavirus (HPV) vaccine series. The patient has had 3 lifetime sexual partners and currently uses condoms as contraception. What interventions are appropriate to offer this patient to decrease her risk of cervical cancer? Choose as many that may apply:

1. cervical cytology with reflex HPV testing

2. cervical cytology with HPV cotesting

3. primary HPV testing

4. HPV vaccine series (3 doses)

5. all of the above

The answer is number 5, all of the above.

Choices 1, 2, and 3 are acceptable methods of cervical cancer screening for this patient. Catch-up HPV vaccination should be offered as well.

Equitable preventive care is needed

Cervical cancer is a unique cancer because it has a known preventative strategy. HPV vaccination, paired with cervical screening and management of abnormal results, has contributed to decreased rates of cervical cancer in the United States, from 13,914 cases in 1999 to 12,795 cases in 2019.¹ In less-developed countries, however, cervical cancer continues to be a leading cause of mortality, with 90% of cervical cancer deaths in 2020 occurring in low- and middle-income countries.²

Disparate outcomes in cervical cancer are often a reflection of disparities in health access. Within the United States, Black women have a higher incidence of cervical cancer, advanced-stage disease, and mortality from cervical cancer than White women.^3,4 Furthermore, the incidence of cervical cancer increased among American Indian and Alaska Native people between 2000 and 2019.⁵ The rate for patients who are overdue for cervical cancer screening is higher among Asian and Hispanic patients compared with non-Hispanic White patients (31.4% vs 20.1%; P=.01) and among patients who identify as LGBTQ+ compared with patients who identify as heterosexual (32.0% vs 22.2%; P<.001).⁶ Younger patients have a significantly higher rate for overdue screening compared with their older counterparts (29.1% vs 21.1%; P<.001), as do uninsured patients compared with those who are privately insured (41.7% vs 18.1%; P<.001). Overall, the proportion of women without up-to-date screening increased significantly from 2005 to 2019 (14.4% vs 23.0%; P<.001).⁶

Unfortunately, despite a known strategy to eliminate cervical cancer, we are not accomplishing equitable preventative care. Barriers to care can include patient-centered issues, such as fear of cancer or of painful evaluations, lack of trust in the health care system, and inadequate understanding of the benefits of cancer prevention, in addition to systemic and structural barriers. As we assess new technologies, one of our most important goals is to consider how such innovations can increase health access—whether through increasing ease and acceptability of testing or by creating more effective screening tests.

Updates to cervical screening guidance

In 2020, the American Cancer Society (ACS) updated its cervical screening guidelines to start screening at age 25 years with the “preferred” strategy of HPV primary testing every 5 years.⁷ By contrast, the US Preventive Services Task Force (USPSTF) continues to recommend 1 of 3 methods: cytology alone every 3 years; cytology alone every 3 years between ages 21 and 29 followed by cytology and HPV cotesting every 5 years at age 30 or older; or high-risk HPV testing alone every 5 years (TABLE).⁸

To successfully prevent cervical cancer, abnormal results are managed by performing either colposcopy with biopsy, immediate treatment, or close surveillance based on the risk of developing cervical intraepithelial neoplasia (CIN) 3 or worse. A patient’s risk is determined based on both current and prior test results. The ASCCP (American Society for Colposcopy and Cervical Pathology) transitioned to risk-based management guidelines in 2019 and has both an app and a web-based risk assessment tool available for clinicians (https://www.asccp.org).⁹

All organizations recommend stopping screening after age 65 provided there has been a history of adequate screening in the prior 10 years (defined as 2 normal cotests or 3 normal cytology tests, with the most recent test within 5 years) and no history of CIN 2 or worse within the prior 25 years.^10,11 Recent studies that examined the rate of cervical cancer diagnosed in patients older than 65 years have questioned whether patients should continue screening beyond 65.¹⁰ In the United States, 20% of cervical cancer still occurs in women older than age 65.¹¹ One reason may be that many women have not met the requirement for adequate and normal prior screening and may still need ongoing testing.¹²

Continue to: Primary HPV screening...

Primary HPV testing means that an HPV test is performed first, and if it is positive for high-risk HPV, further testing is performed to determine next steps. This contrasts with the currently used method of obtaining cytology (Pap) first with either concurrent HPV testing or reflex HPV testing. The first HPV primary screening test was approved by the US Food and Drug Administration (FDA) in 2014.¹³

Multiple randomized controlled trials in Europe have demonstrated the accuracy of HPV-based screening compared with cytology in the detection of cervical cancer and its precursors.^14-17 The HPV FOCAL trial demonstrated increased efficacy of primary HPV screening in the detection of CIN 2+ lesions.¹⁸ This trial recruited a total of 19,000 women, ages 25 to 65, in Canada and randomly assigned them to receive primary HPV testing or liquid-based cytology. If primary HPV testing was negative, participants would return in 48 months for cytology and HPV cotesting. If primary liquid-based cytology testing was negative, participants would return at 24 months for cytology testing alone and at 48 months for cytology and HPV cotesting. Both groups had similar incidences of CIN 2+ over the study period. HPV testing was shown to detect CIN 2+ at higher rates at the time of initial screen (risk ratio [RR], 1.61; 95% confidence interval [CI], 1.24–2.09) and then significantly lower rates at the time of exit screening at 48 months (RR, 0.36; 95% CI, 0.24–0.54).¹⁸ These results demonstrated that primary HPV testing detects CIN 2+ earlier than cytology alone. In follow-up analyses, primary HPV screening missed fewer CIN 2+ diagnoses than cytology screening.¹⁹

While not as many studies have compared primary HPV testing to cytology with an HPV cotest, the current most common practice in the United States, one study performed in the United States found that a negative cytology result did not further decrease the risk of CIN 3 for HPV-negative patients (risk of CIN 3+ at 5 years: 0.16% vs 0.17%; P=0.8) and concluded that a negative HPV test was enough reassurance for a low risk of CIN 3+.²⁰

Another study, the ATHENA trial, evaluated more than 42,000 women who were 25 years and older over a 3-year period.²¹ Patients underwent either primary HPV testing or combination cytology and reflex HPV (if ages 25–29) or HPV cotesting (if age 30 or older). Primary HPV testing was found to have a sensitivity and specificity of 76.1% and 93.5%, respectively, compared with 61.7% and 94.6% for cytology with HPV cotesting, but it also increased the total number of colposcopies performed.²¹

Subsequent management of a primary HPV-positive result can be triaged using genotyping, cytology, or a combination of both. FDA-approved HPV screening tests provide genotyping and current management guidelines use genotyping to triage positive HPV results into HPV 16, 18, or 1 of 12 other high-risk HPV genotypes.

In the ATHENA trial, the 3-year incidence of CIN 3+ for HPV 16/18-positive results was 21.16% (95% CI, 18.39%–24.01%) compared with 5.4% (95% CI, 4.5%–6.4%) among patients with an HPV test positive for 1 of the other HPV genotypes.²¹ While a patient with an HPV result positive for HPV 16/18 should directly undergo colposcopy, clinical guidance for an HPV-positive result for one of the other genotypes suggests using reflex cytology to triage patients. The ASCCP recommended management of primary HPV testing is included in the FIGURE.²²

Many barriers remain to transitioning to primary HPV testing, including laboratory test availability as well as patient and provider acceptance. At present, 2 FDA-approved primary HPV screening tests are available: the Cobas HPV test (Roche Molecular Systems, Inc) and the BD Onclarity HPV assay (Becton, Dickinson and Company). Changes to screening recommendations need to be accompanied by patient and provider outreach and education.

In a survey of more than 500 US women in 2015 after guidelines allowed for increased screening intervals after negative results, a majority of women (55.6%; 95% CI, 51.4%–59.8%) were aware that screening recommendations had changed; however, 74.1% (95% CI, 70.3%–77.7%) still believed that women should be screened annually.²³ By contrast, participants in the HPV FOCAL trial, who were able to learn more about HPV-based screening, were surveyed about their willingness to undergo primary HPV testing rather than Pap testing at the conclusion of the trial.²⁴ Of the participants, 63% were comfortable with primary HPV testing, and 54% were accepting of an extended screening interval of 4 to 5 years.²⁴

Continue to: p16/Ki-67 dual-stain cytology...

An additional tool for triaging HPV-positive patients is the p16/Ki-67 dual stain test (CINtec Plus Cytology; Roche), which was FDA approved in March 2020. A tumor suppressor protein, p16 is found to be overexpressed by HPV oncogenic activity, and Ki-67 is a marker of cellular proliferation. Coexpression of p16 and Ki-67 indicates a loss of cell cycle regulation and is a hallmark of neoplastic transformation. When positive, this test is supportive of active HPV infection and of a high-grade lesion. While the dual stain test is not yet formally incorporated into triage algorithms by national guidelines, it has demonstrated efficacy in detecting CIN 3+

In the IMPACT trial, nearly 5,000 HPV-positive patients underwent p16/Ki-67 dual stain testing compared with cytology and HPV genotyping.²⁵ The sensitivity of dual stain for CIN 3+ was 91.9% (95% CI, 86.1%–95.4%) in HPV 16/18–positive and 86.0% (95% CI, 77.5%–91.6%) in the 12 other genotypes. Using dual stain testing alone to triage HPV-positive results showed significantly higher sensitivity but lower specificity than using cytology alone to triage HPV-positive results. Importantly, triage with dual stain testing alone would have referred significantly fewer women to colposcopy than HPV 16/18 genotyping with cytology triage for the 12 other genotypes (48.6% vs 56.0%; P< .0001).

Self-sampling methods: An approach for potentially improving access to screening

One technology that may help bridge gaps in access to cervical cancer screening is self-collected HPV testing, which would preclude the need for a clinician-performed pelvic exam. At present, no self-sampling method is approved by the FDA. However, many studies have examined the efficacy and safety of various self-sampling kits.²⁶

One randomized controlled trial in the Netherlands compared sensitivity and specificity of CIN 2+ detection in patient-collected versus clinician-collected swabs.²⁷ After a median follow-up of 20 months, the sensitivity and specificity of HPV testing did not differ between the patient-collected and the clinician-collected groups (specificity 100%; 95% CI, 0.91–1.08; sensitivity 96%; 95% CI, 0.90–1.03).²⁷ This analysis did not include patients who did not return their self-collected sample, which leaves the question of whether self-sampling may exacerbate issues with patients who are lost to follow-up.

In a study performed in the United States, 16,590 patients who were overdue for cervical cancer screening were randomly assigned to usual care reminders (annual mailed reminders and phone calls from clinics) or to the addition of a mailed HPV self-sampling test kit.²⁸ While the study did not demonstrate significant difference in the detection of overall CIN 2+ between the 2 groups, screening uptake was higher in the self-sampling kit group than in the usual care reminders group (RR, 1.51; 95% CI, 1.43–1.60), and the number of abnormal screens that warranted colposcopy referral was similar between the 2 groups (36.4% vs 36.8%).²⁸ In qualitative interviews of the participants of this trial, patients who were sent at-home self-sampling kits found that the convenience of at-home testing lowered barriers to scheduling an in-office appointment.²⁹ The hope is that self-sampling methods will expand access of cervical cancer screening to vulnerable populations that face significant barriers to having an in-office pelvic exam.

It is important to note that self-collection and self-sample testing requires multidisciplinary systems for processing results and assuring necessary patient follow-up. Implementing and disseminating such a program has been well tested only in developed countries^27,30 with universal health care systems or within an integrated care delivery system. Bringing such technology broadly to the United States and less developed countries will require continued commitment to increasing laboratory capacity, a central electronic health record or system for monitoring results, educational materials for clinicians and patients, and expanding insurance reimbursement for such testing.

HPV vaccination rates must increase

While we continue to investigate which screening methods will most improve our secondary prevention of cervical cancer, our path to increasing primary prevention of cervical cancer is clear: We must increase rates of HPV vaccination. The 9-valent HPV vaccine is FDA approved for use in all patients aged 9 to 45 years.

The American College of Obstetricians and Gynecologists and other organizations recommend HPV vaccination between the ages of 9 and 13, and a “catch-up period” from ages 13 to 26 in which patients previously not vaccinated should receive the vaccine.³¹ Initiation of the vaccine course earlier (ages 9–10) compared with later (ages 11–12) is correlated with higher overall completion rates by age 15 and has been suggested to be associated with a stronger immune response.³²

A study from Sweden found that HPV vaccination before age 17 was most strongly correlated with the lowest rates of cervical cancer, although vaccination between ages 17 and 30 still significantly decreased the risk of cervical cancer compared with those who were unvaccinated.³³

Overall HPV vaccination rates in the United States continue to improve, with 58.6%³⁴ of US adolescents having completed vaccination in 2020. However, these rates still are significantly lower than those in many other developed countries, including Australia, which had a complete vaccination rate of 80.5% in 2020.³⁵ Continued disparities in vaccination rates could be contributing to the rise in cervical cancer among certain groups, such as American Indian and Alaska Native populations.⁵

Work—and innovations—must continue

In conclusion, the incidence of cervical cancer in the United States continues to decrease, although at disparate rates among marginalized populations. To ensure that we are working toward eliminating cervical cancer for all patients, we must continue efforts to eliminate disparities in health access. Continued innovations, including primary HPV testing and self-collection samples, may contribute to lowering barriers to all patients being able to access the preventative care they need. ●

[polldaddy:11991465]

[polldaddy:11991465]

[polldaddy:11991465]

This patient was given a diagnosis of bullous pemphigoid. Although there were a number of clues that pointed to this diagnosis, confirming that this was the case required 2 biopsies and a blood draw. (More on this in a bit.)

Although rare and potentially lethal, bullous pemphigoid is the most common autoimmune blistering disease in the elderly. Patients present with tense bullae over limited or widespread areas of the skin. The pathogenesis includes development of autoimmune antibodies that target important proteins (BP180 and BP230) that bind basal epidermal keratinocytes to the dermis. When weakened by inflammation at these sites, the skin delaminates at the dermal-epidermal junction, while the cells of the epidermis continue to bind to each other. This leads to itching, hive-like wheals, and tense fluid-filled bullae.

The differential diagnosis of an acute or semi-acute bullous disease includes bullous pemphigoid, IgA pemphigoid, linear IgA bullous dermatosis, epidermolysis bullosa acquisita, and Senear-Usher syndrome. In this case, the large tense bullae suggested bullous pemphigoid over the other diagnoses.

Initial diagnosis requires 2 biopsies be performed: One at the edge of a bulla for a standard pathologic exam to identify the skin level at which the bulla is forming, and another biopsy of skin near the site of inflammation (5-10 mm away) to be sent for direct immunofluorescence (DIF) in Michel’s medium or Zeus medium. In bullous pemphigoid, the separation is at the dermal-epidermal junction, and IgG and C3 are found in the DIF in the same location. There are a couple ways to differentiate this disorder from epidermolysis bullosa acquisita—a similar blistering disorder in which autoantibodies attack collagen at the dermal-epidermal junction. A common approach is to send a patient’s serum for indirect immunofluorescence. This is done because it is impossible to distinguish between the 2 clinically.

While bullous pemphigoid has historically been treated with high-dose prednisone, it is more common now to treat with whole-body topical clobetasol and oral doxycycline 100 mg twice a day to avoid the adverse effects of the prednisone. Other immunosuppressive options, such as mycophenolate mofetil and cyclosporine, can provide the potency of prednisone with a more favorable long-term safety profile. Rituximab infusions are another very powerful and durable option in refractory or severe cases.¹

This patient was treated with topical clobetasol and doxycycline 100 mg twice a day, but he had incomplete clearance after 2 to 3 weeks. At that point, mycophenolate mofetil was added to the regimen and was titrated up to 1000 mg twice daily. When clearance occurred, the clobetasol was discontinued and the mycophenolate mofetil was titrated down to 250 mg/d; the patient continues to maintain clearance at this dose. He continues on doxycycline 100 mg bid.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

This patient was given a diagnosis of bullous pemphigoid. Although there were a number of clues that pointed to this diagnosis, confirming that this was the case required 2 biopsies and a blood draw. (More on this in a bit.)

Although rare and potentially lethal, bullous pemphigoid is the most common autoimmune blistering disease in the elderly. Patients present with tense bullae over limited or widespread areas of the skin. The pathogenesis includes development of autoimmune antibodies that target important proteins (BP180 and BP230) that bind basal epidermal keratinocytes to the dermis. When weakened by inflammation at these sites, the skin delaminates at the dermal-epidermal junction, while the cells of the epidermis continue to bind to each other. This leads to itching, hive-like wheals, and tense fluid-filled bullae.

The differential diagnosis of an acute or semi-acute bullous disease includes bullous pemphigoid, IgA pemphigoid, linear IgA bullous dermatosis, epidermolysis bullosa acquisita, and Senear-Usher syndrome. In this case, the large tense bullae suggested bullous pemphigoid over the other diagnoses.

Initial diagnosis requires 2 biopsies be performed: One at the edge of a bulla for a standard pathologic exam to identify the skin level at which the bulla is forming, and another biopsy of skin near the site of inflammation (5-10 mm away) to be sent for direct immunofluorescence (DIF) in Michel’s medium or Zeus medium. In bullous pemphigoid, the separation is at the dermal-epidermal junction, and IgG and C3 are found in the DIF in the same location. There are a couple ways to differentiate this disorder from epidermolysis bullosa acquisita—a similar blistering disorder in which autoantibodies attack collagen at the dermal-epidermal junction. A common approach is to send a patient’s serum for indirect immunofluorescence. This is done because it is impossible to distinguish between the 2 clinically.

While bullous pemphigoid has historically been treated with high-dose prednisone, it is more common now to treat with whole-body topical clobetasol and oral doxycycline 100 mg twice a day to avoid the adverse effects of the prednisone. Other immunosuppressive options, such as mycophenolate mofetil and cyclosporine, can provide the potency of prednisone with a more favorable long-term safety profile. Rituximab infusions are another very powerful and durable option in refractory or severe cases.¹

This patient was treated with topical clobetasol and doxycycline 100 mg twice a day, but he had incomplete clearance after 2 to 3 weeks. At that point, mycophenolate mofetil was added to the regimen and was titrated up to 1000 mg twice daily. When clearance occurred, the clobetasol was discontinued and the mycophenolate mofetil was titrated down to 250 mg/d; the patient continues to maintain clearance at this dose. He continues on doxycycline 100 mg bid.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

This patient was given a diagnosis of bullous pemphigoid. Although there were a number of clues that pointed to this diagnosis, confirming that this was the case required 2 biopsies and a blood draw. (More on this in a bit.)

Although rare and potentially lethal, bullous pemphigoid is the most common autoimmune blistering disease in the elderly. Patients present with tense bullae over limited or widespread areas of the skin. The pathogenesis includes development of autoimmune antibodies that target important proteins (BP180 and BP230) that bind basal epidermal keratinocytes to the dermis. When weakened by inflammation at these sites, the skin delaminates at the dermal-epidermal junction, while the cells of the epidermis continue to bind to each other. This leads to itching, hive-like wheals, and tense fluid-filled bullae.

The differential diagnosis of an acute or semi-acute bullous disease includes bullous pemphigoid, IgA pemphigoid, linear IgA bullous dermatosis, epidermolysis bullosa acquisita, and Senear-Usher syndrome. In this case, the large tense bullae suggested bullous pemphigoid over the other diagnoses.

Initial diagnosis requires 2 biopsies be performed: One at the edge of a bulla for a standard pathologic exam to identify the skin level at which the bulla is forming, and another biopsy of skin near the site of inflammation (5-10 mm away) to be sent for direct immunofluorescence (DIF) in Michel’s medium or Zeus medium. In bullous pemphigoid, the separation is at the dermal-epidermal junction, and IgG and C3 are found in the DIF in the same location. There are a couple ways to differentiate this disorder from epidermolysis bullosa acquisita—a similar blistering disorder in which autoantibodies attack collagen at the dermal-epidermal junction. A common approach is to send a patient’s serum for indirect immunofluorescence. This is done because it is impossible to distinguish between the 2 clinically.

While bullous pemphigoid has historically been treated with high-dose prednisone, it is more common now to treat with whole-body topical clobetasol and oral doxycycline 100 mg twice a day to avoid the adverse effects of the prednisone. Other immunosuppressive options, such as mycophenolate mofetil and cyclosporine, can provide the potency of prednisone with a more favorable long-term safety profile. Rituximab infusions are another very powerful and durable option in refractory or severe cases.¹

This patient was treated with topical clobetasol and doxycycline 100 mg twice a day, but he had incomplete clearance after 2 to 3 weeks. At that point, mycophenolate mofetil was added to the regimen and was titrated up to 1000 mg twice daily. When clearance occurred, the clobetasol was discontinued and the mycophenolate mofetil was titrated down to 250 mg/d; the patient continues to maintain clearance at this dose. He continues on doxycycline 100 mg bid.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study² of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies³ have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study² of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies³ have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study² of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies³ have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

Girls between 4 and 9 years old were more likely to have high fat mass and a high body mass index if their mothers had excess adiposity – but this relationship was not seen between mothers and sons, or between fathers and sons or daughters, in a new study.

The researchers measured fat mass, lean mass, and BMI in the sons and daughters when they were age 4 (before a phenomenon known as “adiposity rebound”), ages 6-7 (around the adiposity rebound), and ages 8-9 (before or at the onset of puberty).

They also obtained measurements from the mothers and fathers when the offspring were ages 8-9.

The group found “a strong association between the fat mass of mothers and their daughters but not their sons,” Rebecca J. Moon, BM, PhD, and colleagues report.

“It would be important to establish persistence through puberty,” according to the researchers, “but nonetheless, these findings are clinically important, highlighting girls who are born to mothers with high BMI and excess adiposity are at high risk of themselves of becoming overweight/obese or having unfavorable body composition early in childhood.”

The mother-daughter relationship for fat mass appears to be established by age 4 years, note Dr. Moon, of the MRC Lifecourse Epidemiology Centre, University of Southampton (England), and colleagues.

Therefore, “early awareness and intervention is needed in mothers with excess adiposity, and potentially beginning even in the periconception and in utero period.”

Because 97% of the mothers and fathers were White, the findings may not be generalizable to other populations, they caution.

The results, from the Southampton Women’s Survey prospective cohort study, were published online  in the Journal of Clinical Endocrinology & Metabolism.
 

One of the first studies to look at fat mass, not just BMI

Children with overweight or obesity are more likely to have excess weight in adulthood that puts them at risk of developing type 2 diabetes, cardiovascular disease, cancer, and osteoarthritis. Previous research has reported that children with overweight or obesity were more likely to have mothers with adiposity.

However, most prior studies have looked at BMI alone and did not measure fat mass, and it was not known how a father’s obesity might affect offspring or how risk may differ in boy versus girl children.

Researchers analyzed data from a subset of participants in the Southampton Women’s Survey of 3,158 women who were aged 20-34 in 1998-2002 and delivered a liveborn infant.

The current study included 240 mother-father-offspring trios who had data for BMI and dual-energy X-ray absorptiometry (DXA) scans (whole body less head).

Mothers were a mean age of 31 years at delivery and had a median pre-pregnancy BMI of 23.7 kg/m².

The offspring were 129 boys (54%) and 111 girls.

The offspring had DXA scans at ages 4, 6-7, and 8-9 years, and the mothers and fathers had a DXA scan at the last time point.

At ages 6-7 and ages 8-9, BMI and fat mass of the girls reflected that of their mothers (a significant association).

At age 4, BMI and fat mass of the daughters tended to be associated with that of their mothers, but the 95% confidence interval crossed zero.

There were no significant mother-son, father-son, or father-daughter associations for BMI or fat mass at each of the three studied ages.

The study received funding from the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research Southampton Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, the Seventh Framework Program, the Biotechnology and Biological Sciences Research Council, the Horizon 2020 Framework Program, and the National Institute on Aging. Dr. Moon has reported receiving travel bursaries from Kyowa Kirin unrelated to the current study. Disclosures for the other authors are listed with the article.

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

Girls between 4 and 9 years old were more likely to have high fat mass and a high body mass index if their mothers had excess adiposity – but this relationship was not seen between mothers and sons, or between fathers and sons or daughters, in a new study.

The researchers measured fat mass, lean mass, and BMI in the sons and daughters when they were age 4 (before a phenomenon known as “adiposity rebound”), ages 6-7 (around the adiposity rebound), and ages 8-9 (before or at the onset of puberty).

They also obtained measurements from the mothers and fathers when the offspring were ages 8-9.

The group found “a strong association between the fat mass of mothers and their daughters but not their sons,” Rebecca J. Moon, BM, PhD, and colleagues report.

“It would be important to establish persistence through puberty,” according to the researchers, “but nonetheless, these findings are clinically important, highlighting girls who are born to mothers with high BMI and excess adiposity are at high risk of themselves of becoming overweight/obese or having unfavorable body composition early in childhood.”

The mother-daughter relationship for fat mass appears to be established by age 4 years, note Dr. Moon, of the MRC Lifecourse Epidemiology Centre, University of Southampton (England), and colleagues.

Therefore, “early awareness and intervention is needed in mothers with excess adiposity, and potentially beginning even in the periconception and in utero period.”

Because 97% of the mothers and fathers were White, the findings may not be generalizable to other populations, they caution.

The results, from the Southampton Women’s Survey prospective cohort study, were published online  in the Journal of Clinical Endocrinology & Metabolism.
 

One of the first studies to look at fat mass, not just BMI

Children with overweight or obesity are more likely to have excess weight in adulthood that puts them at risk of developing type 2 diabetes, cardiovascular disease, cancer, and osteoarthritis. Previous research has reported that children with overweight or obesity were more likely to have mothers with adiposity.

However, most prior studies have looked at BMI alone and did not measure fat mass, and it was not known how a father’s obesity might affect offspring or how risk may differ in boy versus girl children.

Researchers analyzed data from a subset of participants in the Southampton Women’s Survey of 3,158 women who were aged 20-34 in 1998-2002 and delivered a liveborn infant.

The current study included 240 mother-father-offspring trios who had data for BMI and dual-energy X-ray absorptiometry (DXA) scans (whole body less head).

Mothers were a mean age of 31 years at delivery and had a median pre-pregnancy BMI of 23.7 kg/m².

The offspring were 129 boys (54%) and 111 girls.

The offspring had DXA scans at ages 4, 6-7, and 8-9 years, and the mothers and fathers had a DXA scan at the last time point.

At ages 6-7 and ages 8-9, BMI and fat mass of the girls reflected that of their mothers (a significant association).

At age 4, BMI and fat mass of the daughters tended to be associated with that of their mothers, but the 95% confidence interval crossed zero.

There were no significant mother-son, father-son, or father-daughter associations for BMI or fat mass at each of the three studied ages.

The study received funding from the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research Southampton Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, the Seventh Framework Program, the Biotechnology and Biological Sciences Research Council, the Horizon 2020 Framework Program, and the National Institute on Aging. Dr. Moon has reported receiving travel bursaries from Kyowa Kirin unrelated to the current study. Disclosures for the other authors are listed with the article.

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

Girls between 4 and 9 years old were more likely to have high fat mass and a high body mass index if their mothers had excess adiposity – but this relationship was not seen between mothers and sons, or between fathers and sons or daughters, in a new study.

The researchers measured fat mass, lean mass, and BMI in the sons and daughters when they were age 4 (before a phenomenon known as “adiposity rebound”), ages 6-7 (around the adiposity rebound), and ages 8-9 (before or at the onset of puberty).

They also obtained measurements from the mothers and fathers when the offspring were ages 8-9.

The group found “a strong association between the fat mass of mothers and their daughters but not their sons,” Rebecca J. Moon, BM, PhD, and colleagues report.

“It would be important to establish persistence through puberty,” according to the researchers, “but nonetheless, these findings are clinically important, highlighting girls who are born to mothers with high BMI and excess adiposity are at high risk of themselves of becoming overweight/obese or having unfavorable body composition early in childhood.”

The mother-daughter relationship for fat mass appears to be established by age 4 years, note Dr. Moon, of the MRC Lifecourse Epidemiology Centre, University of Southampton (England), and colleagues.

Therefore, “early awareness and intervention is needed in mothers with excess adiposity, and potentially beginning even in the periconception and in utero period.”

Because 97% of the mothers and fathers were White, the findings may not be generalizable to other populations, they caution.

The results, from the Southampton Women’s Survey prospective cohort study, were published online  in the Journal of Clinical Endocrinology & Metabolism.
 

One of the first studies to look at fat mass, not just BMI

Children with overweight or obesity are more likely to have excess weight in adulthood that puts them at risk of developing type 2 diabetes, cardiovascular disease, cancer, and osteoarthritis. Previous research has reported that children with overweight or obesity were more likely to have mothers with adiposity.

However, most prior studies have looked at BMI alone and did not measure fat mass, and it was not known how a father’s obesity might affect offspring or how risk may differ in boy versus girl children.

Researchers analyzed data from a subset of participants in the Southampton Women’s Survey of 3,158 women who were aged 20-34 in 1998-2002 and delivered a liveborn infant.

The current study included 240 mother-father-offspring trios who had data for BMI and dual-energy X-ray absorptiometry (DXA) scans (whole body less head).

Mothers were a mean age of 31 years at delivery and had a median pre-pregnancy BMI of 23.7 kg/m².

The offspring were 129 boys (54%) and 111 girls.

The offspring had DXA scans at ages 4, 6-7, and 8-9 years, and the mothers and fathers had a DXA scan at the last time point.

At ages 6-7 and ages 8-9, BMI and fat mass of the girls reflected that of their mothers (a significant association).

At age 4, BMI and fat mass of the daughters tended to be associated with that of their mothers, but the 95% confidence interval crossed zero.

There were no significant mother-son, father-son, or father-daughter associations for BMI or fat mass at each of the three studied ages.

The study received funding from the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research Southampton Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, the Seventh Framework Program, the Biotechnology and Biological Sciences Research Council, the Horizon 2020 Framework Program, and the National Institute on Aging. Dr. Moon has reported receiving travel bursaries from Kyowa Kirin unrelated to the current study. Disclosures for the other authors are listed with the article.

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

Wednesday, March 22. Day 4 of SGS.

Day 4, and the final day of the 49th SGS conference started with a sunrise run up and down the hills surrounding the JW Marriott Starr Resort. After breakfast, I entered the Tucson Ballroom to attend the last 2 scientific sessions of the conference.

Highlights from the first session included a look at postoperative outcomes and complication rates between gynecologic surgeons and general surgeons using the National Surgical Quality Improvement Program (NSQIP) database by Dr. Douglas Luchristt, who showed no difference between the 2 surgical specialties (and even better outcomes by gynecologists in certain operative measures), as well as the work of Dr. Christopher Hong who used 2 separate surgical databases (NSQIP and Michigan Surgical Quality Collaborative) to show that rates of vaginal hysterectomy have been decreasing from 2017 to 2020, even amongst patients who are likely good candidates for a vaginal route of hysterectomy. Dr. Jocelyn Fitzgerald presented her unique mixed methods research on how to better design the gynecologic office to improve the patient experience, using 3,000 Twitter responses to a question on this topic. Lastly, Dr. Emily Aldrich shared her work on better understanding the patient perception of same day discharge after major vaginal reconstructive surgery. An interesting finding of Dr. Aldrich’s study was that the most common response to her question about the “worst part of the surgical experience” was going home with a postoperative catheter, which surgeons often consider a small and temporary discomfort. The first session ended with the passing of the gavel from current SGS president Dr. Cheryl Iglesia, to the incoming SGS president Dr. Rosanne Kho, with much applause and excitement for what Dr. Kho will bring to the table in her new role.

The research presented at the final scientific session of the conference did not disappoint. A retrospective study on the influence of body mass index (BMI) on the time to surgical diagnosis of endometriosis by Dr. Melissa Markowitz found that obesity was associated with a delay of over 1 year in surgical diagnosis of endometriosis compared with normal and underweight patients. Dr. David (Ike) Rahn presented additional findings on his randomized, double-blinded, multicenter trial on perioperative use of vaginal estrogen cream in postmenopausal patients with prolapse. He found that 5 weeks of estrogen cream use was not associated with any improvement in urinary incontinence or sexual function.

Dr. Stephanie Glass Clark used the Premier Healthcare Database to show that that there was no difference in postoperative mesh exposure in patients who underwent a total hysterectomy compared with supracervical hysterectomy at the time of sacrocolpopexy. Dr. Kavita Mishra presented results from the FLOWER trial, which found no difference in postoperative outcomes for transgender women undergoing vaginoplasty for gender affirmation who did and did not undergo preoperative pelvic floor physical therapy. Finally, Dr. Carly Crowder shared her video of anatomy for sacral neuromodulation with some excellent cadaveric dissections to exhibit the peri-sacral and gluteal anatomy.

As the conference ended, raindrops pounded the sandy grounds of the resort as I waited in the lobby for my Uber to the airport. Dr. Rosanne Kho happened to walk by and stopped to speak with me and one of my attendings. She smiled as she asked about our experience at the conference and to wish us safe travels. To me, this moment embodies the spirit of mentorship and connection that is so unique to the SGS conference. I feel incredibly lucky to have met some of the physician leaders of our field, who genuinely want to get to know and help the next generation. This year’s meeting was attended by ObGyn generalists and surgeons of all gynecologic subspecialties and certainly met its goal in addressing topics with an “Impact Factor.” I am inspired by all the work that is happening across the country to move the needle and better our field. This was my first SGS experience, but it certainly won’t be the last. I hope you too will consider attending in the future!

Tuesday, March 21. Day 3 of SGS.

It’s Day 3 of the SGS conference! In addition to the academic roundtables, conference attendees had the option of doing early-morning yoga with Dr. Mireille Truong. Yoga sounded nice, but I spent the morning in bed, catching up on sleep. (My own version of wellness!) The scientific sessions of the day started at 7:30 am, and I especially want to highlight the work of Dr. Amy Askew who performed a randomized controlled trial comparing patient removal of urinary catheters placed for postoperative urinary retention to office removal. She found that patient urinary catheter removal was a feasible and safe option with excellent patient satisfaction and a reduction of in-person postoperative office visits. At the end of the session, Dr. Cheryl Iglesia gave her presidential address, where she shared her journey to becoming the physician, educator, researcher, and leader she is today. She emphasized the importance of being a continual learner and to give back by mentoring and educating the next generation. “Learn it, earn it, and return it.”

This was followed by the Te Linde lecture, given by Dr. Pamela Moalli. An exceptional surgeon-scientist, Dr. Moalli shared about her work on the impact of mesh on tissue, as well as alternative biologic options being developed, such as 3D printed membranes, extracellular matrix scaffolds, and living tissue grafts to create new ligamentous supports for the vagina. She discussed novel research using stem cell transplantation to harness the power of regeneration in the urethra or vagina following injury. I think it is safe to say that the entire room was in awe of the work she has done, and what she continues to do to find better therapeutic options for girls and women with pelvic floor disorders. Her talk ended in a standing ovation. Afterwards, all the University of Pittsburgh Medical Center-Magee Womens Hospital trainees, faculty, and several alumni took a picture with Dr. Moalli (fifth from the right in the picture).

Lunch followed, which included a brief walk around the industry exhibition hall. I then returned back to the Tucson Ballroom to listen in on the next scientific session on surgical ergonomics. Organized by Dr. Amy Park who herself suffered from work-related musculoskeletal injuries, the session was composed of an excellent video by Dr. Abby Stork on stretches to prevent and reduce the risk of surgeon-associated musculoskeletal injuries, especially in vaginal surgeons. There was then a panel of 3 experts, Dr. Noor Abu-Alnadi, Dr. Ladin Yurteri-Kaplan, and Dr. Susan Hallbeck (PhD ergonomics expert), moderated by Dr. Amanda Fader and Dr. Kimberly Kho. In particular, Dr. Hallbeck developed a timer app as a reminder for surgeons to stop every 40 minutes to stretch for 1.5 minutes (orstretch.mayoclinic.org). This has been studied and found to reduce musculoskeletal pain after surgery and improve physical performance without increasing total operating time. If you would like to see some of these between- and in-OR stretches yourself, an informative handout can be accessed at mcforms.mayo.edu.

Tuesday afternoon was left open. I joined Dr. Veronica Lerner, Dr. Kelly Wright, and Dr. Louise Perkins King on a 7.5-mile hike into the surrounding desert hills. We marveled at the many Saguaro cacti, some over 100 years old and towering many feet high, as well as the beautiful yellow, purple, and magenta flowers that were scattered among the desert brush. Several rabbits and deer wandered by us during our hike. On one of the trails, the stone skeleton of an old house stood, once a home to the Bowen family who had moved to Arizona for health reasons. I could see why they would want to move here—I felt such a peace looking at the gorgeous view from what was once their doorway.

After a shower and a lot of stretching, I got ready for the evening event, A Taste and Toast with SGS: Under the Arizona Skies. The food and drink were delicious, and I got to spend the evening catching up with a good friend. We watched as conference attendees assigned to different color teams (red, green, blue, and yellow), fought for the hallowed Golden Uterus Trophy in several competitive gynecology-themed games (eg, throwing sacral neuromodulation needle “darts” at balloons and removing small pom poms from a water bottle with a disposable operative hysteroscope). As the evening progressed, the DJ turned up the music and people made their way to the dance floor. The event served as a fundraiser for the SGS Pelvic Anatomy Group and successfully raised $35,000.

Day 2 of the SGS meeting started off with a gentle sunrise over the cacti-covered hills surrounding the JW Marriot Starr Pass Hotel, the venue for the 49th SGS annual scientific meeting. The first official event of the day after some engaging academic round tables was the recognition of the new SGS members. Much celebration was had over the 18 gynecologic surgeons who were inducted.

The second day included the first 3 scientific sessions of the conference. Some highlights include the work of Dr. Shawn Menefee on a randomized trial of sacral colpopexy, transvaginal mesh, and native tissue apical repair for posthysterectomy vault prolapse; a video by Dr. Matthew Fallon on a robotic-assisted laparoscopic approach to repairing a chronic uterine inversion; and the impact of age on regret following hysterectomy by Dr. Nathan King. Dr. Candace Parker-Autry also presented her work on the impact of perineorrhaphy on both female and male sexual function, and Dr. Cassie (Clarissa) Niino spoke elegantly on the “red bag problem” that exists in all of our operating rooms, which increases pollution and cost unnecessarily.

There were also several excellent talks given. Dr. Jason Wright spoke about the importance of surgical volume on gynecologic surgery. In particular, he noted that surgical volume needs to be considered not only at the surgeon level but also at the hospital level. Higher-volume hospitals will provide better care, in the same way that general, high-volume surgeons have less complications and better long-term outcomes. Of note, volume is not the whole picture. We need to also consider measurements of surgery and hospital quality and surgeon skill in addition to volume, as Dr. Shawn Menefee insightfully commented.

Dr. Beri Ridgeway gave the Mark D. Walters Lecture about surgeons in the c-suite and the importance of having a seat at the leadership table as surgeons and medical providers. In her words: “If we aren’t at the table, then we are on the menu.” Overworked and underpaid, burned out doctors feel powerless because they are managed by leaders with a business and not a medical background, and we need to have physicians in leadership who understand how medicine is practiced and to ensure equitable care

Dr. Kelly Wright gave a talk on the environmental impact of gynecologic care—from OR to clinic. She gave examples of how metal, reusable speculums become more cost-effective and produce less waste after only 2-3 uses and how there is no evidence that bouffants reduce surgical site infections (and a reusable scrub cap could work just as well without creating waste). Finally, Dr. Ebony Carter gave an impassioned talk on the need for equity in publication and grant funding in our field. She shared about her initiative through the Green Journal (Obstetrics and Gynecology) to create an issue focused on furthering equity and dispelling racism in medical research.

Later in the afternoon, I attended the Fellows’ Pelvic Research Network (FPRN) meeting, which includes AUGS-SGS (urogynecology fellows) and FMIGS-SGS (fellows of all other gynecologic subspecialities, including minimally invasive gynecologic surgery, family planning, reproductive endocrinology and infertility, and pediatric and adolescent gynecology). Dr. John Gebhart gave an excellent lecture with some impressive photos and videos on how to manage mesh exposure and erosion.

Afterwards, updates were given on the current FPRN projects, and 4 new projects were proposed and underwent audience feedback for improvement. It was exciting to see the multicenter collaborations fostered through the FPRN, and I look forward to seeing which projects will get funded for this upcoming year!

The evening ended with the President's Award Ceremony led by Dr. Cheryl Iglesia, the 49th SGS President, as well as the President's Reception. I also wantd to highlight the winner of the Distinguished Surgeon Award: Dr. Dee Fenner. The remaining awardees are listed on the SGS website (https://sgsonline.org).

Last night around midnight, bleary-eyed from the long flight from Pittsburgh, I walked out into the dimly lit, mild air of Tucson, Arizona. The Saguaro cacti that lined the entrance to the airport stood tall and tree-like, with welcoming green arms. It was as if they too knew that the next 4 days would be filled with the building of new relationships and the strengthening of old ones, as well as with education, innovation, and the sharing of research. That spirit of collegiality, approachability, and connection in an intimate and vibrant meeting is what the Society of Gynecologic Surgeons (SGS) meeting has been known for and why it draws people to come back, year after year.

The first day of the conference was fantastic. As a first-time attendant at SGS, I was excited to have the opportunity to meet and rub elbows with mentors and role models from across the country. My day started off with the SGS Fellows and Young Attendings Course, moderated by 3 incredible faculty: Dr. Matthew Barker, Dr. Sadikah Behbehani, and Dr. Traci Ito. Some high-yield topics such as contract negotiation, developing a urogynecology- or MIGS-based practice, billing, academic promotion, and taking advantage of relationships with industry were discussed at length, and the session ended with a roundtable, where the experts had time to answer questions in smaller groups. One of the quotes that will ring true for many fellows about to embark on the job search was from Dr. Amanda Ecker: “Up until now, you were told where to go and what your schedule is. This is the first time you have flexibility and power to decide for yourself.” Therefore, it is important to reflect on what you really desire and/or prioritize in a job, whether it is location, compensation, protected time, or opportunities for advancement.

In the afternoon, I attended a postgraduate course led by Dr. Veronica Lerner and Dr. Mireille Truong called “The Sim Factor: Making an Impact in Surgical Education.” Several other excellent postgraduate courses were available, including “Advanced Endometriosis Surgery and Pelvic Pain Patient-Centered Approach,” “Social Media Workshop- #Gynfluencing: Using Social Media to Find Your Digital Voice,” and “Urologic Surgery for the Gynecologic Surgeon: GU Injury, Ureteral Stents, Complex Fistula and More.” I was grateful for the hands-on and tangible tools that Drs. Lerner and Truong left the group with—including ideas such as Zoom-based virtual coaching for trainees learning fundamentals of laparoscopic surgery types of tasks, table-top simulation for high-stakes scenarios (eg, operative vascular injury), and the importance of grounding educational activity in objectives and evaluation. I even got to make and take home my own myomectomy model. (Fun fact: The myoma is actually a stress ball wrapped in an Ace bandage and then Glad Press n’ Seal! 

The late afternoon transitioned to an opportunity for trainees to interact with senior SGS members and a welcome reception. The indoor and outdoor spaces were filled with laughing and talking as people connected over drinks and snacks. Finally, the evening ended with a session presented by the SGS Equity Council, “What your Patients REALLY Want to Know.” Patty Brisben, of the Patty Brisben Foundation and founder of the company Pure Romance, was interviewed by Dr. Christine Vaccaro. It was heartwarming to hear how Patty took the stories of women suffering from sexual pain and dissatisfaction and chose to make it her life’s mission to improve women’s sexual health.

Wednesday, March 22. Day 4 of SGS.

Day 4, and the final day of the 49th SGS conference started with a sunrise run up and down the hills surrounding the JW Marriott Starr Resort. After breakfast, I entered the Tucson Ballroom to attend the last 2 scientific sessions of the conference.

Highlights from the first session included a look at postoperative outcomes and complication rates between gynecologic surgeons and general surgeons using the National Surgical Quality Improvement Program (NSQIP) database by Dr. Douglas Luchristt, who showed no difference between the 2 surgical specialties (and even better outcomes by gynecologists in certain operative measures), as well as the work of Dr. Christopher Hong who used 2 separate surgical databases (NSQIP and Michigan Surgical Quality Collaborative) to show that rates of vaginal hysterectomy have been decreasing from 2017 to 2020, even amongst patients who are likely good candidates for a vaginal route of hysterectomy. Dr. Jocelyn Fitzgerald presented her unique mixed methods research on how to better design the gynecologic office to improve the patient experience, using 3,000 Twitter responses to a question on this topic. Lastly, Dr. Emily Aldrich shared her work on better understanding the patient perception of same day discharge after major vaginal reconstructive surgery. An interesting finding of Dr. Aldrich’s study was that the most common response to her question about the “worst part of the surgical experience” was going home with a postoperative catheter, which surgeons often consider a small and temporary discomfort. The first session ended with the passing of the gavel from current SGS president Dr. Cheryl Iglesia, to the incoming SGS president Dr. Rosanne Kho, with much applause and excitement for what Dr. Kho will bring to the table in her new role.

The research presented at the final scientific session of the conference did not disappoint. A retrospective study on the influence of body mass index (BMI) on the time to surgical diagnosis of endometriosis by Dr. Melissa Markowitz found that obesity was associated with a delay of over 1 year in surgical diagnosis of endometriosis compared with normal and underweight patients. Dr. David (Ike) Rahn presented additional findings on his randomized, double-blinded, multicenter trial on perioperative use of vaginal estrogen cream in postmenopausal patients with prolapse. He found that 5 weeks of estrogen cream use was not associated with any improvement in urinary incontinence or sexual function.

Dr. Stephanie Glass Clark used the Premier Healthcare Database to show that that there was no difference in postoperative mesh exposure in patients who underwent a total hysterectomy compared with supracervical hysterectomy at the time of sacrocolpopexy. Dr. Kavita Mishra presented results from the FLOWER trial, which found no difference in postoperative outcomes for transgender women undergoing vaginoplasty for gender affirmation who did and did not undergo preoperative pelvic floor physical therapy. Finally, Dr. Carly Crowder shared her video of anatomy for sacral neuromodulation with some excellent cadaveric dissections to exhibit the peri-sacral and gluteal anatomy.

As the conference ended, raindrops pounded the sandy grounds of the resort as I waited in the lobby for my Uber to the airport. Dr. Rosanne Kho happened to walk by and stopped to speak with me and one of my attendings. She smiled as she asked about our experience at the conference and to wish us safe travels. To me, this moment embodies the spirit of mentorship and connection that is so unique to the SGS conference. I feel incredibly lucky to have met some of the physician leaders of our field, who genuinely want to get to know and help the next generation. This year’s meeting was attended by ObGyn generalists and surgeons of all gynecologic subspecialties and certainly met its goal in addressing topics with an “Impact Factor.” I am inspired by all the work that is happening across the country to move the needle and better our field. This was my first SGS experience, but it certainly won’t be the last. I hope you too will consider attending in the future!

Tuesday, March 21. Day 3 of SGS.

It’s Day 3 of the SGS conference! In addition to the academic roundtables, conference attendees had the option of doing early-morning yoga with Dr. Mireille Truong. Yoga sounded nice, but I spent the morning in bed, catching up on sleep. (My own version of wellness!) The scientific sessions of the day started at 7:30 am, and I especially want to highlight the work of Dr. Amy Askew who performed a randomized controlled trial comparing patient removal of urinary catheters placed for postoperative urinary retention to office removal. She found that patient urinary catheter removal was a feasible and safe option with excellent patient satisfaction and a reduction of in-person postoperative office visits. At the end of the session, Dr. Cheryl Iglesia gave her presidential address, where she shared her journey to becoming the physician, educator, researcher, and leader she is today. She emphasized the importance of being a continual learner and to give back by mentoring and educating the next generation. “Learn it, earn it, and return it.”

This was followed by the Te Linde lecture, given by Dr. Pamela Moalli. An exceptional surgeon-scientist, Dr. Moalli shared about her work on the impact of mesh on tissue, as well as alternative biologic options being developed, such as 3D printed membranes, extracellular matrix scaffolds, and living tissue grafts to create new ligamentous supports for the vagina. She discussed novel research using stem cell transplantation to harness the power of regeneration in the urethra or vagina following injury. I think it is safe to say that the entire room was in awe of the work she has done, and what she continues to do to find better therapeutic options for girls and women with pelvic floor disorders. Her talk ended in a standing ovation. Afterwards, all the University of Pittsburgh Medical Center-Magee Womens Hospital trainees, faculty, and several alumni took a picture with Dr. Moalli (fifth from the right in the picture).

Lunch followed, which included a brief walk around the industry exhibition hall. I then returned back to the Tucson Ballroom to listen in on the next scientific session on surgical ergonomics. Organized by Dr. Amy Park who herself suffered from work-related musculoskeletal injuries, the session was composed of an excellent video by Dr. Abby Stork on stretches to prevent and reduce the risk of surgeon-associated musculoskeletal injuries, especially in vaginal surgeons. There was then a panel of 3 experts, Dr. Noor Abu-Alnadi, Dr. Ladin Yurteri-Kaplan, and Dr. Susan Hallbeck (PhD ergonomics expert), moderated by Dr. Amanda Fader and Dr. Kimberly Kho. In particular, Dr. Hallbeck developed a timer app as a reminder for surgeons to stop every 40 minutes to stretch for 1.5 minutes (orstretch.mayoclinic.org). This has been studied and found to reduce musculoskeletal pain after surgery and improve physical performance without increasing total operating time. If you would like to see some of these between- and in-OR stretches yourself, an informative handout can be accessed at mcforms.mayo.edu.

Tuesday afternoon was left open. I joined Dr. Veronica Lerner, Dr. Kelly Wright, and Dr. Louise Perkins King on a 7.5-mile hike into the surrounding desert hills. We marveled at the many Saguaro cacti, some over 100 years old and towering many feet high, as well as the beautiful yellow, purple, and magenta flowers that were scattered among the desert brush. Several rabbits and deer wandered by us during our hike. On one of the trails, the stone skeleton of an old house stood, once a home to the Bowen family who had moved to Arizona for health reasons. I could see why they would want to move here—I felt such a peace looking at the gorgeous view from what was once their doorway.

After a shower and a lot of stretching, I got ready for the evening event, A Taste and Toast with SGS: Under the Arizona Skies. The food and drink were delicious, and I got to spend the evening catching up with a good friend. We watched as conference attendees assigned to different color teams (red, green, blue, and yellow), fought for the hallowed Golden Uterus Trophy in several competitive gynecology-themed games (eg, throwing sacral neuromodulation needle “darts” at balloons and removing small pom poms from a water bottle with a disposable operative hysteroscope). As the evening progressed, the DJ turned up the music and people made their way to the dance floor. The event served as a fundraiser for the SGS Pelvic Anatomy Group and successfully raised $35,000.

Day 2 of the SGS meeting started off with a gentle sunrise over the cacti-covered hills surrounding the JW Marriot Starr Pass Hotel, the venue for the 49th SGS annual scientific meeting. The first official event of the day after some engaging academic round tables was the recognition of the new SGS members. Much celebration was had over the 18 gynecologic surgeons who were inducted.

The second day included the first 3 scientific sessions of the conference. Some highlights include the work of Dr. Shawn Menefee on a randomized trial of sacral colpopexy, transvaginal mesh, and native tissue apical repair for posthysterectomy vault prolapse; a video by Dr. Matthew Fallon on a robotic-assisted laparoscopic approach to repairing a chronic uterine inversion; and the impact of age on regret following hysterectomy by Dr. Nathan King. Dr. Candace Parker-Autry also presented her work on the impact of perineorrhaphy on both female and male sexual function, and Dr. Cassie (Clarissa) Niino spoke elegantly on the “red bag problem” that exists in all of our operating rooms, which increases pollution and cost unnecessarily.

There were also several excellent talks given. Dr. Jason Wright spoke about the importance of surgical volume on gynecologic surgery. In particular, he noted that surgical volume needs to be considered not only at the surgeon level but also at the hospital level. Higher-volume hospitals will provide better care, in the same way that general, high-volume surgeons have less complications and better long-term outcomes. Of note, volume is not the whole picture. We need to also consider measurements of surgery and hospital quality and surgeon skill in addition to volume, as Dr. Shawn Menefee insightfully commented.

Dr. Beri Ridgeway gave the Mark D. Walters Lecture about surgeons in the c-suite and the importance of having a seat at the leadership table as surgeons and medical providers. In her words: “If we aren’t at the table, then we are on the menu.” Overworked and underpaid, burned out doctors feel powerless because they are managed by leaders with a business and not a medical background, and we need to have physicians in leadership who understand how medicine is practiced and to ensure equitable care

Dr. Kelly Wright gave a talk on the environmental impact of gynecologic care—from OR to clinic. She gave examples of how metal, reusable speculums become more cost-effective and produce less waste after only 2-3 uses and how there is no evidence that bouffants reduce surgical site infections (and a reusable scrub cap could work just as well without creating waste). Finally, Dr. Ebony Carter gave an impassioned talk on the need for equity in publication and grant funding in our field. She shared about her initiative through the Green Journal (Obstetrics and Gynecology) to create an issue focused on furthering equity and dispelling racism in medical research.

Later in the afternoon, I attended the Fellows’ Pelvic Research Network (FPRN) meeting, which includes AUGS-SGS (urogynecology fellows) and FMIGS-SGS (fellows of all other gynecologic subspecialities, including minimally invasive gynecologic surgery, family planning, reproductive endocrinology and infertility, and pediatric and adolescent gynecology). Dr. John Gebhart gave an excellent lecture with some impressive photos and videos on how to manage mesh exposure and erosion.

Afterwards, updates were given on the current FPRN projects, and 4 new projects were proposed and underwent audience feedback for improvement. It was exciting to see the multicenter collaborations fostered through the FPRN, and I look forward to seeing which projects will get funded for this upcoming year!

The evening ended with the President's Award Ceremony led by Dr. Cheryl Iglesia, the 49th SGS President, as well as the President's Reception. I also wantd to highlight the winner of the Distinguished Surgeon Award: Dr. Dee Fenner. The remaining awardees are listed on the SGS website (https://sgsonline.org).

Last night around midnight, bleary-eyed from the long flight from Pittsburgh, I walked out into the dimly lit, mild air of Tucson, Arizona. The Saguaro cacti that lined the entrance to the airport stood tall and tree-like, with welcoming green arms. It was as if they too knew that the next 4 days would be filled with the building of new relationships and the strengthening of old ones, as well as with education, innovation, and the sharing of research. That spirit of collegiality, approachability, and connection in an intimate and vibrant meeting is what the Society of Gynecologic Surgeons (SGS) meeting has been known for and why it draws people to come back, year after year.

The first day of the conference was fantastic. As a first-time attendant at SGS, I was excited to have the opportunity to meet and rub elbows with mentors and role models from across the country. My day started off with the SGS Fellows and Young Attendings Course, moderated by 3 incredible faculty: Dr. Matthew Barker, Dr. Sadikah Behbehani, and Dr. Traci Ito. Some high-yield topics such as contract negotiation, developing a urogynecology- or MIGS-based practice, billing, academic promotion, and taking advantage of relationships with industry were discussed at length, and the session ended with a roundtable, where the experts had time to answer questions in smaller groups. One of the quotes that will ring true for many fellows about to embark on the job search was from Dr. Amanda Ecker: “Up until now, you were told where to go and what your schedule is. This is the first time you have flexibility and power to decide for yourself.” Therefore, it is important to reflect on what you really desire and/or prioritize in a job, whether it is location, compensation, protected time, or opportunities for advancement.

In the afternoon, I attended a postgraduate course led by Dr. Veronica Lerner and Dr. Mireille Truong called “The Sim Factor: Making an Impact in Surgical Education.” Several other excellent postgraduate courses were available, including “Advanced Endometriosis Surgery and Pelvic Pain Patient-Centered Approach,” “Social Media Workshop- #Gynfluencing: Using Social Media to Find Your Digital Voice,” and “Urologic Surgery for the Gynecologic Surgeon: GU Injury, Ureteral Stents, Complex Fistula and More.” I was grateful for the hands-on and tangible tools that Drs. Lerner and Truong left the group with—including ideas such as Zoom-based virtual coaching for trainees learning fundamentals of laparoscopic surgery types of tasks, table-top simulation for high-stakes scenarios (eg, operative vascular injury), and the importance of grounding educational activity in objectives and evaluation. I even got to make and take home my own myomectomy model. (Fun fact: The myoma is actually a stress ball wrapped in an Ace bandage and then Glad Press n’ Seal! 

The late afternoon transitioned to an opportunity for trainees to interact with senior SGS members and a welcome reception. The indoor and outdoor spaces were filled with laughing and talking as people connected over drinks and snacks. Finally, the evening ended with a session presented by the SGS Equity Council, “What your Patients REALLY Want to Know.” Patty Brisben, of the Patty Brisben Foundation and founder of the company Pure Romance, was interviewed by Dr. Christine Vaccaro. It was heartwarming to hear how Patty took the stories of women suffering from sexual pain and dissatisfaction and chose to make it her life’s mission to improve women’s sexual health.

Wednesday, March 22. Day 4 of SGS.

Day 4, and the final day of the 49th SGS conference started with a sunrise run up and down the hills surrounding the JW Marriott Starr Resort. After breakfast, I entered the Tucson Ballroom to attend the last 2 scientific sessions of the conference.

Highlights from the first session included a look at postoperative outcomes and complication rates between gynecologic surgeons and general surgeons using the National Surgical Quality Improvement Program (NSQIP) database by Dr. Douglas Luchristt, who showed no difference between the 2 surgical specialties (and even better outcomes by gynecologists in certain operative measures), as well as the work of Dr. Christopher Hong who used 2 separate surgical databases (NSQIP and Michigan Surgical Quality Collaborative) to show that rates of vaginal hysterectomy have been decreasing from 2017 to 2020, even amongst patients who are likely good candidates for a vaginal route of hysterectomy. Dr. Jocelyn Fitzgerald presented her unique mixed methods research on how to better design the gynecologic office to improve the patient experience, using 3,000 Twitter responses to a question on this topic. Lastly, Dr. Emily Aldrich shared her work on better understanding the patient perception of same day discharge after major vaginal reconstructive surgery. An interesting finding of Dr. Aldrich’s study was that the most common response to her question about the “worst part of the surgical experience” was going home with a postoperative catheter, which surgeons often consider a small and temporary discomfort. The first session ended with the passing of the gavel from current SGS president Dr. Cheryl Iglesia, to the incoming SGS president Dr. Rosanne Kho, with much applause and excitement for what Dr. Kho will bring to the table in her new role.

The research presented at the final scientific session of the conference did not disappoint. A retrospective study on the influence of body mass index (BMI) on the time to surgical diagnosis of endometriosis by Dr. Melissa Markowitz found that obesity was associated with a delay of over 1 year in surgical diagnosis of endometriosis compared with normal and underweight patients. Dr. David (Ike) Rahn presented additional findings on his randomized, double-blinded, multicenter trial on perioperative use of vaginal estrogen cream in postmenopausal patients with prolapse. He found that 5 weeks of estrogen cream use was not associated with any improvement in urinary incontinence or sexual function.

Dr. Stephanie Glass Clark used the Premier Healthcare Database to show that that there was no difference in postoperative mesh exposure in patients who underwent a total hysterectomy compared with supracervical hysterectomy at the time of sacrocolpopexy. Dr. Kavita Mishra presented results from the FLOWER trial, which found no difference in postoperative outcomes for transgender women undergoing vaginoplasty for gender affirmation who did and did not undergo preoperative pelvic floor physical therapy. Finally, Dr. Carly Crowder shared her video of anatomy for sacral neuromodulation with some excellent cadaveric dissections to exhibit the peri-sacral and gluteal anatomy.

As the conference ended, raindrops pounded the sandy grounds of the resort as I waited in the lobby for my Uber to the airport. Dr. Rosanne Kho happened to walk by and stopped to speak with me and one of my attendings. She smiled as she asked about our experience at the conference and to wish us safe travels. To me, this moment embodies the spirit of mentorship and connection that is so unique to the SGS conference. I feel incredibly lucky to have met some of the physician leaders of our field, who genuinely want to get to know and help the next generation. This year’s meeting was attended by ObGyn generalists and surgeons of all gynecologic subspecialties and certainly met its goal in addressing topics with an “Impact Factor.” I am inspired by all the work that is happening across the country to move the needle and better our field. This was my first SGS experience, but it certainly won’t be the last. I hope you too will consider attending in the future!

Tuesday, March 21. Day 3 of SGS.

It’s Day 3 of the SGS conference! In addition to the academic roundtables, conference attendees had the option of doing early-morning yoga with Dr. Mireille Truong. Yoga sounded nice, but I spent the morning in bed, catching up on sleep. (My own version of wellness!) The scientific sessions of the day started at 7:30 am, and I especially want to highlight the work of Dr. Amy Askew who performed a randomized controlled trial comparing patient removal of urinary catheters placed for postoperative urinary retention to office removal. She found that patient urinary catheter removal was a feasible and safe option with excellent patient satisfaction and a reduction of in-person postoperative office visits. At the end of the session, Dr. Cheryl Iglesia gave her presidential address, where she shared her journey to becoming the physician, educator, researcher, and leader she is today. She emphasized the importance of being a continual learner and to give back by mentoring and educating the next generation. “Learn it, earn it, and return it.”

This was followed by the Te Linde lecture, given by Dr. Pamela Moalli. An exceptional surgeon-scientist, Dr. Moalli shared about her work on the impact of mesh on tissue, as well as alternative biologic options being developed, such as 3D printed membranes, extracellular matrix scaffolds, and living tissue grafts to create new ligamentous supports for the vagina. She discussed novel research using stem cell transplantation to harness the power of regeneration in the urethra or vagina following injury. I think it is safe to say that the entire room was in awe of the work she has done, and what she continues to do to find better therapeutic options for girls and women with pelvic floor disorders. Her talk ended in a standing ovation. Afterwards, all the University of Pittsburgh Medical Center-Magee Womens Hospital trainees, faculty, and several alumni took a picture with Dr. Moalli (fifth from the right in the picture).

Lunch followed, which included a brief walk around the industry exhibition hall. I then returned back to the Tucson Ballroom to listen in on the next scientific session on surgical ergonomics. Organized by Dr. Amy Park who herself suffered from work-related musculoskeletal injuries, the session was composed of an excellent video by Dr. Abby Stork on stretches to prevent and reduce the risk of surgeon-associated musculoskeletal injuries, especially in vaginal surgeons. There was then a panel of 3 experts, Dr. Noor Abu-Alnadi, Dr. Ladin Yurteri-Kaplan, and Dr. Susan Hallbeck (PhD ergonomics expert), moderated by Dr. Amanda Fader and Dr. Kimberly Kho. In particular, Dr. Hallbeck developed a timer app as a reminder for surgeons to stop every 40 minutes to stretch for 1.5 minutes (orstretch.mayoclinic.org). This has been studied and found to reduce musculoskeletal pain after surgery and improve physical performance without increasing total operating time. If you would like to see some of these between- and in-OR stretches yourself, an informative handout can be accessed at mcforms.mayo.edu.

Tuesday afternoon was left open. I joined Dr. Veronica Lerner, Dr. Kelly Wright, and Dr. Louise Perkins King on a 7.5-mile hike into the surrounding desert hills. We marveled at the many Saguaro cacti, some over 100 years old and towering many feet high, as well as the beautiful yellow, purple, and magenta flowers that were scattered among the desert brush. Several rabbits and deer wandered by us during our hike. On one of the trails, the stone skeleton of an old house stood, once a home to the Bowen family who had moved to Arizona for health reasons. I could see why they would want to move here—I felt such a peace looking at the gorgeous view from what was once their doorway.

After a shower and a lot of stretching, I got ready for the evening event, A Taste and Toast with SGS: Under the Arizona Skies. The food and drink were delicious, and I got to spend the evening catching up with a good friend. We watched as conference attendees assigned to different color teams (red, green, blue, and yellow), fought for the hallowed Golden Uterus Trophy in several competitive gynecology-themed games (eg, throwing sacral neuromodulation needle “darts” at balloons and removing small pom poms from a water bottle with a disposable operative hysteroscope). As the evening progressed, the DJ turned up the music and people made their way to the dance floor. The event served as a fundraiser for the SGS Pelvic Anatomy Group and successfully raised $35,000.

Day 2 of the SGS meeting started off with a gentle sunrise over the cacti-covered hills surrounding the JW Marriot Starr Pass Hotel, the venue for the 49th SGS annual scientific meeting. The first official event of the day after some engaging academic round tables was the recognition of the new SGS members. Much celebration was had over the 18 gynecologic surgeons who were inducted.

The second day included the first 3 scientific sessions of the conference. Some highlights include the work of Dr. Shawn Menefee on a randomized trial of sacral colpopexy, transvaginal mesh, and native tissue apical repair for posthysterectomy vault prolapse; a video by Dr. Matthew Fallon on a robotic-assisted laparoscopic approach to repairing a chronic uterine inversion; and the impact of age on regret following hysterectomy by Dr. Nathan King. Dr. Candace Parker-Autry also presented her work on the impact of perineorrhaphy on both female and male sexual function, and Dr. Cassie (Clarissa) Niino spoke elegantly on the “red bag problem” that exists in all of our operating rooms, which increases pollution and cost unnecessarily.

There were also several excellent talks given. Dr. Jason Wright spoke about the importance of surgical volume on gynecologic surgery. In particular, he noted that surgical volume needs to be considered not only at the surgeon level but also at the hospital level. Higher-volume hospitals will provide better care, in the same way that general, high-volume surgeons have less complications and better long-term outcomes. Of note, volume is not the whole picture. We need to also consider measurements of surgery and hospital quality and surgeon skill in addition to volume, as Dr. Shawn Menefee insightfully commented.

Dr. Beri Ridgeway gave the Mark D. Walters Lecture about surgeons in the c-suite and the importance of having a seat at the leadership table as surgeons and medical providers. In her words: “If we aren’t at the table, then we are on the menu.” Overworked and underpaid, burned out doctors feel powerless because they are managed by leaders with a business and not a medical background, and we need to have physicians in leadership who understand how medicine is practiced and to ensure equitable care

Dr. Kelly Wright gave a talk on the environmental impact of gynecologic care—from OR to clinic. She gave examples of how metal, reusable speculums become more cost-effective and produce less waste after only 2-3 uses and how there is no evidence that bouffants reduce surgical site infections (and a reusable scrub cap could work just as well without creating waste). Finally, Dr. Ebony Carter gave an impassioned talk on the need for equity in publication and grant funding in our field. She shared about her initiative through the Green Journal (Obstetrics and Gynecology) to create an issue focused on furthering equity and dispelling racism in medical research.

Later in the afternoon, I attended the Fellows’ Pelvic Research Network (FPRN) meeting, which includes AUGS-SGS (urogynecology fellows) and FMIGS-SGS (fellows of all other gynecologic subspecialities, including minimally invasive gynecologic surgery, family planning, reproductive endocrinology and infertility, and pediatric and adolescent gynecology). Dr. John Gebhart gave an excellent lecture with some impressive photos and videos on how to manage mesh exposure and erosion.

Afterwards, updates were given on the current FPRN projects, and 4 new projects were proposed and underwent audience feedback for improvement. It was exciting to see the multicenter collaborations fostered through the FPRN, and I look forward to seeing which projects will get funded for this upcoming year!

The evening ended with the President's Award Ceremony led by Dr. Cheryl Iglesia, the 49th SGS President, as well as the President's Reception. I also wantd to highlight the winner of the Distinguished Surgeon Award: Dr. Dee Fenner. The remaining awardees are listed on the SGS website (https://sgsonline.org).

Last night around midnight, bleary-eyed from the long flight from Pittsburgh, I walked out into the dimly lit, mild air of Tucson, Arizona. The Saguaro cacti that lined the entrance to the airport stood tall and tree-like, with welcoming green arms. It was as if they too knew that the next 4 days would be filled with the building of new relationships and the strengthening of old ones, as well as with education, innovation, and the sharing of research. That spirit of collegiality, approachability, and connection in an intimate and vibrant meeting is what the Society of Gynecologic Surgeons (SGS) meeting has been known for and why it draws people to come back, year after year.

The first day of the conference was fantastic. As a first-time attendant at SGS, I was excited to have the opportunity to meet and rub elbows with mentors and role models from across the country. My day started off with the SGS Fellows and Young Attendings Course, moderated by 3 incredible faculty: Dr. Matthew Barker, Dr. Sadikah Behbehani, and Dr. Traci Ito. Some high-yield topics such as contract negotiation, developing a urogynecology- or MIGS-based practice, billing, academic promotion, and taking advantage of relationships with industry were discussed at length, and the session ended with a roundtable, where the experts had time to answer questions in smaller groups. One of the quotes that will ring true for many fellows about to embark on the job search was from Dr. Amanda Ecker: “Up until now, you were told where to go and what your schedule is. This is the first time you have flexibility and power to decide for yourself.” Therefore, it is important to reflect on what you really desire and/or prioritize in a job, whether it is location, compensation, protected time, or opportunities for advancement.

In the afternoon, I attended a postgraduate course led by Dr. Veronica Lerner and Dr. Mireille Truong called “The Sim Factor: Making an Impact in Surgical Education.” Several other excellent postgraduate courses were available, including “Advanced Endometriosis Surgery and Pelvic Pain Patient-Centered Approach,” “Social Media Workshop- #Gynfluencing: Using Social Media to Find Your Digital Voice,” and “Urologic Surgery for the Gynecologic Surgeon: GU Injury, Ureteral Stents, Complex Fistula and More.” I was grateful for the hands-on and tangible tools that Drs. Lerner and Truong left the group with—including ideas such as Zoom-based virtual coaching for trainees learning fundamentals of laparoscopic surgery types of tasks, table-top simulation for high-stakes scenarios (eg, operative vascular injury), and the importance of grounding educational activity in objectives and evaluation. I even got to make and take home my own myomectomy model. (Fun fact: The myoma is actually a stress ball wrapped in an Ace bandage and then Glad Press n’ Seal! 

The late afternoon transitioned to an opportunity for trainees to interact with senior SGS members and a welcome reception. The indoor and outdoor spaces were filled with laughing and talking as people connected over drinks and snacks. Finally, the evening ended with a session presented by the SGS Equity Council, “What your Patients REALLY Want to Know.” Patty Brisben, of the Patty Brisben Foundation and founder of the company Pure Romance, was interviewed by Dr. Christine Vaccaro. It was heartwarming to hear how Patty took the stories of women suffering from sexual pain and dissatisfaction and chose to make it her life’s mission to improve women’s sexual health.

Patients who are already depressed before they receive a lung cancer diagnosis are more likely to have a worse overall survival (OS), and the driver for this may be inflammation, suggests a new study.

The findings underscore the importance of assessing and treating depression in patients with cancer, particularly given the high rate of depression among those with lung cancer versus other types of cancer, the investigators said.

The study involved 186 patients with newly diagnosed stage IV non–small cell lung cancer (NSCLC), of whom 35% had self-reported moderate to severe depressive symptoms.

Depression was reliably associated with lung-relevant systemic inflammation responses (SIRs), which included neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and Advanced Lung Cancer Inflammation Index (ALI) score.

These SIRs were prognostic for 2-year OS.

Overall mortality at 2 years was 61%. Higher NLRs and PLRs and lower ALI scores all predicted worse OS (hazard ratio, 1.91, 2.08, and 0.53, respectively).

The findings were published online in PLoS ONE (2023 Feb 24.

“These patients with high levels of depression are at much higher risk for poor outcomes,” but the key finding was that patients with the highest depression levels were driving the relationship, lead author Barbara Andersen, PhD, professor of psychology at Ohio State University, Columbus, stated in a press release.

“It was patients with high depression levels who had strikingly higher inflammation levels, and that is what really drove the correlation we saw,” she explained.

For example, 56% of patients with no depression symptoms or only mild depression symptoms had a PLR above the cutoff for dangerous levels of inflammation, compared with 42% whose PLR was below the cutoff. However, among those with high depression levels, 77% and 23% had a PLR above and below the cutoff, respectively.

“These highly depressed patients were 1.3-3 times more likely to have high inflammation levels, even after controlling for other factors related to inflammation biomarker levels, including demographics and smoking status,” Dr. Andersen noted.

“Depression levels may be as important or even more important than other factors that have been associated with how people fare with lung cancer,” she suggested.

In a previous study, the team controlled for baseline depression and found that “the trajectory of depression from diagnosis through 2 years (18 assessments) predicted NSCLC patients’ survival (HR, 1.09), above and beyond baseline depression, sociodemographics, smoking status, cell type, and receipt of targeted treatments and immunotherapies.”

“Taken together, data support psychological, behavioral, and biologic toxicities of depression capable of influencing treatment response and/or survival,” they wrote.

“The results may help explain why a substantial portion of lung cancer patients fail to respond to new immunotherapy and targeted treatments that have led to significantly longer survival for many people with the disease,” Dr. Andersen said.

The investigators concluded that “intensive study of depression among patients with NSCLC, combined with measures of cell biology, inflammation, and immunity, is needed to extend these findings and discover their mechanisms, with the long-term aim to improve patients’ quality of life, treatment responses, and longevity.”

This study was funded by the Ohio State University Comprehensive Cancer Center and Pelotonia through grants to individual authors. Dr. Andersen reported having no relevant disclosures.

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

Patients who are already depressed before they receive a lung cancer diagnosis are more likely to have a worse overall survival (OS), and the driver for this may be inflammation, suggests a new study.

The findings underscore the importance of assessing and treating depression in patients with cancer, particularly given the high rate of depression among those with lung cancer versus other types of cancer, the investigators said.

The study involved 186 patients with newly diagnosed stage IV non–small cell lung cancer (NSCLC), of whom 35% had self-reported moderate to severe depressive symptoms.

Depression was reliably associated with lung-relevant systemic inflammation responses (SIRs), which included neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and Advanced Lung Cancer Inflammation Index (ALI) score.

These SIRs were prognostic for 2-year OS.

Overall mortality at 2 years was 61%. Higher NLRs and PLRs and lower ALI scores all predicted worse OS (hazard ratio, 1.91, 2.08, and 0.53, respectively).

The findings were published online in PLoS ONE (2023 Feb 24.

“These patients with high levels of depression are at much higher risk for poor outcomes,” but the key finding was that patients with the highest depression levels were driving the relationship, lead author Barbara Andersen, PhD, professor of psychology at Ohio State University, Columbus, stated in a press release.

“It was patients with high depression levels who had strikingly higher inflammation levels, and that is what really drove the correlation we saw,” she explained.

For example, 56% of patients with no depression symptoms or only mild depression symptoms had a PLR above the cutoff for dangerous levels of inflammation, compared with 42% whose PLR was below the cutoff. However, among those with high depression levels, 77% and 23% had a PLR above and below the cutoff, respectively.

“These highly depressed patients were 1.3-3 times more likely to have high inflammation levels, even after controlling for other factors related to inflammation biomarker levels, including demographics and smoking status,” Dr. Andersen noted.

“Depression levels may be as important or even more important than other factors that have been associated with how people fare with lung cancer,” she suggested.

In a previous study, the team controlled for baseline depression and found that “the trajectory of depression from diagnosis through 2 years (18 assessments) predicted NSCLC patients’ survival (HR, 1.09), above and beyond baseline depression, sociodemographics, smoking status, cell type, and receipt of targeted treatments and immunotherapies.”

“Taken together, data support psychological, behavioral, and biologic toxicities of depression capable of influencing treatment response and/or survival,” they wrote.

“The results may help explain why a substantial portion of lung cancer patients fail to respond to new immunotherapy and targeted treatments that have led to significantly longer survival for many people with the disease,” Dr. Andersen said.

The investigators concluded that “intensive study of depression among patients with NSCLC, combined with measures of cell biology, inflammation, and immunity, is needed to extend these findings and discover their mechanisms, with the long-term aim to improve patients’ quality of life, treatment responses, and longevity.”

This study was funded by the Ohio State University Comprehensive Cancer Center and Pelotonia through grants to individual authors. Dr. Andersen reported having no relevant disclosures.

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

Patients who are already depressed before they receive a lung cancer diagnosis are more likely to have a worse overall survival (OS), and the driver for this may be inflammation, suggests a new study.

The findings underscore the importance of assessing and treating depression in patients with cancer, particularly given the high rate of depression among those with lung cancer versus other types of cancer, the investigators said.

The study involved 186 patients with newly diagnosed stage IV non–small cell lung cancer (NSCLC), of whom 35% had self-reported moderate to severe depressive symptoms.

Depression was reliably associated with lung-relevant systemic inflammation responses (SIRs), which included neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and Advanced Lung Cancer Inflammation Index (ALI) score.

These SIRs were prognostic for 2-year OS.

Overall mortality at 2 years was 61%. Higher NLRs and PLRs and lower ALI scores all predicted worse OS (hazard ratio, 1.91, 2.08, and 0.53, respectively).

The findings were published online in PLoS ONE (2023 Feb 24.

“These patients with high levels of depression are at much higher risk for poor outcomes,” but the key finding was that patients with the highest depression levels were driving the relationship, lead author Barbara Andersen, PhD, professor of psychology at Ohio State University, Columbus, stated in a press release.

“It was patients with high depression levels who had strikingly higher inflammation levels, and that is what really drove the correlation we saw,” she explained.

For example, 56% of patients with no depression symptoms or only mild depression symptoms had a PLR above the cutoff for dangerous levels of inflammation, compared with 42% whose PLR was below the cutoff. However, among those with high depression levels, 77% and 23% had a PLR above and below the cutoff, respectively.

“These highly depressed patients were 1.3-3 times more likely to have high inflammation levels, even after controlling for other factors related to inflammation biomarker levels, including demographics and smoking status,” Dr. Andersen noted.

“Depression levels may be as important or even more important than other factors that have been associated with how people fare with lung cancer,” she suggested.

In a previous study, the team controlled for baseline depression and found that “the trajectory of depression from diagnosis through 2 years (18 assessments) predicted NSCLC patients’ survival (HR, 1.09), above and beyond baseline depression, sociodemographics, smoking status, cell type, and receipt of targeted treatments and immunotherapies.”

“Taken together, data support psychological, behavioral, and biologic toxicities of depression capable of influencing treatment response and/or survival,” they wrote.

“The results may help explain why a substantial portion of lung cancer patients fail to respond to new immunotherapy and targeted treatments that have led to significantly longer survival for many people with the disease,” Dr. Andersen said.

The investigators concluded that “intensive study of depression among patients with NSCLC, combined with measures of cell biology, inflammation, and immunity, is needed to extend these findings and discover their mechanisms, with the long-term aim to improve patients’ quality of life, treatment responses, and longevity.”

This study was funded by the Ohio State University Comprehensive Cancer Center and Pelotonia through grants to individual authors. Dr. Andersen reported having no relevant disclosures.

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

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the division of medical ethics at New York University’s Grossman School of Medicine in New York City.

We’ve had an organ shortage for many decades now. We can do more transplants than we have organs made available. We try very hard to get organ donation from those who die. That’s a commendable thing to do. I think doctors should always be discussing the opportunity to donate organs upon death, even in primary care settings.

It’s good to find out what people’s attitudes are. Let them learn about organ donation as something they can think about. Let them talk about it with family and friends and partners so that they know their wishes.

However, despite these efforts to encourage organ donation, we still have far fewer organs than we could use to transplant people, many people die on waiting lists because there are no organs to give them, and we’re in a situation where demand for organ transplant is actually increasing.

There is more capacity to do transplants both in the United States and elsewhere, and more people are living longer, so organ failure starts to become more common before, let’s say, terminal illness is really there. Now, we have more people who might benefit from organ transplant in an aging population.

One place to turn to help reduce the shortage of organs is to living donation. At least insofar as kidneys go, kidney donation from living persons has become a prominent source of organs for those who need kidneys – most of whom are surviving on dialysis, by the way, at a very high cost and often with a quality of life that they don’t find particularly easy to accept.

Transplant is far preferred, even though they have to take immunosuppression to keep those organ transplants going, and that has its own risks and side effects. They still get more mobility. They still are able to have a broader diet. They enjoy life far more than they do having to show up for dialysis three times a week for a couple of hours, every week, for every week that they live.

There is an interest in living kidney donation. One battle has been that, well, maybe we could get more kidneys if we just paid people to sell us their kidneys. That has been resisted, and I’ve been resistant to that idea, too, because I worry that it leads to exploitation.

The people who sell their kidneys are poor. They’re often in debt. They feel coerced by their circumstances, so they make a kidney sale. This happens in countries like India, where there are markets underground, and you see that it’s the poorest of the poor who do this, and they don’t really work their way out of debt. They just wind up without a kidney, help relieve their debt a little bit, and pretty soon, because they don’t have a job or an income except that sale of a kidney, they’re not much better off than they were before they started.

Also, people who sell kidneys for money are more likely not to admit to their own health problems, raising risks about the quality of organs. Then, of course, it puts doctors in a position to take out an organ for pay, even though it doesn’t benefit you, so that you can sell it. This raises some questions about whether that’s consistent with medical ethics.

A different idea has emerged. New York State Governor Kathy Hochul just signed legislation that allows living donors to be compensated for legitimate costs. That’s a little different matter. You’re not buying the organ, but you’re saying that if you experience health care problems due to complications from a donation, if you need money for transportation, if you lost money because you did this altruistically and you had to take time off from work and had expenses for a babysitter, restaurants, or other things, the state is going to try to create funds that will compensate you.

That, I think we should agree, is not a bad idea. You’re in a situation there where you don’t want to make people who are heroic, altruistic, and trying to help others by donating a kidney end up financially worse off.

I think there’s a difference between making someone financially whole after the decision to make a kidney available and creating a market where the poorest of the poor come forward to just sell because they see no other choice in terms of how to get rid of debts. I see these situations as not ethically equivalent, so I support efforts to try to compensate people who are our heroes. I don’t think we should ask them to financially suffer.

We’ll watch to see what happens as the New York state law comes into effect. By the way, New York is one of the states that really lags in the supply of organs for transplant, so this measure is particularly important for that state. Many other states should be considering this legislation as well.

It’s one thing to reward, if you will, donors by making sure they don’t suffer financial loss. It’s a very different thing to say, let’s have a free market and we’ll pay whoever it is that’s willing to sell us a kidney to do so. The former seems to me to be humane and just, whereas the latter risks exploitation.
 

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

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the division of medical ethics at New York University’s Grossman School of Medicine in New York City.

We’ve had an organ shortage for many decades now. We can do more transplants than we have organs made available. We try very hard to get organ donation from those who die. That’s a commendable thing to do. I think doctors should always be discussing the opportunity to donate organs upon death, even in primary care settings.

It’s good to find out what people’s attitudes are. Let them learn about organ donation as something they can think about. Let them talk about it with family and friends and partners so that they know their wishes.

However, despite these efforts to encourage organ donation, we still have far fewer organs than we could use to transplant people, many people die on waiting lists because there are no organs to give them, and we’re in a situation where demand for organ transplant is actually increasing.

There is more capacity to do transplants both in the United States and elsewhere, and more people are living longer, so organ failure starts to become more common before, let’s say, terminal illness is really there. Now, we have more people who might benefit from organ transplant in an aging population.

One place to turn to help reduce the shortage of organs is to living donation. At least insofar as kidneys go, kidney donation from living persons has become a prominent source of organs for those who need kidneys – most of whom are surviving on dialysis, by the way, at a very high cost and often with a quality of life that they don’t find particularly easy to accept.

Transplant is far preferred, even though they have to take immunosuppression to keep those organ transplants going, and that has its own risks and side effects. They still get more mobility. They still are able to have a broader diet. They enjoy life far more than they do having to show up for dialysis three times a week for a couple of hours, every week, for every week that they live.

There is an interest in living kidney donation. One battle has been that, well, maybe we could get more kidneys if we just paid people to sell us their kidneys. That has been resisted, and I’ve been resistant to that idea, too, because I worry that it leads to exploitation.

The people who sell their kidneys are poor. They’re often in debt. They feel coerced by their circumstances, so they make a kidney sale. This happens in countries like India, where there are markets underground, and you see that it’s the poorest of the poor who do this, and they don’t really work their way out of debt. They just wind up without a kidney, help relieve their debt a little bit, and pretty soon, because they don’t have a job or an income except that sale of a kidney, they’re not much better off than they were before they started.

Also, people who sell kidneys for money are more likely not to admit to their own health problems, raising risks about the quality of organs. Then, of course, it puts doctors in a position to take out an organ for pay, even though it doesn’t benefit you, so that you can sell it. This raises some questions about whether that’s consistent with medical ethics.

A different idea has emerged. New York State Governor Kathy Hochul just signed legislation that allows living donors to be compensated for legitimate costs. That’s a little different matter. You’re not buying the organ, but you’re saying that if you experience health care problems due to complications from a donation, if you need money for transportation, if you lost money because you did this altruistically and you had to take time off from work and had expenses for a babysitter, restaurants, or other things, the state is going to try to create funds that will compensate you.

That, I think we should agree, is not a bad idea. You’re in a situation there where you don’t want to make people who are heroic, altruistic, and trying to help others by donating a kidney end up financially worse off.

I think there’s a difference between making someone financially whole after the decision to make a kidney available and creating a market where the poorest of the poor come forward to just sell because they see no other choice in terms of how to get rid of debts. I see these situations as not ethically equivalent, so I support efforts to try to compensate people who are our heroes. I don’t think we should ask them to financially suffer.

We’ll watch to see what happens as the New York state law comes into effect. By the way, New York is one of the states that really lags in the supply of organs for transplant, so this measure is particularly important for that state. Many other states should be considering this legislation as well.

It’s one thing to reward, if you will, donors by making sure they don’t suffer financial loss. It’s a very different thing to say, let’s have a free market and we’ll pay whoever it is that’s willing to sell us a kidney to do so. The former seems to me to be humane and just, whereas the latter risks exploitation.
 

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

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the division of medical ethics at New York University’s Grossman School of Medicine in New York City.

We’ve had an organ shortage for many decades now. We can do more transplants than we have organs made available. We try very hard to get organ donation from those who die. That’s a commendable thing to do. I think doctors should always be discussing the opportunity to donate organs upon death, even in primary care settings.

It’s good to find out what people’s attitudes are. Let them learn about organ donation as something they can think about. Let them talk about it with family and friends and partners so that they know their wishes.

However, despite these efforts to encourage organ donation, we still have far fewer organs than we could use to transplant people, many people die on waiting lists because there are no organs to give them, and we’re in a situation where demand for organ transplant is actually increasing.

There is more capacity to do transplants both in the United States and elsewhere, and more people are living longer, so organ failure starts to become more common before, let’s say, terminal illness is really there. Now, we have more people who might benefit from organ transplant in an aging population.

One place to turn to help reduce the shortage of organs is to living donation. At least insofar as kidneys go, kidney donation from living persons has become a prominent source of organs for those who need kidneys – most of whom are surviving on dialysis, by the way, at a very high cost and often with a quality of life that they don’t find particularly easy to accept.

Transplant is far preferred, even though they have to take immunosuppression to keep those organ transplants going, and that has its own risks and side effects. They still get more mobility. They still are able to have a broader diet. They enjoy life far more than they do having to show up for dialysis three times a week for a couple of hours, every week, for every week that they live.

There is an interest in living kidney donation. One battle has been that, well, maybe we could get more kidneys if we just paid people to sell us their kidneys. That has been resisted, and I’ve been resistant to that idea, too, because I worry that it leads to exploitation.

The people who sell their kidneys are poor. They’re often in debt. They feel coerced by their circumstances, so they make a kidney sale. This happens in countries like India, where there are markets underground, and you see that it’s the poorest of the poor who do this, and they don’t really work their way out of debt. They just wind up without a kidney, help relieve their debt a little bit, and pretty soon, because they don’t have a job or an income except that sale of a kidney, they’re not much better off than they were before they started.

Also, people who sell kidneys for money are more likely not to admit to their own health problems, raising risks about the quality of organs. Then, of course, it puts doctors in a position to take out an organ for pay, even though it doesn’t benefit you, so that you can sell it. This raises some questions about whether that’s consistent with medical ethics.

A different idea has emerged. New York State Governor Kathy Hochul just signed legislation that allows living donors to be compensated for legitimate costs. That’s a little different matter. You’re not buying the organ, but you’re saying that if you experience health care problems due to complications from a donation, if you need money for transportation, if you lost money because you did this altruistically and you had to take time off from work and had expenses for a babysitter, restaurants, or other things, the state is going to try to create funds that will compensate you.

That, I think we should agree, is not a bad idea. You’re in a situation there where you don’t want to make people who are heroic, altruistic, and trying to help others by donating a kidney end up financially worse off.

I think there’s a difference between making someone financially whole after the decision to make a kidney available and creating a market where the poorest of the poor come forward to just sell because they see no other choice in terms of how to get rid of debts. I see these situations as not ethically equivalent, so I support efforts to try to compensate people who are our heroes. I don’t think we should ask them to financially suffer.

We’ll watch to see what happens as the New York state law comes into effect. By the way, New York is one of the states that really lags in the supply of organs for transplant, so this measure is particularly important for that state. Many other states should be considering this legislation as well.

It’s one thing to reward, if you will, donors by making sure they don’t suffer financial loss. It’s a very different thing to say, let’s have a free market and we’ll pay whoever it is that’s willing to sell us a kidney to do so. The former seems to me to be humane and just, whereas the latter risks exploitation.
 

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

As chair of the Arkansas State Medical Board, Brian T. Hyatt, MD, often sat in judgment of other physicians. Now, state officials are investigating the psychiatrist for alleged Medicaid fraud. He has stepped down as board chair, and state officials have suspended all Medicaid payments to Dr. Hyatt and his practice, Pinnacle Premier Psychiatry in Rogers, Arkansas.

Dr. Hyatt billed 99.95% of the claims for his patients’ hospital care to Medicaid at the highest severity level, according to an affidavit filed by an investigator with the Medicaid Fraud Control Unit, Arkansas Attorney General’s Office. Other Arkansas psychiatrists billed that same level in only about 39% of claims, the affidavit states.

The possible upcoding alleged in the affidavit was a red flag that prompted the state to temporarily suspend Dr. Hyatt’s Medicaid payments.

Dr. Hyatt has until this Friday to file an appeal. He did not respond to requests from this news organization for comment.

The affidavit pointed to other concerns. For example, a whistleblower who worked at the Northwest Medical Center where Dr. Hyatt admitted patients claimed that Dr. Hyatt was only on the floor a few minutes a day and that he had no contact with patients. A review of hundreds of hours of video by state investigators revealed that Dr. Hyatt did not enter patients’ rooms, nor did he have any contact with patients, according to the affidavit. Dr. Hyatt served as the hospital’s behavioral unit director from 2018 until his contract was abruptly terminated in May 2022, according to the affidavit.

However, Dr. Hyatt claimed to have conducted daily face-to-face evaluation and management with patients, according to the affidavit. In addition, the whistleblower claimed that Dr. Hyatt did not want patients to know his name and instructed staff to cover up his name on patient armbands.
 

Detaining patients

Dr. Hyatt also faces accusations that he held patients against their will, according to civil lawsuits filed in Washington County, Ark., reports the Arkansas Advocate. 

Karla Adrian-Caceres filed suit on Jan. 17. Ms. Adrian-Caceres also named Brooke Green, Northwest Arkansas Hospitals, and 25 unidentified hospital employees as defendants.

According to the complaint, Ms. Adrian-Caceres, an engineering student at the University of Arkansas, arrived at the Northwest Medical Emergency Department after accidentally taking too many Tylenol on Jan. 18, 2022. She was then taken by ambulance to a Northwest psychiatric facility in Springdale, court records show.

According to the complaint, Ms. Adrian-Caceres said that she was given a sedative and asked to sign consent for admission while on the way to Northwest. She said that she “signed some documents without being able to read or understand them at the time.”

When she asked when she could go home, Ms. Adrian-Caceres said, “more than one employee told her there was a minimum stay and that if she asked to leave, they would take her to court where a judge would give her a longer stay because the judge always sides with Dr. Hyatt and Northwest,” according to court documents. Northwest employees stripped Ms. Adrian-Caceres, searched her body, took all of her possessions from her and issued underwear and a uniform, according to the lawsuit.

Ms. Adrian-Caceres’ mother, Katty Caceres, claimed in the lawsuit that she was prohibited from seeing her daughter. Ms. Caceres spoke with five different employees, four of whom had only their first names on their badges. Each of them reportedly said that they could not help, or that the plaintiff “would be in there for some time” and that it was Dr. Hyatt’s decision regarding how long that would be, according to court documents.

Katty Caceres hired a local attorney named Aaron Cash to represent her daughter. On Jan. 20, 2022, Mr. Cash faxed a letter to the hospital demanding her release. When Ms. Caceres arrived to pick up her daughter, she claimed that staff members indicated that the daughter was there voluntarily and refused to release her “at the direction of Dr Hyatt.” During a phone call later that day, the plaintiff told her mother that her status was being changed to an involuntary hold, court documents show.

“At one point she was threatened with the longer time in there if she kept asking to leave,” Mr. Cash told this news organization. In addition, staff members reportedly told Ms. Adrian-Caceres that the “judge always sided with Dr Hyatt” and she “would get way longer there, 30-45 days if [she] went before the judge,” according to Mr. Cash.

Mr. Cash said nine other patients have contacted his firm with similar allegations against Dr. Hyatt.

“We’ve talked to many people that have experienced the same threats,” Mr. Cash said. “When they’re asking to leave, they get these threats, they get coerced … and they’re never taken to court. They’re never given opportunity to talk to a judge or to have a public defender appointed.”
 

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

As chair of the Arkansas State Medical Board, Brian T. Hyatt, MD, often sat in judgment of other physicians. Now, state officials are investigating the psychiatrist for alleged Medicaid fraud. He has stepped down as board chair, and state officials have suspended all Medicaid payments to Dr. Hyatt and his practice, Pinnacle Premier Psychiatry in Rogers, Arkansas.

Dr. Hyatt billed 99.95% of the claims for his patients’ hospital care to Medicaid at the highest severity level, according to an affidavit filed by an investigator with the Medicaid Fraud Control Unit, Arkansas Attorney General’s Office. Other Arkansas psychiatrists billed that same level in only about 39% of claims, the affidavit states.

The possible upcoding alleged in the affidavit was a red flag that prompted the state to temporarily suspend Dr. Hyatt’s Medicaid payments.

Dr. Hyatt has until this Friday to file an appeal. He did not respond to requests from this news organization for comment.

The affidavit pointed to other concerns. For example, a whistleblower who worked at the Northwest Medical Center where Dr. Hyatt admitted patients claimed that Dr. Hyatt was only on the floor a few minutes a day and that he had no contact with patients. A review of hundreds of hours of video by state investigators revealed that Dr. Hyatt did not enter patients’ rooms, nor did he have any contact with patients, according to the affidavit. Dr. Hyatt served as the hospital’s behavioral unit director from 2018 until his contract was abruptly terminated in May 2022, according to the affidavit.

However, Dr. Hyatt claimed to have conducted daily face-to-face evaluation and management with patients, according to the affidavit. In addition, the whistleblower claimed that Dr. Hyatt did not want patients to know his name and instructed staff to cover up his name on patient armbands.
 

Detaining patients

Dr. Hyatt also faces accusations that he held patients against their will, according to civil lawsuits filed in Washington County, Ark., reports the Arkansas Advocate. 

Karla Adrian-Caceres filed suit on Jan. 17. Ms. Adrian-Caceres also named Brooke Green, Northwest Arkansas Hospitals, and 25 unidentified hospital employees as defendants.

According to the complaint, Ms. Adrian-Caceres, an engineering student at the University of Arkansas, arrived at the Northwest Medical Emergency Department after accidentally taking too many Tylenol on Jan. 18, 2022. She was then taken by ambulance to a Northwest psychiatric facility in Springdale, court records show.

According to the complaint, Ms. Adrian-Caceres said that she was given a sedative and asked to sign consent for admission while on the way to Northwest. She said that she “signed some documents without being able to read or understand them at the time.”

When she asked when she could go home, Ms. Adrian-Caceres said, “more than one employee told her there was a minimum stay and that if she asked to leave, they would take her to court where a judge would give her a longer stay because the judge always sides with Dr. Hyatt and Northwest,” according to court documents. Northwest employees stripped Ms. Adrian-Caceres, searched her body, took all of her possessions from her and issued underwear and a uniform, according to the lawsuit.

Ms. Adrian-Caceres’ mother, Katty Caceres, claimed in the lawsuit that she was prohibited from seeing her daughter. Ms. Caceres spoke with five different employees, four of whom had only their first names on their badges. Each of them reportedly said that they could not help, or that the plaintiff “would be in there for some time” and that it was Dr. Hyatt’s decision regarding how long that would be, according to court documents.

Katty Caceres hired a local attorney named Aaron Cash to represent her daughter. On Jan. 20, 2022, Mr. Cash faxed a letter to the hospital demanding her release. When Ms. Caceres arrived to pick up her daughter, she claimed that staff members indicated that the daughter was there voluntarily and refused to release her “at the direction of Dr Hyatt.” During a phone call later that day, the plaintiff told her mother that her status was being changed to an involuntary hold, court documents show.

“At one point she was threatened with the longer time in there if she kept asking to leave,” Mr. Cash told this news organization. In addition, staff members reportedly told Ms. Adrian-Caceres that the “judge always sided with Dr Hyatt” and she “would get way longer there, 30-45 days if [she] went before the judge,” according to Mr. Cash.

Mr. Cash said nine other patients have contacted his firm with similar allegations against Dr. Hyatt.

“We’ve talked to many people that have experienced the same threats,” Mr. Cash said. “When they’re asking to leave, they get these threats, they get coerced … and they’re never taken to court. They’re never given opportunity to talk to a judge or to have a public defender appointed.”
 

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

As chair of the Arkansas State Medical Board, Brian T. Hyatt, MD, often sat in judgment of other physicians. Now, state officials are investigating the psychiatrist for alleged Medicaid fraud. He has stepped down as board chair, and state officials have suspended all Medicaid payments to Dr. Hyatt and his practice, Pinnacle Premier Psychiatry in Rogers, Arkansas.

Dr. Hyatt billed 99.95% of the claims for his patients’ hospital care to Medicaid at the highest severity level, according to an affidavit filed by an investigator with the Medicaid Fraud Control Unit, Arkansas Attorney General’s Office. Other Arkansas psychiatrists billed that same level in only about 39% of claims, the affidavit states.

The possible upcoding alleged in the affidavit was a red flag that prompted the state to temporarily suspend Dr. Hyatt’s Medicaid payments.

Dr. Hyatt has until this Friday to file an appeal. He did not respond to requests from this news organization for comment.

The affidavit pointed to other concerns. For example, a whistleblower who worked at the Northwest Medical Center where Dr. Hyatt admitted patients claimed that Dr. Hyatt was only on the floor a few minutes a day and that he had no contact with patients. A review of hundreds of hours of video by state investigators revealed that Dr. Hyatt did not enter patients’ rooms, nor did he have any contact with patients, according to the affidavit. Dr. Hyatt served as the hospital’s behavioral unit director from 2018 until his contract was abruptly terminated in May 2022, according to the affidavit.

However, Dr. Hyatt claimed to have conducted daily face-to-face evaluation and management with patients, according to the affidavit. In addition, the whistleblower claimed that Dr. Hyatt did not want patients to know his name and instructed staff to cover up his name on patient armbands.
 

Detaining patients

Dr. Hyatt also faces accusations that he held patients against their will, according to civil lawsuits filed in Washington County, Ark., reports the Arkansas Advocate. 

Karla Adrian-Caceres filed suit on Jan. 17. Ms. Adrian-Caceres also named Brooke Green, Northwest Arkansas Hospitals, and 25 unidentified hospital employees as defendants.

According to the complaint, Ms. Adrian-Caceres, an engineering student at the University of Arkansas, arrived at the Northwest Medical Emergency Department after accidentally taking too many Tylenol on Jan. 18, 2022. She was then taken by ambulance to a Northwest psychiatric facility in Springdale, court records show.

According to the complaint, Ms. Adrian-Caceres said that she was given a sedative and asked to sign consent for admission while on the way to Northwest. She said that she “signed some documents without being able to read or understand them at the time.”

When she asked when she could go home, Ms. Adrian-Caceres said, “more than one employee told her there was a minimum stay and that if she asked to leave, they would take her to court where a judge would give her a longer stay because the judge always sides with Dr. Hyatt and Northwest,” according to court documents. Northwest employees stripped Ms. Adrian-Caceres, searched her body, took all of her possessions from her and issued underwear and a uniform, according to the lawsuit.

Ms. Adrian-Caceres’ mother, Katty Caceres, claimed in the lawsuit that she was prohibited from seeing her daughter. Ms. Caceres spoke with five different employees, four of whom had only their first names on their badges. Each of them reportedly said that they could not help, or that the plaintiff “would be in there for some time” and that it was Dr. Hyatt’s decision regarding how long that would be, according to court documents.

Katty Caceres hired a local attorney named Aaron Cash to represent her daughter. On Jan. 20, 2022, Mr. Cash faxed a letter to the hospital demanding her release. When Ms. Caceres arrived to pick up her daughter, she claimed that staff members indicated that the daughter was there voluntarily and refused to release her “at the direction of Dr Hyatt.” During a phone call later that day, the plaintiff told her mother that her status was being changed to an involuntary hold, court documents show.

“At one point she was threatened with the longer time in there if she kept asking to leave,” Mr. Cash told this news organization. In addition, staff members reportedly told Ms. Adrian-Caceres that the “judge always sided with Dr Hyatt” and she “would get way longer there, 30-45 days if [she] went before the judge,” according to Mr. Cash.

Mr. Cash said nine other patients have contacted his firm with similar allegations against Dr. Hyatt.

“We’ve talked to many people that have experienced the same threats,” Mr. Cash said. “When they’re asking to leave, they get these threats, they get coerced … and they’re never taken to court. They’re never given opportunity to talk to a judge or to have a public defender appointed.”
 

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